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Sub-category:
Pediatric Solid Tumors
Category:
Pediatric Cancer
Meeting:
2009 ASCO Annual Meeting
Session Type and Session Title:
Oral Presentation, Pediatric Cancer II
Abstract No:
10067z
Citation:
J Clin Oncol 27:15s, 2009 (suppl; abstr 10067z)
Author(s):
A. L. Yu, A. L. Gilman, M. F. Ozkaynak, W. B. London, S. Kreissman, H. X. Chen, K. K. Matthay, S. L. Cohn, J. M. Maris, P. Sondel;
Abstract:
Background: Anti-GD2
monoclonal antibody ch14.18 has shown preclinical and
early phase clinical activity against neuroblastoma (NB), with enhanced
preclinical
efficacy when combined with GM-CSF or IL2. ANBL0032 is a Phase 3 study
designed to determine if adding ch14.18 + GM-CSF + IL2 to standard
therapy of
13-cis-retinioic acid (RA) given in CR or VGPR after intensive
induction and
consolidation improved outcome for high-risk NB patients. Methods:
Newly
diagnosed high-risk NB patients who achieved a CR or PR to induction
therapy and received myeloablative consolidation with stem
cell rescue were randomized to RA x 6 cycles (standard) or RA x 6 with
5
concomitant cycles of ch14.18 combined with GM-CSF or IL2 in
alternating cycles (ImmRx).
Interim monitoring of event-free survival (EFS) was per Lan-Demets with
an a*t2
spending function for cumulative a of 0.025. An intent-to-treat
randomized
comparison was performed using a 1-sided log rank test for EFS and
overall survival
(OS). Results: As
of 01/12/09, 226 eligible patients were randomized: 113 to
standard therapy and 113 to ImmRx. Standard therapy was well tolerated
while
ImmRx was associated with grade =3 pain (21% of 670 cycles); vascular
leak
syndrome (7.3%); and allergic reactions (7.2%). With median follow-up
of 2.1 yrs after
randomization, EFS was significantly higher for patients randomized to
ImmRx
(p=0.0115), with 2-yr estimates of 66%±5% vs
46%±5% (83 events
observed; 61% of expected information). Preliminary OS was also
significantly higher for ImmRx
(p=0.0223; 86%±4% vs 75%±5% at 2 yrs). The
interim
monitoring boundary for large early benefit of ImmRx was met and
randomization stopped. Conclusion:
Chimeric
anti-GD2 antibody ch14.18 combined with GM-CSF and IL2 improves EFS for
high-risk NBL patients.
Abstract Disclosures
Faculty and Discussant Disclosures
Annual Meeting Planning Committee Disclosures
2009 Annual Meeting Proceedings Part I Errata
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
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1. A phase III randomized trial of the chimeric anti-GD2 antibody ch14.18 with
GM-CSF and IL2 as immunotherapy following dose intensive chemotherapy for
high-risk neuroblastoma: Children’s Oncology Group (COG) study ANBL0032
Meeting:
2009 ASCO Annual Meeting
Presenter:
Alice L. Yu, MD, PhD
Session:
Pediatric Cancer II
(Oral Presentation)
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Other Abstracts in this Sub-Category:
Abstracts by A. L. Yu:
Presentations by A. L. Yu:
Educational Book Manuscripts by A. L. Yu:
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