Cancer studies often downplay chemo side effects: study

Quoting from cp's link:

In fact, a fifth of the studies didn't include serious side effects in results tables, and about a third failed to mention them in either the abstract or the discussion section.

Most surprising, said Tannock, was that in a third of the studies, if the treatment didn't work as well as one might hope, researchers moved the goalposts, reporting results that weren't what the study was originally designed to test.

Often, those so-called "secondary endpoints" may be less important and meaningful. There is a difference, for example, between showing people lived longer overall, or simply lived longer without their cancers coming back.

This is sadly also true with other drugs in other areas of medicine.

Going back to 2007, the following study appeared with Sloan Kettering's Clifford Hudis leading the battle cry:

Proposal for Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials: The STEEP System

http://m.jco.ascopubs.org/content/25/15/2127

Dr. Hudis, bless him, hasn't given up because at the most recent 2012 San Antonio Breast Cancer Symposium he led an educational session on the topic:

Educational Session 3 - Clinical Trial Designs for New Therapies

                     Clinical Trial Designs for New Therapies: What Endpoints Should We Use?                 

CA Hudis

                        Memorial Sloan-Kettering Cancer Center, New York, NY; Weill Cornell Medical College, New York, NY                       

http://m.cancerres.aacrjournals.org/cgi/content/short/72/24_MeetingAbstracts/ES3-3?rss=1

____________________________________________________________________________

Going back to 2006, Harvard medical professor and clinican John Abramson, MD, wrote the terrific book Overdosed America, which I think is a terrific book which really helps one understand clinical trials and the data.  Just wish more physicians took the time to understand the statistics behind the clinical trials and how the trials are designed.

Great discussion.  I too feel lucky to have an informed (he attends the San Antonio conferences) MO that doesn't default to the "let's throw everything at it because we can" philosophy.  But then again, I do a lot of research and we have had pretty in depth discussions about various treatment options.  Oftentimes I bring things up before he has a chance to mention them to me.  Sometimes I wonder if I was a "tell me what to do doc" type of person what would happen?

Athena ~ I can't agree more about not assuming your doc is the only source of information.  Sometimes they might even give you misinformation! Once we had a discussion about whether or not I should take Zometa after a baseline bone scan (that I asked for) indicated I had Osteopenia.  I said one of my concerns was that I was taking Tamoxifen and how that effected my bones.  He said I didn't have to worry because Tamoxifen actually helps bones.  I said, "but that's only for POST menopausel women.  It actually can cause bone loss in PRE-menopausal women - like me. " 

He paused for a minute and thought and said "you're right"!  (In the end we decided against Zometa for various reasons...and I'm sticking with Calcium, Vit D, exercise for now.)

But it does scare me when I think of the patients that DON'T research and advocate for themselves. My MO sees dozens of patients every day.  How could he possibly remember all of my little nuances of my particular case.  I know he doesn't sit and read my chart for an hour before he comes into my room.     

Mary...One doesn't disagree when you're facing an issue like yours, you make the choice of throwing "the whole kitchen sink" at yourself.  But, even in a situation like yours, when you "throw the whole kitchen sink" at yourself, you want to make sure that they are throwing the "right" kitchen sink at you.  There's a huge difference between a stainless steel sink and a porcelain sink So, why not expect that when the doctors are coming up with a protocol for you, they are making that decision based on the best available evidence?  What Sloan Kettering's Dr. Hudis suggests is that all studies be conducted and reported the same way so clinicians can make apples to apples comparisons about treatments.  Physicians have been rumbling for years that they, themselves aren't provided enough information from many clinical trials to make an informed decision for their patients.  So how can we be expected to make a decision? 

What I found most interesting about the recently published Atlas study that came out of the 2012 San Antonio Breast Cancer Symposium, was that many of the physicians quoted, who weren't part of the study, mentioned that they wanted to more closely examine the data and figure out from there how it could be used in a clinical setting.  While the media reported that 10 years of Tamoxifen was better than 5 years, what was left out of most of the stories was that many of the doctors were saying, this was wonderful news because now patients had an option.  Physicians wanted to go back and look at the data and try to see who EXACTLY were benefitting the most with the least side effects.  That's refreshing to see.  Doctors are BEGINNING to really focus more closely on the data. 

I think, as we see more and more genetics used, clinical trials as we know them today will become obsolete.  Physicians will know, based on genetics who will respond to a particular therapy, who is more likely to get a side effect and most importantly, who doesn't need a particular therapy at all because the risks of therapy outweigh the benefit.  Wouldn't that be nice for all of us???

I wish you well Mary. I'm glad to hear that you had little side effects from your treatment. Hopefully, the kitchen sink works its charm on you! I always keep all of our sisters in my thoughts and prayers. At the end of the day, I don't think anyone has it easy or easier when faced with a breast cancer treatment decision.  And I think the toughest thing for all of us is living with that decision, whatever it is, once we've made it.  Hopefully, for all of us, one day the choices we make will truly be easier....

"the unbridled promotion of scientific papers in the media, and the fawning of reporters over meaningless results"  

You hit the nail on the head!  My particular favorite is how studies that show "no significant difference" between two protocols are misrepresented in the media.  The bar for a significant difference in a medical trial is the 95% confidence level. In other words, there must be a 95% chance that the difference in results between two protocols (or two arms of a clinical trial) is not random. I understand why the bar is set so high but what this means is that if there is a difference between two protocols but it's only significant at the 90% level (i.e. there is a 90% chance that the difference found between the two protocols is 'real' and not random), then officially the result of the study or trial is that there is "no significant difference".  And that leads to all sorts of articles in the press that talk about how there is "no difference".  

I recall recently seeing a study where, in digging into the numbers, I discovered that there really did appear to be a difference in the results between the two arms of the study, however the sample size was so small that the only way a 95% statistically significant result could be achieved was if one of the two arms of the study had no patients who achieved the particular result.  As soon as one person did, it was impossible for the other arm to deliver a statistically significant difference in results.

Another study that was recently hailed in the media as showing "no difference" between two treatment protocols actually had results that were significant at the 92% level. 

Grrr.....  That's my hot button!

By the way, my oncologist told me today that while Tamoxifen might be more effective against BC of taken for ten years, the increased risk of uterine cancer outweighs the benefit.

The cumulative risk of endometrial cancer in years 5-14 was 3.1% for women randomized to continue therapy for 10 years, compared with 1.6% for controls. Mortality due to endometrial cancer was rare, however: 0.4% in the extended therapy group and 0.2% in controls.

The findings encourage one to think that aromatase inhibitors, too, might be more effective with longer therapy. However, ongoing clinical trials are comparing outcomes with 10 versus the standard 5 years of adjuvant aromatase inhibitor therapy.

Aromatase inhibitors are not an option in premenopausal patients because they’re ineffective in that setting. And some postmenopausal breast cancer patients can’t tolerate aromatase inhibitors due to arthralgias, bone pain, or other side effects.

The risk of tamoxifen-related endometrial cancer in premenopausal patients is negligible. But some women experience such problematic tamoxifen-induced hot flashes or vaginal symptoms that they may balk at continuing treatment beyond 5 years.