RESUMO
PURPOSE: The IFCT-GFPC-0701 MAPS phase III trial highlighted significant improvement in overall survival from adding bevacizumab to the standard first-line chemotherapy regimen [cisplatin plus pemetrexed (PC)] in advanced malignant pleural mesothelioma (MPM). We present the results of health-related quality of life (HRQoL), a secondary endpoint of MAPS. PATIENTS AND METHODS: HRQoL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 and the lung cancer-specific module QLQ-LC13 at randomization and then every 9 weeks until disease progression.HRQoL deterioration-free survival (QFS), used to analyze longitudinal HRQoL data, was defined as the interval between randomization and the occurrence of the first clinically relevant definitive deterioration compared with the HRQoL score at baseline, or death. RESULTS: A total of 448 patients were included in the MAPS trial between 2008 and 2014. At baseline, 425 patients (94.8%) completed the HRQoL questionnaire. We report that adding bevacizumab to cisplatin and pemetrexed (PCB) significantly improved QFS for the peripheral neuropathy dimension, with a median QFS of 12.09 months [95% confidence interval (CI), 9.59-13.67] in the PCB arm versus 7.59 months (95% CI, 6.57-8.61) in the PC arm [HR (PCB vs. PC) = 0.74; 95% CI, 0.61-0.91; P = 0.004]. QFS was also longer in the PCB arm for the pain dimension (HR = 0.84; 95% CI, 0.69-1.02; P = 0.08). CONCLUSIONS: This study demonstrated that adding bevacizumab to standard chemotherapy in patients with advanced MPM had no negative impact on HRQoL. A significant improvement in the peripheral neuropathy and pain HRQoL dimensions was even observed.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/psicologia , Mesotelioma/tratamento farmacológico , Mesotelioma/psicologia , Idoso , Bevacizumab/administração & dosagem , Cisplatino/administração & dosagem , Feminino , Humanos , Estudos Longitudinais , Masculino , Mesotelioma Maligno , Medição da Dor/efeitos dos fármacos , Pemetrexede/administração & dosagem , Doenças do Sistema Nervoso Periférico/prevenção & controle , Qualidade de Vida , Inquéritos e Questionários , Resultado do TratamentoRESUMO
BACKGROUND: A large proportion of elderly patients (>70 years) with newly diagnosed NSCLC are shown to be frail by a comprehensive geriatric assessment. This population is more vulnerable to adverse effects of chemotherapy and might thus benefit more from targeted therapy. The objective of this study was to assess the cost-effectiveness of erlotinib followed by chemotherapy after progression, compared with the reverse strategy, in frail elderly patients with advanced NSCLC participating in a prospective randomized phase II trial (GFPC 0505). MATERIALS AND METHODS: Outcomes (progression-free survival and overall survival) and costs (limited to direct medical costs, from the third-party payer perspective) were collected prospectively until second progression. Costs after progression and health utilities (based on disease states and grade 3-4 toxicities) were derived from the literature. RESULTS: Median overall survival, QALYs, and total costs for the erlotinib-first strategy were 3.9 months, 0.33, and 15,233, respectively, compared with 4.4 months, 0.35, and 15,363 for the chemotherapy-first strategy. There was no significant difference between the 2 strategies in term of cost-effectiveness (respectively 47,381 and 44,350 per QALY). CONCLUSION: No difference in cost-effectiveness was found between an erlotinib-first strategy and a chemotherapy-first strategy in frail elderly patients with NSCLC.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Receptores ErbB/antagonistas & inibidores , Idoso Fragilizado , Neoplasias Pulmonares/tratamento farmacológico , Inibidores de Proteínas Quinases/uso terapêutico , Quinazolinas/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Análise Custo-Benefício , Custos e Análise de Custo , Cloridrato de Erlotinib , Feminino , Humanos , Masculino , Estudos Prospectivos , Anos de Vida Ajustados por Qualidade de VidaRESUMO
BACKGROUND: The median age of newly diagnosed patients with non-small cell lung cancer (NSCLC) is 67 years, and one-third of patients are older than 75 years. Elderly patients are more vulnerable to the adverse effects of chemotherapy, and targeted therapy might thus be a relevant alternative. The objective of this study was to assess the cost-effectiveness of erlotinib followed by chemotherapy after progression, compared to the reverse strategy, in fit elderly patients with advanced NSCLC participating in a prospective randomized phase 2 trial (GFPC0504). METHODS: Outcomes (PFS and overall survival) and costs (limited to direct medical costs, from the third-party payer perspective) were prospectively collected until second progression. Costs after progression and health utilities (based on disease states and grade 3-4 toxicities) were derived from the literature. RESULTS: Median overall survival, QALY and total costs for the erlotinib-first strategy were respectively 7.1 months, 0.51 and 27 734 , compared to 9.4 months, 0.52 and 31 688 for the chemotherapy-first strategy. The Monte Carlo simulation demonstrates that the two strategies do not differ statistically. CONCLUSION: In terms of cost effectiveness, in fit elderly patients with NSCLC, erlotinib followed by chemotherapy compares well with the reverse strategy.