title: Phase 2 study of BACOPP (bleomycin, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone) in older patients with Hodgkin lymphoma: a report from the German Hodgkin Study Group (GHSG).
abstract: For older patients with early unfavorable or advanced stage Hodgkin lymphoma (HL) the prognosis is much worse than for younger HL patients. We thus developed a new regimen, BACOPP (bleomycin, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone), to improve both tolerability and efficacy of treatment for older HL patients. Between 2004 and 2005, 65 patients with early unfavorable or advanced stage HL aged between 60 and 75 years were enrolled in this phase 2 trial. Treatment consisted of 6 to 8 cycles of BACOPP. Residual tumor masses were irradiated. Primary endpoints were feasibility as determined by adherence to protocol and overall response rate. Secondary endpoints included toxicity, freedom from treatment failure, and progression free and overall survival. For the final analysis 60 patients (92%) were eligible; 75% of treatment courses were administered according to protocol. World Health Organization grade 3/4 toxicities occurred in 52 patients. Fifty-one patients (85%) achieved complete remission, 2 (3%) partial remission, and 4 (7%) developed progressive disease. With a median observation time of 33 months, 18 patients died (30%), including 7 treatment-associated deaths. Three patients died before response assessment. Thus, the BACOPP regimen is active in older HL patients but is compromised by a high rate of toxic deaths. This trial was registered at www.clinicaltrials.gov as #NCT00284271.
authors.affiliation: First Department of Internal Medicine, University Hospital of Cologne, Cologne, Germany.
authors.forename: Teresa V
authors.initials: TV
authors.lastname: Halbsguth
authors.forename: Lucia
authors.initials: L
authors.lastname: Nogová
authors.forename: Horst
authors.initials: H
authors.lastname: Mueller
authors.forename: Michal
authors.initials: M
authors.lastname: Sieniawski
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Eichenauer
authors.forename: Thomas
authors.initials: T
authors.lastname: Schober
authors.forename: Hiltrud
authors.initials: H
authors.lastname: Nisters-Backes
authors.forename: Peter
authors.initials: P
authors.lastname: Borchmann
authors.forename: Volker
authors.initials: V
authors.lastname: Diehl
authors.forename: Andreas
authors.initials: A
authors.lastname: Engert
authors.forename: Andreas
authors.initials: A
authors.lastname: Josting
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000633:toxicity; D001761:Bleomycin / Q000008:administration & dosage; D003520:Cyclophosphamide; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005858:Germany; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D011344:Procarbazine / Q000008:administration & dosage; D012074:Remission Induction; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D001761:Bleomycin; D011344:Procarbazine; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone