891P - Weekly G-Csf Improves the Tolerability of Weekly Paclitaxel-Carboplatin. a Phase Ii Study of the Belgian Gynaecological Oncology Group (Bgog-Ov5)

Abstract

ABSTRACT Aim: Weekly paclitaxel (60mg/m2) and carboplatin (AUC 2.7) (TCw) has been shown to be an effective treatment in patients with recurrent or advanced gynaecological cancer (Vandenput Int J Gyn Cancer 2012; Torfs Eur J Cancer 2012; Cadron Gynecol Oncol, 2013). The main toxicity of the regimen has been neutropenia grade (G) 3-4 and or neutropenic fever. Methods: In this prospective study 108 patients were needed to detect a 15% reduction in the occurrence of G3-4 neutropenia (a: 0.05; b: 0.95) compared with the historical incidence of 84%, by using prophylactic filgrastim on day 5 of each of the 18 weekly planned courses. The main inclusion criteria were: measurable disease, platin-resistant or refractory epithelial ovarian carcinoma (OC), or recurrent or advanced endometrial (EC) or cervical cancer (CC), and no prior weekly or dose-dense TC. Results: 108 (3 cohorts of ovarian, endometrial and cervical cancer of each 36 patients) were included by 12 BGOG centers between February 20, 2012 and March 14, 2013. The median number of prior chemotherapy lines was 3 for OC, 2 for EC and 1 for CC, respectively. The percentage of G3-4 neutropenia was 34% (CI: 26%-44%; p Conclusions: TCw with G-CSF support is feasible with an acceptable toxicity in patients with platin-resistant or –refractory OC, and advanced or recurrent EC or CC. The incidence of G3-4neutropenia is lower with the addition of weekly G-CSF compared with earlier studies without the addition of prophylactic G-CSF. Disclosure: All authors have declared no conflicts of interest.