Liposomal doxorubicin supercharge-containing front-line treatment in patients with advanced-stage diffuse large B-cell lymphoma or classical Hodgkin lymphoma: Preliminary results of a single-centre phase II study.

in British journal of haematology by Marco Picardi, Claudia Giordano, Novella Pugliese, Maria Esposito, Melania Fatigati, Francesco Muriano, Maria G Rascato, Roberta Della Pepa, Alessandro D'Ambrosio, Elena Vigliar, Giancarlo Troncone, Daniela Russo, Massimo Mascolo, Giovanni Esposito, Mariella Prastaro, Roberta Esposito, Carlo G Tocchetti, Rosa Fonti, Ciro Mainolfi, Silvana Del Vecchio, Fabrizio Pane

TLDR

  • The study evaluated the impact of liposomal doxorubicin (NPLD) supercharge-containing therapy on interim fluorodeoxyglucose positron emission tomography (interim-FDG-PET) responses in high-risk diffuse large B-cell lymphoma (DLBCL) or classical Hodgkin lymphoma (c-HL).
  • The study found that 88.9% of patients had a good treatment response at interim-FDG-PET, and 90% reached complete responses at the end of treatment, with a 77.3% progression-free survival rate.

Abstract

We evaluated the impact of liposomal doxorubicin (NPLD) supercharge-containing therapy on interim fluorodeoxyglucose positron emission tomography (interim-FDG-PET) responses in high-risk diffuse large B-cell lymphoma (DLBCL) or classical Hodgkin lymphoma (c-HL). In this phase II study (2016-2021), 81 adult patients with advanced-stage DLBCL (n = 53) and c-HL (n = 28) received front-line treatment with R-COMP-dose-intensified (DI) and MBVD-DI. R-COMP-DI consisted of 70 mg/mof NPLD plus standard rituximab, cyclophosphamide, vincristine and prednisone for three cycles (followed by three cycles with NPLD de-escalated at 50 mg/m); MBVD-DI consisted of 35 mg/mof NPLD plus standard bleomycin, vinblastine and dacarbazine for two cycles (followed by four cycles with NPLD de-escalated at 25 mg/m). Patients underwent R-COMP-DI and MBVD-DI with a median dose intensity of 91% and 94% respectively. At interim-FDG-PET, 72/81 patients (one failed to undergo interim-FDG-PET due to early death) had a Deauville score of ≤3. At end of treatment, 90% of patients reached complete responses. In all, 20 patients had Grade ≥3 adverse events, and four of them required hospitalisation. At a median 21-months of follow-up, the progression-free survival of the entire population was 77.3% (95% confidence interval 68%-88%). Our data suggest that the NPLD supercharge-driven strategy in high-risk DLBCL/c-HL may be a promising option to test in phase III trials, for improving negative interim-FDG-PET cases incidence.

Overview

  • The study evaluated the impact of liposomal doxorubicin (NPLD) supercharge-containing therapy on interim fluorodeoxyglucose positron emission tomography (interim-FDG-PET) responses in high-risk diffuse large B-cell lymphoma (DLBCL) or classical Hodgkin lymphoma (c-HL).
  • The study used a phase II design, enrolling 81 adult patients with advanced-stage DLBCL (n = 53) and c-HL (n = 28) and treating them with front-line therapies R-COMP-dose-intensified (DI) and MBVD-DI.
  • The primary objective of the study was to investigate the efficacy of the NPLD supercharge-driven strategy in improving negative interim-FDG-PET cases incidence in high-risk DLBCL/c-HL.

Comparative Analysis & Findings

  • At interim-FDG-PET, 72/81 patients (88.9%) had a Deauville score of ≤3, indicating a good treatment response.
  • At the end of treatment, 90% of patients reached complete responses, indicating a high overall treatment response rate.
  • The progression-free survival (PFS) of the entire population was 77.3% (95% confidence interval 68%-88%), suggesting a reasonable treatment duration and minimal progression.

Implications and Future Directions

  • The study suggests that the NPLD supercharge-driven strategy in high-risk DLBCL/c-HL may be a promising option to test in phase III trials, potentially improving treatment outcomes.
  • The study highlights the need for further investigation of the optimal dosing and duration of NPLD supercharge therapy in high-risk DLBCL/c-HL to maximize treatment benefits.
  • Future studies may also explore the role of NPLD supercharge therapy in combination with other immunotherapies or targeted therapies to enhance treatment efficacy and minimize adverse events.
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