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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/15912


    Title: A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study
    Other Titles: A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study
    Authors: Tsai, HJ;Yang, SH;Hsiao, CF;Kao, HF;Su, YY;Shan, YS;Yen, CJ;Du, JS;Hsu, C;Wu, IC;Chen, LT
    Contributors: National Institute of Cancer Research;Institute of Population Health Sciences
    Abstract: Background Oxaliplatin- and fluoropyrimidine-based triplet regimens have demonstrated feasibility and efficacy in the treatment of upper gastrointestinal (UGI) cancers. Herein, we evaluate the feasibility and preliminary efficacy of biweekly nab-paclitaxel plus oxaliplatin and S-1/leucovorin (SOLAR) in chemona & iuml;ve UGI cancers.Methods A 3 + 3 phase 1 study was conducted to determine the maximal tolerated dose (MTD) of oxaliplatin in SOLAR (nab-paclitaxel [150 mg/m2 in D1], oxaliplatin [60, 75, or 85 mg/m2 in D1], and oral S-1/leucovorin [35 mg/m2 and 30 mg bid from D1 to D7]). The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.Results Thirteen and 6 accruals were in the dose-escalation and MTD expansion cohorts, respectively. One of 6 patients at level III experienced dose-limiting toxicity (grade 3 diarrhea), which revealed that the MTD of oxaliplatin was 85 mg/m2. After a mean of 15.9 cycles of treatment, the most common treatment-related grade 3/4 toxicities were neutropenia (57.9%) and diarrhea (21.1%). The ORR was 63.2%. The median PFS and OS were 12.5 and 24.7 months, respectively.Conclusion The current study revealed the MTD of oxaliplatin and demonstrated the preliminary efficacy of SOLAR in UGI cancers, which deserves further investigation.ClinicalTrials.gov Identifier NCT03162510 The results of this study revealed the maximal tolerated dose of oxaliplatin and preliminary efficacy of SOLAR in upper gastrointestinal cancers, which deserves further investigation.
    Date: 2024-10
    Relation: Oncologist. 2024 Oct 3;29(10):e1396-e1405.
    Link to: http://dx.doi.org/10.1093/oncolo/oyae109
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1083-7159&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:001251254000001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85205740957
    Appears in Collections:[陳立宗] 期刊論文
    [蔡慧珍] 期刊論文
    [蘇勇曄] 期刊論文
    [蕭金福] 期刊論文

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