title: Raltitrexed plus oxaliplatin-based transarterial chemoembolization in patients with unresectable hepatocellular carcinoma.
abstract: Raltitrexed has shown efficacy and safety in many tumor types; however, the clinical data on the treatment of hepatocellular carcinoma is rare. In this report, we aim to assess the efficacy and safety of raltitrexed plus oxaliplatin (OXA)-based transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (uHCC). Patients with uHCC were recruited from multi-centers in China and assigned randomly to raltitrexed+OXA-based (n=76), fluorouracil+OXA-based (n=76), and doxorubicin+OXA-based (n=75) TACE treatment. The primary end point was overall survival (OS). Tumor response was assessed using response evaluation criteria in solid tumors (RECIST), modified response evaluation criteria in solid tumors (mRECIST), and European Association for the Study of the Liver criteria (EASL). Safety and toxicity were evaluated using the National Cancer Institute Common Toxicity Criteria. The raltitrexed group showed a better disease control rate evaluated using RECIST (raltitrexed vs. fluorouracil vs. doxorubicin: 96.1 vs. 84.2 vs. 86.7%, P=0.05) and a better overall response rate on the basis of mRECIST (67.1 vs. 47.4 vs. 50.7%, P=0.03) and EASL (67.1 vs. 47.4 vs. 49.3%, P=0.02). The median OS and median progression-free survival (PFS) were higher in the raltitrexed group (median OS: 13.4 vs. 9.6 vs. 8.5 months; median PFS: 6.7 vs 4.9 vs 4.6 months). The most common toxicities included elevated aspartate aminotransferase (78.9 vs. 86.8 vs. 81.3%) and abdominal nonspecific pain (68.4 vs. 81.6 vs. 78.7%). No significant differences were found in the overall number of patients who experienced any toxicity. Raltitrexed plus OXA-based TACE suggested a safe and efficacious regimen in uHCC patients. The results warrant further clinical investigation.
authors.affiliation: aDepartment of Interventional Radiology, Affiliated Tumor Hospital of Guangxi Medical University bDepartment of Interventional Radiology, People's Hospital of Guangxi Zhuang Autonomous Region cDepartment of Oncology, People's Hospital of Liuzhou City dDepartment of Oncology, Liuzhou Worker Hospital eDepartment of Oncology, Affiliated Hospital of Youjiang Medical University fDepartment of Oncology, People's Hospital of Beihai City gDepartment of Infection, People's Hospital of Guidong hDepartment of Interventional Radiology, People's Hospital of Hezhou City iDepartment of Oncology, People's Hospital of Rong County, Guangxi, China.
authors.forename: Chang
authors.initials: C
authors.lastname: Zhao
authors.forename: Liwei
authors.initials: L
authors.lastname: Fan
authors.forename: Feng
authors.initials: F
authors.lastname: Qi
authors.forename: Shengqiu
authors.initials: S
authors.lastname: Ou
authors.forename: Lei
authors.initials: L
authors.lastname: Yu
authors.forename: Xiaoyu
authors.initials: X
authors.lastname: Yi
authors.forename: Bingqiang
authors.initials: B
authors.lastname: Ni
authors.forename: Zhiyong
authors.initials: Z
authors.lastname: Zheng
authors.forename: Jianxun
authors.initials: J
authors.lastname: Lu
authors.forename: Chengwen
authors.initials: C
authors.lastname: Zhang
authors.forename: Changsheng
authors.initials: C
authors.lastname: Chen
authors.forename: Xiong
authors.initials: X
authors.lastname: Lu
authors.forename: Lin
authors.initials: L
authors.lastname: Cheng
authors.forename: Tianlian
authors.initials: T
authors.lastname: Hu
authors.forename: Yilong
authors.initials: Y
authors.lastname: Ma
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D006528:Carcinoma, Hepatocellular / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008113:Liver Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011799:Quinazolines / Q000008:administration & dosage; D013876:Thiophenes / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D009944:Organoplatinum Compounds; D011799:Quinazolines; D013876:Thiophenes; D000077150:Oxaliplatin; D004317:Doxorubicin; C068874:raltitrexed; D005472:Fluorouracil