Zhu Qingshan, Zhang Chi, Li Zhuoqi, Ma Tingwei, Wang Nengchao, Liu Weipeng, He Zhijie, Shen Jing, Wei Tao, Zhao Shijie, Feng Lianjie, Tian Yuan
Radiotherapy Department, Anyang Cancer Hospital of Henan Province, Anyang, China.
Radiotherapy Department, Anyang Cancer Hospital affiliated with Henan University of Science and Technology, Anyang, China.
Thorac Cancer. 2024 Oct;15(28):2038-2048. doi: 10.1111/1759-7714.15424. Epub 2024 Aug 28.
This study explored the significance of consolidation maintenance chemotherapy after concurrent chemoradiotherapy with different regimens in patients with esophageal squamous cell carcinoma.
A prospective randomized controlled phase III clinical trial was designed and registered in the China Clinical Trials Registry (Registration number: ChiCTR-TRC-12002719). Survival data were analyzed in terms of intention-to-treat (ITT) and per-protocol (PP) sets for patients undergoing cisplatin and 5-fluorouracil (PF) (group A), or cisplatin and paclitaxel (TP) (group B).
The incidence risk of grade III-IV leukopenia in group B was higher than in group A (49.2% vs. 25.5%, p = 0.012). The survival rates at 1, 2, 3, and 5 years were 83.8%, 62.6%, 53.1%, and 41.3%, respectively. Consolidation chemotherapy after concurrent chemoradiation therapy had no benefit on median progression-free survival (PFS) (p = 0.95) and overall survival (OS) (p = 0.809). According to the ITT analysis, the median PFS in group A and group B was 28.6 months and 30.3 months (X = 0.242, p = 0.623), while the median OS was 31.0 months and 50.3 months (X = 1.25，p = 0.263). For the PP analysis, the median PFS in group A and group B were 28.6 months and 30.3 months (p = 0.584), while the median OS was 31.0 months and 50.3 months (p = 0.259), respectively. Patients receiving consolidation chemotherapy did not show significant OS benefits (46.9 months vs. 38.3 months; X = 0.059, p = 0.866).
Similar PFS and OS were found between PF and TP regimens with concurrent chemoradiotherapy. Consolidation chemotherapy did not show any significant OS benefits.
本研究探讨了食管鳞状细胞癌患者采用不同方案同步放化疗后巩固维持化疗的意义。
设计了一项前瞻性随机对照III期临床试验，并在中国临床试验注册中心注册（注册号：ChiCTR-TRC-12002719）。对接受顺铂和5-氟尿嘧啶（PF）方案（A组）或顺铂和紫杉醇（TP）方案（B组）的患者，按照意向性分析（ITT）和符合方案分析（PP）集对生存数据进行分析。
B组III-IV级白细胞减少的发生率高于A组（49.2%对25.5%，p = 0.012）。1年、2年、3年和5年生存率分别为83.8%、62.6%、53.1%和41.3%。同步放化疗后进行巩固化疗对中位无进展生存期（PFS）（p = 0.95）和总生存期（OS）（p = 0.809）无益处。根据ITT分析，A组和B组的中位PFS分别为28.6个月和30.3个月（X = 0.242，p = 0.623），而中位OS分别为31.0个月和50.3个月（X = 1.25，p = 0.263）。对于PP分析，A组和B组的中位PFS分别为28.6个月和30.3个月（p = 0.584），而中位OS分别为31.0个月和50.3个月（p = 0.259）。接受巩固化疗的患者未显示出显著的OS获益（46.9个月对38.3个月；X = 0.059，p = 0.866）。
PF方案和TP方案同步放化疗的PFS和OS相似。巩固化疗未显示出任何显著的OS获益。
