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Sub-category:
Other: Sarcoma
Category:
Sarcoma
Meeting:
2009 ASCO Annual Meeting
Session Type and Session Title:
Oral Presentation, Sarcoma
Abstract No:
10503
Citation:
J Clin Oncol 27:15s, 2009 (suppl; abstr 10503)
Author(s):
S. Patel, A. Pappo, J. Crowley, D. Reinke, J. Eid, S. Ritland, S. Chawla, A. Staddon, R. Maki, G. Vassal, L. Helman; Sarcoma Alliance for Research and Collaboration, Ann Arbor, MI; Hoffmann-La Roche, Nutley, NJ
Abstract:
Background: The IGF1 system has been implicated in sarcoma development and inhibition of IGF1R function has been shown to induce clinical responses in select sarcomas. Methods: Objectives included response rate (RR) and progression-free survival (PFS) to R1507 in patients with recurrent or refractory Ewing's (ES, 2 cohorts- primary refractory vs. others) osteo (OS), synovial (SS), rhabdomyosarcoma (RMS), and other sarcomas. Eligibility included recurrent/refractory measurable disease, age ≥ 12 yrs, life expectancy ≥ 6 weeks, Karnofsky PS ≥ 70, adequate renal, hepatic and bone marrow function. R1507 was administered i.v. at 9 mg/kg over one hour weekly. Response was assessed by WHO criteria every 6 wks X 4 and every 12 wks thereafter. A two-stage design (Green and Dahlberg) was used. The endpoint for the primary refractory ES cohort was PFS at week 18 (planned n=65). RR was the primary endpoint for the remaining cohorts (planned n=240). Results: From 12/07-12/08, 203 eligible patients from 29 centers across the US, Europe and Australia were enrolled. Age ranged from 12-85 yrs (median=27 yrs) and 126 were male. Verified histologic subtypes were ES (n=71), OS (n=43), RMS (n=28), SS (n=25), and others (n=25). 15 severe adverse events were reported in 9 patients, the most common being fatigue (n=2), thrombocytopenia (n=2), dehydration (n=2), and hyperglycemia (n=2). Clinically significant activity has been observed in ES, RMS and OS with several dramatic responses seen in ES and RMS. Independent radiologic review is currently ongoing and updated data will be presented. Conclusions: The rapid accrual amongst many centers in diverse geographical locations demonstrates the feasibility of collaborative research in sarcomas. R1507 is well tolerated and a promising new agent for the treatment of various sarcomas. SARC and Roche are collaborating in additional clinical trials to better define the role of R1507 in the treatment of selected sarcomas.
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 II trial of R1507, a recombinant human monoclonal antibody to the insulin-like growth factor-1 receptor for the treatment of patients with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas
Meeting:
2009 ASCO Annual Meeting
Presenter:
Shreyaskumar Patel, MD
Session:
Sarcoma
(Oral Presentation)
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Other Abstracts in this Sub-Category:
Abstracts by S. Patel:
Presentations by S. Patel:
Educational Book Manuscripts by S. Patel:
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