JCO Global Oncology最新文献

Purpose: As there is a paucity of data comparing outcomes with different dosing regimens of PD-1 inhibitors in relapsed/refractory Hodgkin lymphoma (R/R HL), this retrospective analysis was undertaken to compare the efficacy of low-dose nivolumab (fixed at 40 mg) with the standard dose of 3 mg/kg.

Methods: Single-center retrospective analysis of patients with R/R HL who failed at least one salvage regimen and were treated with nivolumab between 2015 and 2023, at either 3 mg/kg (standard-dose nivolumab [SD-NIV]) or a flat dose of 40 mg (NIV40), both administered once in 2 weeks. Treatment response was assessed with ¹⁸F-labeled fluorodeoxyglucose-positron emission tomography-computed tomography after four doses of nivolumab.

Results: A total of 45 patients were included: 25 received 3 mg/kg (SD-NIV) and 20 received a flat dose of 40 mg (NIV40). The mean dose of nivolumab administered once in 2 weeks was 2.9 mg/kg (stable disease 0.31) in the SD-NIV group compared with 0.6 mg/kg (stable disease 0.10) in the NIV40 group (P < .001). Responses after four doses of nivolumab were similar in the SD-NIV versus NIV40 group: complete response (48% v 50%), partial response (12% v 10%), stable disease (20% v 20%), and progressive disease (20% v 20%; P = .997). Immune-related adverse effects were similar in the two groups (12% v 10%; P = .790). Two-year event-free survival (EFS) of the whole cohort treated with nivolumab with SD-NIV and NIV40 was 47% and 49.5%, respectively (P = .788). Twenty-two of the 45 patients underwent stem cell transplant (11 from each group), with a 2-year EFS of 90.1% versus 81.8% (P = .545) in the SD-NIV and NIV40 groups, respectively.

Conclusion: Despite the inherent limitations of a retrospective analysis, the data suggests that nivolumab demonstrates biologic efficacy at doses as low as 0.6 mg/kg. Prospective trials comparing different dosing strategies are clearly warranted; such studies may facilitate approval of biologically active and cost-effective regimens, thereby broadening access to checkpoint inhibitors.

Purpose: Breast cancer is the most common cancer and the second leading cause of death among women in Nigeria, with a 5-year survival of 44% versus 90% in the United States. Screening has been promoted to reduce breast cancer mortality. However, there is a paucity of data on the readiness of the Nigerian health system to deliver cancer screening at scale effectively.

Methods: An integrative literature review on the readiness of the Nigerian health care system to support ongoing organized breast screening activities was conducted. The Web of Science, African Journal Online, OVID Medline, Cumulative Index to Nursing and Allied Health Literature, Embase, and PsycINFO databases were searched for relevant terms. Using the Wilson-Jungner framework (1968), a narrative synthesis of relevant studies was performed to highlight areas for future research, practice, and service planning investment.

Results: Forty-four papers were included. Access to diagnostic facilities remains limited, and distribution appears predominantly urban. Significant cultural, religious, and socioeconomic barriers limit the utilization of the available imaging services. Cost remains a significant barrier as the financial burden of out-of-pocket expenses for diagnosis and treatment is overwhelming for many households. Prioritizing cost-effective investments in infrastructure and training, and implementing standardized, evidence-based diagnostic pathways for symptomatic women, may address existing challenges and enhance early diagnosis.

Conclusion: Through the lens of the Wilson-Jungner framework, there are significant barriers to effective breast cancer screening in Nigeria. There should be a focus on expanding the early diagnosis of symptomatic patients and strengthening the cancer registries.

Purpose: Cervical cancer (CC) remains a significant public health challenge in low- and middle-income countries (LMICs), including Brazil. While global incidence has declined, age-specific variations may mask emerging trends among younger women. This study aimed to evaluate trends and age-specific changes in CC incidence in Brazil between 2000 and 2018.

Materials and methods: Incidence data and age at diagnosis were obtained from Brazilian Population-Based Cancer Registries (PBCRs) for the period 2000-2018. Temporal trends were evaluated using Joinpoint regression to estimate annual percent changes (APCs) and average APCs (AAPCs).

Results: Between 2000 and 2018, 66,358 CC cases were identified across 33 PBCRs. The median age at diagnosis was 51 years (IQR, 40-63), declining from 52 years in 2000 to 48 years in 2018. The overall adjusted incidence showed a significant decline between 2000 and 2013 (APC: -4.5% [95% CI, -5.3 to -3.7]; P < .001) followed by a nonsignificant increase from 2013 to 2018 (APC: 3.1 [95% CI, -1.6 to 8.1]; P = .20). Age-stratified analyses revealed rising trends among women age 25-44 years, suggesting a transition to younger age at diagnosis.

Conclusion: The observed decrease in median age and rising incidence among women younger than 45 years indicate a potential epidemiologic shift in CC in Brazil. These findings highlight the need to strengthen national screening programs, expand human papillomavirus (HPV) vaccination coverage, and incorporate molecular HPV testing into prevention strategies.

Purpose: Global oncology trials face increasing scrutiny over regional enrollment imbalances, as regulatory agencies such as the US Food and Drug Administration, European Medicines Agency, and Pharmaceuticals and Medical Devices Agency demand data reflective of population diversity. This push is grounded in evidence that genetic polymorphisms (eg, UGT1A1*28, CYP2D6), human leukocyte antigen-related toxicities, and biomarker prevalence (eg, epidermal growth factor receptor mutations in approximately 15% of Western v approximately 50% of Asian patients with lung cancer) can significantly influence treatment outcomes.

Methods: We reviewed scientific literature, regulatory case studies, and methodological innovations addressing regional heterogeneity in oncology trials. Particular focus was given to statistical tools such as adaptive randomization for real-time enrollment balancing, Bayesian hierarchical models for data borrowing across regions, and Multi-Regional Clinical Trial designs for structured consistency assessments. Control arm variability because of regional differences in standard of care and drug access was also examined.

Results: Recent regulatory setbacks, especially involving Asia-centric trials, underscore the consequences of insufficient regional planning. Emerging statistical approaches, including adaptive and Bayesian methods, show promise in managing heterogeneity while preserving trial integrity. Persistent challenges include disparities in trial infrastructure, molecular subtype distributions, and comorbidity patterns. Broader regional inclusion and integration of real-world evidence are increasingly critical to overcoming these limitations.

Conclusion: Regional enrollment should be viewed not as a regulatory formality, but as a scientific and ethical priority. The future of global oncology trials hinges on proactive regional planning, innovative methodology, and cross-sector collaboration. Aligning global efficiency with local relevance can enhance scientific robustness, support regulatory alignment, and expand equitable access to novel cancer therapies worldwide.

Purpose: Early-onset cancer (EOC), defined as cancer occurring in individuals age 15-49 years, represents a growing global health burden. This study aims to assess the epidemiologic trends of EOC from 1990 to 2021 and project future incidence and mortality trends up to 2040.

Materials and methods: Using data from the Global Burden of Disease (GBD) 2021 study, we analyzed the age-specific incidence rate (AsIR) and death rate (AsDR) per 100,000 patient-years for 31 cancer types across 204 countries. Statistical modeling, including the two sample t test, was done to estimate the standard deviations among each group, which is plugged in the denominator to compute the statistic. Autoregressive integrated moving average and exponential smoothing state space were employed for forecasting future trends.

Results: In 2021, there were approximately 23.6 million new EOC cases and 0.99 million deaths globally. The highest AsIRs were observed in breast, nonmelanoma skin, and cervical cancers, with the highest AsDRs seen in breast and lung cancers in 2021. Although AsIR has increased globally, AsDR has declined from 1990 to 2021. EOC disproportionately affected women, particularly in high-income countries. Risk factor analysis highlights obesity, tobacco use, and dietary patterns as key contributors to EOC burden. Projected analysis till 2040 revealed relatively stable AsIR and declining AsDR for overall EOCs.

Conclusion: The increasing global burden of EOC underscores the need for targeted strategies. Regional disparities highlight the importance of health care access in mitigating EOC mortality. Healthy lifestyle could reduce the burden of EOC.

Purpose: Cancer survivorship evolved over the past few years in developed countries although in developing countries, guidelines and evidence-based recommendations on survivorship care are still lacking. We sought to gather information on cancer survivorship practices in Brazil to identify assets and areas for improvement.

Methods: Two surveys were developed regarding survivorship knowledge and the provision of services. Brazilian providers (physicians and nurses) and cancer center leaders received the surveys' invitation via WhatsApp groups of Brazilian oncology professionals. In addition, they were informed to share the study information with their networks (snowball sampling). The link to the surveys was advertised at Brazilian oncology conferences between August and December 2024. Descriptive statistics were used to summarize the results.

Results: Between August 13 and December 17, 2024, 194 unique providers and 28 cancer center leaders responded to the online survey. Among providers, 70% considered a cancer survivor a patient who completed cancer treatment and has no evidence of disease. The majority (60%) reported never consulting a survivorship guideline. The most common tool used to support survivors was a treatment summary (52.1%). Among cancer center leaders, 32.1% reported that their institutions have survivorship programs. The most common services offered to cancer survivors include medical follow-up, nutrition, and psychology services (100%), whereas reproductive medicine and sexual therapy were offered by 7.7% of cancer centers. Although 28.6% of the cancer center leaders reported that nurses specialized in oncology participate in follow-up care of cancer survivors who completed curative treatment, 14.9% of providers responded that these nurses are involved in survivorship follow-up.

Conclusion: Cancer care providers and cancer centers from Brazil can benefit from culturally tailored survivorship guidelines to better address cancer survivors' needs.

Purpose: The incidence of early-onset colorectal cancer (EOCRC; CRC diagnosed before age 50 years) is increasing globally. This study analyses the trend in the Republic of Ireland over a 28-year period.

Methods: Epidemiologic data on CRC incidence were obtained from the National Cancer Registry of Ireland (NCRI) from January 1994 until December 2021. Additional information on age of diagnosis and tumor sidedness for the entire period was obtained, while data relating to stage and sex were available for the study period 1999-2018. Incidence rates were stratified by sex, age group (20-34, 35-49, and ≥ 50 years), and tumor location.

Results: Between 1994 and 2021, there were 61,180 cases of CRC among adults older than 20 years in the Republic of Ireland. The age-specific rate (ASPR) annual percentage change (APC) in patients younger than 50 years was 0.97 (95% CI, 0.30 to 1.76) in females and 0.57 (95% CI, 0.08 to 1.30) in males, while in patients age 50 years or older, it was -0.60 (95% CI, -1.03 to -0.15) in females and -0.70 in males (95% CI, -1.18 to -0.16), respectively.

Conclusion: In line with global trends, the incidence of EOCRC is increasing in Ireland. Further studies investigating the etiology and optimal treatment strategies for this cohort are necessary.

Purpose: Although substantial improvements in survival of childhood cancer have been achieved, information on long-term survival outside European countries and the United States is scarce. The aim of this study was to clarify the long-term trends and disparities in survival of childhood cancer in Japan.

Materials and methods: Using data from the Osaka Cancer Registry, trends in survival among patients age younger than 15 years diagnosed with cancer during 1976-2015 and followed up to 2020 were analyzed. Childhood cancers were defined and classified according to the International Classification of Childhood Cancer, Third Edition. The primary outcome measure was the probability of 5-year overall survival (OS) after diagnosis.

Results: For all cancer groups combined, the 5-year OS increased substantially across the diagnosis periods (51.4% [95% CI, 49.3% to 53.5%] in 1976-1985; 83.7% [95% CI, 81.8% to 85.4%] in 2006-2015). The improvement in survival was most pronounced during the first 2 decades. Age-standardized 5-year OS was higher than 90% for lymphomas, retinoblastoma, renal tumors, and germ cell tumors in 2006-2015. There were wide varieties in the difference in 5-year OS by cancer type between 1976-1985 and 2006-2015, with the largest increase in leukemias and modest improvements in malignant bone tumors and soft tissue sarcomas.

Conclusion: OS for all cancers combined increased substantially during 1976-2015. The wide and persistent differences in survival outcomes suggest the need for novel strategies to improve outcomes for cancer types with the least changes in survival.

Purpose: To characterize gastric cancer epidemiology in Latin America and the Caribbean, identify country-level predictors of the mortality-to-incidence ratio (MIR), and describe the clinical research landscape with emphasis on precision oncology (PO).

Methods: We conducted a retrospective, country-level study integrating GLOBOCAN 2022 incidence and mortality data, ClinicalTrials.gov records (2004-2025), and socioeconomic indicators (United Nations Development Program Human Development Index [HDI] 2023 and current health expenditure). MIR was calculated per country. Precision-oncology studies were flagged by a curated drug dictionary applied to the Interventions field; country involvement was measured as country-study participations. Analyses included geospatial mapping, Spearman correlation, ordinary least squares regression, K-Means clustering (k = 3), and a Random Forest classifier for feature ranking and discrimination.

Results: Across 24 countries, incidence ranged from 3.97 to 14.31 per 100,000 and mortality from 2.98 to 11.06 per 100,000. MIR was highest in Honduras (0.93), Belize (0.89), and Guatemala (0.88) and lowest in Cuba (0.65), Uruguay (0.66), and Costa Rica (0.68). The HDI correlated inversely with MIR (ρ = -0.71, P < .001); the association with number of trials was weak (ρ = -0.09). Three regional archetypes were identified. The Random Forest model achieved an AUC of 0.94 and ranked HDI as the top predictor. Of the 105 studies, 81 were interventional; phase III accounted for 40.7% and phase II for 30.9%. Country-study participations were concentrated in Brazil (23.4%), Chile (19.1%), and Argentina (15.2%). In PO, participation was dominated by Brazil, Chile, Argentina, and Mexico (72.2% of 140 participations), mostly involving trastuzumab, pembrolizumab, ramucirumab, and nivolumab.

Conclusion: Socioeconomic context was more associated with outcomes than research volume. Regional research remains concentrated and drug-limited, supporting policies to strengthen diagnostics, access, and equitable clinical investigation.