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Sex and Regorafenib Toxicity in Refractory Colorectal Cancer: Safety Analysis of the RegARd-C Trial
Clinical Colorectal Cancer ( IF 3.4 ) Pub Date : 2021-07-24 , DOI: 10.1016/j.clcc.2021.07.006
Caroline Vandeputte 1 , Giacomo Bregni 2 , Paraskevas Gkolfakis 2 , Thomas Guiot 3 , Andrea Pretta 2 , Pashalina Kehagias 1 , Chiara Senti 1 , Elena Acedo Reina 1 , Camille Van Bogaert 1 , Amélie Deleporte 2 , Karen Geboes 4 , Thierry Delaunoit 5 , Gauthier Demolin 6 , Marc Peeters 7 , Lionel D'Hondt 8 , Jos Janssens 9 , Javier Carrasco 10 , Stephane Holbrechts 11 , Jean-Charles Goeminne 12 , Philippe Vergauwe 13 , Jean-Luc Van Laethem 14 , Patrick Flamen 3 , Alain Hendlisz 15 , Francesco Sclafani 15
Affiliation  

Background

Regorafenib is a standard treatment for refractory metastatic colorectal cancer (mCRC). In view of the toxicity burden, significant research efforts have been made to increase the therapeutic ratio of this multikinase inhibitor. Predictive factors for treatment-related adverse events (TRAEs), however, are still lacking.

Materials and Methods

We assessed the association between a number of baseline clinical, laboratory and imaging parameters and the occurrence of TRAEs in 136 patients who had received regorafenib (160 mg/day, 3-weeks-on/1-week-off) in a prospective phase II clinical trial.

Results

Grade ≥ 2 TRAEs during the first cycle of treatment (84% vs. 60%, P = .002) and grade ≥ 3 TRAEs throughout the whole treatment (71% vs. 53%, P = .035) occurred more frequently in females, with sex being the only independent predictive factor of early and any-time toxicity (OR 3.4; 95% CI: 1.2-11.1, P = .02 and OR 2.1; 95% CI: 1.0-4.4, P = .045, respectively). Fatigue, anorexia, hypertension, and rash were reported significantly more frequently by females than males (P < .04). Females were also more likely to suffer early (19% vs. 5%, P = .014) and any-time serious AEs (28% vs. 9%, P = .005), and to require early dose modifications (55% vs. 37%, P = .055).

Conclusion

This is the first study showing an association between sex and TRAEs during regorafenib treatment for mCRC. If confirmed in larger, independent series, these results could pave the way for the implementation of personalized regorafenib dosing strategies with the potential to optimize oncological outcomes while reducing toxicity and preserving quality of life.



中文翻译:

难治性结直肠癌的性别和瑞戈非尼毒性:RegARd-C 试验的安全性分析

背景

瑞戈非尼是难治性转移性结直肠癌 (mCRC) 的标准治疗方法。鉴于毒性负担,已经进行了大量研究工作以提高这种多激酶抑制剂的治疗率。然而,仍然缺乏治疗相关不良事件 (TRAE) 的预测因素。

材料和方法

我们在前瞻性 II 期评估了 136 名接受瑞戈非尼(160 毫克/天,3 周使用/1 周关闭)的患者的一些基线临床、实验室和影像学参数与 TRAE 发生之间的关联临床试验。

结果

第一个治疗周期中≥ 2 级 TRAE(84% 对 60%,P  = .002)和整个治疗过程中 ≥ 3 级 TRAE(71% 对 53%,P  = .035)在女性中更常见,性别是早期和任何时间毒性的唯一独立预测因素(OR 3.4;95% CI:1.2-11.1,P  = .02 和 OR 2.1;95% CI:1.0-4.4,P  = .045,分别)。女性报告疲劳、厌食、高血压和皮疹的频率明显高于男性(P < .04)。女性也更有可能在早期(19% 对 5%,P  = .014)和任何时间出现严重 AE(28% 对 9%,P  = .005),并需要早期剂量调整(55%与 37% 相比,P  = .055)。

结论

这是第一项显示瑞戈非尼治疗 mCRC 期间性别与 TRAE 之间存在关联的研究。如果在更大的独立系列中得到证实,这些结果可能为实施个性化瑞戈非尼给药策略铺平道路,并有可能优化肿瘤学结果,同时降低毒性和保持生活质量。

更新日期:2021-07-24
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