Phase 2 study of PVAG (prednisone, vinblastine, doxorubicin, gemcitabine) in elderly patients with early unfavorable or advanced stage Hodgkin lymphoma

Blood. 2011 Dec 8;118(24):6292-8. doi: 10.1182/blood-2011-07-368167. Epub 2011 Sep 13.

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.

Publication types

  • Clinical Trial, Phase II
  • Controlled Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Combined Modality Therapy / adverse effects
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives
  • Deoxycytidine / therapeutic use
  • Doxorubicin / administration & dosage
  • Doxorubicin / adverse effects
  • Doxorubicin / therapeutic use
  • Female
  • Gemcitabine
  • Hodgkin Disease / diagnosis
  • Hodgkin Disease / drug therapy*
  • Hodgkin Disease / pathology
  • Hodgkin Disease / radiotherapy
  • Humans
  • Male
  • Medication Adherence
  • Middle Aged
  • Neoplasm Staging
  • Patient Dropouts
  • Prednisone / administration & dosage
  • Prednisone / adverse effects
  • Prednisone / therapeutic use
  • Prognosis
  • Recurrence
  • Remission Induction
  • Survival Analysis
  • Vinblastine / administration & dosage
  • Vinblastine / adverse effects
  • Vinblastine / therapeutic use

Substances

  • Antineoplastic Agents
  • Deoxycytidine
  • Vinblastine
  • Doxorubicin
  • Prednisone
  • Gemcitabine

Associated data

  • ClinicalTrials.gov/NCT00147875