Phase II clinical trial preliminary report: Cetuximab, gemcitabine and simultaneous radiotherapy for locally advanced head and neck cancer: Preliminary report

15502 Background: Previous studies with cetuximab in SCCHN demonstrate to be clinically beneficial. In the present study we wished to evaluate the efficacy and safety of a chemotherapeutic scheme using gemcitabine, radiotherapy and cetuximab for SCCHN. Preliminary report of 20 of 40 enrolled patients into a phase II clinical trial. Methods: inclusion criteria; histological confirmation of epidermoid carcinoma, ages 18 to 70, K > 70%, normal renal, hepatic and haematologic functions, without previous treatment, surgically inoperable disease, or patients with operable disease that did not consent to surgery. All patients signed an informed consent form. Radiotherapy: 200 cGy/d/5/w until 70Gy were completed. Cetuximab: an initial dose of 400 mg/m2 one week prior to initiation of radiotherapy, followed by 250 mg/m2 weekly until completion of radiotherapy. Gemcitabine: 50 mg /m2 weeks 1–2, 4–5 and 7. Results: 20 patients were enrolled (16m/4f) from november of 2004 to november of 2005, (5 oral cavity, 5 oropharynx, 8 larynx, 1 hypopharynx and 1 paranasal sinus). Mean age 56 yrs (33–75). Tumor staging: 7/III, 8/IVa and 5/IVb. One female was excluded, 19 completed the study and were evaluated. GR 17/19 (89.5%), CR 13/17 (76.5%) and PR 4/17 (23.5%). 2/19 NR (10.5%). CR of the 1ary tumor 15/19 patients (78.9%); CR 6/11 patients with lymphatic disease at diagnosis (54.5%), PR 3/19 (27.3%). Toxicity: mucositis g/III-IV 8/19 patients; rash g/III 4 patients. 2/19 did not complete treatment with chemotherapy due to mucositis but did with radiotherapy. No relationship was found between clinical response and the severity of the rash. One patient developed leukopenia g/III. 4 patients developed disphagia g/II, one has not resolved after 8 month follow up. Xerostomia g/II was 7/19 patients. Dermatological toxicity resolved by the end of the treatment. Mean follow up: 6 months, 1 patient which did not respond died and 1 patient with a PR recurred. Conclusions: The scheme is safe and effective with tolerable toxicity. In our previously reported experience, the addition of cetuximab to gemcitabine and radiotherapy does not increment local toxicity, statistical validation of these findings require the completion of the 40 patient study. No significant financial relationships to disclose.