title: Phase I study of concurrent selective lymph node late-course accelerated hyperfractionated radiotherapy and S-1 plus cisplatin for locally advanced oesophageal squamous cell carcinoma.
abstract: OBJECTIVE
  This Phase I study aimed to assess the safety and efficacy of concurrent selective lymph node (SLN) late-course accelerated hyperfractionated (LCAF) intensity-modulated radiotherapy (IMRT) and S-1 plus cisplatin (CDDP) for the locally advanced oesophageal squamous-cell carcinoma (ESCC).
  
  
  METHODS
  The total dose of SLN LCAF IMRT was 59.6 Gy/34 fractions in 5.4 weeks. The concurrent chemotherapy (CCRT) was administered as follows: CDDP 25 mg m(-2) on Days 1-3 and Days 22-24; S-1 was applied in a de-escalating dosage with a decrement of 10 mg m(-2) per day, from its full dose level of 80 mg m(-2), orally twice daily on Days 1-14 and Days 22-35. We inferred the maximum-tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended dose, according to adverse reaction during CCRT.
  
  
  RESULTS
  Totally, 15 patients with ESCC with T2-4N0-1M0-1a were enrolled in Dose Level 1 (80 mg m(-2)). In the initial five patients, two patients developed DLTs. As MTD was not reached, five additional patients were treated with the same dose level, and DLTs occurred in only one patient. Similar results were found in the last five patients. After CCRT, the objective response rates were 100% for primary tumours and 86.2% for metastatic lymph nodes, respectively. Totally, the observed Grade 3 toxicities during CCRT were leukopenia (20%), neutropenia (20%) and dermatitis (13.3%), and no Grade 4 toxicity occurred. The Kaplan-Meier-estimated overall and progression survival rates were 86.7% and 66.7% (1 year), 73.3% and 60% (2 years) and 73.3% and 60% (3 years).
  
  
  CONCLUSIONS
  The concurrent SLN LCAF IMRT and chemotherapy with S-1 and CDDP was well tolerated and showed promising efficacy. The dose of S-1 in this regimen was recommended with 80 mg m(-2) orally twice daily on Days 1-14 and Days 22-35.
  
  
  CONCLUSIONS
  CCRT with S-1 plus CDDP exhibited encouraging results with milder toxicities, high objective response rates and ideal overall survival time.
authors.affiliation: 1 Shandong Medical College, Jinan, Shandong Province, China.
authors.forename: Miaomiao
authors.initials: M
authors.lastname: Li
authors.affiliation: 2 Sixth Department of Radiation Oncology, Shandong Cancer Hospital, Jinan, Shandong province, China.
authors.forename: Chengrui
authors.initials: C
authors.lastname: Fu
authors.affiliation: 3 Department of Radiation Oncology, Yuhuangding Hospital of Yantai, Shandong province, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.affiliation: 2 Sixth Department of Radiation Oncology, Shandong Cancer Hospital, Jinan, Shandong province, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Huang
authors.affiliation: 2 Sixth Department of Radiation Oncology, Shandong Cancer Hospital, Jinan, Shandong province, China.
authors.forename: Zhongtang
authors.initials: Z
authors.lastname: Wang
authors.affiliation: 2 Sixth Department of Radiation Oncology, Shandong Cancer Hospital, Jinan, Shandong province, China.
authors.forename: Tao
authors.initials: T
authors.lastname: Zhou
authors.affiliation: 2 Sixth Department of Radiation Oncology, Shandong Cancer Hospital, Jinan, Shandong province, China.
authors.forename: Haiqun
authors.initials: H
authors.lastname: Lin
authors.affiliation: 2 Sixth Department of Radiation Oncology, Shandong Cancer Hospital, Jinan, Shandong province, China.
authors.forename: Baosheng
authors.initials: B
authors.lastname: Li
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods*; D002945:Cisplatin / Q000627:therapeutic use*; D019583:Dose Fractionation, Radiation; D004938:Esophageal Neoplasms / Q000401:mortality / Q000628:therapy*; D000077277:Esophageal Squamous Cell Carcinoma; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D015182:Lymphatic Irradiation / Q000379:methods*; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin