Vall Hebron University Hospital, Vall Hebron Institute of Oncology (VHIO), Bracelona, Spain
Jorge Hernando-Cubero , Enrique Grande , Daniel E. Castellano , Toni Ibrahim , Nicola Fazio , Carlos Lopez , Alex Teule , Juan W. Valle , Rocio Garcia-Carbonero , Marc Diez , Daniel Acosta , Maria Roca , Jaume Capdevila
Background: Retrospective data in some cancer types suggested a possible different toxicity profile with chemotherapy and targeted therapies according to gender. However, data from prospective studies are still very limited, especially in infrequent tumors such as NETs. Methods: Pts with advanced pancreatic and gastrointestinal NETs treated with pazopanib or lenvatinib in the multicenter open-label phase II studies PAZONET and TALENT respectively, were included in the analysis. Both studies were performed by Spanish Task Force Group for Neuroendocrine Tumors (GETNE). All toxicity grades with an incidence higher than 5% were considered for univariate review. Additionally, all grade 3-4 toxicities were analyzed separately. Results: 155 pts (47.7% female) with 1213 adverse events (AEs) (20% G3-4) divided in 121 categories were included. In female patients, liver toxicity, headache, pyrexia, nausea/vomiting, hair/skin disorders and dizziness were significantly more common (table). The only toxicity with higher incidence in men was dysphonia (OR 0.42, 95% CI 0.2-0.9, p 0.02). There were no gender differences in grade 3-4 toxicities. Conclusions: We observed significant differences in toxicity AEs by gender in two prospective phase II studies with MKIs in NETs patients. Potential different approach to manage toxicity may be adopted based on gender.
Toxicity (all grades) | Women (%) | Men (%) | Difference (%) | Odds Ratio (95% CI) | p |
---|---|---|---|---|---|
Liver toxicity | 64.9 | 41.9 | 23 | 2.97 (1.54-5.73) | 0.001 |
Headache | 32.4 | 17.6 | 14.9 | 2.5 (1.16-5.4) | 0.01 |
Pyrexia | 21.6 | 8.1 | 13.5 | 3.44 (1.26-9.36) | 0.01 |
Nausea/Vomiting | 70.3 | 58.1 | 12.2 | 2.08 (1.07-4.05) | 0.02 |
Hair disorders | 23 | 10.8 | 12.2 | 2.72 (1.09-6.75) | 0.03 |
Skin disorders | 56.8 | 44.6 | 12.2 | 1.9 (1.007-3.61) | 0.04 |
Dizziness | 20.3 | 9.5 | 10.8 | 2.68 (1.02-7.02) | 0.04 |
Dysphonia | 17.6 | 36.5 | 18.9 | 0.42 (0.2-0.9) | 0.02 |
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