High-Dose Methotrexate as CNS Prophylaxis in Ultra High-Risk Large B-Cell Lymphoma: An International Multicenter Analysis.
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Wilson Matthew R, Lewis Katharine L, Kirkwood Amy A, Cwynarski Kate, Cheah Chan Y, El-Galaly Tarec C, Villa Diego, Savage Kerry J, Ghione Paola, Bobillo Sabela, Smedby Karin E, Harrysson Sara, Trneny Marek, Klanova Magdalena, Puckrin Robert, Fox Christopher P, Bishton Mark, Thanarajasingam Gita, Wong Doo Nicole, Hapgood Greg, Soussain Carole, Choquet Sylvain, Dickinson Michael, Talaulikar Dipti, de Mel Sanjay, Preston Gavin, Ahearne Matthew, Hawkes Eliza A, Schorb Elisabeth, Clavert Aline, Ku Matthew, Guidetti Anna, Narkhede Mayur, Calimeri Teresa, Durot Eric, Smith Jeffrey, Renaud Loïc, McKay Pamela, Eyre Toby A
Аннотация
METHODS: Data from two previous retrospective analyses were combined to produce a cohort of UHR patients (≥1 of the following criteria: CNS international prognostic index score 5-6; testicular, renal/adrenal, or breast involvement; ≥3 extranodal sites), treated with or without HD-MTX. The primary outcome was CNS relapse rate (isolated or concurrent with systemic relapse) measured from diagnosis with additional landmark analysis of all responding patients with no progression event at 6 months.
RESULTS: Analyses were performed on 1,923 patients meeting UHR criteria. No significant difference in 3-year CNS relapse rate was observed between no HD-MTX (n = 1,051) versus HD-MTX patients (n = 872), including in multivariable analyses adjusting for baseline characteristics (3-year rate, 9.3% v 8.1%; adjusted hazard ratio [HR], 1.13 [95% CI, 0.82 to 1.57]). Analyses restricted to isolated CNS relapse also confirmed no difference (5.9% v 5.7%; adjusted HR, 1.03 [95% CI, 0.69 to 1.53]). In the landmark analysis (no HD-MTX n = 782, HD-MTX n = 773), no difference in 3-year CNS relapse was observed (6.7% v 6.6%, adjusted HR, 0.95 [95% CI, 0.62 to 1.44]).
CONCLUSION: To our knowledge, this is the largest international comparative data set of patients with LBCL with UHR features showing no significant reduction in CNS relapse with HD-MTX in all UHR or in any individual subgroup. Despite inherent limitations of retrospective analyses, the data strongly support previous studies in suggesting HD-MTX prophylaxis has no meaningful benefit for most patients.