子宫切除术辅助治疗宫颈癌的序贯放化疗与同期放化疗或单纯放疗的疗效比较：STARS 三期随机临床试验。

Effectiveness of Sequential Chemoradiation vs Concurrent Chemoradiation or Radiation Alone in Adjuvant Treatment After Hysterectomy for Cervical Cancer: The STARS Phase 3 Randomized Clinical Trial.

机构信息

Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.

Guangdong Provincial People's Hospital, Guangzhou, China.

出版信息

JAMA Oncol. 2021 Mar 1;7(3):361-369. doi: 10.1001/jamaoncol.2020.7168.

DOI:10.1001/jamaoncol.2020.7168

PMID:33443541

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7809615/

Abstract

IMPORTANCE

There is no current consensus on the role of chemotherapy in addition to radiation for postoperative adjuvant treatment of patients with early-stage cervical cancer with adverse pathological factors.

OBJECTIVE

To evaluate the clinical benefits of sequential chemoradiation (SCRT) and concurrent chemoradiation (CCRT) compared with radiation alone (RT) as a postoperative adjuvant treatment in early-stage cervical cancer.

DESIGN, SETTING, AND PARTICIPANTS: After radical hysterectomy at 1 of 8 participating hospitals in China, patients with FIGO (International Federation of Gynecology and Obstetrics) stage IB to IIA cervical cancer with adverse pathological factors were randomized 1:1:1 to receive adjuvant RT, CCRT, or SCRT. Data were collected from February 2008 to December 2018.

INTERVENTIONS

Patients received adjuvant RT (total dose, 45-50 Gy), CCRT (weekly cisplatin, 30-40 mg/m2), or SCRT (cisplatin, 60-75 mg/m2, plus paclitaxel, 135-175 mg/m2) in a 21-day cycle, given 2 cycles before and 2 cycles after radiotherapy, respectively.

MAIN OUTCOMES AND MEASURES

The primary end point was the rate of disease-free survival (DFS) at 3 years.

RESULTS

A total of 1048 women (median [range] age, 48 [23-65] years) were included in the analysis (350 in the RT group, 345 in the CCRT group, and 353 in the SCRT group). Baseline demographic and disease characteristics were balanced among the treatment groups except that the rate of lymph node involvement was lowest in the RT group (18.3%). In the intention-to-treat population, SCRT was associated with a higher rate of DFS than RT (3-year rate, 90.0% vs 82.0%; hazard ratio [HR], 0.52; 95% CI, 0.35-0.76) and CCRT (90.0% vs 85.0%; HR, 0.65; 95% CI, 0.44-0.96). Treatment with SCRT also decreased cancer death risk compared with RT (5-year rate, 92.0% vs 88.0%; HR, 0.58; 95% CI, 0.35-0.95) after adjustment for lymph node involvement. However, neither DFS nor cancer death risk was different among patients treated with CCRT or RT.

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, conducted in a postoperative adjuvant treatment setting, SCRT, rather than CCRT, resulted in a higher DFS and lower risk of cancer death than RT among women with early-stage cervical cancer.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT00806117.

摘要

重要性

目前对于早期宫颈癌伴有不良病理因素的患者，术后辅助治疗中化疗在放疗之外的作用还没有达成共识。

目的

评估与单独放疗（RT）相比，顺铂序贯放化疗（SCRT）和同期放化疗（CCRT）作为早期宫颈癌术后辅助治疗的临床获益。

设计、地点和参与者：在中国 8 家参与医院之一行根治性子宫切除术的FIGO（国际妇产科联合会）分期为 IB 至 IIA 期的宫颈癌伴有不良病理因素的患者，按 1:1:1 随机分配接受辅助 RT、CCRT 或 SCRT。数据收集时间为 2008 年 2 月至 2018 年 12 月。

干预措施

患者接受辅助 RT（总剂量 45-50 Gy）、CCRT（每周顺铂 30-40 mg/m2）或 SCRT（顺铂 60-75 mg/m2，联合紫杉醇 135-175 mg/m2），在 21 天周期中，分别在放疗前 2 个周期和放疗后 2 个周期给予 2 个周期。

主要结局和测量指标

主要终点为 3 年无病生存率（DFS）。

结果

共纳入 1048 例女性（中位[范围]年龄，48[23-65]岁）（RT 组 350 例，CCRT 组 345 例，SCRT 组 353 例）。除淋巴结受累率最低的 RT 组外（18.3%），治疗组之间的基线人口统计学和疾病特征均均衡。在意向治疗人群中，SCRT 的 DFS 率高于 RT（3 年率，90.0% vs 82.0%；HR，0.52；95%CI，0.35-0.76）和 CCRT（90.0% vs 85.0%；HR，0.65；95%CI，0.44-0.96）。与 RT 相比，SCRT 治疗也降低了癌症死亡风险（5 年率，92.0% vs 88.0%；HR，0.58；95%CI，0.35-0.95），且在调整淋巴结受累后。然而，CCRT 或 RT 治疗的患者之间 DFS 或癌症死亡风险均无差异。