Purpose: To determine the efficacy of consolidation chemotherapy (CC) with docetaxel and cisplatin (DP) after concurrent chemoradiotherapy (CCRT) with the same agents in locally advanced non–small-cell lung cancer (LA-NSCLC). Patient and Methods: Patients were randomly assigned to either CCRT alone (observation arm) or CCRT followed by CC (consolidation arm). CCRT with docetaxel (20 mg/m²) and cisplatin (20 mg/m²) was administered every week for 6 weeks with a total dose of 66 Gy of thoracic radiotherapy in 33 fractions. In the consolidation arm, patients were further treated with three cycles of DP (35 mg/m² each on days 1 and 8, every 3 weeks). The primary end point was 40% improvement in progression-free survival (PFS) compared with observation. Results: From October 2005 to April 2011, 437 patients were randomly assigned. Seventeen patients did not start CCRT as a result of consent withdrawal or ineligibility reasons after random assignment, leaving 420 patients for this analysis (n = 211 for observation; n = 209 for consolidation). Patient characteristics were similar in both arms. In the consolidation arm, 143 patients (68%) received CC, of whom 88 (62%) completed three planned cycles. The median PFS was 8.1 months in the observation arm and 9.1 months in the consolidation arm (hazard ratio, 0.91; 95% CI, 0.73 to 1.12; P = .36). Median overall survival times were 20.6 and 21.8 months in the observation and consolidation arms, respectively (HR, 0.91; 95% CI, 0.72 to 1.25; P = .44). Conclusion: CC with DP after CCRT with weekly DP in LA-NSCLC failed to further prolong PFS. CCRT alone should remain the standard of care.

Hye-Kyung Jung, Seung Joo Kang, Yong Chan Lee, Hyo-Joon Yang, Seon-Young Park, Cheol Min Shin, Sung Eun Kim, Hyun Chul Lim, Jie-Hyun Kim, Su Youn Nam, Woon Geon Shin, Jae Myung Park, Il Ju Choi, Jae Gyu Kim, and Miyoung Choi, Korean College of Helicobacter and Upper Gastrointesinal Research. Gut and Liver -0001;0:. https://doi.org/10.5009/gnl20288