Impact of gender on multikinase inhibitors (MKIs) toxicity in patients (pts) with advanced pancreatic and gastrointestinal neuroendocrine tumors (NETs): A pooled analysis of two phase II trials with pazopanib and lenvatinib.

Authors

null

Jorge Hernando-Cubero

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

Organizations

Vall Hebron University Hospital, Vall Hebron Institute of Oncology (VHIO), Bracelona, Spain, MD Anderson Cancer Center Madrid, Madrid, Spain, Medical Oncology Service, Hospital Universitario 12 de Octubre, Madrid, Spain, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy, European Institute of Oncology, IRCCS, Milan, Italy, Marqués de Valdecilla University Hospital, Santander, Spain, Institut Català d’Oncologia, L’Hospitalet, Barcelona, Spain, University of Manchester/The Christie, Manchester, United Kingdom, 12 de Octubre University Hospital, Madrid, Spain, Vall d´Hebron University Hospital, Barcelona, Spain, Vall d’Hebron University Hospital Barcelona Spain y Vall d’hebron insitute of Oncology (VHIO), Barcelona, Spain, Medical Oncology Department, Vall d’Hebron University Hospital; Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain

Research Funding

Other

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 toxicity64.941.9232.97 (1.54-5.73)0.001
Headache32.417.614.92.5 (1.16-5.4)0.01
Pyrexia21.68.113.53.44 (1.26-9.36)0.01
Nausea/Vomiting70.358.112.22.08 (1.07-4.05)0.02
Hair disorders2310.812.22.72 (1.09-6.75)0.03
Skin disorders56.844.612.21.9 (1.007-3.61)0.04
Dizziness20.39.510.82.68 (1.02-7.02)0.04
Dysphonia17.636.518.90.42 (0.2-0.9)0.02

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Neuroendocrine/Carcinoid

Citation

J Clin Oncol 37, 2019 (suppl; abstr 4109)

DOI

10.1200/JCO.2019.37.15_suppl.4109

Abstract #

4109

Poster Bd #

214

Abstract Disclosures