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Sorafenib slowed disease progression in metastatic differentiated thyroid cancer
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CHICAGO — Sorafenib extended DFS by 5 months among patients with metastatic differentiated thyroid cancer that progressed after treatment with standard radioactive iodine therapy, according to phase 3 study results presented at the ASCO Annual Meeting.
“Patients with radioactive iodine-resistant metastatic differentiated thyroid cancer suffer from a rare cancer and are without a known effective treatment,” Marcia Brose, MD, PhD, assistant professor of otolaryngology and head and neck surgery at the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania, said during a press conference. “Our results show that sorafenib is a new effective treatment option for these patients.”
Between 5% and 15% of patients with metastatic differentiated thyroid cancer develop resistance to radioactive iodine. Doxorubicin, the only approved treatment option, is rarely used due to low efficacy and high toxicity.
If approved by the FDA, sorafenib (Nexavar, Bayer) would become the first new active drug for this type of thyroid cancer in 40 years, according to researchers.
The DECISION study included 417 patients with metastatic standard radioactive iodine-resistant differentiated thyroid cancer. Researchers randomly assigned patients to sorafenib (n=207) or placebo (n=210). Those assigned to placebo were able to switch to sorafenib upon disease progression.
Median PFS was 10.8 months among patients assigned to sorafenib vs. 5.8 months for patients assigned to placebo (HR=0.58; 95% CI, 0.45-0.75).
In addition, 12.2% of patients assigned to sorafenib experienced tumor-size reduction of 30% or more, compared with 0.5% of patients assigned to placebo.
Forty-two percent of patients assigned to sorafenib experienced stable disease for 6 months or longer, correlating to a disease control rate of 54%.
“After having no effective drugs for these patients for so many years, it is very exciting to find an oral drug that stops growth of the cancer for several months,” Brose said. “For these patients, a longer progression-free survival means more months without hospitalization and invasive procedures to control pain and other symptoms. This is the first time we have had a systemic treatment that can help.”
For more information:
Brose MS. Abstract #4. Presented at: ASCO Annual Meeting; May 31-June 4, 2013; Chicago.
Disclosure: The researchers report research funding and honoraria from, consultant or advisory roles with, and stock ownership in Amgen, AstraZeneca, Bayer, Celgene, Genomic Health, Onyx, Roche, Sanofi and other pharmaceutical companies.
Perspective
Back to TopGregory A. Masters, MD, FACP
Few good options exist for patients with these more aggressive thyroid cancers, so these findings offer renewed hope and momentum for patients and researchers alike. Sorafenib provides meaningful activity for these patients, nearly doubling PFS. Future studies will help identify which patients can benefit most from this therapy, and how other targeted therapies may further improve the outcome for these patients. Using this for our patients becomes a very attractive option, and I think it will be become a standard of care.
Perspective
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Daniel S. Duick, MD, FACE, FACP
The current report of a multicenter, randomized, large phase 3 trial utilizing sorafenib for advancing, local/regional and metastatic differentiated thyroid cancer is encouraging. It demonstrates we have an oral tyrosine kinase inhibitor that can induce partial responsiveness, improve the timetable of PFS and affect OS for at least half to perhaps more than two-thirds of patients who receive this agent. Side effects are mild to moderate but acceptable and predictable with sorafenib. Because sorafenib inhibits multiple kinases — including Raf, RET, and VEGF and PDGF receptors — this report underscores the need for the development and testing of other oral agents or combinations of such agents with a panoply of antitumor activity to improve PFS of an ultimately fatal disease.
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