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Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin
Jin Seok Ahn1, Yong Chan Ahn1, Joo-Hang Kim1
1Jin Seok Ahn, Yong Chan Ahn, Yoon-La Choi, Jong-Mu Sun, Myung-Ju Ahn, and Keunchil Park, Samsung Medical Center, Sungkyunkwan University School of Medicine; Joo-Hang Kim and Chang Geol Lee, Yonsei Cancer Center, Yonsei University Health System; Dong-Wan Kim, Seoul National University Hospital; Jin-Hyoung Kang, Catholic University Seoul St Mary's Hospital; Sung Rok Kim, Inje University Sanggye Paik Hospital; Sang-We Kim, Asan Medical Center, University of Ulsan College of Medicine; Sin-Ho Jung, Samsung Medical Center, Office of Biomedical Science, Seoul; Eun Kyung Cho and Kyu Chan Lee, Gachon University Gil Medical Center, Incheon; Hoon-Kyo Kim, Catholic University St Vincent's Hospital; Jin-Hyuck Choi, Ajou University Hospital, Suwon; Young Joo Min, Ulsan University Hospital, Ulsan; Kyung Hee Lee, Yeungnam University Medical Center; Hong Suk Song, Keimyung University Dongsan Medical Center, Daegu, Korea; Ming Chen, Sun Yat-Sen University Cancer Center, Guangzhou; Guangying Zhu, Beijing Cancer Hospital, Beijing; Yi-Long Wu, Guandong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangdong, China.
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/m(2)) and cisplatin (20 mg/m(2)) 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/m(2) 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.
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