Ps1070 the Echelon‐2 Trial: Results of a Randomized, Double‐blind Phase 3 Study of Brentuximab Vedotin and CHP (A+chp) Versus Chop in Frontline Treatment of Patients With Cd30+ Peripheral T‐cell Lymphomas

Abstract

m 2 , vincristine 1 mg on day 1 & prednisone 40 mg/m 2 or 100 mg/d x 5) followed by an additional two 21 day cycles of rituximab + ibrutinib (or high dose methotrexate for CNS prophylaxis). Pre-phase prednisone, quinolone prophylaxis during neutropenic period in cycle 1, and G-CSF each cycle were mandated. Deliverability is measured using Average Relative Total Dose (ARTD) [Average delivered dose of the chemotherapy regimen as a % of the target dose] and Average Relative Dose Intensity (ARDI)[Average delivered dose of the chemotherapy regimen per unit time (week) as a % of the target dose intensity]. Results: 80 pts were recruited between Nov 2015 & Dec 2018. Of the fi rst 70 to have completed therapy by the data cut-off 14 Feb 2019, one died prior to commencing therapy but is included in the safety analysis. The remaining 69 are included in the deliverability analysis. Complete analysis for all 80 pts will be presented at the meeting. Median age was 81yrs (range 75-95); 51% female, 81% stage III/IV and 64% IPI 3-5. The ARTD & ARDI data are presented in the Table . Most patients received six cycles (75%; 52/69), with 14% (10/69) receiving <4. Treatment was discontinued in 23 pts (33%) due to: progressive disease 5/69 (7%), ibrutinib toxicity 4/69 (6%), withdrawal of consent 4/69 (6%), intercurrent illness 3/69 (4%), R-mini-CHOP toxicity 2/69 (3%), other reasons 2/69 (3%), and death 2/69 (3%). Most patients 63/70 (91%) experienced an adverse event (AE), and 66% experienced a serious AE (SAE): one SAE in 15/70 (21%), 2 in 8/70 (11%), 3 in 13/70 (19%), ≥4 in 10/70 (15%). The most common SAEs were infection (26 events, 24 ≥Gd 3), atrial fi brillation (8 events, 5 ≥Gd 3), febrile neutropenia (6 events, 6 ≥Gd 3). Of AEs of special interest, diarrhoea occurred in 38/69 (55% pts; 6 ≥Gd 3), atrial fi brillation in 12/69 (17%, 4 ≥Gd 3), and two pts had major bleeding (Gd 3, Gd 5). At a median follow-up of 12.7 months (IQR 5.0-22.1) there were 19/70 (27%) deaths, mostly due to lymphoma (11/70, 16%), and infection (3/70, 4%).