CD30 in PTCLS: correlation between RNA and protein levels in a large european series from the LYSA


Serval ID
Inproceedings: an article in a conference proceedings.
Publication sub-type
Abstract (Abstract): shot summary in a article that contain essentials elements presented during a scientific conference, lecture or from a poster.
CD30 in PTCLS: correlation between RNA and protein levels in a large european series from the LYSA
Title of the conference
12th International Conference on Malignant Lymphoma
Bossard C., Dobay M.P., Lamant L., Missiglia E., Parrens M., Martin A., Tournillac C., Haioun C., Bonnet C., Berger F., Bouchind'homme B., Delarue R., Rousset T., Thiebault S., Picquenot J., Fabiani B., Delorenzi M., Gaulard P., de Leval L.
Lugano, Switzerland, June 19-22, 2013
Publication state
Issued date
Hematological Oncology
Oral presentation
Introduction: CD22 is expressed on most B-non-Hodgkin lymphomas (NHL);
inotuzumab ozogamicin (INO) is an anti-CD22 antibody conjugated to calicheamicin.
This study evaluated the safety and tolerability of INO plus R-CVP in patients (pts) with
relapsed/refractory CD22+ B-NHL. Efficacy data were also collected.
Methods: Part 1 of this open-label study identified a maximum tolerated dose (MTD)
of INO 0.8mg/m,2 on day 2 plus R-CVP (rituximab 375mg/m,2 cyclophosphamide
750mg/m,2 and vincristine 1.4mg/m,2 on day 1; prednisone 40mg/m,2 on days 1-5)
every 21 days. Subsequently, pts were enrolled in the MTD confirmation cohort (part
2, n = 10), which required a dose-limiting toxicity rate of <33% in cycle 1 and <4
pts discontinuing prior to cycle 3 due to an adverse event (AE) in the MTD expansion
cohort (part 3, n = 22), which explored preliminary activity.
Results: Parts 2 and 3 enrolled 32 pts: 16 pts with diffuse large B-cell lymphoma, 15
with follicular lymphoma and one with mantle cell lymphoma. Median age was
64.5 years (range 44-81 years); 34% of pts had 1 prior regimen, 34% had 2, 28% had
≥3 and 3% had none (median 2; range 0-6).Median treatment duration was five cycles
(range 1-6). Part 2 confirmed the MTD as standard dose R-CVP plus INO 0.8mg/m,2;
2/10 pts had a dose-limiting toxicity (grade 3 increased ALT/AST, grade 4 neutropenia
requiring G-CSF). One pt discontinued because of an AE prior to cycle 3.
Common treatment-related AEs were thrombocytopenia (78%), neutropenia (66%), fatigue
(50%), leukopenia (50%), nausea (41%) and lymphopenia (38%); common grade
3/4 AEs were neutropenia (63%), thrombocytopenia (53%), leukopenia (38%) and
lymphopenia (31%). There was one case of treatment-related fatal pneumonia with
grade 4 neutropenia. Ten pts discontinued treatment due to AEs; thrombocytopenia/delayed
platelet recovery was the leading cause (grade 1/2, n = 6; grade 3/4, n = 3). Objective
response rate (ORR) was 77% (n = 24/31 evaluable pts), including 26% (n=8/31)
with complete response (CR); three pts had stable disease. Of the pts with follicular
lymphoma, ORR was 100% (n = 15/15), including seven pts with CR. Of the pts with
diffuse large B-cell lymphoma, ORR was 60% (n = 9/16), including one pt with CR.
Conclusions: Results suggest that INOplus R-CVP has acceptable toxicity and promising
activity in relapsed/refractory CD22+ B-NHL. The most common grade 3/4 AEs were
hematologic. Follow-up for progression-free and overall survival is ongoing.
Create date
05/07/2013 10:09
Last modification date
20/08/2019 13:22
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