What Is The Optimum Timing Of Systemic Therapy In Conjunction With Radical Prostatectomy For Locally Advanced Disease?

UroToday.com - In a debate moderated by Dr. Joel Nelson, University of Pittsburgh, Dr. James Eastham, Memorial Sloan Kettering Cancer Center argued for "Neoadjuvant" systemic therapy. Dr. Eastham discussed established prognostic information that predict for possible clinical outcomes for a particular patient. Examples would be the Partin tables, Kattan nomograms and D'Amico risk stratification. Using these risk assessment modalities, one can identify those at risk for failing local therapy. He stated that those at risk should be considered for multi-modal therapy.

Dr. Eastham stated that the neoadjuvant approach is beneficial as feasibility has been demonstrated in Phase II studies and correlative studies can be performed on pre/post treatment specimens. Men at high-risk for recurrence but with an undetectable PSA post-op may be less inclined for adjuvant treatment. Also, there is no delay in starting therapy, as can occur in the adjuvant setting. He cited CALGB90203, which will randomize patients to neoadjuvant docetaxel and androgen deprivation therapy prior to RP vs. RP alone. As a community of urologists we will need to support trials such as this Dr. Eastham said. The primary limitation of understanding neoadjuvant therapy is the poor enrollment in clinical trials by urologists. In comparison, enrollment in breast cancer clinical trials is over 5-fold higher than in prostate cancer trials. Even negative trials give us information and Phase III trials should take priority he concluded.

Dr. Mario Eisenberger, Johns Hopkins argued for "Adjuvant" systemic therapy. Using data from the CAPSURE database he showed that most patients with localized disease get treated. Using an adjuvant approach permits therapy directed by pathology. Adjuvant treatment targets treatment of minimal tumor burden and a higher growth fraction and shorter cell cycle, resulting in potential increased chemotherapy sensitivity. Better vascular supply and less hypoxia are also advantages, he argued. This might decrease the potential for tumor resistance. Postoperatively it facilitates design of clinical trials and disease free survival can be evaluated. He cited TAX-2501 as an example of being able to accrue patients to an adjuvant chemotherapy trial in a multi-institutional setting. He also cited the TAX-3501 trial, which is a two step randomized trial to treat post-RP high-risk CaP patients with an undetectable PSA post-op or at the time of progression with taxotere with or without ADT. Accrual is slow at present and he encouraged people to contribute patients. The goal is 1,696 patients globally.

The overall message of both speakers is that the need for urologists to participate in clinical trial accrual is critical to answering questions in prostate cancer.

Report from The Society of Urologic Oncology Winter Meeting - National Institutes of Health - December 1-2, 2006
Reviewed by UroToday.com Contributing Editor Christopher P. Evans, M.D

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