BRENTUXIMAB VEDOTIN FOR TREATMENT IN PATIENTS WITH RELAPSED/REFRACTORY CLASSICAL HODGKIN LYMPHOMA IN A REAL WORLD SETTING: CLINICAL OUTCOMES AND IMPACT ON QUALITY OF LIFE
2021; Wiley; Volume: 39; Issue: S2 Linguagem: Inglês
10.1002/hon.67_2881
ISSN1099-1069
AutoresTatyana Ionova, M. I. Andrievskikh, A. A. Amdiev, Е. А. Baryakh, Victoria A. Chang, Anastasiya Endakova, Natalia Fadeeva, Gulnara Husainova, Vladimir Ivanov, Kamil Kaplanov, Oksana Kaverina, Marina V. Kiseleva, T.Yu. Klitochenko, Vyacheslav Kurakin, Olga Larionova, D. G. Lazareva, Kirill V. Lepik, Irina B. Lysenko, В Я Мельниченко, N. Mikhailova, Р. И. Минуллина, Oleg Mironov, E. N. Misyurina, N.E. Mochkin, Tatiana Nikitina, Yuriy Osipov, T. Petrova, Natalia Porfirieva, О. А. Рукавицын, Р. Р. Сафин, A. A. Samoylova, Т. В. Шелехова, Dmitry G. Sherstnev, P. Simashova, Е Г Смирнова, Natalia Trenina, E. V. Vasiliev, Elena Volodicheva,
Tópico(s)CNS Lymphoma Diagnosis and Treatment
ResumoOne of the approved treatment options for pts with relapsed/refractory classical Hodgkin Lymphoma (rr-cHL) is brentuximab vedotin (BV). Comprehensive evaluation of treatment effects of brentuximab vedotin (BV) in pts with rr-cHL, including clinical and patient-reported outcomes, is worthwhile. We aimed to evaluate clinical outcomes and quality of life (QoL) in rr-cHL pts receiving BV in the real world setting. Pts with rr-cHL receiving BV 1.8 mg/kg q3w were included in the multicenter real-world study. Treatment response was assessed using RECIST criteria v. 1.1. The Kaplan-Meier method was used to estimate progression free survival (PFS). For assessment of adverse events (AEs) NCI CTCAE v. 4.0 was used. For QoL assessment pts filled out RAND SF-36. Generalized Estimating Equations (GEE) and McNemar's test were applied. In the total 70 pts with rr-cHL were enrolled in the study. The analysis was carried out in two groups. Group 1 included 62 pts who were ineligible for ASCT or relapsed after ASCT – median age – 31 yrs, 53% males; 50% had IV stage; 66% – B-symptoms; 18% – ECOG 2-3; 19% pts in Group 1 relapsed after ASCT. Group 2 consisted of 8 pts who received BV following ASCT – median age – 28 yrs, 63% males; 25% had IV stage; 13% – B-symptoms; no pts with ECOG 2-3. All the pts received ≥2 previous treatment lines (2-10). Before BV treatment start 60% pts in Group 1 and 38% pts in Group 2 had severe/critical QoL impairment. In Group 1 at median follow-up of 8 mo, 68% pts achieved/maintained objective response (OR). Among them 40% pts achieved complete remission (CR) and 28% – partial remission (PR). The median PFS in Group 1 was 10.6 mo (95% CI: 7.4-12.9). In Group 2 at median follow-up of 15 mo 7/8 pts achieved/maintained OR; among them 6 pts had CR and one – PR. The median PFS in Group 2 was not reached. The most common AEs were peripheral neuropathy and fatigue (55% and 36%). AEs of grades III-IV in Group 1 were reported in one patient (1.6%), SAE – one case (sepsis, respiratory insufficiency due to agranulocytosis), in Group 2 – in 2 pts; one case of SAE in Group 2 was registered (abdominal syndrome). In Group 1 during BV treatment QoL improved by all SF-36 scales (GEE, p < .01) with the most pronounced increase of role physical functioning (∆=60) and role emotional functioning (∆=44) as compared to baseline. Proportion of pts with severe/critical QoL impairment significantly decreased during BV treatment (p < .05). In Group 2 QoL stabilization or improvement was obtained during BV treatment; number of pts with severe/critical QoL impairment slightly diminished as compared to baseline. The results support the notable efficacy and good tolerability of BV for treatment of rr-HL in the real-life setting. Treatment with BV has positive impact on QoL in rr-cHL pts. Improvement of QoL is a valuable outcome of BV treatment and supports patient-centeredness approach in treatment decision-making in this patient's population. The research was funded by: IIR funded by Takeda Keywords: Hodgkin lymphoma, Immunotherapy Conflicts of interests pertinent to the abstract T. Ionova Other remuneration: Principle investigator of the IIR
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