Clinical Report: GMALL B-ALL/NHL 2002 in High-Grade B-Cell Lymphoma
Overview
In this single-institution cohort of 53 patients with high-grade B-cell lymphoma (HGBCL), treatment with the GMALL B-ALL/NHL 2002 protocol was associated with an end-of-treatment metabolic complete response in 42 patients (79.2%) and an overall 6-year progression-free survival (PFS) of 72%. Six-year PFS differed by histology, at 83% for HGBCL-NOS and 49% for double-hit lymphoma (DHL). The report also describes early CNS relapses among three patients who had achieved complete response.
Background
The source describes front-line HGBCL management as challenging because no consensus standard of care has been established. Prospective studies have often grouped HGBCL with diffuse large B-cell lymphoma (DLBCL), leaving clinical recommendations dependent on subset analyses and extrapolation. Intensified regimens such as CODOX-M-IVAC and R-DA-EPOCH are used, but comparisons are limited by differing eligibility criteria and small study populations. The report notes that fluorescence in situ hybridization (FISH) for MYC, BCL2, and BCL6 rearrangements was used to characterize patients in its cohort.
Data Highlights
Measure
Finding
Patients treated
53
Histology
HGBCL-NOS: 34 (64.1%); DHL: 19 (35.9%)
Median age
56 years (range, 21–75); 27 patients (50.9%) were older than 55 years
Median follow-up: 4.5 years (range, 0.4–13); 42 patients (75%) remained alive
Treatment delivery
Full-intensity regimen: 36 patients, including 10 older than 55 years; protocol-based age-reduced schedule: 17 patients. Toxicity required dose-intensity reduction in 5 (9.4%)
Median intercycle time
Overall: 29 days (range, 21–60); no reported difference by histology (p = 0.42) or age (p = 0.65)
Key Findings
The cohort comprised 34 patients with HGBCL-NOS and 19 with DHL, classified according to WHO 2022; median age was 56 years.
At end of treatment, 42 patients (79.2%) achieved metabolic complete response and 7 (13.2%) achieved partial response; four had no clinically meaningful response.
Overall 6-year PFS was 72%, with reported rates of 83% for HGBCL-NOS and 49% for DHL.
Six-year PFS was 61% among patients older than 55 years and 82% among those younger than 55 years. Within the older subgroup, reported 3-year PFS was 88% with full-course therapy and 68% with the dose-reduced schedule.
Three patients who achieved complete response developed CNS relapse within 3 months; all three rapidly progressed and died despite subsequent treatment described in the report.
After a median follow-up of 4.5 years, 42 patients (75%) were alive. Eleven deaths were reported: nine from refractory or relapsed disease and two during complete response; one death followed therapy-related myelodysplastic syndrome.
Conclusion
In this cohort, the GMALL B-ALL/NHL 2002 protocol was associated with a 79.2% end-of-treatment metabolic complete response rate and 72% overall 6-year PFS. Outcomes varied by histology, and early CNS relapse occurred in three patients who had achieved complete response.
by Silvia Ferrari, Francesco Ballardini, Andrea Rossi, Anna Grassi, Chiara Pavoni, Monica Rondi, Paolo Fruscella, Andrea Gianatti, Giuseppe Gritti, Anna Maria Barbui, Federico Lussana, Alessandro Rambaldi