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  • 1.
    Zucca, Emanuele
    et al.
    Oncol Inst Southern Switzerland, Div Med Oncol, Bellinzona, Switzerland;Inst Oncol Res, Bellinzona, Switzerland;Bern Univ Hosp, Dept Med Oncol, Inselspital, Bern, Switzerland.
    Rondeau, Stephanie
    SAKK Coordinating Ctr, Bern, Switzerland.
    Vanazzi, Anna
    European Inst Oncol IRCCS, Clin Hematooncol, Milan, Italy.
    Ostenstad, Bjorn
    Oslo Univ Hosp, Dept Oncol, Oslo, Norway.
    Mey, Ulrich J. M.
    Kantonsspital Graubunden, Med Oncol & Hematol, Chur, Switzerland.
    Rauch, Daniel
    Spital Thun Simmenthal, Div Oncol, Thun, Switzerland.
    Wahlin, Bjorn E.
    Karolinska Inst, Unit Hematol, Dept Med Huddinge, Stockholm, Sweden.
    Hitz, Felicitas
    Kantonsspital St Gallen, Oncol Hematol, St Gallen, Switzerland.
    Hernberg, Micaela
    Helsinki Univ Hosp, Ctr Comprehens Canc, Dept Oncol, Helsinki, Finland.
    Johansson, Ann-Sofie
    Norrlands Univ Sjukhus, Dept Oncol, Umea, Sweden.
    Brown, Peter de Nully
    Rigshosp, Dept Hematol, Copenhagen, Denmark.
    Hagberg, Hans
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Ferreri, Andres J. M.
    IRCCS San Raffaele Sci Inst, Unit Lymphoid Malignancies, Milan, Italy.
    Lohri, Andreas
    Med Univ Clin, Dept Oncol Hematol, Liestal, Switzerland.
    Novak, Urban
    Bern Univ Hosp, Dept Med Oncol, Inselspital, Bern, Switzerland.
    Zander, Thilo
    Luzerner Kantonsspital, Dept Oncol, Luzern, Switzerland.
    Bersvendsen, Hanne
    Univ Hosp North Norway, Dept Oncol, Tromso, Norway.
    Bargetzi, Mario
    Kantonsspital Aarau, Div Hematol Oncol, Aarau, Switzerland.
    Mingrone, Walter
    Kantonsspital Olten, Dept Med Oncol, Olten, Switzerland.
    Krasniqi, Fatime
    Univ Hosp Basel, Dept Oncol, Basel, Switzerland.
    Dirnhofer, Stefan
    Univ Hosp Basel, Inst Pathol, Basel, Switzerland.
    Hayoz, Stefanie
    SAKK Coordinating Ctr, Bern, Switzerland.
    Hawle, Hanne
    SAKK Coordinating Ctr, Bern, Switzerland.
    Vilei, Simona Berardi
    SAKK Coordinating Ctr, Bern, Switzerland.
    Ghielmini, Michele
    Oncol Inst Southern Switzerland, Div Med Oncol, Bellinzona, Switzerland.
    Kimby, Eva
    Karolinska Inst, Unit Hematol, Dept Med Huddinge, Stockholm, Sweden.
    Caspar, Clemens
    Koberle, Dieter
    Zenhausern, Reinhard
    Jost, Lorenz M.
    Mach, Nicolas
    Voegeli, Michele
    Tscherry, Georg
    Fischer, Natalie
    Burkhard, Roger
    Schmid, Mathias
    Panagiotis, Samaras
    Munksgaard, Lars
    Vasala, Kaija
    Lehtinen, Tuula
    Jyrkkio, Sirkku
    Ekanger, Roald
    Rolke, Jurgen
    Meyer, Peter
    Maisenholder, Martin
    Eidem, Monika
    Radlund, Anders
    Lagerlof, Ingemar
    Brandefors, Lena
    Ola, Linde Prime N.
    Arnljots, Kristina
    Strandberg, Maria
    Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy2019In: Blood, ISSN 0006-4971, E-ISSN 1528-0020, Vol. 134, no 4, p. 353-362Article in journal (Refereed)
    Abstract [en]

    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/m(2) 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.

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