title: Phase II study of concurrent selective lymph node late course accelerated hyper-fractionated radiotherapy and pemetrexed and cisplatin for locally advanced oesophageal squamous cell carcinoma.
abstract: OBJECTIVE
  To determine the clinical efficacy and toxicity of pemetrexed combined with low-dose cisplatin (CDDP) concurrent with late-course accelerated hyperfractionated (LCAF) intensity-modulated radiation therapy (IMRT) in patients with inoperable locally advanced oesophageal squamous cell carcinoma (ESCC).
  
  
  METHODS
  Patients with locally advanced ESCC (less than or equal to 75 years of age, clinical stages IIB-IVA and Karnofsky performance status ≥70) were enrolled into the study. A target group size of 22 was projected based on the estimation that 2-year overall survival (OS) would increase from 20% to 40%. Patients were treated with pemetrexed, low-dose CDDP and LCAF IMRT concurrently. The main objective of the study was for a 2-year OS, and the secondary objectives were progression-free survival (PFS), objective response, locoregional failure rate, and acute and late toxicities.
  
  
  RESULTS
  25 patients were recruited from October 2008 to July 2011. The median OS was 21 months, with 2- and 5-year OS rates of 44% and 44%, respectively. The median PFS was 18.2 months. The objective response rate was 96% (24/25), with 11 complete responses and 13 partial responses. The locoregional failure rate was 16%. Grades 4 and 5 acute toxicity rates were 8% and 4%, respectively, while no Grade 3 or greater late toxicity was observed.
  
  
  CONCLUSIONS
  The findings of this Phase II study indicated that the therapeutic regimen appears to achieve an excellent response rate and favourable survival for locally advanced ESCC. However, the severe acute side effects should be considered cautiously in further studies.
  
  
  CONCLUSIONS
  To our knowledge, this is the first study that introduced pemetrexed and low-dose CDDP combined with LCAF IMRT to treat locally advanced ESCC. The 5-year OS rate was as high as 44%, which was more favourable than other studies.
authors.affiliation: Sixth Department of Radiation Oncology, Shandong Cancer Hospital, Jinan, China.
authors.forename: C
authors.initials: C
authors.lastname: Fu
authors.forename: B
authors.initials: B
authors.lastname: Li
authors.forename: L
authors.initials: L
authors.lastname: Guo
authors.forename: H
authors.initials: H
authors.lastname: Li
authors.forename: W
authors.initials: W
authors.lastname: Huang
authors.forename: H
authors.initials: H
authors.lastname: Gong
authors.forename: M
authors.initials: M
authors.lastname: Sun
authors.forename: Z
authors.initials: Z
authors.lastname: Wang
authors.forename: T
authors.initials: T
authors.lastname: Zhou
authors.forename: C
authors.initials: C
authors.lastname: Liu
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D000077277:Esophageal Squamous Cell Carcinoma; D005260:Female; D005971:Glutamates / Q000008:administration & dosage* / Q000009:adverse effects; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008198:Lymph Nodes / Q000528:radiation effects; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods*; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D002945:Cisplatin