{"title":"食管鳞状细胞癌同期化放疗后巩固化疗的意义：随机对照 III 期临床试验。","authors":"Qingshan Zhu, Chi Zhang, Zhuoqi Li, Tingwei Ma, Nengchao Wang, Weipeng Liu, Zhijie He, Jing Shen, Tao Wei, Shijie Zhao, Lianjie Feng, Yuan Tian","doi":"10.1111/1759-7714.15424","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>This study explored the significance of consolidation maintenance chemotherapy after concurrent chemoradiotherapy with different regimens in patients with esophageal squamous cell carcinoma.</p><p><strong>Method: </strong>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).</p><p><strong>Results: </strong>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<sup>2</sup> = 0.242, p = 0.623), while the median OS was 31.0 months and 50.3 months (X<sup>2</sup> = 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<sup>2</sup> = 0.059, p = 0.866).</p><p><strong>Conclusion: </strong>Similar PFS and OS were found between PF and TP regimens with concurrent chemoradiotherapy. Consolidation chemotherapy did not show any significant OS benefits.</p>","PeriodicalId":23338,"journal":{"name":"Thoracic Cancer","volume":" ","pages":"2038-2048"},"PeriodicalIF":2.3000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11444924/pdf/","citationCount":"0","resultStr":"{\"title\":\"The significance of consolidation chemotherapy after concurrent chemoradiotherapy in esophageal squamous cell carcinoma: a randomized controlled phase III clinical trial.\",\"authors\":\"Qingshan Zhu, Chi Zhang, Zhuoqi Li, Tingwei Ma, Nengchao Wang, Weipeng Liu, Zhijie He, Jing Shen, Tao Wei, Shijie Zhao, Lianjie Feng, Yuan Tian\",\"doi\":\"10.1111/1759-7714.15424\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>This study explored the significance of consolidation maintenance chemotherapy after concurrent chemoradiotherapy with different regimens in patients with esophageal squamous cell carcinoma.</p><p><strong>Method: </strong>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).</p><p><strong>Results: </strong>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<sup>2</sup> = 0.242, p = 0.623), while the median OS was 31.0 months and 50.3 months (X<sup>2</sup> = 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<sup>2</sup> = 0.059, p = 0.866).</p><p><strong>Conclusion: </strong>Similar PFS and OS were found between PF and TP regimens with concurrent chemoradiotherapy. 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引用次数: 0
摘要
背景本研究探讨了食管鳞癌患者同时接受不同方案化放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进行了注册（注册号：ChiCTR-TRC-12002719）。对接受顺铂和5-氟尿嘧啶（PF）治疗（A组）或顺铂和紫杉醇（TP）治疗（B组）的患者的意向治疗组（ITT）和按方案治疗组（PP）的生存数据进行分析：B组III-IV级白细胞减少症的发生风险高于A组（49.2%对25.5%，P=0.012）。1年、2年、3年和5年的生存率分别为83.8%、62.6%、53.1%和41.3%。同期化放疗后的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）没有益处。根据 ITT 分析，A 组和 B 组的中位无进展生存期分别为 28.6 个月和 30.3 个月（X2 = 0.242，p = 0.623），而中位总生存期分别为 31.0 个月和 50.3 个月（X2 = 1.25，p = 0.263）。在PP分析中，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并未显示出明显的OS获益（46.9个月 vs. 38.3个月；X2 = 0.059，p = 0.866）：结论：同时接受放化疗的PF和TP方案的PFS和OS相似。结论：PF和TP方案在同时进行化放疗的情况下，PFS和OS相似。
The significance of consolidation chemotherapy after concurrent chemoradiotherapy in esophageal squamous cell carcinoma: a randomized controlled phase III clinical trial.
Background: This study explored the significance of consolidation maintenance chemotherapy after concurrent chemoradiotherapy with different regimens in patients with esophageal squamous cell carcinoma.
Method: 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).
Results: 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 (X2 = 0.242, p = 0.623), while the median OS was 31.0 months and 50.3 months (X2 = 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; X2 = 0.059, p = 0.866).
Conclusion: Similar PFS and OS were found between PF and TP regimens with concurrent chemoradiotherapy. Consolidation chemotherapy did not show any significant OS benefits.
期刊介绍：
Thoracic Cancer aims to facilitate international collaboration and exchange of comprehensive and cutting-edge information on basic, translational, and applied clinical research in lung cancer, esophageal cancer, mediastinal cancer, breast cancer and other thoracic malignancies. Prevention, treatment and research relevant to Asia-Pacific is a focus area, but submissions from all regions are welcomed. The editors encourage contributions relevant to prevention, general thoracic surgery, medical oncology, radiology, radiation medicine, pathology, basic cancer research, as well as epidemiological and translational studies in thoracic cancer. Thoracic Cancer is the official publication of the Chinese Society of Lung Cancer, International Chinese Society of Thoracic Surgery and is endorsed by the Korean Association for the Study of Lung Cancer and the Hong Kong Cancer Therapy Society.
The Journal publishes a range of article types including: Editorials, Invited Reviews, Mini Reviews, Original Articles, Clinical Guidelines, Technological Notes, Imaging in thoracic cancer, Meeting Reports, Case Reports, Letters to the Editor, Commentaries, and Brief Reports.
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