Abstract 829P
Background
It remains unclear whether treatment strategy has to be modified for PSROC patients (pts) during isolated rising serum CA125 (irCA125) without symptoms or RECIST progression.
Methods
REGOVAR is an open-label phase II study including PSROC pts with irCA125 during surveillance or bevacizumab maintenance, randomized between T 40mg PO daily or R 120-160mg PO daily (3 weeks on / 1 week off). Primary objective was Progression-Free-Survival (PFS) according to RECIST 1.1. Secondary endpoints were Objective Response Rate (ORR), Time to start of First-Subsequent Therapy (TFST), Overall Survival (OS), and Quality of Life (QoL). 116 pts should have been enrolled to show PFS improvement.
Results
An interim analysis with 49 pts showed a higher rate of discontinuation with R and low probability of reaching significant PFS improvement. The IDMC recommended premature termination of enrollment. Final analysis with 74 pts (6 screen failures, 35 in T, 33 in R arms) showed median age of 67 y [30-87], 90% serous histology, 84% high grade; 78% were in the first line of treatment. Median initial CA125 was 162 UI/mL [39-3206]. With 32 mo median follow-up, median PFS was 5.6 mo [3.8-7.5] in T arm vs 4.6 mo [3.6-7.3] in R arm (HR 1.10, 90% CI [0.71-1.68], p=0.7). Median duration of treatment was 3.7 mo [0.1-26] and 3.6 mo [0-15] in T and R arm respectively. Reason for treatment permanent discontinuation were disease progression (82% and 62%) or toxicities (9% and 31%), respectively. ORR were 15% and 6%, median TFST were 5.2 mo [4.2-7.8] and 4.5 mo [3.0-5.5], median OS was 33.2 mo [28.6-52] vs 40.1 mo [22.8-41.6] (HR 1.42, 90% CI [0.77-2.63], p=0.3), in T and R arm respectively. G3/4 toxicities were more frequent in the R arm (91% vs 54%): hand-foot syndrome (36%), rash (18%) and fatigue (15%). QoL was more deteriorated in R than in T arm including more fatigue (adjusted mean difference 14.9 [2.7-27.1]), appetite loss (16.2 [3.3-29.1]) and diarrhea (13.3 [2.6-24.0]).
Conclusions
R was not superior to T with regard to PFS and to delay the introduction of subsequent chemotherapy for PSROC pts with irCA125 and show higher rate of toxicity. Both treatments allow nearly 5 mo chemo-free interval.
Clinical trial identification
EudraCT: 2015-001116-35; NCT02584465.
Editorial acknowledgement
Legal entity responsible for the study
ARCAGY-GINECO.
Funding
Bayer.
Disclosure
O. Tredan: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Sandoz; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD-Merck; Research grant/Funding (institution): Bayer. C. Abdeddaim: Advisory/Consultancy, Travel/Accommodation/Expenses: Merck; Advisory/Consultancy: BMS; Advisory/Consultancy: GSK/Tesaro. I. Treilleux: Advisory/Consultancy: Roche; Advisory/Consultancy: AstraZeneca. A-C. Hardy Bessard: Advisory/Consultancy: Roche; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: MSD; Advisory/Consultancy: Clovis; Advisory/Consultancy: Novartis; Advisory/Consultancy: GSK. E. Kalbacher: Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: GSK; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Tesaro; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: PharmaMar; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Leopharma; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Bayer. A. Floquet: Advisory/Consultancy, Travel/Accommodation/Expenses: Tesaro; Advisory/Consultancy: Clovis; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy: GSK; Advisory/Consultancy, Travel/Accommodation/Expenses, Non-remunerated activity/ies: MSD; Travel/Accommodation/Expenses, Non-remunerated activity/ies: Roche. A. Lortholary: Honoraria (self): GSK; Honoraria (self): Roche; Honoraria (self): Novartis. J-S. Frenel: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: GSK; Advisory/Consultancy: Eisai; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis. C. Louvet: Honoraria (self), Travel/Accommodation/Expenses: MSD; Honoraria (self): Halozyme; Honoraria (self), Travel/Accommodation/Expenses: Roche; Honoraria (self): Celgene; Honoraria (self): Amgen. I.L. Ray-Coquard: Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: Agenus; Honoraria (self), Advisory/Consultancy: Advaxis; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): BMS; Honoraria (self), Advisory/Consultancy: PharmaMar; Honoraria (self), Advisory/Consultancy: Genmab; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution): GSK; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): MSD; Honoraria (self), Advisory/Consultancy: Deciphera; Honoraria (self), Advisory/Consultancy: Mersena; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Sereno; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Tesaro; Honoraria (self), Advisory/Consultancy: Clovis; Non-remunerated activity/ies: GINECO; Non-remunerated activity/ies: ENGOT; Non-remunerated activity/ies: GCIG; Non-remunerated activity/ies: European community; Non-remunerated activity/ies: ESMO; Non-remunerated activity/ies: ASCO; Non-remunerated activity/ies: ESGO; Non-remunerated activity/ies: IGSC; Non-remunerated activity/ies: Inca; Non-remunerated activity/ies: Swiss, Italian, Belgium and German health authorities. All other authors have declared no conflicts of interest.