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Study design and early result of a phase I study of SABR for early‐stage glottic cancer
Author(s) -
Yu Tosol,
Wee Chan Woo,
Choi Noorie,
Wu HongGyun,
Kang HyunCheol,
Park Jong Min,
Kim JungIn,
Kim Jin Ho,
Kwon TackKyun,
Chung EunJae
Publication year - 2018
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1002/lary.27226
Subject(s) - medicine , sabr volatility model , radiation therapy , nuclear medicine , toxicity , head and neck cancer , larynx , laryngectomy , cancer , stage (stratigraphy) , radiology , surgery , urology , volatility (finance) , paleontology , stochastic volatility , biology , financial economics , economics
Objective Avoidance of organs at risk has become possible with advances in image‐guided volumetric‐modulated arc therapy (VMAT) techniques. This study was designed to evaluate the safety and feasibility of stereotactic ablative radiotherapy (SABR) for early stage glottic cancer. This report presents the preliminary result of the first and second dose level. Methods Fraction size was increased from 3.5 gray (Gy) (total dose 59.5 Gy) to 9 Gy (total dose 45 Gy). Dose‐limiting toxicities were defined as grade 3 or higher treatment‐related toxicities. Voice outcome was assessed with electroglottography, and quality of life (QoL) was measured with the Head and Neck Cancer Inventory (HNCI). Results Seven patients received 59.5 Gy at 3.5 Gy per fraction as the first dose level, and five patients received 55 Gy at 5 Gy per fraction as the second dose level. None of the patients developed grade 3+ toxicity throughout a median follow‐up of 17.5 months (range, 1.7–30.6 months). One patient in the second dose level recurred in the primary site at 4 months after radiotherapy (RT) and received total laryngectomy. The rest of participants were disease‐free at locoregional and distant sites. Jitter, shimmer, mean phonation time, and noise‐to‐harmony ratio did not change significantly at 6 months after RT. HNCI scores between pretreatment and posttreatment were not significantly different ( P = 0.221). Conclusion This study revealed acceptable toxicity, voice outcome, and QoL in patients treated with hypofractionated VMAT of 3.5 Gy and 5 Gy per fraction. This phase I study is currently ongoing with a dose of 55 Gy in 11 fractions and 45 Gy in five fractions. Level of Evidence 2b. Laryngoscope , 2560–2565, 2018