P0031 Use of FOLFOX4 regimen in stage IV cervical cancer: A pilot study

Abstract

Background We performed a phase 2, single arm, open-label study of FOLFOX4 (oxaliplatin/fluorouracil/leucovorin) chemotherapy as palliative treatment in patients with metastatic cervical cancer to assess its efficacy and safety. Methods The patients recruited for this study were 18–65 years old had metastatic cervical cancer, prior radiotherapy treatment, Eastern Cooperative Oncology Group (ECOG) performance status 0–1, life expectancy more than 6 months, adequate haematological, renal, and hepatic functions, and were able to comply with scheduled follow-up and with management of toxicity. Thirty patients were enrolled from December 2011, to January 2012. All patients received FOLFOX4 (oxaiplatin 85 mg/m2 on day 1, fluorouracil 400 mg/m2 intravenous push on day 1–2, fluorouracil 600 mg/m2 intravenous drip in 22 h on day 1–2, and folinic acid 200 mg/m2 intravenous push on day 1–2). Outcomes were treatment response after six and 12 cycles of FOLFOX4, and every 3 months thereafter, according to World Health Organisation (WHO) criteria and Response Evaluation Criteria in Solid Tumours (RECIST) guidelines, and toxicity. Findings The mean age was 51 years (range 24–64), and 80% of patients had squamous cell metastasis from cervical cancer. 70% had metastasis at a distant lymph node. 59% of patients received at least six cycles of FOLFOX4. Nine patients (31%) achieved an objective response. At the mean follow-up time of 12.8 months, 1-year progression-free and overall survival was 20.7% and 65.5%, respectively. The most common grade ⩾ 2 toxicities during chemotherapy were fatigue (48.3%) and anaemia (37.9%). One patient died during the first cycle of FOLFOX4 due to a non-cancer cause. Interpretation FOLFOX4 regimen in metastatic cervical cancer is feasible and of reasonable toxicity.