Lenalidomide in Pretreated Mantle Cell Lymphoma Patients: An Italian Observational Multicenter Retrospective Study in Daily Clinical Practice (the Lenamant Study)

Stefoni, Vittorio; Pellegrini, Cinzia; Broccoli, Alessandro; Baldini, Luca; Tani, Monica; Cencini, Emanuele; Figuera, Amalia; Ansuinelli, Michela; Bernocco, Elisa; Cox, Maria Christina; Ballerini, Filippo; Rusconi, Chiara; Visco, Carlo; Arcaini, Luca; Famà, Angelo; Marasca, Roberto; Volpetti, Stefano; Castellino, Alessia; Califano, Catello; Cavalierè, Marina; Gini, Guido; Liberati, Anna Marina; Musuraca, Gerardo; Lucania, Anna; Ricciuti, Giuseppina; Argnani, Lisa; Zinzani, Pier Luigi

doi:10.1634/theoncologist.2017-0597

Cited by 5 publications

(8 citation statements)

References 21 publications

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“…This is a common issue which may presumably be solved at least partially with combination or right sequencing therapy [ 13 , 14 ]. Lenalidomide could be an effective opportunity even if in our study the patients (only five) who underwent lenalidomide after ibrutinib failed to achieve response [ 15 , 16 ]. On the other hand, patients who consolidated response with SCT had better outcomes.…”

Section: Discussionmentioning

confidence: 99%

Italian real life experience with ibrutinib: results of a large observational study on 77 relapsed/refractory mantle cell lymphoma

et al. 2018

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Although sometimes presenting as an indolent lymphoma, mantle cell lymphoma (MCL) is an aggressive disease, hardly curable with standard chemo-immunotherapy. Current approaches have greatly improved patients’ outcomes, nevertheless the disease is still characterized by high relapse rates. Before approval by EMA, Italian patients with relapsed/refractory MCL were granted ibrutinib early access through a Named Patient Program (NPP).An observational, retrospective, multicenter study was conducted. Seventy-seven heavily pretreated patients were enrolled. At the end of therapy there were 14 complete responses and 14 partial responses, leading to an overall response rate of 36.4%. At 40 months overall survival was 37.8% and progression free survival was 30%; disease free survival was 78.6% at 4 years: 11/14 patients are in continuous complete response with a median of 36 months of follow up. Hematological toxicities were manageable, and main extra-hematological toxicities were diarrhea (9.4%) and lung infections (9.0%). Overall, 4 (5.2%) atrial fibrillations and 3 (3.9%) hemorrhagic syndromes occurred.In conclusions, thrombocytopenia, diarrhea and lung infections are the relevant adverse events to be clinically focused on; regarding effectiveness, ibrutinib is confirmed to be a valid option for refractory/relapsed MCL also in a clinical setting mimicking the real world.

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Section: Discussionmentioning

confidence: 99%

Italian real life experience with ibrutinib: results of a large observational study on 77 relapsed/refractory mantle cell lymphoma

et al. 2018

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“…Multiple phase II studies have been conducted with lenalidomide alone and in combination with rituximab (R 2 regimen) [35][36][37][38][39][40][41][42]64]. The pivotal phase II MCL-001 (EMERGE) study in the US established the activity of lenalidomide in relapsed/refractory MCL, including patients who received prior bortezomib (median 4 prior regimens) [35].…”

Section: Novel Monotherapy Treatment Options For Relapsed/refractory MCLmentioning

confidence: 99%

Treatment for patients with relapsed/refractory mantle cell lymphoma: European-based recommendations

Dreyling

Aurer

Cortelazzo

et al. 2017

Leukemia & Lymphoma

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Patients with mantle cell lymphoma (MCL) usually respond to initial combination chemotherapy, but the disease inevitably relapses and often follows an aggressive course. Here, clinical study results published since 2008 for patients with relapsed/refractory MCL were reviewed to compare available evidence for treatment guidance. Most trials identified were non-randomized, phase II studies performed at a limited number of sites, and many evaluated MCL as one of multiple non-Hodgkin lymphoma subtypes. Additional randomized, comparative trials are needed. Treatment selection generally depends on patient need, age and fitness, time of relapse, and line of therapy. Combination regimens typically produce higher response rates than single agents, and adding rituximab generally improves outcomes. The inclusion of ibrutinib, lenalidomide, temsirolimus, and bortezomib, represents an important advance for patients ineligible for, unable to tolerate, or failing high-intensity combination chemotherapy. A high need for effective treatments in relapsed/refractory MCL remains, particularly for elderly and frail patients.

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“…In this regard, 22.8% and 45.7% of the patients were refractory to the first and the most recent line of therapy, respectively ( Table 1 ). The authors reported a median PFS of 13.8 months, a median OS of 32.5 months, an ORR of 47.1%, and a CR of 31.4% 31 ( Table 4 ). Similarly, the study of Zinzani et al, which included 33 patients with R/R MCL treated with lenalidomide, reported a PFS of 13.9 months, an ORR of 45.5% and a lower CR of 12.1% 32 ( Table 4 ).…”

Section: Resultsmentioning

confidence: 99%

Real-World Evidence of Relapsed/Refractory Mantle Cell Lymphoma Patients and Treatments: A Systematic Review

Sancho,

Sorigué,

Rubio-Azpeitia

2024

JBM

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Introduction Mantle cell lymphoma (MCL) is an incurable disease with an aggressive clinical course, and most patients eventually relapse after chemotherapy. Targeted therapies developed for relapsed/refractory MCL have been approved based on clinical trial data. However, real-world setting data are scarce and scattered. Areas Covered This systematic review aimed to collect, synthesize, and describe the characteristics and treatment outcomes of patients with relapsed/refractory MCL after receiving a second or subsequent line of therapy in the real-world setting. Expert Opinion R/R MCL is clinically and biologically heterogeneous and still represents a therapeutic challenge, with high-risk and early relapsed patients remaining an unmet medical need. This systematic review is limited by the quality of the available data and the difficulty of comparing outcomes in R/R MCL due to the heterogeneity of the disease, but the results suggest that covalent BTKis should be positioned as second-line therapy, followed by CAR T-cells in BTK-i-relapsed patients. Chemo-free and combination therapies with established chemoimmunotherapy backbones in the relapsed and front-line settings have been recently developed, and front-line options are being improved to move targeted and cellular therapies to earlier lines, including front-line therapy, in elderly and younger fit patients. In the upcoming years, many new targeted agents will play an important role and will be incorporated to the routine practice as their sequence, and outcomes in unselected patients are determined.

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Lenalidomide in Pretreated Mantle Cell Lymphoma Patients: An Italian Observational Multicenter Retrospective Study in Daily Clinical Practice (the Lenamant Study)

Cited by 5 publications

References 21 publications

Italian real life experience with ibrutinib: results of a large observational study on 77 relapsed/refractory mantle cell lymphoma

Italian real life experience with ibrutinib: results of a large observational study on 77 relapsed/refractory mantle cell lymphoma

Treatment for patients with relapsed/refractory mantle cell lymphoma: European-based recommendations

Real-World Evidence of Relapsed/Refractory Mantle Cell Lymphoma Patients and Treatments: A Systematic Review

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