ISSN (print) 1997-6933     ISSN (online) 2500-2139
Vol. 15 No. 1 (2022), LYMPHOID TUMORS
Vol. 15 No. 1 (2022)
LYMPHOID TUMORS

The Efficacy of Brentuximab Vedotin in Relapsed/Refractory Classical Hodgkin’s Lymphoma and Quality of Life: Results of a Multi-Center Observational Prospective Study in the Context of Real Clinical Practice

Published 01.01.2022
T.I. Ionova
Multinational Center for Quality of Life Research, 1 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014; NI Pirogov Clinic for High Medical Technology, Saint Petersburg State University, 154 Fontanki emb., Saint Petersburg, Russian Federation, 198103
A.A. Amdiev
VM Efetov Crimea Republican Clinical Oncology Dispensary, 49A Bespalova str., Simferopol, Russian Federation, 295007
M.I. Andrievskikh
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine, 42 Blyukhera str., Chelyabinsk, Russian Federation, 454087
E.A. Baryakh
Municipal Clinical Hospital No. 52, 5 Marshala Katukova str., Moscow, Russian Federation, 123181
E.V. Vasilev
Krasnoyarsk Krai Clinical Hospital, 3A Partizana Zheleznyaka str., Krasnoyarsk, Russian Federation, 660022
M.V. Volkov
Primorsky Krai Oncology Dispensary, 59 Russkaya str., Vladivistok, Russian Federation, 690105
E.M. Volodicheva
Tula Regional Clinical Hospital, 1A bld. 1 Yablochkova str., Tula, Russian Federation, 300053
V.V. Ivanov
VA Almazov National Medical Research Center, 2 Akkuratova str., Saint Petersburg, Russian Federation, 197341
O.V. Kaverina
Altai Krai Oncology Dispensary, 110 Zmeinogorskii passage, Barnaul, Russian Federation, 656045
K.D. Kaplanov
SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284
T.Yu. Klitochenko
Volgograd Regional Clinical Oncology Dispensary, 78 Zemlyachki str., Volgograd, Russian Federation, 400138
V.I. Kurakin
Clinical Oncology Dispensary, 9 bld. 1 Zavertyaeva str., Omsk, Russian Federation, 644013
D.G. Lazareva
Altai Krai Oncology Dispensary, 110 Zmeinogorskii passage, Barnaul, Russian Federation, 656045
O.G. Larionova
Primorsky Krai Oncology Dispensary, 59 Russkaya str., Vladivistok, Russian Federation, 690105
K.V. Lepik
RM Gorbacheva Scientific Research Institute of Pediatric Oncology, Hematology and Transplantation; IP Pavlov First Saint Petersburg State Medical University, 6/8 L’va Tolstogo str., Saint Petersburg, Russian Federation, 197022
I.B. Lysenko
National Medical Cancer Research Center, 63 bld. 8 14th line str., Rostov-on-Don, Russian Federation, 344037
V.Ya. Melnichenko
NI Pirogov Russian National Medical Center of Surgery, 70 Nizhnyaya Pervomaiskaya str., Moscow, Russian Federation, 105203
R.I. Minullina
Tatarstan Republican Clinical Oncology Dispensary, 29 bld. A Sibirskii passage, Kazan, Russian Federation, 420029
O.V. Mironov
Tambov Regional Clinical Oncology Dispensary, 29B Moskovskaya str., Tambov, Russian Federation, 392000
E.N. Misyurina
Municipal Clinical Hospital No. 52, 5 Marshala Katukova str., Moscow, Russian Federation, 123181
N.B. Mikhailova
RM Gorbacheva Scientific Research Institute of Pediatric Oncology, Hematology and Transplantation; IP Pavlov First Saint Petersburg State Medical University, 6/8 L’va Tolstogo str., Saint Petersburg, Russian Federation, 197022
N.E. Mochkin
NI Pirogov Russian National Medical Center of Surgery, 70 Nizhnyaya Pervomaiskaya str., Moscow, Russian Federation, 105203
Tatyana Pavlovna Nikitina
Multinational Center for Quality of Life Research, 1 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014; NI Pirogov Clinic for High Medical Technology, Saint Petersburg State University, 154 Fontanki emb., Saint Petersburg, Russian Federation, 198103
T.S. Petrova
Tatarstan Republican Clinical Oncology Dispensary, 29 bld. A Sibirskii passage, Kazan, Russian Federation, 420029
N.M. Porfireva
Multinational Center for Quality of Life Research, 1 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014
O.A. Rukavitsyn
NN Burdenko Central Military Clinical Hospital, 3 Gospital’naya sq., Moscow, Russian Federation, 105229
A.A. Samoilova
NI Pirogov Russian National Medical Center of Surgery, 70 Nizhnyaya Pervomaiskaya str., Moscow, Russian Federation, 105203
R.N. Safin
Tatarstan Republican Clinical Oncology Dispensary, 29 bld. A Sibirskii passage, Kazan, Russian Federation, 420029
P.I. Simashova
NN Burdenko Central Military Clinical Hospital, 3 Gospital’naya sq., Moscow, Russian Federation, 105229
E.G. Smirnova
NI Pirogov Russian National Medical Center of Surgery, 70 Nizhnyaya Pervomaiskaya str., Moscow, Russian Federation, 105203
N.A. Trenina
Clinical Oncology Dispensary, 9 bld. 1 Zavertyaeva str., Omsk, Russian Federation, 644013
N.V. Fadeeva
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine, 42 Blyukhera str., Chelyabinsk, Russian Federation, 454087
G.N. Khusainova
Tatarstan Republican Clinical Oncology Dispensary, 29 bld. A Sibirskii passage, Kazan, Russian Federation, 420029
V.L. Chang
Tambov Regional Clinical Oncology Dispensary, 29B Moskovskaya str., Tambov, Russian Federation, 392000
T.V. Shelekhova
VI Razumovskii Saratov State Medical University, 6/9 53rd Strelkovoi Divizii str., Saratov, Russian Federation, 410028
D.G. Sherstnev
VI Razumovskii Saratov State Medical University, 6/9 53rd Strelkovoi Divizii str., Saratov, Russian Federation, 410028
PDF_2022-15-1-42-53 (Russian)

Keywords

classical Hodgkin’s lymphoma
relapsed/refractory form
brentuximab vedotin
quality of life
real clinical practice

How to Cite

Ionova T.I., Amdiev A.A., Andrievskikh M.I., Baryakh E.A., Vasilev E.V., Volkov M.V., Volodicheva E.M., Ivanov V.V., Kaverina O.V., Kaplanov K.D., Klitochenko T.Y., Kurakin V.I., Lazareva D.G., Larionova O.G., Lepik K.V., Lysenko I.B., Melnichenko V.Y., Minullina R.I., Mironov O.V., Misyurina E.N., Mikhailova N.B., Mochkin N.E., Nikitina T.P., Petrova T.S., Porfireva N.M., Rukavitsyn O.A., Samoilova A.A., Safin R.N., Simashova P.I., Smirnova E.G., Trenina N.A., Fadeeva N.V., Khusainova G.N., Chang V.L., Shelekhova T.V., Sherstnev D.G. The Efficacy of Brentuximab Vedotin in Relapsed/Refractory Classical Hodgkin’s Lymphoma and Quality of Life: Results of a Multi-Center Observational Prospective Study in the Context of Real Clinical Practice. Clinical Oncohematology. 2022;(1):42–53. doi:10.21320/2500-2139-2022-15-1-42-53.
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Abstract

Aim. To study the quality of life and symptoms, to assess the clinical effect and treatment safety in relapsed/refractory classical Hodgkin’s lymphoma (r/r cHL) patients treated with brentuximab vedotin (BV) as ≥ 3rd-line therapy in the context of real clinical practice.

Materials & Methods. The study enrolled 62 r/r cHL patients after the second- and subsequent-line chemotherapies, who are either ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) at the time of their enrollment into the study or after the failure of high-dose chemotherapy (HDCT) with auto-HSCT. The median age was 31 years; 46.8 % of patients were women. The patients received BV 1.8 mg/kg intravenously every 3 weeks. Clinical parameters, quality of life, and symptoms were assessed prior to BV therapy and in 3, 6, 9, 12, and 15 months after therapy onset. The RAND SF-36 form was used to assess the quality of life, and the ESAS-R tool was applied to report on symptoms.

Results. Objective response was observed in 68.3 % of patients, 40 % out of them showed complete response. The median progression-free survival was 10.6 months (95% confidence interval 7.4–12.9 months). Safety profile corresponded to the published data. Adverse events of grade 3/4 were identified in 1.6 % of patients. In the period of 15 months after therapy onset, quality of life improvement or stabilization was reported based on all the scales of RAND SF-36 (GEE, p < 0.001), and symptom abatement was proved based on ESAS-R total score (GEE, p < 0.001).

Conclusion. In the context of real clinical practice, BV appeared to be effective in r/r cHL patients either after the second- or subsequent-line chemotherapies or after the failure of HDCT with auto-HSCT. The study demonstrated that BV was well tolerated by the patients. BV therapy contributes to the improvement of r/r cHL patients’ quality of life. Positive changes in quality of life and symptoms on BV therapy testify to its patient-assessed efficacy.

PDF_2022-15-1-42-53 (Russian)

References

  1. Демина Е.А. Руководство по лечению лимфомы Ходжкина. М.: Ремедиум, 2018. 72 с.
  2. [Demina EA. Rukovodstvo po lecheniyu limfomy Khodzhkina. (Guidelines for the treatment of Hodgkin’s lymphoma.) Moscow: Remedium Publ.; 2018. 72 p. (In Russ)]
  3. Engert A, Younes A. Hematologic malignancies: Hodgkin lymphoma (2nd ed.). A Comprehensive Update on Diagnostics and Clinics. Berlin Heidelberg: Springer; 2015. 437 p. doi: 10.1007/978-3-319-12505-3.
  4. Canellos G, Anderson J, Propert K, et al. Chemotherapy of Advanced Hodgkin’s Disease with MOPP, ABVD, or MOPP Alternating with ABVD. N Engl J Med. 1992;327(21):1478–84. doi: 10.1056/nejm199211193272102.
  5. Rancea M, Monsef I, von Tresckow B, et al. High-dose chemotherapy followed by autologous stem cell transplantation for patients with relapsed/refractory Hodgkin lymphoma. Cochrane Database Syst Rev. 2013;(6):CD009411. doi: 10.1002/14651858.CD009411.pub2.
  6. Демина Е.А. Брентуксимаб ведотин: новые возможности лечения рецидивов и рефрактерных форм лимфомы Ходжкина. Клиническая онкогематология. 2016;9(4):398–405. doi: 10.21320/2500-2139-2016-9-4-398-405.
  7. [Demina EA. Brentuximab Vedotin: New Possibilities for Treatment of Relapses and Refractory Hodgkin’s Lymphomas. Clinical oncohematology. 2016;9(4):398–405. doi: 10.21320/2500-2139-2016-9-4-398-405. (In Russ)]
  8. Yi J, Kim S, Kim W. Brentuximab vedotin: clinical updates and practical guidance. Blood Res. 2017;52(4):243–53. doi: 10.5045/br.2017.52.4.243.
  9. Gravanis I, Tzogani K, Hennik P, et al. The European Medicines Agency Review of Brentuximab Vedotin (Adcetris) for the Treatment of Adult Patients With Relapsed or Refractory CD30+ Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use. 2015;21(1):102–9. doi: 10.1634/theoncologist.2015-0276.
  10. Younes A, Bartlett N, Leonard J, et al. Brentuximab Vedotin (SGN-35) for Relapsed CD30-Positive Lymphomas. N Engl J Med. 2010;363(19):1812–21. doi: 10.1056/nejmoa1002965.
  11. 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):2183–9. doi: 10.1200/JCO.2011.38.0410.
  12. Forero‐Torres A, Fanale M, Advani R, et al. Brentuximab Vedotin in Transplant‐Naive Patients with Relapsed or Refractory Hodgkin Lymphoma: Analysis of Two Phase I Studies. Oncologist. 2012;17(8):1073–80. doi: 10.1634/theoncologist.2012-0133.
  13. Chen R, Gopal A, Smith S, et al. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. 2016;128(12):1562–6. doi: 10.1182/blood-2016-02-699850.
  14. Zinzani P, Corradini P, Gianni A, et al. Brentuximab Vedotin in CD30-Positive Lymphomas: A SIE, SIES, and GITMO Position Paper. Clin Lymphoma Myeloma Leuk. 2015;15(9):507–13. doi: 10.1016/j.clml.2015.06.008.
  15. Rothe A, Sasse S, Goergen H, et al. Brentuximab vedotin for relapsed or refractory CD30+ hematologic malignancies: the German Hodgkin Study Group experience. 2012;120(7):1470–2. doi: 10.1182/blood-2012-05-430918.
  16. Gibb A, Jones C, Bloor A, et al. Brentuximab vedotin in refractory CD30+ lymphomas: a bridge to allogeneic transplantation in approximately one quarter of patients treated on a Named Patient Programme at a single UK center. 2012;98(4):611–4. doi: 10.3324/haematol.2012.069393.
  17. Perrot A, Monjanel H, Bouabdallah R, et al. Brentuximab vedotin as single agent in refractory or relapsed CD30-positive Hodgkin lymphoma: the French name patient program experience in 241 patients. 2014;99(1):498.
  18. Zinzani P, Viviani S, Anastasia A, et al. Brentuximab vedotin in relapsed/refractory Hodgkin’s lymphoma: the Italian experience and results of its use in daily clinical practice outside clinical trials. 2013;98(8):1232–6. doi: 10.3324/haematol.2012.083048.
  19. Linendoll N, Saunders T, Burns R, et al. Health-related quality of life in Hodgkin lymphoma: a systematic review. Health Qual Life Outcomes. 2016;14(1):114. doi: 10.1186/s12955-016-0515-6.
  20. Kreissl S, Muller H, Goergen H, et al. Health-Related Quality of Life in Patients With Hodgkin Lymphoma: A Longitudinal Analysis of the German Hodgkin Study Group. J Clin Oncol. 2020;38(25):2839–48. doi: 10.1200/jco.19.03160.
  21. Parsons S. Longitudinal Assessment of Health-Related Quality of Life Among Survivors of Hodgkin Lymphoma: It Is About Time! J Clin Oncol. 2020;38(25):2821–3. doi: 10.1200/jco.20.01585.
  22. Pophali P, Larson M, Rosenthal A, et al. The association of health behaviors with quality of life in lymphoma survivors. Leuk Lymphoma. 2020;62(2):271–80. doi: 10.1080/10428194.2020.1830389.
  23. Novik A, Salek S, Ionova T. Guidelines. Patient-reported outcomes in. Genoa: Forum service editore, 2012. Available from: https://ehaweb.org/assets/Uploads/EHA-Guideline-libro.pdf (accessed 24.06.2021).
  24. Chen R, Bartlett N, Brice P, et al. Patient-reported outcomes of brentuximab vedotin in Hodgkin lymphoma and anaplastic large-cell lymphoma. Onco Targets Ther. 2016;9:2027–34. doi: 10.2147/ott.s96175.
  25. Ramsey S, Nademanee A, Masszi T, et al. Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma. Br J Haematol. 2016;175(5):860–7. doi: 10.1111/bjh.14316.
  26. Parker C, Woods B, Eaton J, et al. Brentuximab vedotin in relapsed/refractory Hodgkin lymphoma post-autologous stem cell transplant: a cost-effectiveness analysis in Scotland. J Med Econ. 2016;20(1):8–18. doi: 10.1080/13696998.2016.1219358.
  27. Eisenhauer E, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–47. doi: 10.1016/j.ejca.2008.10.026.
  28. Moghbel M, Kostakoglu L, Zukotynski K, et al. Response Assessment Criteria and Their Applications in Lymphoma: Part 1. J Nucl Med. 2016;57(6):928–35. doi: 10.2967/jnumed.115.166280.
  29. Common Terminology Criteria for Adverse Evens (CTCAE 4) Version 4.0. Available from: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/Archive/CTCAE_4.0_2009-05-29_QuickReference_8.5х11.pdf (accessed 24.06.2021).
  30. Charlson M, Pompei P, Ales K, MacKenzie C. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–83. doi: 10.1016/0021-9681(87)90171-8.
  31. Hays RD, Sherbourne CD, Mazel RM. User’s Manual for Medical Outcomes Study (MOS) Core measures of health-related quality of life. RAND Corporation, 1995. Available from: www.rand.org (accessed 24.06.2021).
  32. Mols F, Aaronson N, Vingerhoets A, et al. Quality of life among long-term non-Hodgkin lymphoma survivors. 2007;109(8):1659–67. doi: 10.1002/cncr.22581.
  33. Новик А.А., Ионова Т.И., Гандек Б. и др. Показатели качества жизни населения Санкт-Петербурга. Проблемы стандартизации в здравоохранении. 2003;8:14–26.
  34. [Novik AA, Ionova TI, Gandek B, et al. Quality of life indicators for Saint Petersburg citizens. Problemy standartizatsii v zdravookhranenii. 2003;8:14–26. (In Russ)]
  35. Bruera E, Kuehn N, Miller M, et al. The Edmonton Symptom Assessment System (ESAS): A Simple Method for the Assessment of Palliative Care Patients. J Palliat Care. 1991;7(2):6–9. doi: 10.1177/082585979100700202.
  36. Chen R, Gopal AK, Smith SE, et al. Five-Year Survival Data Demonstrating Durable Responses From a Pivotal Phase 2 Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma. Clin Adv Hematol Oncol. 2016;4(2 Suppl 1):6.
  37. Gopal A, Chen R, Smith S, et al. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. 2015;125(8):1236–43. doi: 10.1182/blood-2014-08-595801.
  38. Kuruvilla J, Ramchandren R, Santoro A, et al. Pembrolizumab versus brentuximab vedotin in relapsed or refractory classical Hodgkin lymphoma (KEYNOTE-204): an interim analysis of a multicentre, randomised, open-label, phase 3 study. Lancet Oncol. 2021;22(4):512–24. doi: 10.1016/s1470-2045(21)00005-x.
  39. 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. 2016;21(12):1436–41. doi: 10.1634/theoncologist.2016-0112.
  40. Donato E, Fernandez-Zarzoso M, Hueso J, de la Rubia J. Brentuximab vedotin in Hodgkin lymphoma and anaplastic large-cell lymphoma: an evidence-based review. Onco Targets Ther. 2018;11:4583–90. doi: 10.2147/ott.s141053.
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