Docetaxel, vinorelbine, and zoledronic acid as first-line treatment in patients with hormone refractory prostate cancer: a phase II study.
OBJECTIVE
Combining antineoplastic agents is the key to improving the treatment options for men with hormone refractory prostate cancer (HRPC). The current study investigated the combination of docetaxel, vinorelbine, and zoledronic acid as a first-line treatment for HRPC.


METHODS
Patients were treated repeatedly with docetaxel (25 mg/mq) and vinorelbine (10 mg/mq) intravenously for three consecutive weeks followed by a 1-wk rest until disease progression or side effects. Zoledronic acid was administered every 4 wk. Changes in prostate-specific antigen (PSA) levels and objective responses were evaluated after two and three cycles, respectively. Toxicity and pain evaluation, based on pain intensity reduction and analgesic drug reduction, were assessed every cycle.


RESULTS
Forty men with HRPC (median age: 65 yr) were treated. Among 38 evaluable patients, complete and major PSA responses were observed in seven (18%) and 12 (32%), respectively; a partial objective response was observed in six of 15 (40%) patients with measurable disease. Neutropenia (25%) was the most important grade 3 haematologic toxicity observed. Only three patients (7.5%) reported grade 4 neutropenia. Nineteen patients (47.5%) achieved a reduction of pain intensity and analgesic drug use after two cycles. Median progression-free survival was 7 mo (95% CI: 2-10 mo), with a median overall survival of 17 mo (95% CI: 6-22 mo).


CONCLUSIONS
The combination of docetaxel, vinorelbine, and zoledronic acid is associated with improvement in biochemical, objective, and pain responses and is well tolerated as a first-line treatment for HRPC.
Di Lorenzo
Giuseppe
G
Cattedra di Oncologia Medica, Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica, Università degli Studi Federico II, Napoli, Italy. giuseppedilorenzoncol@hotmail.com
Autorino
Riccardo
R
Perdonà
Sisto
S
De Laurentiis
Michele
M
D'Armiento
Massimo
M
Cancello
Giuseppe
G
Mirone
Vincenzo
V
Imbimbo
Ciro
C
Longo
Nicola
N
Altieri
Vincenzo
V
Tortora
Gianpaolo
G
Figg
William D
WD
De Placido
Sabino
S
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000368:Aged; D014408:Biomarkers, Tumor / Q000097:blood; D001859:Bone Neoplasms / Q000556:secondary; D004164:Diphosphonates / Q000627:therapeutic use* / Q000633:toxicity; D000077143:Docetaxel; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use* / Q000633:toxicity; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016019:Survival Analysis; D017741:Survivors; D043823:Taxoids / Q000627:therapeutic use* / Q000633:toxicity; D016896:Treatment Outcome; D014747:Vinblastine / Q000031:analogs & derivatives* / Q000627:therapeutic use / Q000633:toxicity; D000077235:Vinorelbine; D000077211:Zoledronic Acid
D014408:Biomarkers, Tumor; D004164:Diphosphonates; D007093:Imidazoles; D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D000077211:Zoledronic Acid; D017430:Prostate-Specific Antigen; D000077235:Vinorelbine