What Is More Exciting? The Activity of Docetaxel in Early Prostate Cancer or the Successful Collaboration Between Urologists and Medical Oncologists to Complete a Study in Early Prostate Cancer?
Authors: Michael A. Carducci
Journal: Journal of Clinical Oncology (2005)

In this issue, Goodin et al report on the activity of docetaxel in androgen-dependent prostate cancer. This relatively small, single-institution phase II study found that docetaxel lowered prostate-specific antigen (PSA) by greater than half in 43% of patients with prostate cancer recurrence manifested by a rise in PSA after definitive local therapy. Patients maintained noncastrate levels of testosterone throughout the study, suggesting that docetaxel, a cytotoxic agent, has clinical activity against androgendependent prostate cancer. The authors suggest that this is the first published report of docetaxel activity in this specific patient population. During the last few years, a number of publications have reported similar phase I and II studies consistently demonstrating safety and activity of docetaxel throughout the continuum of prostate cancer, from the neoadjuvant setting to the metastatic hormone-refractory state, supporting a number of phase III studies. Recent reports of the TAX 327 and Southwest Oncology Group (SWOG) 9916 phase III trials in men with progressive metastatic hormone-refractory prostate cancer (HRPC) demonstrated a 2 to 2.5 month improvement in median survival of a docetaxel regimen over mitoxantrone and prednisone, and defined a role for chemotherapy in advanced disease. The report by Goodin et al, in conjunction with these advanced disease studies, clearly supports the need to conduct larger clinical trials to define the role of chemotherapy in earlier stages of prostate cancer. Reporting the docetaxel data across the spectrum of disease states may then influence treatment for those patients who would be eligible for, but who are not currently receiving, appropriate chemotherapy. Additionally, more patients should then be referred for clinical trials of chemotherapy or biologic agents in advanced and early-stage disease. Numerous clinical trial opportunities exist for patients with HRPC, both metastatic and nonmetastatic, and androgen-dependent prostate cancer, including the neoadjuvant, adjuvant and PSA recurrence-only disease settings through the cooperative groups. Accrual to North America cooperative group trials requiring multidisciplinary management of prostate cancer patients in early stages of disease is often slow, despite successful pilot studies from single institutions. These studies in earlier stages of prostate cancer will require greater communication between medical and urologic oncologists. As principal investigator of one of the large phase III randomized, cooperative group studies in earlier-stage prostate cancer that recently closed secondary to poor accrual (Eastern Cooperative Oncology Group [ECOG] study 1899), I have spent substantial time developing educational programs for medical oncologists, urologists, and radiation oncologists on the merits and problems of such studies. These studies include Cancer and Leukemia Group B (CALGB) trial 90203 (neoadjuvant setting), SWOG 9921 (adjuvant setting), SWOG 9482 (new D2 disease), Radiation Therapy Oncology Group (RTOG) 0014 (rising PSA after local therapy without metastasis), and ECOG 1899 (rising PSA on hormonal therapy without metastasis; Table 1). These studies are addressing innovative JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 23 NUMBER 15 MAY 2