title: Phase III trial of concurrent thoracic radiotherapy with either first- or third-cycle chemotherapy for limited-disease small-cell lung cancer.
abstract: BACKGROUND
  We compared late thoracic radiotherapy (TRT) with early TRT in the treatment of limited-disease small-cell lung cancer (LD-SCLC).
  
  
  METHODS
  Patients with LD-SCLC received four cycles of etoposide plus cisplatin every 21 days. Patients were randomly assigned to receive either TRT administered concurrently with the first cycle (early TRT) or the third cycle (late TRT) of chemotherapy. The primary end point was complete response rate.
  
  
  RESULTS
  Two hundred twenty-two patients were randomly assigned.Late TRT was not inferior to early TRT in terms of the complete response rate (early v late; 36.0% v 38.0%). Other efficacy measures including overall survival [median, 24.1 v 26.8 months;hazard ratio (HR) 0.93; 95% CI = 0.67–1.29] and progression free survival (median, 12.4 v 11.2 months; HR 1.09; 95%CI = 0.80–1.48) were not different between two arms. No statistical difference was noted in the pattern of treatment failures.However, neutropenic fever occurred more commonly in the early TRT arm than the late TRT arm (21.6% v 10.2%; P = 0.02) [corrected].
  
  
  CONCLUSIONS
  In LD-SCLC treatment, TRT starting in the third cycle of chemotherapy seemed to be noninferior to early TRT, and had a more favorable profile with regard to neutropenic fever.
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: J-M
authors.initials: JM
authors.lastname: Sun
authors.forename: Y C
authors.initials: YC
authors.lastname: Ahn
authors.forename: E K
authors.initials: EK
authors.lastname: Choi
authors.forename: M-J
authors.initials: MJ
authors.lastname: Ahn
authors.forename: J S
authors.initials: JS
authors.lastname: Ahn
authors.forename: S-H
authors.initials: SH
authors.lastname: Lee
authors.forename: D H
authors.initials: DH
authors.lastname: Lee
authors.forename: H
authors.initials: H
authors.lastname: Pyo
authors.forename: S Y
authors.initials: SY
authors.lastname: Song
authors.forename: S-H
authors.initials: SH
authors.lastname: Jung
authors.forename: J S
authors.initials: JS
authors.lastname: Jo
authors.forename: J
authors.initials: J
authors.lastname: Jo
authors.forename: H J
authors.initials: HJ
authors.lastname: Sohn
authors.forename: C
authors.initials: C
authors.lastname: Suh
authors.forename: J S
authors.initials: JS
authors.lastname: Lee
authors.forename: S-W
authors.initials: SW
authors.lastname: Kim
authors.forename: K
authors.initials: K
authors.lastname: Park
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005047:Etoposide / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D011879:Radiotherapy Dosage; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy; D013534:Survival; D017211:Treatment Failure
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D005047:Etoposide; D002945:Cisplatin
keywords: complete response; overall survival; small cell lung cancer; thoracic radiotherapy