title: Economic analysis of amifostine as adjunctive support for patients with advanced head and neck cancer: preliminary results from a randomized phase II clinical trial from Germany.
abstract: In a randomized phase II trial in Germany, we investigated the clinical and economic impact of amifostine protection against the hematological and oral toxicities of carboplatin administered concurrently with standard fractions of radiotherapy. 28 patients with squamous cell carcinomas of the head and neck received adjunctive or primary radiotherapy (5 days per week with daily fractions of 2 Gy, up to a total dose of 60 Gy) in conjunction with carboplatin (70 mg/m2) 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 receive 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 the control arm, had significantly fewer episodes of grade 3 or 4 thrombocytopenia (p = 0.001), mucositis (p = 0.001), and xerostomia (p = 0.001). The patients receiving amifostine accrued significantly lower supportive care costs for resources related to infection ($241 vs. $1,275, p < 0.01), red blood cell and platelet support ($286 vs. $1,276 p = 0.06) alimentation ($343 vs. $894, p = .01), and hospitalization ($286 vs. $2,429, p < 0.01). Overall, including the costs of amifostine, mean per patient supportive care costs 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 cytoprotection 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.
authors: Lakeside VA Medical Center, 400 East Ontario Street, Suite 205, Chicago, IL 60611, USA. cbenne@nwu.edu
authors: C L
authors: CL
authors: Bennett
authors: D
authors: D
authors: Lane
authors: T
authors: T
authors: Stinson
authors: M
authors: M
authors: Glatzel
authors: J
authors: J
authors: Buntzel
mesh_terms: D004999:Amifostine / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000191:economics / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy; D003365:Costs and Cost Analysis; D005260:Female; D005858:Germany; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000191:economics / Q000532:radiotherapy* / Q000601:surgery; D006760:Hospitalization / Q000191:economics; D006801:Humans; D008297:Male; D008875:Middle Aged; D011837:Radiation-Protective Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D011878:Radiotherapy / Q000009:adverse effects; D011879:Radiotherapy Dosage; D012468:Salivary Gland Neoplasms / Q000188:drug therapy / Q000532:radiotherapy; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011837:Radiation-Protective Agents; D016190:Carboplatin; D004999:Amifostine