title: A phase I dose escalation study of S-1 with concurrent radiotherapy in elderly patients with esophageal cancer.
abstract: BACKGROUND
  Concurrent chemoradiotherapy (CRT) with 5-fluorouracil (5-FU) and cisplatin (CDDP) are often associated with significant incidence of toxic effects in elderly patients with esophageal cancer. This phase I trial was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of S-1, an oral 5-FU derivative, when given with radiotherapy in elderly patients.
  
  
  METHODS
  Patients who were age of 70 years or older with histologically confirmed esophageal cancer, and had an Eastern Cooperative Oncology Group (ECOG) score of 0-2 were eligible for this study. Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy. S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80 mg/m(2)/day.
  
  
  BACKGROUND
  NCT01175447 (ClinicalTrials.gov).
  
  
  RESULTS
  Twelve previously untreated patients were enrolled in this study. No grade 3 or 4 toxicity was observed in six patients treated at the 60 and 70 mg/m(2) dose levels. DLT was observed in four of six patients treated at the 80 mg/m(2) dose level. Two patients developed grade 3 esophagitis, one patient developed grade 3 esophagitis and pneumonitis, and one patient developed grade 3 thrombocytopaenia. Endoscopic complete response (CR) was observed in eight patients (66.7%). The median progression free survival (PFS) was 20 months and median overall survival was 29 months.
  
  
  CONCLUSIONS
  The MTD of S-1 was 80 mg/m(2), and the recommended dose (RD) for phase II studies was 70 mg/m(2). This regimen was well tolerated and active in elderly patients with esophageal cancer, meriting further investigation in phase II studies.
authors.affiliation: 1 Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China ; 2 Key Laboratory of Radiation Oncology, Hangzhou 310022, China ; 3 Key Laboratory of Diagnosis and Treatment Technology on Thoracic Oncology, Hangzhou 310022, China.
authors.forename: Yongling
authors.initials: Y
authors.lastname: Ji
authors.affiliation: 1 Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China ; 2 Key Laboratory of Radiation Oncology, Hangzhou 310022, China ; 3 Key Laboratory of Diagnosis and Treatment Technology on Thoracic Oncology, Hangzhou 310022, China.
authors.forename: Guoqing
authors.initials: G
authors.lastname: Qiu
authors.affiliation: 1 Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China ; 2 Key Laboratory of Radiation Oncology, Hangzhou 310022, China ; 3 Key Laboratory of Diagnosis and Treatment Technology on Thoracic Oncology, Hangzhou 310022, China.
authors.forename: Liming
authors.initials: L
authors.lastname: Sheng
authors.affiliation: 1 Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China ; 2 Key Laboratory of Radiation Oncology, Hangzhou 310022, China ; 3 Key Laboratory of Diagnosis and Treatment Technology on Thoracic Oncology, Hangzhou 310022, China.
authors.forename: Xiaojiang
authors.initials: X
authors.lastname: Sun
authors.affiliation: 1 Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China ; 2 Key Laboratory of Radiation Oncology, Hangzhou 310022, China ; 3 Key Laboratory of Diagnosis and Treatment Technology on Thoracic Oncology, Hangzhou 310022, China.
authors.forename: Yuanda
authors.initials: Y
authors.lastname: Zheng
authors.affiliation: 1 Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China ; 2 Key Laboratory of Radiation Oncology, Hangzhou 310022, China ; 3 Key Laboratory of Diagnosis and Treatment Technology on Thoracic Oncology, Hangzhou 310022, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Chen
authors.affiliation: 1 Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China ; 2 Key Laboratory of Radiation Oncology, Hangzhou 310022, China ; 3 Key Laboratory of Diagnosis and Treatment Technology on Thoracic Oncology, Hangzhou 310022, China.
authors.forename: Xianghui
authors.initials: X
authors.lastname: Du
keywords: S-1; chemoradiotherapy (CRT); elderly; esophageal cancer