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Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study

Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study

1 Apr 2019Journal of Clinical Oncology

Authors

Caroline Houillier, Luc Taillandier, Sylvain Dureau, Thierry Lamy, Mouna Laadhari, Olivier Chinot, Cecile Moluçon-Chabrot, Pierre Soubeyran, Remy Gressin, Sylvain Choquet, Gandhi Damaj, Antoine Thyss, Julie Abraham, Vincent Delwail, Emmanuel Gyan, Laurence Sanhes, Jérôme Cornillon, Reda Garidi, Alain Delmer, Marie-Laure Tanguy, Ahmad Al Jijakli, Pierre Morel, Pascal Bourquard, Marie-Pierre Moles, Adrien Chauchet, Thomas Gastinne, Jean-Marc Constans, Adriana Langer, Antoine Martin, Patricia Moisson, Lucette Lacomblez, Nadine Martin-Duverneuil, Daniel Delgadillo, Isabelle Turbiez, Loïc Feuvret, Nathalie Cassoux, Valérie Touitou, Damien Ricard, Khê Hoang-Xuan, Carole Soussain,

Abstract

PURPOSE

To determine the efficacy and toxicity of chemoimmunotherapy followed by either whole-brain radiotherapy (WBRT) or intensive chemotherapy and autologous stem-cell transplantation (ASCT) as a first-line treatment of primary CNS lymphoma (PCNSL).

PATIENTS AND METHODS

Immunocompetent patients (18 to 60 years of age) with untreated PCNSL were randomly assigned to receive WBRT or ASCT as consolidation treatment after induction chemotherapy consisting of two cycles of R-MBVP (rituximab 375 mg/m2 day (D) 1, methotrexate 3 g/m2 D1; D15, VP16 100 mg/m2 D2, BCNU 100 mg/m2 D3, prednisone 60 mg/m2/d D1-D5) followed by two cycles of R-AraC (rituximab 375 mg/m2 D1, cytarabine 3 g/m2/D, D1, and D2). Intensive chemotherapy consisted of thiotepa (250 mg/m2/d D9; D8; D7), busulfan (8 mg/kg D6 through D4), and cyclophosphamide (60 mg/kg/d D3; D2). WBRT delivered 40 Gy (2 Gy/fraction). The primary end point was 2-year progression-free survival. Cognitive outcome was the main secondary end point. Analysis was intention to treat in a noncomparative phase II trial.

RESULTS

Between October 2008 and February 2014, 140 patients were recruited from 23 French centers. Both WBRT and ASCT met the predetermined threshold (among the first 38 patients in each group, at least 24 patients were alive and disease free at 2 years). The 2-year progression-free survival rates were 63% (95% CI, 49% to 81%) and 87% (95% CI, 77% to 98%) in the WBRT and ASCT arms, respectively. Toxicity deaths were recorded in one and five patients after WBRT and ASCT, respectively. Cognitive impairment was observed after WBRT, whereas cognitive functions were preserved or improved after ASCT.

CONCLUSION

WBRT and ASCT are effective consolidation treatments for patients with PCNSL who are 60 years of age and younger. The efficacy end points tended to favor the ASCT arm. The specific risk of each procedure should be considered.