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Japanese Journal of Clinical Oncology Advance Access published online on April 23, 2007
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hym008
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© 2007 Foundation for Promotion of Cancer Research

Phase I Study of Cisplatin Analogue Nedaplatin, Paclitaxel, and Thoracic Radiotherapy for Unresectable Stage III Non-Small Cell Lung Cancer

Ikuo Sekine1,, Minako Sumi2, Yoshinori Ito2, Terufumi Kato1, Yasuhito Fujisaka1, Hiroshi Nokihara1, Noboru Yamamoto1, Hideo Kunitoh1, Yuichiro Ohe1 and Tomohide Tamura1

1 Divisions of Internal Medicine and Thoracic Oncology
2 Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan

Correspondence: Ikuo Sekine, Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan. E-mail: isekine{at}ncc.go.jp

Received September 6, 2006; accepted November 1, 2006

Background: The standard treatment of unresectable stage III non-small cell lung cancer is concurrent chemoradiotherapy in patients in good general condition, but where the optimal chemotherapeutic regimen has not been determined.

Methods: Patients with unresectable stage III non-small cell lung cancer received nedaplatin (80 mg/m2) and paclitaxel on day 1 every 4 weeks for 3–4 cycles and concurrent thoracic radiotherapy (60 Gy/30 fractions for 6 weeks) starting on day 1. The dose of paclitaxel was escalated from 120 mg/m2 in level 1, 135 mg/m2 in level 2 to 150 mg/m2 in level 3.

Results: A total of 18 patients (14 males and 4 females, with a median age of 62.5 years) were evaluated in this study. Full cycles of chemotherapy were administered in 83% of patients in level 1, and in 50% of patients in levels 2 and 3. No more than 50% of patients developed grade 4 neutropenia. Transient grade 3 esophagitis and infection were noted in one patient, and unacceptable pneumonitis was noted in three (17%) patients, two of whom died of the toxicity. Dose-limiting toxicity (DLT), evaluated in 15 patients, noted in one of the six patients in level 1, three of the six patients in level 2 and one of the three patients in level 3. One DLT at level 2 developed later as radiation pneumonitis. Thus, the maximum tolerated dose was determined to be level 1. The overall response rate (95% confidence interval) was 67% (41–87%) with 12 partial responses.

Conclusion: The doses of paclitaxel and nedaplatin could not be escalated as a result of severe pulmonary toxicity.

Key Words: non-small cell lung cancer • chemoradiotherapy • paclitaxel • nedaplatin • pneumonitis


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