The combination of cetuximab, cisplatin, fluorouracil and radiotherapy leads to a very high proportion of CR and it is feasible with toxic effects similar to those expected by radiochemotherapy. The only unexpected toxicity was skin toxicity: grade 3 radiodermatitis occurred in 73% of the patients.

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The aim of this multicenter trial was to test the feasibility and the activity of a three-drug combination where paclitaxel is added to cisplatin and 5-fluorouracil. Patients with metastatic or relapsed SCC-HN unsuitable for further loco-regional radical treatment, not previously treated with chemotherapy, were eligible to receive paclitaxel 160 mg/m2 (3-hr infusion) day 1, CDDP 25 mg/m2/day and 5-FU 250 mg/m2/day bolus on days 1, 2, 3 every three weeks up to a maximum of five courses. Fourty-seven patients were enrolled by five Institutions in Italy. Main grade III-IV toxicities were: neutropenia (48%), thrombocytopenia (6%), anemia (4%), diarrhea (2%), mucositis (2%). Six patients had a complete response (13.3%) and eight a partial response (17.8%). Median progression free survival and overall survival are 4.1 and 7.9 months. One-year progression free survival and overall survival are 16% and 29%. This three-drug regimen has an excellent safety profile. The activity in the palliation of recurrent SCC-HN, however, does not appear to be improved in comparison with cisplatin and 5-fluorouracil or cisplatin and paclitaxel regimens. Recent studies indicate a more promising role of taxanes including triplets in the induction therapy of previously untreated patients.

6043 Background: C-mab is a monoclonal antibody targeting EGFR. C-mab combined with radiotherapy (RT) improved loco- regional control and overall survival over RT alone in HNC pts (Bonner 2006). Prior data of C-mab and CT-RT (Pfister 2006) were encouraging but the trial was stopped due to an excess of severe toxicities, suggesting the need for a less toxic scheduling. For these reasons we evaluate the safety and activity of C-mab combined with alternating CT-RT in HNC pts. Methods: The primary end-point is C.R. rate. The optimal two stage design was used: the calculated sample size is 45 pts. Eligible pts have locally advanced, measurable, untreated, stage III/IV HNC (excluding nasopharynx). Chemotherapy (CT) consists of Cis-PT 20 mg/m2/day and bolus 5Fu 200 mg/m2/day from day 1 to 5, repeated on days 22 and 43. RT, 2 Gy/day, 5 days a week, is given in the pauses between the chemotherapy courses and after the last CT week, up to a total dose of 70 Gy. Results: From 10/2005 to 12/2006 24 pts were enrolled: median age 59 (49–75); median ECOG P.S. 0 (0–1); Stage IV 73%; N1–3 86%; EGFR >80% cells: 55%; EGFR 3+: 91%; most pts had hypopharynx cancer, only 1 had oral cavity tumor. Toxicity is evaluable on 20 pts (4 ongoing). Grade 3–4 toxicities included febrile neutropenia (20%), diarrhea (20%), hypomagnesaemia (10%), mucositis (60%). Unexpected skin toxicity, starting as desquamating moist dermatitis and confined at the irradiated field, occurred in 18/20 pts, usually during the second part of the treatment. Acute colon diverticulitis with perforation (1 pt), gastric perforation (1 pt), fatal myocardial infarction (1 pt) and arterial thrombosis (1 pt) also occurred. Responses, evaluated 3 months after the treatment, are available for the first 16 pts. Objective responses were observed in all them (11 CR + 5 PR). Two PRs were then rendered disease free with salvage surgery. At a maximum follow-up of 15 months, 16/20 pts are alive and 16/20 progression free. Conclusions: This trial showed a skin toxicity not previously reported in other experiences of C-mab combined with RT or CT-RT. Preliminary activity data seems to confirm the Pfister experience. No significant financial relationships to disclose.

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