A study undertaken by the University of Bologna, Italy, was presented at the 48th Annual Meeting of the American Society of Haematology (ASH) in Orlando, USA, that demonstrates an innovative treatment regimen for Non-Hodgkin's Lymphoma (NHL) may help improve the quality of responses to treatment of elderly patients suffering from the most common type of aggressive NHL, Diffuse Large-B-cell Lymphoma (DLBCL)(1). Zevalin (90Y Ibritumomab Tiuxetan) treatment was given to patients as a first-line consolidation therapy after patients had received standard chemotherapy. The study showed that four out of five elderly patients (80%) boosted the quality of their response from a Partial Response (PR) to a Complete Response (CR) when Zevalin was administered as first-line consolidation therapy.

"The aim of consolidation therapy is to improve the quality of response already achieved by the first-line treatment. These data are promising as they show Zevalin can increase the complete remission rates when used as a consolidation therapy in elderly DLBCL patients. Elderly patients may be less able to tolerate the toxicities associated with conventional chemotherapies, so ensuring that first-line responses are maximised is important in treating DLBCL, where a complete cure is the goal." Commented Professor Pier Luigi Zinzani, Institute of Haematology and Medical Oncology, University of Bologna.

The single arm, phase II study evaluated the efficacy and safety of Zevalin in 20 patients over 60 years of age. Patients who were previously untreated received CHOP chemotherapy (cyclophosphamide, doxorubicin; vincristine and prednisone) and those achieving at least a partial remission (PR) after 6 cycles of CHOP chemotherapy went on to receive consolidation treatment with Zevalin. Results showed that all patients achieved a response after receiving CHOP treatment: 75% (15 patients) achieved a CR and 25% (5 patients) achieved a PR. Following Zevalin consolidation therapy, 4 out of 5 patients (80%) converted from a PR to a CR.

"Cancer patients can suffer from two things: their disease and their chemotherapy side effects. The next step is to see if we can reduce the cycles of chemotherapy and add in Zevalin for these patients, in order to retain or boost the complete response rates, while lessening a patient's exposure to the toxicities of chemotherapies." Commented Professor Zinzani.

While the CHOP chemotherapy regimen has been standard of care for NHL patients for many years, the recent advent of rituximab has meant this drug has now become an addition to standard CHOP therapy (R-CHOP). Professor Zinzani continued: "The next clinical question is to investigate the efficacy of Zevalin when used as a first-line consolidation treatment in DLBCL patients who receive rituximab-containing chemotherapy regimens."

Zevalin was generally well tolerated, neutropenia was the most common adverse event.



Reference:

1. Zinzani et al. ASH 2006 Abstract Number 2431. A Phase II Trial of CHOP chemotherapy followed by Yttrium 90 (90Y) Ibritumomab Tiuxetan (Zevalin®) for previously untreated elderly diffuse large B-cell lymphoma (DLBCL) patients. Poster Presentation; 9am Sunday 10 December 2006.

Non-Hodgkin's Lymphoma (NHL)

Non-Hodgkin's lymphoma (NHL) is an umbrella term that includes a group of related malignancies that originate in the body's lymphatic system - part of the body's immune system. NHL is the most commonly diagnosed malignant haematological disease and among the fastest growing cancers in the world. The incidence is about 10 per 100,000 in Western Europe. There are about 230,000 people living with NHL in the European Union and approximately 70,000 new cases are diagnosed each year. For unknown reasons, this incidence is increasing in Europe by four percent per year.

About Zevalin treatment

Zevalin (90Y ibritumomab tiuxetan) is the first and only approved radiolabelled immunotherapy with the power of Y90 radiation for adult patients with rituximab relapsed or refractory CD20-positive follicular B-cell non-Hodgkin's lymphoma in Europe. Zevalin consists of a monoclonal anti-CD20 antibody (ibritumomab) bound to a radioisotope (yttrium-90). Once administered, Zevalin is transported through the blood stream and binds to the surface of the tumour cells, thus delivering the isotope yttrium-90 directly to the tumour cells. Through the so called "cross-fire effect" the target cells and neighbouring malignant cells in a 5 mm radius are destroyed by the radiation. For Zevalin® Schering AG holds worldwide marketing and distribution rights excluding the U.S., where Biogen idec retains its rights.

Source: Professor Pier Luigi Zinzani, Institute of Haematology and Medical Oncology, University of Bologna

For further information please visit:
Schering AG
Biogen idec
University of Bologna
American Society of Haematology

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