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CATEGORIES [ ASCO ]

Median survival of one month – whoop de doo

BY KATHY LATOUR | JUNE 12, 2013

When I first started reading studies, I remember reading one in particular and everyone was really excited about the fact that it offered an increase of four months of median survival time.

That didn't seem like a lot to me, until I understood what it meant.

Median survival means that there were some patients who lived much longer on the drug, and some who lived a much shorter time on the drug. To be more specific, four months of median survival time means that half of the patients on the treatment died before four months, but also that half of the patients lived beyond four months; some may have lived much longer than four months. Looking at the actual study can illustrate this effect.

Also, unless you have the whole study in front of you, what you don't know is how sick the patients were who took the drug, and that's important. New drugs are often given to patients who have no more options for the obvious reason that they are not going to give an experimental drug to a patient who could get some response from a drug that has shown efficacy.

Another aspect you have to take into account is the patient. What we are learning is that in each group of patients who take a drug, there may be one or two who respond very well. For some reason unknown to anyone, one or two patients may have a great reaction to the drug and their cancer may go into remission or reduce in size.

When these cases are thrown in with the others, it skews the results, but it also makes news and sometimes results in the study being stopped early so the drug can be given to more patients who have one or two similarities that indicate they may respond to the drug.

Right now researchers are trying to find those small pools of patients who respond to certain drugs and single them out. It's the reason that many patients now get a cocktail of chemotherapy drugs instead of just one. They may have one drug that covers all dividing cells and then one that only targets a particular protein known to help that one kind of cancer grow. It gets very complicated.

So, when you hear of a drug showing a median of three months of extended life, look at the surrounding information in the study. Did one patient live a year? Did one have a remarkable response that calls for further investigation?

You may remember the big noise around Avastin when the powers that be wanted to remove it from metastatic breast cancer use. Well there is a subset of women for whom Avastin works wonders. They didn't want it removed for obvious reasons. But there are very few of them.

And as my friend Suzanne Lindley says, even if it is only six months you get, that's half a year and two seasons to watch a 4-year-old begin to notice new things in her life and have new memories. Six months is a lot of live when you are facing not having it.

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COMMENTS

I appreciate your putting these numbers into perspective, that it is often the sickest of patients who get into clinical trials. The patient who is using another medication, or whose cancer seems under control is not likely to seek out a clinical trial, nor is the patient being treated by a less-experience doctor who may not think that the patient has many options--until things go badly, and the patient searches out a larger research center.
It is important to take the small improvements that may come for the patients who do receive benefit, and learn from them--part of the value of the trial. Knowing how to handle side effects so as to maximize the benefit of the drug is also valuable. With the series of drugs that might be used, giving the improvements of six months from one, 12 from another and still more months from a third before the disease progresses is precious time. And just because the cancer starts to progress, that does not mean instant death! Thus, progression free survival in not indicative of overall survival.

Finally, as many of us kidney cancer survivor know, having used two or more drugs, one after another has kept us alive so that we were able to try the next drug--or to "re-challenge" the first of the sequenced drugs. All survivors have to understand and support trial drugs and be aware of the impact of the design of those drugs in making them available to us, as soon as safely possible.
For
- Posted by PeggyZuckerman 6/12/13 10:33 PM

Your post seems to confuse "median" and "average." Median is the point where 50 percent were above and 50 percent were below, which is far different than an average. So a median survival time of four months means half of the patients lived longer and half lived less than four months.

Your point is well taken that the patients in clinical trials are the most advanced in their cancer progression. But once a totally new drug is approved, there may also be subsequent studies of combination therapies and studies of the use of the new drug earlier in treatment protocols or even for completely different cancers. For example, I participated in a trial of Nexavar/sorafenib (approved for liver and kidney cancer) for my prostate cancer, and CURE just reported from ASCO that Nexavar benefited thyroid cancer patients in a trial.

Thank you for taking on this subject. Approval of a new drug with a median of "only" four months of extended life is merely a beginning -- an excellent reminder that we cancerians can 'pay it forward' by participating in clinical trials.
- Posted by Bill Curry 6/13/13 6:01 AM

Yes, thank you for the info! My oncologist has been on the look-out for trials for me, but I have two things against it: not only do I have bilateral breast cancer, but one of them is Inflammatory Breast Cancer(IBC)' a particularly rare and aggressive form. The fact that I am still going is somewhat of a miracle, esp sine it is "just" in my hip and pelvic bones, one femur, and the occasional lymph node. Six months of survival is a lifetime to someone metastatic like me-that's two seasons, esp if you have children in your life. What's even better is six months of progression free survival, which my current regimen of Taxotere-Herceptin-Pertazunab was found to have in trials. One thing not discussed is quality of life issues. I am currently on a short chemo break, since the diarrhea caused by my tx gives me dehydration and anemia, which I need to periodically recover from, What good is it to survive if you are bedridden? It's a constant balance, but! I am still here!
- Posted by DebraD 6/14/13 11:51 AM

Thank you for your comment, Bill. We have updated and corrected the piece.
- Posted by Elizabeth @CURE 7/24/13 9:03 AM

I was diagnosed in 1997 with small cell lung cancer. Treatment did not start until more than a month later (primarily because no one held out much hope I would last too long). When I attended a seminar at a prominent cancer hospital, I asked why "small cell" lung cancer was not on the agenda and was told they did not have any survivors. I spent the next year of my life fighting this "incurable" disease with chemo, radiation (even brain radiation), brewing herbs, juicing fruits and vegetables, and heavy dosages of vitamins. I was proactive on my own (which made me feel I had an active part in fighting this disease). I remained positive (even attended "Healing Masses") with a strong sense of faith. It is now 16 years later and instead of not even having 12 months to live, I now have witnessed the birth of my 12 grandchildren. Would like to see more articles on "small cell" lung cancer. I am living proof that there are survivors!
- Posted by marianne sheehan 1/10/14 11:50 AM

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