1. The significance of consolidation chemotherapy after concurrent chemoradiotherapy in esophageal squamous cell carcinoma: a randomized controlled phase III clinical trial.
- Author
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Zhu, Qingshan, Zhang, Chi, Li, Zhuoqi, Ma, Tingwei, Wang, Nengchao, Liu, Weipeng, He, Zhijie, Shen, Jing, Wei, Tao, Zhao, Shijie, Feng, Lianjie, and Tian, Yuan
- Subjects
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THERAPEUTIC use of antineoplastic agents , *SQUAMOUS cell carcinoma , *LEUCOPENIA , *RISK assessment , *CISPLATIN , *SURVIVAL rate , *RESEARCH funding , *STATISTICAL sampling , *ANTINEOPLASTIC agents , *CHEMORADIOTHERAPY , *RANDOMIZED controlled trials , *CANCER patients , *DESCRIPTIVE statistics , *CHI-squared test , *LONGITUDINAL method , *DRUG efficacy , *CONSOLIDATION chemotherapy , *FLUOROURACIL , *PACLITAXEL , *PROGRESSION-free survival , *COMPARATIVE studies , *ESOPHAGEAL cancer , *OVERALL survival , *EVALUATION , *DISEASE risk factors - Abstract
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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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