Cisplatin-based chemoradiation plus cetuximab in locally advanced head and neck cancer: a phase II clinical study

• Published in: Annals of oncology Vol. 22; no. 3; pp. 712 - 717
• Main Authors: Merlano, M., Russi, E., Benasso, M., Corvò, R., Colantonio, I., Vigna-Taglianti, R., Vigo, V., Bacigalupo, A., Numico, G., Crosetto, N., Gasco, M., Lo Nigro, C., Vitiello, R., Violante, S., Garrone, O.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.03.2011; Oxford University Press
• Subjects: Adult; Aged; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal, Humanized; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Biological and medical sciences; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - mortality; Carcinoma, Squamous Cell - radiotherapy; Cetuximab; chemoradiation; Cisplatin - administration & dosage; Combined Modality Therapy; Female; head and neck cancer; Head and Neck Neoplasms - drug therapy; Head and Neck Neoplasms - mortality; Head and Neck Neoplasms - radiotherapy; Humans; Kaplan-Meier Estimate; Male; Medical sciences; Middle Aged; Neoplasm Recurrence, Local; Neoplasm Staging; Otorhinolaryngology (head neck, general aspects and miscellaneous); Otorhinolaryngology. Stomatology; Pharmacology. Drug treatments; Radiodermatitis - chemically induced; Treatment Outcome; Tumors; Young Adult; head and neck cancer; cetuximab; chemoradiation; Antineoplastic agent; Human; Monoclonal antibody; Malignant tumor; Radiotherapy; Epidermal growth factor receptor; Cisplatin; Alkylating agent; Chemotherapy; Treatment; Phase II trial; ENT disease; Head and neck cancer; Combined treatment; Locally advanced stage; Cetuximab; Cancer; Platinum II Complexes
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdq412

Intensification of chemoradiation for advanced head and neck squamous cell carcinoma (HNSCC) is unlikely due to toxicity. Cetuximab combined either with radiotherapy or with chemotherapy showed favourable toxic profile with positive results in both combinations. Therefore, cetuximab could intensify chemoradiation without worsening toxicity. We conducted a phase II study of chemoradiation and cetuximab. Eligible patients had stage III–IV M0 HNSCC. Treatment consisted of three cycles of cisplatin (20 mg/m2/day × 5 days) and fluorouracil (200 mg/m2/day × 5 days) rapidly alternated to three split courses of radiotherapy up to 70 Gy and concurrent weekly cetuximab. The primary end point of the study was complete response (CR) rate. Secondary end points were toxicity, progression-free survival (PFS) and overall survival (OS). Fourty-five patients were enrolled: median age was 56 years, 38 had stage IV disease and 40 nodal involvement. CR occurred in 32 patients (71%). PFS and OS was 21+ months and 32.6+, respectively. Acute grade 3–4 toxic effects were in the expected range, but grade 3 radiodermatitis occurred in 33 patients. 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.