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Gemcitabine plus vinorelbine as first‐line chemotherapy in advanced nonsmall cell lung carcinoma a Phase II trial
Author(s) -
Bajetta Emilio,
Chiara Stani Simonetta,
De Candis Daniela,
Bidoli Paolo,
Mariani Luigi,
Zilembo Nicoletta,
Pozzi Paola,
Procopio Giuseppe
Publication year - 2000
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(20000815)89:4<763::aid-cncr7>3.0.co;2-f
Subject(s) - vinorelbine , medicine , gemcitabine , vinca alkaloid , tolerability , oncology , lung cancer , regimen , neutropenia , chemotherapy , phases of clinical research , surgery , adverse effect , vincristine , cisplatin , cyclophosphamide
BACKGROUND Response and survival in patients with advanced or metastatic nonsmall cell lung carcinoma (NSCLC) remain poor. As single agents, the nucleoside analog gemcitabine, and the semisynthetic vinca alkaloid vinorelbine, have been shown to be effective in NSCLC and to have a low toxicity profile. METHODS Fifty‐four chemotherapy‐naive patients with NSCLC Stage IIIB (any TN3M0 or T4 any NM0) or IV (any T any NM1) were enrolled in this single‐institution Phase II study. Gemcitabine 1250 mg/m 2 and vinorelbine 25 mg/m 2 were both administered on Days 1 and 8 every 3 weeks for up to 9 courses unless disease progression or severe toxicity required their discontinuation. RESULTS Partial tumor regression was observed in 16 patients, for an overall response rate of 30% (95% confidence interval, 18.4–46.7%) on an intent‐to‐treat basis. The median time to progression was 5 months (range, 3–20). The median survival was 12 months (range, 5–42+); 1‐year and 2‐year survival rates were 49.1% and 17%, respectively. Hematologic toxicity was mild with only 11% of the patients developing Grade 3 neutropenia. None of the patients developed any Grade 4 toxicity. CONCLUSIONS The combination of gemcitabine plus vinorelbine is feasible on an outpatient basis. The good activity and tolerability of the regimen make it a suitable candidate for further trials, using platinum‐based regimens as comparators and possibly selecting elderly and less fit patients. Cancer 2000;89:763–8. © 2000 American Cancer Society.