JCO Global Oncology最新文献

Purpose: Combined-modality therapy (CMT) improves survival in patients with early-stage extranodal natural killer-/T-cell lymphoma (ENKTCL) compared with radiotherapy (RT) alone. However, the effect is inadequate for low-risk patients as defined by nomogram-revised risk index (NRI). As such, it remains unclear whether the survival benefits outweigh the additional costs.

Materials and methods: A Markov model was constructed to compare CMT versus RT alone for patients with early-stage ENKTCL, according to five risk groups defined by NRI model. Transition probabilities, effectiveness, and cost data were derived from the China Lymphoma Collaborative Group cohort, while health utility data were estimated from adverse effects. Life-years, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios were calculated from the perspective of Chinese payers. Evaluations for customized countries or settings can be accomplished using a web-based tool.

Results: Over the 6-year horizon, CMT increased life-years by 5.47, 5.19, 4.82, 4.62, and 4.49 years at $517,472 US dollars (USD)/QALY, $22,871 USD/QALY, $7,865 USD/QALY, $4,598 USD/QALY, and $2,278 USD/QALY for the low-risk (NRI = 0), intermediate-low-risk (NRI = 1), intermediate-high-risk (NRI = 2), high-risk (NRI = 3), and very high-risk (NRI = 4) groups, respectively. The probabilities of cost-effectiveness at a willingness-to-pay threshold of $5,208 USD/QALY were 0.00%, 0.01%, 7.40%, 72.07%, and 99.10% for each risk group. Over the lifetime horizon, all risk groups, except for low-risk group, had a probability of over 90% of being cost-effective. Estimates were varied according to country settings, integrated through a web-based customized analysis.

Conclusion: CMT is unlikely to be cost-effective for low-risk patients but highly likely to be cost-effective for high-risk and very high-risk patients. As for intermediate-low or intermediate-high-risk patients, the cost-effectiveness of CMT varies depending on the time horizon and willingness-to-pay threshold.

Purpose: Breast cancer imposes a substantial disease burden on the Brazilian population. Furthermore, the potential unnecessary use of adjuvant chemotherapy exposes patients to risks and adverse effects without significant therapeutic benefits. The purpose of this study is to determine the extent to which genomic testing for treatment selection, particularly in early stages, is a cost-effective strategy for optimizing care, while minimizing costs and unnecessary interventions.

Methods: We estimated the economic impact of the Oncotype DX test to guide the decision about prescribing adjuvant chemotherapy. The model integrates a decision tree and a Markov model with transitions between the health states of recurrence-free survival, distant recurrence, acute myeloid leukemia, and death. The probabilities of distant recurrence were derived from the TAILORx and RxPONDER clinical trials, combined with local evidence regarding utility and overall survival estimates. The analysis was conducted from the perspective of the Brazilian private health care system, which covers about one quarter of the Brazilian population. Scenario and sensitivity analyses with Monte Carlo simulations were performed.

Results: Compared with clinicopathologic risk assessment alone, use of the Oncotype DX test for both node-negative (N0) and node-positive (N1) leads to an increase in quality-adjusted life-years (QALYs) at lower costs (0.15 QALYs and $-3,975.59 US dollars [USD]). The main impact drivers were chemotherapy costs, chemotherapy prescription probabilities, and Oncotype DX test cost. Considering the Brazilian official cost-effectiveness thresholds ($8,000.00 USD to $24,000.00 USD per QALY), the probabilistic sensitivity analysis indicated a high probability of the test being cost-effective across all analyzed scenarios and indications.

Conclusion: Oncotype DX could be a cost-saving strategy in the Brazilian private health care perspective. Alternative scenarios and testing indications did not alter these conclusions.

Purpose: Breast cancer is the leading cause of cancer-related death among Brazilian women. Understanding the regional disparities in mammographic screening coverage is essential for improving early detection strategies. The purpose of this study was to analyze mammographic screening coverage and proportion of BI-RADS 0 results across Brazilian states and regions.

Patients and methods: This cross-sectional study analyzed mammographic screening data from the Unified Health System (SUS) for 2022. The primary outcomes and measures were mammographic SUS coverage rates and proportion of Breast Imaging Reporting and Data System (BI-RADS) 0 results. Secondary outcomes included the number of mammography devices per state, proportion of municipalities with equipment, and distribution of radiologists both in absolute numbers and relative concentrations in the capital cities. Women age 50-69 years in 2022 without private health services were studied. Mammographic coverage was defined as the proportion of women in the target population (age 50-69 years without private insurance) who underwent screening mammography in 2022 and the proportion of BI-RADS 0 results, defined as examinations classified as inconclusive.

Results: This study analyzed data from over 22 million women age 50-69 years. The annual mammographic screening coverage across the country was low, ranging from 1.3% to 15.9%. A high proportion of BI-RADS 0 results were observed in 44% of the states. Although mammography devices are unequally distributed, coverage remains low even in regions with a high concentration of services. This suggests the influence of other factors, such as accessibility barriers, insufficient screening education, and a lack of active surveillance within the target population.

Conclusions: Mammographic screening coverage in Brazil is insufficient and unevenly distributed. The high rates of BI-RADS 0 suggest significant quality concerns. Addressing these disparities is crucial for the effective early detection of breast cancer.

Purpose: Anticancer therapy increases the risk of hepatitis B virus (HBV) reactivation in patients with occult hepatitis B infection (OHBI), particularly in those who receive rituximab or stem-cell transplantation. However, the exact risk of HBV reactivation in patients with ALL/lymphoblastic lymphoma (LBL) receiving prolonged, intensive myelosuppressive chemotherapy is not known and thus the role of antiviral prophylaxis is not clearly established.

Patients and methods: This prospective observational study was conducted at a single tertiary cancer center in India (October 2017 to August 2021). Patients age 15 years and older with ALL/LBL were screened for OHBI and enrolled. Liver function tests and HBV DNA levels were monitored at baseline, during treatment, and throughout follow-up phase. During episodes of hepatitis, extended serology panel was performed. The primary end point was the incidence of HBV reactivation.

Results: OHBI was identified in 30.4% (172/566) of patients treated at our center during the study period. In the prospective cohort, 65 patients with ALL/LBL and OHBI, treated on a pediatric-inspired protocol, were enrolled. HBV reactivation occurred in six patients (9.2%; 95% CI, 4.3 to 18.7), none of whom developed HBV-related hepatitis. Seventeen patients experienced at least one episode of grade ≥3 hepatitis, with a median AST of 401 U/L (range, 192-3,490) and ALT of 430 U/L (range, 255-1,950). Hepatitis led to chemotherapy delays in five patients, with a median delay of 15.5 days (range, 7-39).

Conclusion: Our findings indicate a moderate to high risk of HBV reactivation in ALL/LBL patients with OHBI treated with pediatric-inspired protocols, particularly during maintenance, supporting prophylactic antiviral therapy as standard practice in regions with high or intermediate HBV endemicity.

Purpose: Breast cancer is the most common cancer in women in Brazil. Despite universal coverage through the Unified Health System (Sistema Único de Saúde [SUS]), major inequities in access, timely diagnosis, and treatment persist when compared with the private sector. We assessed 5-year overall survival (OS) according to health care coverage to provide robust real-world evidence of survival inequities.

Methods: This retrospective cohort study included 63,663 women with invasive breast cancer diagnosed between 2012 and 2019 using the largest South American hospital-based cancer registry (Registro Hospitalar de Câncer da Fundação Oncocentro de São Paulo). Survival probabilities were estimated using the Kaplan-Meier method, and differences across groups were tested with log-rank statistics. Cox proportional hazards models were applied to assess the association between health care coverage and mortality, adjusting for demographic, clinical, and treatment variables.

Results: Patients in the public system (83%) were older, had lower educational attainment, were more often diagnosed with advanced-stage disease (41% v 21.0%), and were less likely to receive minimal standard treatment (75% v 81%). The 5-year OS rate was 66.2% in the SUS group and 79.7% in the private care group. After adjustment, patients with SUS faced a 53% higher risk of death (hazard ratio, 1.53 [95% CI, 1.44 to 1.63]).

Conclusion: Universal health coverage does not guarantee equitable outcomes. Disparities in the stage at diagnosis, treatment access, and social determinants translate into marked survival inequities. Our findings highlight the urgent need for system-level reforms and targeted investments in oncology capacity in Brazil and across the low- and middle-income countries.

Purpose: Building equitable research collaborations between high-income countries (HICs) and low- and middle-income countries (LMICs) requires effective coordination among international ethical review committees, which is often logistically challenging. This case report presents the insights gained when acquiring ethical approval for a cervical cancer research program conducted jointly by the University of Pennsylvania and the University of Botswana.

Methods: We conducted a descriptive case study of the Ipabalele project, a 6-year HIC-LMIC partnership involving three complex research protocols that required approvals by multiple distinct ethical bodies. We analyzed various challenges affecting review procedures, timelines, and staffing. We then documented strategies employed in Ipabalele and other global initiatives to strengthen ethical review processes and build research capacity in LMICs.

Results: In Ipabalele, ethical approvals were initially delayed by 2 years because of fragmented review processes with variable timelines and conflicting recommendations. Innovations to the process included centralizing institutional review board oversight within Botswana, implementing joint virtual meetings among review bodies, enhancing digital infrastructure, and streamlining research staffing and communication.

Conclusion: By providing practical strategies, this study highlights how empowered local leadership, centralized review processes, joint review mechanisms, and intentional capacity building can overcome logistical barriers in multinational ethical review.