title: A phase II study of cisplatin and irinotecan as induction chemotherapy followed by accelerated hyperfractionated thoracic radiotherapy with daily low-dose carboplatin in unresectable stage III non-small cell lung cancer: JCOG 9510.
abstract: OBJECTIVE
  It is important to find optimal regimens of cisplatin (CDDP)-based third-generation chemotherapy and radiotherapy for patients with unresectable Stage III non-small cell lung cancer (NSCLC).
  
  
  METHODS
  This Phase II study was designed to determine the toxicity and efficacy of two courses of chemotherapy (CDDP 80 mg/m(2) on day 1 and irinotecan 60 mg/m(2) on days 1 and 8) followed by accelerated hyperfractionated thoracic radiotherapy (60 Gy/40 fractions in 4 weeks) combined with daily carboplatin (CBDCA) administration. CBDCA was administered at a target area under the plasma level-time curve of 0.4 x (24 h creatinine clearance + 25), according to Calvert's formula.
  
  
  RESULTS
  Twenty-six patients were enrolled in the study. The patients' median age was 63 years (range 40-74 years) and included 22 males and 4 females. Seven patients were Stage IIIA and 19 were Stage IIIB. Twenty had a performance status (PS) of 1 versus six with a PS of 0. There was one treatment-related death due to sepsis and pneumonia associated with Grade 4 neutropenia and diarrhea during chemotherapy. Grade 3 or 4 neutropenia and diarrhea were observed in 14 and 5 patients, respectively. Toxicity of the radiotherapy was mild. There were 0 complete response and 13 partial responses, giving a response rate of 50.0%. Median survival time and 2-year survival were 16.4 months and 21.5%, respectively. This study was designed with Simon's two-stage design, and the response rate did not meet the criteria to proceed to the second stage and the study was terminated early.
  
  
  CONCLUSIONS
  This regimen might be inactive for patients with unresectable Stage III NSCLC.
authors.affiliation: Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
authors.forename: Tomoki
authors.initials: T
authors.lastname: Fujii
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kunikane
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Okamoto
authors.forename: Koshiro
authors.initials: K
authors.lastname: Watanabe
authors.forename: Hideo
authors.initials: H
authors.lastname: Kunitoh
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Mori
authors.forename: Akira
authors.initials: A
authors.lastname: Yokoyama
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic; D000971:Antineoplastic Combined Chemotherapy Protocols; D002166:Camptothecin / Q000031:analogs & derivatives / Q000627:therapeutic use; D016190:Carboplatin / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011879:Radiotherapy Dosage; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D016190:Carboplatin; D002166:Camptothecin