'Rediscovered' Lymphoma Drug Helps Double Survival: Study
SUNDAY June 3, 2012 -- A drug first developed in East Germany in the 1960s has re-emerged as a potent "new" weapon against certain types of non-Hodgkin lymphomas, researchers report.
The drug, bendamustine, more than doubled disease progression-free survival when given along with another therapy, rituximab (Rituxan), compared to the drug cocktail that's long been used to fight indolent non-Hodgkin lymphomas.
The bendamustine/rituximab combination also left patients with fewer side effects than the older treatment, the trial found.
One expert, Dr. Joshua Brody, an assistant professor of hematology/oncology at Mount Sinai School of Medicine in New York City, called the findings "quite exciting."
"Simultaneously increasing efficacy and decreasing toxicity is a rare win-win in oncology, and this has already prompted an enormous shift in the way we care for these patients," he said.
The findings were presented Sunday at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
According to the U.S. National Cancer Institute (NCI), lymphomas are cancers of the body's lymphocytes -- white blood cells that are key to immune function. Indolent lymphomas are labeled as such because, although incurable, they often proceed at a very slow pace.
Non-Hodgkin lymphomas comprise a large number of lymphomas, including mantle cell lymphoma and follicular lymphoma, among others. According to the NCI, more than 70,000 Americans develop a non-Hodgkin lymphoma each year, and nearly 19,000 die from the disease annually.
For years, a combination of five drugs -- rituximab, cyclophosphamide (Cytoxan), doxorubicin (Adriamycin), vincristine and prednisone, collectively called R-CHOP -- has been the preferred therapy for these types of lymphomas.
However, bendamustine (sold as Treanda in the United States) has recently made its way back onto the scene.
"The story of bendamustine is particularly interesting in that, after it's initial development in East Germany in the 1960s, it was cast aside for decades until finally being 'rediscovered' over the past 10 years," Brody said.
Study author Dr. Mathias Rummel, of University Hospital Geissen in Germany, said that West Germans only learned of bendamustine's existence after the Iron Curtain fell in 1989. "And after the reunification, the West German people were a little bit skeptical to adopt a compound out of East Germany, as one can imagine," Rummel said at an ASCO press briefing. That skepticism faded, however, as data emerged confirming the drug's effectiveness, he said.
The new study involved 514 patients with previously untreated indolent non-Hodgkin lymphomas. The patients averaged 64 years of age and were randomly assigned to receive either six cycles of bendamustine/rituximab or R-CHOP.
At a follow-up of just under four years, the median progression-free (meaning the disease did not get worse) survival was more than twice that for those on the dual-drug regimen (69.5 months) than for those on R-CHOP (31.2 months).
Overall survival did not differ between the two groups, but that is probably because many of the patients who had not fared well on R-CHOP were allowed to switch over to bendamustine/rituximab, and because survival is typically very long for these indolent lymphomas, the researchers said.
Another benefit with bendamustine: Much fewer side effects. "Not a single patient experienced any hair loss with bendamustine," Rummel said, "[and] of course nearly all patients have hair loss [with R-CHOP]."
Patients on bendamustine/rituximab also suffered much less nerve toxicity and had a much lower incidence of infectious complications, he added. Patients taking bendamustine/rituximab did have a higher incidence of skin reactions compared to those on R-CHOP, but these conditions were typically mild.
The bendamustine/rituximab combination marks a real advance in the care of patients with these slow-growing lymphomas, the experts said.
Indeed, many oncologists in the United States are already using bendamustine/rituximab as their first-line treatment for indolent lymphomas, said Dr. Bruce Roth, a professor of medicine in the division of oncology at Washington University School of Medicine in St. Louis. "This will likely become the new standard of care for these individuals," he said during the briefing.
Brody agreed. "Because indolent lymphomas are generally considered incurable, the development of novel and, ideally, safer therapies is urgently needed by our patients," he said.
"Additional trials studying bendamustine for other types of lymphoma and in combination with newer targeted therapies are under way," he added. "Taken together, the recent advances in lymphoma therapy are extremely encouraging for our patients and for progress in oncology overall."
Findings presented at medical meetings are typically considered preliminary until published in a peer-reviewed journal.
Find out more about non-Hodgkin lymphomas at the Leukemia & Lymphoma Society.
Posted: June 2012
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