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.

Thieblemont, Catherine; Tilly, Hervé; Gomes da Silva, Maria; Casasnovas, Rene-Olivier; Fruchart, Christophe; Morschhauser, Franck; Haioun, Corinne; Lazarovici, Julien; Grosicka, Anida; Perrot, Aurore; Trotman, Judith; Sebban, Catherine; Caballero, Dolores; Greil, Richard; van Eygen, Koen; Cohen, Amos M; Gonzalez, Hugo; Bouabdallah, Reda; Oberic, Lucie; Corront, Bernadette; Choufi, Bachra; Lopez-Guillermo, Armando; Catalano, John; Van Hoof, Achiel; Briere, Josette; Cabeçadas, Jose; Salles, Gilles; Gaulard, Philippe; Bosly, Andre; Coiffier, Bertrand

Thieblemont, Catherine; Tilly, Hervé; Gomes da Silva, Maria; Casasnovas, Rene-Olivier; Fruchart, Christophe; Morschhauser, Franck; Haioun, Corinne; Lazarovici, Julien; Grosicka, Anida; Perrot, Aurore; Trotman, Judith; Sebban, Catherine; Caballero, Dolores; Greil, Richard; van Eygen, Koen; Cohen, Amos M; Gonzalez, Hugo; Bouabdallah, Reda; Oberic, Lucie; Corront, Bernadette; Choufi, Bachra; Lopez-Guillermo, Armando; Catalano, John; Van Hoof, Achiel; Briere, Josette; Cabeçadas, Jose; Salles, Gilles; Gaulard, Philippe; Bosly, Andre; Coiffier, Bertrand.

Affiliation

Thieblemont C; 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
Tilly H; 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
Gomes da Silva M; 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
Casasnovas RO; 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
Fruchart C; 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
Morschhauser F; 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
Haioun C; 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
Lazarovici J; 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
Grosicka A; 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
Perrot A; 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
Trotman J; 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
Sebban C; 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
Caballero D; 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
Greil R; 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
van Eygen K; 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
Cohen AM; 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
Gonzalez H; 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
Bouabdallah R; 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
Oberic L; 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
Corront B; 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
Choufi B; 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
Lopez-Guillermo A; 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
Catalano J; 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
Van Hoof A; 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
Briere J; 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
Cabeçadas J; 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
Salles G; 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
Gaulard P; 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
Bosly A; 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
Coiffier B; 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

J Clin Oncol ; 35(22): 2473-2481, 2017 Aug 01.

Article de En | MEDLINE | ID: mdl-28426350

ABSTRACT

ABSTRACT

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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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Protocoles de polychimiothérapie antinéoplasique / Lymphome B diffus à grandes cellules Type d'étude: Clinical_trials / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limites: Aged / Aged80 / Female / Humans / Male / Middle aged Langue: En Journal: J Clin Oncol Année: 2017 Type de document: Article

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