Quality-of-life assessment after supradose selective intra-arterial cisplatin and concomitant radiation (RADPLAT) for inoperable stage IV head and neck squamous cell carcinoma

Objective: To evaluate quality-of-life (QOL) aspects of an organ preservation intra-arterial chemotherapy and concomitant radiation protocol, RADPLAT. Design: Nonrandomized phase 2B feasibility trial Patients: Fifty consecutive patients with inoperable stage IV head and neck cancer. Intervention: Supradose selective intra-arterial cisplatin and concomitant standard radiation (RADPLAT). Measures: Assessment with structured questionnaires before treatment and at 3, 6, and 12 months. Results: Twenty-six patients were available for QOL assessment at 1 year (the "1-year QOL" group), as 16 patients died, 5 needed salvage surgery, and 3 were not available for interview (the "failure" group). Twelve-month results were mainly based on the first group. The functional well-being and head and neck scales showed a statistically significant improvement over time (P<.001). After 12 months, 21 patients (81%) returned to an oral diet, while 5 patients still needed tube feeding. For 23 patients (88%), the quality and strength of the voice was more or less normal. Of the 18 patients who were employed before their treatment, 10 were able to return to their job within 12 months. Xerostomia was reported by 17 patients (65%). Further detailed analysis showed statistically significant differences in pretreatment scores between the I-year QOL group and the failure group, ie, physical well-being, functional well-being, and the head and neck scales (P<.05). Differences in these groups with respect to sex, age, tumor site, or stage could not be found. Conclusion: Given that only patients with locally (anatomic or functional) inoperable stage IV disease were treated, the results are promising, underlining the feasibility of the RADPLAT protocol.