Economic analysis of amifostine as adjunctive support for patients with advanced head and neck cancer: Preliminary results from a randomized phase IIclinical trial from Germany

In a randomized phase II trial in Germany, we investigated the clinical and economic impact of amifostine protection against the hematological and ora l toxicities of carboplatin administered concurrently with standard fractio ns of radiotherapy. 28 patients with squamous cell carcinomas of the head and neck received adj unctive or primary radiotherapy (5 days per week with daily fractions of 2 Gy, up to a total dose of 60 Gy) in conjuction with carboplatin (70 mg/m(2) ) on days 1-5 and days 21-26. All patients received radiation encompassing at least 75% of the major salivary glands. Patients were randomized to rece ive radiation and carboplatin (RCT) alone or RCT preceded by rapid infusion of amifostine (500 mg) on days carboplatin was administered. The 14 patients who received amifostine, in comparison to 14 patients in th e control arm, had significantly fewer episodes of grade 3 or 4 thrombocyto penia (p = 0.001), mucositis (p = 0.001), and xerostomia (p = 0.001). The p atients receiving amifostine accrued significantly lower supportive care co sts for resources related to infection ($241 vs. $1,275, p < 0.01), red blo od cell and platelet support ($286 vs. $1,267 p = 0.06) alimentation ($343 vs. $894, p = .01), and hospitalization ($286 vs. $2,429, p < 0.01). Overal l, including the costs of amifostine, mean per patient supportive care cost s were $4,401 for the amifostine group and $5,873 (p = .02) for the control group. Our results from a randomized phase II trial indicate that selective cytopr otection with amifostine potentially offers clinical and economic benefits in patients with advanced head and neck cancer receiving radiochemotherapy. Additional economic studies alongside randomized phase III trials and from other countries are needed.