Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster session 11

795P - Tolerability and effectiveness of niraparib in long-term responders with platinum-sensitive recurrent ovarian cancer (GEICO-88R study)

Date

21 Oct 2023

Session

Poster session 11

Topics

Tumour Site

Ovarian Cancer

Presenters

Juan Cueva Banuelos

Citation

Annals of Oncology (2023) 34 (suppl_2): S507-S542. 10.1016/S0923-7534(23)01937-3

Authors

J.F. Cueva Banuelos1, C. Salvador Coloma2, F. Galvez Montosa3, J. Ferreiro Quintana4, S. Cros Costa5, S. González-Santiago6, J.G. Cassinello7, M. Romeo Marin8, P. Reche9, M.L. Soriano Tabares10, M. Valero Arbizu11, M.J. Rubio Perez12, H.M. Oré Arce13, L. Gaba Garcia14, M.D.M. Gordon Santiago15, C. Gomez Raposo16, S. Hernando Polo17, R. Marquez Vazquez18, J. Fuentes Pradera19, A. Gonzalez Martin20

Author affiliations

  • 1 Medical Oncology, Complejo Hospitalario Universitario de Santiago de Compostela, 15706 - Santiago de Compostela/ES
  • 2 Medical Oncology, Hospital Lluís Alcanyís de Xàtiva, Valencia/ES
  • 3 Medical Oncology, Hospital Universitario de Jaén, 23007 - Jaén/ES
  • 4 Medical Oncology, Hospital Universitario de Galdakao, 48960 - Galdakao/ES
  • 5 Medical Oncology, Hospital General de Granollers, 08402 - Granollers/ES
  • 6 Medical Oncology, Hospital Universitario San Pedro de Alcántara, 10003 - Caceres/ES
  • 7 Medical Oncology, Hospital Universitario de Guadalajara, 19002 - Guadalajara/ES
  • 8 Medical Oncology, ICO - Institut Català d'Oncologia Badalona, 08916 - Badalona/ES
  • 9 Medical Oncology, Hospital Universitario Torrecárdenas, Almería/ES
  • 10 Medical Oncology, Hospital Universitario Nuestra Senora de Candelaria, 38010 - Santa Cruz de Tenerife/ES
  • 11 Medical Oncology, Hospital Quirónsalud Sagrado Corazón, 41013 - Seville/ES
  • 12 Medical Oncology, Hospital Universitario Reina Sofía, 14004 - Córdoba/ES
  • 13 Medical Oncology, Hospital Marina Baixa, 03570 - Villajoyosa/ES
  • 14 Medical Oncology, Hospital Clínic de Barcelona, 08036 - Barcelona/ES
  • 15 Medical Oncology, Hospital Universitario de Jerez, 11407 - Jerez de la Frontera/ES
  • 16 Medical Oncology, Hospital Universitario Infanta Sofía, 28703 - San Sebastian de los Reyes/ES
  • 17 Medical Oncology, Hospital Universitario Fundación Alcorcón, 28922 - Alcorcón/ES
  • 18 Medical Oncology, MD Anderson Cancer Center Madrid, 28033 - Madrid/ES
  • 19 Medical Oncology, Hospital Universitario Virgen de Valme, 41014 - Seville/ES
  • 20 Medical Oncology, Clínica Universidad de Navarra, 28027 - Madrid/ES

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 795P

Background

The GEICO-88R study assessed the real-world use of niraparib as maintenance treatment in patients (pts) with platinum-sensitive recurrent high-grade ovarian cancer (OC) within the Spanish expanded access program. A preplanned sub-analysis of long-term responders (LTR) is presented.

Methods

In this retrospective study across 57 Spanish sites pts received niraparib at a fixed starting dose (FSD) of 300 mg/day or individualized starting dose (ISD) according to weight and platelet count. A specific assessment of LTR to niraparib maintenance treatment (exposure ≥1 year) was performed, describing patient characteristics, niraparib dosing, tolerability, and effectiveness.

Results

This sub-analysis included 107 pts (33.8% of 316 from general study), with median age 64 years (43-88) and a median of 2 previous lines (53.3% 1-2, 46.7% ≥3). Main initial FIGO stages were III (58.8%) and IV (18.6%). Forty-five (42%) pts received prior bevacizumab and 81.3% were gBRCAwt. 99 pts had surgery at primary diagnosis (72.7% primary and 27.3% interval debulking), R0 in 69.9%. 31 (29%) pts had surgery at relapse, R0 in 64.5%. At baseline, ECOG was 0 (56.1%) or 1 (43.9%). Relevant comorbidities were reported in 46.7% of pts. Niraparib was initiated at FSD in 24 pts and at ISD in 83 (80.7% at 200 mg/day; 19.3% at 300 mg/day). Overall median dose was 200 mg. Median treatment duration was 26.2 months (12-60.7). 68.2% of pts required at least one dose interruption or reduction. 39 (36.4%) pts remained on treatment upon analysis (91.1% discontinued due to progression, 2.9% toxicity, and 4.4% physician/patient decision). The most frequent all-grade adverse events were thrombocytopenia (42.1%), anemia (36.4%), and asthenia (29.9%), with no significant differences between FSD vs ISD pts. Of 85 pts with pre-niraparib measurable disease, PR+CR was 63.5%. With median follow-up of 29.95 months, median PFS, PFS2 an OS were 27.2 (95% CI 23.6- 29.6), 42.3 (95% CI 34.2-NA) and not reached (85.4% of pts alive).

Conclusions

A durable response was achieved in a substantial proportion of pts, even despite the high risk of this population (majority BRCAwt, pre-treated, significant comorbidities) with a good tolerability profile in a real-world setting.

Clinical trial identification

NCT04546373.

Editorial acknowledgement

Legal entity responsible for the study

Grupo Español de Investigación en Cáncer de Ovario (GEICO).

Funding

GSK.

Disclosure

C. Salvador Coloma: Financial Interests, Personal, Invited Speaker: Pfizer, GSK, Novartis, MSD; Financial Interests, Personal, Other, Travel expenses: GSK; Financial Interests, Personal, Advisory Board, Travel expenses: Roche. S. Cros Costa: Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Invited Speaker: Tesaro, Roche, Janssen, Pfizer, BMS; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal and Institutional, Local PI: Pfizer, Janssen. M. Romeo Marin: Financial Interests, Advisory Board: GSK, AstraZeneca-MSD; Financial Interests, Other, Congress attendance: GSK, AstraZeneca-MSD. M.J. Rubio Perez: Financial Interests, Personal, Advisory Role: AstraZeneca, MSD, GSK, Clovis, PharmaMar; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, MSD, GSK, Clovis, PharmaMar. S. Hernando Polo: Financial Interests, Advisory Role: AstraZeneca, GSK, Pfizer; Financial Interests, Speaker, Consultant, Advisor: AstraZeneca, GSK, Pfizer; Financial Interests, Other, Travel expenses: GSK. A. Gonzalez Martin: Financial Interests, Advisory Role: Alkermes, Amgen, AstraZeneca, Clovis, Genmab, GSK, HederaDx, Immunogen, Illumina, Mersana, MSD, Novartis, Novocure, Oncoinvent, PharmaMar, Roche, SOTIO, Sutro, Seagen, Takeda, Tubulis, Zailab. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.