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Phase I/IIa Study of Cisplatin and Gemcitabine As Induction Chemotherapy Followed by Concurrent Chemoradiotherapy With Gemcitabine and Paclitaxel for Locally Advanced Non–Small-Cell Lung Cancer

From the University of Alabama at Birmingham; and Birmingham Veterans Administration Medical Center, Birmingham, AL

Address reprint requests to Francisco Robert, MD, FACP, Comprehensive Cancer Center, University of Alabama at Birmingham, 1824 Sixth Ave S, Birmingham, AL 35294-3300; e-mail: pacorobertuab{at}cs.com

PURPOSE: This is a phase I/IIa study to assess tolerance of gemcitabine and paclitaxel with radiotherapy in locally advanced non–small-cell lung cancer after induction chemotherapy.

PATIENTS AND METHODS: Fifty-seven patients with stage III non–small-cell lung cancer were treated with cisplatin 80 mg/m² on days 1 and 22 and gemcitabine 1,250 mg/m² on days 1, 8, 22, and 28. Chemoradiotherapy began on day 43 as follows: cohort 1 (n = 9), gemcitabine 300 mg/m² and paclitaxel 35 mg/m² weekly (except week 9); cohort 2 (n = 9), gemcitabine 150 mg/m² and paclitaxel 35 mg/m² weekly (except week 9); cohort 3 (n = 10) and the 25 phase IIa patients, gemcitabine 300 mg/m² and paclitaxel 135 mg/m² every 21 days. Patients were treated with three-dimensional thoracic radiotherapy concurrently to 60 Gy.

RESULTS: Weekly chemotherapy resulted in grade 4 esophageal and grade 3 or higher pulmonary toxicities. Reduction in dose density (cohort 3) led to a tolerable toxicity profile and was chosen as the phase IIa regimen. The response rate to induction was 49%, with stable disease in 40% of the patients. The response rate after consolidation therapy was 75% (94% for weekly chemotherapy v 82% for every 3 weeks). Median survival was 23 months, and 3-year survival was 45% for eligible patients. Local relapse occurred in 20% of the patients. Performance status of more than 1 predicted for poor outcome, but baseline pulmonary function did not. Dosimetric parameters including V₁₅, V₂₀, V₃₀ (percent lung volume receiving 15, 20, and 30 Gy, respectively), and mean lung dose correlated with pulmonary toxicity.

CONCLUSION: Additional investigation with the 3-week schedule is warranted in patients with a good performance status based on the safety profile and preliminary efficacy data observed in this study.

Supported by P30CA13148, awarded from the National Cancer Institute (National Institutes of Health, Bethesda, MD) and Eli Lilly Oncology (Indianapolis, IN).

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, May 31-June 3, 2003, Chicago, IL.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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