Tag Archives: southwest oncology group

Practice changing results….chemotherapy up front.

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Adding 6 cycles of docetaxel at the outset of hormonal therapy for prostate cancer has been shown to improve survival, especially in men with a high burden of disease. The much anticipated report was presented in detail today at the ASCO annual meeting. Those of you who have followed this blog will remember that I previously highlighted the CHAARTED trial when the trial was stopped prematurely because of the positive result.

The first author, Chris Sweeney, is a good friend and led the study in which several of our patients here in Denver were participants. Thanks guys !

This study randomized 790 men who presented with metastatic prostate cancer and who had never received hormone therapy (ADT) to receive ADT alone (393) vs ADT plus chemothrapy with docetaxel (397) starting up front at the time the ADT was started.  In patients with high volume disease, defined as those men with visceral metastases or >3 skeletal mets including one beyond the pelvis and spine, there was an improvement of 17 months in overall survival from 33 months to 49 months with a p value of <.0006 for significance between the two arms of the trial. The men with lower volume of metastases are also doing better, but the curves for the two treatment arms have not met significance. There was reasonable balance in age, race, psa values, etcetera between the arms. A key point is that 3/4 of the men initially treated with ADT alone went on to receive docetaxel at the time of progressive disease, meaning that this trial can reasonably be considered to reflect a “pay me now or pay me later” with docetaxel toxicity, and the men who were on the “pay me now” arm had the most benefit from the toxicity of the chemotherapy. There was good balance between the arms in terms of the number of men who received others of the newer treatments (abiraterone, enzalutamide, sipuleucel-T).

For prostate cancer, this is akin to the studies of using chemotherapy “up front” in the adjuvant setting that really got medical oncology going in the early 1970’s in women with breast cancer. It opens the door to the study of using aggressive multimodality treatment including the newer hormonal agents, and possibly vaccines, in men with high risk disease at the very outset of their therapy, which should be the next studies. The problems with designing such studies is the very long period of time it takes to get answers. CHAARTED was opened in 2006 and only now, 8 years later, do we have a result. The time could be dramatically shortened if more men would be placed on clinical trials. 1000’s of men were treated with same old same old treatment during the time we worked on CHAARTED. If 50% of them would have been put on this trial in the first two years, we could have had this result about 4 years earlier. Since that takes a major change in how medicine is practiced in the US, don’t hold your breath.


Filed under General Prostate Cancer Issues

Prostate cancer in nodes etc.

I ran across an article I had archived that may be of interest to some patients contemplating surgery. The USC group, where Dr. Skinner has been a pioneer in working on the proper methodologies for lymph node dissection at the time of radical bladder surgery for cancer, reported excellent outcomes in men whose positive lymph nodes were removed at the time of surgery. To put this in context, in the 1990’s our urology group was holding sessions to teach laproscopic node sampling. The idea was that if you found positive lymph nodes, a patient can’t be cured, so there is no reason to do a prostatectomy with the risks for incontinence, impotence, etc. However, even back in the 1980’s, the Mayo Clinic had reported excellent results for men with positive lymph nodes and diploid cancers who were treated with castration, suggesting that nodal metastases aren’t always fatal.

Another perspective on this comes from testis cancer, where retroperitoneal lymph node dissection reduces the relapse rate by about half after orchiectomy. Or, we can consider the issue that even though finding lymph node involvement in breast cancer is a negative prognostic finding, some patients are cured. In the Southwest Oncology Group, we reported preliminary results on patients with high risk factors like positive nodes who received two years of adjuvant androgen deprivation therapy.

My conclusion from all of this is that if I were to choose surgery to treat my newly diagnosed prostate cancer, I would want ample node sampling, completion of the prostatectomy regardless of whether there is nodal involvement, and would take adjuvant hormonal therapy (probably 2 years minimum, depending on how bad the side effects were in my case) and hope that I was cured. In thinking about this, one wonders about how many patients who have already received surgery, salvage radiation, but have persistence of a rising PSA, might still be curable with drastic surgery to remove all the pelvic contents (pelvic exenteration). This procedure has been done for some gyn cancers, sarcomas and the like but is seldom used in prostate cancer. It is obviously difficult to recommend such a procedure without some confidence that cure is possible. A brief review of the topic is here. The challenge is made more difficult by the fact that the majority of men would have much better quality of life by opting for hormonal therapy, even if it isn’t curative.


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