title: Phase II study of combined belotecan and cisplatin as first-line chemotherapy in patients with extensive disease of small cell lung cancer.
abstract: OBJECTIVE
  To determine the efficacy and safety of belotecan in combination with cisplatin as first-line chemotherapy for extensive disease of small cell lung cancer (ED SCLC).
  
  
  METHODS
  Patients with chemotherapy-naïve ED SCLC were eligible if the following criteria were met: age ≥18 years; a measurable lesion; Eastern Cooperative Oncology Group Performance Status (PS) 0-2; and adequate organ function. Each cycle consisted of belotecan (0.5 mg/m(2)/day) on days 1-4 and cisplatin (60 mg/m(2)) intravenously on day 1. The cycle was repeated every 3 weeks until the completion of the 6th cycle, disease progression, or intolerable toxicity.
  
  
  RESULTS
  Thirty-five patients (median age, 68 years) were enrolled: 32 males (91.4%); and PS = 0 (n = 3), PS = 1 (n = 18), and PS = 2 (n = 14). The median number of cycles delivered was 5 (range, 1-6). The relative dose intensity was 70.1% for belotecan and 83.0% for cisplatin. Of 30 evaluable patients, objective response rate was 71.4% (95% confidence interval [CI], 55.7-87.2) by the intent-to-treat principle. The median duration of follow-up was 14.3 months. The median progression-free survival was 5.7 months (95% CI, 3.9-7.5) and the median overall survival was 10.2 months (95% CI, 9.3-11.1). The frequently reported grade 3 or 4 toxicities included neutropenia in 24 patients (68.6%), thrombocytopenia in 10 (28.6%), and anemia in 7 (20.0%). There was no grade 3 or 4 non-hematologic toxicity except three patients (8.6%) with fatigue.
  
  
  CONCLUSIONS
  Belotecan and cisplatin combination therapy showed significant efficacy in ED SCLC with improved non-hematologic toxicities.
authors.affiliation: Department of Internal Medicine, Gachon University Gil Hospital, Gachon University of Medicine and Science School of Medicine, 21 Namdongdae-ro 774-gil, Guwol 1-dong, Namdong-gu, Incheon 405-760, Republic of Korea.
authors.forename: Junshik
authors.initials: J
authors.lastname: Hong
authors.forename: Minkyu
authors.initials: M
authors.lastname: Jung
authors.forename: Yu Jin
authors.initials: YJ
authors.lastname: Kim
authors.forename: Sun Jin
authors.initials: SJ
authors.lastname: Sym
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Kyung
authors.forename: Jinny
authors.initials: J
authors.lastname: Park
authors.forename: Sang Pyo
authors.initials: SP
authors.lastname: Lee
authors.forename: Jeong Woong
authors.initials: JW
authors.lastname: Park
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Cho
authors.forename: Sung Hwan
authors.initials: SH
authors.lastname: Jeong
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
authors.forename: Jae Hoon
authors.initials: JH
authors.lastname: Lee
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: C116963:belotecan; D002945:Cisplatin; D002166:Camptothecin