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    Wyświetlanie 1-9 z 9
    Tytuł:
    Clinical phenotype and management of severe neurotoxicity observed in patients with neuroblastoma treated with dinutuximab beta in clinical trials
    Autorzy:
    Manzitti, Carla
    Pribill, Ingrid
    Fiedler, Stefan
    Lode, Holger N.
    Ladenstein, Ruth
    Papadakis, Vassilios
    Wieczorek, Aleksandra
    Poetschger, Ulrike
    Gray, Juliet
    Zachwieja, Katarzyna
    Valteau-Couanet, Dominique
    Garaventa, Alberto
    Opis:
    Neurotoxicity is an off-tumour, on-target side effect of GD2-directed immunotherapy with monoclonal antibodies. Here, we report the frequency, management and outcome of patients enrolled in two prospective clinical trials who experienced severe neurotoxicity during immunotherapy with the anti-GD2 antibody dinutuximab beta (DB) administered as short-term infusion (HR-NBL1/SIOPEN study, randomisation R2, EudraCT 2006-001489-17) or as long-term infusion (HR-NBL1/SIOPEN study, randomisation R4, EudraCT 2006-001489-17 and LTI/SIOPEN study, EudraCT 2009-018077-31), either alone or with subcutaneous interleukin-2 (scIL-2). The total number of patients included in this analysis was 1102. Overall, 44/1102 patients (4.0%) experienced Grade 3/4 neurotoxicities (HR-NBL1 R2, 21/406; HR-NBL1 R4, 8/408; LTI study, 15/288), including 27 patients with severe neurotoxicities (2.5%). Events occurred predominantly in patients receiving combined treatment with DB and scIL-2. Neurotoxicity was treated using dexamethasone, prednisolone, intravenous immunoglobulins and, in two patients, plasmapheresis, which was highly effective. While neurological recovery was observed in 16 of 21 patients with severe neurotoxicities, 5/1102 (0.45%) patients experienced persistent and severe neurological deficits. In conclusion, severe neurotoxicity is most commonly observed in patients receiving DB with scIL-2. Considering the lack of clinical benefit for IL-2 in clinical trials so far, the administration of IL-2 alongside DB is not recommended.
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
    Tytuł:
    Effect and tolerance of N5 and N6 chemotherapy cycles in combination with dinutuximab beta in relapsed high-risk neuroblastoma patients who failed at least one second-line therapy
    Autorzy:
    Eggert, Angelika
    Zaniewska-Tekieli, Anna
    Ehlert, Karoline
    Troschke-Meurer, Sascha
    Lode, Holger N.
    Ladenstein, Ruth
    Glogova, Evgenia
    Struppe, Linda
    Siebert, Nikolai
    Zumpe, Maxi
    Huber, Stefanie
    Wieczorek, Aleksandra
    Balwierz, Walentyna
    Hundsdoerfer, Patrick
    Opis:
    The anti-disialoganglioside (GD2) monoclonal antibody dinutuximab beta is approved for the maintenance treatment of high-risk neuroblastoma. Dinutuximab beta combined with different chemotherapy regimens is being investigated in various clinical settings. We conducted a retrospective clinical chart review of 25 patients with relapsed/refractory neuroblastoma who had failed ≥1 second-line therapy and received compassionate use treatment with dinutuximab beta long-term infusion combined with the induction chemotherapy regimens N5 (cisplatin, etoposide, vindesine) and N6 (vincristine, dacarbazine, ifosfamide, doxorubicin) recommended by the German Pediatric Oncology and Hematology Group [GPOH] guidelines. The treatment did not result in any unexpected severe toxicities or in any major treatment delays. Grade 3/4 pain was reported by 4/25 patients in cycle 1, decreasing to 0/9 patients in cycles 3 and 4. The median follow-up was 0.6 years. The best response in this group was 48% (12/25 patients), which included three patients with minor responses. At 1 year, the estimated event-free survival was 27% (95% confidence interval [CI] 8–47) and overall survival was 44% (95% CI 24–65). Combining long-term infusion of dinutuximab beta with N5 and N6 chemotherapy demonstrated an acceptable safety profile and encouraging objective response rates in heavily pretreated patients with high-risk neuroblastoma, warranting further evaluation in clinical trials.
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
    Tytuł:
    Dinutuximab Beta versus naxitamab in the treatment of relapsed/refractory neuroblastoma in patients with stable disease, minor response or partial response and disease in bone or bone marrow : systematic review and matching-adjusted indirect comparison
    Autorzy:
    Manzitti, Carla
    Luksch, Roberto
    Lode, Holger N.
    Wieczorek, Aleksandra
    Holko, Przemysław
    Gray, Juliet
    Anderson, John
    Śladowska, Katarzyna
    Ebeling, Torsten
    Yaniv, Isaac
    Canete, Adela
    Ash, Shifra
    Troschke-Meurer, Sascha
    Ladenstein, Ruth L.
    Valteau-Couanet, Dominique
    Garaventa, Alberto
    Kawalec, Paweł
    Siebert, Nikolai
    Opis:
    Objective: Dinutuximab beta (DB) and naxitamab (NAXI) with GM-CSF are used for maintenance treatment of relapsed/refractory neuroblastoma. The objective of this study was to systematically assess comparative efficacy of the two therapies within their designated indications in accordance with established clinical guidelines. Methods: Relevant evidence was identified in systematic literature review. Individual patient data (IPD) from prospective clinical trials of DB were assessed and data on patients with disease in bone or bone marrow, as assessed in MRI, CT, mIBG or biopsy, with incomplete response to previous therapy were included. Patients with complete response, progressive disease and/or soft tissue disease were excluded. DB population was adjusted for sex, MYCN amplification, disease type (relapsed, refractory), and disease site (bone marrow and/or bone) to balance aggregated characteristics of NAXI population. More characteristics were included in sensitivity analyses, including DB treatment without interleukin-2, as currently recommended. Overall response rate (ORR) was assessed as best response. Results: Aggregated data for NAXI from Study 201 (n = 52) and Study 230 (n = 38) and IPD from DB studies (APN311-202, APN311-304, c = 77) met the inclusion criteria. Compared to NAXI, DB significantly extended progression-free survival (PFS): hazard ratio, DB vs. NAXI of 0.47 (95% CI: 0.26 to 0.87, p = 0.015). ORR was 60.1% (95% CI: 48.5% to 71.6%) for DB vs. 43.3% (33.1% to 53.6%) for NAXI (ORR odds ratio, DB vs. NAXI was 1.97, 95% CI: 1.02 to 3.80, p = 0.044). Sensitivity analyses and unadjusted comparisons supported the results. Conclusion: In the indirect comparison, dinutuximab beta significantly extended PFS and increased ORR compared to naxitamab.
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
    Tytuł:
    Frequency and prognostic impact of ALK amplifications and mutations in the European Neuroblastoma Study Group (SIOPEN) High-Risk Neuroblastoma Trial (HR-NBL1)
    Autorzy:
    Popovic-Beck, Maja
    Bown, Nick
    Font de Mora, Jaime
    Noguera, Rosa
    Taschner-Mandl, Sabine
    Muhlethaler-Mottet, Annick
    Laureys, Genevieve
    Malis, Josef
    Pierron, Gaelle
    Kogner, Per
    Rossing, Maria
    Combaret, Valerie
    Chesler, Louis
    Castel, Victoria
    Luksch, Roberto
    Tweddle, Deborah A.
    Bellini, Angela
    de Preter, Katleen
    Ladenstein, Ruth
    George, Sally L.
    Ambros, Peter F.
    Baulande, Sylvain
    Beiske, Klaus
    Marques, Barbara
    Ash, Shifra
    Clement, Nathalie
    van Roy, Nadine
    Valteau-Couanet, Dominique
    Balwierz, Walentyna
    Schleiermacher, Gudrun
    Martinsson, Tommy
    Vicha, Ales
    Delattre, Olivier
    Auger, Nathalie
    Jeison, Marta
    Morini, Martina
    Betts, David R.
    Bhalshankar, Jaydutt
    Lapouble, Eve
    Elliott, Martin
    Bernkopf, Marie
    Mazzocco, Katia
    Potschger, Ulrike
    Bernard, Virginie
    Jimenez, Irene
    Opis:
    Purpose: In neuroblastoma (NB), the ALK receptor tyrosine kinase can be constitutively activated through activating point mutations or genomic amplification. We studied ALK genetic alterations in high-risk (HR) patients on the HR-NBL1/SIOPEN trial to determine their frequency, correlation with clinical parameters, and prognostic impact. Materials and Methods: Diagnostic tumor samples were available from 1,092 HR-NBL1/SIOPEN patients to determine ALK amplification status (n = 330), ALK mutational profile (n = 191), or both (n = 571). Results: Genomic ALK amplification (ALKa) was detected in 4.5% of cases (41 out of 901), all except one with MYCN amplification (MNA). ALKa was associated with a significantly poorer overall survival (OS) (5-year OS: ALKa [n = 41] 28% [95% CI, 15 to 42]; no-ALKa [n = 860] 51% [95% CI, 47 to 54], [P < .001]), particularly in cases with metastatic disease. ALK mutations (ALKm) were detected at a clonal level (> 20% mutated allele fraction) in 10% of cases (76 out of 762) and at a subclonal level (mutated allele fraction 0.1%-20%) in 3.9% of patients (30 out of 762), with a strong correlation between the presence of ALKm and MNA (P < .001). Among 571 cases with known ALKa and ALKm status, a statistically significant difference in OS was observed between cases with ALKa or clonal ALKm versus subclonal ALKm or no ALK alterations (5-year OS: ALKa [n = 19], 26% [95% CI, 10 to 47], clonal ALKm [n = 65] 33% [95% CI, 21 to 44], subclonal ALKm (n = 22) 48% [95% CI, 26 to 67], and no alteration [n = 465], 51% [95% CI, 46 to 55], respectively; P = .001). Importantly, in a multivariate model, involvement of more than one metastatic compartment (hazard ratio [HR], 2.87; P < .001), ALKa (HR, 2.38; P = .004), and clonal ALKm (HR, 1.77; P = .001) were independent predictors of poor outcome. Conclusion: Genetic alterations of ALK (clonal mutations and amplifications) in HR-NB are independent predictors of poorer survival. These data provide a rationale for integration of ALK inhibitors in upfront treatment of HR-NB with ALK alterations.
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
      Wyświetlanie 1-9 z 9

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