BACKGROUND: Concurrent inhibition of epidermal growth factor receptor (EGFR) and cyclooxygenase-2 (COX-2) is an active and well tolerated regimen in recurrent head and neck cancer (HNC). In the current phase 1 trial, the authors sought to determine the maximum tolerated dose (MTD) and efficacy of concurrent erlotinib and celecoxib as a radiosensitizing regimen. METHODS: Fourteen patients with previously irradiated HNC with no distant metastases who required reirradiation were eligible. Treatment consisted of daily erlotinib 150 mg and twice daily celecoxib (escalated from 200 mg to 600 mg using a 3 + 3 design with an expanded cohort at the MTD) starting on Day 1 and was continued during radiation. Daily radiation was started on Day 15, and maintenance erlotinib was recommended. RESULTS: The recommended phase 2 dose of celecoxib was 400 mg. Three dose-limiting toxicities included late in-field orocutaneous fistula (Dose Level 2), osteonecrosis (Dose Level 3), and trismus (Dose Level 3). Acute grade ≥ 3 toxicities were uncommon and included mucositis (21%) and dermatitis (14%). At a median follow-up of 11 months, the 1-year locoregional control, progression-free survival, and overall survival rates were 60%, 37%, and 55%, respectively. CONCLUSIONS: Concurrent erlotinib, celecoxib, and reirradiation was a feasible and clinically active regimen in a population of patients with recurrent HNC who had a poor prognosis.
BACKGROUND: Concurrent inhibition of epidermal growth factor receptor (EGFR) and cyclooxygenase-2 (COX-2) is an active and well tolerated regimen in recurrent head and neck cancer (HNC). In the current phase 1 trial, the authors sought to determine the maximum tolerated dose (MTD) and efficacy of concurrent erlotinib and celecoxib as a radiosensitizing regimen. METHODS: Fourteen patients with previously irradiated HNC with no distant metastases who required reirradiation were eligible. Treatment consisted of daily erlotinib 150 mg and twice daily celecoxib (escalated from 200 mg to 600 mg using a 3 + 3 design with an expanded cohort at the MTD) starting on Day 1 and was continued during radiation. Daily radiation was started on Day 15, and maintenance erlotinib was recommended. RESULTS: The recommended phase 2 dose of celecoxib was 400 mg. Three dose-limiting toxicities included late in-field orocutaneous fistula (Dose Level 2), osteonecrosis (Dose Level 3), and trismus (Dose Level 3). Acute grade ≥ 3 toxicities were uncommon and included mucositis (21%) and dermatitis (14%). At a median follow-up of 11 months, the 1-year locoregional control, progression-free survival, and overall survival rates were 60%, 37%, and 55%, respectively. CONCLUSIONS: Concurrent erlotinib, celecoxib, and reirradiation was a feasible and clinically active regimen in a population of patients with recurrent HNC who had a poor prognosis.
Authors: Rajesh V Lalla; Linda E Choquette; Kathleen F Curley; Robert J Dowsett; Richard S Feinn; Upendra P Hegde; Carol C Pilbeam; Andrew L Salner; Stephen T Sonis; Douglas E Peterson Journal: Oral Oncol Date: 2014-08-21 Impact factor: 5.337
Authors: Dong M Shin; Hongzheng Zhang; Nabil F Saba; Amy Y Chen; Sreenivas Nannapaneni; A R M Ruhul Amin; Susan Müller; Melinda Lewis; Gabriel Sica; Scott Kono; Johann C Brandes; William J Grist; Rachel Moreno-Williams; Jonathan J Beitler; Sufi M Thomas; Zhengjia Chen; Hyung Ju C Shin; Jennifer R Grandis; Fadlo R Khuri; Zhuo Georgia Chen Journal: Clin Cancer Res Date: 2013-02-19 Impact factor: 12.531
Authors: Nabil F Saba; Selwyn J Hurwitz; Scott A Kono; Chung S Yang; Yang Zhao; Zhengjia Chen; Gabe Sica; Susan Müller; Rachel Moreno-Williams; Melinda Lewis; William Grist; Amy Y Chen; Charles E Moore; Taofeek K Owonikoko; Suresh Ramalingam; Jonathan J Beitler; Sreenivas Nannapaneni; Hyung Ju C Shin; Jennifer R Grandis; Fadlo R Khuri; Zhuo Georgia Chen; Dong M Shin Journal: Cancer Prev Res (Phila) Date: 2013-10-03