Michel Fabbro1, Kathleen N Moore2, Anne Dørum3, Anna V Tinker4, Sven Mahner5, Isabel Bover6, Susana Banerjee7, Germana Tognon8, Frederic Goffin9, Ronnie Shapira-Frommer10, Robert M Wenham11, Kristina Hellman12, Diane Provencher13, Philipp Harter14, Isabel Palacio Vázquez15, Philippe Follana16, Mario J Pineda17, Mansoor R Mirza18, Sebastien J Hazard19, Ursula A Matulonis20. 1. Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Paris, France; Institut du Cancer de Montpellier, Montpellier, France. Electronic address: michel.fabbro@icm.unicancer.fr. 2. Stephenson Cancer Center, University of Oklahoma HSC, Oklahoma City, OK, USA; Sarah Cannon Research Institute, Nashville, TN, USA. 3. Nordic Society of Gynaecological Oncology (NSGO), Copenhagen, Denmark; Radiumhospitalet, Oslo University Hospital, Oslo, Norway. 4. BC Cancer Agency, Vancouver, BC, Canada. 5. Arbeitsgemeinschaft Gynäkologische Onkologie (AGO), Taufkirchen, Germany; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Obstetrics and Gynecology, University Hospital Munich, Ludwig-Maximilians-University of Munich, Munich, Germany. 6. Grupo Español de Investigación en Cáncer de Ovario (GEICO), Madrid, Spain; Hospital Son Llàtzer, Palma de Mallorca, Spain. 7. National Cancer Research Institute (NCRI), London, United Kingdom; The Royal Marsden NHS Foundation Trust, London, United Kingdom. 8. Division of Obstetrics and Gynecology, ASST Spedali Civili di Brescia, Brescia, Italy. 9. Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Liège, Belgium; University of Liège, CHU de Liège, Site Hôpital de la Citadelle, Liège, Belgium. 10. Israeli Society of Gynecologic Oncology (ISGO), Hadera, Israel; Sheba Medical Center, Ramat Gan, Israel. 11. H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA. 12. Nordic Society of Gynaecological Oncology (NSGO), Copenhagen, Denmark; Karolinska University Hospital, Stockholm, Sweden. 13. Centre Hospitalier de L'Université de Montréal (CHUM), Montreal, QC, Canada. 14. Arbeitsgemeinschaft Gynäkologische Onkologie (AGO), Taufkirchen, Germany; Department of Gynecology & Gynecologic Oncology, Kliniken Essen-Mitte, Essen, Germany. 15. Grupo Español de Investigación en Cáncer de Ovario (GEICO), Madrid, Spain; Hospital Universitario Central de Asturias, Oviedo, Spain. 16. Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Paris, France; Centre Antoine Lacassagne, Nice, France. 17. Northwestern University, Chicago, IL, USA. 18. Nordic Society of Gynaecological Oncology (NSGO), Copenhagen, Denmark; Rigshospitalet-Copenhagen University Hospital, Copenhagen, Denmark. 19. TESARO, Inc., Waltham, MA, USA. 20. Dana-Farber Cancer Institute, Boston, MA, USA.
Abstract
OBJECTIVE: To analyze the safety and efficacy of niraparib in patients aged ≥70 years with recurrent ovarian cancer in the ENGOT-OV16/NOVA trial. METHODS: The trial enrolled 2 independent cohorts with histologically diagnosed recurrent ovarian, fallopian tube, or peritoneal cancer who responded to platinum rechallenge, on the basis of germline breast cancer susceptibility gene mutation (gBRCAmut) status. Patients were randomized 2:1 to receive niraparib (300 mg) or placebo once daily until disease progression. The primary endpoint was progression-free survival (PFS) by blinded independent central review. Adverse events (AEs) of special interest were based on the known safety profile of poly(ADP-ribose) polymerase inhibitors. RESULTS:Patients aged ≥70 years in the gBRCAmut cohort receivingniraparib (n = 14) had not yet reached a median PFS compared with a median PFS of 3.7 months for the same age group in the placebo arm (hazard ratio [HR], 0.09 [95% confidence interval (CI), 0.01 to 0.73]). Non-gBRCAmut patients aged ≥70 years receivingniraparib (n = 47) had a median PFS of 11.3 months compared with 3.8 months in the placebo arm (HR, 0.35 [95% CI, 0.18 to 0.71]). Median duration of follow-up in the niraparib arm was 17.3 months in patients ≥70 years and 17.2 months in patients <70 years. Frequency, severity of AEs, and dose reductions in the niraparib arm were similar in patients aged <70 and ≥ 70 years population. The most common grade ≥ 3 AEs in patients ≥70 years were hematologic: thrombocytopenia event (34.4%), anemia event (13.1%), and neutropenia event (16.4%). CONCLUSIONS: For patients ≥70 years of age receiving niraparib as maintenance treatment in the ENGOT-OV16/NOVA trial, PFS benefits and incidence of any grade or serious treatment-emergent AEs were comparable to results in the younger population. Use of niraparib should be considered in this population.
RCT Entities:
OBJECTIVE: To analyze the safety and efficacy of niraparib in patients aged ≥70 years with recurrent ovarian cancer in the ENGOT-OV16/NOVA trial. METHODS: The trial enrolled 2 independent cohorts with histologically diagnosed recurrent ovarian, fallopian tube, or peritoneal cancer who responded to platinum rechallenge, on the basis of germline breast cancer susceptibility gene mutation (gBRCAmut) status. Patients were randomized 2:1 to receive niraparib (300 mg) or placebo once daily until disease progression. The primary endpoint was progression-free survival (PFS) by blinded independent central review. Adverse events (AEs) of special interest were based on the known safety profile of poly(ADP-ribose) polymerase inhibitors. RESULTS:Patients aged ≥70 years in the gBRCAmut cohort receiving niraparib (n = 14) had not yet reached a median PFS compared with a median PFS of 3.7 months for the same age group in the placebo arm (hazard ratio [HR], 0.09 [95% confidence interval (CI), 0.01 to 0.73]). Non-gBRCAmut patients aged ≥70 years receiving niraparib (n = 47) had a median PFS of 11.3 months compared with 3.8 months in the placebo arm (HR, 0.35 [95% CI, 0.18 to 0.71]). Median duration of follow-up in the niraparib arm was 17.3 months in patients ≥70 years and 17.2 months in patients <70 years. Frequency, severity of AEs, and dose reductions in the niraparib arm were similar in patients aged <70 and ≥ 70 years population. The most common grade ≥ 3 AEs in patients ≥70 years were hematologic: thrombocytopenia event (34.4%), anemia event (13.1%), and neutropenia event (16.4%). CONCLUSIONS: For patients ≥70 years of age receiving niraparib as maintenance treatment in the ENGOT-OV16/NOVA trial, PFS benefits and incidence of any grade or serious treatment-emergent AEs were comparable to results in the younger population. Use of niraparib should be considered in this population.