RESUMO
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.
Assuntos
Carcinoma de Células Escamosas/terapia , Quimiorradioterapia/efeitos adversos , Análise Custo-Benefício , Neoplasias de Cabeça e Pescoço/terapia , Terapia com Luz de Baixa Intensidade/economia , Mucosite/prevenção & controle , Idoso , Brasil , Carcinoma de Células Escamosas/economia , Quimiorradioterapia/economia , Método Duplo-Cego , Feminino , Neoplasias de Cabeça e Pescoço/economia , Humanos , Masculino , Pessoa de Meia-Idade , Mucosite/economia , Estudos Prospectivos , Resultado do TratamentoRESUMO
Trials have shown benefits of palifermin in reducing the incidence and severity of oral mucositis in patients with hematological malignancies undergoing autologous hematopoietic stem cell transplantation (HSCT) with total body irradiation (TBI)-based conditioning regimens. Similar outcome data are lacking for patients receiving non-TBI-based regimens. We performed a retrospective evaluation on the pharmacoeconomic benefit of palifermin in the setting of non-TBI-based conditioning and autologous HSCT. Between January 2002 and December 2010, 524 patients undergoing autologous HSCT for myeloma (melphalan 200 mg/m²) and lymphoma (high-dose busulfan, cyclophosphamide, and etoposide) as preparative regimen were analyzed. Use of patient-controlled analgesia (PCA) was significantly lower in the palifermin-treated groups (myeloma: 13% versus 53%, P < .001; lymphoma: 46% versus 68%, P < .001). Median total transplant charges were significantly higher in the palifermin-treated group, after controlling for inflation (myeloma: $167,820 versus $143,200, P < .001; lymphoma: $168,570 versus $148,590, P < .001). Palifermin treatment was not associated with a difference in days to neutrophil engraftment, length of stay, and overall survival and was associated with an additional cost of $5.5K (myeloma) and $14K (lymphoma) per day of PCA avoided. Future studies are suggested to evaluate the cost-effectiveness of palifermin compared with other symptomatic treatments to reduce transplant toxicity using validated measures for pain and quality of life.
Assuntos
Fator 7 de Crescimento de Fibroblastos/economia , Fator 7 de Crescimento de Fibroblastos/uso terapêutico , Transplante de Células-Tronco Hematopoéticas/métodos , Mucosite/prevenção & controle , Adolescente , Adulto , Idoso , Farmacoeconomia , Feminino , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Humanos , Linfoma/terapia , Masculino , Pessoa de Meia-Idade , Mucosite/economia , Mucosite/etiologia , Mieloma Múltiplo/terapia , Estudos Retrospectivos , Condicionamento Pré-Transplante/efeitos adversos , Condicionamento Pré-Transplante/métodos , Transplante Autólogo , Adulto JovemRESUMO
OBJECTIVE: To evaluate the role of WF10-immunotherapy in reducing oro-pharyngeal complications in head and neck cancer chemoradiotherapy. MATERIAL AND METHOD: Thirteen patients were enrolled and assigned either to WF10- (n = 6) or control group (n = 7). After completion of their initial (neoadjuvant) chemotherapy, patients received WF10 intravenous infusions at 0.5 mL/kg body weight/day for five consecutive days and repeated every 3 weeks, concomitantly to standard radiotherapy (6,600-7,500 cGy, 200 cGy/day). Control patients received radiotherapy alone. RESULTS: Patients in the WF10-group had a lower incidence of oro-pharyngeal complications grade > 2, including oral mucositis (1 vs. 5), dysphagia (2 vs. 7), oral pain (3 vs. 5), taste alteration (4 vs. 6) and weight loss (2 vs. 4). The statistical significances were achieved for the parameters of oral mucositis (p = 0. 048) and dysphagia (p = 0.009). CONCLUSION: WF10 appears to reduce severity of oro-pharyngeal complications associated with standard chemoradiotherapy for head and neck cancer.