Gemcitabine-oxaliplatin combination for ovarian cancer resistant to taxane-platinum treatment: a phase II study from the GINECO group

Advanced ovarian carcinoma in early progression (<6 months) (AOCEP) is considered resistant to most cytotoxic drugs. Gemcitabine (GE) and oxaliplatin (OXA) have shown single-agent activity in relapsed ovarian cancer. Their combination was tested in patients with AOCEP in phase II study. Fifty patients pre-treated with platinum–taxane received q3w administration of OXA (100 mg m(–2), d1) and GE (1000 mg m(–2), d1, d8, 100-min infusion). Patient characteristics were a : median age 64 years (range 46–79),and 1 (84%) or 2 (16%) earlier lines of treatment. Haematological toxicity included grade 3–4 neutropaenia (33%), anaemia (8%), and thrombocytopaenia (19%). Febrile neutropaenia occurred in 3%. Non-haematological toxicity included grade 2–3 nausea or vomiting (34%), grade 3 fatigue (25%),and grade 2 alopecia (24%). Eighteen (37%) patients experienced response. Median progression-free (PF) and overall survivals (OS) were 4.6 and 11.4 months, respectively. The OXA–GE combination has high activity and acceptable toxicity in AOCEP patients. A comparison of the doublet OXA–GE with single-agent treatment is warranted.