Clinical usefulness of the oral chemotherapy agent S-1 in heavily pre-treated patients with advanced or recurrent cervical cancer.

Purpose: Our aim was to evaluate the efficacy and safety of S-1 in heavily pre-treated patients with advanced (FIGO stage IVB) or recurrent cervical cancer.

Methods: The Institutional Review Board of our hospital approved the protocol for this retrospective phase II study. Patients with measurable disease received two oral doses of S-1 (35 mg/m(2)) daily for 4 weeks of a 6-week cycle or 2 weeks of a 3-week cycle. The antitumor effect, time to progression, overall survival, and adverse events were investigated.

Results: We retrospectively analyzed relevant data of 28 patients with advanced or recurrent cervical cancer. Twenty-two patients had prior chemotherapy (not including chemoradiotherapy) and 27 had prior radiotherapy. The median number of prior chemotherapy regimens and cycles was 2 (range 0-4) and 7 (range 0-35), respectively. Two patients (7.1%) had partial response, and 10 patients (35.7%) had stable disease. Ten patients (35.7%) discontinued the therapy because of progressive disease. The response in 5 patients could not be evaluated because of termination of treatment in the middle of the first cycle. The disease control rate was 42.8%. After a median follow-up duration of 7.5 months, the median time to progression was 4.2 months (95% CI 2.7-5.4) and the median overall survival was 9.92 months (95% CI 9.20-NA). The two patients with partial response had received less prior chemotherapy.

Conclusions: Oral S-1 in palliative chemotherapy is a useful and well-tolerated treatment in heavily pre-treated patients with advanced or recurrent uterine cervical cancer.