Phase II study of docetaxel re-treatment in docetaxel-pretreated castration-resistant prostate cancer.
OBJECTIVE
To determine the activity and tolerability of docetaxel re-treatment after first-line therapy with docetaxel in castration-resistant prostate cancer (CRPC).


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.
Di Lorenzo
Giuseppe
G
Dipartimento di Endocrinologia ed Oncologia Clinica e Molecolare, Università Federico II, Napoli, Italy. giuseppedilorenzoncol@hotmail.com
Buonerba
Carlo
C
Faiella
Adriana
A
Rescigno
Pasquale
P
Rizzo
Mimma
M
Autorino
Riccardo
R
Perdonà
Sisto
S
Riccardi
Nando
N
Scagliorini
Sarah
S
Scognamiglio
Florinda
F
Masala
Daniele
D
Ferro
Matteo
M
Palmieri
Giovannella
G
Aieta
Michele
M
Marinelli
Alfredo
A
Altieri
Vincenzo
V
De Placido
Sabino
S
Cartenì
Giacomo
G
D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000077143:Docetaxel; D004812:Epidemiologic Methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D009919:Orchiectomy; D017430:Prostate-Specific Antigen / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D019233:Retreatment; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D017430:Prostate-Specific Antigen