title: Bleomycin in older early-stage favorable Hodgkin lymphoma patients: analysis of the German Hodgkin Study Group (GHSG) HD10 and HD13 trials.
abstract: Doxorubicin, bleomycin, vinblastine sulfate, and dacarbazine (ABVD) is associated with severe toxicity in older patients, particularly from bleomycin-induced lung toxicity (BLT). Therefore, using bleomycin has been questioned in older Hodgkin lymphoma (HL) patients, especially in early-stage HL. We therefore analyzed feasibility, toxicity, and efficacy of ABVD or AVD in 287 older early-stage favorable HL patients. We included patients ≥60 years of age in the German Hodgkin Study Group HD10 and HD13 trials randomized to either 2 cycles of ABVD (2×ABVD; n = 137) or AVD (2×AVD; n = 82), each followed by involved-field radiotherapy (IF-RT), with patients randomized to 4×ABVD+IF-RT (n = 68). Patients' median age was 65 years (range, 60-75) with comparable patient and disease characteristics. Grade III-IV adverse event rates were similar in patients receiving 2×AVD and 2×ABVD (40% and 39%, respectively), but considerably higher in patients receiving 4×ABVD (65%). Similarly, BLT was rare in patients receiving 2×ABVD/AVD, but occurred in 7/69 (10%) of patients randomized to 4×ABVD, with 3 lethal events. In conclusion, no effects of bleomycin on toxicity rates were detectable in older patients receiving 2 cycles of chemotherapy. However, we found a high risk of severe toxicity of bleomycin in older HL patients receiving more than 2 cycles of ABVD. These trials are registered at www.clinicaltrials.gov and www.isrctn.com as #NCT00265018 (HD10) and #ISRCTN63474366 (HD13).
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Boris
authors.initials: B
authors.lastname: Böll
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Helen
authors.initials: H
authors.lastname: Goergen
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Karolin
authors.initials: K
authors.lastname: Behringer
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Bröckelmann
authors.affiliation: Cantonal Hospital of St Gallen, St Gallen, Switzerland, and Swiss Group for Clinical Cancer Research, Bern, Switzerland;
authors.forename: Felicitas
authors.initials: F
authors.lastname: Hitz
authors.affiliation: University Hospital Münster, Münster, Germany; and.
authors.forename: Andrea
authors.initials: A
authors.lastname: Kerkhoff
authors.affiliation: Third Medical Department, Paracelcus Medical University, Salzburg, Austria.
authors.forename: Richard
authors.initials: R
authors.lastname: Greil
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Bastian
authors.initials: B
authors.lastname: von Tresckow
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Eichenauer
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Carolin
authors.initials: C
authors.lastname: Bürkle
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Sven
authors.initials: S
authors.lastname: Borchmann
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Michael
authors.initials: M
authors.lastname: Fuchs
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Volker
authors.initials: V
authors.lastname: Diehl
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Andreas
authors.initials: A
authors.lastname: Engert
authors.affiliation: German Hodgkin Study Group, First Department of Internal Medicine, University Hospital Cologne, Cologne, Germany;
authors.forename: Peter
authors.initials: P
authors.lastname: Borchmann
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000532:radiotherapy; D006801:Humans; D053208:Kaplan-Meier Estimate; D008171:Lung Diseases / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012074:Remission Induction; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D001761:Bleomycin; D014747:Vinblastine; D003606:Dacarbazine; D004317:Doxorubicin