Recurrent non-squamous cell carcinoma (non-SCC) of the uterine cervix 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 was examined in a phase II study. Fifteen patients were enrolled between August 2013 and March 2023. S-1 was administered orally at a daily dose of 80–120 mg for 14 days, and oxaliplatin was administered intravenously at a dose of 100 mg/m2on day 1. Each treatment cycle lasted 21 days. The anti-tumor effects, adverse events, progression-free survival (PFS), and overall survival (OS) were investigated. The median patient age was 54 (41–74) years. The anti-tumor effect was rated as a partial response in five patients, stable disease in four, and progressive disease in 6. The overall response rate was 33% and the disease control rate was 60%. Regarding hematologic toxicities of grade 3 or more severity, leukopenia, neutropenia, anemia, and thrombocytopenia occurred in 26.6–40.0%. None of the patients discontinued the treatment because of adverse events. The median PFS and OS were 6 months (95% confidence interval [CI]: 2–11 months) and 22 months (95% CI: 11–23 months), respectively. No treatment-related deaths occurred. These results suggest that SOX therapy is useful for the treatment of recurrent non-SCC with promising anti-tumor effects and minimal adverse events.
复发性宫颈非鳞状细胞癌(non-SCC)对治疗反应不佳且预后较差。一项II期研究评估了S-1联合奥沙利铂(SOX)方案治疗复发性宫颈非鳞癌的疗效与安全性。研究于2013年8月至2023年3月期间纳入15例患者。治疗方案为:S-1每日口服80-120 mg(连续14天),奥沙利铂于第1天静脉给药(100 mg/m²),每21天为一个治疗周期。研究主要观察指标包括抗肿瘤效果、不良事件、无进展生存期(PFS)和总生存期(OS)。患者中位年龄为54岁(范围41-74岁)。抗肿瘤疗效评估显示:5例患者达到部分缓解,4例疾病稳定,6例疾病进展。总体缓解率为33%,疾病控制率达60%。≥3级血液学毒性方面,白细胞减少、中性粒细胞减少、贫血及血小板减少的发生率为26.6%-40.0%。无患者因不良事件终止治疗。中位PFS为6个月(95%置信区间[CI]:2-11个月),中位OS为22个月(95% CI:11-23个月)。未发生治疗相关死亡事件。研究结果表明,SOX方案对复发性宫颈非鳞癌具有潜在治疗价值,其抗肿瘤效果显著且不良事件可控。