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J Clin Oncol. 2017 Aug 1;35(22):2473-2481. doi: 10.1200/JCO.2017.72.6984. Epub 2017 Apr 20.

Lenalidomide Maintenance Compared With Placebo in Responding Elderly Patients With Diffuse Large B-Cell Lymphoma Treated With First-Line Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.

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Catherine Thieblemont, Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis; Diderot University, Sorbonne Paris-Cité; Catherine Thieblemont and Josette Briere, Descartes University; Josette Briere, Hôpital Necker, Paris; Hervé Tilly, University of Rouen, Institut National de la Santé et de la Recherche Médicale U1245, Rouen; Rene-Olivier Casasnovas, Centre Hospitalier Universitaire Dijon; Institut National de la Santé et de la Recherche Médicale UMR1231, Dijon; Christophe Fruchart, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Franck Morschhauser, Centre Hospitalier Universitaire Régional de Lille, Lille; Corinne Haioun and Philippe Gaulard, Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Mondor; Philippe Gaulard, Institut National de la Santé et de la Recherche Médicale U955; Université Paris-Est, Créteil; Julien Lazarovici, Gustave Roussy Cancer Center, Villejuif; Aurore Perrot, University Hospital, Vandoeuvre les Nancy; Catherine Sebban, Centre Leon Berard, University Claude Bernard Lyon 1; Gilles Salles, Hospices Civils de Lyon, Université Claude Bernard U1052, Lyon; Hugo Gonzalez, Centre Hospitalier René Dubos, Pontoise; Reda Bouabdallah, Institut Paoli Calmettes, Marseille; Lucie Oberic, Institut Universitaire du Cancer-Oncopole de Toulouse, Toulouse; Bernadette Corront, Centre Hospitalier Régional Annecy, Annecy; Bachra Choufi, Centre Hospitalier Dr Duchenne, Boulogne-sur-mer; Gilles Salles and Bertrand Coiffier, Institut National de la Santé et de la Recherche Médicale U1052, Hospices Civils de Lyon, Pierre-Benite, France; Maria Gomes da Silva and Jose Cabeçadas, Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisboa, Portugal; Anida Grosicka, Medical University of Silesia, Katowice, Poland; Judith Trotman, Concord Repatriation General Hospital, University of Sydney, Concord; John Catalano, Frankston Hospital and Monash University, Frankston, Australia; Dolores Caballero, Hospital Universitario de Salamanca, Salamanca; Armando Lopez-Guillermo, Hospital Clinic Barcelona, Barcelona, Spain; Richard Greil, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute; Arbeitsgemeinschaft Medikamentöse Tumortherapie, Salzburg, Austria; Koen van Eygen, Algemeen Ziekenhuis Groeninge Hospital, President Kennedylaan 4, Kortrijk; Achiel Van Hoof, Algemeen Ziekenhuis Sint Jan AV, Brugge; Andre Bosly, UCL Mont Godinne, Yvoir, Belgium; and Amos M. Cohen, Rabin Medical Center, Beilinson Hospital, Davidoff Cancer Center, Tel-Aviv University, Ramat-Aviv, Israel.


Purpose The standard treatment of patients with diffuse large B-cell lymphoma (DLBCL) is rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Lenalidomide, an immunomodulatory agent, has shown activity in DLBCL. This randomized phase III trial compared lenalidomide as maintenance therapy with placebo in elderly patients with DLBCL who achieved a complete response (CR) or partial response (PR) to R-CHOP induction. Methods Patients with previously untreated DLBCL or other aggressive B-cell lymphoma were 60 to 80 years old, had CR or PR after six or eight cycles of R-CHOP, and were randomly assigned to lenalidomide maintenance 25 mg/d or placebo for 21 days of every 28-day cycle for 24 months. The primary end point was progression-free survival (PFS). Results A total of 650 patients were randomly assigned. At the time of the primary analysis (December 2015), with a median follow-up of 39 months from random assignment, median PFS was not reached for lenalidomide maintenance versus 58.9 months for placebo (hazard ratio, 0.708; 95% CI, 0.537 to 0.933; P = .01). The result was consistent among analyzed subgroups (eg, male v female, age-adjusted International Prognostic Index 0 or 1 v 2 or 3, age younger than 70 v ≥ 70 years), response (PR v CR) after R-CHOP, and positron emission tomography status at assignment (negative v positive). With longer median follow-up of 52 months (October 2016), overall survival was similar between arms (hazard ratio, 1.218; 95% CI, 0.861 to 1.721; P = .26). Most common grade 3 or 4 adverse events associated with lenalidomide versus placebo maintenance were neutropenia (56% v 22%) and cutaneous reactions (5% v 1%), respectively. Conclusion Lenalidomide maintenance for 24 months after obtaining a CR or PR to R-CHOP significantly prolonged PFS in elderly patients with DLBCL.

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