Marta Maddalo1, Paolo Borghetti1, Davide Tomasini2, Renzo Corvò3, Pierluigi Bonomo4, Alessia Petrucci5, Fabiola Paiar6, Luciana Lastrucci7, Marco Lorenzo Bonù1, Diana Greco1, Loredana Costa1, Ludovica Pegurri1, Luca Triggiani1, Liliana Belgioia3, Isacco Desideri4, Salvatore Grisanti8, Michela Buglione1, Stefano Maria Magrini1. 1. Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy. 2. Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy. Electronic address: tomad88@libero.it. 3. Health Science Department (DISSAL) University of Genova, Genova - Radiation Oncology Department IRCCS San Martino Hospital, Genova, Italy. 4. Department of Radiation Oncology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy. 5. Pistoia Hospital, Azienda Unità Sanitaria Locale No. 3, Pistoia, Italy. 6. Department of Radiation Oncology, Azienda Ospedaliera Universitaria Pisana, University of Pisa, Pisa, Italy. 7. S. Donato Hospital, Azienda Unità Sanitaria Locale No. 8, Arezzo, Italy. 8. Medical Oncology ASST-Spedali Civili, Brescia, Italy.
Abstract
PURPOSE: This study describes the long-term survival and toxicity outcomes of a multicenter randomized phase 2 trial comparing radiation therapy (RT) plus cisplatin (CDDP) or cetuximab (CTX) as first line treatment in locally advanced head and neck cancer (LASCCHN). METHODS AND MATERIALS: Between January 2011 and August 2014, 70 patients were enrolled and randomized to receive RT plus weekly CDDP (40 mg/m2) or CTX (250 mg/m2 plus a loading dose of 400 mg/m2). This updated series focuses on late toxicities (graded by using Common Terminology Criteria for Adverse Events version 4.0) and long-term survival outcomes in terms of local control, overall survival, cancer-specific survival, and metastasis-free survival (MFS). A supplementary analysis based on human papilloma virus (HPV) status was also performed. RESULTS: No statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss). In the CDDP arm and the CTX arm, 5-year local control rates were 67% and 48%; 5-year MFS rates were 83% and 97%; 5-year overall survival rates were 61% and 52%; and 5-year cancer-specific survival rates were 70% and 59%, respectively. None of these differences reached statistical significance. A subgroup analysis by HPV status and anatomic subsites revealed that in HPV+ oropharyngeal carcinoma, better survival was obtained in the CDDP arm (although statistical tests were not performed owing to the small sample size). Conversely, no statistically significant differences were observed in HPV- oropharyngeal carcinoma and other anatomic subsites, except for the confirmed better MFS rates of the CTX arm. CONCLUSIONS: Long-term results are in line with current literature suggesting that RT + CTX is inferior to RT + CDDP for the definitive treatment of LASCCHN. However, if not as an alternative to CDDP, CTX might still play a role in LASCCHN, particularly in HPV- cases.
RCT Entities:
PURPOSE: This study describes the long-term survival and toxicity outcomes of a multicenter randomized phase 2 trial comparing radiation therapy (RT) plus cisplatin (CDDP) or cetuximab (CTX) as first line treatment in locally advanced head and neck cancer (LASCCHN). METHODS AND MATERIALS: Between January 2011 and August 2014, 70 patients were enrolled and randomized to receive RT plus weekly CDDP (40 mg/m2) or CTX (250 mg/m2 plus a loading dose of 400 mg/m2). This updated series focuses on late toxicities (graded by using Common Terminology Criteria for Adverse Events version 4.0) and long-term survival outcomes in terms of local control, overall survival, cancer-specific survival, and metastasis-free survival (MFS). A supplementary analysis based on human papilloma virus (HPV) status was also performed. RESULTS: No statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss). In the CDDP arm and the CTX arm, 5-year local control rates were 67% and 48%; 5-year MFS rates were 83% and 97%; 5-year overall survival rates were 61% and 52%; and 5-year cancer-specific survival rates were 70% and 59%, respectively. None of these differences reached statistical significance. A subgroup analysis by HPV status and anatomic subsites revealed that in HPV+ oropharyngeal carcinoma, better survival was obtained in the CDDP arm (although statistical tests were not performed owing to the small sample size). Conversely, no statistically significant differences were observed in HPV- oropharyngeal carcinoma and other anatomic subsites, except for the confirmed better MFS rates of the CTX arm. CONCLUSIONS: Long-term results are in line with current literature suggesting that RT + CTX is inferior to RT + CDDP for the definitive treatment of LASCCHN. However, if not as an alternative to CDDP, CTX might still play a role in LASCCHN, particularly in HPV- cases.
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