國家衛生研究院 NHRI:Item 3990099045/11845
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    題名: Randomized, phase III trial comparing adjuvant gemcitabine (Gem) versus Gem plus chemoradiation (CCRT) in curatively resected pancreatic ductal adenocarcinoma (PDAC): A Taiwan cooperative oncology group study
    作者: Chang, HJ;Chiu, YF;Chen, JS;Li, CP;Ho, CL;Shyr, YM;Chiou, WC;Yeh, CN;Hsieh, RK;Lin, YL;Tien, YW;Hwang, TL;Shan, YS;Chen, LT
    貢獻者: National Institute of Cancer Research
    摘要: Background: Adjuvant chemotherapy is the standard of care for PDAC after curative intent surgery. Current study aims to evaluate the role of additional consolidation CCRT to 6-month adjuvant Gem therapy in resectable PDAC. Methods: Patients with R0/R1 resected PDAC, and negative CT finding within 2 weeks and CA-19.9 <2.5x NUL within one week before registration were eligible. Enrolled patients were stratified by section margin, tumor size and lymph node status then randomized to have either 6 cycles of weekly gemcitabine, day 1, 8 and 15 every 28 days (Arm 1) or 3 cycles of weekly Gem followed by Gem-based CCRT and then another 3 cycles of Gem (Arm 2). The treatment should be initiated within 8 weeks after surgery. The primary end-point was recurrence-free survival (RFS). Secondary end points were overall survival (OS), progression pattern, safety profile and quality of life. Results: Between 2009 and 2015, 147 patients were included, 74 in Arm 1 and 73 in Arm 2. With a minimum of 2 years follow-up, the median RFS was similar between Arm 1 and Arm 2: 12.1(95% CI, 9·0-15·8) versus 13.3 (95% CI, 10.0-17.1) months, (hazard ratio 0.96 [95% CI, 0·67-1·37, p = 0.80]); while OS was 23·5 (95% CI, 18·1-30.8) versus 21·5 (95% CI, 16·7-28·1) months, (hazard ratio 1.07 [95% CI, 0·74-1·55, p = 0·73]). Local recurrence rate was marginally less in Arm 2 (17.6% vs 15.1%, p = 0·68). Grade 3/4 toxicity was 66% vs 73% in Arm 1 and 2, respectively, p = 0·34. Patients in Arm 1 had a trend of better global health status, p = 0·12. Conclusions: This is the first randomized trial using survival as primary endpoint to evaluate the role of add-on CCRT for curatively resected PDAC receiving standard, adjuvant Gem therapy. Despite a trend of better loco-regional control, the add-on CCRT did not improve the RFS and OS in such a patient population. Systemic chemotherapy should remain as the standard of care for PDAC after curative-intent surgery.
    日期: 2018-10
    關聯: Annals of Oncology. 2018 Oct;29(Suppl. 8):Meeting Abstract 626PD.
    Link to: https://doi.org/10.1093/annonc/mdy282.010
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000459277301206
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85081531246
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