title: A phase II study of AT-101 (Gossypol) in chemotherapy-sensitive recurrent extensive-stage small cell lung cancer.
abstract: BACKGROUND
  AT-101 is an oral inhibitor of the antiapoptotic Bcl proteins (Bcl-2, Bcl-XL, Bcl-W, and Mcl-1) and an inducer of the pro-apoptotic proteins noxa and puma. We studied the efficacy of AT-101 in patients with recurrent chemosensitive extensive-stage small cell lung cancer (SCLC).
  
  
  METHODS
  Patients with recurrent "sensitive" SCLC (defined as no progression during and no disease recurrence <2 months after completion of first-line platinum-based chemotherapy) were eligible. AT-101 was administered 20 mg orally daily for 21 of 28 days each cycle for up to six cycles. The primary end point was the objective response rate.
  
  
  RESULTS
  At the time of planned interim evaluation, none of the 14 evaluable patients enrolled in the first stage had any response to therapy, and the study was closed permanently for further accrual. Three patients (21%) achieved stable disease after two cycles of therapy. Grade 3 toxicities included anorexia, fatigue, and nausea/vomiting.
  
  
  CONCLUSIONS
  AT-101 is not active in patients with recurrent chemosensitive SCLC.
authors.affiliation: Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri, USA. Mbaggstr@dom.wustl.edu
authors.forename: Maria Q
authors.initials: MQ
authors.lastname: Baggstrom
authors.forename: Yingwei
authors.initials: Y
authors.lastname: Qi
authors.forename: Marianna
authors.initials: M
authors.lastname: Koczywas
authors.forename: Athanassios
authors.initials: A
authors.lastname: Argiris
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Johnson
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Millward
authors.forename: Sara C
authors.initials: SC
authors.lastname: Murphy
authors.forename: Charles
authors.initials: C
authors.lastname: Erlichman
authors.forename: Charles M
authors.initials: CM
authors.lastname: Rudin
authors.forename: Ramaswamy
authors.initials: R
authors.lastname: Govindan
mesh_terms: D000368:Aged; D003272:Contraceptive Agents, Male / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006072:Gossypol / Q000627:therapeutic use*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D016879:Salvage Therapy; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D003272:Contraceptive Agents, Male; D006072:Gossypol