Phase I/II study of induction chemotherapy using carboplatin plus irinotecan and sequential thoracic radiotherapy (TRT) for elderly patients with limited-disease small-cell lung cancer (LD-SCLC): TORG 0604

BMC Cancer

Research Article

Yosuke Miura¹  Koichi Minato¹  Terufumi Kato²  Takashi Ogura²  Masafumi Sata²  Jiichiro Sasaki³  Sakiko Otani³  Akira Takakura³  Noriyuki Masuda³  Takuma Yokoyama⁴  Saori Takata⁴  Koshiro Watanabe⁵  Mari Ishii⁵  Hiroaki Okamoto⁵  Yuki Misumi⁵  Tsuneo Shimokawa⁵  Yukio Hosomi⁶  Yusuke Okuma⁶  Makoto Nagamata⁶  Katsuhiko Naoki⁷ 

[1] Department of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1 Takahayashinishi-cho, Ohta, Gunma, Japan;Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 6-16-1 Tomiokahigashi, Kanazawa-ku, Yokohama, Kanagawa, Japan;Department of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1 Minami-ku, Sagamihara, Kanagawa, Japan;Department of Respiratory Medicine, Kyorin University School of Medicine, Kyorin University Hospital, 6-20-2 Shinkawa, Mitaka, Tokyo, Japan;Department of Respiratory Medicine, Yokohama Municipal Citizen’s Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, Japan;Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, Japan;Division of Pulmonary Medicine, Keio University School of Medicine, Keio University Hospital, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan;

关键词: LD-SCLC;    Irinotecan;    Sequential radiotherapy;    Elderly;    Carboplatin;    Phase I;    Phase II;   

DOI  :  10.1186/s12885-017-3353-y

 received in 2016-09-22, accepted in 2017-05-15,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThe role of irinotecan for elderly patients with LD-SCLC has been unclear, and the timing of TRT combined with chemotherapy has not been fully evaluated.MethodsPatients aged > 70 years with untreated, measurable, LD-SCLC, performance status (PS) 0–2, and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8, every 21 days for 4 cycles, and sequential TRT (54Gy in 27 fractions). Carboplatin doses were based on AUC of 4 and 5 (levels 1 and 2, respectively), with a fixed irinotecan dose (50 mg/m2). Primary objective of the phase II study was overall responce rate. ResultsForty-three patients were enrolled and forty-one were finally analyzed (median age: 75 years [range 70–86 years); males 31; PS 0/1/2, n = 22/18/1]. Two patients were excluded because of protocol violation (ascertained to be extensive disease). Twelve patients were accrued at phase I and the number of patients with carboplatin dose-limiting toxicities at levels-1 (n = 6) and −2 (n = 6) were 1(grade 3 hypertension) and 2 (grade 4 thrombocytopenia), respectively. The phase II trial was expanded to 29 additional patients receiving the level 1 carboplatin dose, total of 35 patients. The median number of chemotherapy cycles was 4 (range 1–4), and the median radiation dose was 54Gy (range 36–60). Toxicities were generally mild. There were 4 complete and 27 partial responses (response rate 88.6%). With a median follow-up of 52 months, the median progression-free and overall survival times of phase II were 11.2 and 27.1 months, respectively.ConclusionsInduction chemotherapy of carboplatin plus irinotecan and sequential TRT was well tolerated and effective for elderly patients with LD-SCLC. Additional confirmatory studies are warranted.Trial registrationTrial registration number: UMIN000007352Name of registry: UMIN.Date of registration: 1/Dec/2006.Date of enrolment of the first participant to the trial: 6/Feb/2007.Clinical trial registration date: 1/Feb/2006 (prospective).

【 授权许可】

CC BY   
© The Author(s). 2017