1. An Open-Label Single-Arm Phase II Study of Treatment with Neoadjuvant S-1 Plus Cisplatin for Clinical Stage III Squamous Cell Carcinoma of the Esophagus.
- Author
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Kanda M, Koike M, Iwata N, Shimizu D, Tanaka C, Hattori N, Hayashi M, Yamada S, Omae K, Nakayama G, and Kodera Y
- Subjects
- Aged, Cisplatin therapeutic use, Drug Combinations, Esophagectomy, Female, Fluorouracil therapeutic use, Humans, Japan, Male, Middle Aged, Neoadjuvant Therapy, Neoplasm Staging, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Carcinoma, Squamous Cell drug therapy, Carcinoma, Squamous Cell pathology, Esophageal Neoplasms drug therapy, Esophageal Neoplasms pathology, Esophageal Squamous Cell Carcinoma pathology, Oxonic Acid, Tegafur
- Abstract
Lessons Learned: Two courses of neoadjuvant therapy using S-1 plus cisplatin for clinical stage III esophageal squamous cell carcinoma did not achieve expected response rate according to endoscopic evaluation of primary tumors. Subsequent esophagectomy was safely performed., Background: In Japan, esophagectomy after two courses of 5-fluorouracil plus cisplatin is regarded a standard strategy for treating stage II or III esophageal squamous cell carcinoma (ESCC). However, 5-fluorouracil plus cisplatin does not benefit cohorts with clinical stage III ESCC, suggesting the need for a more effective regimen., Methods: A single-arm, open-label phase II trial was conducted to evaluate the safety and efficacy of two courses of neoadjuvant chemotherapy using S-1 plus cisplatin (NAC-SP) for clinical stage III ESCC. The primary endpoint was overall response rate as defined by endoscopic evaluation of primary tumors., Results: We enrolled 26 patients. The completion rate for the two courses of NAC-SP was 61.5%. Grade 3 or higher adverse events were experienced by 38.4% of patients. The treatment response rate according to endoscopic findings, acquired before the second course, was 34.6% and below the expected level (55.0%). The morbidity rate of patients who underwent radical subtotal esophagectomy (96.2%) was 32.0%. Repeat surgery was unnecessary, and surgery-associated deaths did not occur. The 5-year progression-free survival (PFS) and overall survival (OS) rates were 84.6% and 92.2%, respectively., Conclusion: We demonstrate safety of NAC-SP, but not its efficacy, for patients with clinical stage III ESCC. Subsequent esophagectomy was safely performed., (© AlphaMed Press; the data published online to support this summary are the property of the authors.)
- Published
- 2020
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