Oncology Medical News about metastatic thyroid cancer;Sorafenib

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Phase II trial of sorafenib in metastatic thyroid cancer
Journal of Clinical Oncology, 04/02/09

Kloos RT et al. - In a trial to assess the use of sorafenib targeting RAF and vascular endothelial growth factor (VEGF) receptor kinases in papillary thyroid cancer (PTC), it was shown that sorafenib is a reasonably well-tolerated therapy with clinical and biologic antitumor activity in metastatic PTC.

Methods

Primary endpoint was the objective response rate.
Secondary endpoints included response correlation with serum thyroglobulin (Tg); functional imaging; tumor genotype; and signaling inhibition in tumor biopsies.
Using a Simon minimax 2-stage design, 16 or 25 chemotherapy-naïve metastatic PTC pts were enrolled in arm A (accessible tumor for biopsy).
Arm B pts had other subtypes of thyroid carcinoma or prior chemotherapy, and did not require tumor biopsies.
Pts received 400 mg orally twice per day of sorafenib.
Response was assessed every 2 mos using RECIST.

Results

Of 41 PTC pts, 6 had a partial response (PR; 15%) and 23 pts (56%) had stable disease longer than 6 mos.
Median duration of PR was 7.5 mos; median progression-free survival was 15 mos.
In 14 (78%) of 18 Tg-assessable PTC pts, Tg declined more than 25%.
Common grade 3 adverse events included hand-foot skin reaction, musculoskeletal pain, and fatigue.
BRAF mutation was detected in 17 (77%) of 22 PTCs analyzed.
4 of 10 paired tumor biopsies from PTC pts showed a reduction in levels of vascular endothelial growth factor receptor phosphorylation, ERK phosphorylation, and in VEGF expression during sorafenib therapy.
No PRs were noted among non-PTC pts.

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