A phase Ⅱ prospective trial of photobiomodulation therapy in limiting oral mucositis in the treatment of locally advanced head and neck cancer patients.

Autor: Taylor JK; School of Medicine University of Pittsburgh Pittsburgh Pennsylvania USA., Mady LJ; Department of Otorhinolaryngology-Head and Neck Surgery University of Pennsylvania Philadelphia Pennsylvania USA., Baddour K; Department of Otolaryngology-Head and Neck Surgery UPMC Pittsburgh Pennsylvania USA., Iheagwara UK; UPMC Department of Radiation Oncology UPMC Pittsburgh Pennsylvania USA., Zhai S; Biostatistics UPMC Hillman Cancer Center Pittsburgh Pennsylvania USA., Ohr JP; Department of Medicine, Division of Hematology/Oncology UPMC Hillman Cancer Center Pittsburgh Pennsylvania USA., Zandberg DP; Department of Medicine, Division of Hematology/Oncology UPMC Hillman Cancer Center Pittsburgh Pennsylvania USA., Gorantla VC; Department of Medicine, Division of Hematology/Oncology UPMC Hillman Cancer Center Pittsburgh Pennsylvania USA., Ferris RL; Department of Otolaryngology-Head and Neck Surgery UPMC Pittsburgh Pennsylvania USA.; UPMC Department of Radiation Oncology UPMC Pittsburgh Pennsylvania USA.; Biostatistics UPMC Hillman Cancer Center Pittsburgh Pennsylvania USA.; Department of Immunology UPMC Pittsburgh Pennsylvania USA., Kim S; Department of Otolaryngology-Head and Neck Surgery UPMC Pittsburgh Pennsylvania USA., Duvvuri U; Department of Otolaryngology-Head and Neck Surgery UPMC Pittsburgh Pennsylvania USA., Kubik MW; Department of Otolaryngology-Head and Neck Surgery UPMC Pittsburgh Pennsylvania USA.; Department of Plastic and Reconstructive Surgery University of Pittsburgh Medical Center Pittsburgh Pennsylvania USA., Sridharan S; Department of Otolaryngology-Head and Neck Surgery UPMC Pittsburgh Pennsylvania USA.; Department of Plastic and Reconstructive Surgery University of Pittsburgh Medical Center Pittsburgh Pennsylvania USA., Johnson JT; Department of Otolaryngology-Head and Neck Surgery UPMC Pittsburgh Pennsylvania USA., Holeva KD; UPMC Department of Radiation Oncology UPMC Pittsburgh Pennsylvania USA., Quinn AE; UPMC Department of Radiation Oncology UPMC Pittsburgh Pennsylvania USA., Clump DA; UPMC Department of Radiation Oncology UPMC Pittsburgh Pennsylvania USA.
Jazyk: angličtina
Zdroj: World journal of otorhinolaryngology - head and neck surgery [World J Otorhinolaryngol Head Neck Surg] 2022 Jul 14; Vol. 8 (4), pp. 345-354. Date of Electronic Publication: 2022 Jul 14 (Print Publication: 2022).
DOI: 10.1002/wjo2.18
Abstrakt: Objective: This study aimed to compare the historical incidence rate of severe oral mucositis (OM) in head and neck cancer patients undergoing definitive concurrent chemoradiation therapy (CRT) versus a prospective cohort of patients with locally advanced head and neck squamous cell carcinoma (HNSCC) treated with prophylactic photobiomodulation therapy (PBMT).
Methods: This US-based, institutional, single-arm, phase Ⅱ prospective clinical trial was initiated in 50 patients (age ≥ 18 years, Karnofsky Performance Scale Index > 60, with locally advanced HNSCC (excluding oral cavity) receiving definitive or adjuvant radiation therapy (RT) with concurrent platinum-based chemotherapy (CT). PBMT was delivered three times per week throughout RT utilizing both an intraoral as well extraoral delivery system. Primary outcome measure was incidence of severe OM utilizing both the National Cancer Institute Common Toxicity Criteria, version 4.0 (NCI-CTCAE) Grade ≥3 and the World Health Organization Mucositis Grading Scale (WHO) Grade ≥3 versus historical controls; secondary outcome measures included time to onset of severe OM following therapy initiation.
Results: At baseline, all patients included in final analysis ( N  = 47) had OM Grade 0. Average RT and CT dose was (66.3 ± 5.1) Gy and (486.1 ± 106.8) mg/m 2 , respectively. Severe OM was observed in 11 of 47 patients (23%, confidence interval: 12, 38). OM toxicity grade trended upward during treatment, reaching a maximum at 7 weeks (WHO: 1.8 vs. NCI-CTCAE: 1.7). Subsequently, OM grade returned to baseline 3 months following completion of RT. The mean time to onset of severe OM was (35 ± 12) days. The mean time to resolution of severe OM was (37 ± 37) days.
Conclusions: Compared to historical outcomes, PBMT aides in decreasing severe OM in patients with locally advanced HNSCC. PBMT represents a minimally invasive, prophylactic intervention to decrease OM as a major treatment-related side effect.
Competing Interests: The authors declare no conflict of interest.
(© 2022 The Authors. World Journal of Otorhinolaryngology ‐ Head and Neck Surgery published by John Wiley & Sons Ltd on behalf of Chinese Medical Association.)
Databáze: MEDLINE
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