Jin Seok Ahn1, Yong Chan Ahn1, Joo-Hang Kim1, Chang Geol Lee1, Eun Kyung Cho1, Kyu Chan Lee1, Ming Chen1, Dong-Wan Kim1, Hoon-Kyo Kim1, Young Joo Min1, Jin-Hyoung Kang1, Jin-Hyuck Choi1, Sang-We Kim1, Guangying Zhu1, Yi-Long Wu1, Sung Rok Kim1, Kyung Hee Lee1, Hong Suk Song1, Yoon-La Choi1, Jong-Mu Sun1, Sin-Ho Jung1, Myung-Ju Ahn1, Keunchil Park2. 1. Jin 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. 2. Jin 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. kpark@skku.edu.
Abstract
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.
RCT Entities:
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.
Authors: M Majem; J Hernández-Hernández; F Hernando-Trancho; N Rodríguez de Dios; A Sotoca; J C Trujillo-Reyes; I Vollmer; R Delgado-Bolton; M Provencio Journal: Clin Transl Oncol Date: 2019-06-06 Impact factor: 3.405
Authors: David E Gerber; James J Urbanic; Corey Langer; Chen Hu; I-Fen Chang; Bo Lu; Benjamin Movsas; Robert Jeraj; Walter J Curran; Jeffrey D Bradley Journal: Clin Lung Cancer Date: 2016-10-26 Impact factor: 4.785
Authors: Ameen Abdulla Salahudeen; Manali I Patel; Paul Baas; Walter J Curran; Jeffrey D Bradley; David R Gandara; Glenwood D Goss; Tony S Mok; Suresh S Ramalingam; Everett E Vokes; Shakun M Malik; Heather A Wakelee Journal: Clin Lung Cancer Date: 2016-06-27 Impact factor: 4.785