Gemcitabine-oxaliplatin (GEMOX) as salvage treatment in pretreated epithelial ovarian cancer patients

Patrizia Vici, Domenico Sergi, Laura Pizzuti, Luciano Mariani, Maria Grazia Arena, Maddalena Barba, Marcello Maugeri-Saccà, Cristina Vincenzoni, Enrico Vizza, Giacomo Corrado, Giancarlo Paoletti, Federica Tomao, Silverio Tomao, Diana Giannarelli, Luigi Di Lauro

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Currently, no clearly superior management strategy exists for recurrent, platinum-resistant ovarian cancer. We tested the efficacy and safety of gemcitabine combined with oxaliplatin (GEMOX) in a multicentre phase II clinical trial. Methods. Forty one patients with recurrent, platinum-resistant ovarian cancer were enrolled. Prior to study entry, all the participants had received at least one platinum-based regimen. Gemcitabine was administered at 1000 mg/m2 as protracted infusion (100 min) on day 1, and oxaliplatin at the dose of 100 mg/m2 on day 2 in a 2 hour infusion. Cycles were repeated every two weeks. Results: We observed an overall response rate of 37% [95% Confidence Interval (CI), 22.3-51.7]. Objective responses plus disease stabilization (clinical benefit) occurred in 78% of patients. Median progression-free survival was 6.8 months (95% CI, 5.8-7.8), and median overall survival was 16.5 months (95% CI, 12.2-20.8). Median time to self-reported symptom relief, which was described by 22 out of 27 symptomatic patients (81.5%), was 4 weeks (range, 2-8). Grade 4 neutropenia and febrile neutropenia were observed in 2 (5%) and 1 (2.5%) patients, while grade 3 anemia was encountered in 2 (5%) patients, respectively. The most common adverse effects of any grade were gastrointestinal symptoms, fatigue and neutropenia. Nine patients (22%) experienced mild allergic reaction to oxaliplatin, with no treatment discontinuation. Conclusions: In our cohort of recurrent, platinum-resistant ovarian cancer patients, GEMOX showed encouraging activity and manageable toxicity. Under circumstances requiring a rapid disease control, this combination regimen may offer a particularly viable option, particularly in heavily pretreated patients.

Original languageEnglish
Article number49
JournalJournal of Experimental and Clinical Cancer Research
Volume32
Issue number1
DOIs
Publication statusPublished - 2013

Keywords

  • Combination therapy
  • Gemcitabine
  • Ovarian cancer
  • Oxaliplatinum
  • Platinum-resistant

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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