title: Efficacy and toxicity of belotecan for relapsed or refractory small cell lung cancer patients.
abstract: BACKGROUND
  Belotecan (Camtobell, CKD602) is a new camptothecin-derivative antitumor agent that belongs to the topoisomerase inhibitors. The aim of this study was to evaluate the efficacy and safety of belotecan monotherapy as a second-line therapy in patients with relapsed or refractory small cell lung cancer (SCLC).
  
  
  METHODS
  Between June 2008 and August 2011, a total of 50 patients with relapsed or refractory SCLC were treated with belotecan 0.5 mg/m for 5 consecutive days, every 3 weeks. We evaluated the overall response rate (ORR), the progression-free survival (PFS), and the overall survival (OS), and toxicity according to sensitivity to initial chemotherapy.
  
  
  RESULTS
  The median age was 66 years (range, 43-84 years) and Eastern Cooperative Oncology Group performance was 0 or 1 in 34 patients (68%) and 2 in 16 patients (32%). Twenty patients (40%) had sensitive relapse and 30 patients (60%) had refractory disease. The ORR, PFS, and OS for sensitive patients were 20% (95% confidence interval [CI], 8-40), 2.8 months (95% CI, 0.53-5.06), and 6.5 months (95% CI, 1.58-11.42), respectively. In the refractory group, the ORR, PFS, and OS were 10% (95% CI, 1-21), 1.5 months (95% CI, 1.25-1.75), and 4.0 months (95% CI, 3.40-4.60), respectively. Most commonly reported grade-3 or -4 adverse events included neutropenia (54%), thrombocytopenia (38%), and anemia (32%).
  
  
  CONCLUSIONS
  Belotecan showed modest activity with an acceptable safety profile as a second-line therapy in patients with relapsed or refractory SCLC.
authors.affiliation: Department of Medical Oncology, Yonsei Cancer Center, Seoul, Korea.
authors.forename: Gun Min
authors.initials: GM
authors.lastname: Kim
authors.forename: Young Sam
authors.initials: YS
authors.lastname: Kim
authors.forename: Young
authors.initials: Y
authors.lastname: Ae Kang
authors.forename: Jae-Heon
authors.initials: JH
authors.lastname: Jeong
authors.forename: Sun Mi
authors.initials: SM
authors.lastname: Kim
authors.forename: Yun Kyoung
authors.initials: YK
authors.lastname: Hong
authors.forename: Ji Hee
authors.initials: JH
authors.lastname: Sung
authors.forename: Seung Taek
authors.initials: ST
authors.lastname: Lim
authors.forename: Joo Hang
authors.initials: JH
authors.lastname: Kim
authors.forename: Se Kyu
authors.initials: SK
authors.lastname: Kim
authors.forename: Byoung Chul
authors.initials: BC
authors.lastname: Cho
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D012189:Retrospective Studies; D059004:Topoisomerase I Inhibitors / Q000627:therapeutic use*
chemical_list: D059004:Topoisomerase I Inhibitors; C116963:belotecan; D002166:Camptothecin