Estudo de fase II de pregabalina para prevenção de náuseas e vômitos induzidos por quimioterapia / Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting

Para avaliar o papel da pregabalina na proteção das náuseas e vômitos induzidos pela quimioterapia, foi realizado um ensaio clínico de fase II, aleatorizado, duplamente cego, controlado por placebo, para investigar se a pregabalina poderia melhorar o controle completo das náuseas e vômitos (desfecho primário). Inscrevemos 82 pacientes virgens de quimioterapia, programados para receber quimioterapia moderadamente e altamente emetogênica. Todos os doentes receberam ondansetron 8mg por via intravenosa, dexametasona 10mg antes da quimioterapia no primeiro dia e, dexametasona 4 mg por via oral, b.d., nos dias dois e três. Os doentes foram distribuídos aleatoriamente para tomar pregabalina 75 mg ou placebo, bd, desde a noite anterior à quimioterapia até ao quinto dia. A resposta completa global não foi estatisticamente significativa entre os grupos (53,7 versus 48,8%, respetivamente, no grupo da pregabalina e no grupo de controlo (P=0,65)). Também não houve diferença estatística significativa durante a fase aguda (primeiras 24 horas) e a fase tardia (24-120h): 80,5% versus 82,9% (P=0,77), 53,7 versus 51,2% (P=0,82), respectivamente. Neste estudo não foi identificada ação da pregabalina na prevenção de náuseas e vômitos induzidos por quimioterapia. Número de registo no Clinicaltrial.gov: NCT04181346.

To evaluate the role of pregabalin in the protection of chemotherapy-induced nausea and vomiting, we performed a phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin could improve the complete control of nausea and vomiting (primary end point). We enrolled 82 chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy. All patients received IV ondansetron 8mg, dexamethasone 10mg before chemotherapy on day one and oral dexamethasone 4mg, b.d., on days two and three. Patients were randomly assigned to take pregabalin 75mg or placebo, bd, from the night before chemotherapy to day five. The overall complete response was not statistically significant between the groups (53.7 versus 48.8%, respectively, in the pregabalin group and the control group (P=0.65)). There was also no significant difference during the acute phase (first 24 hours) and delayed phase (24-120h): 80.5% versus 82.9% (P=0.77), 53.7 versus 51.2% (P=0.82), respectively. There is no role for pregabalin preventing chemotherapy-induced nausea and vomiting. Clinicaltrial.gov registration number: NCT04181346.

Critical assessment of resource waste in staging and follow-up of breast cancer.

BACKGROUND: Breast cancer is a public health problem with both high incidence and cure rates. After treatment, patients are monitored for long periods of time due to the risk of recurrence. Thus, staging and follow-up strategies should consider not only the best results for the patient but also its costs for the public health system. OBJECTIVE: The objective of this study was to quantify the waste of resources on breast cancer follow-up and evaluate its impact on the public health system. METHODS: This is a retrospective analysis of consecutive medical records to identify the intervals between consultations and tests used for staging and during the first 2 years of follow-up of patients with breast cancer treated at a public hospital in Brazil. Data were compared with the guidelines of the main international consensus. RESULTS: Medical records of 60 consecutive patients treated in 2018 were selected, of whom 52 had 2 or more years of follow-up, and 8 had only 1 year of complete follow-up. A total of 34 patients (56.67%) underwent excessive examinations for stating. During follow-up, 125 surplus consultations were performed (33.6%). In this phase, 111 surplus exams were also performed, representing an increase of 100.9%. A total of 423 laboratory tests were performed for 18 patients in the first year and 229 tests for 14 patients in the second year. CONCLUSION: Excessive tests and consultations significantly burdened the Unified Health System without any benefit to patients. Better adherence to staging and follow-up recommendations could reduce costs and optimize the limited resources used in the public health system.

Evaluation of factors predicting the benefit from systemic oncological treatment for severely ill hospitalized patients: a retrospective study.

BACKGROUND: Patients with cancer in the disease's end-stage with poor performance represent a challenging clinical scenario, as they have high chance of a fatal outcome due to clinical conditions, oncological emergencies, and/or metastatic disease. This study examines the factors predicting the potential benefit of "urgent" chemotherapy during hospitalization in this setting, thus addressing a research gap. METHODS: This retrospective observational study was conducted in the largest cancer center in the outskirts of São Paulo. It identified factors predicting the benefit from antineoplastic treatment in severe in-hospital patients admitted during 2019-2020, considering post-chemotherapy survival time as the main dependent variable. Data were retrieved from medical records. All patients aged ≥ 18 years, with an ECOG-PS score ≥ 2, and undergoing non-elective systemic cancer treatment were included. RESULTS: This study evaluated 204 records, of which 89 were included in the final analysis. A statistically significant association with the worse outcome (death within 30 days of chemotherapy) was found with higher ECOG performance status; chemotherapy dose reduction; lower values of serum albumin, hemoglobin, and creatinine clearance; and higher values of leukocytes, neutrophils, direct bilirubin, urea, and C-reactive protein. In the multivariate analysis, only albumin remained statistically associated with the outcome (hazard ratio = 0.35; confidence interval: 0.14, 0.90; p = 0.034). CONCLUSIONS: Serum albumin and other clinical and laboratory variables might be associated with early post-treatment deaths in patients with cancer. The study data might help guide the decision to administer systemic treatment in this scenario and manage critically ill patients. This study adds to our knowledge of the factors predicting the objective benefits from "heroic" or "urgent" chemotherapy for hospitalized and severely ill patients with cancer.

The use of artificial intelligence to improve the scientific writing of non-native english speakers.

OBJECTIVE: Scientific writing in English is a daunting task for non-native English speakers. The challenges of writing in a foreign language are evident in the scientific literature where texts by non-native English-speaking scientists tend to be less clear and succinct, contain grammatical errors, and are often rejected by prestigious journals. METHODS: We conducted a non-systematic review of the most recent literature using the terms "Artificial Intelligence," "Scientific Writing," and "Non-English Speaking" to create a narrative review. RESULTS: Artificial intelligence can be a solution to improve scientific writing, especially for non-native English-speaking scientists. Artificial intelligence can assist in the search for pertinent scientific papers, generate summaries, and help with the writing of different sections of the manuscript, including the abstract, introduction, methods, results, and discussion. Artificial intelligence-based programs can correct grammatical errors and improve writing style, both of which are particularly helpful for non-native English speakers. Two artificial intelligence programs that can help with the search for pertinent scientific papers on the internet are Elicit and ResearchRabbit. Scispace Copilot can be used to summarize the retrieved reference. The artificial intelligence software programs such as Grammarly and Paperpal can correct grammatical and spelling errors, while ChatGPT can also restructure sentences and paragraphs, reword text, and suggest appropriate words and phrases. CONCLUSION: Overall, artificial intelligence can be an effective tool to improve the clarity, style, and coherence of scientific writing, helping non-native English-speaking scientists to communicate their research more effectively.

The use of artificial intelligence to improve the scientific writing of non-native english speakers

SUMMARY OBJECTIVE: Scientific writing in English is a daunting task for non-native English speakers. The challenges of writing in a foreign language are evident in the scientific literature where texts by non-native English-speaking scientists tend to be less clear and succinct, contain grammatical errors, and are often rejected by prestigious journals. METHODS: We conducted a non-systematic review of the most recent literature using the terms "Artificial Intelligence," "Scientific Writing," and "Non-English Speaking" to create a narrative review. RESULTS: Artificial intelligence can be a solution to improve scientific writing, especially for non-native English-speaking scientists. Artificial intelligence can assist in the search for pertinent scientific papers, generate summaries, and help with the writing of different sections of the manuscript, including the abstract, introduction, methods, results, and discussion. Artificial intelligence-based programs can correct grammatical errors and improve writing style, both of which are particularly helpful for non-native English speakers. Two artificial intelligence programs that can help with the search for pertinent scientific papers on the internet are Elicit and ResearchRabbit. Scispace Copilot can be used to summarize the retrieved reference. The artificial intelligence software programs such as Grammarly and Paperpal can correct grammatical and spelling errors, while ChatGPT can also restructure sentences and paragraphs, reword text, and suggest appropriate words and phrases. CONCLUSION: Overall, artificial intelligence can be an effective tool to improve the clarity, style, and coherence of scientific writing, helping non-native English-speaking scientists to communicate their research more effectively.

Critical assessment of resource waste in staging and follow-up of breast cancer

SUMMARY BACKGROUND: Breast cancer is a public health problem with both high incidence and cure rates. After treatment, patients are monitored for long periods of time due to the risk of recurrence. Thus, staging and follow-up strategies should consider not only the best results for the patient but also its costs for the public health system. OBJECTIVE: The objective of this study was to quantify the waste of resources on breast cancer follow-up and evaluate its impact on the public health system. METHODS: This is a retrospective analysis of consecutive medical records to identify the intervals between consultations and tests used for staging and during the first 2 years of follow-up of patients with breast cancer treated at a public hospital in Brazil. Data were compared with the guidelines of the main international consensus. RESULTS: Medical records of 60 consecutive patients treated in 2018 were selected, of whom 52 had 2 or more years of follow-up, and 8 had only 1 year of complete follow-up. A total of 34 patients (56.67%) underwent excessive examinations for stating. During follow-up, 125 surplus consultations were performed (33.6%). In this phase, 111 surplus exams were also performed, representing an increase of 100.9%. A total of 423 laboratory tests were performed for 18 patients in the first year and 229 tests for 14 patients in the second year. CONCLUSION: Excessive tests and consultations significantly burdened the Unified Health System without any benefit to patients. Better adherence to staging and follow-up recommendations could reduce costs and optimize the limited resources used in the public health system.

Assessment of costs related to cancer treatment.

INTRODUCTION: Cancer patients and their caregivers incur costs not covered by the Sistema Único de Saúde - SUS(Unified Health System) during their treatment, with expenses related to transportation, symptomatic medications, food, loss of working days, and others. OBJECTIVE: To evaluate the costs incurred and not covered for cancer patients and their caregivers during cancer treatment at SUS. METHODS: This is a cross-sectional study of 110 cancer patients undergoing chemotherapy, radiotherapy, and 88 caregivers in the last month prior to their inclusion in the study. We correlated costs with clinical and sociodemographic variables such as gender, race, age, marital status, education, occupation, place of birth, origin, monthly income, family income, housing, comorbidities, types of cancer, and staging. RESULTS: We observed that the average cost for study patients was R$ 747.92, which corresponds to 78.4% of the minimum wage, and the average cost for caregivers was R$ 118.86, which is 12.46% of the minimum wage. Among all variables analyzed, the average overall monthly cost for patients was positively correlated with the occupation (p = 0.021) and origin (p = 0.038) variables. For the other variables, no significant associations were detected. CONCLUSION: The positive correlation found between occupation and origin variables with costs incurred and not covered for patients suggests that the creation of programs that enable the payment of costs not covered by SUS and the decentralization of access to cancer treatment could potentially facilitate patients' adherence to cancer treatment.

Assessment of costs related to cancer treatment

SUMMARY INTRODUCTION: Cancer patients and their caregivers incur costs not covered by the Sistema Único de Saúde - SUS(Unified Health System) during their treatment, with expenses related to transportation, symptomatic medications, food, loss of working days, and others. OBJECTIVE: To evaluate the costs incurred and not covered for cancer patients and their caregivers during cancer treatment at SUS. METHODS: This is a cross-sectional study of 110 cancer patients undergoing chemotherapy, radiotherapy, and 88 caregivers in the last month prior to their inclusion in the study. We correlated costs with clinical and sociodemographic variables such as gender, race, age, marital status, education, occupation, place of birth, origin, monthly income, family income, housing, comorbidities, types of cancer, and staging. RESULTS: We observed that the average cost for study patients was R$ 747.92, which corresponds to 78.4% of the minimum wage, and the average cost for caregivers was R$ 118.86, which is 12.46% of the minimum wage. Among all variables analyzed, the average overall monthly cost for patients was positively correlated with the occupation (p = 0.021) and origin (p = 0.038) variables. For the other variables, no significant associations were detected. CONCLUSION: The positive correlation found between occupation and origin variables with costs incurred and not covered for patients suggests that the creation of programs that enable the payment of costs not covered by SUS and the decentralization of access to cancer treatment could potentially facilitate patients' adherence to cancer treatment.

RESUMO INTRODUÇÃO: Pacientes oncológicos e seus acompanhantes incorrem em custos não cobertos pelo Sistema Único de Saúde (SUS) durante o seu tratamento, com gastos relacionados a transporte, medicações sintomáticas, alimentação, perda de dias de trabalho dentre outros. OBJETIVO: Avaliar os custos incorridos e não cobertos pelo SUS por pacientes com câncer e seus acompanhantes durante a realização do tratamento, oncológico. MÉTODOS: Trata-se de um estudo transversal realizado com 110 pacientes oncológicos em tratamento com quimioterapia ou quimioterapia e radioterapia e 88 acompanhantes, no último mês, antes de sua inclusão no estudo. Correlacionamos os custos dispendidos com variáveis clínicas e sociodemográficas como sexo, idade, raça, estado civil, escolaridade, ocupação, naturalidade, procedência, renda mensal, renda familiar, moradia, comorbidades, tipo de neoplasia e estadiamento. RESULTADOS: Observamos que a média do custo global dos pacientes do estudo foi de R$ 747,92, que corresponde a 78,4% do salário mínimo e a média do custo dos acompanhantes foi de R$ 118,86 reais que equivale a 12,46% do salário mínimo. Dentre todas as variáveis analisadas, a média do custo global mensal dos pacientes correlacionou-se positivamente com a variável ocupação (p=0,021) assim como com a variável procedência (p = 0,038). Para as demais variáveis, não foram detectadas associações significantes. CONCLUSÃO: A correlação positiva encontrada entre ocupação e procedência com custos incorridos e não cobertos por pacientes sugere a criação de programas que viabilizem o pagamento dos custos não cobertos pelo SUS e a descentralização do acesso ao tratamento oncológico podem potencialmente facilitar a aderência do paciente ao tratamento oncológico.

Distinct models to assess the cost-effectiveness of EGFR-tyrosine kinase inhibitors for the treatment of metastatic non-small cell lung cancer in the context of the Brazilian Unified Health Care System.

OBJECTIVE: Lung cancer is an important health problem due to its high incidence and mortality. The treatment of metastatic disease improved after the molecular pathways of cancer came to be known. However, targeted therapy is unavailable to many patients treated within the Brazilian Sistema Único de Saúde (SUS, Unified Health Care System). Our objective was to assess the cost-effectiveness of erlotinib, gefitinib, and afatinib versus that of chemotherapy for the treatment of non-small cell lung cancer in the context of the SUS. METHODS: Different analytical models were developed based on data in the literature. The outcomes were presented in quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) per QALY gained. All costs related to treatment and supportive therapies were included in the models. RESULTS: In one model, data from retrospective studies showed 2.01 life-years saved and a mean QALY gain of 1.169. The ICER per QALY gained ranged from R$48,451.29 (for gefitinib) to R$85,559.22 (for erlotinib). In another model, data from a meta-analysis showed -0.01 life-years saved and a mean QALY gain of 0.178. The ICER per QALY gained ranged from R$27,028.30 (for gefitinib) to R$75,203.26 (for erlotinib). CONCLUSIONS: There is no ideal analytical model for the SUS. However, targeted therapy with EGFR-tyrosine kinase inhibitors has been shown to be cost-effective in various scenarios. The adoption of drug price discounts will improve the cost-effectiveness of treatment.

Distinct models to assess the cost-effectiveness of EGFR-tyrosine kinase inhibitors for the treatment of metastatic non-small cell lung cancer in the context of the Brazilian Unified Health Care System / Diferentes modelos para avaliar a relação custo-efetividade de inibidores de tirosina quinase do EGFR no tratamento do câncer de pulmão não pequenas células metastático no contexto do Sistema Único de Saúde

ABSTRACT Objective: Lung cancer is an important health problem due to its high incidence and mortality. The treatment of metastatic disease improved after the molecular pathways of cancer came to be known. However, targeted therapy is unavailable to many patients treated within the Brazilian Sistema Único de Saúde (SUS, Unified Health Care System). Our objective was to assess the cost-effectiveness of erlotinib, gefitinib, and afatinib versus that of chemotherapy for the treatment of non-small cell lung cancer in the context of the SUS. Methods: Different analytical models were developed based on data in the literature. The outcomes were presented in quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) per QALY gained. All costs related to treatment and supportive therapies were included in the models. Results: In one model, data from retrospective studies showed 2.01 life-years saved and a mean QALY gain of 1.169. The ICER per QALY gained ranged from R$48,451.29 (for gefitinib) to R$85,559.22 (for erlotinib). In another model, data from a meta-analysis showed −0.01 life-years saved and a mean QALY gain of 0.178. The ICER per QALY gained ranged from R$27,028.30 (for gefitinib) to R$75,203.26 (for erlotinib). Conclusions: There is no ideal analytical model for the SUS. However, targeted therapy with EGFR-tyrosine kinase inhibitors has been shown to be cost-effective in various scenarios. The adoption of drug price discounts will improve the cost-effectiveness of treatment.

RESUMO Objetivo: O câncer de pulmão é um importante problema de saúde pela sua alta incidência e mortalidade. O tratamento da doença metastática melhorou após o conhecimento de vias moleculares tumorais. Contudo, a terapia-alvo está indisponível para muitos pacientes do Sistema Único de Saúde (SUS). Nosso objetivo foi avaliar a relação custo-efetividade de erlotinibe, gefitinibe e afatinibe vs. quimioterapia no tratamento do câncer de pulmão não pequenas células no contexto do SUS. Métodos: Foram desenvolvidos modelos analíticos distintos baseados em dados da literatura. Os desfechos foram apresentados em quality-adjusted life years (QALY, anos de vida ajustados pela qualidade) e incremental cost-effectiveness ratio (ICER, relação custo-efetividade incremental). Todos os custos relacionados ao tratamento e terapias de suporte foram incluídos nos modelos. Resultados: No primeiro modelo, dados de estudos retrospectivos apontaram 2,01 anos de vida salvos e uma média de ganho de QALY de 1,169. O ICER variou entre R$ 48.451,29 (gefitinibe) e R$ 85.559,22 (erlotinibe). No segundo modelo, dados de uma meta-análise evidenciaram −0,01 ano de vida salvos e uma média de ganho de QALY de 0,178. O ICER foi de R$ 27.028,30 (gefitinibe) a R$ 75.203,26 (erlotinibe). Conclusões: Não existe um modelo analítico ideal para o SUS. Contudo, diferentes cenários disponíveis na literatura mostram que a terapia-alvo com o uso dessas drogas é custo-efetiva. A adoção de descontos nos preços dos medicamentos melhorará a relação custo-efetividade do tratamento.

Potential life years not saved due to lack of access to anti-EGFR tyrosine kinase inhibitors for lung cancer treatment in the Brazilian public healthcare system: Budget impact and strategies to improve access. A pharmacoeconomic study

ABSTRACT BACKGROUND: Lung cancer is the fourth most common cancer in Brazil. In the 2000s, better understanding of molecular pathways led to development of epidermal growth factor receptor (EGFR)-targeted treatments that have improved outcomes. However, these treatments are unavailable in most Brazilian public healthcare services (Sistema Único de Saúde, SUS). OBJECTIVE: To assess the potential number of years of life not saved, the budget impact of the treatment and strategies to improve access. DESIGN AND SETTING: Pharmacoeconomic study assessing the potential societal and economic impact of adopting EGFR-targeted therapy within SUS. METHODS: We estimated the number of cases eligible for treatment, using epidemiological data from the National Cancer Institute. We used data from a single meta-analysis and from the Lung Cancer Mutation Consortium (LCMC) study as the basis for assessing differences in patients' survival between use of targeted therapy and use of chemotherapy. The costs of targeted treatment were based on the national reference and were compared with the amount reimbursed for chemotherapy through SUS. RESULTS: There was no life-year gain with EGFR-targeted therapy in the single meta-analysis (hazard ratio, HR, 1.01). The LCMC showed that 1,556 potential life-years were not saved annually. We estimated that the annual budget impact was 125 million Brazilian reais (BRL) with erlotinib, 48 million BRL with gefitinib and 52 million BRL with afatinib. Their incremental costs over chemotherapy per life-year saved were 80,329 BRL, 31,011 BRL and 33,225 BRL, respectively. A drug acquisition discount may decrease the budget impact by 30% (with a 20% discount). A fixed cost of 1,000 BRL may decrease the budget impact by 95%. CONCLUSION: Reducing drug acquisition costs may improve access to EGFR-targeted therapy for lung cancer.

Evaluation of the systemic and therapeutic repercussions caused by drug interactions in oncology patients.

INTRODUCTION: Drug interaction is an important cause of global morbidity. It is of particular importance in cancer patients since they are often in use of polypharmacy, related to interactions between the drugs and the chemotherapeutics used. OBJECTIVE: To evaluate the drug interaction between chemotherapy and other drugs in cancer patients. METHODS: a cross-sectional study carried out in the outpatient oncology department of a public tertiary hospital. Two hundred thirty-five patients were included, and the drugs they were using were identified. Using the MedScape and Epocrates database, we evaluated the interactions between medications and chemotherapy by defining their frequency and dividing their severity from interaction into mild, close monitoring necessity and severe. RESULTS: 161 patients had some drug interaction. We identified 9 types of mild interactions, 23 types of interactions with close monitoring necessity, and 2 types of serious interactions. The most frequent interactions were between fluorouracil and leucovorin (32 cases) and cyclophosphamide and doxorubicin (19 cases). Serious interactions were between aspirin and pemetrexed; and leucovorin and Bactrim. CONCLUSION: In the present study, drug interactions were frequent, including serious interactions with a potential increase in morbidity and mortality. Thus, it is necessary for oncologists to draw up a therapeutic plan considering potential interactions between prescribed chemotherapy and current medications in use by patients.

Evaluation of the systemic and therapeutic repercussions caused by drug interactions in oncology patients

SUMMARY INTRODUCTION: Drug interaction is an important cause of global morbidity. It is of particular importance in cancer patients since they are often in use of polypharmacy, related to interactions between the drugs and the chemotherapeutics used. OBJECTIVE: To evaluate the drug interaction between chemotherapy and other drugs in cancer patients. METHODS: a cross-sectional study carried out in the outpatient oncology department of a public tertiary hospital. Two hundred thirty-five patients were included, and the drugs they were using were identified. Using the MedScape and Epocrates database, we evaluated the interactions between medications and chemotherapy by defining their frequency and dividing their severity from interaction into mild, close monitoring necessity and severe. RESULTS: 161 patients had some drug interaction. We identified 9 types of mild interactions, 23 types of interactions with close monitoring necessity, and 2 types of serious interactions. The most frequent interactions were between fluorouracil and leucovorin (32 cases) and cyclophosphamide and doxorubicin (19 cases). Serious interactions were between aspirin and pemetrexed; and leucovorin and Bactrim. CONCLUSION: In the present study, drug interactions were frequent, including serious interactions with a potential increase in morbidity and mortality. Thus, it is necessary for oncologists to draw up a therapeutic plan considering potential interactions between prescribed chemotherapy and current medications in use by patients.

RESUMO INTRODUÇÃO: Interação medicamentosa é uma importante causa de morbidade mundial. Apresenta especial importância em pacientes oncológicos, pois esses frequentemente estão em uso de polifarmácia, podendo haver interações entre os medicamentos e os quimioterápicos utilizados. OBJETIVO: Avaliar a interação medicamentosa entre a quimioterapia e outros medicamentos em pacientes oncológicos. MÉTODOS: Estudo transversal realizado em serviço ambulatorial de oncologia de um hospital público terciário. Foram incluídos 235 pacientes, identificando-se quais medicamentos eram utilizados por eles. Por meio do auxílio do banco de dados do MedScape e Epocrates, avaliaram-se as interações entre as medicações e os quimioterápicos, definindo sua frequência e dividindo sua gravidade da interação em leve, monitorização próxima e grave. RESULTADOS: Do total estudado, 161 pacientes apresentavam alguma interação medicamentosa, sendo nove tipos de interações leves, 23 tipos de interações com necessidade de monitorização próxima e dois tipos de interações graves. As interações mais frequentes foram entre fluoracil e leucovorin (32 casos) e ciclofosfamida e doxorrubicina (19 casos). As interações sérias foram entre aspirina e pemetrexed; e leucovorim e bactrim. CONCLUSÃO: No presente trabalho, interações medicamentosas foram frequentes, incluindo interações graves com potencial aumento de morbimortalidade. Assim, faz-se necessário que oncologistas tracem um plano terapêutico levando em consideração as possíveis interações medicamentosas entre a quimioterapia prescrita e demais medicações em uso pelos pacientes.

Cost-effectiveness analysis of abiraterone, docetaxel or placebo plus androgen deprivation therapy for hormone-sensitive advanced prostate cancer.

OBJECTIVE: To evaluate the cost-effectiveness of the addition of chemotherapy or abiraterone to androgen deprivation. METHODS: We developed an analytical model to determine the cost-effectiveness of the addition of docetaxel or abiraterone versus androgen deprivation therapy alone. Direct and indirect costs were included in the model. The effects were expressed in Quality-Adjusted Life Years adjusted for side effects. RESULTS: Compared to androgen deprivation therapy alone, the addition of chemotherapy and of abiraterone generated 0.492 and 0.999, respectively, in Quality-Adjusted Life Years. Abiraterone led to a Quality-Adjusted Life Years gain of 0.506 compared to docetaxel. The incremental costs per Quality-Adjusted Life Years were R$ 133.649,22 for docetaxel, R$ 330.828,70 for abiraterone and R$ 571.379,42 for abiraterone compared to docetaxel, respectively. CONCLUSION: The addition of chemotherapy to androgen deprivation therapy is more cost-effective than the addition of abiraterone to androgen deprivation therapy. However, discounts on abiraterone cost might improve cost-effectiveness.

Potential life years not saved due to lack of access to anti-EGFR tyrosine kinase inhibitors for lung cancer treatment in the Brazilian public healthcare system: Budget impact and strategies to improve access. A pharmacoeconomic study.

BACKGROUND: Lung cancer is the fourth most common cancer in Brazil. In the 2000s, better understanding of molecular pathways led to development of epidermal growth factor receptor (EGFR)-targeted treatments that have improved outcomes. However, these treatments are unavailable in most Brazilian public healthcare services (Sistema Único de Saúde, SUS). OBJECTIVE: To assess the potential number of years of life not saved, the budget impact of the treatment and strategies to improve access. DESIGN AND SETTING: Pharmacoeconomic study assessing the potential societal and economic impact of adopting EGFR-targeted therapy within SUS. METHODS: We estimated the number of cases eligible for treatment, using epidemiological data from the National Cancer Institute. We used data from a single meta-analysis and from the Lung Cancer Mutation Consortium (LCMC) study as the basis for assessing differences in patients' survival between use of targeted therapy and use of chemotherapy. The costs of targeted treatment were based on the national reference and were compared with the amount reimbursed for chemotherapy through SUS. RESULTS: There was no life-year gain with EGFR-targeted therapy in the single meta-analysis (hazard ratio, HR, 1.01). The LCMC showed that 1,556 potential life-years were not saved annually. We estimated that the annual budget impact was 125 million Brazilian reais (BRL) with erlotinib, 48 million BRL with gefitinib and 52 million BRL with afatinib. Their incremental costs over chemotherapy per life-year saved were 80,329 BRL, 31,011 BRL and 33,225 BRL, respectively. A drug acquisition discount may decrease the budget impact by 30% (with a 20% discount). A fixed cost of 1,000 BRL may decrease the budget impact by 95%. CONCLUSION: Reducing drug acquisition costs may improve access to EGFR-targeted therapy for lung cancer.

Cost-effectiveness analysis of abiraterone, docetaxel or placebo plus androgen deprivation therapy for hormone-sensitive advanced prostate cancer / Análise de custo-efetividade da adição de abiraterona ou quimioterapia ao tratamento do câncer de próstata metastático hormônio-sensível

ABSTRACT Objective To evaluate the cost-effectiveness of the addition of chemotherapy or abiraterone to androgen deprivation. Methods We developed an analytical model to determine the cost-effectiveness of the addition of docetaxel or abiraterone versus androgen deprivation therapy alone. Direct and indirect costs were included in the model. The effects were expressed in Quality-Adjusted Life Years adjusted for side effects. Results Compared to androgen deprivation therapy alone, the addition of chemotherapy and of abiraterone generated 0.492 and 0.999, respectively, in Quality-Adjusted Life Years. Abiraterone led to a Quality-Adjusted Life Years gain of 0.506 compared to docetaxel. The incremental costs per Quality-Adjusted Life Years were R$ 133.649,22 for docetaxel, R$ 330.828,70 for abiraterone and R$ 571.379,42 for abiraterone compared to docetaxel, respectively. Conclusion The addition of chemotherapy to androgen deprivation therapy is more cost-effective than the addition of abiraterone to androgen deprivation therapy. However, discounts on abiraterone cost might improve cost-effectiveness.

RESUMO Objetivo Avaliar a relação custo-efetividade da adição de quimioterapia ou abiraterona à terapia de privação hormonal. Métodos Um modelo analítico foi desenvolvido para determinar a relação custo-efetividade da adição de docetaxel ou abiraterona comparada à terapia de privação hormonal isolada. Custos diretos e indiretos foram incluídos no modelo. Os efeitos foram expressos em Anos de Vida Ajustados para Qualidade corrigidos pelos efeitos colaterais de cada terapia. Resultados A adição de quimioterapia e de abiraterona à terapia de privação hormonal aumentou os Anos de Vida Ajustados para Qualidade em 0,492 e 0,999, respectivamente, em comparação à terapia de privação hormonal isolada. A abiraterona promoveu ganho de Anos de Vida Ajustados para Qualidade de 0,506 em relação ao docetaxel. O custo incremental por Anos de Vida Ajustados para Qualidade foi R$ 133.649,22 para o docetaxel, R$ 330.828,70 para a abiraterona e R$ 571.379,42 para a abiraterona comparada ao docetaxel. Conclusão A adição de quimioterapia à terapia de privação hormonal é mais custo-efetiva que a adição de abiraterona à terapia de privação hormonal. Contudo, descontos no custo da abiraterona poderiam tornar esse tratamento mais custo-efetivo.

Cost-effectiveness and budget impact of lung cancer immunotherapy in South America: strategies to improve access.

AIM: Immune checkpoint inhibitors revolutionized the treatment of non-small-cell lung cancer, although their costs are a limitation. METHODS: The number of patients with non-small-cell lung cancer eligible for immunotherapy was estimated using local epidemiology data. We extracted survival data from RCTs to estimate the life-years saved in a 5-year time horizon. All costs were in local prices converted to US dollars. RESULTS: In the first-line, the budget impact of pembrolizumab decreased by 35% through risk-sharing. In the second-line, patient selection by programmed-death receptor ligand 1 expression decreased the budgetary impact by 45%, and improved cost-effectiveness. Immunotherapy was more cost-effective in the first-line. CONCLUSION: Given current pricing, Immune checkpoint inhibitors are cost-prohibitive in the majority of South American health services. Nevertheless, several strategies should improve access to immunotherapy.

Chemotherapy-Induced Fatigue Correlates With Higher Fatigue Scores Before Treatment.

PURPOSE: Cancer chemotherapy can induce fatigue in about 20% to 30% of patients. So far, there is very little information as to the predictors of chemotherapy-induced fatigue (CIF). We evaluated potential predictors of CIF in a sample of patients with cancer with several types of solid tumors scheduled to receive chemotherapy according to institutional protocols. METHODS: Before their first and second chemotherapy cycles, patients answered to the Brief Fatigue Inventory (BFI), Chalder, Mini Nutritional Assessment (MNA), Stress thermometer, and HADS questionnaires as well as provided blood samples for inflammatory markers. RESULTS: We evaluated 52 patients, 37 (71%) were female and mean age was 53 years. The most common tumors were breast cancer 21 (40%) and gastrointestinal tumors 12 (23%). Although 14 (25.2%) patients had an increase in their fatigue BFI scores equal or above 3 points from baseline, we observed no significant overall differences between BFI scores before and after chemotherapy. The only 2 factors associated with an increase of 3 points in the BFI scores after chemotherapy were race and higher baseline BFI levels. By multivariate analysis, overall BFI and Chalder scores after chemotherapy also correlated significantly with their respective baseline scores before treatment. HADS scores before treatment correlated with overall BFI scores postchemotherapy, whereas MNA scores before chemotherapy and female sex correlated with higher Chalder scores after treatment. CONCLUSION: We conclude that fatigue induced by chemotherapy is common and consistently associated with higher fatigue scores before treatment. Screening for fatigue before chemotherapy may help to identify patients who are prone to develop CIF.