title: Oral vinorelbine as first line chemotherapy in unfit elderly patients with hormone-refractory prostate cancer.
abstract: Hormone-refractory prostate cancer (HRPC) is a rapidly progressive disease which produces considerable morbidity and involves mostly men over 70, often comorbid and with poor tolerance to chemotherapy. Low-toxicity chemotherapy is a reasonable option in this setting. Vinorelbine and a corticosteroid show activity and clinical benefit responses in HRPC. An oral regimen is preferable for elderly patients. This study aimed to evaluate safety, prostate-specific antigen (PSA) response, clinical benefit and progression-free survival in chemonaive elderly HRPC patients. 33 men, median age 78.2, were treated with oral vinorelbine 60 mg/m2 days 1 and 8 every 3 weeks, escalable to 80 mg/m2 after the first cycle, and prednisone 5 mg b.i.d. The main toxicity was hematopoietic (mild at 60 mg/m2 and moderate at 80 mg/m2). Of 27 evaluable patients, 9 (33%) had PSA responses and 9 had clinical benefit, PSA-correlated in 5 cases (56%). Median progression-free survival was 13.4 weeks, median overall survival 45 weeks. Oral vinorelbine plus prednisone is safe and has moderate activity, with biochemical and clinical responses in about one-third of patients and could be an option in unfit elderly HRPC patients.
authors.affiliation: Unità Operativa di Oncologia Medica, Azienda Ospedaliera Universitaria, Policlinico G Martino Messina, Italy. nicolacaristi@libero.it
authors.forename: N
authors.initials: N
authors.lastname: Caristi
authors.forename: R
authors.initials: R
authors.lastname: Maisano
authors.forename: M
authors.initials: M
authors.lastname: Iorfida
authors.forename: A
authors.initials: A
authors.lastname: Scimone
authors.forename: G
authors.initials: G
authors.lastname: Lupo
authors.forename: C
authors.initials: C
authors.lastname: Buda
authors.forename: C
authors.initials: C
authors.lastname: Scisca
authors.forename: V
authors.initials: V
authors.lastname: Adamo
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D018572:Disease-Free Survival; D006410:Hematopoiesis / Q000187:drug effects; D006801:Humans; D008297:Male; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D011239:Prednisolone; D017430:Prostate-Specific Antigen; D000077235:Vinorelbine