SCOTTSDALE, Ariz., Feb. 13, 2018 /PRNewswire-USNewswire/ -- Results
of a new phase II clinical trial indicate that cabozantinib offers
an active therapy option for patients with differentiated thyroid
cancer (DTC) that has progressed following surgery and treatment
with radioactive iodine (RAI). Thirty-four of 35 patients in the
trial experienced a reduction in tumor size following treatment
with the targeted kinase inhibitor, and more than half experienced
reductions in excess of 30 percent. The study will be presented
today in an online news briefing and at the 2018 Multidisciplinary
Head and Neck Cancers Symposium in Scottsdale, Arizona.
"The recent introduction of targeted therapy with kinase
inhibitors for patients with advanced thyroid cancer created a
possible path to control the cancers of patients we previously
could treat only with supportive care. Our trial shows that
cabozantinib also is an active agent and could significantly
improve the care of patients with advanced disease," said
Marcia S. Brose, MD, PhD, an
associate professor in the Department of Otorhinolaryngology: Head
and Neck surgery and the director of the Center for Rare Cancers
and Personalized Therapy at the Perelman School of Medicine at the
University of Pennsylvania in
Philadelphia.
Five years ago, there were no federally approved curative
options for RAI-refractory differentiated thyroid cancer. Two
kinase inhibitors have come to market for advanced DTC in the years
since, but responses to these agents are not durable and when
patients progress they need additional therapeutic options.
"While prior agents that attack the vascular endothelial growth
factor (VEGF) receptor have been active in advanced DTC, patients
on these therapies eventually progress or are unable to tolerate
the drug," explained Dr. Brose. "Our positive trial results
indicate that cabozantinib offers an additional option to shrink
patients' tumors and provide an additional progression-free
period."
NCT02041260 is a single-arm, open-label phase II study of
cabozantinib in the first-line setting for metastatic,
RAI-refractory, unresectable or locally-advanced thyroid carcinoma.
Thirty-five patients were enrolled between March 2014 and August
2017. Patients in the trial were administered 60 mg of oral
cabozantinib each day. Median time on the study was 35 weeks (range
3-197), and 16 patients remain enrolled as of February 6, 2018.
Most patients had papillary histology (63%), followed by poorly
differentiated (29%) and Hürthle cell (9%) carcinomas. Patients had
not received prior kinase inhibitor therapy. Median patient
age was 65 years (range 45-84), and 49 percent of the enrolled
patients were male.
Thirty-four of the 35 patients experienced tumor shrinkage.
Partial response (i.e., greater than 30%) was achieved in 19 of the
35 patients (with short follow-up for four patients enrolled at the
end of the study), for an overall response rate of 54 percent.
Duration of partial responses ranged from 11 weeks to more than 174
weeks. Stable disease was achieved in 15 patients, with duration of
stability ranging from eight weeks to more than 142 weeks. Cancer
progressed in six patients, with a median time to progression of 35
weeks (range 8-40).
Cabozantinib was well-tolerated, although dose interruptions and
dose adjustments were needed for the majority of patients (23 of
35) at some point on treatment. Treatment-related adverse events of
any grade were experienced by all patients (100%). The most common
adverse events attributable to cabozantinib included hyperglycemia
(28 patients, 80%), diarrhea (27, 77%), malaise/fatigue (26, 74%)
and weight loss (25, 71%). The majority of these adverse
events were grades 1 and 2. Grade 3 or higher adverse events
that occurred in more than one patient included hypertension (5
patients, 14%), increased lipase (3, 9%), weight loss (2, 6%),
pulmonary embolism (2, 6%) and hyponatremia (2, 6%).
The abstract, "A Phase II Trial of Cabozantinib for the
Treatment of Radioiodine (RAI)-refractory Differentiated Thyroid
Carcinoma (DTC) in the First-line Setting," will be presented in
detail during the Oral Abstract Session at the 2018
Multidisciplinary Head and Neck Cancers Symposium in Scottsdale, Arizona. To schedule an interview
with Dr. Brose and/or outside experts in head and neck cancer,
contact ASTRO's media relations team at press@astro.org.
ATTRIBUTION TO THE 2018 MULTIDISCIPLINARY HEAD AND NECK
CANCERS SYMPOSIUM REQUESTED IN ALL COVERAGE.
This study was funded by Exelixis.
This news release contains additional and/or updated study
information from the author(s). Original abstract available;
email press@astro.org for a copy.
Patient Resources on Head and Neck Cancer and Radiation
Therapy
- Digital brochure: Radiation Therapy for Head and Neck
Cancer
- Videos: Radiation Therapy for Head and Neck Cancer (Spanish
version), An Introduction to Radiation Therapy (Spanish
version)
- Additional brochures, videos and information on radiation
therapy from ASTRO's patient site, RTAnswers.org
ABOUT THE SYMPOSIUM
The 2018
Multidisciplinary Head and Neck Cancer Symposium is
sponsored by the American Society for Radiation Oncology (ASTRO),
the American Society of Clinical Oncology (ASCO) and the American
Head & Neck Society (AHNS). The two-and-a-half day meeting
includes interactive educational sessions focused on topics such as
novel multidisciplinary therapies, directed therapy, treatment
guidelines, prevention, surveillance and supportive care, as well
as oral abstract presentations of the current science of relevance
to the head and neck cancer community.
ABOUT ASTRO
The American Society for Radiation
Oncology (ASTRO) is the world's largest radiation oncology society,
with more than 10,000 members who are physicians, nurses,
biologists, physicists, radiation therapists, dosimetrists and
other health care professionals who specialize in treating patients
with radiation therapies. The Society is dedicated to improving
patient care through professional education and training, support
for clinical practice and health policy standards,
advancement of science and research, and advocacy. ASTRO
publishes three medical journals, International Journal of
Radiation Oncology • Biology • Physics
(www.redjournal.org), Practical Radiation Oncology
(www.practicalradonc.org) and Advances in
Radiation Oncology (www.advancesradonc.org);
developed and maintains an extensive patient website, RT Answers
(www.rtanswers.org); and created the Radiation
Oncology Institute (www.roinstitute.org), a nonprofit
foundation to support research and education efforts around the
world that enhance and confirm the critical role of radiation
therapy in improving cancer treatment. To learn more about ASTRO,
visit www.astro.org and follow us on our
blog, Facebook and
Twitter.
ABOUT ASCO
Founded in 1964, the American Society of
Clinical Oncology, Inc. (ASCO®) is committed to making a
world of difference in cancer care. As the world's leading
organization of its kind, ASCO represents more than 40,000 oncology
professionals who care for people living with cancer. Through
research, education, and promotion of the highest-quality patient
care, ASCO works to conquer cancer and create a world where cancer
is prevented or cured, and every survivor is healthy. ASCO is
supported by its affiliate organization, the Conquer Cancer
Foundation. Learn more at www.ASCO.org, explore
patient education resources at www.Cancer.Net, and
follow us on Facebook, Twitter, LinkedIn, and YouTube.
ABOUT AHNS
The American Head & Neck Society
(AHNS) is the single largest organization in North America for the advancement of research
and education in head and neck oncology. The mission of the
American Head and Neck Society is: to promote and advance
the knowledge of prevention, diagnosis, treatment, and
rehabilitation of neoplasms and other diseases of the head and
neck; to promote and advance research in diseases of the head and
neck, and; to promote and advance the highest professional and
ethical standards. For more information, visit
www.ahns.info.
Contact: Liz Gardner
703-286-1600
liz.gardner@astro.org
Jeff
White
703-839-7392
jeff.white@astro.org
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SOURCE American Society for Radiation Oncology