Michela Buglione1, Marta Maddalo2, Renzo Corvò3, Luigi Pirtoli4, Fabiola Paiar5, Luciana Lastrucci6, Marco Stefanacci7, Liliana Belgioia3, Monica Crociani4, Stefania Vecchio8, Pierluigi Bonomo5, Silvia Bertocci6, Paolo Borghetti2, Nadia Pasinetti2, Luca Triggiani2, Loredana Costa2, Sandro Tonoli2, Salvatore Grisanti9, Stefano Maria Magrini2. 1. Department of Radiation Oncology, Brescia University, Istituto del Radio "O. Alberti," Spedali Civili Hospital, Brescia, Italy. Electronic address: michela.buglione@unibs.it. 2. Department of Radiation Oncology, Brescia University, Istituto del Radio "O. Alberti," Spedali Civili Hospital, Brescia, Italy. 3. Department of Radiation Oncology, IRCCS San Martino, IST National Cancer Research Institute and University, Genova, Italy. 4. Department of Radiation Oncology, University of Siena, Siena, Italy. 5. Department of Radiation Oncology, Azienda Ospedaliero, Universitaria Careggi, Firenze, Italy. 6. Department of Radiation Oncology, San Donato Hospital, Arezzo, Italy. 7. Department of Radiation Oncology, Pistoia Hospital, Pistoia, Italy. 8. Department of Medical Oncology, IRCCS San Martino, IST National Cancer Research Institute and University, Genova, Italy. 9. Department of Medical Oncology, Brescia University, Brescia, Italy.
Abstract
PURPOSE: We report a subgroup analysis primarily focused on human papillomavirus (HPV)-related oropharyngeal cancer (OPC) from theCetuximab Plus Radiotherapy Versus Cisplatin Plus Radiotherapy in Locally Advanced Head and Neck Cancer (CTXMAB+RT; ClinicalTrials.gov identifier NCT01216020) trial comparing radiation therapy with concomitant cisplatin (CDDP) versus concomitant cetuximab (CTX) as first-line treatment of locally advanced head and neck cancer. METHODS AND MATERIALS: The data from all the patients in the CTXMAB+RT trial were reviewed and separately analyzed in 3 groups: p16-positive OPC, p16-negative OPC, and all other cancer sites. The endpoints of interest were locoregional control (LC), metastasis-free survival, cancer-specific survival (CSS), and overall survival (OS). Severe and fatal infectious complications were also reanalyzed to more thoroughly investigate the association between CTX treatment and potentially life-threatening reactions. RESULTS: A total of 33 patients had OPC. The HPV status was available for 30 of the 33 patients. Thus, 3 patients treated with CDDP but with unknown HPV status were excluded from the survival analysis. The small number of patients in each group did not allow for significance to be reached for any of the outcomes analyzed. A trend favored the CDDP arm in the p16-positive group for the 2-year LC and OS/CSS rates (100% vs 72.9% and 100% vs 77.8% for CDDP vs CTX). In this group of patients, the hazard ratio for the treatment arm (CTX vs CDDP) was 4.7 (95% confidence interval [CI] 0.5-40.3) for LC, 3.4 (95% CI 0.4-30.5) for OS, and 2.4 for CSS (95% CI 0.2-23.2). A survival benefit favoring the CDDP arm was not evident in the p16-negative OPC group or for patients with cancer located in other sites. Serious or fatal infectious complications occurred only in the CTX arm. CONCLUSIONS: In patients with p16-positive OPC in the CTXMAB+RT trial, CTX had lower efficacy than CDDP, with possible implications for treatment selection in this clinical setting.
RCT Entities:
PURPOSE: We report a subgroup analysis primarily focused on human papillomavirus (HPV)-related oropharyngeal cancer (OPC) from the Cetuximab Plus Radiotherapy Versus Cisplatin Plus Radiotherapy in Locally Advanced Head and Neck Cancer (CTXMAB+RT; ClinicalTrials.gov identifier NCT01216020) trial comparing radiation therapy with concomitant cisplatin (CDDP) versus concomitant cetuximab (CTX) as first-line treatment of locally advanced head and neck cancer. METHODS AND MATERIALS: The data from all the patients in the CTXMAB+RT trial were reviewed and separately analyzed in 3 groups: p16-positive OPC, p16-negative OPC, and all other cancer sites. The endpoints of interest were locoregional control (LC), metastasis-free survival, cancer-specific survival (CSS), and overall survival (OS). Severe and fatal infectious complications were also reanalyzed to more thoroughly investigate the association between CTX treatment and potentially life-threatening reactions. RESULTS: A total of 33 patients had OPC. The HPV status was available for 30 of the 33 patients. Thus, 3 patients treated with CDDP but with unknown HPV status were excluded from the survival analysis. The small number of patients in each group did not allow for significance to be reached for any of the outcomes analyzed. A trend favored the CDDP arm in the p16-positive group for the 2-year LC and OS/CSS rates (100% vs 72.9% and 100% vs 77.8% for CDDP vs CTX). In this group of patients, the hazard ratio for the treatment arm (CTX vs CDDP) was 4.7 (95% confidence interval [CI] 0.5-40.3) for LC, 3.4 (95% CI 0.4-30.5) for OS, and 2.4 for CSS (95% CI 0.2-23.2). A survival benefit favoring the CDDP arm was not evident in the p16-negative OPC group or for patients with cancer located in other sites. Serious or fatal infectious complications occurred only in the CTX arm. CONCLUSIONS: In patients with p16-positive OPC in the CTXMAB+RT trial, CTX had lower efficacy than CDDP, with possible implications for treatment selection in this clinical setting.
Authors: Ambika Parmar; Michaelina Macluskey; Niall Mc Goldrick; David I Conway; Anne-Marie Glenny; Janet E Clarkson; Helen V Worthington; Kelvin Kw Chan Journal: Cochrane Database Syst Rev Date: 2021-12-20
Authors: Nam Bui; Justin K Huang; John Paul Shen; Ana Bojorquez-Gomez; Katherine Licon; Kyle S Sanchez; Sean N Tang; Alex N Beckett; Tina Wang; Wei Zhang; Jason F Kreisberg; Trey Ideker Journal: Mol Cancer Ther Date: 2018-04-10 Impact factor: 6.261