The 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.
Patients 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 objectives of the phase II study were efficacy, adverse events, and feasibility.
Forty-one patients were enrolled (median age75 years [range 70-86 years); males 31; PS 0/1/2, n = 22/18/1]. 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. 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 5 complete and 30 partial responses (response rate 90%).With a median follow-up of 80.4 months (n = 41), the median progression-free and overall survival times were 12.5 and 27.5 months, respectively.
Induction chemotherapy of carboplatin plus irinotecan and sequential TRT was well tolerated and effective for elderly patients with LD-SCLC. Additional confirmatory studies are warranted.
Clinical trial identification
Legal entity responsible for the study
Thoracic Oncology Reserch Group (TORG)
Nippon Kayaku, Taiho, Lilly, Sanofi, Chugai, Astra Zeneca, Daiichi Sankyo, Shionogi
All authors have declared no conflicts of interest.