Myeloablative vs nonmyeloablative consolidation for primary central nervous system lymphoma: results of Alliance 51101
Year: 2024
Type: article
Study design: Clinical Trial
Abstract: ABSTRACT: Although it is evident that standard-dose whole-brain radiotherapy as consolidation is associated with significant neurotoxicity, the optimal consolidative strategy for primary central nervous system lymphoma (PCNSL) is not defined. We performed a randomized phase 2 clinical trial via the US Alliance cancer cooperative group to compare myeloablative consolidation supported by autologous stem cell transplantation with nonmyeloablative consolidation after induction therapy for PCNSL. To our knowledge, this is the first randomized trial to be initiated that eliminates whole-brain radiotherapy as a consolidative approach in newly diagnosed PCNSL. Patients aged 18 to 75 years were randomly assigned in a 1:1 manner to induction therapy (methotrexate, temozolomide, rituximab, and cytarabine) followed by consolidation with either thiotepa plus carmustine and autologous stem cell rescue vs induction followed by nonmyeloablative, infusional etoposide plus cytarabine. The primary end point was progression-free survival (PFS). A total of 113 patients were randomized, and 108 (54 in each arm) were evaluable. More patients in the nonmyeloablative arm experienced progressive disease or death during induction (28% vs 11%; P = .05). Thirty-six patients received autologous stem cell transplant, and 34 received nonmyeloablative consolidation. The estimated 2-year PFS was higher in the myeloablative vs nonmyeloablative arm (73% vs 51%; P = .02). However, a planned secondary analysis, landmarked at start of the consolidation, revealed that the estimated 2-year PFS in those who completed consolidation therapy was not significantly different between the arms (86% vs 71%; P = .21). Both consolidative strategies yielded encouraging efficacy and similar toxicity profiles. This trial was registered at www.clininicals.gov as #NCT01511562.
Source: Blood Advances
Institutions: Brigham and Women's Hospital, Dana-Farber Cancer Institute, Dana-Farber Brigham Cancer Center, Mayo Clinic, The Ohio State University, Loyola University Chicago, University of Rochester Medicine, Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, University of Rochester, Washington University in St. Louis, Wake Forest University Health Sciences, Georgetown University, MedStar Georgetown University Hospital, Cornell University, Weill Cornell Medicine, Weill Cornell Medical Center, University of California San Francisco Medical Center, UCSF Helen Diller Family Comprehensive Cancer Center
Language: English
Subfield: Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,000
Awards: ECOG-ACRIN Network Group Operations Center, G1938688226, G1974211183, G3053988604, G4185274752, NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer Care, G6105514657, G657126048, Johns Hopkins University NCTN Lead Academic Site Program, G8225661566, Alliance for Clinical Trials in Oncology Operations Center, G9000097678, G9000137838, G9000268870
OpenAlex ID: W4394646389