title: Cryotherapy is associated with improved clinical outcomes of Sorafenib therapy for advanced hepatocellular carcinoma.
abstract: We assessed the safety and efficacy of sorafenib with cryotherapy (cryoRx) in advanced hepatocellular carcinoma (HCC). One hundred four HCC patients were enrolled, who met the following criteria: (i) Barcelona Clinic Liver Cancer stage C; (ii) HCC without distant metastasis; (iii) the presence of portal vein thrombosis (PVT); (iv) Child-Pugh class A or B; and (v) life expectancy of at least 12 weeks. The patients were randomly divided into sorafenib-cryoRx and sorafenib (control) groups. Primary endpoint was time to progression (TTP); secondary endpoints included overall survival (OS) and tolerability. Microvessel density (MVD) was assessed by CD34-immunostaining. After a median 10.5 (4-26) months follow-up, the data showed that median TTP was 9.5 (8.4-13.5) months in combinatorial therapy group vs. 5.3 (3.8-6.9) months in sorafenib group (P = 0.02). The median OS was 12.5 (95 % CI 10.6-16.4) months in combination therapy group vs. 8.6 (7.3-10.4) months in sorafenib group (P = 0.01). Low MVD patients in combination therapy exhibited significantly longer median TTP and OS than controls. High MVD was predictive of poor responses to sorafenib. CryoRx did not increase frequency/degree of sorafenib-related adverse events. Therefore, it was concluded that the addition of cryoRx significantly improved clinical outcomes of Sorafenib therapy in advanced HCC with acceptable tolerance and similar safety profiles as previously reported.
authors.affiliation: Center of Therapeutic Research for Hepatocellular Carcinoma, Beijing the 302nd Hospital, 100 Xisihuan Middle Road, Beijing 100039, China. yongpingyang@hotmail.com
authors.forename: Yongping
authors.initials: Y
authors.lastname: Yang
authors.forename: Yinying
authors.initials: Y
authors.lastname: Lu
authors.forename: Chunping
authors.initials: C
authors.lastname: Wang
authors.forename: Wenlin
authors.initials: W
authors.lastname: Bai
authors.forename: Jianhui
authors.initials: J
authors.lastname: Qu
authors.forename: Yan
authors.initials: Y
authors.lastname: Chen
authors.forename: Xiujuan
authors.initials: X
authors.lastname: Chang
authors.forename: Linjing
authors.initials: L
authors.lastname: An
authors.forename: Lin
authors.initials: L
authors.lastname: Zhou
authors.forename: Zhen
authors.initials: Z
authors.lastname: Zeng
authors.forename: Min
authors.initials: M
authors.lastname: Lou
authors.forename: Jiyun
authors.initials: J
authors.lastname: Lv
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000098:blood supply / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D017679:Cryotherapy / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000098:blood supply / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D055806:Microvessels / Q000473:pathology; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib