Sixty-two patients with HPV-related head and neck cancers were enrolled in OPTIMA. Patients were classified as either low-risk (?T3, ?N2B, ?10 pack-year smoking history) (45% of patients) or high-risk (T4 or ?N2C or >10 pack-years) (55%). The median patient age was 57 years (range 31-85 years), and most patients (85%) were male.
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. Patients without a favorable response received regular-dose chemoradiation therapy to 75 Gy. Radiation therapy was delivered over five weeks of 2 Gy daily fractions on the RT50 arm. On the CRT45 and CRT75 arms, treatment consisted of paclitaxel, 5-fluorouracil and hydroxyurea systemic therapy with 1.5 Gy twice-daily radiation every other week. Median follow-up for the study was 22.3 months (range 9-39 months).
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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. One high-risk patient on the CRT45 arm experienced a local recurrence at 11 months following treatment, but the recurrence was treated with salvage surgery.
Side effects from de-escalated therapy were significantly improved compared to standard treatment. Rates of grade 3 or higher mucositis were 16 percent for RT50, 46 percent for CRT45 and 60 percent for CRT75 (p = 0.033). No RT50 patients experienced grade three or higher dermatitis, and the rates were 21 percent for CRT45 and 30 percent for CRT75 (p = 0.056). No RT50 patients experienced long-term dependency on a feeding tube, and the rates were 3.5 percent for CRT45 and 9 percent for CRT75 (p < 0.0001).
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