Prolonged gemcitabine infusion in advanced non–small cell lung carcinoma

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Abstract
BACKGROUND: Preclinical and clinical evidence suggests that a fixed infusion rate of 10 mg/m2 per minute may be more effective than the standard 30‐minute infusion of gemcitabine. To investigate the activity and toxicity of the cisplatin plus gemcitabine combination with gemcitabine at a fixed infusion rate in patients with advanced non–small cell lung carcinoma (NSCLC), the authors conducted a randomized Phase II trial of cisplatin plus gemcitabine at the 30‐minute standard infusion (calibration arm) or cisplatin plus gemcitabine at a fixed infusion rate (experimental arm).METHODS: A total of 112 chemonaive patients with advanced NSCLC entered the study: 57 patients in Arm A and 55 patients in Arm B. The patients were randomly assigned to receive gemcitabine at a dose of 1000 mg/m2 on Days 1, 8, and 15 over 30 minutes (Arm A) or at a rate of 10 mg/m2 per minute (Arm B). In both treatment arms, cisplatin at a dose of 80 mg/m2 was administered on Day 15 every 28 days.RESULTS: The overall response rates in Arms A and B were 26% (95% confidence interval [95% CI], 10–42%) and 34% (95% CI, 17–52%) (intent‐to‐treat‐analysis), respectively. The median time to disease progression was 6 months (range, 1–26 months) and 8 months (range, 2–21 months), respectively, for Arms A and B and the median overall survival was 13 months (range, 2–26 months) for each arm. It is interesting to note that a high response rate (67%) of brain metastases was noted in the experimental arm. Toxicity was tolerable and comparable in the two arms.CONCLUSIONS: The results of this randomized Phase II trial demonstrated that cisplatin plus gemcitabine with gemcitabine at fixed infusion rate (10 mg/m2 per minute) is active and well tolerated in patients with advanced NSCLC. Cancer 2003;98:337–43. © 2003 American Cancer Society.DOI 10.1002/cncr.11501

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