Impact of gender on the safety profile of chemotherapy plus bevacizumab in mCRC: A pooled analysis of TRIBE and TRIBE2 studies in Journal of Clinical Oncology

2019
AO Cuneo
AOU Città della Salute di Torino

Tipo pubblicazione

Conference Abstract

Autori/Collaboratori (20)Vedi tutti...

Zucchelli G

Moretto R

Schirripa M


et alii...

Abstract

Background: Based on retrospective experiences, gender seems to affect the safety profile of chemotherapy (CT), with a higher incidence of CT-related adverse events (AEs) among females than males. Here we focus on the impact of gender on the toxicity of FOLFOXIRI/bevacizumab (bev) as compared with doublets (FOLFOX or FOLFIRI)/bev in two randomized phase III studies by GONO: TRIBE and TRIBE2. Methods: The risk of experiencing CTrelated AEs in males and females was estimated in univariabl Among 1187 patients enrolled in TRIBE and TRIBE2 studies, 1176 (684 males, 58%, and 492 females, 42%) were included in the safety population. Overall, women had a significantly higher risk of CTrelated AEs, in particular gastrointestinal and hematologic AEs, asthenia and alopecia, independently of the treatment arm. The risk of CT-related AEs was increased with FOLFOXIRI/bev vs doublets/bev independently of gender (p for interaction: 0.329). Notably, among women treated with FOLFOXIRI/bev 50% and 68% experienced any grade of vomiting and nausea, respectively. Conclusions: Female mCRC patients have a higher risk to develop CT-related AEs. In women treated with FOLFOXIRI/bev the high incidence of nausea and vomiting may suggest the need for an intensification of the antiemetic prophylaxis.

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DOI : 10.1200/JCO.2019.37.15-suppl.3534

Keywords

side effect; risk assessment; randomized controlled trial (topic); prophylaxis; phase 3 clinical trial (topic); pharmacokinetics; nausea and vomiting; meta analysis; male; incidence; human; gender; female; drug therapy; drug safety; controlled study; conference abstract; cancer chemotherapy; asthenia; alopecia; adverse drug reaction; adult; unclassified drug; bevacizumab; antiemetic agent;