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1639 Survival after First Relapse in Marginal Zone Lymphomas: Prospective Data from the International Observational NF10 Study By the Fondazione Italiana Linfomi

Program: Oral and Poster Abstracts
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Research, Adult, Lymphomas, Clinical Research, Diseases, Indolent lymphoma, Real-world evidence, Lymphoid Malignancies, Study Population, Human
Saturday, December 7, 2024, 5:30 PM-7:30 PM

Stefano Luminari1, Michele Merli, MD2*, Sara Rattotti, MD3*, Maria Elena Nizzoli, MD4,5*, Vittoria Tarantino, MD6*, Simone Ferrero, MD7, Annalisa Talami, MD8*, Roberta Murru, MD9*, Marina Deodato, MD10*, Emanuele Cencini, MD11*, Francesca Re, MD12*, Carlo Visco, MD13*, Marcia Delamain, MD, PhD14*, Michele Spina, MD15*, Ombretta Annibali, MD16*, Alessandro Pulsoni, MD17*, Andrés José María Ferreri, MD18, Caterina Stelitano, MD19*, Elsa Pennese, MD20*, Emiliano Barbieri5*, Stefano Pozzi, MD4,5*, Luigi Marcheselli21*, Francesco Merli22*, Marco Paulli, MD23* and Luca Arcaini24*

1Hematology, Azienda Unità Sanitaria Locale IRCCS of Reggio Emilia, Reggio Emilia, Italy
2Hematology, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy
3Fondazione IRCCS Policlinico San Matteo and University of Pavia, Pavia, Italy
4Hematology Unit, Azienda USL- IRCCS di Reggio Emilia, Reggio Emilia, Italy
5Clinical and Experimental Medicine PhD Program, University of Modena and Reggio Emilia, Modena, Italy
6Division of Hematology, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy
7Department of Molecular Biotechnology and Health Sciences, Hematology Division, University of Torino, Torino, TO, Italy
8Clinical and Experimental Medicine Doctorate School, Università degli Studi di Modena e Reggio Emilia, Reggio Emilia, Italy
9Hematology and Stem Cell Transplantation Unit, Ospedale Oncologico A. Businco, ARNAS G. Brotzu, Cagliari, Italy
10Department of Hematology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
11Division of Hematology, Azienda Ospedaliera Universitaria Senese & University of Siena, Siena, Italy
12Division of Hematology, Azienda Ospedaliera Universitaria di Parma, Parma, Italy
13Hematology and Bone Marrow Transplant Unit, Department of Engineering for Innovative Medicine, University of Verona, Verona, Italy
14Faculdade Ciências Médicas de Minas Gerais, Belo Horizonte, Brazil
15Division of Medical Oncology, IRCCS Centro Di Riferimento Oncologico, Aviano, Italy
16Division of Hematology, Stem Cell Transplantation,, Fondazione Policlinico Universitario Campus Bio Medico, Roma, Italy
17Division of Hematology, Sapienza University – Polo Pontino, Department of Translational and Precision Medicine, S.M. Goretti Hospital, Latina, Italy
18Unit of Lymphoid Malignancies, Department of Onco-Haematology, IRCCS San Raffaele Scientific Institute, Milano, Italy
19Division of Hematology, Grande Ospedale Metropolitano, Bianchi Melacrino Morelli, Reggio Calabria, Italy
20Centro diagnosi e terapia dei linfomi, Presidio Ospedaliero Spirito Santo, Pescara, Italy
21Fondazione Italiana Linfomi, Clinical Trial Office, Modena, Italy
22Hematology Department, AZIENDA USL-IRCCS DI REGGIO EMILIA, Reggio Emilia, Italy
23Pathology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
24Division of Hematology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Background: Marginal Zone Lymphomas (MZL) include Splenic (SMZL), Nodal (NMZL), and Extranodal (ENMZL) pathologic subtypes and are typically associated with an indolent clinical course. Even if outcomes of most MZL cases are excellent, a significant proportion of patients relapse after first line therapy showing heterogenous behavior, with few studies describing outcomes after first relapse. In this report we investigated clinical characteristics and survival of MZL patients prospectively enrolled in the NF10 observational study who experienced a first relapse after induction systemic therapy.

Methods: The NF10 Project was started in 2010 by Fondazione Italiana Linfomi (FIL) as a prospective registry specifically conceived to investigate the prognosis of Indolent Non-Follicular B-Cell Lymphomas (INFL). All pts with a histologic confirmed diagnosis of INFL were eligible for NF10 study with no exclusion criteria. In addition to conventional MZL subtypes the category of disseminated MZL (dissMZL) was defined for cases with undefined presentation. For the current study we selected only patients who experienced a first relapse after systemic therapy. Pts were followed and treated based on local institution guidelines. Primary endpoint was Progression free survival from first relapse (PFS2) which was defined as the time from the date of first relapse (Index date) from subsequent progression, re-treatment, or death due to any cause: secondary endpoint was Survival after relapse (SAR) which was calculated from the index date to death.

Results: Between July 2010 and July 2018, 740 MZL cases had been registered by 65 centres in Europe and South America. Systemic therapy was administered to 435 patients (pts) at time of diagnosis and to 66 cases after initial watch& wait. Overall, 122 patients were identified who had a first relapse after systemic therapy and represented the study population. At index date 51% were older than 70 years (yrs), 47% were male, 36% 15% 29%, and 20% were SMZL, NMZL, ENMZL and dissMZL, respectively. LDH was elevated in 45%, MZL-IPI (Arcaini et al. 2024) was Low, Intermediate (int) and High in 14%, 57% and 29% respectively. For 57% of cases time form initial diagnosis to first relapse was shorter than 24 months (POD24). Regarding second line therapy rituximab was used in 82% of cases, mainly in combination regimens, and ASCT was used in 14% of cases. With a median follow up of 31 months (1 to 84), median PFS2 was 24 months (95% CI 14 – 54) and 2-year PFS2 rate was 49% (95%CI 39- 58). In univariate analysis a shorted PFS2 was anticipated by older age (>70 yrs), POD24, and by intermediate or high risk MZL-IPI (int vs low HR 3.21 95%IC 0.98 – 10.5); High vs low HR 6.58 95%CI 1.97 – 21.9). Among MZL subtypes both SMZL and dissMZL were associated with lower PFS rates vs ENMZL. Median SAR was not achieved and 2-y SAR rate was 64% (95% CI 54-73). In univariate analysis a shorter SAR was anticipated by older age (> 70 yrs), high risk MZL-IPI, POD24, and SMZL and dissMZL subtypes. Both PFS2 and SAR were not modified by an initial period of WW before first line therapy.

Conclusions: With this NF10 sub-study we provide prospective data about survival after first relapse in MZL and confirm the role of known prognostic factors for MZL to predict survival also in the relapsed setting, including the new MZL-IPI prognostic model. Larger collaboration studies are warranted to further analyse the outcome of relapsed MZL patients.

Disclosures: Luminari: Janssen: Membership on an entity's Board of Directors or advisory committees; Sobi: Membership on an entity's Board of Directors or advisory committees; Kite: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Regeneron Pharmaceuticals, Inc.: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Incyte: Membership on an entity's Board of Directors or advisory committees; Genmab: Membership on an entity's Board of Directors or advisory committees; BeiGene: Membership on an entity's Board of Directors or advisory committees; AbbVie: Membership on an entity's Board of Directors or advisory committees. Ferrero: Italfarmaco: Membership on an entity's Board of Directors or advisory committees; Sandoz: Consultancy, Speakers Bureau; Eli Lilly: Speakers Bureau; Gentili: Speakers Bureau; Beigene: Research Funding, Speakers Bureau; Gilead: Research Funding, Speakers Bureau; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte: Membership on an entity's Board of Directors or advisory committees; EUSA Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Murru: Abbvie, AstraZeneca, Beigene, Janssen: Honoraria. Stelitano: Roche, Novartis, Sandoz,Morphosys, Takeda, Octapharma, Celgene: Other: Investigartor of clinical trials. Arcaini: Kile/Gilead: Membership on an entity's Board of Directors or advisory committees; ADC Therapeutics: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Janssen-Cilag: Membership on an entity's Board of Directors or advisory committees; Verastem: Membership on an entity's Board of Directors or advisory committees; Incyte: Membership on an entity's Board of Directors or advisory committees; Celgene/Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; EUSA Pharma: Honoraria, Membership on an entity's Board of Directors or advisory committees.

*signifies non-member of ASH