1. Phase 2 study of PVAG (prednisone, vinbiastine, doxorubicin, gemcitabine) in elderly patients with early unfavorable or advanced stage Hodgkin lymphoma.
- Author
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Boll, Boris, Bredenfeld, Henning, Gorgen, Helen, Halbsguth, Teresa, Eich, Hans T., Soekler, Martin, Markova, Jana, Keller, Ulrich, Graeven, Ulirich, Kremers, Stephan, Geissler, Michael, Trenn, Guido, Fuchs, Michael, von Tresckow, Bastian, Eichenauer, Dennis A., Borchmann, Peter, and Engert, Andreas
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PREDNISONE , *DOXORUBICIN , *HODGKIN'S disease treatment , *OLDER patients , *CLINICAL trials , *DRUG therapy , *ACUTE toxicity testing - Abstract
Approximately 20% of all Hodgkin lymphoma (HL) patients are older than 60 years and have a poor prognosis, mainly because of increased treatmentrelated toxicity resulting in reduced overall dose intensity and more treatmentrelated 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.clinlcaltrials.gov as #NCT00147875. [ABSTRACT FROM AUTHOR]
- Published
- 2011
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