ISSN 1866-8836
Клеточная терапия и трансплантация

Quality of life and clinical response to brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma (RR HL) in the real-world setting

Tatyana I. Ionova1, Boris V. Afanasyev2, Alim A. Amdiev3, Maria I. Andrievskikh4, Elena A. Baryakh5, Eugeniy V. Vasiliev6, Mikhail V. Volkov7, Elena M. Volodicheva8, Vladimir V. Ivanov9, Oksana V. Kaverina10, Kamil D. Kaplanov11, Maria Ya. Kiseleva3, Tatiana Yu. Klitochenko11, Vyacheslav I. Kurakin12, Daria G. Lazareva10, Olga G. Larionova7, Kirill V. Lepik2, Irina B. Lysenko13, Raisa I. Minullina14, Oleg V. Mironov15, Elena N. Misyurina5, Natalia B. Mikhailova2, Nikita Eu. Mochkin16, Tatiana P. Nikitina1, Yuriy S. Osipov9, Tatiana S. Petrova14, Natalia M. Porfirieva1, Oleg A. Rykavitcin17, Rustem N. Safin14, Polina I. Simashova17, Elena G. Smirnova16, Natalia A. Trenina12, Natalia V. Fadeeva4, Gulnara N. Husainova14, Victor L. Chang15, Tatiana V. Shelekhova18, Dmitriy G. Sherstnev18

1 Multinational Center for Quality of Life Research, St. Petersburg, Russia
2 Raisa Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, St. Petersburg, Russia
3 V. M. Efetov Crimean Republican Oncology Center, Simferopol, Russia
4 Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine, Chelyabinsk, Russia
5 City Clinical Hospital №52, Moscow, Russia
6 Regional Clinical Hospital, Krasnoyarsk, Russia
7 Primorskiy Regional Oncologic Center, Vladivostok, Russia
8 Tula Regional Clinical Hospital, Tula, Russia
9 Almazov National Medical Research Centre, Saint-Petersburg, Russia
10 Altai Regional Oncology Center, Barnaul, Russia
11 Volgograd Regional Clinical Oncological Center, Volgograd, Russia
12 Clinical Onclological Center, Omsk, Russia
13 Rostov Research Institute of Oncology, Rostov-on-Don, Russia
14 Republican Clinical Oncology Center of the Ministry of Health of the Republic of Tatarstan, Kazan, Russia
15 Tambov Regional Oncological Clinical Center, Tambov, Russia
16 N. I. Pirogov National Medical Surgical Center, Moscow, Russia
17 N. N. Burdenko Principal Military Clinical Hospital, Moscow, Russia
18 Department of Occupational Pathology, Hematology and Clinical Pharmacology, V. I. Rasymovsky Saratov State Medical University, Saratov, Russia


Contacts: Dr. Tatyana I. Ionova
E-mail: tion16@mail.ru

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Cellular Therapy and Transplantation (CTT)
Volume 8, number 3
Contents 

Summary

There is a continued unmet medical need in pts with relapsed/refractory Hodgkin’s lymphoma (RR HL). There are data available indicating that brentuximab vedotin (BV) has proven effectiveness and safety and brings considerable promise for the treatment of pts with RR HL. Information about BV treatment effectiveness and tolerability both from physician’s and patient’s perspective is worthwhile in this difficult patient population. We aimed to evaluate clinical and patient-reported outcomes in RR HL patients receiving BV as >2nd treatment line in the real world setting.

Patients and methods

Pts with RR HL who received BV 1.8 mg/kg q3w were included in the multicenter observational real-world study. Treatment response was assessed using RECIST criteria v. 1.0. Adverse events (AEs) were assessed in accordance with NCI CTCAE v. 4. For QoL assessment pts filled out RAND SF-36, for symptom assessment – ESAS-R questionnaire before BV treatment start and in 3 mos after; also pts filled out PGIC scale for self-assessment of changes in their health in 3 mos after BV treatment start. For QoL analysis paired t-test, Wilcoxon test and χ2 were used.

Results

The analysis was performed in the group of 55 pts RR HL (median age – 28 years, range 18-67, 54.5% males) who were involved in the study: 63.6% pts had advanced stage (III–IV) at diagnosis; 58.2% pts had Bsymptoms; 81.8% pts – ECOG 0-1. All the pts received a median of 3 previous treatment lines (2-10); half of pts were primary chemotherapy-resistant (49%); 25.5% pts failed to ASCT in the past. Before BV treatment start QoL was dramatically worsened, the most QoL impairment was revealed for role functioning, vitality and general health (Means: 33-48 scores out from 100 scores). All the pts experienced symptoms, 83.3% pts had moderate-to-severe symptoms (≥4 scores out from 10 scores). More than half pts had moderate-to-severe tiredness, drowsiness, lack of appetite, depression and worsened wellbeing before BV treatment start. After 3 mos of BV treatment objective response was registered in 55% pts with 27.5% complete response. Adverse events of grade I-II were reported in 8 pts (20%) and were consistent with known toxicities. In 3 mos after BV treatment start meaningful QoL Improvement and symptom decrease were revealed. Significant QoL improvement was observed for all SF-36 scales (p<0.05) excluding mental health. Integral QoL Index significantly increased at 3 mos after treatment start as compared to baseline: 0.260 at baseline vs 0.390 at 3 mos (p<0.001). QoL response to treatment in terms of stabilization or improvement was registered in 85% pts; in 50% pts the twice increase of Integral QoL Index was registered. The most pronounced meaningful improvement was revealed for role functioning scales (Δ>20.0). The severity of the vast majority of symptoms excluding depression significantly decreased during 3 mos of treatment (p<0.05). Total Symptom Score by ESAS-R significantly decreased at 3 mos after BV treatment start (35.8 vs 25.4, p<0.05). In 3 mo after BV treatment start the vast majority of pts (90%) noted the improvement of their health according to PGIC.

Conclusion

The first results obtained in this study demonstrate notable effectiveness and safety of BV as a treatment modality for RR HL in a real world setting. BV treatment was accompanied with QoL response in terms of QoL stabilization/improvement and significant decrease of symptom burden in the majority of pts already in 3 mos after the treatment was started.

Keywords

Relapsed/refractory Hodgkin lymphoma, brentuximab vedotin, quality of life, clinical response, real world setting.


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