ZhengGang Ren1, KangShun Zhu1, HaiYan Kang1, MinQiang Lu1, ZengQiang Qu1, LiGong Lu1, TianQiang Song1, WeiPing Zhou1, Hui Wang1, WeiZhu Yang1, Xuan Wang1, YongPing Yang1, LeHua Shi1, YuXian Bai1, XiaoFeng Guo1, Sheng-Long Ye2. 1. ZhengGang Ren and Sheng-Long Ye, Liver Cancer Institute, Zhongshan Hospital, Fudan University, and Key Laboratory of Carcinogenesis and Cancer Invasion, Ministry of Education; ZengQiang Qu, WeiPing Zhou, and LeHua Shi, Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai; KangShun Zhu and MinQiang Lu, The Third Affiliated Hospital of Sun Yat-sen University; LiGong Lu, Guangdong Provincial People's Hospital, Guangdong; HaiYan Kang, 301 Military Hospital; YongPing Yang, 302 Military Hospital; XiaoFeng Guo, Chinese Anti-Cancer Association, Beijing; TianQiang Song, Tianjin Cancer Hospital, Tianjin; Hui Wang, Jilin Provincial Tumor Hospital, Jilin; WeiZhu Yang, Union Hospital of Fujian Medical University, Fujian; Xuan Wang, The 81 Hospital of the Chinese People's Liberation Army, Nanjing; and YuXian Bai, Heilongjiang Provincial Cancer Hospital, Heilongjiang, People's Republic of China. 2. ZhengGang Ren and Sheng-Long Ye, Liver Cancer Institute, Zhongshan Hospital, Fudan University, and Key Laboratory of Carcinogenesis and Cancer Invasion, Ministry of Education; ZengQiang Qu, WeiPing Zhou, and LeHua Shi, Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai; KangShun Zhu and MinQiang Lu, The Third Affiliated Hospital of Sun Yat-sen University; LiGong Lu, Guangdong Provincial People's Hospital, Guangdong; HaiYan Kang, 301 Military Hospital; YongPing Yang, 302 Military Hospital; XiaoFeng Guo, Chinese Anti-Cancer Association, Beijing; TianQiang Song, Tianjin Cancer Hospital, Tianjin; Hui Wang, Jilin Provincial Tumor Hospital, Jilin; WeiZhu Yang, Union Hospital of Fujian Medical University, Fujian; Xuan Wang, The 81 Hospital of the Chinese People's Liberation Army, Nanjing; and YuXian Bai, Heilongjiang Provincial Cancer Hospital, Heilongjiang, People's Republic of China. slye@shmu.edu.cn.
Abstract
PURPOSE: To assess whether urea-based cream (UBC) has prophylactic benefits on sorafenib-induced hand-foot skin reaction (HFSR) in patients with advanced hepatocellular carcinoma (HCC). PATIENTS AND METHODS: In this randomized, open-label trial, 871 patients with advanced HCC throughout China were treated with10% UBC three times per day plus best supportive care (BSC; n = 439) or BSC alone excluding all creams (n = 432), starting on day 1 of sorafenib treatment, for up to 12 weeks. HFSR was assessed every 2 weeks and at 14 weeks for patients completing the study. Once HFSR occurred, patients were allowed any cream, including a UBC. RESULTS: The 12-week incidence of any grade HFSR was significantly lower in the UBC group versus the BSC-alone group (56.0% v 73.6%, respectively; odds ratio [OR], 0.457; 95% CI, 0.344 to 0.608; P < .001), as was the incidence of grade ≥ 2 HFSR (20.7% v 29.2%, respectively; OR, 0.635; 95% CI, 0.466 to 0.866; P = .004). Median time to first occurrence of HFSR was significantly longer in the UBC group than the BSC-alone group (84 v 34 days, respectively; hazard ratio, 0.658; 95% CI, 0.541 to 0.799; P < .001). Elevated AST was associated with increased risk of HFSR but did not alter the treatment effect of UBC. UBC plus BSC, compared with BSC alone, did not affect the sorafenib dose reduction or interruption rate (9.1% v 11.8%, respectively; P = .1937), response rate (11.1% v 10.1%, respectively; P = .6674), or disease control rate (98.8% v 98.2%, respectively; P = .5350) at week 12. CONCLUSION:UBC prophylaxis in patients with advanced HCC startingsorafenib reduced HFSR rates, extended the time to first occurrence of HFSR, and improved patient quality of life compared with BSC. Blinded, randomized, placebo-controlled trials to determine the role of UBC on the incidence and severity of HFSR are warranted.
RCT Entities:
PURPOSE: To assess whether urea-based cream (UBC) has prophylactic benefits on sorafenib-induced hand-foot skin reaction (HFSR) in patients with advanced hepatocellular carcinoma (HCC). PATIENTS AND METHODS: In this randomized, open-label trial, 871 patients with advanced HCC throughout China were treated with 10% UBC three times per day plus best supportive care (BSC; n = 439) or BSC alone excluding all creams (n = 432), starting on day 1 of sorafenib treatment, for up to 12 weeks. HFSR was assessed every 2 weeks and at 14 weeks for patients completing the study. Once HFSR occurred, patients were allowed any cream, including a UBC. RESULTS: The 12-week incidence of any grade HFSR was significantly lower in the UBC group versus the BSC-alone group (56.0% v 73.6%, respectively; odds ratio [OR], 0.457; 95% CI, 0.344 to 0.608; P < .001), as was the incidence of grade ≥ 2 HFSR (20.7% v 29.2%, respectively; OR, 0.635; 95% CI, 0.466 to 0.866; P = .004). Median time to first occurrence of HFSR was significantly longer in the UBC group than the BSC-alone group (84 v 34 days, respectively; hazard ratio, 0.658; 95% CI, 0.541 to 0.799; P < .001). Elevated AST was associated with increased risk of HFSR but did not alter the treatment effect of UBC. UBC plus BSC, compared with BSC alone, did not affect the sorafenib dose reduction or interruption rate (9.1% v 11.8%, respectively; P = .1937), response rate (11.1% v 10.1%, respectively; P = .6674), or disease control rate (98.8% v 98.2%, respectively; P = .5350) at week 12. CONCLUSION:UBC prophylaxis in patients with advanced HCC starting sorafenib reduced HFSR rates, extended the time to first occurrence of HFSR, and improved patient quality of life compared with BSC. Blinded, randomized, placebo-controlled trials to determine the role of UBC on the incidence and severity of HFSR are warranted.
Authors: Mario E Lacouture; David J Kopsky; Raphael Lilker; Fiona Damstra; Mecheline H M van der Linden; Azael Freites-Martinez; Mischa P M Nagel Journal: J Am Podiatr Med Assoc Date: 2018-11
Authors: Kathryn A Guerriero; Steven R Wilson; Nabil E Boutagy; Chi Liu; Albert J Sinusas; Caroline J Zeiss Journal: Comp Med Date: 2018-02-01 Impact factor: 0.982
Authors: Aminah Jatoi; Fang-Shu Ou; Daniel H Ahn; Tyler J Zemla; Jennifer G Le-Rademacher; Patrick Boland; Kristen K Ciombor; Nisha L Jacobs; Boris Pasche; James M Cleary; Jeannine S McCune; Katrina S Pedersen; Afsaneh Barzi; E Gabriela Chiorean; Erica N Heying; Heinz-Josef Lenz; Jeff A Sloan; Axel Grothey; Mario E Lacouture; Tanios Bekaii-Saab Journal: Oncologist Date: 2021-03-06