William N William1, Lei Feng2, Renata Ferrarotto3, Lawrence Ginsberg4, Merrill Kies3, Scott Lippman5, Bonnie Glisson3, Edward S Kim6. 1. Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas. Electronic address: wnwillia@mdanderson.org. 2. Department of Biostatistics, The University of Texas M.D. Anderson Cancer Center, Houston, Texas. 3. Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas. 4. Department of Diagnostic Radiology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas. 5. Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas; Moores Cancer Center, University of California San Diego, La Jolla, California. 6. Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas; Levine Cancer Institute, Carolinas HealthCare System, Charlotte, North Carolina.
Abstract
BACKGROUND: Preclinical data demonstrate a key role for the epidermal growth factor receptor (EGFR) in the carcinogenesis of cutaneous squamous cell carcinomas (CSCCs). There are, however, limited data on the efficacy of EGFR inhibitors in incurable, recurrent, and/or metastatic CSCC. OBJECTIVE: To determine the response rate to gefitinib in patients with CSCC not amenable to curative therapy including surgery or radiation. METHODS: This was a single-arm phase II study. A total of 40 patients were treated with gefitinib, 250 mg orally daily, until disease progression or intolerable toxicities. The prespecified target response rate of interest was 20%. RESULTS: The overall response rate was 16% (95% confidence interval, 0.06-0.32; 6 partial responses in 37 evaluable patients). An additional 13 patients (35%) had stable disease at 8 weeks. The median durations of response and progression-free survival were 31.4 months (95% confidence interval, 3.91-not applicable) and 3.8 months (95% confidence interval, 2.2-5.7), respectively. The side effect profile was consistent with the previous experience with gefitinib in other tumor types. LIMITATIONS: This was a single-institution, single-arm study. The prespecified target response rate was not met. CONCLUSION: Gefitinib demonstrated modest activity in incurable CSCC, with a favorable adverse event profile.
BACKGROUND: Preclinical data demonstrate a key role for the epidermal growth factor receptor (EGFR) in the carcinogenesis of cutaneous squamous cell carcinomas (CSCCs). There are, however, limited data on the efficacy of EGFR inhibitors in incurable, recurrent, and/or metastatic CSCC. OBJECTIVE: To determine the response rate to gefitinib in patients with CSCC not amenable to curative therapy including surgery or radiation. METHODS: This was a single-arm phase II study. A total of 40 patients were treated with gefitinib, 250 mg orally daily, until disease progression or intolerable toxicities. The prespecified target response rate of interest was 20%. RESULTS: The overall response rate was 16% (95% confidence interval, 0.06-0.32; 6 partial responses in 37 evaluable patients). An additional 13 patients (35%) had stable disease at 8 weeks. The median durations of response and progression-free survival were 31.4 months (95% confidence interval, 3.91-not applicable) and 3.8 months (95% confidence interval, 2.2-5.7), respectively. The side effect profile was consistent with the previous experience with gefitinib in other tumor types. LIMITATIONS: This was a single-institution, single-arm study. The prespecified target response rate was not met. CONCLUSION:Gefitinib demonstrated modest activity in incurable CSCC, with a favorable adverse event profile.
Authors: Carol M Lewis; Bonnie S Glisson; Lei Feng; Fiona Wan; Ximing Tang; Ignacio I Wistuba; Adel K El-Naggar; David I Rosenthal; Mark S Chambers; Robert A Lustig; Randal S Weber Journal: Clin Cancer Res Date: 2012-01-18 Impact factor: 12.531
Authors: Rami N Al-Rohil; Ashley J Tarasen; J Andrew Carlson; Kai Wang; Adrienne Johnson; Roman Yelensky; Doron Lipson; Julia A Elvin; Jo-Anne Vergilio; Siraj M Ali; James Suh; Vincent A Miller; Philip J Stephens; Prasanth Ganesan; Filip Janku; Daniel D Karp; Vivek Subbiah; Martin C Mihm; Jeffrey S Ross Journal: Cancer Date: 2015-10-19 Impact factor: 6.860
Authors: Taghrid B El-Abaseri; Jill Fuhrman; Carol Trempus; Igor Shendrik; Raymond W Tennant; Laura A Hansen Journal: Cancer Res Date: 2005-05-01 Impact factor: 12.701
Authors: Andreas Mauerer; Eva Herschberger; Wolfgang Dietmaier; Michael Landthaler; Christian Hafner Journal: Exp Dermatol Date: 2011-07-19 Impact factor: 3.960
Authors: Young Wook Park; Maher N Younes; Samar A Jasser; Orhan G Yigitbasi; Ge Zhou; Corazon D Bucana; Benjamin N Bekele; Jeffrey N Myers Journal: Clin Cancer Res Date: 2005-03-01 Impact factor: 12.531
Authors: M C Foote; M McGrath; A Guminski; B G M Hughes; J Meakin; D Thomson; D Zarate; F Simpson; S V Porceddu Journal: Ann Oncol Date: 2014-08-04 Impact factor: 32.976
Authors: Keith Syson Chan; Steve Carbajal; Kaoru Kiguchi; John Clifford; Shigetoshi Sano; John DiGiovanni Journal: Cancer Res Date: 2004-04-01 Impact factor: 12.701
Authors: Curtis R Pickering; Jane H Zhou; J Jack Lee; Jennifer A Drummond; S Andrew Peng; Rami E Saade; Kenneth Y Tsai; Jonathan L Curry; Michael T Tetzlaff; Stephen Y Lai; Jun Yu; Donna M Muzny; Harshavardhan Doddapaneni; Eve Shinbrot; Kyle R Covington; Jianhua Zhang; Sahil Seth; Carlos Caulin; Gary L Clayman; Adel K El-Naggar; Richard A Gibbs; Randal S Weber; Jeffrey N Myers; David A Wheeler; Mitchell J Frederick Journal: Clin Cancer Res Date: 2014-10-10 Impact factor: 12.531
Authors: Kathryn A Gold; Merrill S Kies; William N William; Faye M Johnson; J Jack Lee; Bonnie S Glisson Journal: Cancer Date: 2018-03-26 Impact factor: 6.860
Authors: Neil K Mehta; Andraia R Li; Shaun A Nguyen; John M Kaczmar; David M Neskey; Terry A Day Journal: Target Oncol Date: 2021-10-22 Impact factor: 4.864
Authors: Kristin Bibee; Andrew Swartz; Shaum Sridharan; Cornelius H L Kurten; Charles B Wessel; Heath Skinner; Dan P Zandberg Journal: Oral Oncol Date: 2020-02-14 Impact factor: 5.337
Authors: Michael R Migden; Nikhil I Khushalani; Anne Lynn S Chang; Karl D Lewis; Chrysalyne D Schmults; Leonel Hernandez-Aya; Friedegund Meier; Dirk Schadendorf; Alexander Guminski; Axel Hauschild; Deborah J Wong; Gregory A Daniels; Carola Berking; Vladimir Jankovic; Elizabeth Stankevich; Jocelyn Booth; Siyu Li; David M Weinreich; George D Yancopoulos; Israel Lowy; Matthew G Fury; Danny Rischin Journal: Lancet Oncol Date: 2020-01-14 Impact factor: 41.316