Maintenance Rituximab May Be Unnecessary in FL

Retreatment Recommended as Preferred, Cost-Effective Strategy
February 2012 Vol 5, No 1, Special Issue - Leukemia
Caroline Helwick
Caroline Helwick

Patients with low-burden follicular lymphoma (FL) treated upfront with rituximab can be managed as well with “watchful waiting,” with retreatment on progression, as with extended dosing, or maintenance therapy, according to a randomized phase 3 study that compared the approaches.

“Rituximab retreatment is our recommended strategy if opting for ri­tuximab monotherapy in low-tumor-burden FL,” said Brad Kahl, MD, of the University of Wisconsin School of Medicine and Public Health in Madison, who presented the findings as a late-breaking abstract.

He referred to the “excellent outcomes, lack of a difference in quality of life, and fewer doses required with retreatment.”

Patients in the maintenance arm received 15.8 doses of rituxumab compared with only 4.5 in the retreatment arm. The number of doses ranged from 5 to 31 in the maintenance arm and from 4 to 16 in the retreatment arm.

“Treat without Breaking the Bank”
Andrew Zelenetz, MD, Chief of the Lymphoma Service at Memorial Sloan-Kettering Cancer Center, New York, said these findings have great clinical and economic implications, based on the vast amount of rituximab that could be spared with the retreatment approach. “We are in an era when, without question, we have to figure out how to give effective high-quality care, without breaking the bank. Retreatment may give us the same benefit at a much, much lower cost.”

“Some people in the field say that maintenance is unequivocally the standard of care. I happen not to share that opinion,” Dr Zelenetz added.
The Eastern Cooperative Oncology Trials group conducted the RESORT (Rituximab Extended Schedule or Retreatment Trial) study to compare maintenance rituximab with retreatment on progression. The study included 545 untreated patients with stage III or IV indolent non-Hodgkin lymphoma and low tumor burden, including 384 with FL histology who formed the basis of this analysis.

After median follow-up of 3.8 years, there was no difference in the primary end point of time to treatment failure: 3.9 years with maintenance rituximab and 3.6 years with retreatment, Dr Kahl said. “Both strategies appear to delay time to chemotherapy compared with historical controls.”

Treatment failures occurred in 69 patients in the maintenance arm and 65 in the retreatment arm. Time to first chemotherapy treatment was longer in the maintenance arm, with 95% of patients remaining chemotherapy-free compared with 86% in the retreatment arm (P = .03).

There were no appreciable differences in toxicity or in the development of second cancers between the arms. More patients withdrew from the maintenance arm—26 versus 16 in the retreatment arm.

“We also wondered if there might be a psychological benefit to being maintained in remission, but at 1-year postrandomization we found no difference in quality of life,” Dr Kahl reported.

“Rituximab retreatment was as effective as maintenance rituximab for time to treatment failure. And although maintenance was superior to retreatment for time to cytotoxic therapy, this came at a cost of 3.5 times more rituximab,” Dr Kahl concluded. “There was also no benefit in terms of better quality of life or less anxiety at 12 months with maintenance.”

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Last modified: March 16, 2012
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