Sex and regorafenib-induced adverse events in mCRC: Is there a link?

Key clinical point: Female sex was the only independent risk factor for early and any time toxicity to regorafenib treatment for metastatic colorectal cancer (mCRC), with females being 2- to 3-fold more likely than men to suffer from moderate-to-severe treatment-related adverse events (TRAEs).

Major finding: Females vs males had more frequent grade 2 or more TRAEs during the first cycle of treatment (84% vs 60%; P = .002) and grade 3 or more TRAEs throughout the treatment (71% vs 53%; P = .035), with sex being the only independent predictive factor for early grade 2 or more (odds ratio [OR], 3.4; P = .02) and late grade 3 or more (OR, 2.1; P = .045) TRAEs.

Study details: Findings are from the safety analysis of RegARd-C, a phase 2 clinical trial including 136 patients who received regorafenib treatment for mCRC.

Disclosures: This work was supported by ESMO. The clinical part of the RegARd-C trial was supported by Bayer Pharmaceuticals. A Deleporte, A Hendlisz, and F Sclafani reported receiving travel grants, consultancy, advisory board, and/or research grants from various sources including Bayer.

Source: Vandeputte C et al. Clin Colorectal Cancer. 2021 Jul 24. doi: 10.1016/j.clcc.2021.07.006.

Key clinical point: Female sex was the only independent risk factor for early and any time toxicity to regorafenib treatment for metastatic colorectal cancer (mCRC), with females being 2- to 3-fold more likely than men to suffer from moderate-to-severe treatment-related adverse events (TRAEs).

Major finding: Females vs males had more frequent grade 2 or more TRAEs during the first cycle of treatment (84% vs 60%; P = .002) and grade 3 or more TRAEs throughout the treatment (71% vs 53%; P = .035), with sex being the only independent predictive factor for early grade 2 or more (odds ratio [OR], 3.4; P = .02) and late grade 3 or more (OR, 2.1; P = .045) TRAEs.

Study details: Findings are from the safety analysis of RegARd-C, a phase 2 clinical trial including 136 patients who received regorafenib treatment for mCRC.

Disclosures: This work was supported by ESMO. The clinical part of the RegARd-C trial was supported by Bayer Pharmaceuticals. A Deleporte, A Hendlisz, and F Sclafani reported receiving travel grants, consultancy, advisory board, and/or research grants from various sources including Bayer.

Source: Vandeputte C et al. Clin Colorectal Cancer. 2021 Jul 24. doi: 10.1016/j.clcc.2021.07.006.

Key clinical point: Female sex was the only independent risk factor for early and any time toxicity to regorafenib treatment for metastatic colorectal cancer (mCRC), with females being 2- to 3-fold more likely than men to suffer from moderate-to-severe treatment-related adverse events (TRAEs).

Major finding: Females vs males had more frequent grade 2 or more TRAEs during the first cycle of treatment (84% vs 60%; P = .002) and grade 3 or more TRAEs throughout the treatment (71% vs 53%; P = .035), with sex being the only independent predictive factor for early grade 2 or more (odds ratio [OR], 3.4; P = .02) and late grade 3 or more (OR, 2.1; P = .045) TRAEs.

Study details: Findings are from the safety analysis of RegARd-C, a phase 2 clinical trial including 136 patients who received regorafenib treatment for mCRC.

Disclosures: This work was supported by ESMO. The clinical part of the RegARd-C trial was supported by Bayer Pharmaceuticals. A Deleporte, A Hendlisz, and F Sclafani reported receiving travel grants, consultancy, advisory board, and/or research grants from various sources including Bayer.

Source: Vandeputte C et al. Clin Colorectal Cancer. 2021 Jul 24. doi: 10.1016/j.clcc.2021.07.006.