Phase II study of PVAG (prednisone, vinblastine, doxorubicin, gemcitabine) in elderly patients with early unfavorable or advanced stage Hodgkin lymphoma
Mené sur 59 patients atteints d'un lymphome hodgkinien de stade avancé (age médian : 68 ans), cet essai de phase II évalue un protocole de chimiothérapie combinant prednisone, vinblastine, doxorubicine et gemcitabine
About 20% of all Hodgkin Lymphoma (HL) patients are older than 60 years and have a poor prognosis. This is mainly due to 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 (GHSG) developed a new regimen, PVAG (prednisone, vinblastine, doxorubicin, gemcitabine). In this multicenter phase II study, elderly HL patients in early unfavorable and advanced stages received 6-8 cycles PVAG and additional radiotherapy if they were not in CR after chemotherapy. Endpoints included feasibility, acute toxicity and response rate. A total of 59 patients between 60 and 75 years (median 68 years) were eligible for analysis; 93% had advanced stage disease. WHO grade III/IV toxicities were documented in 43 patients, 46 patients responded with CR/CRu (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 due to treatment-related toxicity. The 3-year estimates for overall survival and progression-free survival were 66% (95%-CI 50% to 78%) and 58% (95%-CI 43% to 71%), respectively. We conclude that PVAG is safe and feasible in elderly HL patients (www.clinicaltrials.gov ID: NCT00147875).