Randomized PII Trial Comparing CDDP/TS1 With CDDP/DTX With Concurrent Radiotherapy in Locally Advanced NSCLC (TORG1018)

Abstract

Purpose: This randomized phase II study evaluated the usefulness and safety of concurrent TS‐1‐cisplatin and thoracic radiation therapy (TRT) compared with docetaxel‐cisplatin and TRT. Patients and Methods: Patients with stage IIIA/B unresectable nonsquamous nonsmall cell lung cancer were randomly divided into (1:1): Group A, TS‐1 40 mg/m2 (days 1‐14) and cisplatin 60 mg/m2 (day 1) for four cycles plus concurrent TRT (60 Gy/30f); or Group B, docetaxel etoposide 50 mg/m2 (day 1) and cisplatin 80 mg/m2 (day 1) for four cycles plus concurrent TRT. The primary objective was the two‐year survival rate. Results: One hundred and six patients were enrolled from May 2011‐ August 2014 (A: 53 cases, B: 53 cases). The ORR was A: 71.7% and B: 67.9%. DCR was A: 98.1% and B: 92.5%.The average courses were A: 3.5 and B: 3.6. G3 and greater hematologic toxicities (A/B) were: leukopenia (34.0/62.3%), neutropenia (28.3/56.6%), thrombocytopenia (0/ 5.7%) and anemia (9.4/13.2%). G3 and greater nonhematological toxicities (A/B) were: febrile neutropenia (1.9/11.3%), anorexia (9.4/18.9%), nausea (1.9/5.7%), diarrhea (3.8/ 3.8%), pneumonitis (0/7.5%) and esophagitis (3.8/3.8%). G3 and G4 toxicities were much more frequently observed in Group B. There was no death due to treatment. The PFS was A: 11.5 months and B: 17.2 months, and the 1‐year survival rate was A: 45% and B: 64%. Conclusion: The toxicities are more severe in CDDP/DOC/TRT compared with CDDP/TS1/TRT. However, the PFS tends to be longer in CDDP/DOC/TRT compared with CDDP/TS1/TRT.