Response to Brentuximab Vedotin and Quality of Life in Patients with Relapsed/Refractory Hodgkin Lymphoma (RR HL) in the Real World Setting
| العنوان: | Response to Brentuximab Vedotin and Quality of Life in Patients with Relapsed/Refractory Hodgkin Lymphoma (RR HL) in the Real World Setting |
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| المؤلفون: | Mironov Oleg I, Elena Volodicheva, Raisa Minullina, Elena G. Smirnova, Gulnara Husainova, Tatyana Ionova, Tatiana Shelekhova, Olga Larionova, Vyacheslav Kurakin, Oksana Kaverina, Iurii Osipov, Alim Amdiev, Mikhail Yu Volkov, NE Mochkin, N. Mikhailova, V. E. Ivanov, Natalia Trenina, Dmitrij Sherstnev, Oleg Rykavitcin, Tatiana Nikitina, Polina Simashova, E A Baryakh, Viktor Chang, Kirill V. Lepik, Darya Lazareva, Boris V. Afanasiev, Evgeniy V. Vasiliev, Elena N. Misyurina, Irina Lysenko, Maria Andrievskih, K D Kaplanov, Tatiana Klitochenko, Rustem Safin, Tatiana V. Petrova, Natalia Porfirieva |
| المصدر: | Blood. 134:5296-5296 |
| بيانات النشر: | American Society of Hematology, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | medicine.medical_specialty, business.industry, Immunology, Cell Biology, Hematology, Biochemistry, Chemotherapy regimen, Quality of life, Tolerability, Refractory, Response Evaluation Criteria in Solid Tumors, Internal medicine, Medicine, business, Adverse effect, Brentuximab vedotin, Depression (differential diagnoses), medicine.drug |
| الوصف: | There is a continued unmet medical need in pts with relapsed/refractory Hodgkin's lymphoma (RR HL). Curing HL pts who have refractory disease after salvage chemotherapy, who relapse after ASCT, or those who are not candidates for ASCT, remains a clinical challenge due to limited effective treatments. There are data available indicating that brentuximab vedotin (BV) 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. Here we report the outcomes with respect to clinical response, tolerability, quality of life (QoL) and symptoms after 3 mos of BV treatment. The total number of pts to be included in the multicenter observational real-world study is 70 pts with RR HL who received BV 1.8 mg/kg q3w till disease progression, intolerance toxicity of BV or refusal. Treatment response was assessed using RECIST criteria v. 1.0. Adverse events (AEs) were assessed in accordance with NCI CTCAE v. 4.03. For QoL assessment pts filled out RAND SF-36, for symptom assessment - ESAS questionnaire; also pts filled out PGIC scale for self-assessment of changes in their health. For QoL analysis paired t-test, Mann-Whitney test, Wilcoxon test and χ2 were used. 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; ≥50% pts had B-symptoms (58.2%); 82% pts - ECOG 0-1. All the pts received a median of 3 previous treatment lines; among them 14 pts (25.5%) failed to ASCT in the past; half of pts were primary chemotherapy resistant (49%). Before BV treatment start QoL was dramatically worsened for all SF-36 scales (p70% pts) symptoms were drowsiness, tiredness, anxiety, and worse wellbeing. More than half pts had moderate-to-severe drowsiness,tiredness, depression, lack of appetite 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. Most common adverse events (≥10%) were increasing ALT and AST (each 4/8), peripheral neuropathy, fatigue, skin itch (each 3/8). Severe adverse event (III grade) not related with BV occurred in one patient (2.5%) - sepsis, respiratory insufficiency due to agranulocytosis (BV was temporary stopped). During BV treatment meaningful QoL improvement was revealed for all SF-36 scales (p20.0). The severity of the vast majority of symptoms excluding depression significantly decreased during 3 mos of treatment (p The first results obtained in this multicenter observational real world study demonstrate notable activity of BV as a treatment modality for RR HL. BV showed a safety profile consistent with known toxicities. BV treatment was accompanied with dramatic QoL improvement and significant decrease of symptom burden already after 3 mos of treatment. Evaluation of BV treatment outcomes both from physician's and patient's perspective may provide unique information which will be helpful in decision making for patients with RR HL. Disclosures Ionova: Takeda, BMS: Other: Principal Investigator of IISR, Research Funding. Baryakh:Takeda: Consultancy, Honoraria, Speakers Bureau. |
| تدمد: | 1528-0020 0006-4971 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::852fbc2b794b614e5d87a8b7e8011b31 https://doi.org/10.1182/blood-2019-121997 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi...........852fbc2b794b614e5d87a8b7e8011b31 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15280020 00064971 |
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