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Br J Cancer. Feb 2000; 82(4): 806–811.
PMCID: PMC2374380
Activity of high-dose epirubicin combined with gemcitabine in advanced non-small-cell lung cancer: a multicenter phase I and II study
J W G van Putten,1 P Eppinga,3 Z Erjavec,4 G de Leede,5 J Nabers,6 J B E Smeets,7 D Th Sleijfer,2 and H J M Groen1
1Departments of Pulmonary Diseases and 2Medical Oncology, University Hospital, Hanzeplein 1, Groningen, GZ, 9713, The Netherlands
3Department of Pulmonary Diseases, Hospital ‘Nij Smellinghe’, Drachten, The Netherlands
4Department of Internal Medicine, Delfzicht Hospital, Delfzijl, The Netherlands
5Department of Pulmonary Diseases, Bethesda Hospital, Hoogeveen, The Netherlands
6Department of Pulmonary Diseases, Medical Center, Leeuwarden, The Netherlands
7Pharmacia & Upjohn, Woerden, The Netherlands
Received June 9, 1999; Revised September 16, 1999; Accepted September 24, 1999.
The aim of the study was to evaluate efficacy and tolerance of epirubicin and gemcitabine as first-line chemotherapy in patients with advanced non-small-cell lung cancer. A phase I study was performed with the combination of escalating doses of epirubicin intravenously on day 1 and a fixed dose of gemcitabine on days 1 and 8 of a 21-day cycle. Eighteen patients were included in the phase I part of the study before the maximum tolerated dose was found. Dose-limiting toxicity was febrile neutropenia. The phase II part of the study was continued with epirubicin 100 mg m−2on day 1 and gemcitabine 1125 mg m−2on days 1 and 8 of a 21-day cycle. Forty-three chemotherapy-naive patients were included. The median age of the patients was 60 years (range 26–75). Most patients (74%) were in stage IV. Granulocytopenia CTC grade 4 occurred in 32.5% and thrombocytopenia grade 4 in 11.6% of cycles. Febrile neutropenia occurred in six patients. Non-haematological toxicity was mainly mucositis CTC grade 2 and 3 in 35% of patients. The tumour response rate was 49% (95% confidence interval (CI) 35–63%). The median survival time for the patients was 42 weeks (95% CI 13–69). © 2000 Cancer Research Campaign
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