title: Phase II Study of Concurrent Pemetrexed, Cisplatin, and Radiation Therapy for Stage IIIA/B Unresectable Non-Small Cell Lung Cancer.
abstract: BACKGROUND
  Concurrent thoracic radiation and platinum-based chemotherapy is the standard of care for treatment of unresectable stage IIIA-IIIB non-small-cell lung cancer (NSCLC), but the optimal drug regimen has not been established.
  
  
  METHODS
  In the present single-arm phase II trial, patients with previously untreated, unresectable stage IIIA-IIIB NSCLC (all histologic types) were treated with pemetrexed-cisplatin (500 mg/m(2) intravenously on days 1 and 22, 20 mg/m(2) intravenously on days 1-5 and days 22-26) concurrent with radiotherapy (61-66 Gy in 31-35 fractions), followed by 2 cycles of consolidation pemetrexed-cisplatin (75 mg(2)) therapy. The primary endpoint was the 1-year overall survival (OS) rate. The study treatment was considered active if the 1-year OS rate was ≥ 70%.
  
  
  RESULTS
  A total of 39 patients, including 6 from the previous phase I trial who had been treated at the recommended phase II dose, were eligible for analysis. The most common drug-related grade 3 to 4 adverse events during the concurrent phase were hematologic and 5.1% of patients experienced grade 3 esophagitis. The response rate was 45.9% (17 of 37 patients), with no complete responses. The 1-, 2-, and 3-year OS survival rates were 79.5%, 56.4%, and 46.2%, respectively. The median OS, time to progressive disease, and progression-free survival was 30.3, 13.7, and 11.8 months, respectively.
  
  
  CONCLUSIONS
  Full-dose cisplatin and pemetrexed can be administered concurrently with conventional doses of thoracic radiation. The median and 1-year OS rates were favorable compared with published clinical trials in this setting. The regimen was tolerable, and the toxicity profile was consistent with the known toxicity profiles of pemetrexed, cisplatin, and radiation.
authors.affiliation: Princess Margaret Cancer Centre, Toronto General Hospital, University of Toronto, Toronto, ON, Canada. Electronic address: anthony.brade@rmp.uhn.on.ca.
authors.forename: Anthony
authors.initials: A
authors.lastname: Brade
authors.affiliation: The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, Canada.
authors.forename: Robert
authors.initials: R
authors.lastname: MacRae
authors.affiliation: The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, Canada.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Laurie
authors.affiliation: Princess Margaret Cancer Centre, Toronto General Hospital, University of Toronto, Toronto, ON, Canada.
authors.forename: Andrea
authors.initials: A
authors.lastname: Bezjak
authors.affiliation: Princess Margaret Cancer Centre, Toronto General Hospital, University of Toronto, Toronto, ON, Canada.
authors.forename: Ronald
authors.initials: R
authors.lastname: Burkes
authors.affiliation: Department of Oncology, University of Alberta, Edmonton, AB, Canada.
authors.forename: Quincy
authors.initials: Q
authors.lastname: Chu
authors.affiliation: Department of Oncology, McMaster University, Hamilton, ON, Canada.
authors.forename: John R
authors.initials: JR
authors.lastname: Goffin
authors.affiliation: Princess Margaret Cancer Centre, Toronto General Hospital, University of Toronto, Toronto, ON, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Cho
authors.affiliation: Princess Margaret Cancer Centre, Toronto General Hospital, University of Toronto, Toronto, ON, Canada.
authors.forename: Andrew
authors.initials: A
authors.lastname: Hope
authors.affiliation: Princess Margaret Cancer Centre, Toronto General Hospital, University of Toronto, Toronto, ON, Canada.
authors.forename: Alex
authors.initials: A
authors.lastname: Sun
authors.affiliation: Princess Margaret Cancer Centre, Toronto General Hospital, University of Toronto, Toronto, ON, Canada.
authors.forename: Natasha
authors.initials: N
authors.lastname: Leighl
authors.affiliation: University of Toronto, Toronto, ON, Canada.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Capobianco
authors.affiliation: Princess Margaret Cancer Centre, Toronto General Hospital, University of Toronto, Toronto, ON, Canada.
authors.forename: Ronald
authors.initials: R
authors.lastname: Feld
authors.affiliation: Eli Lilly Canada Inc, Medicines Development Unit, Toronto, ON, Canada.
authors.forename: Essai
authors.initials: E
authors.lastname: Mahalingam
authors.affiliation: Eli Lilly and Company, Indianapolis, IN.
authors.forename: Anwar
authors.initials: A
authors.lastname: Hossain
authors.affiliation: Eli Lilly Canada Inc., Scarborough, ON, Canada.
authors.forename: Neill
authors.initials: N
authors.lastname: Iscoe
authors.affiliation: Princess Margaret Cancer Centre, Toronto General Hospital, University of Toronto, Toronto, ON, Canada.
authors.forename: Frances A
authors.initials: FA
authors.lastname: Shepherd
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D002945:Cisplatin / Q000627:therapeutic use*; D004941:Esophagitis / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000068437:Pemetrexed; D002945:Cisplatin
keywords: Chemoradiotherapy; Concurrent chemotherapy; Radiotherapy