Corrigendum to “Cetuximab activity in dysplastic lesions of the upper aerodigestive tract” [Oral Oncol. 53 (2016) 60–66]

Oral Oncology 53 (2016) 60–66 Contents lists available at ScienceDirect Oral Oncology journal homepage: www.elsevier.com/locate/oraloncology Cetuximab activity in dysplastic lesions of the upper aerodigestive tract q Zubair Khan a , Joel B. Epstein e,1 , Shanthi Marur b , M. Boyd Gillespie f , Lawrence Feldman e , Hua-Ling Tsai a , Zhe Zhang c , Hao Wang c , James Sciubba d , Robert L. Ferris g , Jennifer R. Grandis g , Michael Gibson g , Wayne Koch a , Ralph Tufano a , William Westra b , Nancy Tsottles b , Hiroyuki Ozawa b , Christine Chung b , Joseph A. Califano a,d, ⇑ a Department of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA Oncology Department, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA c Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA d Milton J Dance Head and Neck Center, Greater Baltimore Medical Center, Baltimore, MD, USA e University of Illinois Cancer Center, Chicago, IL, USA f Medical University of South Carolina, Charleston, SC, USA g University of Pittsburg Medical Center, Pittsburgh, PA, USA b a r t i c l e i n f o Article history: Received 7 August 2015 Received in revised form 17 November 2015 Accepted 19 November 2015 Available online 10 December 2015 Keywords: Oral dysplasia Head and neck cancer Head and neck premalignancy s u m m a r y Background: High risk head and neck mucosal premalignancy has a malignant conversion rate of up to 40%, despite adequate surgical therapy. Epidermal Growth Factor Receptor (EGFR) blocking agents, including cetuximab, have shown activity in head and neck squamous cell carcinoma (HNSCC) and have potential for therapy in high risk premalignancy. Methods: We conducted a randomized, prospective, phase II clinical trial to determine the effects of cetuximab on patients with high risk premalignancy. Patients were randomized to treatment with cetux- imab 400 mg/m 2 on week one followed by 250 mg/m 2 on week 2–8 or observation, with the option for crossover to cetuximab therapy for patients originally randomized to the observation arm. Results: Two of 19 enrolled patients did not complete therapy due to treatment toxicity. Analysis of 17 patients who completed the trial regimen show a trend toward a larger mean decrease in grade of dys- plasia in the cetuximab treated group ( 1.0) vs. the observation group ( 0.2) (P = 0.082, one-sided exact Wilcoxon rank sum test). However, in the observation group, none of the 5 patients (0%) achieved com- plete resolution of dysplasia; while 4 of 12 (33.3%) cetuximab treated patients had no remaining dys- plasia after therapy. Conclusions: Treatment of high risk premalignancy of the upper aerodigestive tract with cetuximab alone may result in significant, durable, and complete clinical and histological resolution of moderate to severe dysplasia in at least a subset of high risk patients. These results warrant further investigation in larger studies with increased statistical power. O 2015 Elsevier Ltd. All rights reserved. Background q This study was supported by National Cancer Institute Grant R21CA126055. ⇑ Corresponding author at: Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of California at San Diego, 3855 Health Sciences Dr., MC 0803La Jolla, CA 92037-0803, USA. E-mail address: jcalifano@ucsd.edu (J.A. Califano). Present address: Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA and City of Hope National Medical Center, Duarte, CA, USA. http://dx.doi.org/10.1016/j.oraloncology.2015.11.016 1368-8375/O 2015 Elsevier Ltd. All rights reserved. Over 45,000 new cases of HNSCC are diagnosed in the United States yearly, and this disease affects over 600,000 people world- wide [12]. Despite high cure rates for early stage cancers, the majority of late stage malignancies are fatal. Molecular genetic progression models and data on pre-malignant lesions have demonstrated that chromosomal loss occurs early in HNSCC pro- gression. Early detection can improve patient survival and dimin- ish the morbidity of treatment for advanced disease and hence