title: Pilot study of concurrent etoposide and cisplatin plus accelerated hyperfractionated thoracic radiotherapy followed by irinotecan and cisplatin for limited-stage small cell lung cancer: Japan Clinical Oncology Group 9903.
abstract: OBJECTIVE
  Irinotecan and cisplatin (IP) significantly improved survival compared with etoposide and cisplatin (EP), in patients with extensive-stage small cell lung cancer (SCLC) in a previous Japan Clinical Oncology Group (JCOG) randomized trial. JCOG9903 was conducted to evaluate the safety of sequentially given IP following concurrent EP plus twice-daily thoracic irradiation (TRT) for the treatment of limited-stage SCLC (LSCLC).
  
  
  METHODS
  Between October 1999 and July 2000, 31 patients were accrued from 10 institutions. Thirty patients were assessable for toxicity, response, and survival. Treatment consisted of etoposide 100 mg/m(2) on days 1 to 3, cisplatin 80 mg/m(2) on day 1, and concurrent twice-daily TRT of 45 Gy beginning on day 2. The IP regimen started on day 29 and consisted of irinotecan 60 mg/m(2) on days 1, 8, and 15 and cisplatin 60 mg/m(2) on day 1, with three 28-day cycles.
  
  
  RESULTS
  There were no treatment-related deaths. The response rate was 97% (complete response, 37%; partial response, 60%). Median overall survival was 20.2 months; 1-, 2-, and 3-year survival rates were 76%, 41%, and 38%, respectively. Of the 24 patients who started the IP regimen, 22 received two or more cycles. Hematologic toxicities of grade 3 or 4 included neutropenia (67%), anemia (50%), and thrombocytopenia (4%). Nonhematologic toxicities of grade 3 or 4 included diarrhea (8%), vomiting (8%), and febrile neutropenia (8%). Of the 20 patients with recurrence, none had local recurrence alone and only two had both local and distant metastasis as the initial sites of disease progression.
  
  
  CONCLUSIONS
  IP following concurrent EP plus twice-daily TRT is safe with acceptable toxicities. A randomized phase III trial comparing EP with IP following EP plus concurrent TRT for LSCLC is ongoing (JCOG0202).
authors.affiliation: National Cancer Center Hospital East, Kashiwa, Japan. kkubota@east.ncc.go.jp
authors.forename: Kaoru
authors.initials: K
authors.lastname: Kubota
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Nishiwaki
authors.forename: Takahiko
authors.initials: T
authors.lastname: Sugiura
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Noda
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Mori
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kawahara
authors.forename: Shunichi
authors.initials: S
authors.lastname: Negoro
authors.forename: Koshiro
authors.initials: K
authors.lastname: Watanabe
authors.forename: Fumio
authors.initials: F
authors.lastname: Imamura
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005047:Etoposide / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005047:Etoposide; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin