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: KCSG-LU05-04
In: Journal of Clinical Oncology, Jg. 33 (2015-08-20), S. 2660-2666
Online
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Zugriff:
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.
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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: KCSG-LU05-04
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Autor/in / Beteiligte Person: | Yong Chan Ahn ; Kyung Hee Lee ; Wu, Yi-Long ; Young Joo Min ; Jong Mu Sun ; Chen, Ming ; Eun Kyung Cho ; Choi, Yoon-La ; Sang We Kim ; Jung, Sin-Ho ; Dong Wan Kim ; Joo Hang Kim ; Ahn, Myung-Ju ; Park, Keunchil ; Hong Suk Song ; Jin Hyuck Choi ; Jin Hyoung Kang ; Jin Seok Ahn ; Zhu, Guangying ; Sung Rok Kim ; Kyu Chan Lee ; Chang Geol Lee ; Hoon Kyo Kim |
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Zeitschrift: | Journal of Clinical Oncology, Jg. 33 (2015-08-20), S. 2660-2666 |
Veröffentlichung: | American Society of Clinical Oncology (ASCO), 2015 |
Medientyp: | unknown |
ISSN: | 1527-7755 (print) ; 0732-183X (print) |
DOI: | 10.1200/jco.2014.60.0130 |
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