Both CDDP+S-1 and CDDP+PEM could be given at full systemic doses with TRT in locally advanced NSCLC, and CDDP+PEM is one of the standard chemotherapy regimens in patients with advanced non-sq NSCLC. This multicenter, randomized, open-label, phase II study (SPECTRA) compared the efficacy and safety of the two above-mentioned promising regimens combined with TRT in patients with unresectable locally advanced non-sq NSCLC.
Patients were randomly assigned to receive CDDP+S-1 (CDDP 60mg/m2, d1, and S-1 80mg/m2, d1-14, q4w, up to 4 cycles) or CDDP+PEM (CDDP 75mg/m2, d1, and PEM 500mg/m2, d1, q3w, up to 4 cycles) combined with TRT 60Gy in 30 fractions. The primary endpoint was 2-year progression-free survival (PFS) rate. The sample size was set at 100 patients.
Between Jan 2013 and Oct 2016, 102 patients were enrolled in this study from 9 institutions in Japan. All 102 patients were eligible and assessable, of whom 52 were assigned to CDDP+S-1 and 50 to CDDP+PEM. Baseline characteristics were similar (CDDP+S-1/CDDP+PEM): median age (range) 64.5 (39-73)/63.5 (32-74) years; women, n = 17 (33%)/n=17 (34%); stage IIIB, n = 21 (40%)/n=20 (40%); ECOG PS of 1, n = 14 (27%)/n=14 (28%); never smoker, n = 12 (23%)/n=12 (24%); and adenocarcinoma, n = 47(90%)/n=45(90%). Completion rate of TRT (60Gy) and chemotherapy (4 cycles) was 92%/98% and 73%/86%, respectively. Response rate was 60%/64%. Grade 3 toxicities included febrile neutropenia (12%/2%), anorexia (8%/16%), diarrhea (8%/0%), esophagitis (6%/8%), pneumonia (4%/4%), neutropenia (35%/50%), anemia (8%/12%), thrombocytopenia (4%/6%), and hyponatremia (12%/12%). Grade 2 radiation pneumonitis was observed in 8 (15%)/2 (4%) patients. No treatment-related death was observed. The data on PFS and overall survival is immature.
Response rate was similar between two arms. Toxicities were tolerable and manageable in both arms; however febrile neutropenia was more frequently observed in the CDDP+S-1 arm. Survival data will be analyzed in late 2018.
Clinical trial identification
UMIN000009914 (release date: 31/Jan/2013)
Legal entity responsible for the study
Japan Agency for Medical Research and Development
S. Niho, T. Seto: Received honoraria from Taiho and Eli Lilly and research funding from Eli Lilly. K. Sakamaki, T. Yamanaka: Received honoraria from Taiho. T. Takahashi: Received research funding from Taiho and Eli Lilly and honoraria from Eli Lilly. M. Nishio, T. Hida, H. Okamoto, M. Satouchi, K. Goto, Y. Ohe: Received research funding and honoraria from Taiho and Eli Lilly. N. Yamamoto: Received research funding from Taiho. T. Kurata: Received research funding and honoraria from Eli Lilly. All other authors have declared no conflicts of interest.