© 2004 Foundation for Promotion of Cancer Research
Weekly Paclitaxel and Nedaplatin With Concurrent Radiotherapy for Locally Advanced Non-small-cell Lung Cancer: a Phase I/II Study
1 The Second Department of Internal Medicine, 2 Department of Radiology and 3 Department of Clinical Pharmacology, Hirosaki University School of Medicine, Hirosaki, Aomori, Japan
For reprints and all correspondence: Yukihiro Hasegawa, Second Department of Internal Medicine, Hirosaki University School of Medicine, 5 Zaifu-cho, Hirosaki 036-8562, Japan. E-mail: yukihase{at}cc.hirosaki-u.ac.jp
Received June 19, 2004; accepted September 3, 2004
Objective: The purpose of this study was to determine the safety and efficacy of nedaplatin and paclitaxel when given concurrently with radiation therapy (RT) for locally advanced non-small-cell lung cancer (NSCLC).
Methods: Nedaplatin was administered at a fixed dose of 20 mg/m2, and paclitaxel was administered at a starting dose of 30 mg/m2 with an incremental increase of 5 mg/m2 until dose-limiting toxicity (DLT) occurred in more than one-third of the patients. The chemotherapy was administered once a week for 6 weeks. The RT was given at a single daily dose of 2 Gy for 5 days per week. The pharmacokinetics of nedaplatin and paclitaxel were investigated.
Results: Overall, 20 patients were recruited and assigned to three different treatment groups: group 1 (paclitaxel 30 mg/m2), group 2 (paclitaxel 35 mg/m2) and group 3 (paclitaxel 40 mg/m2). Pulmonary toxicity was the main toxicity which occurred in 16 of 20 patients. In group 3, grades 3 and 4 pulmonary toxicity occurred in two of six patients and grade 3 esophagitis in one patient. The maximum tolerated dose of paclitaxel in this study was 40 mg/m2 and the recommended dose of paclitaxel was therefore 35 mg/m2. Four complete and 11 partial responses were observed, resulting in a 75% overall response rate. The area under the concentration–time curve of paclitaxel in group 3 was significantly higher than that in group 1.
Conclusion: Nedaplatin 20 mg/m2 and paclitaxel 35 mg/m2 could be safely administered for NSCLC with concurrent thoracic RT, and this regimen was effective. The most important DLT was pulmonary toxicity.
Key Words: non-small cell lung cancer • paclitaxel • nedaplatin • radiotherapy • pulmonary toxicity • pharmacokinetics
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