title: Randomized phase II study of cisplatin, irinotecan and etoposide combinations administered weekly or every 4 weeks for extensive small-cell lung cancer (JCOG9902-DI).
abstract: BACKGROUND
  The purpose of this study was to evaluate the toxicity and antitumor effect of cisplatin, irinotecan and etoposide combinations on two schedules, arms A and B, for previously untreated extensive small-cell lung cancer (E-SCLC), and to select the right arm for phase III trials.
  
  
  METHODS
  Sixty patients were randomized to receive either arm A (cisplatin 25 mg/m(2) day 1, weekly for 9 weeks, irinotecan 90 mg/m(2) day 1, on weeks 1, 3, 5, 7 and 9, and etoposide 60 mg/m(2) days 1-3, on weeks 2, 4, 6, 8), or arm B (cisplatin 60 mg/m(2) day 1, irinotecan 60 mg/m(2) days 1, 8, 15, and etoposide 50 mg/m(2) days 1-3, every 4 weeks for four cycles). Prophylactic granulocyte colony-stimulating factor support was provided in both arms.
  
  
  RESULTS
  Full cycles were delivered to 73% and 70% of patients in arms A and B, respectively. Incidences of grade 3-4 neutropenia, anemia, thrombocytopenia, infection and diarrhea were 57, 43, 27, 7 and 7%, respectively, in arm A, and 87, 47, 10, 13 and 10%, respectively, in arm B. A treatment-related death developed in one patient in arm A. Complete and partial response rates were 7% and 77%, respectively, in arm A, and 17% and 60%, respectively, in arm B. Median survival time was 8.9 months in arm A, and 12.9 months in arm B.
  
  
  CONCLUSIONS
  Arm B showed a promising complete response rate and median survival with acceptable toxicity in patients with E-SCLC, and should be selected for the investigational arm in phase III trials.
authors.affiliation: Department of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan. isekine@ncc.go.jp
authors.forename: I
authors.initials: I
authors.lastname: Sekine
authors.forename: Y
authors.initials: Y
authors.lastname: Nishiwaki
authors.forename: K
authors.initials: K
authors.lastname: Noda
authors.forename: S
authors.initials: S
authors.lastname: Kudoh
authors.forename: M
authors.initials: M
authors.lastname: Fukuoka
authors.forename: K
authors.initials: K
authors.lastname: Mori
authors.forename: S
authors.initials: S
authors.lastname: Negoro
authors.forename: A
authors.initials: A
authors.lastname: Yokoyama
authors.forename: K
authors.initials: K
authors.lastname: Matsui
authors.forename: Y
authors.initials: Y
authors.lastname: Ohsaki
authors.forename: T
authors.initials: T
authors.lastname: Nakano
authors.forename: N
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015996:Survival Rate
chemical_list: D005047:Etoposide; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin