USE OF BENDAMUSTINE

Pharmacological Use of Bendamustine in the Management of Indolent Non-Hodgkin's Lymphoma and its effects on lymphocytic cells



Pharmacological Use of Bendamustine in the Management of Indolent Non-Hodgkin's Lymphoma and its effects on lymphocytic cells

Introduction

Bendamustine is a hybrid between an alkylating agent and purine analog. It has proved effective in patients with follicular lymphoma refractory orrelapsed, even in patients who have used purine analogues, with very little toxicity. He is studying the effectiveness in other lymphomas and synergistic activity with other chemotherapeutic agents. Preliminary results have documented a complete response rates similar to CHOP and a better toxicity profile in the treatment of follicular lymphoma first line-lar, other indolent lymphomas and mantle lymphomas.

Bendamustine was used in East Germany since the 1970 and earned an MA in Germany in 2003 in chronic lymphocytic leukemia, the non-Hodgkin lymphoma and multiple myeloma. In the U.S., bendamustine was approved in 2007 in lymphocytic leukemia Chronic and 2008 in the NHL. In France, this specialty is the subject of temporary authorizations for personal use since November 2005.

A marketing authorization application in a decentralized procedure was submitted in November 2007 in Europe in the three approved indications in Germany. Two of these indications were subject to arbitration by the EMA (non-Hodgkin lymphoma and multiple myeloma).

Discussion

Hodgkin's disease is a type of lymphoma, a cancer that originates in white blood cells called lymphocytes. Lymphocytes are part of the system body's immune. There are two types of lymphomas:

Hodgkin's disease (Dr. Thomas Hodgkin was the first to identify this disease in 1832).

NHL

These two major types of lymphomas are different in terms of how they behave, is propagate and respond to treatment. Usually, doctors can distinguish the cancer cells look under a microscope. In some cases, it is necessary to sensitive laboratory tests to differentiate them. Both children and adults can suffer from Hodgkin's disease. In this document provides information on treatment in both groups.

Chronic Lymphocytic Leukemia

The file submitted includes:

1.Three phase I / II

2.Two phase II studies available only as abstracts in Congress. They will therefore not analyze in this paper.

A Comparative Phase III Studies

A randomized open study compare the efficacy and safety of bendamustine in those of chlorambucil in first-line treatment in 319 patients with leukemia chronic lymphocytic stage B or C of the Binet classification.

Inclusion criteria:

Chronic lymphocytic leukemia stage B or C according to Binet classification,

Patients under 75 years

Have not received previous treatment for chronic lymphocytic leukemia,

WHO performance status = 2,

Life expectancy of at least 3 months.

Treatments (up to a total of 6 courses):

Group bendamustine 100 mg / m

IV on D1 and D2 every 4 weeks (n = 162);

Chlorambucil group: 0.8 mg / kg orally, on day 1 and day 15 every 4 weeks (n = 157) or a schedule different from that used in France.

Main Criteria

Progression-free survival, defined as time from randomization to the occurrence of one of the following events: tumor progression, relapse after remission intercurrent or death from any cause. This second criterion was analyzed only if a significant difference was observed the first ...