New Therapy Extends Survival for People with Stubborn Lymphomas

Drug Offers Options for People after Standard Chemotherapy Fails

January 08, 2008

"Typically these patients need several different therapies over the years and none of them are curative. This data shows that bendamustine will add to our treatment options for this disease"

People with non-Hodgkin’s lymphoma who face the repeated disappointment of the disease returning have a new option to prolong survival, according to researchers at the University of Rochester Medical Center.

Bendamustine, also known as Treanda, attacks cancer cells’ on two levels – by altering the cancer cells’ DNA forcing them to self-destruct and also disrupting the cell-division cycle. After decades of relatively unstudied use in the former German Democratic Republic, the therapy has proven to be successful in pushing the stubborn lymphomas into remission for three-quarters of patients in a Phase II study led by oncologists at the James P. Wilmot Cancer Center at the University of Rochester Medical Center. Scientists published results in the Jan. 10 Journal of Clinical Oncology.

Between 2003 and 2005, the new therapy was given to 76 patients with advanced indolent lymphoma who did not respond to treatment with rituximab (Rituxan), considered the wonder-drug for lymphomas. The response rate was 77 percent, including 35 percent who were brought into remission for six months on average.

“This is good news for patients who are running out of options for further treatment,” said Jonathan Friedberg, M.D., principal investigator on the 14-site study. These results open the door for additional studies of bendamustine in combination with other standard therapies for various forms of lymphoma.

Bendamustine is a welcome addition to the arsenal of therapies for people with stubborn lymphomas. Doctors were optimistic when rituximab was developed because it prompted quick and extended remissions for many people with lymphomas.  However, now after extended use, oncologists are seeing a growing number of patients whose rituximab-induced remission has ended. 

Doctors are searching for new ways to treat this growing class of patients and prolong survival.

“Typically these patients need several different therapies over the years and none of them are curative. This data shows that bendamustine will add to our treatment options for this disease,” said Friedberg, director of hematological malignancies clinical research at the Wilmot Cancer Center.

Bendamustine is making its way into the U.S. pharmaceutical market after many years of use in Germany. Doctors used it for a variety of diseases with limited scientific data on its mechanisms and effectiveness.  Following the collapse of the Berlin Wall, Western oncologists studied it further and learned of its unique two-pronged attack on lymphoma cells. 

In the last decade, Salmedix brought the drug to the U.S. for extensive clinical trials. Cephalon Oncology bought the rights to develop the drug and is now seeking the approval of the Food and Drug Administration for standard use in patients with indolent non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.

Other institutions that participated in the 2003 study include Georgetown University, University of Alabama at Birmingham, M.D. Anderson Cancer Center, Dana-Farber Cancer Institute, University of Virginia, Pacific Oncology and Hematology Associates and Desert Regional Medical Center in California, and Queen Elizabeth II Health Science Center and Ottawa Hospital in Canada.

A Phase III pivotal study of bendamustine for patients with indolent non-Hodgkin’s lymphoma who are resistant to rituximab has been completed.

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