Kibel AS et al. (2007) Adjuvant weekly docetaxel for patients with high risk prostate cancer after radical prostatectomy: a multi-institutional pilot study. J Urol 177: 1777–1781

There is currently no standard adjuvant therapy for patients at high risk of disease recurrence or distant metastases following radical prostatectomy. Kibel et al., therefore, performed a multi-institutional, phase II pilot study of the systemic adjuvant docetaxel, which has shown survival benefits for patients with hormone-refractory prostate carcinoma in randomized controlled trials.

The trial included 77 patients who had undergone radical prostatectomy for localized disease, and who had a risk of biochemical recurrence within 3 years of ≥50%. Postoperatively, 50 (65%) of 77 patients had positive seminal vesicles, 29 (38%) of 77 had positive lymph nodes, and 50 (65%) of 77 had positive surgical margins. Patients underwent six 28-day cycles of 35 mg/m2 intravenous docetaxel infusions (administered on days 1, 8 and 15 of each cycle) with 10 mg dexamethasone pretreatment. Patients were evaluated weekly during treatment cycles, and were followed up every 3 months after treatment.

At the median follow-up (29.2 months, range 1.3–39.2 months), 46 (60.5%) out of 76 patients in the final analysis had disease progression. Median progression-free survival was 15.7 months, compared with a nomogram-predicted progression-free survival of 10.0 months. Grade I/II toxicity occurred in 54 (70%) patients, grade III toxicity occurred in 20 (26%) patients and grade IV toxicity occurred in 3 (4%) patients.

The authors conclude that adjuvant docetaxel increases progression-free survival with acceptable toxicity in high-risk patients, and suggest that a phase III trial investigating the efficacy of adjuvant androgen deprivation, with or without docetaxel, is warranted.