Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia
| العنوان: | Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia |
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| المؤلفون: | Philippe Rousselot, Shira Dinner, Robert J. Kreitman, Bjørn Tore Gjertsen, Monica Bocchia, Andrzej Hellmann, Lionel Karlin, Fritz Offner, Philipp le Coutre, Gary J. Schiller, Agostino Cortelezzi, Xavier Troussard, Nai Shun Yao, Mirjana Gotic, Shannon Marshall, Tamar Tadmor, Michael Doubek, Ira Pastan, Wyndham H. Wilson, Kemal Balic, Gail J. Roboz, Sascha Dietrich, Peng He, Marco Gobbi, Ronan T. Swords, Francis J. Giles, Loree Larratt, Tadeusz Robak, Dimitri Breems, Tanya Siddiqi, Nathan Standifer, Giuseppe Saglio, Larry Bacon, Douglas E. Gladstone, Krimo Bouabdallah, Pier Luigi Zinzani, Farhad Ravandi, Julio Delgado, Mathias J. Rummel, Cecilia Arana Yi, Frédéric Maloisel, Claire Dearden, Stéphane Leprêtre |
| المساهمون: | National Cancer Institute [Bethesda] (NCI-NIH), National Institutes of Health [Bethesda] (NIH), Royal Marsden NHS Foundation Trust, University of Bologna, Barcelona Centre for International Health Research, Hospital Clinic (CRESIB), Universitat de Barcelona (UB), Service d’Hématologie [Centre Hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Medical University of Łódź (MUL), Johns Hopkins University (JHU), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Universität Heidelberg [Heidelberg], Clinical Center of Serbia (KCS), University of Alberta, Universiteit Gent = Ghent University [Belgium] (UGENT), David Geffen School of Medicine [Los Angeles], University of California [Los Angeles] (UCLA), University of California-University of California, University of Miami [Coral Gables], St James's University Hospital, Leeds Teaching Hospitals NHS Trust, Università degli Studi di Siena = University of Siena (UNISI), CHU Bordeaux [Bordeaux], Ziekenhuis Netwerk Antwerpen (ZNA), Università degli Studi di Milano [Milano] (UNIMI), Northwestern University Feinberg School of Medicine, Faculty of Science [Brno] (SCI / MUNI), Masaryk University [Brno] (MUNI), Haukeland University Hospital, University of Bergen (UiB), Ospedale Policlinico San Martino [Genoa], Medical University of Gdańsk, Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Clinique Sainte Anne [Strasbourg], MD Anderson Cancer Center [Houston], The University of Texas Health Science Center at Houston (UTHealth), Infection et inflammation (2I), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Justus-Liebig-Universität Gießen (JLU), City of Hope National Medical Center, Bnai Zion Medical Center [Israël], Hôpital Côte de Nacre [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), The University of New Mexico [Albuquerque], University of Turin, New York Presbyterian Hospital, MedImmune, University of Bologna/Università di Bologna, Universiteit Gent = Ghent University (UGENT), University of California (UC)-University of California (UC), Università degli Studi di Milano = University of Milan (UNIMI), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Justus-Liebig-Universität Gießen = Justus Liebig University (JLU), Università degli studi di Torino = University of Turin (UNITO), Normandie, Université, Kreitman, Robert J, Dearden, Claire, Zinzani, Pier Luigi, Delgado, Julio, Karlin, Lionel, Robak, Tadeusz, Gladstone, Douglas E, le Coutre, Philipp, Dietrich, Sascha, Gotic, Mirjana, Larratt, Loree, Offner, Fritz, Schiller, Gary, Swords, Ronan, Bacon, Larry, Bocchia, Monica, Bouabdallah, Krimo, Breems, Dimitri A, Cortelezzi, Agostino, Dinner, Shira, Doubek, Michael, Gjertsen, Bjorn Tore, Gobbi, Marco, Hellmann, Andrzej, Lepretre, Stephane, Maloisel, Frederic, Ravandi, Farhad, Rousselot, Philippe, Rummel, Mathia, Siddiqi, Tanya, Tadmor, Tamar, Troussard, Xavier, Yi, Cecilia Arana, Saglio, Giuseppe, Roboz, Gail J, Balic, Kemal, Standifer, Nathan, He, Peng, Marshall, Shannon, Wilson, Wyndham, Pastan, Ira, Yao, Nai-Shun, Giles, Francis |
| المصدر: | Leukemia Leukemia, Nature Publishing Group: Open Access Hybrid Model Option B, 2018, 32 (8), pp.1768-1777. ⟨10.1038/s41375-018-0210-1⟩ Leukemia, 2018, 32 (8), pp.1768-1777. ⟨10.1038/s41375-018-0210-1⟩ LEUKEMIA |
| بيانات النشر: | HAL CCSD, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | 0301 basic medicine, Male, [SDV.MHEP.HEM] Life Sciences [q-bio]/Human health and pathology/Hematology, Cancer Research, ERADICATION, Peripheral edema, Salvage therapy, Gastroenterology, Moxetumomab pasudotox, 0302 clinical medicine, Medicine and Health Sciences, Medicine, Aged, 80 and over, Leukemia, Hairy Cell, Remission Induction, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Hematology, Middle Aged, Prognosis, 3. Good health, Survival Rate, Tolerability, Oncology, 030220 oncology & carcinogenesis, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Female, Moxetumomab pasudotox hairy cell leukemia, medicine.symptom, Adult, medicine.medical_specialty, Bacterial Toxins, Exotoxins, MINIMAL RESIDUAL DISEASE, Antineoplastic Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, DIAGNOSIS, Article, 03 medical and health sciences, Refractory, [SDV.CAN] Life Sciences [q-bio]/Cancer, Internal medicine, Humans, Hairy cell leukemia, RITUXIMAB, IMMUNOHISTOCHEMISTRY, Survival rate, TERM-FOLLOW-UP, Aged, Salvage Therapy, CLADRIBINE, business.industry, medicine.disease, EFFICACY, Minimal residual disease, 030104 developmental biology, ANTIBODY, Drug Resistance, Neoplasm, PATTERNS, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Neoplasm Recurrence, Local, business, Follow-Up Studies |
| الوصف: | International audience; This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/ refractory HCL who had ≥2 prior systemic therapies, including ≥1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 µg/kg intravenously on days 1, 3, and 5 every 28 days for ≤6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability. |
| وصف الملف: | application/pdf; STAMPA |
| اللغة: | English |
| تدمد: | 0887-6924 1476-5551 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::123d1eee2c9a87f61fc90d7a0c01e116Test https://hal-normandie-univ.archives-ouvertes.fr/hal-02194148/documentTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....123d1eee2c9a87f61fc90d7a0c01e116 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 08876924 14765551 |
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