SCOTTSDALE, Ariz., Feb. 13, 2018 /PRNewswire-USNewswire/
-- Analysis of a clinical trial, RTOG Foundation 3504, finds
that nivolumab immunotherapy can be administered safely in
conjunction with radiation therapy and chemotherapy for patients
with newly diagnosed local-regionally advanced head and neck
cancers. All patients in the trial were able to complete
curative-intent radiation therapy even with the addition of the
PD-1 inhibitor to platinum-based chemotherapy, and maintenance
immunotherapy to one year was found to be feasible. The study will
be presented today in an online news briefing and at the 2018
Multidisciplinary Head and Neck Cancers Symposium in Scottsdale, Arizona.
"Patients diagnosed with cancers in the mouth and throat often
are diagnosed at advanced stages of disease and relapse within two
years," said Maura Gillison, MD,
PhD, lead author of the study and a professor of thoracic/head and
neck medical oncology at the University of
Texas MD Anderson Cancer Center in Houston. "We previously found that nivolumab
improves survival for patients who experience head and neck cancer
relapse after platinum chemotherapy. Thus, we are compelled to
evaluate whether adding immunotherapy to the initial treatment of
head and neck cancer could prevent these relapses from
happening."
"In this trial, we evaluated the safety and feasibility of
adding immunotherapy to curative-intent cisplatin and radiation
therapy, a treatment that is already quite taxing for patients due
to side effects. We found that it is possible to add nivolumab
immunotherapy to cisplatin treatment without compromising radiation
delivery, and patients were also able to tolerate continuing
immunotherapy for up to a year."
RTOG 3504 was designed to evaluate the safety of adding
nivolumab to standard treatment options for local-regionally
advanced head and neck cancer, and the current analysis reports
early safety data for the two cohorts who received weekly or
high-dose cisplatin chemoradiation therapy. Twenty patients with
newly-diagnosed intermediate-risk HNSCC (p16+, oropharynx
T1-2N2b-N3/T3-4N0-3, >10 pack-years smoking; or T4N0-N3, T1-3N3,
≤10 pack-years) (65% of patients) or high-risk HNSCC (oral cavity,
larynx, hypopharynx, or p16(-) oropharynx, stage T1-2N2a-N3 or
T3-4N0-3) (35% of patients) were enrolled. Median patient age was
56 years (range 35-76), and most patients were male (70%) and
Caucasian (85%). Most patients were in advanced stages of disease
(80% T3-4 and 45% N2-3) and were former smokers (55% >10
pack-year smokers).
Patients received nivolumab in addition to chemoradiation with
either weekly or high-dose cisplatin. Ten patients were enrolled in
each treatment group; eight and nine patients from the weekly and
high-dose cohorts, respectively, were evaluable for this
analysis.
All patients in both treatment groups completed radiation
therapy. Additionally, 15 of 17 patients received at least 70
percent of their prescribed dose of platinum chemotherapy;
cisplatin was stopped for two patients for an allergic reaction and
for cholecystitis not related to nivolumab. Immunotherapy was
discontinued for three patients due to known side effects of
nivolumab, including blurred vision, diarrhea and joint pain.
Most patients were able to both start and continue nivolumab
following first-line treatment. On the weekly cisplatin arm, five
of the eight evaluable patients received 10 doses of concurrent
nivolumab and two patients received nine doses. On the high-dose
cisplatin arm, five of the nine evaluable patients received seven
doses and three patients received six doses. Six of the first eight
patients enrolled in the trial completed a year of nivolumab
therapy; other patients in the study continue to receive treatment,
but the trial was designed to evaluate the first eight
enrolled.
Nivolumab was tolerated well by patients in both treatment
groups. No patients in either cohort experienced dose-limiting
toxicities, which were defined as grade 3 or higher
nivolumab-related adverse events not resolved within four weeks,
radiation therapy delays of more than two weeks, or an inability to
receive at least 70 percent of prescribed chemotherapy.
On the weekly cisplatin arm, there was one case each of
anaphylaxis and cholecystitis, though neither was attributable to
nivolumab. Grade 3 side effects attributable to the immunotherapy
on this arm included three cases of decreased white blood cell
count (two leukopenia, one lymphopenia) and one case each of
fatigue, loss of appetite, lipase elevation, mucositis and adrenal
insufficiency. On the high-dose cisplatin arm, grade 3 side effects
related to nivolumab included one case each of diarrhea, lipase
elevation and amylase elevation. There were no grade 4 or 5 side
effects on either treatment arm.
The abstract, "Safety evaluation of nivolumab (Nivo) concomitant
with platinum-based chemoradiotherapy (CRT) for intermediate (IR)
and high-risk (HR) local-regionally advanced head and neck squamous
cell carcinoma (HNSCC): RTOG Foundation 3504," will be presented in
detail during the Plenary Session at the 2018 Multidisciplinary
Head and Neck Cancers Symposium in Scottsdale, Arizona. To schedule an interview
with Dr. Gillison 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 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