Molecular Characterization and Outcomes of Aggressive B-Cell Lymphomas.

Andrés José Maria Ferreri555 enrolled

Overview

This is a retrospective analysis of the presence of chromosomal rearrangements involving MYC, BCL2 and BCL6 genes by FISH in a retrospective, single-center series of large B-cell lymphomas, in order to allow a better classifications of these cases according to the current WHO 2017 classification. If this evaluation will be confirmed as a reliable method to reclassify in different groups the evaluated tumors, it can be subsequently routinely apply to indicate the best treatment approaches in this high-risk setting of patients with a significant impact on patients' morbidity and mortality, and also on the health system and related costs.

Study Type

OBSERVATIONAL

Enrollment

555

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

Treatments: anthracycline-based combinations followed or not by involved-field radiotherapyCOMBINATION_PRODUCT

Anthracycline-based combinations followed or not by involved-field radiotherapy

Medical Language ↔ Plain English

* Histologically-confirmed diagnosis of LBCL (i.e., DLBCL, HGBCL, unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL), or aggressive B-cell lymphomas with blastoid morphology (excluding blastoid variant of mantle cell lymphoma and lymphoblastic lymphoma) * Histopathological diagnosis performed between 2000 and 2019. * HIV sero-negativity * Age ≥18 * Treatment with R-CHOP or other intensified polychemotherapy regimen * Availability of adequate histopathological samples at diagnosis for FISH analysis * Availability of clinical records and outcomes data Exclusion criteria • Histologic diagnosis other than DLBCL or unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL

Outcomes

Primary Outcomes

Overall Survival (OS)

Overall survival (OS) is time from the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first.

Time frame: From the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first, assessed up to 60 months

Secondary Outcomes

Progression-free Survival (PFS)

Progression-Free Survival (PFS) is the length of time during and after a disease treatment that a patient lives without the disease worsening or progressing

Time frame: From the first day of treatment until relapse, progression, death , or last follow-up, whichever occurs first, assessed up to 60 months

Overall Response Rate

the Overall Response Rate (ORR) measures the percentage of patients whose disease shows a reduction in size or is eliminated after a specific treatment. It includes patients who achieve either a Complete Response (CR), where all signs of the lymphoma disappear, or a Partial Response (PR), where there is a significant reduction in tumor burden but some signs of the disease remain

Time frame: From the first day of treatment until the date of first documented response assessment, typically within 6 months of treatment initiation

Duration of response (DOR; partial response [PR] + complete remission [CR])

Time from the date of first documented response (complete or partial) until disease progression, relapse, death from any cause, or last follow-up, whichever occurs first.

Time frame: From the date of first documented response (CR or PR) until disease progression, relapse, death from any cause, or last follow-up, whichever occurs first, assessed up to 60 months

Relapse rates

Proportion of patients who experience disease relapse after achieving a complete or partial response.

Time frame: From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months

Relapse Pattern

Description of the type and location of disease relapse, including nodal vs extranodal and local vs systemic recurrence

Time frame: From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months

Incidence of chromosomal rearrangements involving MYC gene and BCL2 gene (so called "double hit lymphoma", representing 60% of HGBL) and/or BCL6 (also called "triple hit lymphoma", representing 20% of HG in Large B-cell Lymphomas.

Proportion of patients with documented genetic rearrangements of MYC, BCL2, or BCL6 detected at the time of pathologic diagnosis.

Time frame: At the time of pathologic diagnosis (baseline)