Naoki Nishio1, Nynke S van den Berg1, Stan van Keulen1,2, Brock A Martin3, Shayan Fakurnejad1, Quan Zhou1, Guolan Lu1, Stefania U Chirita1,4, Michael J Kaplan1, Vasu Divi1, Alexander D Colevas5, Eben L Rosenthal6. 1. Department of Otolaryngology-Head and Neck Surgery, Stanford University, 875 Blake Wilbur Drive, Palo Alto, CA, 94304, USA. 2. Department of Oral and Maxillofacial Surgery/Oral Pathology, VU University Medical Center/Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, The Netherlands. 3. Department of Pathology, Stanford University, Stanford, CA, USA. 4. Cancer Clinical Trials Office, Stanford Cancer Institute, Stanford University, Stanford, CA, USA. 5. Department of Medicine, Division of Medical Oncology, Stanford University, Stanford, CA, USA. 6. Department of Otolaryngology-Head and Neck Surgery, Stanford University, 875 Blake Wilbur Drive, Palo Alto, CA, 94304, USA. elr@stanford.edu.
Abstract
PURPOSE: To identify the optimal dosing strategy for fluorescence-guided surgery in patients with head and neck squamous cell carcinoma, we conducted a dose-ranging study evaluating the anti-epidermal growth factor receptor (EGFR) therapeutic antibody, panitumumab, that was fluorescently labeled with the near-infrared dye IRDye800CW. PROCEDURES: Patients (n = 24) received either 0.5 or 1.0 mg/kg panitumumab-IRDye800CW in the weight-based dosing group or 25 or 50 mg panitumumab-IRDye800CW in the fixed dosing group. Following surgery, whole primary specimens were imaged in a closed-field device and the mean fluorescence intensity (MFI) and tumor-to-background ratio (TBR) were assessed. Clinical variables, including dose, time of infusion-to-surgery, age, unlabeled dose, gender, primary tumor site, and tumor size, were analyzed to evaluate the factors affecting the fluorescence intensity in order to identify the optimal dose for intraoperative fluorescence imaging. RESULTS: A total of 24 primary tumor specimens were imaged and analyzed in this study. Although no correlations between TBR and dose of panitumumab-IRDye800CW were found, there were moderate-strong correlations between the primary tumor MFI and panitumumab-IRDye800CW dose for fixed dose (mg) (R2 = 0.42) and for dose/weight (mg/kg) (R2 = 0.54). Results indicated that the optimal MFI was at approximately 50 mg for fixed dose and 0.75 mg/kg for dose/weight. No significant differences were found for the primary tumor MFI and TBRs between the weight-based dosing and the fixed dosing groups. MFIs significantly increased when the infusion-to-surgery window was reduced to within 2 days (vs. 3 days or more, p < 0.05). CONCLUSIONS: Antibody-based imaging for surgical resection is under investigation in multiple clinical trials. Our data suggests that a fixed dose of 50 mg is an appropriate diagnostic dose for successful surgical fluorescence imaging.
PURPOSE: To identify the optimal dosing strategy for fluorescence-guided surgery in patients with head and neck squamous cell carcinoma, we conducted a dose-ranging study evaluating the anti-epidermal growth factor receptor (EGFR) therapeutic antibody, panitumumab, that was fluorescently labeled with the near-infrared dye IRDye800CW. PROCEDURES: Patients (n = 24) received either 0.5 or 1.0 mg/kg panitumumab-IRDye800CW in the weight-based dosing group or 25 or 50 mg panitumumab-IRDye800CW in the fixed dosing group. Following surgery, whole primary specimens were imaged in a closed-field device and the mean fluorescence intensity (MFI) and tumor-to-background ratio (TBR) were assessed. Clinical variables, including dose, time of infusion-to-surgery, age, unlabeled dose, gender, primary tumor site, and tumor size, were analyzed to evaluate the factors affecting the fluorescence intensity in order to identify the optimal dose for intraoperative fluorescence imaging. RESULTS: A total of 24 primary tumor specimens were imaged and analyzed in this study. Although no correlations between TBR and dose of panitumumab-IRDye800CW were found, there were moderate-strong correlations between the primary tumor MFI and panitumumab-IRDye800CW dose for fixed dose (mg) (R2 = 0.42) and for dose/weight (mg/kg) (R2 = 0.54). Results indicated that the optimal MFI was at approximately 50 mg for fixed dose and 0.75 mg/kg for dose/weight. No significant differences were found for the primary tumor MFI and TBRs between the weight-based dosing and the fixed dosing groups. MFIs significantly increased when the infusion-to-surgery window was reduced to within 2 days (vs. 3 days or more, p < 0.05). CONCLUSIONS: Antibody-based imaging for surgical resection is under investigation in multiple clinical trials. Our data suggests that a fixed dose of 50 mg is an appropriate diagnostic dose for successful surgical fluorescence imaging.
Entities:
Keywords:
EGFR; Fluorescence; Head and neck cancer; IRDye800CW; Image-guided surgery; Near-infrared imaging; Optimal dosing strategy; Panitumumab
Authors: Venu G Bandi; Michael P Luciano; Mara Saccomano; Nimit L Patel; Thomas S Bischof; Jakob G P Lingg; Peter T Tsrunchev; Meredith N Nix; Bastian Ruehle; Chelsea Sanders; Lisa Riffle; Christina M Robinson; Simone Difilippantonio; Joseph D Kalen; Ute Resch-Genger; Joseph Ivanic; Oliver T Bruns; Martin J Schnermann Journal: Nat Methods Date: 2022-02-28 Impact factor: 47.990
Authors: Guolan Lu; Nynke S van den Berg; Brock A Martin; Naoki Nishio; Zachary P Hart; Stan van Keulen; Shayan Fakurnejad; Stefania U Chirita; Roan C Raymundo; Grace Yi; Quan Zhou; George A Fisher; Eben L Rosenthal; George A Poultsides Journal: Lancet Gastroenterol Hepatol Date: 2020-05-14
Authors: Tessa Buckle; Albertus W Hensbergen; Danny M van Willigen; Frank Bosse; Kevin Bauwens; Rob C M Pelger; Fijs W B van Leeuwen Journal: EJNMMI Res Date: 2021-05-29 Impact factor: 3.138
Authors: Solmaz AghaAmiri; Jo Simien; Alastair M Thompson; Julie Voss; Sukhen C Ghosh; Servando Hernandez Vargas; Sarah Kim; Ali Azhdarinia; Hop S Tran Cao Journal: Mol Imaging Date: 2021-02-02 Impact factor: 4.488
Authors: Syed Muhammad Usama; Ek Raj Thapaliya; Michael P Luciano; Martin J Schnermann Journal: Curr Opin Chem Biol Date: 2021-03-05 Impact factor: 8.972
Authors: Quan Zhou; Nynke S van den Berg; Eben L Rosenthal; Michael Iv; Michael Zhang; Johana C M Vega Leonel; Shannon Walters; Naoki Nishio; Monica Granucci; Roan Raymundo; Grace Yi; Hannes Vogel; Romain Cayrol; Yu-Jin Lee; Guolan Lu; Marisa Hom; Wenying Kang; Melanie Hayden Gephart; Larry Recht; Seema Nagpal; Reena Thomas; Chirag Patel; Gerald A Grant; Gordon Li Journal: Theranostics Date: 2021-05-21 Impact factor: 11.556
Authors: Giri Krishnan; Nynke S van den Berg; Naoki Nishio; Georgina Juniper; Jaqueline Pei; Quan Zhou; Guolan Lu; Yu-Jin Lee; Kimberly Ramos; Andrei H Iagaru; Fred M Baik; Alexander D Colevas; Brock A Martin; Eben L Rosenthal Journal: Theranostics Date: 2021-05-24 Impact factor: 11.556