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Sub-category:
Tyrosine Kinase Inhibitors
Category:
Developmental Therapeutics: Molecular Therapeutics
Meeting:
2009 ASCO Annual Meeting
Session Type and Session Title:
Poster Discussion, Developmental Therapeutics: Molecular Therapeutics
Abstract No:
3521
Citation:
J Clin Oncol 27:15s, 2009 (suppl; abstr 3521)
Author(s):
K. C. Bible, R. C. Smallridge, W. J. Maples, J. R. Molina, M. E. Menefee, V. J. Suman, J. K. Burton, C. C. Bieber, S. P. Ivy, C. Erlichman, Endocrine Malignancies Disease Oriented Group, Mayo Phase 2 Consortium; Mayo Clinic, Rochester, MN; Mayo Clinic, Jacksonville, FL; National Cancer Institute, Bethesda, MD
Abstract:
Background: Systemic therapies have had little impact on the outcomes of patients with advanced differentiated thyroid cancers. Methods: A three-outcome one-stage Phase II trial was conducted to assess the anti-tumor activity and toxicities of the orally bioavailable VEGF/tyrosine kinase inhibitor pazopanib (800 mg daily) in patients with advanced and progressive radioiodine-insensitive differentiated thyroid cancers. Up to 2 prior therapies were allowed, with measurable disease required. Design: at the 0.10 significance level, there would be a 90% chance of detecting a RECIST response rate of >20% given a true response rate of >5%; with the regimen considered promising if >4 confirmed responses observed. Results: From February to November 2008, 32 patients (53% male) aged 23-79 years (median: 63 years) were enrolled. Common sites of metastases were: lung (100%), nodes (52%), and bone (39%). Measurement data are available for 26 patients, with the median number of cycles administered thus far 4 (range: 1-8, total: 101). Overall, therapy has been well tolerated. Six patients (23%) required dose reduction due to: grade 2+ ALT (3 pts), grade 3 mucositis (1 pt); grade 3 diarrhea and dehydration (1 pt), and grade 3 abdominal pain (1 pt.). Other serious toxicities included grade 3 colon perforation and grade 3 chest pain (1 pt). No thyroglobulin antibody (TGA) negative patient has become TGA positive, and 11 of 16 patients (69%) with initially elevated thyroglobulin levels experienced a decline in thyroglobulin of >50%. Five RECIST partial responses have been confirmed to date (19%). Two patients are alive with disease progression and another has died from disease progression. Conclusions: Pazopanib appears to have both a favorable toxicity profile and promising clinical activity in patients with advanced and progressive differentiated thyroid cancers. Supported in part by NCI CA15083 and CM62205.
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):
Other Abstracts in this Sub-Category:
Abstracts by K. C. Bible:
Presentations by K. C. Bible:
Educational Book Manuscripts by K. C. Bible:
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