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  • Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-Small-Cell Lung Cancer: KC

    성균관의대/ 안진석, 박근칠*

  • 출처
    J Clin Oncol
  • 등재일
    2015 Aug 20
  • 저널이슈번호
    33(24):2660-6
  • 내용

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    [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.

    © 2015 by American Society of Clinical Oncology.

     

    [Author information]

    Ahn JS1, Ahn YC1, Kim JH1, Lee CG1, Cho EK1, Lee KC1, Chen M1, Kim DW1, Kim HK1, Min YJ1, Kang JH1, Choi JH1, Kim SW1, Zhu G1, Wu YL1, Kim SR1, Lee KH1, Song HS1, Choi YL1, Sun JM1, Jung SH1, Ahn MJ1, Park K2.

    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.

    2Jin 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. 

  • 편집위원

    아직 Def CCRT의 성적이 좋지 않기 때문에 도움이 되지 않을까하는 믿음하에 consolidation chemotherapy를 경험적으로 시행하고 있는데,

    2015-09-03 12:00:04

  • 편집위원

    이 연구결과를 바탕으로 consolidation chemotherapy의 routine use가 줄어들고, 치료 성적을 향상시킬 수 있는 새로운 연구개발을 위한 디딤돌이 되었으면 합니다.

    2015-09-03 12:00:04

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