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EPOCH Regimen Plus Rituximab Effective and Well Tolerated for Aggressive Diffuse Large B-Cell and Mantle Cell Lymphoma: Presented at NHL

By Chris Berrie

PRAGUE, CZECH REPUBLIC -- September 14, 2004 -- The combination of rituximab and the EPOCH regimen (R-EPOCH) is effective and well tolerated for patients with relapsed or refractory aggressive diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL).

The EPOCH regimen involves a combination of doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone.

These updated results, from a multicentre phase 2 trial, were presented here September 12^th at The Role of Immunotherapy in NHL: Optimising Treatment Outcomes, sponsored by Roche.

With conventional chemotherapy, patients with relapsed and refractory aggressive lymphoma have a 5-year overall survival (OS) of less than 15%. However, both the EPOCH regimen and rituximab monotherapy have shown efficacies as salvage therapies and have nonoverlapping toxicities.

"The aim of our trial combining rituximab and EPOCH chemotherapy was to evaluate the efficacy and safety of the regimen as salvage therapy prior to stem cell harvest in patients eligible for autologous stem cell transplantation [ASCT] or as the only salvage therapy in other patients," said Christian Taverna, MD, clinical investigator, Zurich University Hospital, Zurich, Switzerland.

The 50 patients enrolled had a median age of 56 years (range, 32-72) and histologically confirmed DLBCL (50%), transformed B-cell lymphoma (36%) or MCL (14%), with 88% showing stage III/IV cancers. Previous treatments had included radiotherapy (38%) and chemotherapy (mean number, 1.7; range 1-4), the latter of which included both rituximab (8 treatments) and high dose chemotherapy (5 treatments).

The R-EPOCH treatment was given every 21 days for 4 to 6 cycles, and included rituximab 375 mg/m² IV on day 1, doxorubicin 15 mg/m² continuous IV on days 2-4, etoposide 65 mg/m² continuous IV on days 2-4, vincristine 0.5 mg continuous IV on days 2-4, cyclophosphamide 750 mg/m² IV on day 5, and prednisone 60 mg/m² PO on days 1-14. Patients who were younger than 60 years and showed at least a partial response after 3 cycles of treatment (38% of total) were eligible for ASCT.

The overall response rate of 68% included 28% of patients in complete remission and 40% in partial remission. Of the 31 patients younger than 60 years, 61% underwent stem cell harvest and went on to high dose therapy. With a median follow-up of 33 months, the median event-free survival (EFS) was 11.9 months and the median OS was 17.9 months. At 3 years, the EFS rate has reached 28% and the OS 38%.

A comparison of the patients with low versus high International Prognostic Index (IPI), as determined at trial entry, showed significantly greater EFS (P =.0007) and OS (P =.0023) associated with low baseline IPI. Similarly, for the patients who underwent subsequent ASCT, EFS (P =.0034) and OS (P =.0298) were significantly improved.

Infusion-related reactions (mainly first infusion) were seen in 28% of patients. Other complications included febrile neutropaenia, which was the main cause of hospitalizations (7% of 181 cycles), grade 4 neutropaenia (56% of patients) and grade 3/4 anaemia (8% of cycles). There were 2 possible treatment-related deaths, after the 1st and 4th cycles, and 1 independent death (cerebral hemorrhage after 1st cycle).

Dr. Taverna concluded that this R-EPOCH treatment is effective and well tolerated in patients with relapsed and refractory aggressive and mantle cell lymphoma, even following heavy pretreatment of patients. At the same time, it is an effective induction therapy for patients considered for ASCT.


[Presentation title: Rituximab-EPOCH, an Effective Salvage Therapy for Relapsed, Refractory or Transformed B-Cell Lymphomas. Abstract 532]

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