Clinical trial NCT01266668: The Impact of Rituximab in Patients With Primary Breast Diffuse Large B Cell Lymphoma (DLBCL)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Large B-Cell, Diffuse
Keywords: Diffuse large B cell lymphoma
Breast
Rituximab
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The primary breast DLBCL group was identified from the nation-wide surveys in the university hospital, general hospital, and cancer institute of Korea. And, the nodal DLBCL group, as a matching control group, was selected from the data registry of Korean Society of Hematology Lymphoma Working Party.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: 3 year
Secondary outcomes:
measure: Progression-free survival
timeFrame: 3 year
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Jae-Yong Kwak, MD.,PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yhim HY, Kim JS, Kang HJ, Kim SJ, Kim WS, Choi CW, Eom HS, Kim JA, Lee JH, Won JH, Shim H, Huh J, Lee DH, Suh C, Kwak JY. Matched-pair analysis comparing the outcomes of primary breast and nodal diffuse large B-cell lymphoma in patients treated with rituximab plus chemotherapy. Int J Cancer. 2012 Jul 1;131(1):235-43. doi: 10.1002/ijc.26352. Epub 2011 Aug 30.