F9/1 - RITUXIMAB AND INFUSIONAL CYCLOPHOSPHAMIDE, DOXORUBICIN, AND ETOPOSIDE (CDE) IN COMBINATION WITH HAART: A SAFE AND HIGHLY ACTIVE REGIMEN IN HIV-RELATED NON-HODGKIN'S LYMPHOMAS (NHL)

9^TH EUROPEAN AIDS CONFERENCE (EACS)
1^st EACS RESISTANCE & PHARMACOLOGY WORKSHOP

October 25 - 29, 2003 Warsaw, Poland

12.2 Malignant Lymphomas

F9/1 - RITUXIMAB AND INFUSIONAL CYCLOPHOSPHAMIDE, DOXORUBICIN, AND ETOPOSIDE (CDE) IN COMBINATION WITH HAART: A SAFE AND HIGHLY ACTIVE REGIMEN IN HIV-RELATED NON-HODGKIN'S LYMPHOMAS (NHL)

* Spina M.¹, Simonelli C.¹, Vaccher E.¹, Jaeger U.², Sparano J.A.³, Tirelli U.¹

(1) National Cancer Center, Aviano, Italy, for the GICAT,² University of Vienna, Austria,³ Montefiore Medical Center NY, USA

Background of Study: The combination of Rituximab plus chemotherapy (CT) is more effective than CT alone in the treatment of high grade NHL.

Objectives: To evaluate the efficacy and activity of combining infusional CDE plus Rituximab in HIV-NHL.

Methods: In June 1998 we started a phase II study using infusional CDE (Cyclophosphamide 187.5 mg/m2/day, Doxorubicin 12.5 mg/m2/day and Etoposide 60 mg/m2/day) administered by continuous intravenous infusion for 4 days every 4 weeks and Rituximab 375 mg/m2 i.v. on day 1. HAART was given concomitantly with CT.

Results: Sixty-four patients (pts) have been enrolled. The median CD4+ cell count was 161 (range 3-691) and the median Performance Status was 1 (range 0-3). Sixty-nine percent of pts had advanced stage (III-IV) disease and 52% had B symptoms. Forty-five out of 64 pts (71%) achieved a complete remission (CR), 4/64 (6%) had a partial remission and 15 pts progressed. Only 7 pts out of 64 (11%) CRs have relapsed and 44/64 pts are alive. Grade 3-4 neutropenia, anemia and thrombocytopenia were observed in 78%, 36% and 25% of pts respectively. Twenty-five % of pts developed bacterial infections during neutropenia. The actuarial overall survival and time to treatment failure (TTF) at 2 years were 65% and 63%, respectively.

Conclusions: The combination of Rituximab and CDE in HIV-NHL treated concomitantly with HAART is safe, feasible and active. CR rate (71%) and TTF at 2 years (63%) are comparable to those observed in high grade NHL of the general population. Supported by ISS and AIRC grants.

Presenting Author: Dr. Michele Spina, Division of Medical Oncology A, National Cancer Institute, via Pedemontana Occidentale 12, 33081, Aviano (PN), Italy, Phone: +39 0434 659284

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