In the international trial, 538 patients with squamous cell carcinomas in the larynx, pharynx, or oral cavity and stage 3 or 4 disease were randomized between the two induction treatments. Groups were matched by primary tumor location and stage.

In both groups, about one third of patients had inoperable tumors, one third had operable tumors but poor prognoses, and one third needed to avoid surgery in order to preserve crucial organs.

Patients received three cycles of induction chemotherapy with either the experimental TPF combination or the control PF combination, followed by chemoradiation therapy as part of a sequential therapy plan. Some patients had surgery after chemoradiotherapy. Fifty centers participated in the study, mostly in North America, Argentina, and Europe.

The average follow-up was 41.9 months. Researchers found that overall survival for the experimental group at three years was 62.1 percent compared with 48.1 percent for the control group. The majority of late side effects were related to radiation therapy. Side effects during chemotherapy were usually temporary and included mouth sores, nausea, vomiting, and low blood count.

“This is the first study with survival as the primary endpoint that used this combination of drugs as induction chemotherapy prior to chemoradiotherapy,” said Marshall R. Posner, MD, Medical Director of the Head and Neck Oncology Program at Dana-Farber Cancer Institute, and the study’s lead author.

“It’s extremely significant to have a third drug to add to our arsenal for this type of cancer, because the standard induction chemotherapy has not changed in 25 years, and survival rates for advanced head and neck cancer have historically been low. In addition, the combination of induction chemotherapy with chemoradiotherapy represents an important change in our treatment paradigm. This study supports sequential therapy with TPF as an acceptable standard of care.”