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Pilot Study of Concurrent Etoposide and Cisplatin Plus Accelerated Hyperfractionated Thoracic Radiotherapy Followed by Irinotecan and Cisplatin for Limited-Stage Small Cell Lung Cancer: Japan Clinical Oncology Group 9903

Authors' Affiliations: ¹ National Cancer Center Hospital East, Kashiwa, Japan; ² Aichi Cancer Center, Nagoya, Japan; ³ Kanagawa Cancer Center, ⁴ Yokohama Municipal Citizen's Hospital, Yokohama, Japan; ⁵ Tochigi Cancer Center, Utsunomiya, Japan; ⁶ National Kinki Central Hospital for Chest Disease, Sakai, Japan; ⁷ Osaka City General Hospital, ⁸ Osaka Adult Disease and Cancer Center, Osaka, Japan; and ⁹ National Cancer Center Hospital, Tokyo, Japan

Requests for reprints: Kaoru Kubota, Thoracic Oncology Division, National Cancer Center Hospital East, 6-5-1 Kashiwanoha Kashiwa, Chiba 277-8577 Japan. Phone: 81-4-7133-1111; Fax: 81-4-7131-4724; E-mail: kkubota{at}east.ncc.go.jp.

Purpose: Irinotecan and cisplatin (IP) significantly improved survival compared with etoposide and cisplatin (EP), in patients with extensive-stage small cell lung cancer (SCLC) in a previous Japan Clinical Oncology Group (JCOG) randomized trial. JCOG9903 was conducted to evaluate the safety of sequentially given IP following concurrent EP plus twice-daily thoracic irradiation (TRT) for the treatment of limited-stage SCLC (LSCLC).

Experimental Design: Between October 1999 and July 2000, 31 patients were accrued from 10 institutions. Thirty patients were assessable for toxicity, response, and survival. Treatment consisted of etoposide 100 mg/m² on days 1 to 3, cisplatin 80 mg/m² on day 1, and concurrent twice-daily TRT of 45 Gy beginning on day 2. The IP regimen started on day 29 and consisted of irinotecan 60 mg/m² on days 1, 8, and 15 and cisplatin 60 mg/m² on day 1, with three 28-day cycles.

Results: There were no treatment-related deaths. The response rate was 97% (complete response, 37%; partial response, 60%). Median overall survival was 20.2 months; 1-, 2-, and 3-year survival rates were 76%, 41%, and 38%, respectively. Of the 24 patients who started the IP regimen, 22 received two or more cycles. Hematologic toxicities of grade 3 or 4 included neutropenia (67%), anemia (50%), and thrombocytopenia (4%). Nonhematologic toxicities of grade 3 or 4 included diarrhea (8%), vomiting (8%), and febrile neutropenia (8%). Of the 20 patients with recurrence, none had local recurrence alone and only two had both local and distant metastasis as the initial sites of disease progression.

Conclusions: IP following concurrent EP plus twice-daily TRT is safe with acceptable toxicities. A randomized phase III trial comparing EP with IP following EP plus concurrent TRT for LSCLC is ongoing (JCOG0202).

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