Dr. Len's Cancer Blog

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Dr. Len's Cancer Blog

The American Cancer Society

Prostate Cancer Surgery: Is The Robot Better?

by Dr. Len June 23, 2008

There is a revolution going on in prostate cancer surgery over the past several years since the introduction of robot assisted surgery in 2000. But the question that has not been answered to date in a meaningful way is whether or not all the hype about the robot is in fact born out by the evidence.

 

A recent article in the Journal of Clinical Oncology (JCO), along with an accompanying editorial, suggests that the advantages of the robot may be real in some respects, but may not be so great when it comes to the most important outcome, which is whether or not a man’s prostate cancer is effectively treated.

 

Where to get prostate cancer surgery is one of the more common questions I am asked by people who ask my advice. 

 

I find it interesting that men (usually with enough money to make the trip) will travel across the country to get robotic surgery by an “expert,” when a very competent and highly regarded prostate cancer surgeon is available in their home town.  The problem, these men tell me, is that Dr. So and So doesn’t use the robot, and they want the robot.

 

That’s part of the hype that can come along with any new procedure.  You learn as a doctor that sometimes what seems so new and special may not be so new and special after all.  Just more “space age,” more “gee whiz”, more “fancy.”  But not necessarily better.

 

I have asked some of my expert urology colleagues—the type that deal with urology related issues of national interest—who they think the best prostate cancer surgeons are.  They give me a list, and frequently these surgeons do the traditional “open” prostate operation.  They are not all using the robot.

 

When I ask my surgical friends why this is, they tell me very straightforwardly that having a robot doesn’t make up for the experience of a surgeon who does a lot of open prostate cancer operations.

 

Nonetheless, the medical arms race continues.

 

So what does the evidence say?

 

The JCO article looked at Medicare data from 2003 to 2005, and examined the claims records of about 2700 men who had either a robot-assisted surgery or a traditional open operation during that time.

 

They found that the men who underwent the robot procedure had shorter hospital stays after surgery (1.4 compared to 4.4 days) and fewer complications (29.8% vs. 36.4%).

 

However, the researchers also found that the odds of requiring further treatment within the 6 months after the surgery (meaning that the prostate specific antigen levels, a marker of complete resection of the prostate and possibly cancer containing tissue, didn’t fall low enough) was 27.8% for the men who had robotic surgery compared to 9.1% of the men who had the standard operation.

 

In plainer words, over 1 out of 4 men failed to get an adequate resection of their cancer with the robot compared to about 1 out of 11 men who underwent the open procedure.

 

The men who underwent robot surgery also had a higher incidence of strictures (scarring) of the urethra after the surgery compared to the men with the open procedure.  This meant more difficulty urinating and more chances they would have to undergo additional procedures over time which could result in further discomfort and a higher chance of incontinence.

 

One important cautionary note about these numbers is that the men who underwent robotic surgery tended to be older and had a higher number of other serious medical conditions, so one would expect they would be at greater risk of problems.  The study found just the opposite.

 

The study also found that there was a significant shift in urology practice over the two years of the study, with the percentage of men treated with the open procedure dropping from 82% to 66.1%, and the number of men treated with the robot increasing from 12.1% to 31.4%.   Clearly, the robot is catching the fancy of both doctors and patients.

 

This study wasn’t ideal, as the authors pointed out, since the information was gleaned from Medicare claims data.  There is a lot about these men that the researchers couldn’t determine, and this was not a randomized trial which hopefully would eliminate differences between the two groups.  That said, however, this is at least a study that gives us some idea of the differences in the benefits and risks of the two procedures.

 

The authors also point out that “open radical prostatectomy is preformed through a relatively small incision that is infrequently associated with significant pain”, and that length of sty in the hospital for the open procedure are relatively short, averaging 1 to 3 days at high volume referral centers.  “Nevertheless, many patients intuitively perceive minimally invasive approaches to reduce complications compared with conventional open operations and prefer them due to smaller incisions requiring less analgesics and shorter hospital stays even at greater costs.”

 

But you can’t ignore the recurrence data, which is significantly higher in the robot patients as well as the risks of becoming incontinent because of the strictures in the urethra postoperatively.

 

The authors also point out that doctors who do a lot of robotic surgery do have lower complication rates, fewer strictures and less risk of salvage therapy at 6 months.  The same, however, is also true for doctors who do a lot of open procedures.

 

What is the “right” number of surgeries your doctor should do in order to demonstrate they are good at either of these operations?

 

For robotic surgery, the paper says your doctor should have done at least 40 to 150 robotic surgeries before they do one on you.  They also say that in a recent survey, 37% of urologists “reported doing fewer than 11 radical prostatectomies per year, while 84% reported doing fewer than 31 per year.  Consequently, the learning curve may be extended for years.  Paradoxically, there is no formal certification process…Surgeons may perform the procedure after completing brief courses lasting 2 days or less.”

 

My friends, I urge you to ask your doctor about their qualifications and the number of procedures—both open and robotic—they perform a year and how many in their career.  If the answers don’t add up to a lot, then find someone who does have the experience you want and you need.

 

In an editorial published in the same issue of the Journal, a urologist from the Mayo Clinic points out that the numbers of complications in the “open” group is much higher than that seen in centers that do a high volume of the traditional radical prostatectomy, or open procedure.  The length of stay in these centers is also much less than that reported in this paper, on the order of two days as opposed to the four days reported in this study.

 

This doctor also points out that the long term recurrence and survival results from open surgery are well documented and well known, while similar statistics for the robotic surgery don’t exist since the procedure is so new.

 

He concludes, “Currently, open technique is the state-of-the-art procedure in experienced hands, as the long term results for (robotic surgery) do not exist.  The published literature fails to answer whether (robotic surgery) meets ‘quality standards.’”

 

So what do you do?

 

What this paper and my discussions with my experienced colleagues tell me is that robotic surgery remains an option for prostate cancer surgery, but it is only an option.  If you are going to drive down the street and pass by the world expert because they don’t do robotic surgery, I would think twice.  Experience clearly matters when you are having your cancerous prostate removed, and I suspect that a highly experienced surgeon who does open surgery is every bit as good as a highly experienced robot surgeon.

 

Just remember: the operative word here is “experienced.”

 

Which leads me to another observation, which I have also discussed with several colleagues recently.

 

Experience counts, as noted above.  The way you find out about experience is to ask the doctor how many procedures they have performed in a week, or a year, or in their career.  Increasingly, we hear back from people that when they ask their doctor how many of these robotic operations they do, the answer is frequently in the hundreds if not over one thousand.

 

I guess that’s possible, but some of us are beginning to question some of those numbers, especially from young doctors.  There simply aren’t enough prostates to go around.  Yes, the world experts have those kinds of numbers, but not a whole lot of doctors are world experts.

 

So when you hear a number, just keep in the back of your mind that there just may some “number inflation” going on here.  Unfortunately, there is no way for you to confirm the accuracy of a doctor’s reported experience.  Perhaps it is time for the hospitals—when they certify doctors to perform certain procedures—to determine accurately how many procedures of a certain type they have performed over the past year or so as part of the credentialing process.

 

One thing is clear, however, and that is if your doctor doesn’t do a lot of either type of operation, experts would advise you to find one that does.  This is simply a procedure where research has shown that “practice makes perfect.”

 

 

Ron Davis, MD: Followup

by Dr. Len June 19, 2008

For those of you who are interested, the American Medical Association has posted the video of Dr. Davis' speech on their website.

The URL is:

http://www.ama-assn.org/ama/pub/category/18187.html

Ron Davis MD: The Circle Of Life

by Dr. Len June 15, 2008

Imagine…

 

You are a physician in your 50’s.  You have devoted your professional life to public health, and are a recognized international expert on tobacco control.  You have been active in medical affairs from the beginning of your professional career, and you rise in stature in several leading local, state and medical organization.  You are highly regarded by your colleagues and your friends (many of whom fit both categories).  You lead a “good” life, doing everything right.  You have a wonderful family, devoted with love to each other.  You are reflective and admired for your accomplishments and your insights.  You have unusual level of humility for one who has achieved so much.

 

In June, 2007 you are inaugurated as the President of the American Medical Association and become the primary representative of the voice of medicine not only in the United States but in the world as well.

 

In March, 2008—while actively serving in your capacity as a leader of medicine, travelling the country, speaking in Washington, meeting with physicians and opinion leaders at the highest levels—you become ill.  You are diagnosed with Stage IV pancreatic cancer, and you know the outlook is not good.  You openly share your disease with your family, friends and colleagues around the world—and there are literally thousands of concerned people from all walks of life who care about this man.

 

Such is the real life story of our current President of the AMA, Ron Davis MD.

 

 Ron is a realist.  He has shared his journey openly on his care page.  He is not ignorant of his disease or its prognosis.

 

Yesterday afternoon, Ron Davis gave his last talk as the President of the AMA at the AMA’s annual House of Delegates meeting I am currently attending in Chicago.

 

I doubt there was any one of the over 1000 physicians, spouses and staff who relished the thought of hearing that speech.  I also doubt there was anyone who would have missed it.

 

Say what you will about doctors, the reality is that those of us who participate in the politics of medicine are a very committed group.  We may differ in our ideas, we may argue and disagree vigorously, we may never share the same points of view.  But there are few groups so devoted to each other in terms of our respect and our care for our colleagues in distress.

 

I have been interviewed frequently about the impact of cancer in celebrities, their prognosis, and what their impact can be on the public.  Peter Jennings, Patrick Swayze, Senator Kennedy and many more come to mind.

 

I always make the comment that, although celebrities and public figures are important in our national lives—they are still people.  And, they really serve as surrogates for so many others that have developed cancer and been treated for it.  They represent the hopes, the struggles, the successes and unfortunately the failures of all those who have had cancer make an unwelcome entrance into their lives.  So although they are highly visible, they are also very human like the rest of us.

 

Ron Davis is our celebrity.  This cancer thing shouldn’t happen to anyone, much less to someone like Ron who has done so much for so many, and done so much to commit to a healthy lifestyle for himself and his family.

 

But it did happen, and here we are, listening to someone who is one of us now going through chemotherapy to do what can be done to save his life, and reduce his pain and discomfort.

 

And here is, ready to give his final AMA Presidential speech.  What do you say, standing in front of a crowd whose prayers for the past 3 months have focused on your treatment and recovery?

 

The lights in the room dim, the sound comes up, and the “Circle of Life” video and opening song play through the hall.  And what you see—bald from his chemotherapy—is the same person who has always been there.  Looking well, speaking calmly, and focused on the issues.  Just as if nothing much was otherwise wrong in his life.

 

But something is very wrong in this life.  As Ron begins to speak, one wonders what tone and path this speech will take.

 

Traditionally, these “final speeches” focus on AMA policy successes over the past year, current issues that need to be addressed, and a hearty thank you to everyone who make the successful presidential year possible.

 

This speech would not be traditional.  Those in attendance knew it.

 

So bear with me as a provide excerpts from Ron’s speech, focusing on those topics

that may be of importance to some of you who either face or have faced a battle with cancer whether your own, or with someone you love or someone you know.

 

Remember that this is from a physician, who is now no longer just a doctor, but a man with a serious illness as well.  This is a man who has decided to fight his battle with cancer vigorously, publicly and while always moving forward with his responsibilities every day as a leader in medicine.

 

Read this and envision the laughter, and understand the tears.

 

“Legacies in the Circle of Life”

 

Opening Session of the AMA House of Delegates

Hyatt Regency Chicago

Chicago, Illinois

Saturday, June 14, 2008

 

Ronald M. Davis, MD

President

American Medical Association

 

 

Thank you so much.  Good afternoon.

 

I wanted to start out with that song, because “The Lion King” was by far the best stage play I’ve ever seen.  And that opening music reminds us that we all eventually will take a journey around that circle of life.  What’s important is what we accomplish on that path.  Leaving a good legacy is something each of us will eventually consider, some sooner than others.

 

This year has been the most eventful year of my life, in large part because I’ve had the privilege of being the president of this extraordinary organization.  And as those lyrics said, “There’s more to see than can ever be seen; more to do than can ever be done.”  I can’t think of a better job description.  It’s overwhelming.

 

It’s also been an eventful time because I was diagnosed earlier this year with pancreatic cancer.  And I want to thank all of you for your thoughts and prayers over these past few months.  They mean the world to me, and to my family.

 

Things were especially eventful a couple of weeks ago when my hair began falling out because of a toxic chemotherapy reaction.  I used to have a pretty decent head of hair.  Now, as you’ve seen, I have this new hairstyle.

 

It’s actually been kind of fun, to be honest with you.  I very briefly had a Mohawk, and an earring.  There’s evidence out there, somewhere.  And being bald is a medical reminder of our natural state of being.  It happens to those who age, and those who get sick.  We very often lose our hair, there’s simply no denying it.  But getting back to the circle of life, that’s how we came into the world as well.  Telly Savalas used to say, “We’re all born bald, baby.”

 

There’s another quote I actually prefer, from the Roman philosopher Seneca the Younger.  He said, “I don’t consider myself bald, I’m just taller than my hair.”  My wife Nadine’s favorite is that there are three ways a man wears his hair:  parted, unparted, or departed.

 

As a physician trained in epidemiology, I look for data to understand the effects of illness.  So I was happy to find a survey on HairBoutique.com in which more than 2,600 people answered the question, “What do you think of bald men?”  Of course, this survey does not meet the CDC’s standards for valid epidemiologic research.  But I was interested to read that the top response was, “Bald men are hot.”

 

I’d argue that there’s no profession as closely identified with the circle of life as is the physician.  Even before conception, we have those who specialize in Reproductive Medicine.  Then we have the OB/GYNs who administer prenatal care, and bring newborns into the world.  We have Pediatricians and Family Physicians who nurture our children.  The majority of physicians care for adults.  And then we have Geriatricians and physicians who specialize in Hospice and Palliative Medicine who take care of people in their twilight years.  So we physicians help people move through the circle of life.

 

++++++++++Content abridged++++++++++

 

I’d like to end with some personal comments about being a patient.

 

Of course, having a serious illness is not what I’d call fun.  But I’ve always been a cup-half-full kind of guy, so let me tell you about some of the good things that have come out of my experience.

 

First, getting back to this business about being bald.  My son Connor no longer tells me in the morning that I have “wacky hair.”  I didn’t have to pack a large tube of hair gel in my toiletry bag.  And when I was walking here in the Windy City a few days ago, I reached for the comb in my pocket, and then realized that I didn’t have one.  And I didn’t need it.

 

Also, people are giving me caps to wear.  Just a few days ago, a few AMA staffers gave me a collection of AMA caps, plus a cap to recognize my affection for Star Trek.  It shows a quote from Dr. Leonard McCoy, the ship’s physician in the original Star Trek series.  It says, “Damn it, Jim!  I’m a doctor, not an engineer.”

 

The caps come in handy because I’ve now realized, for the first time in my life, that it can get cold up there, especially when the air conditioning is blasting away.  And as we move into the hot summer months, the caps will help me avoid getting sun burns on my newly exposed scalp.

 

On a more serious note, I’ve learned about another noble cause, raising awareness about pancreatic cancer, and raising funds for research to improve treatment for this nasty disease.  Pancreatic cancer is the fourth leading cause of cancer death in the United States.  This year, more than 38,000 Americans will be diagnosed with pancreatic cancer, and more than 34,000 will die from it.  But pancreatic cancer research accounts for less than 2% of the National Cancer Institute’s research funding.

 

The Pancreatic Cancer Action Network (or PanCAN) is leading an effort to enact and fully fund a National Plan to Advance Pancreatic Cancer Research.  I’m very proud that our son Jared and many other members of my family put together a team of walkers who raised $25,000 for PanCAN at the PurpleStride Walk, right here in Chicago six weeks ago.  AMA staff and Michigan State Medical Society delegates and colleagues at Pfizer were among the major contributors to our team effort.

 

Another good thing to come out of my illness is that I’ve learned about a few essential ingredients in improving the quality and safety of health care, from the patient’s perspective.  In my president’s column in our “eVoice” newsletter two weeks ago, I wrote about the value of team care, and how it has benefited me.  I’ve had wonderful care from physicians representing many specialties, and from oncology nurses, registered dieticians, genetics counselors, and many others.

 

Of course some teams work well, and others do not.  So we must ensure that health care teams operate within a framework based on good communication, coordination, and cooperation.  I’ve seen breakdowns in communication, now from the view of an educated patient, that have led to several near-misses.  And so now I’m more convinced than ever before, that we must continue to intensify our efforts to improve communication, among our colleagues and with our patients, in order to prevent medical errors.

 

Another positive to come out of my illness is that family and friendship have been redefined for me.  It’s cliché to say this, but yes, a serious illness does force one to reexamine one’s priorities in life.  And I’ve been so very happy to be able to spend more time with Nadine and our three sons during these past four months.  A person cannot be president of the AMA without having incredible love and support back home.  And when you add the big “C” to the mix, that love and support become your lifeline.  So Nadine and Jared and Evan and Connor, I can’t thank you enough.

 

I’ve been so happy, as well, to reconnect in a more meaningful way with many members of our large extended families.  I’ve been happy to hear recently from friends and former classmates with whom I’ve had no contact for years, or even decades.  And I’ve been blessed to receive good wishes and prayers from many of you.

 

I’ve been asked several times, “What’s it like being a physician with your illness?  Does being a doctor help or hamper your situation?”

 

Well, here’s my answer:  A benefit of being a physician is that I understand what’s happening to me.  But a disadvantage of being a physician is that I understand what’s happening to me.

 

As a physician, I know the survival statistics for someone with stage 4 pancreatic cancer.  But if the five-year survival is 5%, that’s not zero.  And as someone with relative youth, good functional status, outstanding health care, love and support from family and friends, and a thirst for life that feeds into a strong mind-body connection, then who knows what the future holds for someone in my situation.  So never take away someone’s hope.

 

And there’s one more ingredient to add to that equation, and that’s faith and spirituality.  Through the years I have not had a strong religious faith.  But since my diagnosis, it has been rekindled.

 

Dr. Ed Langston, chair of our AMA Board of Trustees, pointed me toward Proverbs 3:5:  “Trust in the Lord with all your heart and lean not on your own understanding.”  Applied to my situation, it seems to say that I should ignore the statistics on the prognosis for pancreatic cancer, but instead put my faith in God.  And so, Nadine and I have prayed together several times, asking for God to help my chemotherapy to work, and for Him to heal me, and to give strength to my family in dealing with this situation.  And so I count that rekindling of faith as another positive that has come out of my illness.

 

The last benefit of my illness that I’ll mention is that it has helped me to appreciate, and to teach others about, the value of patient websites, such as those on CarePages.com and CaringBridge.com.  Many of you have been reading the updates I’ve posted on my own CarePage.  These websites make it easy for patients and their families to share information, to receive good wishes and prayers, and to build a community of support.  I’m pleased that the Associated Press ran a story last Monday about patient websites, and I encourage physicians to educate their patients about this therapeutic tool.

 

When I’ve experienced pain from my cancer, or nausea from my chemotherapy, my physicians and nurses have often asked me to rank that pain or nausea on a one-to-ten scale.  Part of the reason for that, as you know, is to assess my response to treatment, and the effectiveness of anti-nausea and analgesic medication.  Hearing this, my wife began to ask me the same question:  “How’s that Compazine working?  How bad is the nausea now?  What’s the number?”

 

Well, I got tired of saying two, or three, or four.  So at one point, I said, “I’d put my nausea at Pi.”

 

She said, “What?”

 

I said, “You know, the Greek letter Pi.  3.14159. That’s where my nausea is right now, on a one-to-ten scale.”

 

Pi, as you know, is connected to the circle in a fundamental way.  It’s the ratio of the circumference of a circle to its diameter.

 

What got me thinking about Pi was a book I’d read recently by Daniel Tammet, entitled “Born on a Blue Day.”  Tammet, a 27-year-old Briton, described his life as an autistic savant with Asperger syndrome.  His functional level was not only good enough to allow him to write a compelling autobiography, but also enabled him to establish the European record for reciting Pi to 22,514 digits.  He did so on March 14, 2004, as a charity event to raise funds for epilepsy, a condition he experienced as a child.

 

So what’s Daniel Tammet’s legacy?  I think, in part, it’s to remind us how extraordinarily powerful the human mind is.  To remind us that anything is possible, as we contemplate what legacy we want to leave.

 

If a person with autism can recite Pi to more than 22,000 digits, we ought to be able to figure out why some cancers are so amenable to effective treatment, while others are not.  We ought to be able to figure out how to get more of ourselves and our patients to live a healthy lifestyle.  We ought to be able to figure out how to get off the SGR hamster wheel.  And we ought to be able to figure out how to provide health insurance to all Americans.

 

There’s one thing that we may never be able to figure out, and that’s how I had the good fortune to become the President of the American Medical Association.  I’ve been humbled with the privilege of representing the healers of this nation.  I’ve been one of your designated advocates with the leaders of our government.  You put me in a unique position to try to make lives better for both physicians and patients, all across this country.

 

So thank you.  Thank you all, for your part in this great association.  Thank you for your help in our achievements during this last amazing year.  And thank you for your friendship, as we continue our journeys through the circle of life.  God bless you all.

 

 

+++++++++++++

 

 

My friends, this is an extraordinary man in ordinary circumstances, living with cancer. I admire Ron Davis, and share that admiration with many of his friends and colleagues.

 

I hope you understand why I wanted to share his thoughts and his perspectives with you, and hope that in his words you will find—like I did--some humor, some laughter, some hope, some reality and some understanding.

 

Perhaps you will even see a bit of yourself as you pass through your own circle of life.

 

 

++++++++++++

 

Editorial note:  I know this is a very long blog entry.  But I made the decision to include as much of the speech as possible and relevant.  I hope you agree that was the right choice.

 

This is the link to Dr. Davis' entire speech (including his comments regarding AMA specific activities):

 

http://www.ama-assn.org/ama/pub/category/18670.html

 

6/19/08:

 

The video is now posted on the AMA website:

 

http://www.ama-assn.org/ama/pub/category/18187.html

 

 

 

When Disaster Strikes...

by Dr. Len June 14, 2008

Having cancer is difficult enough.  Getting treatment is even more stressful.  But imagine having cancer, being in the midst of treatment, and having a natural disaster to deal with at the same time.

 

That’s the situation cancer patients and their families are now facing in many parts of the Midwest as heavy rains result in flooding in small and large communities to a degree not seen for many years.

 

I suspect that many of you have your own ideas about who the American Cancer Society is, and what we do.  But what you don’t see is the incredible staff spread throughout this great nation, many of whom work in large and small communities alike, including those now finding themselves struggling as a result of this natural disaster.

 

One of the things that makes me proud to be part of this organization every day is the incredible commitment of my colleagues at all levels to helping patients with cancer. 

 

That spirit of concern and commitment was evident in an emergency call convened this morning by our Midwest division staff to get updates on the current status of the communities and states that have been impacted by these floods and, more importantly, put actions into place that will help cancer patients and their families.

 

First, there were the updates from the people “on the ground”.  The reports were not good.

 

Stories of floods encroaching beyond what has been seen previously.  Hospitals being evacuated.  Electricity interrupted, and treatment programs in jeopardy.  Long highway detours—in some cases hours in length—to get to treatment.  No place to stay, since the hotels are booked.

 

So people come together, and resources are mobilized.  Problems and needs are identified, and solutions are developed.

 

That in essence is what my colleagues are doing right now in our Midwest Division.

 

For example, take our patient navigator program.

 

Over the past couple of years, the American Cancer Society has placed patient navigators in selected hospitals throughout the country.  The program was developed to help patients and their families navigate the difficult paths through their cancer treatment, or offer help when patients with cancer are hospitalized.

 

I don’t know that anyone envisioned that those navigators would become a first line of defense, so to speak, when tragedy strikes.  These are people who live in their communities, work in the hospitals and clinics and are viewed as a resource by patients and their families.

 

Now, they are becoming a resource for those same patients and families who have been displaced as a result of these floods.  Trying to help patients figure out not only where they need to go for treatment, but how to get there—and how to pay for it.  For some, they are responding to the calls despite their own personal and family difficulties posed by these floods.

 

So as this disaster takes its form, and as everyone affected tries to get their arms around the extent of the damage and how to cope with it, we have staff and volunteers who live in these areas--along with their colleagues in our national home office--working to develop resources to help. 

 

If you are a patient with cancer who lives in the areas hit by these floods, and you need help, call us at 800-ACS-2345.  Our cancer information specialists are available 24 hours a day to take your call and help you get information and assistance.

 

Over the next several days, you can anticipate that additional resources will be put into place, and I will update our progress with short notes on this blog.

 

In the meantime, I remain so proud of my colleagues, this Society and the volunteers who work with us and support us.  The concern and commitment that I heard today on that phone call was palpable. 

 

I know my colleagues’ work didn’t stop when we hung up the phone this morning.  They will be working all weekend and throughout next week doing what they can to ease the suffering of those who need their help, sometimes even ignoring their own personal circumstances in order to provide help to others.

 

I know that the American Cancer Society is not alone in its efforts.  When tragedy of this magnitude strikes a part of this country, it strikes all of us. 

 

Knowing that there are people who care and are there to help somehow makes a difficult day just a bit brighter.

Filed Under:

Cancer Care | Treatment

Off-label Drugs And The Little Rooms

by Dr. Len June 03, 2008

There is a recurring question I simply cannot get out of my mind as I am flying back from ASCO’s annual meeting in Chicago: “What the heck goes on in ‘the little room?’”

 

The little rooms, my friends, are the sound-proofed spaces that are an intrinsic part of many of the drug companies’ booths on the ASCO convention floor. 

 

From what I can tell, they must be part of another sovereign country. 

 

As a physician licensed in the United States, I am forbidden from going into the little room.  And I do mean forbidden. Very pleasant young women and men will forcibly prevent me from entering if I don’t have a convention badge that designates me as a physician from a country other than the United States.

 

What goes on in these little rooms? 

 

That’s where the pharmaceutical companies can have discussions about off-label and new uses of drugs for the treatment of cancer. 

 

Bottom line, my international physician colleagues can hear about these new drugs for cancer treatment, but I cannot.  I am forbidden to have access to that information.

 

This might give you pause as well:

 

I was told by one source that the United States Food and Drug Administration (FDA) actually has “secret shoppers” that roam the floor of medical conventions such as ASCO in an effort to trap the drug company representatives into making a mistake and talking about off-label drug use within hearing range of an American oncologist or saying anything that should not be said.

 

If I ask them a question about an off-label drug, the pharmaceutical representative can ask me if I am an FDA gumshoe.  If I was an FDA representative looking for bad behavior, I would have to answer yes.  That would call off the “sting.”  Sounds to me like a different kind of undercover drug information request.

 

I kid you not.  You simply cannot make this stuff up.

 

What makes this even more problematic is that I would guess many of the treatments given to cancer patients today by their medical oncologists are actually “off-label.”  For the most part, cancer treatment in the United States is indeed “off-label.”  But you won’t get much help from anyone outside the little room.

 

What does “off-label” mean?

 

When a new drug comes to market, it does so after extensive research in the lab and the clinic.  If the drug successfully treats a cancer, the company applies to the FDA to market the drug in the United States.  If the FDA approves the drug, then it does so for the specific cancer that was studied, and at the doses and regimens studied in the trial.  That then becomes the “labeled indication.”

 

When a drug is approved, the drug company can then market that drug to doctors, but they must do so only for the approved indication.  They are free to discuss how the drug works, how to administer the drug, what the side effects of the drug may be, and so on but only for that specific disease.

 

But many of these drugs are actively and appropriately used in the treatment of other cancers. 

 

Doctors continue to research the use of the drug beyond its original indication, and they may find the drug works in different cancers or maybe at different doses than originally approved.  Then they publish their results in medical journals.  But these do not necessarily become “approved uses” since the drug companies don’t or can’t afford to make the investment to go through the FDA process to get approval for that specific new indication supported by published research in peer reviewed journals.

 

Take Avastin (bevacizumab) for example.  This drug is approved for the treatment of colon cancer, lung cancer and most recently breast cancer.  Those are “approved indications.”

 

But Avastin appears to be effective in other cancers as well. 

 

Given the current prominence of brain tumors in the media, I would offer the treatment of brain cancers as another form of cancer where Avastin appears to be effective.  In fact, the National Comprehensive Cancer Network’s Drug and Biologics Compendium, which assesses off-label and on-label use of drugs includes brain cancer in its list of appropriate off-label indications for Avastin.

 

So let’s say I am a doctor who is interested in using Avastin for the treatment of my patients with recurrent glioblastoma multiforme, a very aggressive and lethal form of brain cancer with a very poor outlook.

 

I come to the ASCO meeting, and go over to the manufacturer’s booth where there are clinical experts who know something about the research on that drug.

 

I ask the experts from the company, “Tell me about using Avastin in brain cancer.  My patient is dying and I would like to help them.”

 

The quick answer: they can’t answer my question.

 

So I rephrase my question, “Do you have any information about current clinical trials using Avastin for brain cancer?”

 

Now the expert can tell me about the trial and the doses of Avastin in the trial, and what other drugs are being used in those protocols.

 

So, I ask for some scientific literature, perhaps an article that has been published in a leading medical journal.

 

Absolutely not.  Can’t do it.  Go find it yourself.  That is an off-label indication and we can’t give you any literature on this drug’s use in brain cancer to help you and your patient, even though they are dying.

 

And, by the way, if I ask the specific question above, the people who talk to me—by law/regulation—have to answer my question out of earshot of any other United States licensed physician, lest they too might hear information about using Avastin in the treatment of their dying patient with brain cancer.

 

Get the picture????

 

However, if I am a physician from, let’s say for example, Iran or Iraq, they can take that doctor into the little room and safely tell them all sorts of things they can’t tell me.

 

Sounds like that little room is part of a sovereign country on United States soil, sort of like an embassy.  I’m surprised they don’t have the Marines guarding the entrance.  But they’ll just have to rely on the secret FDA police circulating the convention floor to protect us doctors from ourselves.

 

My government is happy, the foreign doctors are happy, the drug companies are following the rules, and my patient is dying.

 

I know there are reasons for these rules, and I know there is some effort afoot to try to make them more reasonable.  But the scenarios I outlined above are real, and multiplied many, many times over during the course of this recent ASCO meeting and any other medical meeting that occurs on United States soil.

 

A couple of weeks ago I participated on a program panel hosted by the American Enterprise Institute (AEI) in Washington, DC.  The topic was off-label drugs, with an emphasis on oncologists and how they prescribe off-label.

 

The AEI is a well-known conservative think tank, and they are very concerned about the effects of off-label issues, especially regarding cancer care.

 

One of their staff, Dr. Scott Gottlieb, has written on this subject and also spoke at this meeting.  He described the issues faced by women and their doctors when Herceptin was reported to be so effective in reducing the recurrence of breast cancer in women at high risk.

 

Dr. Gottlieb believes that the off-label prohibition about talking to doctors prevented many women from receiving this truly life-saving therapy as quickly as possible.   He maintains that if the data was so compelling, and if the drug companies had been permitted to ethically spread the word around the country, then lives that have been lost would have otherwise been saved.

 

I don’t know that I completely agree with Dr. Gottlieb’s contention regarding Herceptin, since there was so much publicity about the drug that an oncologist would have had to be under a rock not to have heard about the stunning results.  In fact, I blogged about some of the off-label issues surrounding Herceptin and its use in the United States compared to Europe back in May 2006.

 

But Dr. Gottlieb has a point, and the little room is one more extension of how the best-intended rules and regulations can result in bizarre situations.

 

We need to take a very careful look at how we deal with off-label indications and drug promotion through pharmaceutical companies.

 

Yes, they are not innocent participants.  They have drugs they want to sell, and they want to make profits.

 

But no one should have to face jail time or have the very viability of their company threatened because I asked the wrong question and someone cared enough to provide me information which may save the life of my patient.

 

With all of the new drugs coming down the pipeline, and the inevitable fact that many of these drugs will have research reports published in highly-regarded scientific journals long before the FDA can approve them, it’s time we figured out how to take the conversation out of the little room and move it into the mainstream. 

 

After all, I don’t like being treated like a second-class, lawbreaking citizen in my own country just because I want to help my patients.

Filed Under:

Cancer Care | Medications | Treatment

Chemotherapy: The Right Drugs At The Right Dose

by Dr. Len June 02, 2008

Did you ever wonder how your oncologist knows which drugs to give you at what doses if you are receiving chemotherapy?  Or how they stay up with the latest chemotherapy recommendations for the treatment of your cancer?

 

This is actually a very important question, and one that has intrigued me for many years.

 

After all, our knowledge about cancer treatment is constantly increasing.  There is no way the typical physician can stay abreast of all there is to know about chemotherapy recommendations for all the different types of cancers.

 

That’s why I find the recent release of “chemotherapy order templates” by the National Comprehensive Cancer Network (NCCN) so interesting. 

 

Determining the right regimen and the right doses of chemotherapy drugs is not a new problem.  When I started practice in 1977, it became evident to me and others that staying up-to-date with the latest chemotherapy treatment options was difficult.  And that was at a time when we had nowhere the number of drugs and regimens that we have today.

 

But the problem was more than just one of knowing the drugs and the doses.  Research at the time showed that many physicians—especially those treating patients in community practices—didn’t give the same doses of drugs that had been shown to be effective in the original clinical trials.

 

The implications of that research were substantial.  We didn’t have much that worked, but when it worked it could cure patients.  But if you didn’t give the right doses, or wanted to have your patients avoid some of the more severe side effects, then the impact would be that the patient wouldn’t have the benefit of a proven chemotherapy program. 

 

The chemotherapy may have cured patients in a research program, but wouldn’t save a life elsewhere if the drugs weren’t given as recommended.

 

Now, our knowledge about cancer treatment has increased many times over.  Even here at the annual meeting of the American Society of Clinical Oncology currently underway in Chicago, there are over 11,000 published abstracts.  Many of these deal with new drugs and new treatment regimens.

 

When I talk to my colleagues in practice, I hear them expressing concerns about the variability of chemotherapy programs administered by doctors not only in different practices but even within the same practice.

 

Some doctors feel that it is ok to change a regimen from that reported in the original study.  They may want to give a drug on a different schedule or different dose than that which produced the best results when studied as part of a clinical trial for the treatment of a particular cancer.

 

In short, there is little validation that the chemotherapy treatment regimens given by different doctors across the country meet some sort of standard. 

 

I do know of practices where the physicians in the practice will get together and agree on how they will treat particular cancers.  But many times I suspect that doesn’t happen.  And, you as a patient have no way to know.  Why would you ask?  You make the assumption that your doctor is adhering to evidence based recommendations.  But we don’t know that for certain.

 

I recently wrote about the work done by NCCN, especially in the area of cancer treatment guidelines.

 

Now, NCCN has published chemotherapy order templates for a number of cancers which provide the oncologist with a recommended chemotherapy treatment program that has met the test of review by nationally and internationally recognized experts in a particular cancer.  According to NCCN, these chemotherapy templates enhance patient safety by helping doctors to standardized patient care, reduce medication errors and anticipate and manage side effects.

 

Interestingly, the guidelines incorporate recommended treatment regimens that include “off label” uses of chemotherapy drugs, where research has shown that drugs are effective but have not yet been approved by the Food and Drug Administration for use in a particular cancer. From my view, much of cancer chemotherapy is “off label” care, so this resource is especially important.

 

In my personal opinion, I think that this is a good idea which has been a long time coming.

 

As physicians, we always should preserve the obligation to adjust treatment programs based on our judgment and individual need.  But, for the most part, we should assure our patients that the treatments they receive comply with some sort of recognized, nationally accepted standard.

 

There are additional implications and applications for this NCCN program.

 

As chemotherapy and targeted therapies become more expensive and perhaps more complicated, those who pay the bills are going to become more concerned that the treatments they pay for are the appropriate treatments.  They are going to look less and less kindly on someone getting very expensive therapy that has been “customized” by their doctor without an evidence basis to make those customizations.

 

I can envision a world where we have electronic medical record systems that provide this type of information, and validate the drugs and the doses that the doctor prescribes.  If we could do this, then patients and insurers alike could get their arms around a significant quality issue. 

 

I also think that there would be value for physicians to participate in this type of quality effort, perhaps through increased reimbursement which would acknowledge their commitment to quality medical care.

 

Our world is changing, and is becoming more electronic.  Quality of care is drawing the attention of many parties involved in medical care.  Using electronic records, we now have relatively simple, seamless technology to verify for all to see that what we are doing is consistent with good medical practice.

 

It is time for us to acknowledge that at the heart of cancer care is the need to be certain that we are treating our patients within the parameters of a recognized standard.  The NCCN chemotherapy template program moves us one step further down that path.

 

 

Filed Under:

Cancer Care | Medications | Treatment

Cetuximab In Lung Cancer: A Small Step Forward

by Dr. Len June 01, 2008

A study being presented this afternoon at the plenary session of the American Society of Clinical Oncology (ASCO) annual meeting reports on the success of cetuximab (Erbitux) on improving survival for patients treated for advanced non-small cell lung cancer.

 

Cetuximab is a drug which was found several years ago to improve the response to treatment for patients with advanced colorectal cancer, and more recently in advanced head and neck cancer.

 

Today's report suggests that by using cetuximab in addition to chemotherapy, the outlook for lung cancer patients may be a small bit brighter.  The improvement in survival may be limited, but it is a step in the right direction.

 

Cetuximab targets a receptor on cancer cells called epidermal growth factor receptor, or EGFR.  We can actually study tumor samples and determine whether or not EGFR is present.

 

In colon cancer, when the drug was first approved, it was recommended that only patients who had EGFR found in their cancer should receive this drug.  Subsequently, researchers determined that the presence or absence of this marker didn’t make much difference whether or not cetuximab improved the outlook of these patients.

 

Today’s report looked at whether or not adding cetuximab to standard chemotherapy for advanced non-small cell lung cancer (NSCLC) improved survival.

 

As you probably know, lung cancer is common in men and women and accounts for an estimated 161,840 deaths in the United States this year according to American Cancer Society statistics.  It is the leading cause of cancer death for both men and women.

 

NSCLC is the most common form of lung cancer, accounting for 85-90% of all lung cancer diagnoses according to information supplied by ASCO.  ASCO also notes that over 80% of NSCLC cases have the EGFR receptor, and with advanced disease—which is the way most people present with this cancer—the one year survival is 30% and the five year survival an unfortunately low 1%.

 

Prior trials of EGFR-directed targeted therapies in NSCLLC have shown no benefit in the primary treatment of NSCLC.  This is in contrast to the positive benefit of bevacizumab, or Avastin, in the treatment of some forms of NSCLC.  However, bevacizumab focuses on a different target, called vascular endothelial growth factor or VEGF.  This target promotes blood vessel growth in cancer cells.

 

In today’s presentation, the researchers treated 1,125 patients in 30 countries.  They randomly assigned half the patients to receive just the chemotherapy (cisplatin and vinorelbine), and half the patients received the standard chemotherapy with the addition of cetuximab.

 

The results showed a significant improvement in survival for the patients who received the standard chemotherapy with the addition of cetuximab.  Those patients had a median survival of 11.3 months, compared to a survival of 10.1 months for patients who received only chemotherapy (median means half the patients lived less than the number of months noted, and half the patients lived longer).

 

Benefits were seen across all of the different types of non-small cell lung cancer (including squamous cell lung cancer and adenocarcinoma).  The most common side effect related to Cetuximab was a skin rash, which is similar to what is seen when patients with other types of cancer are treated with this drug.

 

However, the authors also reported that Asian patients did not benefit from the use of cetuximab.  In fact, for Asian patients with NSCLC, their survival was less when treated with the addition of Cetuximab to chemotherapy, compared to chemotherapy alone (17.6 vs. 20.4 months).  However, during the actual presentation, the researcher noted that there were several possible explanations for this discrepancy, and that no conclusions could be drawn regarding the effects of cetuximab in the Asian patients treated with this drug as a result of this study.

 

The net result is that the typical patient with advanced NSCLC treated with chemotherapy and Cetuximab gains an additional 1.2 months of life, or about 36 days.

 

This may not seem like much but in the history of treating NSCLC, this is a significant benefit.  (We need to remember that this applies only to the 80% of NSCLC patients who are EGFR positive, and not to the remaining 20% EGFR negative lung cancer patients who were not included in this study.)

 

Gains in cancer survival are made in small steps over a long time.  The best example I usually offer is colorectal cancer, where patients with advanced disease had a 6 month median survival in the early 1970’s and now have a median survival approaching 2 years.  This was the result of small improvements over many years.

 

What this study offers us is another option to offer many of our patients.  However, we obviously have a long way to go in improving the treatment of patients with NSCLC.

 

And, if you ask whether combining the targeted therapies of cetuximab and bevacizumab in the treatment of patients with NSCLC (except squamous cell cancers, where bevacizumab can cause severe bleeding in the lungs) may offer even more benefit to patients—since they target different targets—then I would suggest you are asking just the right question.

 

Time will tell, but I suspect that we will continue to see incremental benefits in the treatment of many different forms of cancer using targeted therapies. 

 

As this study demonstrates, our ability to measure unique tumor characteristics (such as the presence of EGFR in this study) will increasingly guide our ability to effectively improve the outlook for patients with different types of cancers.

 

++++

Please note: this report was updated on Sunday, 6/1/08 at 4:48 just after the presentation was completed.  The text added was a comment regarding the implications of the data for Asian patients.

 

Filed Under:

Lung Cancer | Medications | Treatment

Finding New Treatments Where You Don't Expect Them

by Dr. Len June 01, 2008

It is always fascinating to learn about a new cancer treatment that essentially comes out of nowhere and ends up helping to improve the lives of patients with cancer.

 

Such is the story of zolendronic acid, commonly known by the trade name Zometa.  This drug—which was originally developed and used to prevent the destruction of bone in cancers that can spread to the bone and more recently has been approved to treat osteoporosis—has apparent direct anticancer treatment benefits in breast cancer.  The study is being reported this afternoon at the annual meeting of the American Society of Clinical Oncology.

 

Working with Zometa, researchers recognized that the drug had other actions beyond its impact on the bone to prevent destruction from cancer cells. 

 

They found in the laboratory that Zometa reduced the ability of cancer cells to travel through the body, improved immune responsiveness, prevented the growth of new blood vessels in cancer tumors (anti-angiogenesis), increased the effectiveness of other anti-cancer drugs and led to cancer cell death.

 

The next step was to take these discoveries in the lab and apply them to the treatment of cancer patients. 

 

So, the researchers designed a clinical trial to answer this question.  In this trial, they focused on pre-menopausal women with primary breast cancer that was hormonally sensitive.

 

All of the women—who were premenopausal—were treated with a drug called goserelin, which is designed to stop the ovaries from making female hormones, and effectively making the women post-menopausal. 

 

Half of the women were then assigned to treatment with tamoxifen, which is a long-used anti-estrogen drug.  Tamoxifen is the standard treatment for pre-menopausal women with breast cancer who have hormonally sensitive tumors.  The other half of the women were treated with a newer drug called anastrozole, which is in a class of breast cancer drugs called aromatase inhibitors.  These drugs block conversion of estrogen precursors in the blood to estrogen.

 

Aromatase inhibitors can only be used in women who are post-menopausal and have hormone sensitive tumors.  They can also be used in pre-menopausal women who are treated with goserelin, which as noted above basically makes these women post-menopausal (when I started practice in 1977, we used to do oophorectomies to achieve the same effect, but that is no longer done since we have medicines like goserelin).

 

The researchers then took each of the groups and divided them in half once again, treating half the women in the tamoxifen group with Zometa and the other half no further treatment.  The same plan was put into place for the women treated with anastrozole.

 

The end result was that all of the pre-menopausal women with primary breast cancer were treated with goserelin, one half got either tamoxifen or anastrozole alone, and one half got either tamoxifen with Zometa or anastrozole with Zometa.

 

About 1800 women were treated in this study.  Median follow-up was 5 years (which means half of the women were followed less than 5 years, and half were followed for more than 5 years).

 

The researchers then measured how long it took for the breast cancer to return, or whether it returned at all.

 

The results showed that the women treated with just tamoxifen or anastrozole had equal outcomes in terms of their disease free survival.

 

But, when Zometa was added to either treatment, the recurrence rate dropped by a little more than a third.  This is what we call the “relative benefit.”

 

It is still too early to find a difference in improved overall survival when comparing the women treated with Zometa compared to those who received just tamoxifen or anastrozole.

 

Said another way, 9% of the women treated with just goserelin plus tamoxifen or anastrozole had their breast cancer return, while women who received the same treatment with the addition of Zometa had a 6% recurrence rate.  What we call the “absolute benefit” was about 3%. 

 

That means for every 100 pre-menopausal women with primary breast cancer treated with the addition of Zometa, 3 women would avoid a recurrence of their breast cancer.

 

Why is recurrence so important in breast cancer? 

 

Simply, when breast cancer recurs it is no longer curable.  The major goal of the primary treatment of breast cancer with surgery, radiation and/or chemotherapy and/or hormonal therapy is to prevent that cancer from coming back in the first place.  Reduce the recurrence rate, and you improve survival.

 

A 3% decrease in the risk of breast cancer recurrence does not sound like much.  But as I have mentioned many times before, much of our progress in cancer treatment is based on small increments which, when looked at over time, add up to substantial improvements.

 

Basically, improve cancer treatment a bit here and improve a bit there and sooner or later you accumulate a lot of those bits and they become something significant that impacts patients’ lives.

 

What is especially important about Zometa treatment is that it is a reasonably quick intravenous injection given once every 6 months without a lot of side effects.  So you end up getting an improvement in outlook without a lot of the side effects or inconveniences associated with many cancer treatments.

 

Not everyone agrees that we should start treating women with this regimen right away.

 

Here in the United States, pre-menopausal women with hormonally sensitive breast cancers will almost always get intravenous chemotherapy as part of their primary adjuvant therapy. 

 

That was not the case in this European study, so we really can’t say for sure what the impact of Zometa would be the treatment programs commonly offered to women with primary breast cancer here in the United States.

 

For now, these results have to be considered in the context they were presented: an interesting, well-done, intriguing study that deserves further evaluation. 

 

We need a clinical trial incorporating Zometa into the typical current treatment regimens in the United States.   We also need to compare the hormonally based European approach to the chemotherapy/hormone therapy based approach common in this country.

 

I suspect that many women with breast cancer are going to have discussions with their oncologists about this report.  There is no clear answer whether or not they should receive Zometa, but the opportunity to improve survival at little inconvenience with few side effects is certainly something that many women and their doctors are going to consider.

 

 

Vitamin D And Breast Cancer Redux: Caution Ahead

by Dr. Len June 01, 2008

A couple of weeks ago, I wrote a blog about vitamin D deficiency and its impact on breast cancer recurrence.  The information was based on an abstract that had been released in advance of the American Society of Clinical Oncology’s annual meeting, currently underway in Chicago.

 

In that blog, I reported on the conclusions of the researchers from the University of Toronto, Canada, that outcomes for women with breast cancer were worse if they were vitamin D deficient at the time of diagnosis, compared to women who had sufficient amounts of vitamin D in their blood.

 

Yesterday, the researchers presented their paper at the ASCO meeting.  And that presentation emphasized the fact that what appears in an abstract is not always the whole story.

 

The basic results reported at the meeting were essentially the same as those in the abstract.  Adequate levels of vitamin D in the blood of newly diagnosed breast cancer patients were associated with a less aggressive cancer and a better prognosis.

 

But there were two important points that were made that were in fact different from what was in the abstract or weren’t in the abstract at all.

 

First, during her presentation, Dr. P.J. Goodwin, who was the lead author on the study, commented that unlike what was printed in the abstract about the vitamin D relationship only pertaining to women with hormonally sensitive (estrogen receptor (ER) positive) breast cancers, in fact the study data showed that higher vitamin D levels were associated with an improved prognosis of all women with breast cancer—whether or not their cancers were hormonally sensitive.

 

That is an important point, since ER negative breast cancers—although representing a minority of breast cancers—are known to be more aggressive.  If vitamin D levels didn’t influence their prognosis, then that would represent one more negative differentiating factor for women diagnosed with these tumors.

 

Another interesting corollary—although not addressed specifically in this abstract presentation—is the fact that recent research has shown that African American women have a greater proportion of ER negative breast cancers. They also have more aggressive disease, with presentation at younger ages and with higher mortality compared to white women.  (It remains unclear how much of this difference is related to biology vs. lack of access to affordable, adequate health care.)

 

African Americans are also known to have a greater prevalence and degree of vitamin D deficiency.

 

If that is the case, then there is an intriguing question of whether or not there is a link here.  If we addressed vitamin D deficiency in African American women, could we reduce their risk of developing ER negative breast cancers, and improve their prognosis once diagnosed?

 

The second point that was presented in yesterday’s session was not addressed in the printed abstract.  Yet, in my opinion, it is possibly one of the most important observations regarding vitamin D being used to decrease the risk of cancer.  It is critical to assessing  the claims of many researchers and others that vitamin D supplementation is not toxic, and that we should be routinely recommending large doses of vitamin D through supplements or UV exposure to prevent cancer.

 

Dr. Goodwin showed a slide which looked at mortality in the women who participated in this study, based solely on their measured vitamin D levels.  (Unfortunately, I have not been able to get hold of a copy of this slide.)

 

The finding as reported, from my point of view, was unexpected and certainly should provide us with a sense of caution as we pursue to question of vitamin D as a cancer prevention agent.

 

The slide showed death rates over time as a function of vitamin D levels in these women with newly diagnosed breast cancer.

 

As would be expected, increased deaths were seen with low levels of vitamin D.  That in large part was due to increased deaths from breast cancer.

 

As vitamin D levels in the blood at the time of diagnosis increased, there was a fall-off in deaths, again probably due to fewer deaths from breast cancer.

 

But then there was the unexpected finding that as vitamin D levels increased, death rates increased as well.  That should not have happened from breast cancer, since the data was clear that higher levels of vitamin D were associated with better prognosis.  So something else was leading to more deaths than expected.  (For the scientists among you, this is what we call a “U” shaped mortality curve—increased deaths at the upper and lower limits of the measured variable, with a low level in the middle.)

 

What Dr. Goodwin reported was that there essentially was a “sweet spot” for blood levels of vitamin D that maximized its benefit with respect to breast cancer, while minimizing harm.  But the data also suggests that increased levels of vitamin D were in fact potentially harmful.

 

Dr. Goodwin mentioned that she did not know why this happened, and that it merits further research as to the cause as well as careful evaluation in upcoming studies.  She cited prior research that has suggested higher blood vitamin D levels may be associated with an increased number of cardiac events.

 

In any event, this is the first time I have heard of a potentially harmful relationship of this type, implying that we should be cautious before we recommend megadoses of vitamin D for women for the prevention of breast cancer, or as part of their treatment.

 

So what are the lessons?

 

First, what we see in print in an abstract is frequently never the whole story, and we don’t have the “final word” until a study is actually published in a peer review journal.  Even then, research studies are always subject to further discussion and scrutiny.

 

In this situation, the abstract said the benefits of higher vitamin D levels were limited to women with ER positive cancers.  In the presentation yesterday, we heard that women with both ER positive and ER negative breast cancers who had higher levels of vitamin D in their blood had better prognoses.

 

Second, there may be harm with having too much vitamin D in the blood.  This is very much a preliminary observation, and clearly needs more study to help us understand if this is a consistent, real finding. 

 

As I have noted before, we must always approach new ideas with caution.  We need to do the appropriate research to demonstrate both the benefits and the risks of vitamin D before we make recommendations for millions of people.

 

Only then can we have the confidence that the recommendations we are making are backed by the strongest and best scientific studies, and won’t result in more harm than good.

Filed Under:

Breast Cancer | Prevention | Vitamins

About Dr. Len

Dr. Len

J. Leonard Lichtenfeld, MD, MACP - Dr. Lichtenfeld is Deputy Chief Medical Officer for the national office of the American Cancer Society.

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