SORAFENIB FOR THYROID CANCER

Some patients with advanced thyroid cancer may benefit from sorafenib

26.06.09

Category: Scientific News

Response not related to histology and worse in patients with bone metastases

Nearly 8,000 attendees from more than 75 countries attended Endocrine Society meeting in Washington, DC, 10-13 June, 2009. The strong relevance of science and clinical practice at the annual meeting brought together unparalleled access to the most sought after experts sharing groundbreaking innovations and progressive clinical treatments, and meeting endocrinology’s emerging challenges.

Almost two-thirds of patients with advanced thyroid cancer benefited from treatment with the tyrosine kinase inhibitor sorafenib according data from a small clinical trial presented during the meeting. Of the 26 patients in the study, 19 (62%) had partial responses or stable disease during 26 weeks of treatment. Median progression-free survival exceeded a year, and 14 patients remained alive after a median follow-up of 63 weeks.

Karen Heemstra, MD, of Leiden University in the Netherlands presented data from the phase II clinical trial involving 31 patients, median age 65, who had differentiated thyroid cancer that could not be treated with surgery or radioiodine ablation. All patients received sorafenib 400 mg twice a day for a maximum of 26 weeks, and response was assessed at baseline and at 26 weeks by CT scan and thyroglobulin measurement. Patients who completed the study could remain on treatment during an open-ended extension phase. Median time from diagnosis was three years. Only one patient had localized disease. Papillary and follicular histology accounted for 90% of the cases.

Of the 13 patients with papillary disease, 12 had the BRAFV600E mutation and one had NRAS mutation. Among the 14 patients with follicular histology, 10 had Hurtle-cell metaplasia and one had mutated NRAS. At the end of 26 weeks, five patients had withdrawn because of adverse events. An additional four patients had progressive disease.

Of the 22 patients who entered the open-phase extension, six had progressive disease and two withdrew because of adverse events. Eight patients had partial responses and 11 others had stable disease, resulting in a total clinical benefit of 62% (19 of 26).

When grouped according to presence of bone metastases, patients in whom the cancer had not spread were significantly more likely to have objective responses or stable disease (P=0.04). All patients with progressive disease had bone metastases. Progression-free survival was 69 weeks without bone metastases and 47 weeks in patients who had bone metastases.

Toxicity was common. A majority of patients had hand-foot syndrome, weight loss, diarrhea, alopecia, and rash/mucositis, and almost half had treatment-emergent hypertension and hypocalcemia. Almost 60% of patients required temporary sorafenib dose reductions.