Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial

Radiation Oncology

Eric Jadaud¹  Florence Legouté¹  Gilles Calais¹  Delphine Caron¹  Olivier Capitain²  Alain Prévost³  Philippe Lang⁴  Benjamin Morvant⁵  Ulrike Schick⁶  Yoann Pointreau⁷  Laurent Martin⁸  Valérie Seegers⁹  René-Jean Bensadoun^1,10 

[1] 0000 0000 9437 3027, grid.418191.4, Département de Radiothérapie, Institut de Cancérologie de l’Ouest - Paul Papin, 15 rue André Boquel, F-49055 Cedex 02, Angers, France;0000 0000 9437 3027, grid.418191.4, Département d’Oncologie médicale, Institut de Cancérologie de l’Ouest - Paul Papin, 15 rue André Boquel, F-49055 Cedex 02, Angers, France;0000 0001 0131 9695, grid.418448.5, Département de Radiothérapie, Institut Jean Godinot, 1 avenue du Général Koenig, F-51056, Reims, France;0000 0001 2150 9058, grid.411439.a, Site intégré d’Oncologie - Groupe hospitalier Pitié-Salpétrière, 47-83 boulevard de l’Hôpital, F-75651 Cedex 13, Paris, France;0000 0004 0472 0283, grid.411147.6, Département de pathologie cellulaire et tissulaire, Centre Hospitalier Universitaire d’Angers, 4 rue Larrey, F-49933, Cedex 09, Angers, France;0000 0004 0472 3249, grid.411766.3, Département de Radiothérapie, Centre Hospitalier Universitaire de Brest, Hôpital Morvan, 2 avenue Foch, F-29200, Brest, France;0000 0004 0642 0655, grid.477089.5, Centre Jean-Bernard - Clinique Victor-Hugo, 9 rue Beauverger, F-72000, Le Mans, France;Centre de Radiothérapie Guillaume le Conquérant, 61 rue Denfert Rochereau, F-76600, Le Havre, France;Institut de Cancérologie de l’Ouest - Paul Papin, Direction de la Recherche clinique et de l’innovation, 15 rue André Boquel, F-49055 Cedex 02, Angers, France;grid.477038.f, Centre de haute énergie – Oncologie-radiothérapie, 10 boulevard Pasteur, F-06000, Nice, France;

关键词: Oral mucositis;    Chemoradiotherapy;    Head and neck cancer;    Lasertherapy;    Supportive care;   

DOI  :  10.1186/s13014-019-1292-2

来源: publisher

【 摘 要 】

BackgroundLow-level laser therapy (LLLT) also called Photobiomodulation therapy (PBMT) could reduce oral mucositis (OM) incidence and severity in head and neck cancer patients treated by chemoradiotherapy, however randomised data about efficacy and safety are missing with curative dose 4 J/cm2.MethodsThis phase III trial was conducted in patients with oral cavity, or oro/hypopharyngeal cancers (stage III or IV). Patients were treated by lasertherapy on OM lesions grade ≥ 2 (4 J/cm2 or placebo), during chemoradiotherapy and until recovery. Severity of OM (incidence and duration of grades ≥3) was used as primary endpoint and blindly assessed.ResultsAmong 97 randomised patients, 83 patients (85.6%) could be assessed finally (erroneous inclusions, chemoradiotherapy interruptions) and 32 patients had no lasertherapy because of unreachable OM lesions. Randomisation and population characteristics (sex ratio, age, chemoradiotherapy procedures, toxicities incidence) were still comparable between the two LLLT/PBMT groups. An acute OM (grade ≥ 3) was observed in 41 patients (49.4%): 23 patients (54.8%) of the active laser group versus 18 (43.9%) in the control group (modified intend to treat, p = 0.32). Median time before occurrence of OM ≥ grade 3 in half of the patients was 8 weeks in active laser group (vs. 9 weeks in control group). However, 95% of patients exhibited a very good tolerance of LLLT/PBMT.ConclusionsThis study assessed LLLT/PBMT according to the Multinational Association of Supportive care in Cancer recommendations but lacked power. LLLT/PBMT was well tolerated with a good safety profile, which promotes its use in clinical routine for severe OM treatment.Trial registrationClinicalTrials.gov Identifier: NCT01772706.Title: Laser Mucite ORL: Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer (LaserMucite).Study Start Date: October 2008.Primary Completion Date: October 2016.Responsible Party: Institut de Cancérologie de l’Ouest – Paul Papin.Principal Investigator: Eric Jadaud, M.D., Institut de Cancérologie de l’Ouest – Paul Papin.Funding: French Ministry of Health, French national funding scheme (PHRC 2008).

【 授权许可】

CC BY