Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology 2, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy
Gemma Zucchelli , Roberto Moretto , Marta Schirripa , Rossana Intini , Daniele Rossini , Daniele Santini , Claudio Pizzo , Carlotta Antoniotti , Beatrice Borelli , Federica Marmorino , Federica Urbano , Valentina Burgio , Michela Libertini , Michele Prisciandaro , Angela Buonadonna , Sara Bustreo , Giacomo Allegrini , Vincenzo Ricci , Chiara Cremolini , Alfredo Falcone
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 CT-related AEs in males and females was estimated in univariable analysis in the overall safety population and according to treatment arms (doublets/bev and FOLFOXIRI/bev). In order to assess the independent weight of gender on the risk of developing AEs, multivariable logistic regression models were built. Results: 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 CT-related 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.
Grade | Females (%) | Males (%) | Univariate | Multivariate | |||
---|---|---|---|---|---|---|---|
OR | p | OR | p | ||||
Nausea | All | 65 | 54 | 1.57 | < 0.01 | 1.55 | < 0.01 |
≥ 3 | 6 | 3 | 2.08 | 0.01 | 1.98 | 0.02 | |
Vomiting | All | 41 | 29 | 1.73 | < 0.01 | 1.72 | < 0.01 |
≥ 3 | 5 | 1 | 4.18 | < 0.01 | 4.07 | < 0.01 | |
Diarrhea | All | 65 | 61 | 1.16 | 0.24 | 1.13 | 0.34 |
≥ 3 | 15 | 12 | 1.34 | 0.09 | 1.33 | 0.11 | |
Asthenia | All | 66 | 60 | 1.30 | 0.03 | 1.31 | 0.03 |
≥ 3 | 12 | 8 | 1.62 | 0.02 | 1.65 | 0.01 | |
Alopecia | All | 14 | 10 | 1.55 | 0.02 | 1.56 | 0.02 |
Anemia | All | 57 | 49 | 1.33 | 0.02 | 1.31 | 0.03 |
≥ 3 | 3 | 1 | 2.62 | 0.04 | 2.55 | 0.05 | |
Neutropenia | All | 69 | 54 | 1.86 | < 0.01 | 1.90 | < 0.01 |
≥ 3 | 44 | 30 | 1.86 | < 0.01 | 1.90 | < 0.01 | |
Febrile Neutropenia | All | 8 | 5 | 1.60 | 0.06 | 1.67 | 0.04 |
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