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• W4205255795 abstract "456 Background: Recent advances in treatment of advanced hepatocellular carcinoma (HCC) includes novel immunotherapy and anti-angiogenic tyrosine kinases. However, there is no treatment option for the heavily treated HCC patients, and the role of cytotoxic chemotherapy regimens, such as oxaliplatin based doublets, are unknown. We aimed to investigate the antitumor activity of gemcitabine and oxaliplatin in advanced HCC patients who failed sorafenib treatment. Methods: This prospective single-arm, single-center phase II trial was conducted in Yonsei Cancer Center, Korea. Gemcitabine 1000mg/m 2 IV D1 and oxaliplatin 100mg/m 2 IV D1 were given every 2 weeks to Child Pugh Class A or B7 HCC patients who progressed after or cannot tolerate sorafenib treatment. Patients with HCC of >60% liver occupation or portal vein invasion at the main portal branch (Vp4) were excluded. The primary endpoint was progression-free survival (PFS) rate at 6months and the secondary endpoints included PFS, overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety profile, and exploratory molecular biomarker analysis. Results: Total of 32 patients were treated between May 2015 and July 2019 with median follow up of 10.2 months. Most of the patients were ECOG PS 1 (93.8%), B-viral (90.6%), and BCLC-C (96.9%). Patients had multiple distant metastatic sites including lung (81.2%) and lymph node (34.3%). Patients were heavily treated with 25% of patients treated as fourth-line and 18.7% of patients treated as fifth-line or later. The PFS rate at 6 months was 15.6%. Median PFS was 3.87 months and median OS was 10.5 months. 9.4% of the patients achieved partial response, and DCR was 65.6%. Median number of treatment cycles were 6 (range, 3 to 25). Treatment-related AE (≥G3) occurred in 15 patients (46.9%) including 5 patients (15.6%) with asthenia, 5 patients (15.6%) with sensory neuropathy, and 4 patients (12.5%) with thrombocytopenia. Conclusions: Gemcitabine and oxaliplatin for sorafenib failed, heavily treated advanced HCC were tolerable and showed modest efficacy. Although novel agents are currently adopted in clinics to treat advanced HCC, gemcitabine and oxaliplatin could be considered as later-line treatment option for heavily treated HCC patients. Exploratory molecular biomarker analysis results will be presented." @default.
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• W4205255795 date "2022-02-01" @default.
• W4205255795 modified "2023-09-26" @default.
• W4205255795 title "Phase II study of gemcitabine with oxaliplatin (GEMOX) in heavily treated patients with advanced hepatocellular carcinoma after failure of sorafenib treatment (PEACH)." @default.
• W4205255795 doi "https://doi.org/10.1200/jco.2022.40.4_suppl.456" @default.
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