891P - Weekly G-CSF improves the tolerability of weekly paclitaxel-carboplatin. A phase II study of the Belgian Gynaecological Oncology Group (BGOG-ov5)

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Supportive Care
Presenter Ignace Vergote
Citation Annals of Oncology (2014) 25 (suppl_4): iv305-iv326. 10.1093/annonc/mdu338
Authors I.B. Vergote1, P.R. Debruyne2, F. Kridelka3, P. Berteloot1, F. Amant1, B. Honhon4, W. Lybaert5, K. Leunen1, K. Geldhof6, D.M.E.C. Verhoeven7, F. Forget8, P. Vuylsteke9, L. D'Hondt10, M.T. Huizing11, H.F.M. Van den Bulck12, A. Laenen13
  • 1Gynaecology, UZ Leuven, 3000 - Leuven/BE
  • 2., AZ Groeninge, 8500 - Kortrijk/BE
  • 3., CHU de Liège, 4000 - Liège/BE
  • 4., Grand Hôpital de Charleroi, 6000 - Charleroi/BE
  • 5., AZ Nikolaas, 9100 - St. Niklaas/BE
  • 6., Jan Yperman ziekenhuis, 8900 - Ieper/BE
  • 7., AZ Klina, 2930 - Brasschaat/BE
  • 8., CHA - Centre Hospitalier de l'Ardenne, 6800 - Libramont/BE
  • 9., Clinique et maternité Sainte Elisabeth, 5000 - Namur/BE
  • 10., Cliniques universitaires UCL de Mont-Godinne, 5530 - Yvoir/BE
  • 11., UZ Antwerpen, 2650 - Edegem/BE
  • 12., Imeldaziekenhuis, 2820 - Bonheiden/BE
  • 13., Leuvens Biostatistiek en Statistische Bioinformatica Centrum, 3000 - Leuven/BE

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 (α: 0.05; ß: 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 <0.0001; OC: 29%; EC: 36%; CC: 38%) (G4: 15%). The incidence of sepsis was 5%, G3-4 thrombocytopenia 41% (G4: 13%), and G2-3 peripheral neuropathy 16%. Transfusion of platelets was needed in 10% and red blood cells in 71%. Erythropoietin was administered in 24% of the patients. Dose was delayed in 71% of the patients with a median of 2 weeks. Dose reduction was needed for C in 47% and for T in 18% of the patients (mean dose/week taking reductions and delays into account, respectively AUC 2.3 and 52 mg/m2). The most frequent reason for dose delay and C dose reduction was thrombocytopenia (46% and 68%, respectively).

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.