Héliton S Antunes1, Luciene Fontes Schluckebier2, Daniel Herchenhorn3, Isabele A Small2, Carlos M M Araújo4, Celia Maria Pais Viégas4, Mariana P Rampini2, Elza M S Ferreira5, Fernando L Dias6, Vanessa Teich7, Nelson Teich7, Carlos G Ferreira8. 1. Clinical Research Division, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil. Electronic address: hspindola@inca.gov.br. 2. Clinical Research Division, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil. 3. Clinical Oncology Division, INCA, Brazil. 4. Radiation Oncology Division, INCA, Brazil. 5. Private Practice, Brazil. 6. Head and Neck Surgery Division, INCA, Brazil. 7. Instituto COI de Educação e Pesquisa, Brazil. 8. Clinical Research Division, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil; Brazilian Network for Clinical Cancer Research (RNPCC), Brazil; D'OR Institute for Research and Education (IDOR), Brazil.
Abstract
BACKGROUND:Oral mucositis is a major event increasing treatment costs of head and neck squamous cell carcinoma (HNSCC) patients treated with chemoradiation (CRT). This study was designed to estimate the cost-effectiveness of low-level laser therapy (LLLT) to prevent oral mucositis in HNSCC patients receiving CRT. METHODS:From June 2007 to December 2010, 94 patients with HNSCC of nasopharynx, oropharynx, and hypopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial. CRT consisted of conventional radiotherapy (RT: 70.2 Gy, 1.8 Gy/d, 5 times/wk)+concurrent cisplatin (100mg/m2) every 3 weeks. An InGaAlP (660 nm-100 mW-4J/cm2) laser diode was used for LLLT. RESULTS: From the perspective of Brazil's public health care system (SUS), total costs were higher in Placebo Group (PG) than Laser Group (LG) for opioid use (LG=US$ 9.08, PG=US$ 44.28), gastrostomy feeding (LG=US$ 50.50, PG=US$ 129.86), and hospitalization (PG=US$ 77.03). In LG, the cost was higher for laser therapy only (US$ 1880.57). The total incremental cost associated with the use of LLLT was US$ 1689.00 per patient. The incremental cost-effectiveness ratio (ICER) was US$ 4961.37 per grade 3-4 OM case prevented compared to no treatment. CONCLUSIONS: Our results indicate that morbidity was lower in the Laser Group and that LLLT was more cost-effective than placebo up to a threshold of at least US$ 5000 per mucositis case prevented. CLINICAL TRIAL INFORMATION: NCT01439724.
RCT Entities:
BACKGROUND:Oral mucositis is a major event increasing treatment costs of head and neck squamous cell carcinoma (HNSCC) patients treated with chemoradiation (CRT). This study was designed to estimate the cost-effectiveness of low-level laser therapy (LLLT) to prevent oral mucositis in HNSCCpatients receiving CRT. METHODS: From June 2007 to December 2010, 94 patients with HNSCC of nasopharynx, oropharynx, and hypopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial. CRT consisted of conventional radiotherapy (RT: 70.2 Gy, 1.8 Gy/d, 5 times/wk)+concurrent cisplatin (100mg/m2) every 3 weeks. An InGaAlP (660 nm-100 mW-4J/cm2) laser diode was used for LLLT. RESULTS: From the perspective of Brazil's public health care system (SUS), total costs were higher in Placebo Group (PG) than Laser Group (LG) for opioid use (LG=US$ 9.08, PG=US$ 44.28), gastrostomy feeding (LG=US$ 50.50, PG=US$ 129.86), and hospitalization (PG=US$ 77.03). In LG, the cost was higher for laser therapy only (US$ 1880.57). The total incremental cost associated with the use of LLLT was US$ 1689.00 per patient. The incremental cost-effectiveness ratio (ICER) was US$ 4961.37 per grade 3-4 OM case prevented compared to no treatment. CONCLUSIONS: Our results indicate that morbidity was lower in the Laser Group and that LLLT was more cost-effective than placebo up to a threshold of at least US$ 5000 per mucositis case prevented. CLINICAL TRIAL INFORMATION: NCT01439724.
Authors: Mariana de Pauli Paglioni; Karina Morais Faria; Natália Rangel Palmier; Ana Carolina Prado-Ribeiro; Reinaldo Brito E Dias; Henrique da Graça Pinto; Nathaniel Simon Treister; Joel B Epstein; César Augusto Migliorati; Alan Roger Santos-Silva; Thais Bianca Brandão Journal: Lasers Med Sci Date: 2020-07-05 Impact factor: 3.161
Authors: Natália Rangel Palmier; Adriana Franco Paes Leme; Tatiane De Rossi; Guilherme Pimentel Telles; Karina Morais-Faria; Luiz Paulo Kowalski; Gustavo Nader Marta; Thaís Bianca Brandão; Praveen R Arany; César Augusto Migliorati; Alan Roger Santos-Silva; Ana Carolina Prado-Ribeiro Journal: Support Care Cancer Date: 2020-10-02 Impact factor: 3.603