title: Phase 2 study of PVAG (prednisone, vinblastine, doxorubicin, gemcitabine) in elderly patients with early unfavorable or advanced stage Hodgkin lymphoma.
abstract: Approximately 20% of all Hodgkin lymphoma (HL) patients are older than 60 years and have a poor prognosis, mainly because of increased treatment-related toxicity resulting in reduced overall dose intensity and more treatment-related mortality. To possibly improve the treatment of elderly HL patients, the German Hodgkin Study Group developed a new regimen, PVAG (prednisone, vinblastine, doxorubicin, and gemcitabine). In this multicenter phase 2 study, elderly HL patients in early unfavorable and advanced stages received 6 to 8 cycles of PVAG and additional radiotherapy if they were not in complete remission (CR) after chemotherapy. Endpoints included feasibility, acute toxicity, and response rate. Fifty-nine patients 60 to 75 years of age (median, 68 years) were eligible for analysis; 93% had advanced stage disease. WHO grade 3/4 toxicities were documented in 43 patients; 46 patients responded with CR/CR uncertain (78%). Within 37 months median observation time, 15 progressions or relapses and 17 deaths were observed, of which 8 were related to HL and 1 was the result of treatment-related toxicity. The 3-year estimates for overall survival and progression-free survival were 66% (95% CI, 50%-78%) and 58% (95% CI, 43%-71%), respectively. We conclude that PVAG is safe and feasible in elderly HL patients. This trial was registered at www.clinicaltrials.gov as #NCT00147875.
authors.affiliation: Department I of Internal Medicine, University Hospital Cologne, Cologne, Germany.
authors.forename: Boris
authors.initials: B
authors.lastname: Böll
authors.forename: Henning
authors.initials: H
authors.lastname: Bredenfeld
authors.forename: Helen
authors.initials: H
authors.lastname: Görgen
authors.forename: Teresa
authors.initials: T
authors.lastname: Halbsguth
authors.forename: Hans T
authors.initials: HT
authors.lastname: Eich
authors.forename: Martin
authors.initials: M
authors.lastname: Soekler
authors.forename: Jana
authors.initials: J
authors.lastname: Markova
authors.forename: Ulrich
authors.initials: U
authors.lastname: Keller
authors.forename: Ullrich
authors.initials: U
authors.lastname: Graeven
authors.forename: Stephan
authors.initials: S
authors.lastname: Kremers
authors.forename: Michael
authors.initials: M
authors.lastname: Geissler
authors.forename: Guido
authors.initials: G
authors.lastname: Trenn
authors.forename: Michael
authors.initials: M
authors.lastname: Fuchs
authors.forename: Bastian
authors.initials: B
authors.lastname: von Tresckow
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Eichenauer
authors.forename: Peter
authors.initials: P
authors.lastname: Borchmann
authors.forename: Andreas
authors.initials: A
authors.lastname: Engert
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006689:Hodgkin Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009367:Neoplasm Staging; D010352:Patient Dropouts; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011379:Prognosis; D012008:Recurrence; D012074:Remission Induction; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D014747:Vinblastine; D004317:Doxorubicin; D011241:Prednisone; D000093542:Gemcitabine