Astro declares positive results of phase II OPTIMA Clinical trial

Astro indicates positive results of  phase II OPTIMA Clinical Trial signifying that patients with head and neck cancers associated with the human papillomavirus (HPV), including those with advanced nodal disease, can receive substantially lower radiation doses safely and effectively if they respond to induction chemotherapy initially.

Patients who responded well to induction chemotherapy and subsequently received the lower-dose treatment experienced excellent survival—92 percent were without evidence of recurrence two years after treatment—and had improved functional outcomes with fewer side effects, compared to those who received standard chemoradiation therapy. HPV-positive disease is more responsive to radiation therapy and chemotherapy and is associated with significantly higher cure rates.

Tanguy Seiwert, MD, lead author of the study and an assistant professor of medicine at University of Chicago Medicine claimed “In fact, the effectiveness of combined treatment with radiation and chemotherapy has been so well documented that newer studies such as OPTIMA are focused on selecting patients who can safely receive less treatment.”

Dr. Seiwert. said “With our approach of using induction chemotherapy to identify candidates for de-escalated radiation therapy, we achieved excellent treatment outcomes with giving 30 to 35 percent smaller radiation doses, even for patients with advanced nodal stages such as N2C. Patients experienced less toxicity and survival rates exceeded historic data, although more follow-up is needed to confirm these findings.”

All patients in the trial received three cycles of induction chemotherapy consisting of carboplatin and nab-paclitaxel, and those who responded well received one of two de-escalated treatment regimens: 50 Gray (Gy) of radiation therapy alone (RT50 arm) for low-risk disease, or 45Gy of chemoradiation therapy (CRT45 arm) for high-risk disease. Favorable response to induction chemotherapy was defined as 50 percent or greater reduction in tumor size for high-risk patents and 30 percent or greater reduction for low-risk patients.All low-risk patients and 32 of the 34 (94%) of the high-risk patients were progression-free at two years following treatment. Two-year overall survival rates were 100 percent for low-risk patients and 97 percent for high-risk patients.