R1507, a monoclonal antibody to the insulin-like growth factor 1 receptor, in patients with recurrent or refractory Ewing sarcoma family of tumors: Results of a phase II Sarcoma Alliance for research through Collaboration study Journal Article


Authors: Pappo, A. S.; Patel, S. R.; Crowley, J.; Reinke, D. K.; Kuenkele, K. P.; Chawla, S. P.; Toner, G. C.; Maki, R. G.; Meyers, P. A.; Chugh, R.; Ganjoo, K. N.; Schuetze, S. M.; Juergens, H.; Leahy, M. G.; Geoerger, B.; Benjamin, R. S.; Helman, L. J.; Baker, L. H.
Article Title: R1507, a monoclonal antibody to the insulin-like growth factor 1 receptor, in patients with recurrent or refractory Ewing sarcoma family of tumors: Results of a phase II Sarcoma Alliance for research through Collaboration study
Abstract: Purpose: The type 1 insulin-like growth factor 1 receptor (IGF-1R) has been implicated in the pathogenesis of the Ewing sarcoma family of tumors (ESFT). We conducted a multicenter phase II study of the fully human IGF-1R monoclonal antibody R1507 in patients with recurrent or refractory ESFT. Patients and Methods: Patients ≥ 2 years of age with refractory or recurrent ESFT received R1507 at doses of 9 mg/kg intravenously one a week or 27 mg/kg intravenously every three weeks. Response was measured by using WHO criteria. Tumor imaging was performed every 6 weeks for 24 weeks and then every 12 weeks. Results: From December 2007 through April 2010, 115 eligible patients from 31 different institutions were enrolled. The median age was 25 years (range, 8 to 78 years). The location of the primary tumor was bone in 57% of patients and extraskeletal in 43% of patients. A total of 109 patients were treated with R1507 9 mg/kg/wk, and six patients were treated with 27 mg/kg/3 wk. The overall complete response/partial response rate was 10% (95% CI, 4.9% to 16.5%). The median duration of response was 29 weeks (range, 12 to 94 weeks), and the median overall survival was 7.6 months (95% CI, 6 to 9.7 months). Ten of 11 responses were observed in patients who presented with primary bone tumors (P = .016). The most common adverse events of grades 3 to 4 were pain (15%), anemia (8%), thrombocytopenia (7%), and asthenia (5%). Conclusion: R1507 was a well-tolerated agent that had meaningful and durable benefit in a subgroup of patients with ESFT. The identification of markers that are predictive of a benefit is necessary to fully capitalize on this approach. © 2011 by American Society of Clinical Oncology.
Keywords: adolescent; adult; cancer survival; child; preschool child; school child; treatment response; aged; bone tumor; primary tumor; unclassified drug; major clinical study; overall survival; treatment duration; pain; phase 2 clinical trial; anemia; thrombocytopenia; monoclonal antibody; r 1507; somatomedin c receptor; asthenia; ewing sarcoma; ewing sarcoma family of tumor
Journal Title: Journal of Clinical Oncology
Volume: 29
Issue: 34
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2011-12-01
Start Page: 4541
End Page: 4547
Language: English
DOI: 10.1200/jco.2010.34.0000
PROVIDER: scopus
PMCID: PMC3236654
PUBMED: 22025149
DOI/URL:
Notes: --- - "Cited By (since 1996): 1" - "Export Date: 3 January 2012" - "CODEN: JCOND" - "Source: Scopus"
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MSK Authors
  1. Robert Maki
    205 Maki
  2. Paul Meyers
    239 Meyers