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CHICAGO -- A chemotherapy-free combination of rituximab (Rituxan)/lenalidomide (Revlimid), or R², appears to be a feasible option for the first-line treatment of advanced follicular lymphoma, results of the RELEVANCE trial found.

An interim analysis revealed a "nearly identical" rate of progression-free survival (PFS), one of the study's co-primary endpoints, for patients treated with R² versus patients treated with rituximab plus investigator's choice of chemotherapy (R-chemotherapy), reported Nathan Fowler, of MD Anderson Cancer Center in Houston, at the American Society of Clinical Oncology annual meeting here.

By independent review committee, the 3-year PFS rate was 77% with R² compared with 78% with R-chemotherapy (P=0.48). The other co-primary endpoint of complete response (CR) or CR unconfirmed (CR/CRu) at 120 weeks, showed a slight, nonsignificant disadvantage for R² (48% versus 53% with R-chemo, P=0.13).

"I think that these results show that lenalidomide-rituximab, which is a novel immunomodulatory approach, is a potential first-line option for patients with follicular lymphoma that require treatment," said Fowler.

Secondary endpoints were also similar for R² versus R-chemotherapy:

• best CR/CRu: 59% versus 67%, respectively
• best overall response: 84% versus 89%
• overall response at 120 weeks: 61% versus 65%

The overall survival rates at 3 years were "identical" (94% versus 94%), said Fowler, but cautioned that for this group of patients, who can have long-lasting survival following initial treatment, this is a short follow-up window and long-term data will be required to confirm these findings.

"R² can be considered as an option for the frontline therapy for patients with follicular lymphoma," said discussant Bruce Cheson, MD, of the Lombardi Comprehensive Cancer Center in Washington, DC.

However, as it was designed for superiority, the trial actually failed to meet both co-primary endpoints.

"Unfortunately this was designed as a superiority trial and not a noninferiority trial," said Cheson. "However, R² showed a similar PFS at 120 weeks in all major patient subgroups, a similar overall survival, less non-hematologic toxicity (except for rash), less neutropenia, less febrile neutropenia, fewer infections -- despite the increased use of growth factors with chemoimmunotherapy."

Cheson noted that quality-of-life data have been collected and will be of considerable interest in the future.

"I think it's very important to note that, as we would expect, there [were] different safety profiles between the two arms," said Fowler.

In the R-chemo arm, more grade 3/4 neutropenia (50% versus 32%) and febrile neutropenia (7% versus 2%) occurred, and there was more nausea, vomiting, and neuropathy. In the R² arm, patients experienced more frequent rash (7% versus 1%) and diarrhea, and had occasional tumor flare.

Rates of treatment discontinuation due to adverse events were similar -- 29% with the R² combination versus 31% with R-chemotherapy). Rates of secondary malignancy were also similar -- 7% with R² versus 10% with R-chemotherapy. One patient died in each treatment arm.

The phase III RELEVANCE trial was a global, multicenter trial that randomized 1,030 patients with previously untreated grade 1-3A follicular lymphoma.

In the R-chemotherapy group, 72% were treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP); 23% were treated with rituximab plus bendamustine; and 5% were treated with rituximab plus cyclophosphamide, vincristine and prednisone (R-CVP).

Baseline characteristics were similar in the two groups, and all patients in both arms received maintenance rituximab following their initial treatment.

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