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Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy

Emanuele Zucca, Stephanie Rondeau, Anna Vanazzi, Bjørn Østenstad, Ulrich J. M. Mey, Daniel Rauch, Björn E. Wahlin, Felicitas Hitz, Micaela Hernberg, Ann-Sofie Johansson, Peter de Nully Brown, Hans Hagberg, Andrés J. M. Ferreri, Andreas Lohri, Urban Novak, Thilo Zander, Hanne Bersvendsen, Mario Bargetzi, Walter Mingrone, Fatime Krasniqi, Stefan Dirnhofer, Stefanie Hayoz, Hanne Hawle, Simona Berardi Vilei, Michele Ghielmini and Eva Kimby for the Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group

Key Points

  • Compared with rituximab only, a short rituximab-lenalidomide regimen improved CR rate and PFS in untreated symptomatic follicular lymphomas.

  • Excellent OS in both arms suggests that chemotherapy-free strategies should be further explored in follicular lymphoma.

Abstract

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. Patients were randomized to rituximab (375 mg/m2 IV on day 1 of weeks 1-4 and repeated during weeks 12-15 in responding patients) or rituximab (same schedule) in combination with lenalidomide (15 mg orally daily for 18 weeks). Primary end point was complete response (CR)/unconfirmed CR (CRu) rate at 6 months. In total, 77 patients were allocated to rituximab monotherapy and 77 to the combination (47% poor-risk Follicular Lymphoma International Prognostic Index score in each arm). A significantly higher CR/CRu rate at 6 months was documented in the combination arm by the investigators (36%; 95% confidence interval [CI], 26%-48% vs 25%; 95% CI, 16%-36%) and confirmed by an independent response review of computed tomography scans only (61%; 95% CI, 49%-72% vs 36%; 95% CI, 26%-48%). After a median follow-up of 4 years, significantly higher 30-month CR/CRu rates and longer progression-free survival (PFS) and time to next treatment (TTNT) were observed for the combination. Overall survival (OS) rates were similar in both arms (≥90%). Toxicity grade ≥3 was more common in the combination arm (56% vs 22% of patients), mainly represented by neutropenia (23% vs 7%). Addition of lenalidomide to rituximab significantly improved CR/CRu rates, PFS, and TTNT, with expected higher, but manageable toxicity. The excellent OS in both arms suggests that chemotherapy-free strategies should be further explored. This trial was registered at www.clinicaltrials.gov as #NCT01307605.

  • Submitted October 11, 2018.
  • Accepted April 3, 2019.
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