The best strategy for management of low-tumor-burden follicular lymphoma (FL) following response to induction therapy is controversial. The phase 3 RESORT study compared maintenance rituximab therapy versus rituximab retreatment at disease progression, and results suggest that retreatment is the preferred approach. The study was presented at the 53rd Annual Meeting of the American Society of Hematology. The strategies achieved a similar time to treatment failure (TTTF) in this FL patient population, with no difference in quality of life or anxiety at 12 months. Both strategies appear to delay time to chemotherapy compared with historical controls. Although maintenance therapy prolonged the time until cytotoxic therapy was needed, almost 4 times more rituximab was used, making maintenance therapy by far the more costly approach.
“Given the excellent outcome with retreatment, the toxicity profile, the lack of quality of life difference [between the 2 approaches], and the required doses of rituximab, retreatment is our recommended strategy if electing to use rituximab,” stated lead investigator Brad Kahl, MD, University of Wisconsin, Madison. “The retreatment strategy is less costly, and we believe it is the preferred option to help patients with low-tumor-burden FL manage their disease.”
Kahl said that the study did not determine which strategy is best for improving overall survival. Such a study would have to compare watch and wait versus retreatment versus maintenance therapy.
RESORT enrolled 384 patients with FL histology; of these, 274 (71%) responded to induction therapy with rituximab and were randomized to retreatment (n = 134) or maintenance rituximab (n = 140).
Median TTTF (primary end point) was 3.6 years with retreatment versus 3.9 years with maintenance rituximab. At 3 years of follow-up, only 5% of patients in the maintenance arm required cytotoxic chemotherapy versus 14% of patients in the retreatment arm. However, patients assigned to retreatment used a mean of 4.5 doses of rituximab over that time, while those assigned to maintenance rituximab used a mean of about 16 doses. RESORT enrolled 384 patients with FL histology; of these, 274 (71%) responded to induction therapy with rituximab and were randomized to retreatment (n = 134) or maintenance rituximab (n = 140).
Fewer than 5% of patients in the trial experienced severe hematologic or nonhematologic toxicities. No difference between the arms was observed in deaths and second cancers. There was 1 adverse event leading to discontinuation in the retreatment arm and 7 in the maintenance arm.
At 12 months’ follow-up after randomization, no difference was found in health-related quality of life or burden of stress.
Kahl said that the investigators were concerned that patients assigned to retreatment might experience more anxiety than those in the maintenance arm because they knew they had cancer and weren’t being treated, but this concern was not borne out.
Commenting on this study, Jane Winter, MD, moderator of the press conference where RESORT was discussed, and Professor at Northwestern University Feinberg School of Medicine, Chicago, said: “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 healthcare community.”