The Bexxar therapeutic regimen (GlaxoSmithKline), which combines the anti-CD20 antibody tositumomab with radioactive iodine, can induce prolonged remissions in patients with follicular lymphoma when used as a first-line therapy, according to the results of a drug trial reported in The New England Journal of Medicine.

“This appears to be as good as any state-of-the-art chemotherapy regimen that’s out there for follicular lymphoma,” Dr. Mark S. Kaminski told Reuters Health. And with minimal side effects, “it’s very patient-friendly,” he added.

Kaminski, an oncologist at the University of Michigan Medical Center in Ann Arbor, and colleagues enrolled 76 previously untreated patients who had advanced cases (stage III or IV) follicular lymphoma. The treatment involved two infusions of Bexxar given approximately one week apart.

Seventy-two patients (95 percent) responded to treatment, and 57 (75 percent) had complete responses. The five-year progression-free survival rate was 59 percent overall, and 77 percent for patients who had a complete response. The overall five-year survival rate was 89 percent.

The annual relapse rate declined progressively over time, the authors note, from 15 percent during the first year to 4.4 percent per year after 3 years.

Side effects were moderate and reversible, and no patients required blood transfusions or treatment with blood cell growth factors. Furthermore, “there was no hair loss and only minimal nausea,” Kaminski added.

These results “compare favorably” with other first-line therapies for this type of lymphoma, the authors note.

However, Kaminski stressed that “this article is not advocating Bexxar as front-line treatment, but it opens the door for further clinical trials so we can best determine which of the many different approaches to use for this kind of lymphoma and in what sequence.”

But perhaps the “bigger message,” he added, is that “this is so effective up front, don’t wait until the last minute to give this to your patients. Move it further up in the treatment plan.”

In a related editorial, Dr. Joseph M. Connors, from the University of British Columbia in Vancouver, cautions that the superiority of this new treatment stills needs to be verified with additional “carefully designed” trials.

Also, Connors added that an economic analysis is needed “to answer the important question of cost for this potentially very expensive new treatment.”

SOURCE: The New England Journal of Medicine, February 3, 2005.