Introduction Recurrent cervical non-squamous cell carcinoma (non-SCC) is resistant to treatment and has a poor prognosis. The efficacy and safety of S-1/oxaliplatin (SOX) therapy in patients with recurrent non-SCC of uterine cervix were examined in a phase II study.

Methods Fourteen patients were enrolled from January 2013 to December 2022. S-1 was orally administered for 14 days at a dose of 80–120 mg/body/day with oxaliplatin being administered intravenously at a dose of 100 mg/m² on day 1. Each treatment cycle was 21 days, and repeated until disease progression or serious adverse events occurred. The antitumor effect, adverse events, progression-free survival (PFS), and overall survival (OS) were investigated.

Results The median age of the patients was 54 (41–73) years. The PS was 0 in 10 and 1 in 4 patients. The median number of prior regimens was 2 (1–5). The histological type was usual type adenocarcinoma in 10 patients, endometrioid carcinoma, clear cell carcinoma, signet-ring cell carcinoma and unclassified in 1. The overall response rate was 35.7%, and the disease control rate was 64.2%. As for hematologic toxicities of grade 3 or more severe, leukopenia, neutropenia, anemia and thrombocytopenia occurred in 21.4%, 35.7%, 42.8 and 35.7%, respectively, as for non-hematologic toxicities, fatigue occurred in 7.1%, of the patients. The median PFS and OS were 5 (1–17) months, 14 (3–23) months respectively.

Conclusion/Implications These results suggest that SOX therapy is useful for the treatment of recurrent non-SCC of uterine cervix, having a promising antitumor effect and minimal adverse effects.