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

Author:

Ionova T.I.12,Amdiev A.A.3,Andrievskikh M.I.4,Baryakh E.A.5,Vasil’ev E.V.6,Volkov M.V.7,Volodicheva E.M.8,Ivanov V.V.9,Kaverina O.V.10,Kaplanov K.D.11,Klitochenko T.Yu.12,Kurakin V.I.13,Lazareva D.G.10,Larionova O.G.7,Lepik K.V.14,Lysenko I.B.15ORCID,Melnichenko V.Ya.16,Minullina R.I.17,Mironov O.V.18,Misyurina E.N.5,Mikhailova N.B.14ORCID,Mochkin N.E.16,Nikitina Tatyana Pavlovna12ORCID,Petrova T.S.17,Porfirieva N.M.1,Rukavitsyn O.A.19,Samoilova A.A.16,Safin R.N.17,Simashova P.I.19,Smirnova E.G.16,Trenina N.A.1313,Fadeeva N.V.4,Khusainova G.N.17,Chang V.L.18,Shelekhova T.V.20,Sherstnev D.G.20

Affiliation:

1. Multinational Center for Quality of Life Research

2. Saint Petersburg State University Hospital

3. VM Efetov Crimea Republican Clinical Oncology Dispensary

4. Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

5. Municipal Clinical Hospital No. 52

6. Krasnoyarsk Krai Clinical Hospital

7. Primorsky Krai Oncology Dispensary

8. Tula Regional Clinical Hospital

9. VA Almazov National Medical Research Center

10. Altai Krai Oncology Dispensary

11. SP Botkin City Clinical Hospital

12. Volgograd Regional Clinical Oncology Dispensary

13. Clinical Oncology Dispensary, Omsk

14. RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University

15. National Medical Research Center for Oncology

16. NI Pirogov National Medical and Surgical Center

17. Tatarstan Republican Clinical Oncology Dispensary

18. Tambov Regional Clinical Oncology Dispensary

19. NN Burdenko Main Military Clinical Hospital

20. VI Razumovskii Saratov State Medical University

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 relief was shown 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 and safety.

Publisher

Practical Medicine Publishing House

Subject

Oncology,Hematology

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