Phase II trial of i.v. vinorelbine and cisplatin in inoperable locally advanced or disseminated non-small-cell lung cancer: The South African experience
Date
1999
Authors
Goedhals L.
Vorobiof D.A.
Bezwoda W.
Van Merwe A.
Jordaan J.P.
Barnardt P.
Smith B.L.
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Abstract
Purpose. This multicentre phase II trial was conducted in South Africa to evaluate the activity of a combination of vinorelbine, administered in a new schedule, and cisplatin, in chemonaive patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods. Between September 1995 and December 1996, 35 patients were enrolled. All patients had at least one bidimensionally measurable lesion. Vinorelbine was administered intravenously on day 1 and day 8 at a dose of 30 mg/m2 and cisplatin was administered intravenously on day 1 at a does on 100 mg/m2. The chemotherapy cycle was repeated every three weeks. Results. Of 35 evaluable patients, 14 (40%) achieved a response (one complete response and 13 partial responses). The median time to progression was 6.4 months (range 12-572 days) and the median survival was 15.7 months (range 12-882+ days). One-year survival was 56%. Toxicity was manageable and consisted of nausea and vomiting (grade 3 in 45% of patients) and grade 3-4 neutropenia seen in 13 patients with three patients experiencing grade 3 infection. Other side-effects were mild, including constipation grade 3 in 9.1%. A total of 153 courses were administered with patients receiving a median dose intensity of 81.7% for vinorelbine, while that of cisplatin was 74.1%. Conclusion. The combination of vinorelbine and cisplatin demonstrated substantial activity in terms of objective response and survival with manageable side-effects in patients with advanced NSCLC. These findings confirm the data from previous randomised studies. Further studies are ongoing in order to evaluate the efficacy of this combination in the neoadjuvant and adjuvant setting.
Description
Keywords
antineoplastic alkaloid, antineoplastic metal complex, cisplatin, navelbine, adult, advanced cancer, aged, alopecia, article, cancer combination chemotherapy, cancer survival, clinical article, clinical trial, constipation, drug response, female, human, infection, intravenous drug administration, lung non small cell cancer, male, multicenter study, nausea, neuropathy, neutropenia, phase 2 clinical trial, South Africa, vomiting, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Cisplatin, Female, Humans, Lung Neoplasms, Male, Middle Aged, South Africa, Survival Rate, Vinblastine
Citation
Current Medical Research and Opinion
15
3
15
3