J Clin Oncol. 2010 Jul 12. [Epub ahead of print]
Phase III Study Comparing Second- and Third-Generation Regimens With Concurrent Thoracic Radiotherapy in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer: West Japan Thoracic Oncology Group WJTOG0105.
Yamamoto N, Nakagawa K, Nishimura Y, Tsujino K, Satouchi M, Kudo S, Hida T, Kawahara M, Takeda K, Katakami N, Sawa T, Yokota S, Seto T, Imamura F, Saka H, Iwamoto Y, Semba H, Chiba Y, Uejima H, Fukuoka M.
Kinki University Hospital, Osaka-Sayama; Shizuoka Cancer Center, Naga-izumi; Hyogo Cancer Center, Akashi; Osaka City University Hospital; Osaka City General Hospital; Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka; Aichi Cancer Center Hospital; Nagoya Medical Center, Nagoya; Kinki-chuo Chest Medical Centre, Sakai; Kobe City Medical Center General Hospital, Kobe; Gifu Municipal Hospital, Gifu; Toneyama National Hospital, Toyonaka; Tokai University Hospital, Isehara; Hiroshima City Hospital, Hiroshima; and Kumamoto Regional Medical Center, Kumamoto, Japan.
Abstract
PURPOSE This phase III trial of concurrent thoracic radiotherapy (TRT) was conducted to compare third-generation chemotherapy with second-generation chemotherapy in patients with unresectable stage III non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS Eligible patients received the following treatments: A (control), four cycles of mitomycin (8 mg/m(2) on day 1)/vindesine (3 mg/m(2) on days 1, 8)/cisplatin (80 mg/m(2) on day 1) plus TRT 60 Gy (treatment break for 1 week); B, weekly irinotecan (20 mg/m(2))/carboplatin (area under the plasma concentration-time curve [AUC] 2) for 6 weeks plus TRT 60 Gy, followed by two courses of irinotecan (50 mg/m(2) on days1, 8)/carboplatin (AUC 5 on day1); C, weekly paclitaxel (40 mg/m(2))/carboplatin (AUC 2) for 6 weeks plus TRT 60 Gy, followed by two courses of paclitaxel (200 mg/m(2) on day1)/carboplatin (AUC 5 on day 1). Results The median survival time and 5-year survival rates were 20.5, 19.8, and 22.0 months and 17.5%, 17.8%, and 19.8% in arms A, B, and C, respectively. Although no significant differences in overall survival were apparent among the treatment arms, noninferiority of the experimental arms was not achieved. The incidences of grade 3 to 4 neutropenia, febrile neutropenia, and gastrointestinal disorder were significantly higher in arm A than in arm B or C (P < .001). Chemotherapy interruptions were more common in arm B than in arm A or C. CONCLUSION Arm C was equally efficacious and exhibited a more favorable toxicity profile among three arms. Arm C should be considered a standard regimen in the management of locally advanced unresectable NSCLC.
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