title: Phase II study of accelerated high-dose radiotherapy with concurrent chemotherapy for patients with limited small-cell lung cancer: Radiation Therapy Oncology Group protocol 0239.
abstract: OBJECTIVE
  To investigate whether high-dose thoracic radiation given twice daily during cisplatin-etoposide chemotherapy for limited small-cell lung cancer (LSCLC) improves survival, acute esophagitis, and local control rates relative to findings from Intergroup trial 0096 (47%, 27%, and 64%).
  
  
  METHODS
  Patients were accrued over a 3-year period from 22 US and Canadian institutions. Patients with LSCLC and good performance status were given thoracic radiation to 61.2 Gy over 5 weeks (daily 1.8-Gy fractions on days 1-22, then twice-daily 1.8-Gy fractions on days 23-33). Cisplatin (60 mg/m(2) IV) was given on day 1 and etoposide (120 mg/m(2) IV) on days 1-3 and days 22-24, followed by 2 cycles of cisplatin plus etoposide alone. Patients who achieved complete response were offered prophylactic cranial irradiation. Endpoints included overall and progression-free survival; severe esophagitis (Common Toxicity Criteria v 2.0) and treatment-related fatalities; response (Response Evaluation Criteria in Solid Tumors); and local control.
  
  
  RESULTS
  Seventy-two patients were accrued from June 2003 through May 2006; 71 were evaluable (median age 63 years; 52% female; 58% Zubrod 0). Median survival time was 19 months; at 2 years, the overall survival rate was 36.6% (95% confidence interval [CI] 25.6%-47.7%), and progression-free survival 19.7% (95% CI 11.4%-29.6%). Thirteen patients (18%) experienced severe acute esophagitis, and 2 (3%) died of treatment-related causes; 41% achieved complete response, 39% partial response, 10% stable disease, and 6% progressive disease. The local control rate was 73%. Forty-three patients (61%) received prophylactic cranial irradiation.
  
  
  CONCLUSIONS
  The overall survival rate did not reach the projected goal; however, rates of esophagitis were lower, and local control higher, than projected. This treatment strategy is now one of three arms of a prospective trial of chemoradiation for LSCLC (Radiation Therapy Oncology Group 0538/Cancer and Leukemia Group B 30610).
authors.affiliation: Department of Radiation Oncology, Unit 97, University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd. Houston, TX 77030, USA. rkomaki@mdanderson.org
authors.forename: Ritsuko
authors.initials: R
authors.lastname: Komaki
authors.forename: Rebecca
authors.initials: R
authors.lastname: Paulus
authors.forename: David S
authors.initials: DS
authors.lastname: Ettinger
authors.forename: Gregory M M
authors.initials: GM
authors.lastname: Videtic
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Bradley
authors.forename: Bonnie S
authors.initials: BS
authors.lastname: Glisson
authors.forename: Corey J
authors.initials: CJ
authors.lastname: Langer
authors.forename: William T
authors.initials: WT
authors.lastname: Sause
authors.forename: Walter J
authors.initials: WJ
authors.lastname: Curran
authors.forename: Hak
authors.initials: H
authors.lastname: Choy
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D002985:Clinical Protocols; D004334:Drug Administration Schedule; D004941:Esophagitis / Q000517:prevention & control; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011879:Radiotherapy Dosage; D055752:Small Cell Lung Carcinoma / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate
chemical_list: D005047:Etoposide; D002945:Cisplatin