國家衛生研究院 NHRI:Item 3990099045/11818
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    题名: Multicenter, phase II trial of biweekly S-1, leucovorin (LV), oxaliplatin and gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma (mPDAC): Final report of TCOG T1211 study
    作者: Chiang, NJ;Tsai, KK;Chen, JS;Yang, SH;Hsiao, HH;Shan, YS;Chen, LT
    贡献者: National Institute of Cancer Research
    摘要: Background: Our previous studies showed a triplet GOFL regimen consisting of gemcitabine plus modified FOLFOX4 was well-tolerated and moderate active in advanced PDAC, and the feasibility of replacing infusion 5-FU/LV with oral S-1/LV, the SLOG regimen, in a dose-escalating, phase I study. Herein, we report the phase II results of the SLOG in mPDAC patients. Methods: Patients with chemo-naïve mPDAC, ECOG PS 0-1, and 20-75 y/o of age were eligible. Intravenous fixed-rate infusion of 800 mg/m2 gemcitabine followed by 2-hr infusion of 85mg/m2 oxaliplatin on D1 plus oral S-1/LV 35/20 mg/m2, twice daily, D1-D7 were given Q 14 days as a cycle. The primary endpoint was objective response rate (ORR). Simon’s optimal two-stage design was used with estimated p0=25% and p1=40%. Results: Between Jun. 2013 and Oct. 2015, a total of 54 patients were included, with median age of 59 y/o, ECOG PS = 1 in 82%, and the presence of liver metastases in 66.7%. At the cut-off Feb.01, 2017, nine patients remained alive and their median follow-up time was 21.3 months. The ORR was partial response in 22 patients (ORR=40.7%, 95% CI, 28-55%) and stable diseases in 19 patients (35.2%). Long-term disease control rate (stable disease >16 weeks) was 64.8% (95% CI, 51-77%). The median progression-free survival and overall survival was 7.6 (95% CI, 4.4-10.7) and 11.4 (95% CI, 8.1-16.3) months, respectively. One-year and two-year survival rates were 46% and 17%, respectively. The most common treatment-related grade 3-4 adverse events included neutropenia (40.7%), anorexia (14.8%), nausea (11.1%), thrombocytopenia (9.3%), and diarrhea (7.4%). Conclusions: Current study demonstrated SLOG is a highly active regimen with manageable and favorable safety profiles for mPDAC patients. A randomized phase II trial comparing SLOG vs. modified FOLFIRINOX in advanced PDAC patients is ongoing.Clinical trial identification: NCT01415713.
    日期: 2018-10
    關聯: Annals of Oncology. 2018 Oct;29(Suppl. 8):Meeting Abstract 736P.
    Link to: https://doi.org/10.1093/annonc/mdy282.119
    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:000459277301315
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85081531798
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