Remco de Bree1, Lisa van der Putten2, Harm van Tinteren3, Jan Wedman4, Wim J G Oyen5, Luuk M Janssen6, Michiel W M van den Brekel7, Emile F I Comans8, Jan Pruim9, Robert P Takes10, Monique G G Hobbelink11, Renato Valdés Olmos12, Bernard F A M van der Laan4, Maarten Boers13, Otto S Hoekstra8, C René Leemans2. 1. Department of Otolaryngology - Head and Neck Surgery, VU University Medical Center, Amsterdam, The Netherlands; Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, University Medical Center Utrecht, The Netherlands. Electronic address: r.bree@vumc.nl. 2. Department of Otolaryngology - Head and Neck Surgery, VU University Medical Center, Amsterdam, The Netherlands. 3. Department of Statistics, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands. 4. Department of Otorhinolaryngology - Head & Neck Surgery, University Medical Center Groningen, The Netherlands. 5. Department of Nuclear Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. 6. Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, University Medical Center Utrecht, The Netherlands; Department of Otorhinolaryngology, University Medical Center Utrecht, The Netherlands. 7. Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands; Department of Otolaryngology, Academic Medical Center Amsterdam, The Netherlands; Amsterdam Center for Language and Communication, University of Amsterdam, The Netherlands. 8. Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands. 9. Department of Nuclear Medicine, University Medical Center Groningen, The Netherlands. 10. Department of Otolaryngology - Head and Neck Surgery, Radboud University Nijmegen Center, The Netherlands. 11. Department of Nuclear Medicine, University Medical Center Utrecht, The Netherlands. 12. Department of Nuclear Medicine, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands. 13. Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
Abstract
PURPOSE: The purpose of this study is to evaluate the efficacy of (18)F-FDG-PET as first-line diagnostic investigation, prior to performing a direct laryngoscopy with biopsy under general anesthesia, in patients suspected of recurrent laryngeal carcinoma after radiotherapy. PATIENTS AND METHODS: 150 patients suspected of recurrent T2-4 laryngeal carcinoma at least two months after prior (chemo)radiotherapy with curative intent for resectable disease were randomized to direct laryngoscopy (CWU: conventional workup strategy) or to (18)F-FDG-PET only followed by direct laryngoscopy if PET was assessed 'positive' or 'equivocal' (PWU: PET based workup strategy), to compare the effectiveness of these strategies. Primary endpoint was the number of indications for direct laryngoscopies classified as unnecessary based on absence of recurrence, both on direct laryngoscopy and on six month follow up. Safety endpoints comprised resectability of recurrent lesions and completeness of surgical margins following salvage laryngectomy. RESULTS: Intention-to-treat analyses were performed on all randomized patients (CWU: n=74, PWU: n=76). Tumor recurrence was similar in both groups: 45 patients (30%; 21 CWU, 24 PWU) within six months. In 53 patients in the CWU arm (72%, 95% CI: 60-81) unnecessary direct laryngoscopies were performed compared to 22 in the PWU arm (29%, 95% CI: 19-40) (p<0·0001). The percentage of salvage laryngectomies (resectability) and positive surgical margins were similar between CWU and PWU (81%, 63% respectively, p=0·17, and 29%, 7%, respectively, p=0.20). The prevalence of the combination of local unresectability and positive margins is in the CWU group 24% and in the PWU group 8%. No difference (p=0.32) in disease specific survival between both groups was found. CONCLUSION: In patients with suspected laryngeal carcinoma afterradiotherapy, PET as the first diagnostic procedure can reduce the need for direct laryngoscopy by more than 50% without jeopardizing quality of treatment.
RCT Entities:
PURPOSE: The purpose of this study is to evaluate the efficacy of (18)F-FDG-PET as first-line diagnostic investigation, prior to performing a direct laryngoscopy with biopsy under general anesthesia, in patients suspected of recurrent laryngeal carcinoma after radiotherapy. PATIENTS AND METHODS: 150 patients suspected of recurrent T2-4 laryngeal carcinoma at least two months after prior (chemo)radiotherapy with curative intent for resectable disease were randomized to direct laryngoscopy (CWU: conventional workup strategy) or to (18)F-FDG-PET only followed by direct laryngoscopy if PET was assessed 'positive' or 'equivocal' (PWU: PET based workup strategy), to compare the effectiveness of these strategies. Primary endpoint was the number of indications for direct laryngoscopies classified as unnecessary based on absence of recurrence, both on direct laryngoscopy and on six month follow up. Safety endpoints comprised resectability of recurrent lesions and completeness of surgical margins following salvage laryngectomy. RESULTS: Intention-to-treat analyses were performed on all randomized patients (CWU: n=74, PWU: n=76). Tumor recurrence was similar in both groups: 45 patients (30%; 21 CWU, 24 PWU) within six months. In 53 patients in the CWU arm (72%, 95% CI: 60-81) unnecessary direct laryngoscopies were performed compared to 22 in the PWU arm (29%, 95% CI: 19-40) (p<0·0001). The percentage of salvage laryngectomies (resectability) and positive surgical margins were similar between CWU and PWU (81%, 63% respectively, p=0·17, and 29%, 7%, respectively, p=0.20). The prevalence of the combination of local unresectability and positive margins is in the CWU group 24% and in the PWU group 8%. No difference (p=0.32) in disease specific survival between both groups was found. CONCLUSION: In patients with suspected laryngeal carcinoma after radiotherapy, PET as the first diagnostic procedure can reduce the need for direct laryngoscopy by more than 50% without jeopardizing quality of treatment.
Authors: Christian Philipp Reinert; Julia Sekler; Christian la Fougère; Christina Pfannenberg; Sergios Gatidis Journal: Eur Radiol Date: 2019-11-14 Impact factor: 5.315
Authors: Jan Wedman; Jan Pruim; Lisa van der Putten; Otto S Hoekstra; Remco de Bree; Boukje A C van Dijk; Bernard F A M van der Laan Journal: Clin Otolaryngol Date: 2018-11-18 Impact factor: 2.597