(SAN DIEGO, December 11, 2011) Asymptomatic patients diagnosed with nonbulky follicular lymphoma, a slow-growing type of non-Hodgkin lymphoma, have traditionally been watched for signs or symptoms of disease progression and then treated with a combination of rituximab and chemotherapy or rituximab alone for select cases. Recent trials have suggested a role for treatment of asymptomatic patients with single-agent rituximab followed by additional periodic dosing, called "maintenance therapy." However, new research suggests that these patients may have similar success rates simply with as-needed treatment. Results from the study will be presented today at the 53rd Annual Meeting of the American Society of Hematology.
"Current research aims to ensure that we are not only giving our patients the best possible chance to live long, healthy lives after their cancer diagnoses, but also improving their quality of life while reducing their health-care costs," said Jane N. Winter, MD, moderator of the press conference and Professor of Medicine in the Division of Hematology-Oncology at Northwestern University Feinberg School of Medicine in Chicago. "If we can limit the frequency of treatment or reduce the need for chemotherapy and still maintain good outcomes, we can reduce some of the burdens on both the patients and the health care community."
This press conference will take place on Sunday, December 11, at 8:00 a.m. PST.
Results of Eastern Cooperative Oncology Group Protocol E4402 (RESORT): A Randomized Phase III Study Comparing Two Different Rituximab Dosing Strategies for Low Tumor Burden Follicular Lymphoma [LBA-6]
Results from a study evaluating two different strategies for management of asymptomatic low-tumor-burden (LTB) follicular lymphoma (FL) patients found that, following an induction course of rituximab, repeated treatment with the therapy at time of progression is just as effective in managing the disease as ongoing maintenance therapy.
Historically, patients with LTB (defined as small tumor size, limited lymph node involvement, limited or no symptoms, and other factors) disease have been observed rather than treated, with treatment deferred until the patient was symptomatic or the disease progressed, risking the individual's well-being. This has been called the "watch and wait" strategy, which allows physicians to delay chemotherapy treatment for their patients for three years or more. Researchers have hypothesized that rituximab could delay the need for chemotherapy and that maintenance rituximab (MR) would provide disease control superior to rituximab retreatment (RR) when the disease progressed. In order to evaluate the two different rituximab dosing strategies for LTB follicular lymphoma, researchers embarked on the Eastern Cooperative Oncology Group Protocol E4402 (RESORT), a randomized, Phase III clinical trial.
The primary endpoint was time to treatment failure (TTTF), defined as disease that progresses within six months of the last rituximab treatment, disease that doesn't respond to therapy, need for alternative therapy, or inability to complete the treatment protocol. Secondary endpoints included time to first chemotherapy, quality of life (QOL), and safety.
The RESORT trial compared the treatment strategies for 384 patients with previously untreated LTB FL. All patients received rituximab for four weeks, and the 274 patients who achieved a complete or partial response were then randomized to MR (single dose of rituximab every three months, n=140) or RR (four weekly doses of rituximab at disease progression, n=134). Patients were evaluated every three months and were followed until treatment failure. The average number of total doses in the MR arm was 15.8 per patient versus 4.5 doses per patient in the RR arm.
The analysis showed that TTTF was 3.9 years for MR-treated FL patients versus 3.6 years for RR-treated patients, rates longer than historical "watch and wait" strategies in this population. At three years of follow-up, 95 percent of MR patients had avoided cytotoxic therapy, as compared with 86 percent of RR patients. Less than 5 percent of patients in the trial experienced any severe hematologic or non-hematologic toxicities. At 12 months after randomization, there was no discernible difference in health-related quality of life or burden of stress between the two study arms.
"In summary, our study found no significant difference between administering maintenance therapy and re-treating with rituximab as needed for this patient population. In addition, given the significant difference in total doses administered, re-treatment with rituximab is less costly than rituximab maintenance therapy," said lead author Brad S. Kahl, MD, Assistant Professor of Medicine at the University of Wisconsin in Madison, Wis. "We believe the re-treatment strategy is the preferred option to help patients with low-tumor-burden FL manage their disease."
Dr. Kahl will present this study in the Late-Breaking Abstracts Session on Tuesday, December 13, at 7:30 a.m. PST at the San Diego Convention Center in Hall AB.
|Contact: Lindsey Love|
American Society of Hematology