The Impact of Rituximab in Patients With Primary Breast Diffuse Large B Cell Lymphoma (DLBCL)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the impact of rituximab in primary breast DLBCL using a matched pair analysis following strict matching criteria in patients with primary breast and nodal DLBCL treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) regimen.

Detailed Description
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Primary breast lymphoma represents 1.7% to 2.2% of all extranodal non-Hodgkin's lymphoma. Histologically, the diffuse large B cell lymphoma (DLBCL) is the most predominant subtype of PBL. Previous studies in the pre-rituximab era have identified the worse outcomes in primary breast DLBCL compared with nodal DLBCL. Few clinical studies have been reported for investigating the efficacy of rituximab in patients with primary breast DLBCL. For clarifying this, a large randomized trial comparing survival in patients with primary breast DLBCL is required. However, the rarity of primary breast DLBCL makes large trial virtually difficult in single center or study group. Additionally, retrospective studies for evaluating the role of rituximab in primary breast DLBCL had bias according to the difference of treatment period between CHOP and R-CHOP era. Thus, in attempt to clarify the impact of rituximab on survival and patterns of progression in patients with primary breast DLBCL, the investigators performed this matched pair analysis following strict matching criteria in patients with primary breast DLBCL, who were identified from our previous nation-wide survey, and nodal DLBCL, who were selected from the data registry of Korean Society of Hematology Lymphoma Working Party, treated with R-CHOP regimen.

Official Title
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Matched Pair Analysis Comparing the Outcomes of Primary Breast and Nodal Diffuse Large B Cell Lymphoma in Patients Treated With R-CHOP; Consortium for Improving Survival of Lymphoma (CISL) Study

Conditions
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Lymphoma, Large B-Cell, Diffuse

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage I or II of primary breast DLBCL treated with R-CHOP Stage I or II of nodal DLBCL treated with R-CHOP Definition of primary breast DLBCL - Isolated breast involvement with or without nodal disease, which include distant nodal disease as well as regional nodal disease Definition of nodal DLBCL - The disease was only limited to the lymph nodes or lymphoid organs Exclusion Criteria: Primary breast DLBCL or nodal DLBCL treated without rituximab Secondary breast DLBCL Recurrent DLBCL Stage III or IV of nodal DLBCL with extranodal involvement as a dissemination process

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary breast DLBCL<br>Primary breast DLBCL was defined as that involving single extranodal organ (i.e. breast) regardless of the status of nodal disease. | |
| Nodal DLBCL<br>The disease was only limited to the lymph nodes or lymphoid organs without extranodal organ involvements. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffuse large B cell lymphoma, Breast, Rituximab