Hodgkin's disease in 35 patients with HIV infection: An experience with epirubicin, bleomycin, vinblastine and prednisone chemotherapy in combinationwith antiretroviral therapy and primary use of G-CSF

Background: The optimal therapeutic approach for patients with Hodgkin's di sease and human immunodeficiency virus infection (HD-HIV) is unknown. In an attempt to improve the results previously obtained with EBV (epirubicin, b leomycin and vinblastine) without G-CSF (Cancer 1994, 73. 437-44), in Janua ry 1993 we started a trial using chemotherapy (CT) consisting of EBV plus p rednisone (EBVP), concomitant antiretroviral therapy (zidovudine, AZT or di deoxinosyne, DDI), and G-CSF. Patients and methods: Up to August, 1997, 35 (30 M/5 F) consecutive previou sly untreated patients (median age 34, range 21-53 years) with HD-HIV were enrolled in the European Intergroup Study HD-HIV. Their median performance status was 1 (range 1-3). At diagnosis of HD, 26% of the patients had AIDS, 90% had B symptoms at HD presentation and 83% had advanced-stage HD. Patie nts received E 70 mg/m(2) i.v. on day 1, B 10 mg/m(2) i.v. on day 1, V 6 mg /m(2) i.v. on day 1 and P 40 mg/m(2) p.o. from day 1 to day 5 (EBVP). Cours es were repeated every 21 days for six cycles. AZT (250 mg x 2/day), or DDI (200 or 300 mg x 2/day) if AZT had been previously used, were given orally from the beginning of CT. G-CSF was given at the dose of 5 mcg/kg/day s.c. from day 6 to day 20 in all cycles. Results: An overall response rate of 91% was observed. There were 74% compl ete responses (CR) and 17% partial responses (PR). Toxicity was moderate, w ith grade 3-4 leukopenia and thrombocytopenia in 10 (32%) and three (10%) p atients, respectively. The median number of administered cycles was 6 (rang e 3-6). Twenty-three of 35 patients received AZT and nine patients received DDI. Three (8%) patients had opportunistic infections (OI) during or immed iately after CT. The median CD4+ cell count was 219/mm(3) (6-812) at HD dia gnosis and 220/mm(3) (2-619) after the end of combined therapy and these nu mbers remained unchanged. Ten of 26 (38%) patients who achieved CR relapsed . Twenty-three patients died of HD progression alone or in association with OI, being the cause of death in 48% and 9% of patients respectively. The m edian survival was 16 months, with a survival rate of 32% and a disease-fre e survival of 53% at 36 months. Conclusions: The combined antineoplastic and antiretroviral treatment is fe asible, but HD in HIV setting is associated with a more adverse prognosis t han in the general population. Although the CR rate obtained was satisfacto ry, the relapse rate was high. Furthermore, comparison of the results of ou r two consecutive prospective studies demonstrated no overall improvement i n the current trial with respect to the CR rate and survival.