Titre :

Combination of pixantrone with rituximab, ifosfamide and etoposide in relapsed/refractory aggressive non-Hodgkin lymphoma. Results from a phase II LYSA study (PIVeR)

Auteur(s) :

Fornecker, L. [Auteur]
Institut de Cancérologie de Strasbourg Europe [ICANS]
Delwail, V. [Auteur]
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital [CHU de Poitiers [La Milétrie]]
Thieblemont, C. [Auteur]
Hopital Saint-Louis [AP-HP] [AP-HP]
Ghesquieres, H. [Auteur]
Centre Hospitalier Lyon Sud [CHU - HCL] [CHLS]
Bouabdallah, K. [Auteur]
Hôpital Haut-Lévêque [CHU Bordeaux]
Tilly, H. [Auteur]
Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen [CLCC Henri Becquerel]
Le Calloch, R. [Auteur]
Centre Hospitalier Intercommunal de Cornouaille [CHIC]
Morschhauser, Franck [Auteur]
Hôpital Claude Huriez [Lille]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Costello, R. [Auteur]
Hôpital de la Conception [CHU - APHM] [LA CONCEPTION]
Slama, B. [Auteur]
Centre Hospitalier Henri Duffaut (Avignon)
Gyan, E. [Auteur]
Hôpital Bretonneau
Chauchet, A. [Auteur]
Centre Hospitalier Régional Universitaire de Besançon [CHRU Besançon]
Ngirabacu, M. [Auteur]
Durot, E. [Auteur]
Hôpital Robert Debré
Choquet, S. [Auteur]
CHU Pitié-Salpêtrière [AP-HP]
Capdupuy, C. [Auteur]
Centre Hospitalier de la Côte Basque [CHCB]
Le Goff, M. [Auteur]
Centre Jean Bernard [Institut Inter-régional de Cancérologie - Le Mans]
Voillat, L. [Auteur]
Centre Hospitalier Chalon-sur-Saône William Morey
Snauwaert, S. [Auteur]
Amorim, S. [Auteur]
Hôpital Saint Vincent de Paul de Lille

Titre de la manifestation scientifique :

17th International Conference on Malignant Lymphoma

Ville :

Lugano

Pays :

Suisse

Date de début de la manifestation scientifique :

2023-06-13

Titre de la revue :

Hematological Oncology

Éditeur :

Wiley

Date de publication :

2023-06-09

ISSN :

1099-1069

Mot(s)-clé(s) en anglais :

Aggressive B-cell non-Hodgkin lymphoma
Chemotherapy

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Introduction: The prognosis of patients with relapsed/refractory aggressive non-hodgkin lymphoma (R/R aNHL) remains poor with conventional immunochemotherapies. Pixantrone is an aza-anthracenedione agent designed to improve ...
Lire la suite >Introduction: The prognosis of patients with relapsed/refractory aggressive non-hodgkin lymphoma (R/R aNHL) remains poor with conventional immunochemotherapies. Pixantrone is an aza-anthracenedione agent designed to improve the efficacy and reduce the toxicity associated with anthracyclines and anthracenediones. In this context, we conducted a phase II trial combining pixantrone with ifosfamide, etoposide and rituximab (PIVeR) in R/R aNHL. The primary objective was to assess the efficacy measured by the overall metabolic response (OMR) rate after 2 cycles. Methods: Patients were eligible if they had a histologically proven CD20+ aNHL (de novo diffuse large B-cell lymphoma (DLBCL) or transformed low-grade NHL or grade 3B follicular lymphoma). R/R disease was defined as follows: (1) autologous stem-cell transplantation (ASCT) eligible patients who failed to achieve a CR after at least one salvage therapy, (2) patients in first relapse after ASCT or (3) patients not eligible for ASCT who failed to achieve a CR after at least one prior treatment. First response evaluation by PET-scan was performed after 2 cycles. Responders could then proceed, if eligible, to ASCT or CAR T-Cells therapies after a third optional cycle. Others responding patients were treated with four additional cycles. The study was designed in order to detect an OMR rate increase from 40% to 55%, assuming an 80% power at a 5% (1-sided) significance level using a two-stage phase II design. A total of 84 evaluable patient was expected. Results: Between March 2018 and December 2021, 74 patients were enrolled. The median age was 70 y (range 35–87). The majority of the patients had a diagnosis of de novo DLBCL (85.1%) and 43.2% were primary refractory. After 2 cycles, the OMR rate was 59.5% (90% CI = 49.2%–69.1%) with 18.9% complete metabolic response (CMR). A total of 44 patients completed the treatment. At the end of treatment, the OMR rate was 36.5% with 24.3% CMR. With a median follow-up of 16.6 mo, median PFS and OS were respectively 3.7 mo (95% CI = 2.6–5.6) and 19.2 mo (95% CI = 11.9–36.5). Three patients had an ASCT and 16 were treated with CAR T-Cells. For patients treated with CAR T-Cells, the OMR rate after CAR T-Cells was 31.3% and median OS was not reached. A total of 53 patients (71.6%) reported at least one AE. The most frequent grade 3–4 AEs were neutropenia (28.4%), thrombocytopenia (18.9%) and anemia (17.6%). Cardiac AEs occurred in 6 patients (11.3%) and 5 (9.4%) had a grade 3–4 heart failure. Serious AEs occurred in 30.9% of the patients, leading to treatment discontinuation in 3 cases. Conclusion: The primary objective of this trial was met with a high OMR rate of 59.5% after 2 cycles of the PIVeR regimen. The safety profile appeared manageable with few grade 3–4 cardiac AEs. Based on these results, the use of pixantrone in salvage treatment of R/R aNHL should be further evaluated, in particular in the context of bridging therapy before CAR T-Cells.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille

Collections :

• Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365

Date de dépôt :

2024-09-06T21:08:47Z
2024-09-25T16:02:08Z
2024-09-26T13:22:27Z