medigraphic.com

2020, Number 4

Next >>

Rev Hematol Mex 2020; 21 (4)

Administration of brentuximab vedotin in the real world in the classic Hodgkin lymphoma and systemic anaplastic large cell lymphoma in Argentina

Miodosky M, Cruset S, Beligoy LE, Freitas MJ, García-Lombardi M, Alfonso G, Cerutti A, Cordini G, De Stefano G, Gil M, Gómez S, Marull M, Zabaljauregui S, Agra M, Basso A, Beccacece M, Canosa V, Cugliari S, Devecchi C, Fragapane P, Funes ME, Gabriel A, Garate G, Giannini ME, Giordano L; Godoy MV, Golubizky V, Guanchiale L, Jarchum S, Mari LS, Márquez M, Nieto R, Noviello V, Plaza I, Premoli MS, Rodríguez A, Shanley C, Stemmelin G, Stivel M, Streitenberger D, Sturich AG, Ventriglia MV, Verón D, Viudez ML, Lis C, Rodger J, Hovsepian E, Bordone J

Language: Spanish
References: 31
Page: 179-194
PDF size: 432.74 Kb.


ABSTRACT

Background: Brentuximab vedotin is a novel therapeutic option in the management of CD30+ Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
Objective: To evaluate response criteria and adverse events at three and six months after treatment initiation with brentuximab vedotin as a therapy for classic Hodgkin lymphoma and systemic anaplastic large cell lymphoma in Argentina.
Material and Method: Observational, multicenter, retrospective analysis as part of a Post-marketing Clinical Efficacy and Safety Monitoring Plan.
Results: Our study included 89 classic Hodgkin lymphoma and 5 systemic anaplastic large cell lymphoma patients with relapsed or refractory (R/R) disease. Data were available from 71 (median: 3 brentuximab vedotin cycles, overall response rate [ORR]: 78%, complete remission [CR]: 37%) and 51 (cumulative median: 6 brentuximab vedotin cycles, ORR: 74.5%, CR: 45%) patients with Hodgkin lymphoma at 3 and 6 months, respectively. Overall, treatment with brentuximab vedotin was well tolerated.
Conclusiones: The use of brentuximab vedotin can lead to favorable responses in classic Hodgkin lymphoma and systemic anaplastic large cell lymphoma patients with relapsed or refractory disease and thus allow those with chemo-resistant lymphoma to proceed to therapy such as auto-SCT or allogenic transplantation.


REFERENCES

  1. Jiang M, Bennani NN, Feldman AL. Lymphoma classification update: T-cell lymphomas, Hodgkin lymphomas, and histiocytic/ dendritic cell neoplasms. Expert Rev Hematol 2017; 10 (3): 239‐249. doi: 10.1080/17474086.2017.1281122

  2. Diefenbach CS, Connors JM, Friedberg JW, et al. Hodgkin lymphoma: Current status and clinical trial recommendations. JNCI J Natl Cancer Inst 2017; 109 (4): djw249. doi: 10.1093/jnci/djw249

  3. Borchmann P, Goergen H, Kobe C, et al. PET-guided treatment in patients with advanced-stage Hodgkin's lymphoma (HD18): final results of an open-label, international, randomised phase 3 trial by the German Hodgkin Study Group. Lancet 2018; 390 (10114): 2790-2802. doi: 10.1016/S0140-6736(17)32134-7

  4. Schmitz N, Pfistner B, Sextro M, et al. Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin’s disease: a randomised trial. Lancet 2002; 359: 2065-71. doi: 10.1016/S0140-6736(02)08938-9

  5. Sureda A, Constans M, Iriondo A, et al. Prognostic factors affecting long-term outcome after stem cell transplantation in Hodgkin’s lymphoma autografted after a first relapse. Ann Oncol 2005; 16: 625-633. doi: 10.1093/ annonc/mdi119

  6. Spaepen K, Stroobants S, Dupont P, et al. Prognostic value of pretransplantation positron emission tomography using fluorine 18-fluorodeoxyglucose in patients with aggressive lymphoma treated with high-dose chemotherapy and stem cell transplantation. Blood 2003; 102 (1): 53-9. doi: 10.1182/blood-2002-12-3842

  7. Mehrzad V, Ashrafi F, Farrashi AR, et al. Comparison of ifosfamide, carboplatin and etoposide versus etoposide, steroid, and cytarabine cisplatin as salvage chemotherapy in patients with refractory or relapsed Hodgkin’s lymphoma. Adv Biomed Res 2017; 6: 30. DOI: 10.4103/2277- 9175.201687

  8. Crump M. Management of Hodgkin lymphoma in relapse after autologous stem cell transplant. Hematology 2008; 1: 326-33. doi: 10.1182/asheducation-2008.1.326

  9. Kewalramani T, Nimer SD, Zelenetz AD, et al. Progressive disease following autologous transplantation in patients with chemosensitive relapsed or primary refractory Hodgkin’s disease or aggressive non-Hodgkin’s lymphoma. Bone Marrow Transplantation 2003; 32: 673-679. doi: 10.1038/ sj.bmt.1704214

  10. Connors JM, Gerrie AS, Power MM, et al. Outcome of Hodgkin lymphoma after progression following autologous stem cell transplantation. Blood 2016; 128: 2994. https:// doi.org/10.1182/blood.V128.22.2994.2994

  11. Swerdlow SH, Campo E, Pileri SA, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood 2016; 127 (20): 2375-2390. https://doi. org/10.1182/blood-2016-01-643569

  12. Sibon D, Fournier M, Brière J, et al. Long-term outcome of adults with systemic anaplastic large-cell lymphoma treated within the Groupe d’Etude des Lymphomes de l’Adulte Trials. J Clin Oncol 2012; 30: 3939-3946. doi: 10.1200/JCO.2012.42.2345

  13. Savage KJ, Harris NL, Vose JM, et al. ALK- anaplastic largecell lymphoma is clinically and immunophenotypically different from both ALK_ALCL and peripheral T-cell lymphoma, not otherwise specified: report from the International Peripheral T-Cell Lymphoma Project. Blood 2008; 111: 5496-5504. doi: 10.1182/blood-2008-01-134270

  14. Francisco JA, Cerveny CG, Meyer DL, et al. cAC10-vcMMAE, an anti-CD30–monomethyl auristatin E conjugate with potent and selective antitumor activity. Blood 2003; 102: 1458-1465. doi: 10.1182/blood-2003-01-0039

  15. Younes A, Gopal AK, Smith SE, et al. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin’s lymphoma. J Clin Oncol 2012; 30 (18): 2183-2189. doi: 10.1200/JCO.2011.38.0410

  16. Chen R, Gopal AK, Smith SE, et al. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood 2016; 128: 1562-1566. doi: 10.1182/blood-2016-02-699850

  17. Gandolfi L, Pellegrini C, Casadei B, et al. Long-term responders after brentuximab vedotin: single-center experience on relapsed and refractory Hodgkin lymphoma and anaplastic large cell lymphoma patients. Oncologist 2016; 21 (12): 1436-1441. doi: 10.1634/theoncologist.2016-0112

  18. Pro B, Advani R, Brice P, et al. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol 2012; 30: 2190-2196. doi: 10.1200/ JCO.2011.38.0402

  19. Pro B, Advani R, Brice P, et al. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood 2017; 130 (25): 2709-2717. doi: 10.1182/blood-2017-05-780049

  20. Adcetris (brentuximab vedotin) package insert (Jan 13, 2012). 13 January 2012; http://www.accessdata.fda.gov/ drugsatfda_docs/label/2012/125388s0005lbl.pdf. Consultado el 1 de octubre de 2017.

  21. Moskowitz CH, Nademanee A, Masszi T, et al. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin’s lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015; 385 (9980): 1853-62. doi: 10.1016/ S0140-6736(15)60165-9

  22. Disposición 8722. ANMAT. (21 de octubre de 2015) http://www.anmat.gov.ar/boletin_anmat/octubre_2015/ Dispo_8722-15.pdf. Consultada el 1 de octubre de 2017.

  23. Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007; 25 (5): 579-86. doi: 10.1200/JCO.2006.09.2403

  24. Zinzani PL, Sasse S, Radford J y col. Brentuximab vedotin in relapsed/refractory Hodgkin lymphoma: An updated review of published data from the named patient program. Crit Rev Oncol Hematol 2016; 104: 65-70. doi: 10.1016/j. critrevonc.2016.04.019

  25. Angelopoulou MK, Vassilakopoulos TP, Batsis I, et al. Brentuximab vedotin in relapsed/refractory Hodgkin lymphoma. The Hellenic experience. Hematol Oncol 2018; 36 (1): 174-181. doi: 10.1002/hon.2383

  26. Salihoglu A, Elverdi T, Karadogan I, et al. Brentuximab vedotin for relapsed or refractory Hodgkin lymphoma: experience in Turkey. Ann Hematol 2015; 94: 415-420. doi: 10.1007/s00277-014-2215-9

  27. Perrot A, Monjanel H, Bouabdallah R, et al. Impact of postbrentuximab vedotin consolidation on relapsed/refractory CD30+ Hodgkin lymphomas: a large retrospective study on 240 patients enrolled in the French Named-Patient Program. Haematologica 2016; 101 (4): 466-73. doi: 10.3324/ haematol.2015.134213

  28. Broccoli A, Pellegrini C, Di Rocco A, et al. Italian real-life experience with brentuximab vedotin: results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma. Haematologica 2017; 102 (11): 1931-1935. doi: 10.3324/haematol. 2017.171355

  29. Carson KR, Newsome SD, Kim EJ, et al. Progressive multifocal leukoencephalopathy associated with brentuximab vedotin therapy: a report of 5 cases from the Southern Network on Adverse Reactions (SONAR) project. Cancer 2014; 120 (16): 2464-71. doi: 10.1002/cncr.28712

  30. Baxley AA, Kumm DE, Bishop CB, et al. Severe infusion reactions to brentuximab vedotin in two patients with Hodgkin lymphoma previously treated with allogeneic stem cell transplantation. J Oncol Pharm Pract 2013; 19 (3): 279-83. doi: 10.1177/1078155212464021

  31. O’Connor OA, Lue JK, Sawas A, et al. Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin's lymphoma: an international, multicentre, single-arm, phase 1-2 trial. Lancet Oncol 2018; 19 (2): 257-266. doi: 10.1016/S1470-2045(17)30912-9




2020     |     www.medigraphic.com