دورية أكاديمية
أعرض في EDS

Bortezomib maintenance after R-CHOP, cytarabine and autologous stem cell transplantation in newly diagnosed patients with mantle cell lymphoma, results of a randomised phase II HOVON trial.

التفاصيل البيبلوغرافية
العنوان: Bortezomib maintenance after R-CHOP, cytarabine and autologous stem cell transplantation in newly diagnosed patients with mantle cell lymphoma, results of a randomised phase II HOVON trial.
المؤلفون: Doorduijn JK; Haematology, Erasmus MC Cancer Centre, Rotterdam, Netherlands., Zijlstra JM; Amsterdam UMC - Locatie VUMC, Amsterdam, Netherlands., Lugtenburg PJ; Erasmus MC Cancer Centre, Rotterdam, Netherlands., Kersten MJ; Haematology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam and LYMMCARE (lymphoma and myeloma Center), Amsterdam, Netherlands., Böhmer LH; Haematology, Haga Teaching Hospital, The Hague, USA., Minnema MC; Haematology, UMC Utrecht Cancer Centre, Utrecht, Netherlands., MacKenzie MA; UMCN, Nijmegen, Netherlands., van Marwijk Kooij R; Internal Medicine, Isala Clinic, Zwolle, Netherlands., de Jongh E; Albert Schweitzer Hospital Location Dordwijk, Dordrecht, Netherlands., Snijders TJF; Medisch Spectrum Twente, Enschede, Netherlands., de Weerdt O; Sint Antonius Hospital, Nieuwegein, Netherlands., van Gelder M; Maastricht University Medical Centre+, Maastricht, Netherlands., Hoogendoorn M; Medical Centre Leeuwarden, Leeuwarden, Netherlands., Leys RBL; Maasstad Ziekenhuis, Rotterdam, Netherlands., Kibbelaar RE; Department of Pathology, Pathology Friesland, Groningen, Netherlands., de Jong D; Amsterdam UMC - Locatie VUMC, Amsterdam, Netherlands., Chitu DA; Erasmus MC Cancer Center, Rotterdam, Netherlands., Van't Veer MB; Erasmus MC Cancer Centre, Rotterdam, Netherlands., Kluin-Nelemans HC; Haematology, University Medical Center Groningen, Groningen, Netherlands.
المصدر: British journal of haematology [Br J Haematol] 2020 Aug; Vol. 190 (3), pp. 385-393. Date of Electronic Publication: 2020 Mar 09.
نوع المنشور: Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 0372544 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2141 (Electronic) Linking ISSN: 00071048 NLM ISO Abbreviation: Br J Haematol Subsets: MEDLINE
أسماء مطبوعة: Publication: Oxford : Wiley-Blackwell
Original Publication: Oxford : Blackwell Scientific Publications
مواضيع طبية MeSH: Hematopoietic Stem Cell Transplantation*, Antineoplastic Combined Chemotherapy Protocols/*therapeutic use , Bortezomib/*therapeutic use , Lymphoma, Mantle-Cell/*drug therapy, Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Carmustine/administration & dosage ; Combined Modality Therapy ; Cyclophosphamide/administration & dosage ; Cytarabine/administration & dosage ; Disease-Free Survival ; Doxorubicin/administration & dosage ; Etoposide/administration & dosage ; Female ; Follow-Up Studies ; Humans ; Kaplan-Meier Estimate ; Lymphoma, Mantle-Cell/therapy ; Male ; Melphalan/administration & dosage ; Middle Aged ; Netherlands ; Prednisone/administration & dosage ; Progression-Free Survival ; Remission Induction ; Rituximab/administration & dosage ; Transplantation, Autologous ; Treatment Failure ; Vincristine/administration & dosage ; Young Adult
مستخلص: Rituximab-containing induction followed by autologous stem cell transplantation (ASCT) is the standard first-line treatment for young mantle cell lymphoma patients. However, most patients relapse after ASCT. We investigated in a randomised phase II study the outcome of a chemo-immuno regimen and ASCT with or without maintenance therapy with bortezomib. Induction consisted of three cycles R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone), two cycles high-dose cytarabine, BEAM (carmustine, etoposide, cytarabine, melphalan) and ASCT. Patients responding were randomised between bortezomib maintenance (1·3 mg/m 2 intravenously once every 2 weeks, for 2 years) and observation. Of 135 eligible patients, 115 (85%) proceeded to ASCT, 60 (44%) were randomised. With a median follow-up of 77·5 months for patients still alive, 5-year event-free survival (EFS) was 51% (95% CI 42-59%); 5-year overall survival (OS) was 73% (95% CI 65-80%). The median follow-up of randomised patients still alive was 71·5 months. Patients with bortezomib maintenance had a 5-year EFS of 63% (95% CI 44-78%) and 5-year OS of 90% (95% CI 72-97%). The patients randomised to observation had 5-year PFS of 60% (95% CI, 40-75%) and OS of 90% (95% CI 72-97%). In conclusion, in this phase II study we found no indication of a positive effect of bortezomib maintenance after ASCT.
(© 2020 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.)
References: Blood. 2008 Jan 15;111(2):558-65. (PMID: 17962512)
N Engl J Med. 2017 Sep 28;377(13):1250-1260. (PMID: 28953447)
Br J Haematol. 2009 Feb;144(4):524-30. (PMID: 19036081)
Br J Haematol. 2012 Aug;158(3):355-62. (PMID: 22640180)
Lancet. 2016 Aug 6;388(10044):565-75. (PMID: 27313086)
Hematol Oncol. 2013 Dec;31(4):179-82. (PMID: 23108928)
Blood. 2012 Mar 22;119(12):2764-7. (PMID: 22323483)
N Engl J Med. 2012 Aug 9;367(6):520-31. (PMID: 22873532)
J Clin Oncol. 1999 Apr;17(4):1244. (PMID: 10561185)
J Clin Oncol. 2006 Oct 20;24(30):4867-74. (PMID: 17001068)
Blood. 2008 Oct 1;112(7):2687-93. (PMID: 18625886)
Leukemia. 2016 Jun;30(6):1428-30. (PMID: 26598017)
Clin Cancer Res. 2007 Sep 15;13(18 Pt 1):5291-4. (PMID: 17875757)
Ann Oncol. 2009 Mar;20(3):520-5. (PMID: 19074748)
J Clin Oncol. 2009 Sep 10;27(26):4365-70. (PMID: 19652064)
Ann Oncol. 2017 Jul 1;28(suppl_4):iv62-iv71. (PMID: 28881919)
معلومات مُعتمدة: CKTO 2006-07 KWF Kankerbestrijding; Janssen Pharmaceuticals
فهرسة مساهمة: Keywords: Mantle cell lymphoma; bortezomib; cytarabine; maintenance therapy; phase II trial; randomised
المشرفين على المادة: 04079A1RDZ (Cytarabine)
4F4X42SYQ6 (Rituximab)
5J49Q6B70F (Vincristine)
69G8BD63PP (Bortezomib)
6PLQ3CP4P3 (Etoposide)
80168379AG (Doxorubicin)
8N3DW7272P (Cyclophosphamide)
Q41OR9510P (Melphalan)
U68WG3173Y (Carmustine)
VB0R961HZT (Prednisone)
SCR Protocol: BEAM regimen; CHOP protocol
تواريخ الأحداث: Date Created: 20200310 Date Completed: 20210303 Latest Revision: 20240801
رمز التحديث: 20240801
مُعرف محوري في PubMed: PMC7496560
DOI: 10.1111/bjh.16567
PMID: 32150297
قاعدة البيانات: MEDLINE
الوصف
تدمد:1365-2141
DOI:10.1111/bjh.16567