Center for Gynaecologic Oncology Amsterdam, Amsterdam University Medical Center, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Gynaecologic Oncology, Istituto Nazionale Tumori di Napoli IRCCS "Fondazione G. Pascale", Naples, Italy.
J Clin Oncol. 2023 Nov 10;41(32):5035-5043. doi: 10.1200/JCO.22.02852. Epub 2023 Sep 1.
This multicenter trial by the European Organisation for Research and Treatment of Cancer Gynecological Cancer Group was motivated by conflicting evidence on the value of neoadjuvant chemotherapy before surgery compared with concomitant chemoradiotherapy (CCRT) in stage IB2-IIB cervical carcinoma.
Between May 2002 and January 2014, 626 patients with International Federation of Gynecology and Obstetrics stage IB2-IIb were randomly assigned between neoadjuvant chemotherapy followed by surgery (NACT-S; n = 314) and standard CCRT (n = 312). The primary end point was 5-year overall survival (OS) rate. Secondary end points were progression-free survival, OS, toxicity, and health-related quality of life (HRQOL).
After a median follow-up of 8.7 years, 198 patients (31.6%) died. Age, stage, and cell type were balanced in both arms. Protocol treatment was completed in 223 of 314 (71%) patients in NACT-S and 257 of 312(82%) in CCRT arms. Main reasons for incomplete protocol treatment were toxicity (30 of 314; 9.6%) and progressive disease (21 of 314; 6.7%) in the NACT-S arm and toxicity (23 of 312; 7.4%) and patient refusal (13 of 312; 4.2%) in the CCRT arm. Additional radiotherapy after completed NACT-S was given to 107 patients (48%), and additional surgery to 20 patients (8%) after completed CCRT. Short-term adverse events (AEs) ≥grade 3 occurred more frequently with NACT-S (41% 23%), and long-term AEs ≥grade 3 more often with CCRT (21% 15%). The 5-year OS was not significantly different between NACT-S (72%; 95% CI, 66 to 77) and CCRT (76%; 95% CI, 70 to 80).
This trial failed to demonstrate superiority in favor of the NACT-S arm but resulted in acceptable morbidity and HRQOL in both arms.
本项由欧洲癌症研究与治疗组织妇科癌症组开展的多中心试验，旨在探讨新辅助化疗（NACT）与同期放化疗（CCRT）在国际妇产科联合会（FIGO）分期 IB2-IIB 宫颈癌中的应用价值。既往关于该问题的研究结果存在矛盾。
2002 年 5 月至 2014 年 1 月，共纳入 626 例FIGO 分期 IB2-IIb 宫颈癌患者，随机分为 NACT 后手术组（NACT-S 组，n=314）和 CCRT 组（n=312）。主要研究终点为 5 年总生存率（OS）。次要研究终点为无进展生存率、OS、毒性和健康相关生活质量（HRQOL）。
中位随访 8.7 年后，198 例（31.6%）患者死亡。两组患者年龄、分期和细胞类型均衡可比。NACT-S 组和 CCRT 组分别有 223 例（71%）和 257 例（82%）患者完成了方案治疗。NACT-S 组未完成方案治疗的主要原因为毒性（30 例，9.6%）和疾病进展（21 例，6.7%），CCRT 组未完成方案治疗的主要原因为毒性（23 例，7.4%）和患者拒绝（13 例，4.2%）。NACT-S 组有 107 例（48%）患者接受了辅助放疗，CCRT 组有 20 例（8%）患者接受了辅助手术。NACT-S 组治疗相关短期不良事件（AE）≥3 级的发生率高于 CCRT 组（41%比 23%），CCRT 组治疗相关长期 AE≥3 级的发生率高于 NACT-S 组（21%比 15%）。NACT-S 组和 CCRT 组的 5 年 OS 率分别为 72%（95%CI，66%77%）和 76%（95%CI，70%80%），差异无统计学意义。
本试验未能证明 NACT-S 组的优势，但两组患者的发病率和 HRQOL 均在可接受范围内。
