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1.
BMJ Open ; 14(8): e081270, 2024 Aug 22.
Artigo em Inglês | MEDLINE | ID: mdl-39179275

RESUMO

OBJECTIVE: Icotinib has been approved for adjuvant treatment of stage II-IIIA non-small cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations in China, yet the long-term costs and outcomes of this strategy are unknown. Thus, we examined the cost effectiveness of adjuvant icotinib, compared with adjuvant chemotherapy, for the treatment of resected stage II-IIIA EGFR-mutated NSCLC. DESIGN: We performed a cost-effectiveness analysis from the perspective of the Chinese healthcare system, comparing 2-year adjuvant icotinib with four cycles of adjuvant chemotherapy. Costs and quality-adjusted life years (QALYs) were estimated using a Markov model. Model inputs were obtained from local data and literature. The influence of model parameters and assumptions was explored in sensitivity analyses. All costs are expressed in 2022 US dollars, and costs and QALYs were discounted at a rate of 5% per year. The willingness-to-pay (WTP) threshold was set at three times the per capita gross domestic product. SETTING: The Chinese healthcare system perspective. PARTICIPANTS: A hypothetical Chinese cohort of patients with resected stage II-IIIA EGFR-mutated NSCLC. INTERVENTIONS: Icotinib versus chemotherapy. PRIMARY OUTCOME MEASURE: Costs, QALYs, incremental cost-effectiveness ratio. RESULTS: The incremental cost per QALY gained with the use of 2-year icotinib, from the Chinese healthcare system perspective, was $3440.66 compared with adjuvant chemotherapy. At a WTP threshold of $40 500, adjuvant icotinib was the optimal treatment in over 99% of replications. The interpretation of the results was insensitive to model and input assumptions. CONCLUSIONS: Compared with adjuvant chemotherapy, adjuvant icotinib may be a cost-effective treatment for resected stage II-IIIA EGFR-mutated NSCLC as the WTP threshold is set at $40 500 per QALY.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Análise Custo-Benefício , Éteres de Coroa , Receptores ErbB , Neoplasias Pulmonares , Mutação , Anos de Vida Ajustados por Qualidade de Vida , Quinazolinas , Humanos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/genética , Carcinoma Pulmonar de Células não Pequenas/economia , Carcinoma Pulmonar de Células não Pequenas/patologia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/economia , Neoplasias Pulmonares/patologia , Éteres de Coroa/uso terapêutico , Éteres de Coroa/economia , Quimioterapia Adjuvante/economia , Receptores ErbB/genética , Quinazolinas/uso terapêutico , Quinazolinas/economia , China , Estadiamento de Neoplasias , Cadeias de Markov , Antineoplásicos/uso terapêutico , Antineoplásicos/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Feminino , Masculino
2.
J Med Econ ; 27(1): 972-981, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39010830

RESUMO

AIMS: Use of gene expression signatures to predict adjuvant chemotherapy benefit in women with early-stage breast cancer is increasing. However, high cost, limited access, and eligibility for these tests results in the adoption of less precise assessment approaches. This study evaluates the cost impact of PreciseDx Breast (PDxBr), an AI-augmented histopathology platform that assesses the 6-year risk of recurrence in early-stage invasive breast cancer patients to help improve informed use of adjuvant chemotherapy. MATERIALS AND METHODS: A decision-tree Markov model was developed to compare the costs of treatment guided by standard of care (SOC) risk assessment (i.e. clinical diagnostic workup with or without Oncotype DX) versus PDxBr with SOC in a hypothetical cohort of U.S. women with early-stage invasive breast cancer. A commercial payer perspective compares costs of testing, adjuvant therapy, recurrence, adverse events, surveillance, and end-of-life care. RESULTS: PDxBr use in prognostic evaluation resulted in savings of $4 million (M) in year one compared to current SOC in 1 M females members. Over 6-years, savings increased to $12.5 M. The per-treated patient costs in year one amounted to $19.5 thousand (K) for SOC and $16.9K for PDxBr. LIMITATIONS: For simplicity, recurrence was not specified. We performed scenario analyses to account for variations in rates for local, regional, and distant recurrence. Second, a recurrent patient incurs the total cost of treated recurrence in the first year and goes back to remission or death. Third, CDK4/6i treatment is only incorporated in the recurrence costs but not in the first line of treatment for early-stage breast cancer due to limited data. CONCLUSIONS: Sensitivity analyses demonstrated robust overall savings to changes in all variables in the model. The use of PDxBr to assess breast cancer recurrence risk has the potential to fill gaps in care and reduce costs when gene expression signatures are not available.


Assuntos
Neoplasias da Mama , Cadeias de Markov , Recidiva Local de Neoplasia , Humanos , Neoplasias da Mama/patologia , Feminino , Medição de Risco , Árvores de Decisões , Quimioterapia Adjuvante/economia , Análise Custo-Benefício , Estados Unidos , Inteligência Artificial , Estadiamento de Neoplasias , Pessoa de Meia-Idade
3.
JCO Glob Oncol ; 10: e2300433, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39024528

RESUMO

PURPOSE: Incorporating adjuvant cyclin-dependent kinase (CDK) 4/6 inhibitors abemaciclib and ribociclib along with endocrine therapy has been shown to improve invasive disease-free survival (iDFS) for hormone receptor-positive (HR+) human epidermal receptor 2-negative (HER2-) early breast cancer (EBC). This study assesses the cost-effectiveness of this strategy, along with adjuvant aromatase inhibitors from an Indian perspective. METHODS: A Markov chain model evaluated the cost-effectiveness of abemaciclib and ribociclib with letrozole compared with letrozole alone for HR+/HER2- EBC from a payer perspective in India. Key measures included lifetime quality-adjusted life-years (QALY), life-years (LY), and total costs. This study explores two scenarios for effectiveness: a best-case (BC) scenario, where the benefit of CDK4/6 inhibitors in improving iDFS lasts a lifetime, and a worst-case (WC) scenario, where benefits disappear after 5 years. Probabilistic sensitivity analyses (PSA) were used to account for simulation uncertainty. RESULTS: In the BC scenario, abemaciclib added 2.17 QALY and 4.96 LY, incurring ₹2,317,957.7 ($27,756.65 in US dollars [USD]) in additional costs. However, the incremental cost-effectiveness ratio (ICER) for abemaciclib exceeded India's willingness-to-pay threshold in the BC and WC scenarios. In the BC scenario, ribociclib added 0.98 QALY and 2.58 LY with added costs of ₹1,711,504.32 ($20,494.6 USD). The ICER for ribociclib also surpassed India's threshold in both scenarios. PSA showed that neither drug was cost-effective at the current market prices in either BC/WC scenario. The cost of abemaciclib and ribociclib needs to be reduced by at least 78.61% and 87.19%, respectively, to be cost-effective in the BC scenario. CONCLUSION: The combination of adjuvant abemaciclib or ribociclib with letrozole is not cost-effective for HR+/HER2- EBC in India in either the BC or WC scenario.


Assuntos
Aminopiridinas , Benzimidazóis , Neoplasias da Mama , Análise Custo-Benefício , Purinas , Humanos , Aminopiridinas/economia , Aminopiridinas/administração & dosagem , Aminopiridinas/uso terapêutico , Benzimidazóis/economia , Benzimidazóis/administração & dosagem , Benzimidazóis/uso terapêutico , Purinas/economia , Purinas/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/economia , Feminino , Índia , Quimioterapia Adjuvante/economia , Quimioterapia Adjuvante/métodos , Anos de Vida Ajustados por Qualidade de Vida , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cadeias de Markov , Receptores de Estrogênio/metabolismo , Receptores de Progesterona/metabolismo
4.
Curr Oncol ; 31(6): 3301-3310, 2024 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-38920734

RESUMO

This epidemiological model forecasted reductions in recurrences and recurrence treatment cost savings with adjuvant atezolizumab vs best supportive care among Canadians with stage II-IIIA non-small cell lung cancer (NSCLC) at national and provincial levels. The population had resected, programmed cell death 1 ligand 1 (PD-L1)-high (≥50%), EGFR-, ALK-, stage II-IIIA NSCLC eligible for adjuvant treatment. Patients with recurrence or death and the costs of treating recurrences were estimated for those receiving adjuvant atezolizumab or best supportive care each year (2024-2034). Proportions of patients expected to be event free up to 10 years after treatment initiation were extrapolated with parametric survival analyses. In the base case analysis, 240 fewer recurrences were estimated to occur over 10 years (2024-2034) with adjuvant atezolizumab vs best supportive care across Canada, with 136 (57%) and 104 (43%) fewer locoregional and metastatic recurrences, respectively. Projected costs of treated recurrences were CAD 33.2 million less over 10 years with adjuvant atezolizumab at a national level (adjuvant atezolizumab, CAD 135.8 million; best supportive care, CAD 169.0 million). This model predicts a considerable long-term reduction in recurrences and substantial treatment cost savings with adjuvant atezolizumab vs best supportive care for patients with PD-L1-high early-stage NSCLC in Canada.


Assuntos
Anticorpos Monoclonais Humanizados , Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/economia , Carcinoma Pulmonar de Células não Pequenas/patologia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/economia , Neoplasias Pulmonares/patologia , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/economia , Canadá , Recidiva Local de Neoplasia/tratamento farmacológico , Estadiamento de Neoplasias , Quimioterapia Adjuvante/métodos , Quimioterapia Adjuvante/economia , Redução de Custos , Feminino , Masculino , Idoso , Pessoa de Meia-Idade
5.
J Med Econ ; 27(1): 858-865, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38904118

RESUMO

BACKGROUND: Triple Negative Breast Cancer (TNBC) is an aggressive subtype of breast cancer that can impact patients' employment and workforce participation. This study estimates how the employment effects of TNBC impact government tax revenue and public benefits expenditure in Switzerland, representing the fiscal burden of disease (FBoD), and likely consequences of introducing new treatment options. METHODS: A four-state cohort model was used to calculate fiscal effects for two treatments: Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab monotherapy (P + C→P) and neoadjuvant chemotherapy alone (C). Lifetime present values of tax revenue, social benefit payments, and healthcare costs were calculated for the average population and those undergoing treatment to assess the FBoD. RESULTS: An average TNBC patient treated with C and P + C→P is expected to generate CHF128,999 and CHF97,008 less tax than the average population, respectively, and require increased social benefit payments. Compared to C, 75% of the incremental healthcare costs of P + C→P are estimated to be offset through tax revenue gains. CONCLUSIONS: This analysis demonstrates that 75% of the additional costs of a new TNBC treatment option can be offset by gains in tax revenue. Fiscal analysis can be a useful tool to complement existing methods for evaluating new treatments.


Assuntos
Anticorpos Monoclonais Humanizados , Neoplasias de Mama Triplo Negativas , Humanos , Neoplasias de Mama Triplo Negativas/tratamento farmacológico , Neoplasias de Mama Triplo Negativas/economia , Suíça , Feminino , Pessoa de Meia-Idade , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/economia , Gastos em Saúde/estatística & dados numéricos , Impostos , Terapia Neoadjuvante/economia , Adulto , Efeitos Psicossociais da Doença , Idoso , Quimioterapia Adjuvante/economia , Emprego/estatística & dados numéricos , Antineoplásicos/economia , Antineoplásicos/uso terapêutico
6.
Breast Cancer ; 31(5): 917-925, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38878154

RESUMO

BACKGROUND: Tamoxifen (TAM) is recommended as the first-line strategy for men with estrogen receptor (ER)-positive early breast cancer who are candidates for adjuvant endocrine therapy in ASCO guideline. Our study aims to analyze the cost-effectiveness of receiving adjuvant endocrine therapy with TAM compared to no TAM, and to assess the cost-effectiveness of using TAM with high adherence over low adherence for ER-positive early male breast cancer in the USA. METHODS: Two Markov models comprising three mutually exclusive health states were constructed: (1) the first Markov model compared the cost-effectiveness of adding TAM with not using TAM (TAM versus Not-TAM); (2) the second model compared the cost-effectiveness of receiving TAM with high adherence and low adherence (High-adherence-TAM versus Low-adherence-TAM). The simulation time horizon for both models was the lifetime of patients. The efficacy and safety data of two models were elicited from the real-world studies. Model inputs were derived from the US website and published literature. The main outcomes of two models both included the total cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS: In the first model, TAM yielded an ICER of $5707.29 per QALY compared to Not-TAM, which was substantially below the WTP threshold of $50,000.00 per QALY in the USA. Probabilistic sensitivity analysis results demonstrated a 100.00% probability of cost-effectiveness for this strategy. In the second model, High-adherence-TAM was dominated absolutely compared to Low-adherence-TAM. The High-adherence-TAM was cost-effective with a 99.70% probability over Low-adherence-TAM when WTP was set as $50,000.00/QALY. All of these parameters within their plausible ranges did not reversely change the results of our models. CONCLUSIONS: Our study will offer valuable guidance for physicians or patients when making treatment decisions and provide an effective reference for decision-making to consider the appropriate allocation of funds to this special group.


Assuntos
Antineoplásicos Hormonais , Neoplasias da Mama Masculina , Análise Custo-Benefício , Cadeias de Markov , Anos de Vida Ajustados por Qualidade de Vida , Tamoxifeno , Humanos , Tamoxifeno/uso terapêutico , Tamoxifeno/economia , Masculino , Antineoplásicos Hormonais/uso terapêutico , Antineoplásicos Hormonais/economia , Neoplasias da Mama Masculina/tratamento farmacológico , Neoplasias da Mama Masculina/economia , Quimioterapia Adjuvante/economia , Quimioterapia Adjuvante/métodos , Pessoa de Meia-Idade , Idoso , Receptores de Estrogênio/metabolismo , Adesão à Medicação/estatística & dados numéricos , Estados Unidos
7.
Pharmacoeconomics ; 42(6): 679-691, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38584239

RESUMO

OBJECTIVES: Accurate risk stratification of patients with stage II and III colorectal cancer (CRC) prior to treatment selection enables limited health resources to be efficiently allocated to patients who are likely to benefit from adjuvant chemotherapy. We aimed to investigate the cost-effectiveness of a recently developed deep learning-based prognostic method, Histotyping, from the perspective of the Norwegian healthcare system. METHODS: Two partitioned survival models were developed to assess the cost-effectiveness of Histotyping for two treatment cohorts: patients with CRC stage II and III. For each of the two cohorts, Histotyping was used for risk stratification to assign adjuvant chemotherapy and was compared with the standard of care (SOC) (adjuvant chemotherapy to all patients). Health outcomes measured in the model were quality-adjusted life years (QALYs) and life years (LYs) gained. Deterministic and probabilistic sensitivity analyses were performed to determine the impact of uncertainty. Scenario analyses were performed to assess the impact of the parameters with the greatest uncertainty. RESULTS: Risk-stratifying patients with CRC stage II and III using Histotyping was dominant (less costly and more effective) compared to SOC. In patients with CRC stage II, the net monetary benefit of Histotyping was 270,934 Norwegian kroners (NOK) (year of valuation is 2021), and the net health benefit of Histotyping was 0.99. In stage III, the net monetary benefit of Histotyping was 195,419 NOK, and the net health benefit of Histotyping was 0.71. CONCLUSIONS:  Risk-stratifying patients with CRC using Histotyping prior to the administration of adjuvant chemotherapy is likely to be a cost-effective strategy in Norway.


Assuntos
Neoplasias Colorretais , Análise Custo-Benefício , Aprendizado Profundo , Anos de Vida Ajustados por Qualidade de Vida , Humanos , Neoplasias Colorretais/economia , Neoplasias Colorretais/patologia , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/diagnóstico , Noruega , Prognóstico , Quimioterapia Adjuvante/economia , Estadiamento de Neoplasias , Medição de Risco , Biomarcadores Tumorais , Masculino , Feminino
8.
Int J Radiat Oncol Biol Phys ; 119(5): 1379-1385, 2024 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-38432284

RESUMO

PURPOSE: The optimal adjuvant therapy (antiestrogen therapy [ET] + radiation therapy or ET alone, or in some reports radiation therapy alone) in older women with early-stage breast cancer has been highly debated. However, granular details on the role of insurance in the out-of-pocket cost for patients receiving ET with or without radiation therapy are lacking. This project disaggregates out-of-pocket costs by insurance plans to increase treatment cost transparency. METHODS AND MATERIALS: Several radiation therapy schedules are accepted standards as per the National Comprehensive Cancer Network guidelines. For our financial estimate model, we used the 5-fraction and 15-fraction radiation therapy and ET prescribed over a 5-year duration. The total aggregate out-of-pocket costs were determined from the sum of treatment costs, deductibles, and copays/coinsurance based on Medicaid, Original Medicare, Medigap Plan G, and Medicare Part D Rx plans. The model assumes a Medicare- and/or Medicaid-eligible patient ≥70 years of age with node-negative, early-stage estrogen-receptor-positive breast cancer. Patient out-of-pocket costs were estimated from publicly available insurance data from plan-specific benefit coverage materials using a 5-year time horizon. RESULTS: Original Medicare beneficiaries face a total out-of-pocket treatment charge of $2738.52 for ET alone, $2221.26 for 5-fraction radiation therapy alone, $2573.92 for 15-fraction radiation therapy alone, $3361.26 for combined ET+ 5-fraction radiation therapy, and $3713.92 for combined ET + 15-fraction radiation therapy. Medigap Plan G beneficiaries have an out-of-pocket charge of $1130.00 with radiation therapy alone and face an out-of-pocket of $2270.00 for ET alone and combined ET+ radiation therapy. For Medicaid beneficiaries, all treatments approved by Medicaid are covered without limit, resulting in no out-of-pocket expense for either adjuvant treatment option. CONCLUSIONS: This model (based on actual cost estimates per insurance plan rather than claims data), by estimating expenses within Medicare and Medicaid plans, provides a level of transparency to patient cost. With knowledge of the costs borne by patients themselves, treatment decisions informed by patients' individual priorities and preferences may be further enhanced.


Assuntos
Neoplasias da Mama , Gastos em Saúde , Mastectomia Segmentar , Medicaid , Medicare , Humanos , Neoplasias da Mama/radioterapia , Neoplasias da Mama/patologia , Neoplasias da Mama/economia , Neoplasias da Mama/cirurgia , Neoplasias da Mama/terapia , Feminino , Estados Unidos , Medicaid/economia , Gastos em Saúde/estatística & dados numéricos , Mastectomia Segmentar/economia , Medicare/economia , Moduladores de Receptor Estrogênico/uso terapêutico , Moduladores de Receptor Estrogênico/economia , Radioterapia Adjuvante/economia , Dedutíveis e Cosseguros/economia , Idoso , Modelos Econômicos , Quimioterapia Adjuvante/economia , Medicare Part D/economia , Fracionamento da Dose de Radiação
9.
Value Health Reg Issues ; 41: 15-24, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38154365

RESUMO

OBJECTIVES: In the absence of evidence on whether neoadjuvant (NAC) or adjuvant chemotherapy (AC) is more beneficial for various tumor treatments, economic evaluation (EE) can assist medical decision making. There is limited evidence on their cost-effectiveness and their prospective evaluation is less likely in the future. Therefore, a systematic review and meta-analysis about EE for NAC versus AC in solid tumor help compare these therapies from various perspectives. METHODS: Various databases were searched for studies published from inception to 2021. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines and economic-specific guidelines. The data were pooled using a random effects model when possible. RESULTS: The retrieval identified 15 EE studies of NAC versus AC in 8 types of cancer. NAC is the dominant strategy for pancreatic, head and neck, rectal, prostate cancers and colorectal liver metastases. For ovarian cancer, NAC is cost-effective with a lower cost and higher or similar quality-adjusted life-year. There were no significant differences in cost and outcomes for lung cancer. For stage IV or high-risk patients with ovarian or prostate cancer, NAC was cost-effective but not for patients who were not high risk. CONCLUSIONS: The EEs results for NAC versus AC were inconsistent because of their different model structures, assumptions, cost inclusions, and a shortage of studies. There are multiple sources of heterogeneity across EEs evidence synthesis. More high-quality EE studies on NAC versus AC in initial cancer treatment are necessary.


Assuntos
Análise Custo-Benefício , Terapia Neoadjuvante , Neoplasias , Humanos , Quimioterapia Adjuvante/métodos , Quimioterapia Adjuvante/economia , Terapia Neoadjuvante/métodos , Terapia Neoadjuvante/economia , Terapia Neoadjuvante/estatística & dados numéricos , Terapia Neoadjuvante/normas , Análise Custo-Benefício/métodos , Neoplasias/tratamento farmacológico , Neoplasias/economia
10.
Value Health ; 25(3): 409-418, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35227453

RESUMO

OBJECTIVES: Adjuvant chemotherapy is not recommended for patients with average-risk stage II (T3N0) colon cancer. Nevertheless, a subgroup of these patients who are CDX2-negative might benefit from adjuvant chemotherapy. We evaluated the cost-effectiveness of testing for the absence of CDX2 expression followed by adjuvant chemotherapy (fluorouracil combined with oxaliplatin [FOLFOX]) for patients with stage II colon cancer. METHODS: We developed a decision model to simulate a hypothetical cohort of 65-year-old patients with average-risk stage II colon cancer with 7.2% of these patients being CDX2-negative under 2 different interventions: (1) test for the absence of CDX2 expression followed by adjuvant chemotherapy for CDX2-negative patients and (2) no CDX2 testing and no adjuvant chemotherapy for any patient. We derived disease progression parameters, adjuvant chemotherapy effectiveness and utilities from published analyses, and cancer care costs from the Surveillance, Epidemiology, and End Results (SEER)-Medicare data. Sensitivity analyses were conducted. RESULTS: Testing for CDX2 followed by FOLFOX for CDX2-negative patients had an incremental cost-effectiveness ratio of $5500/quality-adjusted life-years (QALYs) compared with no CDX2 testing and no FOLFOX (6.874 vs 6.838 discounted QALYs and $89 991 vs $89 797 discounted US dollar lifetime costs). In sensitivity analyses, considering a cost-effectiveness threshold of $100 000/QALY, testing for CDX2 followed by FOLFOX on CDX2-negative patients remains cost-effective for hazard ratios of <0.975 of the effectiveness of FOLFOX in CDX2-negative patients in reducing the rate of developing a metastatic recurrence. CONCLUSIONS: Testing tumors of patients with stage II colon cancer for CDX2 and administration of adjuvant treatment to the subgroup found CDX2-negative is a cost-effective and high-value management strategy across a broad range of plausible assumptions.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Fator de Transcrição CDX2/biossíntese , Quimioterapia Adjuvante/economia , Neoplasias do Colo/tratamento farmacológico , Neoplasias do Colo/patologia , Idoso , Biomarcadores Tumorais , Quimioterapia Adjuvante/métodos , Neoplasias do Colo/mortalidade , Neoplasias do Colo/terapia , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Intervalo Livre de Doença , Feminino , Fluoruracila/economia , Fluoruracila/uso terapêutico , Humanos , Leucovorina/economia , Leucovorina/uso terapêutico , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Econômicos , Estadiamento de Neoplasias , Compostos Organoplatínicos/economia , Compostos Organoplatínicos/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida , Medição de Risco
11.
Am J Clin Oncol ; 44(7): 340-349, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-34151896

RESUMO

OBJECTIVE: Ado-trastuzumab emtansine (T-DM1) was recently approved for patients with human epidermal growth factor receptor 2 positive (HER2+) early breast cancer (eBC) with residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Cost-effectiveness analysis was conducted to compare T-DM1 versus trastuzumab in the United States. MATERIALS AND METHODS: A Markov cohort-based model tracked clinical and economic outcomes over a lifetime horizon from a US payer perspective. The model included 6 health states: invasive disease-free, nonmetastatic (locoregional) recurrence, remission, first-line and second-line metastatic BC and death. Model state transitions were based on statistical extrapolation of the head-to-head KATHERINE study and published sources. Dosing and treatment duration reflected prescribing information and trials. Costs (2019 US dollars) associated with pharmaceutical treatment (wholesale acquisition costs), health state specific care, adverse events, and end-of-life care were included. Health state utilities were obtained from KATHERINE and published literature. RESULTS: T-DM1 dominated trastuzumab, yielding lower lifetime costs (-$40,271), and higher life-years (2.980) and quality-adjusted life-years (2.336). Results were driven by patients receiving T-DM1 spending less time in more costly downstream health states, as these patients are less likely to experience a recurrence overall, despite having a higher likelihood of metastatic disease (distant recurrence) in the subset of patients who experience recurrence. Probabilistic sensitivity analysis indicated robust results, with 96.7% of 5000 stochastic simulations producing dominance for T-DM1. The most influential variables were related to treatment costs, off treatment utilities, and health state costs. Additional scenario analyses tested a range of model inputs and assumptions, and produced consistent results. CONCLUSION: Relative to trastuzumab, T-DM1 treatment for patients with HER2+ eBC who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment is likely to reduce the overall financial burden of cancer, while simultaneously improving patient outcomes.


Assuntos
Ado-Trastuzumab Emtansina/economia , Ado-Trastuzumab Emtansina/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Quimioterapia Adjuvante/economia , Ado-Trastuzumab Emtansina/efeitos adversos , Antineoplásicos Imunológicos/efeitos adversos , Antineoplásicos Imunológicos/economia , Antineoplásicos Imunológicos/uso terapêutico , Neoplasias da Mama/economia , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Análise Custo-Benefício , Custos de Medicamentos , Feminino , Humanos , Recidiva Local de Neoplasia , Qualidade de Vida , Trastuzumab/efeitos adversos , Trastuzumab/economia , Trastuzumab/uso terapêutico , Estados Unidos
12.
Value Health ; 24(6): 770-779, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-34119074

RESUMO

OBJECTIVES: Approximately 20% of UK women aged 70+ with early breast cancer receive primary endocrine therapy (PET) instead of surgery. PET reduces surgical morbidity but with some survival decrement. To complement and utilize a treatment dependent prognostic model, we investigated the cost-effectiveness of surgery plus adjuvant therapies versus PET for women with varying health and fitness, identifying subgroups for which each treatment is cost-effective. METHODS: Survival outcomes from a statistical model, and published data on recurrence, were combined with data from a large, multicenter, prospective cohort study of over 3400 UK women aged 70+ with early breast cancer and median 52-month follow-up, to populate a probabilistic economic model. This model evaluated the cost-effectiveness of surgery plus adjuvant therapies relative to PET for 24 illustrative subgroups: Age {70, 80, 90} × Nodal status {FALSE (F), TRUE (T)} × Comorbidity score {0, 1, 2, 3+}. RESULTS: For a 70-year-old with no lymph node involvement and no comorbidities (70, F, 0), surgery plus adjuvant therapies was cheaper and more effective than PET. For other subgroups, surgery plus adjuvant therapies was more effective but more expensive. Surgery plus adjuvant therapies was not cost-effective for 4 of the 24 subgroups: (90, F, 2), (90, F, 3), (90, T, 2), (90, T, 3). CONCLUSION: From a UK perspective, surgery plus adjuvant therapies is clinically effective and cost-effective for most women aged 70+ with early breast cancer. Cost-effectiveness reduces with age and comorbidities, and for women over 90 with multiple comorbidities, there is little cost benefit and a negative impact on quality of life.


Assuntos
Antineoplásicos Hormonais/economia , Antineoplásicos Hormonais/uso terapêutico , Neoplasias da Mama/economia , Neoplasias da Mama/terapia , Custos de Medicamentos , Mastectomia/economia , Fatores Etários , Idoso , Antineoplásicos Hormonais/efeitos adversos , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Quimioterapia Adjuvante/economia , Tomada de Decisão Clínica , Comorbidade , Pesquisa Comparativa da Efetividade , Análise Custo-Benefício , Feminino , Nível de Saúde , Humanos , Mastectomia/efeitos adversos , Mastectomia/mortalidade , Modelos Econômicos , Modelos Estatísticos , Aptidão Física , Qualidade de Vida , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Reino Unido
13.
Cancer Epidemiol Biomarkers Prev ; 30(9): 1726-1734, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34162659

RESUMO

BACKGROUND: To explore the potential value of consensus molecular subtypes (CMS) in stage II colon cancer treatment selection, we carried out an early cost-effectiveness assessment of a CMS-based strategy for adjuvant chemotherapy. METHODS: We used a Markov cohort model to evaluate three selection strategies: (i) the Dutch guideline strategy (MSS+pT4), (ii) the mutation-based strategy (MSS plus a BRAF and/or KRAS mutation or MSS plus pT4), and (iii) the CMS-based strategy (CMS4 or pT4). Outcomes were number of colon cancer deaths per 1,000 patients, total discounted costs per patient (pp), and quality-adjusted life-years (QALY) pp. The analyses were conducted from a Dutch societal perspective. The robustness of model predictions was assessed in sensitivity analyses. To evaluate the value of future research, we performed a value of information (VOI) analysis. RESULTS: The Dutch guideline strategy resulted in 8.10 QALYs pp and total costs of €23,660 pp. The CMS-based and mutation-based strategies were more effective and more costly, with 8.12 and 8.13 QALYs pp and €24,643 and €24,542 pp, respectively. Assuming a threshold of €50,000/QALY, the mutation-based strategy was considered as the optimal strategy in an incremental analysis. However, the VOI analysis showed substantial decision uncertainty driven by the molecular markers (expected value of partial perfect information: €18M). CONCLUSIONS: On the basis of current evidence, our analyses suggest that the mutation-based selection strategy would be the best use of resources. However, the extensive decision uncertainty for the molecular markers does not allow selection of an optimal strategy at present. IMPACT: Future research is needed to eliminate decision uncertainty driven by molecular markers.


Assuntos
Quimioterapia Adjuvante/economia , Neoplasias do Colo/economia , Quimioterapia Adjuvante/métodos , Neoplasias do Colo/tratamento farmacológico , Neoplasias do Colo/mortalidade , Análise Custo-Benefício , Humanos , Cadeias de Markov , Estadiamento de Neoplasias , Países Baixos/epidemiologia , Anos de Vida Ajustados por Qualidade de Vida , Medição de Risco
14.
Breast Cancer Res Treat ; 188(1): 141-147, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33860387

RESUMO

PURPOSE: Genomic tests can guide the decision to administer adjuvant chemotherapy in women with hormone receptor (HR)-positive, Human Epidermal growth Factor 2 (HER2)-negative breast cancer (BC) at intermediate risk of recurrence. We assessed the decision-making and economic impact of the Prosigna test in a real-life setting. METHODS: Retrospective cohort study of HR + , HER2- BC patients managed from 2016 to 2020, potential candidates for adjuvant chemotherapy, at intermediate risk of recurrence, in whom a Prosigna test was performed according to contemporary guidelines. The additional cost of chemotherapy over one year in terms of direct medical and non-medical costs was estimated in this study to be €9,737 (derived from a previous study, NCT02813317). The cost of the Prosigna test, as defined by the reimbursement system, was €1,849. RESULTS: Among the 809 patients included in this study, 2.3 Prosigna tests had to be performed to avoid adjuvant chemotherapy for one patient. The number of tests that had to be performed to avoid chemotherapy for one patient was higher for patients with grade 3 tumors and pN1mic axillary node involvement and lower for grade 1 tumors or in the absence of axillary node involvement (pN0), but did not vary according to the 10-year overall survival gain predicted by the Predict online test. The cost saving related to withholding of adjuvant chemotherapy for one patient on the basis of the Prosigna test results was €5,485. CONCLUSION: We present one of the largest cohorts of HR + , HER2- BC patients at intermediate risk of recurrence, in whom a Prosigna test was used to guide the adjuvant therapy decision in a real-life setting, resulting in a 44% decrease in the indication for chemotherapy.


Assuntos
Neoplasias da Mama , Tomada de Decisão Clínica , Neoplasias da Mama/tratamento farmacológico , Quimioterapia Adjuvante/economia , Custos e Análise de Custo , Feminino , Humanos , Recidiva Local de Neoplasia , Estudos Observacionais como Assunto , Receptor ErbB-2 , Estudos Retrospectivos
15.
J Am Coll Surg ; 232(6): 921-932.e12, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33865977

RESUMO

BACKGROUND: Hepatopancreatobiliary (HPB) and gastric oncologic operations are frequently performed at referral centers. Postoperatively, many patients experience care fragmentation, including readmission to "outside hospitals" (OSH), which is associated with increased mortality. Little is known about patient-level and hospital-level variables associated with this mortality difference. STUDY DESIGN: Patients undergoing HPB or gastric oncologic surgery were identified from select states within the Healthcare Cost and Utilization Project database (2006-2014). Follow-up was 90 days after discharge. Analyses used Kruskal-Wallis test, Youden index, and multilevel modeling at the hospital level. RESULTS: There were 7,536 patients readmitted within 90 days of HPB or gastric oncologic surgery to 636 hospitals; 28% of readmissions (n = 2,123) were to an OSH, where 90-day readmission mortality was significantly higher: 8.0% vs 5.4% (p < 0.01). Patients readmitted to an OSH lived farther from the index surgical hospital (median 24 miles vs 10 miles; p < 0.01) and were readmitted later (median 25 days after discharge vs 12; p < 0.01). These variables were not associated with readmission mortality. Surgical complications managed at an OSH were associated with greater readmission mortality: 8.4% vs 5.7% (p < 0.01). Hospitals with <100 annual HPB and gastric operations for benign or malignant indications had higher readmission mortality (6.4% vs 4.7%, p = 0.01), although this was not significant after risk-adjustment (p = 0.226). CONCLUSIONS: For readmissions after HPB and gastric oncologic surgery, travel distance and timing are major determinants of care fragmentation. However, these variables are not associated with mortality, nor is annual hospital surgical volume after risk-adjustment. This information could be used to determine safe sites of care for readmissions after HPB and gastric surgery. Further analysis is needed to explore the relationship between complications, the site of care, and readmission mortality.


Assuntos
Continuidade da Assistência ao Paciente/organização & administração , Neoplasias do Sistema Digestório/terapia , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Readmissão do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Idoso , Quimioterapia Adjuvante/economia , Quimioterapia Adjuvante/estatística & dados numéricos , Continuidade da Assistência ao Paciente/economia , Continuidade da Assistência ao Paciente/estatística & dados numéricos , Bases de Dados Factuais/estatística & dados numéricos , Neoplasias do Sistema Digestório/economia , Neoplasias do Sistema Digestório/mortalidade , Procedimentos Cirúrgicos do Sistema Digestório/economia , Procedimentos Cirúrgicos do Sistema Digestório/estatística & dados numéricos , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Readmissão do Paciente/economia , Complicações Pós-Operatórias/economia , Complicações Pós-Operatórias/etiologia , Radioterapia Adjuvante/economia , Radioterapia Adjuvante/estatística & dados numéricos , Estudos Retrospectivos , Medição de Risco/estatística & dados numéricos , Fatores de Risco , Centros de Atenção Terciária/economia , Centros de Atenção Terciária/organização & administração , Centros de Atenção Terciária/estatística & dados numéricos , Fatores de Tempo
16.
J Surg Res ; 264: 279-286, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33839343

RESUMO

BACKGROUND: Safety-net hospitals serve a vital role in society by providing care for vulnerable populations. Existing data regarding oncologic outcomes of patients with colon cancer treated at safety-net hospitals are limited and variable. The objective of this study was to delineate disparities in treatment and outcomes for patients with colon cancer treated at safety-net hospitals. METHODS: This retrospective cohort study identified 802,304 adult patients with colon adenocarcinoma from the National Cancer Database between 2004-2016. Patients were stratified according to safety-net burden of the treating hospital as previously described. Patient, tumor, facility, and treatment characteristics were compared between groups as were operative and short-term outcomes. Cox proportional hazards regression was utilized to compare overall survival between patients treated at high, medium, and low burden hospitals. RESULTS: Patients treated at safety-net hospitals were demographically distinct and presented with more advanced disease. They were also less likely to receive surgery, adjuvant chemotherapy, negative resection margins, adequate lymphadenectomy, or a minimally invasive operative approach. On multivariate analysis adjusting for patient and tumor characteristics, survival was inferior for patients at safety-net hospitals, even for those with stage 0 (in situ) disease. CONCLUSION: This analysis revealed inferior survival for patients with colon cancer treated at safety-net hospitals, including those without invasive cancer. These findings suggest that unmeasured population differences may confound analyses and affect survival more than provider or treatment disparities.


Assuntos
Adenocarcinoma/mortalidade , Neoplasias do Colo/mortalidade , Disparidades em Assistência à Saúde/estatística & dados numéricos , Provedores de Redes de Segurança/estatística & dados numéricos , Populações Vulneráveis/estatística & dados numéricos , Adenocarcinoma/diagnóstico , Adenocarcinoma/economia , Adenocarcinoma/terapia , Idoso , Idoso de 80 Anos ou mais , Quimioterapia Adjuvante/economia , Quimioterapia Adjuvante/estatística & dados numéricos , Colectomia/economia , Colectomia/estatística & dados numéricos , Colo/patologia , Colo/cirurgia , Neoplasias do Colo/diagnóstico , Neoplasias do Colo/economia , Neoplasias do Colo/terapia , Bases de Dados Factuais/estatística & dados numéricos , Feminino , Disparidades em Assistência à Saúde/economia , Humanos , Masculino , Margens de Excisão , Pessoas sem Cobertura de Seguro de Saúde/estatística & dados numéricos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Estudos Retrospectivos , Medição de Risco/estatística & dados numéricos , Provedores de Redes de Segurança/economia , Análise de Sobrevida , Estados Unidos/epidemiologia
17.
Expert Rev Pharmacoecon Outcomes Res ; 21(5): 1001-1010, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32972260

RESUMO

INTRODUCTION: As the availability of new economic evaluations (EE) on adjuvant trastuzumab therapy for early-stage breast cancer (EBC) with HER2-positive since last search and other EEs missed warrant a more extensive review, this study aimed to systematically review EEs of adjuvant trastuzumab compared with chemotherapy alone for HER2-positive EBC. AREA COVERED: The search was performed in February 2019 using MEDLINE and Scopus. Reviewers independently selected studies based on eligibility criteria, extracted data, assessed quality of reporting, and appraised quality of data sources. EXPERT OPINION: 22 studies were included which were from high-income (HICs) and upper-middle income countries (UMICs). Incremental cost-effectiveness ratios (ICERs) from HICs were within their cost-effectiveness thresholds and ranged from 6,018 to 78,929 USD per quality-adjusted life year (QALY) gained. ICERs from UMICs mostly exceeded their thresholds ranging from 3,526 to 174,901 USD per QALY gained. Evidence shows cost-effectiveness of trastuzumab for HER2-positive EBC in HICs. There were no methodological variations. The extent and adequacy of reporting were high. The quality of data sources was moderate to high. The quality of future EEs can be improved by enhancing the reporting quality, by using context-based data and real-world efficacy data, which would impact cost-effectiveness.


Assuntos
Antineoplásicos Imunológicos/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Trastuzumab/administração & dosagem , Antineoplásicos Imunológicos/economia , Neoplasias da Mama/economia , Quimioterapia Adjuvante/economia , Análise Custo-Benefício , Feminino , Humanos , Estadiamento de Neoplasias , Anos de Vida Ajustados por Qualidade de Vida , Receptor ErbB-2/metabolismo , Projetos de Pesquisa , Trastuzumab/economia
18.
Urology ; 149: 154-160, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33373709

RESUMO

OBJECTIVE: To assess social and clinical correlates of neoadjuvant chemotherapy (NAC) utilization among Medicare beneficiaries. MATERIALS AND METHODS: A cohort of SEER-Medicare (2004-2015) patients with muscle-invasive bladder cancer treated by radical cystectomy were stratified into 3-groups: standard of care NAC (cisplatin-based combination), non-standard of care NAC, and upfront cystectomy. Multivariable logistic regression analysis was used to assess social, demographic and clinical correlates of each treatment category. Survival analyses were performed to compare propensity matched treatment groups. RESULTS: In total, 6214 patients were identified with a median follow-up of 21 [IQR 7-54] months. NAC utilization increased from 10.7% to 39.1%, between 2004 and 2015, largely due to increased use of standard of care regimens. The most commonly used nonstandard regimen was gemcitabine/carboplatin (50.2%). Older age, Hispanic and Black race, lower socioeconomic status, and contraindications to cisplatin were associated with increased odds of receiving nonstandard of care NAC compared to standard of care. Standard of care NAC was associated with improved overall survival HR 0.85 (95% CI 0.76, 0.94) and HR 0.75 (95% CI 0.63, 0.89) compared to both upfront cystectomy and nonstandard of care NAC, respectively. CONCLUSION: NAC utilization has increased to nearly 40%; however, the use of non-standard of care NAC regimen have persisted (~8%). Cisplatin-ineligibility, older age, race/ethnicity, and lower socioeconomic status were correlated with nonstandard of care NAC, which provided no clinical benefit at the risk of potential harm. In accordance with current clinical guidelines, cisplatin-ineligible patients should be considered for timely upfront cystectomy or novel clinical trials.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cistectomia , Terapia Neoadjuvante/estatística & dados numéricos , Neoplasias da Bexiga Urinária/terapia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Carboplatina/economia , Carboplatina/uso terapêutico , Quimioterapia Adjuvante/economia , Quimioterapia Adjuvante/estatística & dados numéricos , Cisplatino/economia , Cisplatino/uso terapêutico , Desoxicitidina/análogos & derivados , Desoxicitidina/economia , Desoxicitidina/uso terapêutico , Feminino , Humanos , Masculino , Medicare/economia , Medicare/estatística & dados numéricos , Músculos/patologia , Músculos/cirurgia , Terapia Neoadjuvante/economia , Terapia Neoadjuvante/métodos , Invasividade Neoplásica/patologia , Estudos Retrospectivos , Classe Social , Estados Unidos , Bexiga Urinária/patologia , Bexiga Urinária/cirurgia , Neoplasias da Bexiga Urinária/economia , Gencitabina
19.
J Am Coll Surg ; 231(5): 547-554.e1, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32889093

RESUMO

BACKGROUND: Indiscriminate use of adjuvant therapy in stage IIIA melanoma is controversial. We sought to model the clinical impact and cost of implementing a gene expression profile (GEP) test to guide adjuvant therapy. STUDY DESIGN: A Markov decision-analysis model was created to represent resected stage IIIA melanoma with 3 treatment options: observation (OBS), adjuvant pembrolizumab for all patients (ALL), and selective adjuvant therapy (SEL). In the SEL option, only high-risk patients based on GEP stratification were treated with pembrolizumab. Cost of adjuvant therapy was normalized to reflect Medicare reimbursement schedules. The primary outcome was cost per mortality avoided at 10 years. RESULTS: Model projections for 10-year overall survival were 68% for OBS, 73% for SEL, and 76% for ALL. The estimated incremental cost-per-mortality-avoided (compared to OBS) was $2.1 million for SEL and $2.4 million for ALL. These translate to costs of $583.0K and $697.1K per life-year for the SEL and ALL strategies, respectively. CONCLUSIONS: Routine adjuvant pembrolizumab for stage IIIA melanoma is costly, and risk-stratification by GEP only marginally improves the value of therapy.


Assuntos
Quimioterapia Adjuvante/economia , Análise Custo-Benefício , Perfilação da Expressão Gênica , Melanoma/genética , Neoplasias Cutâneas/genética , Adulto , Anticorpos Monoclonais Humanizados/economia , Antineoplásicos Imunológicos/economia , Feminino , Humanos , Masculino , Cadeias de Markov , Medicare/economia , Melanoma/mortalidade , Melanoma/patologia , Melanoma/terapia , Estadiamento de Neoplasias , Neoplasias Cutâneas/mortalidade , Neoplasias Cutâneas/patologia , Neoplasias Cutâneas/terapia , Taxa de Sobrevida , Estados Unidos
20.
BMC Cancer ; 20(1): 790, 2020 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-32819390

RESUMO

BACKGROUND: Accurate detection of patients with minimal residual disease (MRD) after surgery for stage II colon cancer (CC) remains an urgent unmet clinical need to improve selection of patients who might benefit form adjuvant chemotherapy (ACT). Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease. The MEDOCC-CrEATE trial investigates how many stage II CC patients with detectable ctDNA after surgery will accept ACT and whether ACT reduces the risk of recurrence in these patients. METHODS/DESIGN: MEDOCC-CrEATE follows the 'trial within cohorts' (TwiCs) design. Patients with colorectal cancer (CRC) are included in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) and give informed consent for collection of clinical data, tissue and blood samples, and consent for future randomization. MEDOCC-CrEATE is a subcohort within PLCRC consisting of 1320 stage II CC patients without indication for ACT according to current guidelines, who are randomized 1:1 into an experimental and a control arm. In the experimental arm, post-surgery blood samples and tissue are analyzed for tissue-informed detection of plasma ctDNA, using the PGDx elio™ platform. Patients with detectable ctDNA will be offered ACT consisting of 8 cycles of capecitabine plus oxaliplatin while patients without detectable ctDNA and patients in the control group will standard follow-up according to guideline. The primary endpoint is the proportion of patients receiving ACT when ctDNA is detectable after resection. The main secondary outcome is 2-year recurrence rate (RR), but also includes 5-year RR, disease free survival, overall survival, time to recurrence, quality of life and cost-effectiveness. Data will be analyzed by intention to treat. DISCUSSION: The MEDOCC-CrEATE trial will provide insight into the willingness of stage II CC patients to be treated with ACT guided by ctDNA biomarker testing and whether ACT will prevent recurrences in a high-risk population. Use of the TwiCs design provides the opportunity to randomize patients before ctDNA measurement, avoiding ethical dilemmas of ctDNA status disclosure in the control group. TRIAL REGISTRATION: Netherlands Trial Register: NL6281/NTR6455 . Registered 18 May 2017, https://www.trialregister.nl/trial/6281.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Biomarcadores Tumorais/sangue , DNA Tumoral Circulante/sangue , Neoplasias do Colo/terapia , Recidiva Local de Neoplasia/epidemiologia , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/normas , Capecitabina/administração & dosagem , Capecitabina/efeitos adversos , Quimioterapia Adjuvante/economia , Quimioterapia Adjuvante/psicologia , Quimioterapia Adjuvante/normas , Quimioterapia Adjuvante/estatística & dados numéricos , Colectomia , Neoplasias do Colo/sangue , Neoplasias do Colo/diagnóstico , Neoplasias do Colo/mortalidade , Análise Custo-Benefício , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Biópsia Líquida , Masculino , Recidiva Local de Neoplasia/prevenção & controle , Estadiamento de Neoplasias , Neoplasia Residual , Países Baixos/epidemiologia , Oxaliplatina/administração & dosagem , Oxaliplatina/efeitos adversos , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
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