caa a22 4500 60549150X CHVBK 20210128100510.0 cr unu---uuuuu 210128e20151001xx s 000 0 eng 10.1007/s10147-015-0796-5 doi (NATIONALLICENCE)springer-10.1007/s10147-015-0796-5 First-line gemcitabine and oxaliplatin (GEMOX) plus sorafenib, followed by sorafenib as maintenance therapy, for patients with advanced hepatocellular carcinoma: a preliminary study [Elektronische Daten] [Ying Liu, Han Yue, Shuning Xu, Feng Wang, Ning Ma, Ke Li, Lei Qiao, Jufeng Wang] Background: Because of the poor prognosis of unresectable or metastatic hepatocellular carcinoma there is a need for effective systemic therapy. The purpose of this study was to assess the efficacy and safety of gemcitabine and oxaliplatin (GEMOX) combined with sorafenib, as first-line therapy, followed by sorafenib as maintenance therapy for patients with advanced hepatocellular carcinoma (HCC). Methods: In this open-label, multicenter, single-group, prospective study, eligible patients with advanced HCC received oral sorafenib 400mg twice daily, gemcitabine 1,000mg/m2 intravenously (i.v.) on day 1 and oxaliplatin 85mg/m2 i.v. on day 2 every 14days for up to six cycles. Patients without disease progression were then treated further with sorafenib as maintenance therapy until disease progression. Results: All forty-nine patients completed six cycles of combined GEMOX and sorafenib therapy. The objective response was 26.5%. The median time to progression was 10.3months (95% CI: 8.7-11.9months) and median overall survival was 15.7months (95% CI: 13.0-18.4months). During the combination therapy, the most common grade 3/4 hematologic toxicity was neutropenia (22.4%, 11/49 patients) and thrombocytopenia (14.3%, 7/49 patients); grade 3/4 non-hematologic toxicity was fatigue (22.4%, 11/49 patients) and appetite loss (18.4%, 9/49 patients). During the maintenance therapy, grade 3/4 adverse events were nonhematologic toxicity, for example fatigue (16.0%, 4/25 patients) and appetite loss (16.0%, 4/25 patients). Conclusions: GEMOX combined with sorafenib as first-line therapy followed by sorafenib as maintenance therapy was effective with manageable toxicity for patients with advanced hepatocellular carcinoma. However, the results should be further validated in controlled phase II trials. Japan Society of Clinical Oncology, 2015 Gemcitabine nationallicence Oxaliplatin nationallicence Sorafenib nationallicence Hepatocellular carcinoma nationallicence Chemotherapy nationallicence Liu Ying Department of Oncology, Henan Cancer Hospital, Zhengzhou University Affiliated Cancer Hospital, 127th Dongming Rd, 450003, Zhengzhou, Henan, China aut Yue Han Department of Oncology, The First People's Hospital of Zhengzhou City, Zhengzhou, Henan, China aut Xu Shuning Department of Oncology, Henan Cancer Hospital, Zhengzhou University Affiliated Cancer Hospital, 127th Dongming Rd, 450003, Zhengzhou, Henan, China aut Wang Feng Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China aut Ma Ning Department of Oncology, Henan Provincial People Hospital, Zhengzhou, Henan, China aut Li Ke Department of Oncology, Henan Cancer Hospital, Zhengzhou University Affiliated Cancer Hospital, 127th Dongming Rd, 450003, Zhengzhou, Henan, China aut Qiao Lei Department of Oncology, Henan Cancer Hospital, Zhengzhou University Affiliated Cancer Hospital, 127th Dongming Rd, 450003, Zhengzhou, Henan, China aut Wang Jufeng Department of Oncology, Henan Cancer Hospital, Zhengzhou University Affiliated Cancer Hospital, 127th Dongming Rd, 450003, Zhengzhou, Henan, China aut International Journal of Clinical Oncology Springer Japan 20/5(2015-10-01), 952-959 1341-9625 20:5<952 2015 20 10147 https://doi.org/10.1007/s10147-015-0796-5 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-015-0796-5 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Liu Ying Department of Oncology, Henan Cancer Hospital, Zhengzhou University Affiliated Cancer Hospital, 127th Dongming Rd, 450003, Zhengzhou, Henan, China aut NATIONALLICENCE 700 1- Yue Han Department of Oncology, The First People's Hospital of Zhengzhou City, Zhengzhou, Henan, China aut NATIONALLICENCE 700 1- Xu Shuning Department of Oncology, Henan Cancer Hospital, Zhengzhou University Affiliated Cancer Hospital, 127th Dongming Rd, 450003, Zhengzhou, Henan, China aut NATIONALLICENCE 700 1- Wang Feng Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China aut NATIONALLICENCE 700 1- Ma Ning Department of Oncology, Henan Provincial People Hospital, Zhengzhou, Henan, China aut NATIONALLICENCE 700 1- Li Ke Department of Oncology, Henan Cancer Hospital, Zhengzhou University Affiliated Cancer Hospital, 127th Dongming Rd, 450003, Zhengzhou, Henan, China aut NATIONALLICENCE 700 1- Qiao Lei Department of Oncology, Henan Cancer Hospital, Zhengzhou University Affiliated Cancer Hospital, 127th Dongming Rd, 450003, Zhengzhou, Henan, China aut NATIONALLICENCE 700 1- Wang Jufeng Department of Oncology, Henan Cancer Hospital, Zhengzhou University Affiliated Cancer Hospital, 127th Dongming Rd, 450003, Zhengzhou, Henan, China aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/5(2015-10-01), 952-959 1341-9625 20:5<952 2015 20 10147