title: Phase II trial of second-line bendamustine chemotherapy in relapsed small cell lung cancer patients.
abstract: OBJECTIVE
  The efficacy and toxicity of bendamustine chemotherapy in relapsed small cell lung cancer (SCLC) was determined in this phase II trial.
  
  
  METHODS
  Patients with cytologically or histologically proven SCLC, who had a sensitive relapse, which was defined as a relapse>or=2 months after completion of primary therapy, were eligible for this study. After informed consent patients received 120 mg/m2 of bendamustine on Days 1 and 2 every 3 weeks. A maximum of six cycles was administered. Primary endpoint was response rate, secondary endpoints included toxicity, progression free survival and overall survival (OS).
  
  
  RESULTS
  Twenty-one patients with a median age of 59 years (range 47-76) were accrued to this trial. Six (29%) of 21 patients achieved a confirmed partial remission, 6 (29%) had stable disease and 9 (42%) patients progressed according to RECIST criteria. Median progression free survival was 4 months (95% CI 0-8, 3), median overall survival was 7 months (95% CI 5, 8-8, 2). One- and 2-year survival was 16% and 8%, respectively. Grade III/IV neutropenia occurred in 3 (15%) of 21 patients, 1 patient had a lethal Gram-negative sepsis in neutropenia. Two additional patients had pneumonia in the absence of neutropenia. Two patients (10%) had a grade III anemia, no grade III or IV thrombocytopenia was observed.
  
  
  CONCLUSIONS
  This trial demonstrates efficacy of bendamustine in relapsed SCLC and a favourable toxicity profile. Therefore, single-agent bendamustine is a treatment option for patients with SCLC, who have responded to initial platinum containing chemotherapy and should further be investigated in randomized trials.
authors.affiliation: Medizinische Klinik III (Hämatologie, Onkologie und Transfusionsmedizin), Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany. alexander.schmittel@charite.de
authors.forename: Alexander
authors.initials: A
authors.lastname: Schmittel
authors.forename: Maren
authors.initials: M
authors.lastname: Knödler
authors.forename: Patricia
authors.initials: P
authors.lastname: Hortig
authors.forename: Karsten
authors.initials: K
authors.lastname: Schulze
authors.forename: Eckhard
authors.initials: E
authors.lastname: Thiel
authors.forename: Ulrich
authors.initials: U
authors.lastname: Keilholz
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use* / Q000633:toxicity; D000069461:Bendamustine Hydrochloride; 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; D009588:Nitrogen Mustard Compounds / Q000627:therapeutic use* / Q000633:toxicity; D012008:Recurrence; D016019:Survival Analysis; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride