Vinorelbine and prednisone in older cancer patients with hormone-refractory metastatic prostate cancer. A phase II study.
OBJECTIVE
Prostate cancer is a common disease in older men. Since it is hormone resistant, no treatment may improve survival. In patients with hormone-refractory prostate cancer, clinical benefit is an important treatment end point.


METHODS
This study evaluated the efficacy and toxicity of a vinorelbine and prednisone combination in hormone-refractory prostate cancer patients. Vinorelbine was administered at the dose of 25 mg/m2 on days 1 and 8, every three weeks; prednisone was administered orally at the dose of 12 mg/day. Thirty consecutive patients, 65 years or older, with progressive (PSA increase or increase in bidimensionally measurable lesion) metastatic prostate adenocarcinoma were enrolled. Four patients (13%) had a partial response and 14 (46%) stable disease. Time to progression for the entire group was 4.5 months (range, 2-13) and 7.5 months for the group of responders (range, 3-13). A PSA decrease >50% was registered in 36% of the patients. Pain reduction was recorded in 44.4% of the patients and stability in 14.8%.


RESULTS
The treatment was well tolerated and grade 3 toxicity was found in 2 cases of anemia and 2 cases of leukopenia without fever.


CONCLUSIONS
The schedule is able to control the evolution of hormone-refractory prostate cancer and to give a clinical benefit. These results provide information for further clinical trials in a large series of elderly cancer patients.
Medical Oncology Unit, G Di Maria Hospital, Avola, Italy. tralongo.paolo@virgilio.it
Paolo
P
Tralongo
Roberto
R
Bollina
Rosanna
R
Aiello
Anna
A
Di Mari
Giovanni
G
Moruzzi
Gianni
G
Beretta
Gaetano
G
Mauceri
Gianfranco
G
Conti
D000284:Administration, Oral; D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D006801:Humans; D008297:Male; D011241:Prednisone / Q000008:administration & dosage; D017430:Prostate-Specific Antigen; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000276:immunology / Q000378:metabolism / Q000473:pathology; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D014747:Vinblastine; D017430:Prostate-Specific Antigen; D000077235:Vinorelbine; D011241:Prednisone