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Clinical Trial
. 2011 Jan;107(2):234-9.
doi: 10.1111/j.1464-410X.2010.09498.x.

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

Giuseppe Di Lorenzo  1 , Carlo Buonerba, Adriana Faiella, Pasquale Rescigno, Mimma Rizzo, Riccardo Autorino, Sisto Perdonà, Nando Riccardi, Sarah Scagliorini, Florinda Scognamiglio, Daniele Masala, Matteo Ferro, Giovannella Palmieri, Michele Aieta, Alfredo Marinelli, Vincenzo Altieri, Sabino De Placido, Giacomo Cartenì
Affiliations
Clinical Trial

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

Giuseppe Di Lorenzo et al. BJU Int. 2011 Jan.

Abstract

Objective: To determine the activity and tolerability of docetaxel re-treatment after first-line therapy with docetaxel in castration-resistant prostate cancer (CRPC).

Patients and methods: Between November 2005 and January 2009, 45 patients initially responding to docetaxel and then experiencing disease progression after a period of biochemical remission of at least 5 months were enrolled in a prospective multicenter study and re-treated with docetaxel. The primary endpoint was the biochemical response (biochemical partial response defined as > 50% prostate-specific antigen [PSA] decline); secondary endpoints were objective response, toxicity, progression-free survival (PFS) and overall survival (OS).

Results: Partial 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.

Conclusions: Docetaxel re-treatment preserves anti-tumour activity and is well tolerated in a selected population of pretreated patients with CRPC. Further randomized trials are needed to confirm our preliminary results.

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