title: Phase II study of bendamustine in relapsed chemotherapy sensitive or resistant small-cell lung cancer.
abstract: BACKGROUND
  To determine the time to progression (TTP), response rate (RR), and toxicity for North American patients with relapsed small-cell lung cancer (SCLC) treated with bendamustine in the second- or third-line setting.
  
  
  METHODS
  Patients with relapsed, histologically confirmed SCLC were eligible for enrollment on study. The study population included patients with both chemotherapy-sensitive and chemotherapy-resistant disease treated with up to two prior lines of chemotherapy. Patients were treated with 120 mg/m of bendamustine on days 1 and 2 of a 21-day cycle for up to six cycles. Primary end point was TTP; secondary end points included toxicity, RR, and overall survival.
  
  
  RESULTS
  Fifty-nine patients were accrued, 50 patients met eligibility for enrollment. The median age of patients was 62, and 56% were men. Twenty-nine patients (58%) had chemotherapy-sensitive disease. Median TTP was 4.0 months (95% confidence interval [CI], 3.3-5.4), median overall survival was 4.8 months (95% CI, 3.8-6.3), and the RR was 26% (95% CI, 13.3%-39.5%). Patients with chemosensitive disease had a median TTP of 4.2 months (95% CI, 3.3-6.0) compared with 3.4 months (95% CI, 2.7-∞) for chemotherapy-resistant disease. The RR was 33% (95% CI, 14.2%-51.8%) in patients with chemosensitive disease and 17% (95% CI, 0%-34.4%) in those with chemoresistant disease. The most common grade 3/4 adverse events were fatigue (20%), dyspnea (12%), and anemia (12%).
  
  
  CONCLUSIONS
  Bendamustine has modest activity in relapsed SCLC similar to other agents evaluated in this patient population.
authors.affiliation: *Department of Internal Medicine, Meharry Medical College, Nashville, Tennessee; †Department of Biostatistics, Center for Quantitative Science, Vanderbilt University Medical Center, Nashville, Tennessee; ‡South Carolina Oncology Associates, Columbia, South Carolina; §Department of Medicine, Division of Hematology and Medical Oncology, Oregon Health and Science University, OHSU Knight Cancer Institute, Portland, Oregon; ‖Department of Medicine, Division of Medical Oncology, The Ohio State University Medical Center, Arthur G. James Cancer Hospital, Columbus, Ohio; ¶Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas; and #Department of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.
authors.forename: Philip E
authors.initials: PE
authors.lastname: Lammers
authors.forename: Yu
authors.initials: Y
authors.lastname: Shyr
authors.forename: Chung-I
authors.initials: CI
authors.lastname: Li
authors.forename: Anne Smith
authors.initials: AS
authors.lastname: Hutchison
authors.forename: Alan
authors.initials: A
authors.lastname: Sandler
authors.forename: David Paul
authors.initials: DP
authors.lastname: Carbone
authors.forename: David H
authors.initials: DH
authors.lastname: Johnson
authors.forename: Vicki Leigh
authors.initials: VL
authors.lastname: Keedy
authors.forename: Leora
authors.initials: L
authors.lastname: Horn
mesh_terms: D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D009588:Nitrogen Mustard Compounds / Q000627:therapeutic use*; D011379:Prognosis; D016879:Salvage Therapy; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate
chemical_list: D018906:Antineoplastic Agents, Alkylating; D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride
references.citation: J Clin Oncol. 2008 Jan 10;26(2):204-10
references.pmid: 18182663
references.citation: J Clin Oncol. 2009 Sep 10;27(26):4378-84
references.pmid: 19652068
references.citation: Jpn J Clin Oncol. 1997 Jun;27(3):166-9
references.pmid: 9255271
references.citation: J Clin Oncol. 1999 Feb;17(2):658-67
references.pmid: 10080612
references.citation: Cancer. 2010 Jan 1;116(1):106-14
references.pmid: 19890959
references.citation: Lung Cancer. 2007 Jan;55(1):109-13
references.pmid: 17097191
references.citation: Cancer. 2002 Jul 1;95(1):155-63
references.pmid: 12115329
references.citation: J Clin Oncol. 2001 Mar 15;19(6):1743-9
references.pmid: 11251005
references.citation: CA Cancer J Clin. 2013 Jan;63(1):11-30
references.pmid: 23335087
references.citation: J Thorac Oncol. 2007 Aug;2(8):764-72
references.pmid: 17762346
references.citation: Lung Cancer. 2011 Apr;72(1):114-8
references.pmid: 20701993
references.citation: J Clin Oncol. 2006 Dec 1;24(34):5441-7
references.pmid: 17135646