000389: COULD CAPECITABINE-INDUCED DISEASE STABILISATION WITH GOOD SYMPTOM CONTROL BE CONSIDERED A FAVORABLE TREATMENT OUTCOME IN CHEMOTHERAPY- PRETREATED METASTATIC SQUAMOUS-CELL CERVICAL CARCINOMA PATIENTS?

Objective: Phase II study investigated the safety and efficacy of ca- pecitabine in cisplatin-pretreated patients with advanced cervical cancer. Patients and Methods: Patients with cisplatin-pretreated metastatic cervical cancer with measurable disease and ECOG performance status < 2 were treated with capecitabine 1250 mg/m2 twice-daily, given days 1-14 Q 3w. Patients were treated until disease progression or unacceptable toxicity. Clinical benefit response was assessed, defined as improvement of PS and/or decrease of analgetic therapy consumption. Results: Twenty-five patients with metastatic disease were enrolled and evaluable. Six patients were previously treated with two chemotherapy lines, and 11 pts had two metastatic sites involved. 114 therapy cycles (median 4, range 1-9) were administrated. Chemotherapy was generally well tolerated: grade 3/4 toxicities included anemia (20%), thrombocytopenia (8%), neutropenia (4%), diarrhea (4%) and hand/foot syndrome (4%). None of the patients achieved complete response and in three patients capecitabine produced partial response, making the overall response 12% (CI 95%: 4%- 27%). Thirteen (52%) patients experienced stable disease, median duration 3,5 months, with the effect of significant symptom palliation in 9 of them (69%). Progression-free survival and overall survival were 3,5 and 7,5 months, respectively. Significant difference in OS was found between pts with PR1SD compared to those with PD. Conclusion: Capecitabine produced disease stabilization enabling good symptom control in considerable number of chemotherapy pretreated patients with disseminated cervical cancer. Thus, capeci- tabine should be further investigated as a promising agent in patients with cervical cancer.