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Poster Display session 2

3931 - Differences in multikinase inhibitors (MKI) toxicity profile according to gender. A pooled analysis of three phase II trials with lenvatinib, pazopanib and sorafenib in patients (pts) with advanced gastroenteropancreatic (GEP) neuroendocrine tumors (NETs).

Date

29 Sep 2019

Session

Poster Display session 2

Presenters

Jorge Hernando Cubero

Citation

Annals of Oncology (2019) 30 (suppl_5): v564-v573. 10.1093/annonc/mdz256

Authors

J. Hernando Cubero1, E. Grande2, D. Castellano Gauna3, T. Ibrahim4, N. Fazio5, C. Lopez6, A. Teulé7, J.W. Valle8, V. Alonso9, J. Molina-Cerrillo10, S. Tafuto11, A. Custodio12, L. Trejo1, A. Casteras13, R. Manneh Kopp3, C. Miqueo14, M. Roca Herrera1, R. Garcia-Carbonero15, R. Salazar16, J. Capdevila17

Author affiliations

  • 1 Medical Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 2 Head Of Medical Oncology Department, MD Anderson Cancer Center Madrid, 28033 - Madrid/ES
  • 3 Medical Oncology Department, University Hospital 12 De Octubre, 28041 - Madrid/ES
  • 4 Tumori Rari E Testa-collo Dept., Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 5 Unit Of Gastrointestinal Medical Oncology And Neuroendocrine Tumors, Istituto Europeo di Oncologia, 20141 - Milan/IT
  • 6 Medical Oncology, Marques de Valdecilla University Hospital, Santander/ES
  • 7 Oncology, Institut Catala d'Oncologia (ICO), 08907 - Hospitalet de Llobregat/ES
  • 8 Medical Oncology / Institute Of Cancer Sciences, University of Manchester / The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 9 Medical Oncology, Miguel Servet University Hospital, Zaragoza/ES
  • 10 Medical Oncology, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
  • 11 Oncology, Istituto Nazionale Tumori - IRCCS - Fondazione Pascale, 80131 - Napoli/IT
  • 12 Oncology, Hospital Universitario La Paz, 28046 - Madrid/ES
  • 13 Endocrinology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 14 Documentation Science Department, Zaragoza University, Zaragoza/ES
  • 15 Medical Oncology, University Hospital 12 De Octubre, 28041 - Madrid/ES
  • 16 Medical Oncology Department, Institut Català d'Oncologia Hospital Duran i Reynals, 08907 - Barcelona/ES
  • 17 Gastrointestinal And Endocrine Tumor Unit, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
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Resources

Abstract 3931

Background

There is a dearth of understanding of gender influence in targeted therapies toxicity. Increasing evidence suggests a possible different toxicity profile according to gender, but mostly retrospective studies in common tumors. Currently, data from prospective studies are minimal. In the present study, we will review MKI toxicity profiles according to gender in pts with NETs in three clinical trials.

Methods

Multicenter open-label phase II studies TALENT, PAZONET and GETNE0801 included pts with advanced GEP NETs treated with lenvatinib, pazopanib, and sorafenib-bevacizumab respectively. All studies were performed by the Spanish Task Force Group for Neuroendocrine Tumors (GETNE). All pts were included in the review, considering all toxicity grades with an incidence higher than 5% for the univariate analysis. Bevacizumab specific toxicities were excluded in patients from GETNE0801 trial. Additionally, all grade 3-4 toxicities were analyzed separately.

Results

199 pts (46.23% female) with 1349 adverse events (AEs) (12.23% G3-4) divided into 125 categories were included. In female patients, nausea/vomiting, skin disorders (excluding palmar-plantar erythrodysesthesia), liver alterations (including transaminase and bilirubin), headache, pyrexia, hair disorders and dizziness were significantly more common (Table). The only toxicity with a higher incidence in men was dysphonia (OR 0.42, 95% CI 0.2-0.9, p0.02). The only G3-4 toxicity significantly more frequent in women was liver toxicity (20.65% vs. 7.55%, OR 3.18, p0.009).Table: 1387P

Toxicity (all grades)Women (%)Men (%)Difference (%)Odds Ratio (95% CI)p
Nausea/Vomiting63.0444.86182.090.01
Skin disorders60.8745.79151.840.03
Liver toxicity57.6130.84263.040.0002
Headache28.2612.15162.840.005
Pyrexia17.395.61113.440.01
Hair disorders20.658.41122.830.01
Dizziness17.396.54103.000.02
Dysphonia16.3037.38210.320.001

Conclusions

In our study, we observed significant differences in toxicity AEs by gender, especially in women with seven increased toxicities. A different approach in toxicity management should be adopted based on gender in pts with GEP NETs treated with MKI.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

J. Hernando Cubero: Speaker Bureau / Expert testimony: Eisai, Ipsen, Roche, Angelini, ; Travel / Accommodation / Expenses: Ipsen, Novartis, AAA, Roche, AstraZeneca, Eisai. E. Grande: Speaker Bureau / Expert testimony: Pfizer, Ipsen, BMS, Eisai, Roche, MSD, Sanofi, Adacap, Novartis, EUSA Pharma, Pierre Fabre, Lexicon, Celgene; Research grant / Funding (institution): MSD, Roche. T. Ibrahim: Advisory / Consultancy: Eisai; Research grant / Funding (institution): Novartis; Travel / Accommodation / Expenses: Ipsen, PharmaMar, Novartis. J.W. Valle: Advisory / Consultancy: Abbott, Agios, AstraZeneca, Baxalta, Bioven, Celgene, Delcath, Genoscience Pharma, Incyte, Ipsen, Keocyt, Lilly, Merck, MidaTech, Mundipharma, Novartis, NuCana, PCI Biotech, Pfizer, Pieris Pharmaceuticals, QED Pharmaceuticals; Speaker Bureau / Expert testimony: Abbott, Celgene, Ipsen, Novartis, Pfizer, Sirtex; Travel / Accommodation / Expenses: Celgene, Ipsen, Novartis, NuCana. V. Alonso: Advisory / Consultancy: Amgen, Roche, Merck, Servier, Sanofi, Ipsen, Bayer, Novartis. R. Manneh Kopp: Speaker Bureau / Expert testimony: Pfizer, Ipsen, BMS, Roche, MSD, Sanofi, Novartis; Research grant / Funding (institution): MSD, Roche, BMS. R. Salazar: Advisory / Consultancy: VCN-BCN, Agendia, Guardant Health, Roche Diagnostics, Ferrer, Pfizer, Novartis, Ipsen, Amgen, Merck, Roche Farma, Lylli, MSD; Speaker Bureau / Expert testimony: Pfizer, Amgen, Novartis, Merck, MSD, AZD, Celgene,. J. Capdevila: Honoraria (self): Novartis, Pfier, Ipsen, Exelixis, Bayer, Eisai, AAA, Amgen, Sanofi, Merck; Research grant / Funding (institution): Eisai, Novartis, Ipsen, AstraZeneca, Pfier, AAA. All other authors have declared no conflicts of interest.

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