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Lenalidomide–Rituximab Combo Improves Outcomes in Untreated Follicular Lymphoma

First-line treatment with lenalidomide plus rituximab significantly improved outcomes among patients with follicular lymphoma, according to results from the phase 2 SAKK 35/10 trial (Blood. 2019;134[4]:353-362).

“The SAKK 35/10 phase 2 trial, developed by the Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group, compared the activity of rituximab vs rituximab plus lenalidomide in untreated follicular lymphoma patients in need of systemic therapy,” explained lead investigator Emanuele Zucca, MD, Division of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, and colleagues.

Patients in the study were randomized in a 1:1 ratio to receive rituximab (n = 77) or rituximab in combination with lenalidomide (n = 77). Rituximab at 375 mg/m2 was administered on day 1 of weeks 1 to 4 and repeated during weeks 12 to 15 in patients who experienced a response. Lenalidomide 15 mg was administered daily for 18 weeks.

The primary end point of the trial was the rate of complete response (CR) or unconfirmed complete response (CRu) at 6 months.

At 6 months, a significantly higher rate of CR/CRu was reported by investigators in the rituximab plus lenalidomide arm (36%; 95% CI, 26%-48%) versus the rituximab-alone arm (25%; 95% CI, 16%-36%), and was confirmed by independent response review of computed tomography scans (61%; 95% CI, 49%-72% vs 36%; 95% CI, 26%-48%, respectively).

After a median follow-up of 4 years, significantly higher 30-month rates of CR/CRu were reported in the rituximab plus lenalidomide arm, as well as longer progression-free survival (PFS) and time to next treatment (TTNT). Dr Zucca and colleagues noted that overall survival was similar between the 2 arms (≥90%).

Toxicity of grade ≥3 was more common in patients who received rituximab plus lenalidomide versus rituximab alone (56% vs 22%, respectively); neutropenia was the most frequently reported adverse event (23% vs 7%, respectively).

“Addition of lenalidomide to rituximab significantly improved CR/CRu rates, PFS, and TTNT, with expected higher, but manageable toxicity,” concluded Dr Zucca and colleagues.

“The excellent OS in both arms suggests that chemotherapy-free strategies should be further explored,” they added.Janelle Bradley

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