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Effectiveness of sorafenib dose modifications on treatment outcome of hepatocellular carcinoma: Analysis in real-life settings.
International Journal of Cancer ( IF 6.4 ) Pub Date : 2020-03-13 , DOI: 10.1002/ijc.32964
Kwon Yong Tak 1 , Hee Chul Nam 1 , Jong Young Choi 1 , Seung Kew Yoon 1 , Chang Wook Kim 2 , Hee Yeon Kim 2 , Sung Won Lee 3 , Hae Lim Lee 3 , U Im Chang 4 , Do Seon Song 4 , Jin Mo Yang 5 , Jung Hyun Kwon 5 , Sun Hong Yoo 5 , Pil Soo Sung 1 , Sang Wook Choi 6 , Myeong Jun Song 7 , Seok Hwan Kim 7 , Jeong Won Jang 1
Affiliation  

Controlling adverse events (AEs) through dose reduction can enhance drug adherence and treatment response. Currently, there is no guide for sorafenib dosing. The aim of this study was to evaluate whether sorafenib dosing could affect treatment outcomes. A total of 782 hepatocellular carcinoma (HCC) patients treated with sorafenib were evaluated for sorafenib dosing and its modifications via medical records at baseline and regular follow‐up. Study outcomes included progression‐free survival (PFS), overall survival (OS), sorafenib duration, cumulative dose, AEs and drug discontinuation. The median patient survival was 7.7 months. Overall, 242 (30.9%) patients underwent dose reduction and 121 (17.5%) discontinued sorafenib due to AEs. In multivariate analysis, dose reduction was identified to be independently predictive of PFS and OS. The 800‐to‐400 mg/day group provided significantly better PFS than the 800 mg/day‐maintained group or the 800‐to‐600 mg/day group. Likewise, the 800‐to‐400 mg/day group resulted in a significantly better OS than other dosing. However, dose reduction to 200 mg/day led to significantly worse PFS and OS. Hand‐foot skin reaction and drug discontinuation due to AEs were higher in the 800‐to‐600 mg/day group than the 800‐to‐400 mg/day group. The 800‐to‐400 mg/day group had significantly longer treatment duration and higher cumulative dose than the 800 mg/day‐maintained group. Sorafenib dose reduction can improve HCC survival and increase patient tolerance and adherence coupled with longer duration and higher cumulative dose. Dose reduction from 800 to 400 mg/day than to 600 mg/day is recommended when clinically warranted. However, dose reduction to 200 mg/day is not recommendable.

中文翻译:

索拉非尼剂量调整对肝细胞癌治疗效果的有效性:现实生活中的分析。

通过减少剂量控制不良事件(AE)可以增强药物依从性和治疗反应。目前,尚无索拉非尼给药指南。这项研究的目的是评估索拉非尼的剂量是否会影响治疗效果。通过基线和定期随访的医疗记录评估了总共782名接受索拉非尼治疗的肝细胞癌(HCC)患者的索拉非尼剂量及其修改。研究结果包括无进展生存期(PFS),总生存期(OS),索拉非尼持续时间,累积剂量,不良事件和停药。患者中位生存期为7.7个月。总体而言,有242例(30.9%)的患者接受了减量治疗,而121例(17.5%)的患者因AE停药。在多变量分析中,降低剂量被确定为PFS和OS的独立预测指标。800至400 mg / day组的PFS明显优于800 mg / day维持组或800-600 mg / day组。同样,每天800至400 mg组的OS比其他剂量要好得多。但是,将剂量减少至200 mg / day会导致PFS和OS严重恶化。800至600 mg / day组的手足皮肤反应和因AEs引起的停药高于800至400 mg / day组。800至400 mg / day组比800 mg / day维持组具有更长的治疗时间和更高的累积剂量。降低索拉非尼的剂量可以改善HCC生存率,提高患者的耐受性和依从性,并具有更长的持续时间和更高的累积剂量。临床上建议将剂量从800毫克/天减少到600毫克/天。然而,
更新日期:2020-03-13
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