دورية أكاديمية
IELSG38: phase II trial of front-line chlorambucil plus subcutaneous rituximab induction and maintenance in mucosa-associated lymphoid tissue lymphoma.
| العنوان: | IELSG38: phase II trial of front-line chlorambucil plus subcutaneous rituximab induction and maintenance in mucosa-associated lymphoid tissue lymphoma. |
|---|---|
| المؤلفون: | Stathis A; Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Università della Svizzera Italiana, Faculty of Biomedical Sciences, Lugano. anastasios.stathis@eoc.ch., Pirosa MC; Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Institute of Oncology Research, Bellinzona., Orsucci L; S.C. Ematologia, AOU Città della Salute e della Scienza di Torino, Turin., Feugier P; Department of Clinical Hematology, Nancy University Hospital, INSERM 1256, Nancy., Tani M; U.O. Ematologia, Dipartimento Oncologia e Ematologia, Ospedale Santa Maria delle Croci, Ravenna., Ghesquières H; Hematology Department, Hospices Civils de Lyon, CHU Lyon-Sud, Pierre-Bénite., Musuraca G; Hematology Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola., Rossi FG; Hematology-BMT Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milano., Merli F; AUSL-IRCCS of Reggio Emilia, Reggio Emilia., Guièze R; Service d'Hématologie Clinique et de Thérapie Cellulaire, CHU Estaing, Clermont- Ferrand., Gyan E; Hématologie et thérapie cellulaire, CIC Inserm U1415, Centre Hospitalier Universitaire de Tours, Tours., Gini G; Hematology, Department of Clinical and Molecular Sciences, Marche Polytechnic University, Ancona., Marino D; Oncology 1 Unit, Istituto Oncologico Veneto IOV-IRCCS, Padova., Gressin R; Institute for Advanced Biosciences, INSERM U1209/CNRS UMR 5309/Grenoble Alpes University, Grenoble., Morschhauser F; Université de Lille, CHU Lille, Department of Hematology, Lille., Cavallo F; Division of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino/AOU Città della Salute e della Scienza di Torino, Turin., Palombi F; Hematology and Stem Cell Transplant Unit, IRCCS. National Cancer Institute, Istituto Regina Elena, Rome Italy., Conconi A; Division of Hematology, Ospedale degli Infermi, Biella., Tessoulin B; Hématologie Clinique, CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes., Tilly H; Department of Hematology and U1245, Centre Henri Becquerel, Rouen., Zanni M; Hematology Unit, Antonio e Biagio e Cesare Arrigo Hospital, Alessandria., Cabras MG; Ospedale Oncologico, Ematologia e CTMO, Cagliari., Capochiani E; Hematology Unit, Azienda USL Toscana NordOvest, Center for Translational Medicine, Livorno., Califano C; Hematology Unit, P.O. A. Tortora, Pagani., Celli M; Hematology Unit, Ospedale degli Infermi, Rimini., Pulsoni A; Department of Translational and Precision Medicine, Sapienza University, Rome., Angrilli F; Unità Operativa Semplice Dipartimentale Centro Diagnosi e Terapia Linfomi, Presidio Ospedaliero, Pescara., Occhini U; Unità Operativa di Ematologia, Ospedale San Donato, AUSL Toscana Sud-Est, Arezzo., Casasnovas RO; Department of Hematology, University Hospital F Mitterrand and INSERM 1231, Dijon., Cartron G; Hématologie Clinique, CHU Montpellier, UMR 5535 Montpellier., Devizzi L; Hematology Unit, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan., Haioun C; Lymphoid Malignancies Unit, Hôpital Henri Mondor, AP-HP, Créteil., Liberati AM; SC Oncoematologia, Azienda Ospedaliera Santa Maria, Università degli studi di Perugia, Terni., Houot R; Department of Clinical Hematology, University Hospital of Rennes, Rennes., Merli M; Division of Hematology, University Hospital Ospedale di Circolo e Fondazione Macchi ASST Sette Laghi, University of Insubria, Varese., Pietrantuono G; Hematology Unit, Centro di Riferimento Oncologico della Basilicata IRCCS Rionero in Vulture., Re F; Hematology and BMT Center, Azienda Ospedaliera Universitaria, Parma., Spina M; Division of Medical Oncology, Centro di Riferimento Oncologico IRCCS, Aviano., Landi F; Oncology Institute of Southern Switzerland, EOC, Bellinzona., Cavalli F; Institute of Oncology Research, Bellinzona., Bertoni F; Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Università della Svizzera Italiana, Faculty of Biomedical Sciences, Lugano, Switzerland; Institute of Oncology Research, Bellinzona., Rossi D; Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Università della Svizzera Italiana, Faculty of Biomedical Sciences, Lugano, Switzerland; Institute of Oncology Research, Bellinzona., Ielmini N; Institute of Oncology Research, Bellinzona., Borgo E; FIL, Fondazione Italiana Linfomi ONLUS, Alessandria., Luminari S; AUSL-IRCCS of Reggio Emilia, Reggio Emilia, Italy; CHIMOMO Department, University of Modena and Reggio Emilia, Reggio Emilia., Zucca E; Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Università della Svizzera Italiana, Faculty of Biomedical Sciences, Lugano, Switzerland; Institute of Oncology Research, Bellinzona, Switzerland; Medical Oncology, University Hospital and University of Bern., Thieblemont C; APHP - Service d'Hématologie-Oncologie, Hôpital Saint Louis, Université de Paris - Diderot, Paris. |
| المصدر: | Haematologica [Haematologica] 2024 Aug 01; Vol. 109 (8), pp. 2564-2573. Date of Electronic Publication: 2024 Aug 01. |
| نوع المنشور: | Journal Article; Clinical Trial, Phase II; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Ferrata Storti Foundation Country of Publication: Italy NLM ID: 0417435 Publication Model: Electronic Cited Medium: Internet ISSN: 1592-8721 (Electronic) Linking ISSN: 03906078 NLM ISO Abbreviation: Haematologica Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 1999- : Pavia, Italy : Ferrata Storti Foundation Original Publication: Pavia [etc.] |
| مواضيع طبية MeSH: | Lymphoma, B-Cell, Marginal Zone*/drug therapy , Lymphoma, B-Cell, Marginal Zone*/mortality , Rituximab*/administration & dosage , Rituximab*/therapeutic use , Chlorambucil*/administration & dosage , Chlorambucil*/therapeutic use , Antineoplastic Combined Chemotherapy Protocols*/therapeutic use , Antineoplastic Combined Chemotherapy Protocols*/adverse effects, Humans ; Middle Aged ; Female ; Male ; Aged ; Adult ; Aged, 80 and over ; Maintenance Chemotherapy ; Injections, Subcutaneous ; Treatment Outcome ; Remission Induction |
| مستخلص: | The IELSG38 trial was conducted to investigate the effects of subcutaneous (SC) rituximab on the complete remission (CR) rate and the benefits of SC rituximab maintenance in patients with extranodal marginal zone lymphoma (MZL) who received front-line treatment with chlorambucil plus rituximab. Study treatment was an induction phase with oral chlorambucil 6 mg/m2/day on weeks 1-6, 9-10, 13-14, 17-18, and 21-22, and intravenous rituximab 375 mg/m2 on day 1 of weeks 1-4, and 1,400 mg SC on weeks 9, 13, 17, and 21. Then, a maintenance phase followed with rituximab administered at 1,400 mg SC every two months for two years. Of the 112 patients enrolled, 109 were evaluated for efficacy. The CR rates increased from 52% at the end of the induction phase to 70% upon completion of the maintenance phase. With a median follow-up of 5.8 years, the 5-year event-free, progression-free, and overall survival rates were 87% (95% CI: 78-92), 84% (95% CI: 75-89), and 93% (95% CI: 86-96), respectively. The most common grade ≥3 toxicities were neutropenia (33%) and lymphocytopenia (16%). Six patients experienced treatment-related serious adverse events, including fever of unknown origin, sepsis, pneumonia, respiratory failure, severe cerebellar ataxia, and fatal acute myeloid leukemia. The trial showed that SC rituximab did not improve the CR rate at the conclusion of the induction phase, which was the main endpoint. Nevertheless, SC rituximab maintenance might have facilitated long-term disease control, potentially contributing to enhanced event-free and progression-free survival. |
| References: | Hemasphere. 2022 Feb 24;6(3):e699. (PMID: 35233508) Ann Lymphoma. 2021 Mar;5:. (PMID: 33829216) Br J Haematol. 2019 Jun;185(5):874-882. (PMID: 30919940) Gut. 2003 Nov;52(11):1656. (PMID: 14570741) J Clin Oncol. 2005 Feb 20;23(6):1088-95. (PMID: 15657401) Br J Cancer. 1995 Aug;72(2):511-8. (PMID: 7640241) Haematologica. 2020 Jan 02;105(11):2592-2597. (PMID: 33131248) J Clin Oncol. 2007 Feb 10;25(5):579-86. (PMID: 17242396) Am J Hematol. 2022 Dec;97(12):1529-1537. (PMID: 36057138) Am J Hematol. 2019 May;94(5):585-596. (PMID: 30784098) Cancer Commun (Lond). 2019 Oct 16;39(1):58. (PMID: 31619290) Blood. 2019 Sep 5;134(10):798-801. (PMID: 31292118) Ann Oncol. 2020 Jan;31(1):17-29. (PMID: 31912792) J Clin Oncol. 2017 Jun 10;35(17):1905-1912. (PMID: 28355112) Blood. 2017 Oct 12;130(15):1772-1774. (PMID: 28801448) Ann Oncol. 1995 Sep;6(7):726-8. (PMID: 8664197) Br J Haematol. 2016 Jun;173(6):867-75. (PMID: 26970533) Blood. 2017 Sep 21;130(12):1409-1417. (PMID: 28720586) J Natl Compr Canc Netw. 2023 Nov;21(11):1118-1131. (PMID: 37935098) Brain. 2003 Jun;126(Pt 6):1409-18. (PMID: 12764061) Blood Adv. 2022 Apr 12;6(7):2035-2044. (PMID: 35196377) J Clin Oncol. 1999 Apr;17(4):1244. (PMID: 10561185) Chin Med J (Engl). 2020 Apr 20;133(8):1005-1007. (PMID: 32187048) N Engl J Med. 2022 Feb 10;386(6):568-581. (PMID: 35139275) ESMO Open. 2022 Apr;7(2):100403. (PMID: 35272130) Lancet. 2011 Jan 1;377(9759):42-51. (PMID: 21176949) Ann Oncol. 1999 Mar;10(3):317-21. (PMID: 10355576) J Clin Oncol. 2016 Feb 10;34(5):495-500. (PMID: 26712227) J Gastroenterol. 2014 May;49(5):843-52. (PMID: 23793380) |
| المشرفين على المادة: | 4F4X42SYQ6 (Rituximab) 18D0SL7309 (Chlorambucil) |
| تواريخ الأحداث: | Date Created: 20240222 Date Completed: 20240801 Latest Revision: 20240802 |
| رمز التحديث: | 20240802 |
| مُعرف محوري في PubMed: | PMC11290511 |
| DOI: | 10.3324/haematol.2023.283918 |
| PMID: | 38385243 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1592-8721 |
|---|---|
| DOI: | 10.3324/haematol.2023.283918 |