A phase II study of S-1 with concurrent radiotherapy in elderly patients with esophageal cancer
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Yongling Ji1,2,3,*, Xianghui Du2,3,*, Ye Tian1, Liming Sheng2,3, Lei Cheng2,3, Ying Chen2,3, Guoqing Qiu2,3, Xia Zhou2,3, Wuan Bao2,3, Danhong Zhang2,3 and Ming Chen1,2,3
1Department of Radiotherapy and Oncology, The Second Affiliated Hospital of Soochow University, 215000 Suzhou, China
2Department of Radiation Oncology, Zhejiang Cancer Hospital, 310022 Hangzhou, China
3Zhejiang Key Laboratory of Radiation Oncology, Hangzhou 310022, China
*These authors have contributed equally to this work
Ming Chen, email: [email protected]
Keywords: S-1, chemoradiotherapy, esophageal cancer, elderly
Received: March 29, 2017 Accepted: July 25, 2017 Published: September 15, 2017
Background: Concurrent chemoradiotherapy (CCRT) using conventional platinum-based doublets are often associated with significant incidence of toxic effects in elderly patients with esophageal cancer. We previously reported a phase I trial of CCRT using S-1, an oral 5-fluorouracil derivative, which yielded well safe and active outcomes.
Methods: Patients with histologically confirmed esophageal cancer, who were age of 70 years or older with performance status (PS) score of 0-2 or age of 66 to 69 with PS score of 2, were eligible for this Phase II trial. Radiotherapy was delivered in 1.8 Gy per fraction to a total dose of 54 Gy. Concurrently, S-1 was administered at 70 mg/m2 on days 1–14 and 29–42. The primary end point was 2-year overall survival rate.
Results: Thirty patients were enrolled, and 28 patients completed the full course of radiotherapy. No grade 4 toxicity or treatment-related death occurred. The grade 3 toxicities included esophagitis (16.7%), leucopoenia (13.3%), neutropenia (10%), anaemia (3.3%), pneumonitis (3.3%) and fatigue (3.3%). The median progression-free survival time and median survival time was 19 and 24 months, respectively. The 2-year overall survival rate was 45.1%, which exceeded the predefined threshold of 2-year OS 35% and met the primary end point of the study.
Conclusions: The results suggest that CCRT using S-1 is effective with mild toxicity in elderly patients with esophageal cancer. A phase III trial is needed to further evaluate this regimen.
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