title: Gemcitabine added to doxorubicin, bleomycin, and vinblastine for the treatment of de novo Hodgkin disease: unacceptable acute pulmonary toxicity.
abstract: BACKGROUND
  Gemcitabine is an effective treatment for recurrent Hodgkin disease (HD), with relatively minimal associated toxicity. The authors conducted a trial substituting this drug for dacarbazine in the standard regimen to form ABVG (doxorubicin, bleomycin, vinblastine, gemcitabine) for patients with newly diagnosed, high-risk HD.
  
  
  METHODS
  Twelve patients (median age, 34 years) with advanced-stage de novo HD were enrolled. Standard doses of doxorubicin, bleomycin, and vinblastine were given for six cycles. Cohorts of three patients were enrolled and the dose of gemcitabine was escalated to identify the maximally tolerated dose in this combination.
  
  
  RESULTS
  The maximally tolerated dose of gemcitabine was determined to be 800 mg/m(2) in this combination. Five patients developed clinically significant pulmonary toxicity. Three required hospitalization during the final two cycles of treatment. Pneumonitis could not be predicted with serial diffusion capacity for carbon monoxide (DECO) evaluations, and reversed after discontinuation of bleomycin in three patients and steroid therapy in two patients. All 12 patients are alive to date, and 4 patients have experienced disease progression.
  
  
  CONCLUSIONS
  The bleomycin/gemcitabine combination should not be pursued for de novo HD due to significant pulmonary toxicity.
authors.affiliation: James P. Wilmot Cancer Center, University of Rochester, 601 Elmwood Avenue, PO Box 704, Rochester, NY 14642, USA. Jonathan_Friedberg@urmc.rochester.edu
authors.forename: Jonathan W
authors.initials: JW
authors.lastname: Friedberg
authors.forename: Donna
authors.initials: D
authors.lastname: Neuberg
authors.forename: Helen
authors.initials: H
authors.lastname: Kim
authors.forename: Sarah
authors.initials: S
authors.lastname: Miyata
authors.forename: Mary
authors.initials: M
authors.lastname: McCauley
authors.forename: David C
authors.initials: DC
authors.lastname: Fisher
authors.forename: Tak
authors.initials: T
authors.lastname: Takvorian
authors.forename: George P
authors.initials: GP
authors.lastname: Canellos
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000139:chemically induced*; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage
chemical_list: D003841:Deoxycytidine; D001761:Bleomycin; D014747:Vinblastine; D004317:Doxorubicin