A phase 3 randomized double-blind trial of maintenance with niraparib versus placebo in patients with platinum-sensitive ovarian cancer ( ENGOT-OV 16 / NOVA trial )

In high grade OC, most deaths occur in the first 36-50 months after diagnosis. Beyond the median survival time, mortality decreases down to a plateau observed from 5-6 years. This long-term survivor population represents around 20% of the patients initially treated. Methods: This retrospective study aimed to estimate the CPS and to identify prognostic factors among long-term survivors. From patients (pts) with advanced OC treated at the ICM from 1995 to 2012, we collected the cancer histology, surgical staging (FIGO), BRCA status, delivered chemotherapy and outcome. Overall survival (OS), progression-free survival (PFS), and CPS were calculated. To estimate 95% confidence intervals (CIs) we used a variation of the "Greenwood’s formula," usual for unconditional survival. Prognostic factors were evaluated using the Cox proportional hazards model. Results: Among the 359 pts identified (med age 59 years [17-89]), 80% and 20% were stage III and IV, respectively. Histology was of serous type in 71% of pts, not specified in 17% and of other subtypes in 12%. Surgery was performed first in 91% of pts including 67% of debulking, and 33% of exploratory surgery. Out of the 208 pts operated at diagnosis, 39% had no macroscopic residual disease left, and 32% and 29% had 0-1-cm and >1-cm lesions left, respectively. The pts received a median of 7 cycles (1-10) of first-line chemotherapy. Median OS was 44 mths (95% CI [39.6-51.6]), and median PFS was 18 mths (95% CI [16.8-20.4]). Survivors at 1 y post-diagnosis had a CPS of 26% at 8 y (95% CI [18.8%-32.5%]). The CPS Zotero Report zotero://report/items/1331711_R44K2FAK-1331711_8XK9AKR7-133... 10 sur 28 28/05/2014 18:19 increased up to 49% (95% CI [37.0%-61.0%]) and 61% (95% CI [47.6%-75.2%]) when assessed at 4 and 5 y, respectively. The usual prognostic factors at diagnosis (PS, serous histology , no residual disease, sensitivity to chemotherapy, progression free interval) were not found as well when assessed at 4 y survival; PFI > 18 m was the only prognostic factor (RR 0.29 (IC95% [0.16-0.54]. BRCA status was available for 24 pts; among the 12 mutated pts, 9 were long-term survivor pts. Conclusions: These results showed that intrinsic biological factors, related to sensitivity to chemotherapy, significantly influence the prognostic of OC, and shall be a challenge for the next years. Proceedings Title Journal of Clinical Oncology Short Title Conditional probability of survival (CPS) in ovarian cancer (OC) long-term survivors Date Added 28/5/2014 16:55:50 Modified 28/5/2014 18:17:10