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Blood. 2019 May 17. pii: blood-2018-10-879643. doi: 10.1182/blood-2018-10-879643. [Epub ahead of print]

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

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Division of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland;
SAKK Coordinating Center, Bern, Switzerland.
Clinical Hemato-Oncology, European Institute of Oncology IRCCS, Milan, Italy.
Department of Oncology, Oslo University Hospital, Oslo, Norway.
Medical Oncology and Hematology, Kantonsspital Graubuenden, Chur, Switzerland.
Division of Oncology, Spital Thun Simmenthal, Thun, Switzerland.
Unit of Hematology, Department of Medicine at Huddinge, Karolinska Institutet, Stockholm, Sweden.
Oncology/Hematology, Kantonsspital St. Gallen, St. Gallen, Switzerland.
Department of Oncology, Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland.
Department of Oncology, Norrlands Universitetssjukhus, Umea, Sweden.
Department of Hematology, Rigshospitalet, Copenhagen, Denmark.
Oncology, Uppsala University Hospital, Uppsala, Sweden.
Unit of Lymphoid Malignancies, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Department of Oncology/Hematology, Medical University Clinic, Liestal, Switzerland.
Department of Medical Oncology, Inselspital / Bern University Hospital, Bern, Switzerland.
Department of Oncology, Luzerner Kantonsspital, Luzern, Switzerland.
Department of Oncology, University Hospital of North Norway, Tromso, Norway.
Division of Hematology/Oncology, Kantonsspital Aarau, Aarau, Switzerland.
Department of Medical Oncology, Kantonsspital Olten, Olten, Switzerland.
Department of Oncology, University Hospital Basel, Basel, Switzerland.
Institute of Pathology, University Hospital Basel, Basel, Switzerland.
Division of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.


The SAKK 35/10 phase-2 trial (NCT01307605), developed by the Swiss Group for Clinical Cancer Research (SAKK) and the Nordic Lymphoma Group (NLG), compared the activity of rituximab versus 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, weeks 1-4, repeated week 12-15 in responding patients) or to rituximab (same schedule) in combination with lenalidomide (15 mg PO daily for 18 weeks). Primary endpoint was complete response (CR/CRu) rate at 6 months. In total, 77 patients were allocated to rituximab monotherapy and 77 to the combination (47% poor-risk FLIPI in each arm). A significantly higher CR/CRu rate at 6 months was documented in the combination arm by the investigators (36%, 95% CI: 26-48% vs. 25%, 95% CI: 16-36%) and confirmed by an independent response review of only CT scans (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, 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 pts), mainly represented by neutropenia (23% vs. 7%). Addition of lenalidomide to rituximab significantly improved CR/CRu rates, PFS, and TTNT, with higher but expected and manageable toxicity. The excellent OS in both arms suggests that chemotherapy-free strategies should be further explored.

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