4CPS-121 Cost-minimisation analysis of maintenance therapy of antineutrophil cytoplasm antibody-associated vasculitides

Abstract

during the past 5 years. Collected variables: age, sex, ECOG, adjuvant chemotherapy, treatment line, dose reduction and adverse events (AE). Efficacy endpoints were progression-free survival (PFS) and overall survival (OS) obtained by the Kaplan-Meier method. Adverse effects (AE) were collected for safety profile assessment. Descriptive statistical analysis was performed using the SPSS Statistics program V22.0. Results Forty-seven patients (30 men and 17 women) were included. The median age was 59 years . At the beginning of the treatment, more than 80% presented ECOG 0-1: 23.4% had received previous adjuvant chemotherapy (gemcitabine and/or fluoropyrimidines). They were treated with nab-paclitaxel 125 mg/m 2 and gemcitabine 1000 mg/m 2 on days 1, 8 and 15 every 28 days. In 89.4% of the patients it was prescribed as first-line treatment. Dose reduction was performed in 68.1%. The median duration of treatment was 4.5 months (0.5-22.9), with four long survivors (longer than 15 months). The median PFS was 9.1 months (95% CI 8.36 to 9.73) and the median OS was 9.11 months (95% CI 4.0 to 14.2). Eighty-three per cent of patients (n=39) had AE of some grade and 17% (n=8) of grade 3-4. The most common AE were: asthaenia (n=17), neutropaenia (n=16), thrombocytopaenia (n=15), neuropathy (n=13), alopecia (n=5), diarrhoea (n=7), mucositis (n=3), vomiting (n=3), oedema (n=3) and dermatitis (n=2). These were grade 3-4: neutropaenia (n=7), thrombocytopaenia (n=4), mucositis (n=1), alopecia (n=1) and neuropathy (n=1). The causes of treatment discontinuation were mainly due to progression in 42.6% and deterioration of general health in 29.8%. At the end of the study, five patients continued treatment. ConclusionThe PFS obtained in our study is greater than those described in the pivotal trial MPACT or CA046. This difference may be due to the four patients with a considerably longer treatment than the average and a small sample. Regarding OS, there are no significant differences with the pivotal trial. The AE described were similar to those published in the literature REFERENCE AND/OR ACKNOWLEDGEMENTS BMC Cancer 2016;16:817. No conflict of interest.

Monitoring disease activity in antineutrophil antibody‐associated vasculitis

“…giving the next dose only after B cell reconstitution) is superior in comparison to a prophylactic one (i.e. giving the next dose at fixed time‐scheduled intervals, independently of the absolute B cell count) 114–117 . Nowadays, B cell return and ANCA reversal are both considered to guide RTX‐based maintenance therapy.…”

“…giving the next dose at fixed time-scheduled intervals, independently of the absolute B cell count). [114][115][116][117] Nowadays, B cell return and ANCA reversal are both considered to guide RTX-based maintenance therapy. When B cells are undetectable and ANCA remain negative relapses are rare, whereas the risk for relapse increases substantially if ANCA switch from negative to positive and CD19/CD20 positive B cells repopulate.…”