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

AUTOIMMUNE THROMBOCYTOPENIA , ,

TI Ionova1,2, AA Amdiev3, MI Andrievskikh4, EA Baryakh5, EV Vasilev6, MV Volkov7, EM Volodicheva8, VV Ivanov9, OV Kaverina10, KD Kaplanov11, TYu Klitochenko12, VI Kurakin13, DG Lazareva10, OG Larionova7, KV Lepik14, IB Lysenko15, VYa Melnichenko16, RI Minullina17, OV Mironov18, EN Misyurina5, NB Mikhailova14, NE Mochkin16, TP Nikitina1,2, TS Petrova17, NM Porfireva1, OA Rukavitsyn19, AA Samoilova16, RN Safin17, PI Simashova19, EG Smirnova16, NA Trenina13, NV Fadeeva4, GN Khusainova17, VL Chang18, TV Shelekhova20, DG Sherstnev20

1 Multinational Center for Quality of Life Research, 1 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014

2 NI Pirogov Clinic for High Medical Technology, Saint Petersburg State University, 154 Fontanki emb., Saint Petersburg, Russian Federation, 198103

3 VM Efetov Crimea Republican Clinical Oncology Dispensary, 49A Bespalova str., Simferopol, Russian Federation, 295007

4 Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine, 42 Blyukhera str., Chelyabinsk, Russian Federation, 454087

5 Municipal Clinical Hospital No. 52, 5 Marshala Katukova str., Moscow, Russian Federation, 123181

6 Krasnoyarsk Krai Clinical Hospital, 3A Partizana Zheleznyaka str., Krasnoyarsk, Russian Federation, 660022

7 Primorsky Krai Oncology Dispensary, 59 Russkaya str., Vladivistok, Russian Federation, 690105

8 Tula Regional Clinical Hospital, 1A bld. 1 Yablochkova str., Tula, Russian Federation, 300053

9 VA Almazov National Medical Research Center, 2 Akkuratova str., Saint Petersburg, Russian Federation, 197341

10 Altai Krai Oncology Dispensary, 110 Zmeinogorskii passage, Barnaul, Russian Federation, 656045

11 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284

12 Volgograd Regional Clinical Oncology Dispensary, 78 Zemlyachki str., Volgograd, Russian Federation, 400138

13 Clinical Oncology Dispensary, 9 bld. 1 Zavertyaeva str., Omsk, Russian Federation, 644013

14 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

15 National Medical Cancer Research Center, 63 bld. 8 14th line str., Rostov-on-Don, Russian Federation, 344037

16 NI Pirogov Russian National Medical Center of Surgery, 70 Nizhnyaya Pervomaiskaya str., Moscow, Russian Federation, 105203

17 Tatarstan Republican Clinical Oncology Dispensary, 29 bld. A Sibirskii passage, Kazan, Russian Federation, 420029

18 Tambov Regional Clinical Oncology Dispensary, 29B Moskovskaya str., Tambov, Russian Federation, 392000

19 NN Burdenko Central Military Clinical Hospital, 3 Gospital’naya sq., Moscow, Russian Federation, 105229

20 VI Razumovskii Saratov State Medical University, 6/9 53rd Strelkovoi Divizii str., Saratov, Russian Federation, 410028

For correspondence: Tatyana Pavlovna Nikitina, MD, PhD, 1 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014; e-mail: qolife@mail.ru

For citation: Ionova TI, Amdiev AA, Andrievskikh MI, et al. 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;15(1):42–53. (In Russ).

DOI: 10.21320/2500-2139-2022-15-1-42-53

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.

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

Received: June 29, 2021

Accepted: November 19, 2021

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