Department of Gastroenterology, Hitachi General Hospital, Ibaraki 317-0077, Japan.
Department of Gastroenterology and Hepatology, Ibaraki Prefectural Central Hospital, Ibaraki Cancer Center, Ibaraki 309-1793, Japan.
World J Gastroenterol. 2021 Aug 28;27(32):5424-5437. doi: 10.3748/wjg.v27.i32.5424.
Sorafenib is an oral drug that prolongs overall survival (OS) in patients with hepatocellular carcinoma. Adverse events, including hand-foot skin reaction (HFSR), lead to permanent sorafenib discontinuation.
To clarify the association between interventions for adverse events and patient prognosis.
We performed a retrospective, multicenter study of patients treated with sorafenib monotherapy between May 2009 and March 2018. We developed a mutual cooperation system that was initiated at the start of sorafenib treatment to effectively manage adverse events. The mutual cooperation system entailed patients receiving consultations during which pharmacists provided accurate information about sorafenib to alleviate the fear and anxiety related to adverse events. We stratified the patients into three groups: Group A, patients without HFSR but with pharmacist intervention; Group B, patients with HFSR and pharmacist interventions unreported to oncologists (nonmutual cooperation system); and Group C, patients with HFSR and pharmacist interventions known to oncologists (mutual cooperation system). OS and time to treatment failure (TTF) were evaluated using the Kaplan-Meier method.
We enrolled 134 patients (Group A, = 41; Group B, = 30; Group C, = 63). The median OS was significantly different between Groups A and C (6.2 13.9 mo, p < 0.01) but not between Groups A and B (6.2 7.7 mo, = 0.62). Group A Group C was an independent OS predictor (HR, 0.41; 95%CI: 0.25-0.66; < 0.01). In Group B alone, TTF was significantly lower and the nonadherence rate was higher ( < 0.01). In addition, the Spearman's rank correlation coefficients between OS and TTF in each group were 0.41 (Group A; < 0.01), 0.13 (Group B; = 0.51), and 0.58 (Group C; < 0.01). There was a highly significant correlation between OS and TTF in Group C. However, there was no correlation between OS and TTF in Group B.
The mutual cooperation system increased treatment duration and improved prognosis in patients with HFSR. Future prospective studies (, randomized controlled trials) and improved adherence could help prevent OS underestimation.
索拉非尼是一种口服药物，可延长肝细胞癌患者的总生存期 (OS)。不良事件，包括手足皮肤反应 (HFSR)，导致索拉非尼永久停药。
阐明干预不良事件与患者预后之间的关系。
我们对 2009 年 5 月至 2018 年 3 月期间接受索拉非尼单药治疗的患者进行了回顾性、多中心研究。我们开发了一种相互合作系统，该系统在开始索拉非尼治疗时启动，以有效管理不良事件。相互合作系统涉及到患者接受咨询，药剂师提供有关索拉非尼的准确信息，以减轻与不良事件相关的恐惧和焦虑。我们将患者分为三组：A 组，无 HFSR 但接受药剂师干预的患者；B 组，有 HFSR 且未向肿瘤学家报告药剂师干预的患者（非相互合作系统）；C 组，有 HFSR 且肿瘤学家知晓药剂师干预的患者（相互合作系统）。使用 Kaplan-Meier 方法评估 OS 和治疗失败时间 (TTF)。
我们纳入了 134 名患者（A 组 = 41 例；B 组 = 30 例；C 组 = 63 例）。A 组和 C 组之间的中位 OS 差异具有统计学意义（6.2 13.9 mo，p < 0.01），但 A 组和 B 组之间的差异无统计学意义（6.2 7.7 mo， = 0.62）。A 组与 C 组相比是 OS 的独立预测因素（HR，0.41；95%CI：0.25-0.66； < 0.01）。在 B 组中，TTF 明显降低，不依从率更高（ < 0.01）。此外，每组中 OS 与 TTF 之间的 Spearman 秩相关系数分别为 0.41（A 组； < 0.01）、0.13（B 组； = 0.51）和 0.58（C 组； < 0.01）。在 C 组中，OS 与 TTF 之间存在高度显著的相关性。然而，在 B 组中，OS 与 TTF 之间没有相关性。
相互合作系统延长了 HFSR 患者的治疗持续时间并改善了预后。未来的前瞻性研究（ 、随机对照试验）和改善依从性有助于防止 OS 低估。
