A phase II study of cisplatin and vinorelbine in patients with metastatic breast cancer.
BACKGROUND
To evaluate the efficacy and safety of the combination of cisplatin and vinorelbine in metastatic breast cancer.


METHODS
Cisplatin (80 mg/m(2) day 1) and vinorelbine (25 mg/m(2) days 1 and 8) were administrated every 3 weeks to 52 patients (mean age 57 years; range 35-75 years) with metastatic breast cancer. Thirty-two patients were previously untreated for metastatic disease. Treatment was repeated for a maximum of six cycles.


RESULTS
Objective responses were obtained in 27 patients (52.9%; complete response 9.8%). The response rate was similar in pretreated and untreated patients (50% and 54.7%, respectively; P = 0.7). ECOG performance status was good (grade 0 or 1) in 55.7% of patients at baseline assessment and in 90.3% at the end of treatment (P = 0.0001). Median time to progression was 8.5 months (8.5 months in first-line and 8.7 months in second-line patients). Median survival was 16.6 months (21.2 months in first-line and 16.1 months in second-line patients). Grade 3/4 toxicity included neutropenia (44% in first-line, 60% in second-line patients), nausea (17.3%), anemia (17%), asthenia (3.8%) and thrombocytopenia (1.9%). There were no cases of febrile neutropenia or treatment-related deaths. Alopecia did not develop in any of the patients.


CONCLUSIONS
Cisplatin plus vinorelbine is active and tolerable in metastatic breast cancer, in untreated and pretreated patients.
Mustacchi
G
G
Centro Oncologico, Azienda per i Servizi Sanitari 1, Università di Trieste, Trieste, Italy. co@ass.1sanita.fvg.it
Muggia
M
M
Milani
S
S
Ceccherini
R
R
Leita
M L
ML
Dellach
C
C
D000328:Adult; D000368:Aged; D000616:Aminoglutethimide / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001707:Biopsy, Needle; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary*; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary*; D019290:Megestrol Acetate / Q000008:administration & dosage; D008875:Middle Aged; D009367:Neoplasm Staging; D011336:Probability; D018570:Risk Assessment; D012983:Soft Tissue Neoplasms / Q000188:drug therapy / Q000556:secondary; D016019:Survival Analysis; D013629:Tamoxifen / Q000008:administration & dosage; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D013629:Tamoxifen; D000616:Aminoglutethimide; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine; D019290:Megestrol Acetate