Abstract

There are limited data from prospective controlled trials regarding optimal treatment strategies in patients with primary breast diffuse large B-cell lymphoma (DLBCL). In this phase 2 study (NCT01448096), we examined the efficacy and safety of standard immunochemotherapy and central nervous system (CNS) prophylaxis using intrathecal methotrexate (IT-MTX). Thirty-three patients with newly diagnosed primary breast DLBCL received six cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) and four fixed doses of IT-MTX (12 mg). The median age was 50 years (range, 29–75), and all patients were females. According to the CNS-International Prognostic Index, most patients (n = 28) were categorized as the low-risk group. Among the 33 patients, 32 completed R-CHOP, and 31 completed IT-MTX as planned. With a median follow-up of 46.1 months (interquartile range (IQR), 31.1–66.8), the 2-year progression-free and overall survival rates were 81.3% and 93.5%, respectively. Six patients experienced treatment failures, which included the CNS in four patients (two parenchyma and two leptomeninges) and breast in two patients (one ipsilateral and one contralateral). The 2-year cumulative incidence of CNS relapse was 12.5%. Although standard R-CHOP and IT-MTX without routine radiotherapy show clinically meaningful survival outcomes, this strategy may not be optimal for reducing CNS relapse and warrants further investigation.

Highlights

  • Primary breast diffuse large B-cell lymphoma (DLBCL) is a rare subtype of primary extranodal non-Hodgkin lymphoma (NHL), consisting of approximately 1% of all NHL [1]

  • The rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) therapy has been established as the standard first-line therapy in newly diagnosed nodal DLBCL patients [11], there is no consensus on the optimal treatment strategy because of the paucity of controlled prospective data

  • We report here the results of our prospective trial in patients with primary breast DLBCL, which addressed the efficacy and safety of R-CHOP plus central nervous system (CNS) prophylaxis using intrathecal methotrexate (IT-MTX) without routine consolidative radiotherapy

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Summary

Introduction

Primary breast diffuse large B-cell lymphoma (DLBCL) is a rare subtype of primary extranodal non-Hodgkin lymphoma (NHL), consisting of approximately 1% of all NHL [1]. Most patients with primary breast DLBCL have localized-stage disease at diagnosis, but their outcomes are quite poor [2,3,4,5,6,7,8]. It is not clear whether primary breast DLBCL differs intrinsically from nodal DLBCL, it has different clinical features from nodal DLBCL, which shows predominant relapse in specific extranodal organs, that is, breast and central nervous system (CNS) [2,3,4,5,6,7,8]. We designed a standard R-CHOP immunochemotherapy and CNS prophylaxis using intrathecal methotrexate (IT-MTX) to examine the improvement in progression-free survival (PFS)

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