5507 ORAL A phase 2 study of axitinib (AG-013736; AG) in patients (pts) with advanced thyroid cancers

Cohen, Ezra; Vokes, E.; Rosen, L.; Kies, M. S.; Forastiere, A.; Worden, Frank; Kane, Madeline; Liau, Katherine; Shalinsky, David R.; Cohen, Romain

doi:10.1016/s1359-6349(07)71224-7

Cited by 6 publications

(7 citation statements)

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“…10 Recent preliminary results presented suggest the utility of using newer targeted therapies in treating metastatic thyroid cancer. [9][10][11][12] Of the targeted therapies that have recently shown promise in metastatic thyroid cancer, only sorafenib targets both VEGFR and BRAF signaling.…”

Section: Discussionmentioning

confidence: 99%

“…The importance of VEGFR inhibition is evident by the encouraging results of other VEGFR inhibitors in trials for thyroid cancer. [9][10][11][12] Although BRAF signaling (a target of sorafenib) is important in thyroid cancer, its therapeutic significance remains unclear. Genotyping and immunohistochemistry experiments are underway in our laboratory to better elucidate the relationship of BRAF activity and outcome with sorafenib treatment.…”

Section: Phase II Clinical Trial Of Sorafenib In Advanced Thyroid Cancermentioning

confidence: 99%

“…7 In addition, inhibition of VEGF receptor (VEGFR) signaling has been shown to inhibit growth of thyroid tumors in xenograft models, 8 thereby providing a strong rationale for targeting VEGFR in this disease. Recent early reports of trials with multikinase inhibitors have shown promise for patients with metastatic thyroid cancer, [9][10][11][12] and most of these compounds under study cause inhibition of VEGFR.…”

Section: Introductionmentioning

confidence: 99%

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Phase II Trial of Sorafenib in Advanced Thyroid Cancer

Gupta-Abramson

Troxel

Nellore

et al. 2008

JCO

623

391

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A B S T R A C T PurposeGiven the molecular pathophysiology of thyroid cancer and the spectrum of kinases inhibited by sorafenib, including Raf kinase, vascular endothelial growth factor receptors, platelet-derived growth factor receptor, and RET tyrosine kinases, we conducted an open-label phase II trial to determine the efficacy of sorafenib in patients with advanced thyroid carcinoma. Patients and MethodsEligible patients with metastatic, iodine-refractory thyroid carcinoma received sorafenib 400 mg orally twice daily. Responses were measured radiographically every 2 to 3 months. The study end points included response rate, progression-free survival (PFS), and best response by Response Evaluation Criteria in Solid Tumors. ResultsThirty patients were entered onto the study and treated for a minimum of 16 weeks. Seven patients (23%; 95% CI, 0.10 to 0.42) had a partial response lasting 18ϩ to 84 weeks. Sixteen patients (53%; 95% CI, 0.34 to 0.72) had stable disease lasting 14 to 89ϩ weeks. Seventeen (95%) of 19 patients for whom serial thyroglobulin levels were available showed a marked and rapid response in thyroglobulin levels with a mean decrease of 70%. The median PFS was 79 weeks. Toxicity was consistent with other sorafenib trials, although a single patient died of liver failure that was likely treatment related. ConclusionSorafenib has clinically relevant antitumor activity in patients with metastatic, iodine-refractory thyroid carcinoma, with an overall clinical benefit rate (partial response ϩ stable disease) of 77%, median PFS of 79 weeks, and an overall acceptable safety profile. These results represent a significant advance over chemotherapy in both response rate and PFS and support further investigation of this agent in these patients.

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Section: Discussionmentioning

confidence: 99%

Section: Phase II Clinical Trial Of Sorafenib In Advanced Thyroid Cancermentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Phase II Trial of Sorafenib in Advanced Thyroid Cancer

Gupta-Abramson

Troxel

Nellore

et al. 2008

JCO

623

391

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“…Therefore we do not recommend this regimen for further study in non-medullary thyroid cancer. Recently, a number of novel, molecularly targeted agents have shown modest single-agent activity in well-differentiated thyroid cancer [31,32]. The prospective evaluation of novel regimens should continue in thyroid cancer.…”

Section: Discussionmentioning

confidence: 99%

A phase II trial of doxorubicin and interferon alpha 2b in advanced, non-medullary thyroid cancer

et al. 2007

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“…Several other protein-kinase inhibitors have been evaluated. Axitinib, an inhibitor of VEGF receptor, was evaluated in 12 patients with some stabilization of disease results (Cohen et al 2007). Sorafenib, a selective inhibitor of RET tyrosine kinases, was evaluated in 5 patients with a surprising complete response in one patient and partial in another, but serious toxicity reduced the dose by 50 % (Kober et al 2007).…”

Section: Targeted Therapy With Multikinase Inhibitorsmentioning

confidence: 99%