Kunos Charles A, Miller Rachel W, Fabian Denise
Department of Radiation Medicine, University of Kentucky, Lexington, KY 40508, USA.
Department of Obstetrics & Gynecology, Division of Gynecologic Oncology, University of Kentucky, Lexington, KY 40508, USA.
Cancers (Basel). 2024 Sep 28;16(19):3319. doi: 10.3390/cancers16193319.
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. 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. 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). 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.
先前的临床前研究表明，放射性药物对转移性、持续性或复发性子宫颈癌患者具有良好的抗肿瘤活性和可接受的安全性。在这类患者中，化疗联合放射性药物是否会显著提高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线数和无进展生存期关联起来，作为下一代放射性药物研发的基准。我们将2002年至2023年间不适合进行根治性手术或放疗的转移性、持续性或复发性子宫颈癌患者，按照双联、三联和四联化疗或其他干预措施的治疗线数进行分组。一线治疗后，对患者每三个月进行一次影像学进展监测，最长持续三年。主要终点是首次以及任何第二次或第三次无进展生存期。共有127例患者提供了人口统计学、肿瘤、治疗线数和结局数据，中位随访时间为18个月（四分位间距：9至37个月）。一线治疗后，113例患者出现局部或远处进展或因任何原因死亡，最常见的是死于疾病（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）。这项研究凸显了当前治疗对转移性、持续性或复发性子宫癌患者疗效有限。五个月的无进展生存期可作为临床疗效试验中新型疗法（如放射性药物）研发的基准。
