Contributions
Abstract: EP1190
Type: E-Poster Presentation
Session title: Quality of life, palliative care, ethics and health economics
Background
For patients with relapsed/refractory classical Hodgkin Lymphoma (R/R cHL) who are ineligible for auto-SCT, or who are relapsed after auto-SCT, one of promising treatment options is brentuximab vedotin (BV). Real-world data about risks/benefits of this treatment are limited. Comprehensive evaluation of effects of BV, including patient-reported outcomes, in this patients population is worthwhile.
Aims
Here we demonstrate the results of multicenter observational study aimed to evaluate clinical and patient-reported outcomes in R/R cHL pts receiving BV as ≥3rd treatment line in the real world setting.
Methods
Pts with R/R cHL receiving BV 1.8 mg/kg q3w as ≥3rd treatment line were included in the real-world study. Treatment response was assessed using RECIST criteria v. 1.1. Duration of response (DOR) and progression free survival (PFS) were evaluated by Kaplan-Meier analysis. Adverse events (AEs) were evaluated in accordance with NCI CTCAE v. 4.0. For QoL and symptom assessment pts filled out RAND SF-36 and ESAS-R, accordingly. Generalized Estimating Equations (GEE), Friedman ANOVA and McNemar’s test were used for statistical analysis.
Results
In total, 62 pts with R/R cHL (median age – 31 yrs, range 18–67, 53% males) were recruited in the study: 69% pts had advanced stage (III–IV) at diagnosis; 66% pts – B-symptoms; 18% pts – ECOG 2-3; 29% – comorbidities. All pts received 2-10 previous treatment lines (median – 3); 98% pts were primary refractory/relapsed, among them 19% relapsed after auto-SCT. Before BV treatment start 60% pts had severe/critical QoL impairment. All the pts experienced symptoms; 88.7% pts had moderate-to-severe symptoms, more than half pts had moderate-to-severe worse wellbeing (76%), tiredness (67%), drowsiness (60%), depression and lack of appetite (each 53%). At median follow-up of 8 mo (5.3–15 mo) one patient died at 2 mo after treatment start not because of HL, one patient was lost. For the entire follow-up period 68.3% pts achieved/maintained the objective response (OR). Among them 40% pts achieved the best response in terms of complete remission, 28.3% pts – partial remission. Median of DOR in 41 pts with OR was 11 mo (95% CI: 0.8– -).The median PFS was 10.6 mo (95% CI: 7.4-12.9). Most common AEs were peripheral neuropathy (55%) and fatigue (38%), AEs of grades III-IV were reported in 1.6% pts. SAE was reported in one case (sepsis, respiratory insufficiency due to agranulocytosis, BV was temporary stopped). During 15 mo of BV treatment significant QoL improvement was revealed for all SF-36 scales (GEE, p<.01). The most pronounced meaningful improvement was found for role physical functioning (∆=60 scores), role emotional functioning (∆=44) and vitality (∆=28). Proportion of pts with severe/critical QoL impairment dramatically decreased during BV treatment (at 9, 12 and 15 mo, p<.05). The severity of all symptoms by ESAS-R decreased (p≤.001). Total Symptom Score by ESAS-R became significantly less after treatment start: 36.5 at baseline vs 5.6 at 15 mo (p<.001).
Conclusion
The results of this multicenter real world study confirm notable effectiveness and good tolerability of BV as a treatment modality for R/R cHL pts. Median PFS was 10.6 mo; 68.3% pts achieved OR (CR – 40%). Treatment toxicity is comparable with clinical data; AEs of grades III-IV – in 1.6% pts. BV treatment is accompanied with dramatical QoL improvement and significant decrease of symptom burden.
Keyword(s): Clinical outcome, Hodgkin's lymphoma, Quality of life, Refractory
Abstract: EP1190
Type: E-Poster Presentation
Session title: Quality of life, palliative care, ethics and health economics
Background
For patients with relapsed/refractory classical Hodgkin Lymphoma (R/R cHL) who are ineligible for auto-SCT, or who are relapsed after auto-SCT, one of promising treatment options is brentuximab vedotin (BV). Real-world data about risks/benefits of this treatment are limited. Comprehensive evaluation of effects of BV, including patient-reported outcomes, in this patients population is worthwhile.
Aims
Here we demonstrate the results of multicenter observational study aimed to evaluate clinical and patient-reported outcomes in R/R cHL pts receiving BV as ≥3rd treatment line in the real world setting.
Methods
Pts with R/R cHL receiving BV 1.8 mg/kg q3w as ≥3rd treatment line were included in the real-world study. Treatment response was assessed using RECIST criteria v. 1.1. Duration of response (DOR) and progression free survival (PFS) were evaluated by Kaplan-Meier analysis. Adverse events (AEs) were evaluated in accordance with NCI CTCAE v. 4.0. For QoL and symptom assessment pts filled out RAND SF-36 and ESAS-R, accordingly. Generalized Estimating Equations (GEE), Friedman ANOVA and McNemar’s test were used for statistical analysis.
Results
In total, 62 pts with R/R cHL (median age – 31 yrs, range 18–67, 53% males) were recruited in the study: 69% pts had advanced stage (III–IV) at diagnosis; 66% pts – B-symptoms; 18% pts – ECOG 2-3; 29% – comorbidities. All pts received 2-10 previous treatment lines (median – 3); 98% pts were primary refractory/relapsed, among them 19% relapsed after auto-SCT. Before BV treatment start 60% pts had severe/critical QoL impairment. All the pts experienced symptoms; 88.7% pts had moderate-to-severe symptoms, more than half pts had moderate-to-severe worse wellbeing (76%), tiredness (67%), drowsiness (60%), depression and lack of appetite (each 53%). At median follow-up of 8 mo (5.3–15 mo) one patient died at 2 mo after treatment start not because of HL, one patient was lost. For the entire follow-up period 68.3% pts achieved/maintained the objective response (OR). Among them 40% pts achieved the best response in terms of complete remission, 28.3% pts – partial remission. Median of DOR in 41 pts with OR was 11 mo (95% CI: 0.8– -).The median PFS was 10.6 mo (95% CI: 7.4-12.9). Most common AEs were peripheral neuropathy (55%) and fatigue (38%), AEs of grades III-IV were reported in 1.6% pts. SAE was reported in one case (sepsis, respiratory insufficiency due to agranulocytosis, BV was temporary stopped). During 15 mo of BV treatment significant QoL improvement was revealed for all SF-36 scales (GEE, p<.01). The most pronounced meaningful improvement was found for role physical functioning (∆=60 scores), role emotional functioning (∆=44) and vitality (∆=28). Proportion of pts with severe/critical QoL impairment dramatically decreased during BV treatment (at 9, 12 and 15 mo, p<.05). The severity of all symptoms by ESAS-R decreased (p≤.001). Total Symptom Score by ESAS-R became significantly less after treatment start: 36.5 at baseline vs 5.6 at 15 mo (p<.001).
Conclusion
The results of this multicenter real world study confirm notable effectiveness and good tolerability of BV as a treatment modality for R/R cHL pts. Median PFS was 10.6 mo; 68.3% pts achieved OR (CR – 40%). Treatment toxicity is comparable with clinical data; AEs of grades III-IV – in 1.6% pts. BV treatment is accompanied with dramatical QoL improvement and significant decrease of symptom burden.
Keyword(s): Clinical outcome, Hodgkin's lymphoma, Quality of life, Refractory