Real-life data: Women with recurrent platinum-sensitive ovarian cancer and BCARGEM treatment.

Abstract

5566 Background: Ovarian cancer is still the most mortal gynaecological cancer in the world. Even after achieving a good clinical response after initial treatment, the cancer will relapse in 80% of the patients. Treatments that improves progression-free survival (PFS) are necessary. In 2012, the OCEANS trial showed an improved PFS (12.4 months) for patients with platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian cancer (ROC) treated with carboplatin, gemcitabine plus the monoclonal antibody bevacuzimab followed by maintenance therapy of bevacuzimab (BV) till progression (BCARGEM). Based on this trial, bevacizumab was incorporated in the second line treatment protocol of various European countries for patients with platinum-sensitive ROC. However, there is no real life information yet available on the effectivity and tolerance of this one randomized clinical trial (RCT) in clinical practise. Therefore, the aim of this study was to assess what the real time efficacy and tolerance of treatment with BCARGEM was in patients with platinum-sensitive ROC. Methods: All patients with platinum-sensitive ROC and treated with BCARGEM in the UMC Utrecht Cancer Center were retrospectively selected for analysis. All data such as baseline information, assessments and adverse events during cycles were obtained from medical records. The primary outcome was PFS; secondary outcomes were relative dose intensity (RDI), adverse events (AE) leading to dose modifications, and overall survival (OS). Results: Overall, the median PFS of the 39 patients with platinum-sensitive ROC and treated with BCARGEM was 9.4 months (95% CI 4.6 - 14.2). The median OS was 20.9 months (95% CI 15.0-26.7). The average RDI for BCARGEM was 67%. None of the patients reached a RDI of 100%. In most patients (69%) neutropenia grade ≥ 3 led to dose modifications or discontinuance of BCARGEM. After treatment with BCARGEM, 34 patients started treatment with BV till progression. The median number of cycles of BV was 5. In 26 of the cases the BV was ended due to progression. Conclusions: In our retrospective study, the PFS of real life patients treated with BCARGEM is lower compared to the study patients in the OCEANS trial; 9.4 versus 12.4 months. In addition, the RDI of BCARGEM is very low reflecting the many AEs leading to dose modifications or discontinuation. Therefore, this study underlines the fact that results of RCTs with strict in- and exclusion criteria do not represent actual outcomes in clinical care, because the selected study patient does not match the patient we face in real time.