Background:Prior preclinical studies showed promising antitumor activity and an acceptable safety profile associated with radiopharmaceuticals for patients with metastatic, persistent, or recurrent uterine cervix cancers. Whether the addition of a radiopharmaceutical to chemotherapy would significantly increase progression-free survival in such patients is untested. Our retrospective study sought to associate the line of treatment and progression-free survival as benchmarks for next-generation radiopharmaceutical development.Methods:We grouped metastatic, persistent, or recurrent uterine cervix cancer patients not amenable to curable surgery or radiotherapy between 2002 and 2023 by the line of doublet, triplet, and quadruplet chemotherapy or another intervention. After the first-line treatment, patients were monitored for radiographic progression every three months for up to three years. The primary endpoints were the first and any second or third progression-free survival intervals.Results:A total of 127 patients contributed demographic, tumor, line of treatment, and outcome data with a median follow-up of 18 months (25–75% interquartile range: 9 to 37 months). After the first-line treatment, 113 patients had local or distant progression or died from any cause, most often death from the disease (67%). Median progression-free survivals were 5.5 months (95% confidence interval: 4.8–6.0 months), 5.3 months (95% confidence interval: 4.5–6.3 months), and 3.0 months (95% confidence interval: 2.1–3.7 months) for the first-, second-, and third-line treatments, respectively. For a first-line cisplatin-containing regimen, the median progression-free survival was 6.5 months (95% confidence interval: 5.5–7.7 months).Conclusions:This study highlights the limited efficacy of current treatments for metastatic, persistent, or recurrent uterine cancer patients. A five-month progression-free survival might serve as a benchmark for the development of novel therapies in clinical efficacy trials, such as radiopharmaceuticals.
背景：既往临床前研究表明，放射性药物对转移性、持续性或复发性宫颈癌患者显示出良好的抗肿瘤活性和可接受的安全性。然而，在化疗基础上加用放射性药物是否能显著延长此类患者的无进展生存期尚未得到验证。我们的回顾性研究旨在将治疗方案与无进展生存期相关联，为下一代放射性药物的研发提供基准。 方法：我们收集了2002年至2023年间无法接受根治性手术或放疗的转移性、持续性或复发性宫颈癌患者，根据其接受的双药、三药、四药化疗或其他干预方案的治疗线数进行分组。一线治疗后，患者每三个月接受影像学评估以监测疾病进展，持续随访至三年。主要研究终点为首次及后续任何二次或三次治疗后的无进展生存期。 结果：共纳入127例患者，收集了人口统计学、肿瘤特征、治疗方案及预后数据，中位随访时间为18个月（四分位距：9-37个月）。一线治疗后，113例患者出现局部或远处进展或因各种原因死亡，其中最常见为疾病相关死亡（67%）。一线、二线和三线治疗的中位无进展生存期分别为5.5个月（95%置信区间：4.8-6.0个月）、5.3个月（95%置信区间：4.5-6.3个月）和3.0个月（95%置信区间：2.1-3.7个月）。对于含顺铂的一线治疗方案，中位无进展生存期为6.5个月（95%置信区间：5.5-7.7个月）。 结论：本研究揭示了当前治疗方案对转移性、持续性或复发性宫颈癌患者的疗效有限。五个月的无进展生存期可作为新型疗法（如放射性药物）临床疗效试验的疗效基准。
肿瘤(癌症)患者之家