Phase II study of vinorelbine and estramustine in combination with conformational radiotherapy for patients with high-risk prostate cancer.
OBJECTIVE
To evaluate the efficacy and safety profile of vinorelbine and estramustine in combination with three-dimensional conformational radiotherapy (3D-CRT) in patients with localized high-risk prostate cancer.


METHODS
Fifty patients received estramustine, 600 mg/m(2) daily, and vinorelbine, 25 mg/m(2), on days 1 and 8 of a 21-day cycle for three cycles in combination with 8 weeks of 3D-CRT (total dose of 70.2 gray [Gy] at 1.8-Gy fractions or 70 Gy at 2.0-Gy fractions). Additionally, patients received luteinizing hormone-releasing hormone analogs for 3 years.


RESULTS
All patients were evaluated for response and toxicity. Progression-free survival at 5 years was 72% (95% confidence interval [CI]: 52-86). All patients who relapsed had only biochemical relapse. The most frequent severe toxicities were cystitis (16% of patients), leucopenia (10% of patients), diarrhea (10% of patients), neutropenia (8% of patients), and proctitis (8% of patients). Six patients (12%) did not complete study treatment due to the patient's decision (n = 1) and to adverse events such as hepatotoxicity, proctitis, paralytic ileus, and acute myocardial infarction.


CONCLUSIONS
Vinorelbine and estramustine in combination with 3D-CRT is a safe and effective regimen for patients with localized high-risk prostate cancer. A randomized trial is needed to determine whether the results of this regimen are an improvement over the results obtained with radiotherapy and androgen ablation.
Carles
Joan
J
Hospital del Mar, Barcelona, Spain. jocarles@vhebron.net
Nogue
Miguel
M
Sole
Josep M
JM
Foro
Palmira
P
Domenech
Montserrat
M
Suarez
Marta
M
Gallardo
Enrique
E
García
Darío
D
Ferrer
Ferrán
F
Gelabert-Mas
Antoni
A
Gayo
Javier
J
Fabregat
Xavier
X
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000379:methods; D003556:Cystitis / Q000209:etiology; D003967:Diarrhea / Q000209:etiology; D004334:Drug Administration Schedule; D004961:Estramustine / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007970:Leukopenia / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000209:etiology; D011349:Proctitis / Q000209:etiology; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D020266:Radiotherapy, Conformal / Q000009:adverse effects; D012074:Remission Induction; D013030:Spain; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
D004961:Estramustine; D014747:Vinblastine; D000077235:Vinorelbine