Nivolumab immunotherapy safe and feasible during chemoradiation for advanced head and neck cancer

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 [email protected].

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 [email protected] 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
[email protected]

Jeff White
703-839-7392
[email protected]

SOURCE American Society for Radiation Oncology

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