Phase II study of docetaxel re‐treatment in docetaxel‐pretreated castration‐resistant prostate cancer

Abstract

specific antigen [PSA] decline); secondary endpoints were objective response, toxicity, progression-free survival (PFS) and overall survival (OS). RESULTSPartial PSA responses were observed in 11 patients (24.5%), 4 (25%) of whom also had an objective response. The treatment was well tolerated, with grade 1-2 neutropenia, thrombocytopenia, vomiting and peripheral neuropathy noted in 18 (40%), 11 (24.5%), 8 (17.8%), and 6 (13.3%) patients, respectively. The most common grade 3 toxicity was neutropenia, which was observed in 8 patients (17.8%). Median PFS was 5 months and median OS was 13 months. CONCLUSIONSDocetaxel re-treatment preserves antitumour activity and is well tolerated in a selected population of pretreated patients with CRPC. Further randomized trials are needed to confirm our preliminary results. KEYWORDS docetaxel, chemotherapy, castrationresistant prostate cancerWhat's known on the subject? and What does the study add? We show that (i) docetaxel re-treatment, after a treatment-free interval, preserves activity; (ii) the treatment is especially well tolerated in patients who were effectively pretreated with docetaxel; and (iii) it could be speculated that combining docetaxel with other agents in this setting might be safe and result in greater activity.Study Type -Therapy (cohort) Level of Evidence 2b

Phase II trial of cisplatin plus prednisone in docetaxel-refractory castration-resistant prostate cancer patients

“…Docetaxel has represented the sole efficacious treatment for castration-resistant prostate cancer (CRPC) for several years [2,3] and is also a viable option for re-treatment of selected patients who received docetaxel but interrupted it for reasons other than disease progression [4]. Presently, a variety of novel drugs have great potential to become part of the therapeutic armamentarium for the management of this disease [3].…”

Systemic Medical Treatment in Men with Metastatic Castration-Resistant Prostate Cancer: Recommendations for Daily Routine

“…This approach has never been tested in prospective randomized clinical trials, but there is level II-III evidence from retrospective series to identify patients who might be good candidates for re-exposure to docetaxel [46,47,48,49,50,51] (table 3). Patients who respond with a PSA decrease ≥ 30% maintained for at least 8 weeks after the end of docetaxel treatment demonstrate a positive PSA response in about 55-60% during re-exposure without increasing treatment-related toxicity.…”

How to approach castration-resistant prostate cancer?

“…The clinical benefit data is mostly retrospective. In a Phase II clinical trial in a group of pretreated patients with CRPC, it was demonstrated that docetaxel retreatment preserves antitumor activity and is well tolerated [38]. Docetaxel re-challenge, once popular in the era of no treatments with demonstrated survival benefit, must be considered carefully today, for fear of delaying effective treatment choices.…”