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J Clin Oncol. 2019 Apr 1;37(10):823-833. doi: 10.1200/JCO.18.00306. Epub 2019 Feb 20.

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.

Author information

1
1 Groupe Hospitalier Universitaire Pitié-Salpétrière, Paris, France.
2
2 Centre Hospitalier Universitaire de Nancy, Nancy, France.
3
3 Institut Curie, Site Saint-Cloud, Saint-Cloud, France.
4
4 Centre Hospitalier Universitaire de Rennes, Rennes, France.
5
5 Centre Hospitalier Universitaire de la Timone, Marseille, France.
6
6 Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.
7
7 Institut Bergonié, Bordeaux, France.
8
8 Centre Hospitalier Universitaire de Grenoble, La Tronche, France.
9
9 Centre Hospitalier Universitaire d'Amiens, Salouël, France.
10
10 Centre Antoine Lacassagne, Nice, France.
11
11 Centre Hospitalier Universitaire de Limoges, Limoges, France.
12
12 Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
13
13 Centre Hospitalier Regional Universitaire de Tours, Tours, France.
14
14 Centre Hospitalier de Perpignan, Perpignan, France.
15
15 Institut de Cancérologie de la Loire, Saint-Priest-en-Jarez, France.
16
16 Centre Hospitalier de Saint Quentin, Saint Quentin, France.
17
17 Centre Hospitalier Universitaire de Reims, Reims, France.
18
18 Centre Hospitalier d'Argenteuil, Argenteuil, France.
19
19 Centre Hospitalier de Lens, Lens, France.
20
20 Centre Hospitalier Universitaire de Nîmes, Nîmes, France.
21
21 Centre Hospitalier Universitaire d'Angers, Angers, France.
22
22 Centre Hospitalier Universitaire de Besançon, Besançon, France.
23
23 Centre Hospitalier Universitaire de Nantes, Nantes, France.
24
24 Hôpital Avicenne, Bobigny, France.
25
25 Hôpital d'Instruction des Armées Percy, Clamart, France.

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/kg/d D1-D5) followed by two cycles of R-AraC (rituximab 375 mg/m2 D1, cytarabine 3 g/m2 D1 to 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.

PMID:
30785830
DOI:
10.1200/JCO.18.00306

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