JCO Global Oncology最新文献

Purpose: We assessed the availability, price, and affordability of commonly used chemotherapy medications in Cameroon, Ethiopia, Kenya, and Malawi. We also examined the characteristics that could predict chemotherapy medication quality.

Methods: Samples of seven commonly used chemotherapy medications were collected: cisplatin, cyclophosphamide, doxorubicin, ifosfamide, leucovorin, methotrexate, and oxaliplatin. Stockouts and medicine prices were recorded at public national hospitals and community pharmacies. Using the National Comprehensive Cancer Network's harmonized guidelines for sub-Saharan Africa, we estimated the costs of medications to treat early-stage breast cancer, colorectal cancer (CRC), and head and neck cancer. Every sample was tested for quality using high-performance liquid chromatography against USP standards. We ran logistic regressions to assess medicine characteristics that could predict substandard and falsified chemotherapy medications.

Results: Stockouts of chemotherapy medications in public hospitals were observed in three of four countries. Other than in Malawi where medications are free when available in the public sector, chemotherapy medications were unaffordable, costing government worker salary equivalents of 47-242 days, 233-869 days, and 22-196 days to treat early-stage breast cancer, CRC, and head and neck cancer, respectively. On average across the population, $36 US dollars (USD) (95% CI, $50 USD to $134 USD, 9%-25% of medication cost) was spent on poor-quality medicines for treatment of breast cancer, $32 USD (95% CI, $6 USD to $214 USD, 0.5%-17%) for CRC, and $15 USD (95% CI, $4 USD to $49 USD, 2%-21%) for head and neck cancer. Price of the medication, public/private source, and medicine registration status were poor predictors of medicine quality.

Conclusion: We found that medicines for cancer treatment are unaffordable without government subsidies. Moreover, poor-quality chemotherapy medicines are hard to detect without chemical testing. Government policies and supply chain practice changes are needed to improve the availability, affordability, and quality of chemotherapy medications in sub-Saharan Africa.

Purpose: Adult ALL is typically treated with intensive chemotherapy although novel agents like blinatumomab and inotuzumab remain largely inaccessible in low- and middle-income countries (LMICs). Early mortality (EM) during induction is substantially higher in LMICs (10%-25%) than in high-income countries (<5%). This study aimed to identify EM risk factors in patients with adult ALL in LMICs to guide context-specific interventions.

Methods: A retrospective cohort study analyzed patients 15 years and older with newly diagnosed ALL between 2009 and 2023, regardless of the phenotype or Philadelphia status. EM was defined as death within 30 days of diagnosis.

Results: Among 203 patients (median age 36 years), the overall EM was 9.8% and 7.9% was younger than 50 years. Univariate analysis identified positive cerebral spinal fluid, cyclophosphamide during the prephase, low albumin, and obesity as associated with higher EM. In multivariable models, predictors of EM for the full cohort included age, albumin, cyclophosphamide use, and obesity. In patients 50 years and younger, only albumin and cyclophosphamide remained significant. After induction, 51.2% achieved complete response; 17.3% was unevaluable because of complications or death. Infection was common (72.9%). Sociodemographic variables were not associated with EM.

Conclusion: EM was elevated, reflecting LMIC-specific challenges like late diagnosis and limited supportive care. Low albumin and prephase cyclophosphamide use were strongly linked to EM, likely via increased immunosuppression and infection risk. Findings stress the need for locally adapted protocols and simple risk markers to reduce EM in adult ALL.

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: 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: 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.

Purpose: In 2021, Ministry of Health conducted a pilot study to screen 50,000 women with human papillomavirus (HPV) testing in Uzbekistan and assess the feasibility of national implementation. The present article describes organization of the pilot, evaluation of the program using key performance indicators (KPIs), and lessons learned.

Methods: Women age 30-55 years were invited for HPV screening via a communication campaign at 11 polyclinics in Karakalpakstan province. Samples were collected and analyzed locally in nine polyclinics using GeneXpert test. HPV-positive women were triaged with colposcopy, although colposcopists were not trained to obtain biopsies or perform treatment. Abnormal results led to further diagnostic colposcopy and treatment. Pilot data were managed using an Excel database, with quality assurance through regular monitoring visits and estimation of KPIs.

Results: Over 10 months, 50,000 women were tested for HPV, with 98% yielding satisfactory results and a 6.8% positivity rate. Of the HPV-positive women, 93.9% underwent triaging colposcopy, revealing abnormalities in 32.5%, although results varied by district. Diagnostic colposcopy and histopathology data were available for 87.9% of referrals. Treatment adherence was not systematically tracked. An external review showed 64.6% agreement with local histopathology, and the correlation between diagnostic colposcopy and histopathology was 53.2%.

Conclusion: The pilot successfully recruited a large number of women and ensured high participation of the HPV-positive women in triage and diagnostic evaluation. Key strengths were the use of existing health infrastructure, and decentralization of services. However, challenges were identified in HPV test procurement, referral pathways, quality of pathology and colposcopy, and adequate data collection. Addressing these issues is critical to the future success of cervical cancer screening in Uzbekistan.

Purpose: Cancer burden in sub-Saharan Africa is high, driven by infections and behavioral risks. Nigeria had Africa's second-highest number of new cancers in 2022. This study estimated the proportion of new cancers attributable to alcohol, tobacco, and human papillomavirus (HPV) infection in Edo State, Nigeria.

Methods: We analyzed cancer incidence data from the Edo-Benin Cancer Registry (EBCR; 2009-2018) for cancer sites associated with alcohol consumption, tobacco use, and HPV infection, as outlined in the International Agency for Research on Cancer Monographs. For each site, we calculated the number of attributable cancers and the population attributable fraction for the three exposures by sex, using country-specific exposure prevalence and relative risk estimates from previous research.

Results: Between 2009 and 2018, the EBCR reported 4,937 cancer cases (2,069 men [41.9%] and 2,868 women [58.1%]). Nine alcohol-associated sites accounted for 30.1% of all cases (12.3% in men and 43% in women), 13 tobacco-related sites accounted for 27.5% (18.4% in men and 34.1% in women), and six HPV-related sites accounted for 15.2% (4% in men and 34.1% in women). Of alcohol-associated cancers (n = 1,488), 25.6% (381/1,488) were attributable to alcohol use; 5.3% (72/1,359) of smoking-related cancers were attributable to tobacco use, and high-risk HPV genotypes were estimated to cause 77.5% (581/750) of HPV-related cancers.

Conclusion: Our study suggests that nearly three fourths of HPV- and about one fourth of alcohol-associated cancers could be prevented through targeted and evidence-based interventions in Edo State, Nigeria. These findings highlight the need for strengthening both individual and policy-level prevention efforts, prioritizing high-impact risk factors to achieve measurable reductions in cancer burden.

Purpose: Treatment completion (TC), defined by completing the recommended treatment regimen, and treatment adherence (TA), defined by completing the prescribed treatment in the expected time frame, are critical for improving breast cancer (BC) mortality. Therefore, we conducted this study to measure TC and TA in Tanzania.

Methods: BC treatment data from 2019 to 2020 at Ocean Road Cancer Institute (ORCI) were collected. Demographic, socioeconomic, and clinical profiles were identified. TC and TA were measured by comparing chemotherapy and radiotherapy prescribed regimens to received treatment.

Results: Overall, 813 patients were seen at ORCI between 2019 and 2020. Mean age of patients was 51 ± 12.5 years; 97.9% identified as female; and 67.6% resided outside of Dar es Salaam. Stage III/IV disease was identified in 43.8% patients, with 24.1% showing clinical evidence of metastasis on arrival. TC across treatments ranged between 46.8% and 47.4%, while overall TA was 21.2%. TC was associated with not having metastasis on arrival (P = .01) and residing in proximity to ORCI (P = .04). TA was associated with having insurance (P < .0001) and attending a follow-up appointment after treatment (P < .0001).

Conclusion: Poor TC and TA rates in Tanzania pose a significant risk to treatment efficacy. Interventions are needed to specifically target patients with advanced-stage disease and greater geographic distance to treatment to increase treatment compliance.

Purpose: This multicenter observational study conducted in Poland aims to analyze referral patterns and clinical practice in patients with unresectable stage III non-small cell lung cancer (NSCLC), during the early stage of the national implementation of consolidation immunotherapy, focusing on the use of concurrent chemoradiotherapy (cCRT), sequential chemoradiotherapy (sCRT), and definitive radiotherapy (dRT).

Materials and methods: Adult patients with unresectable stage III NSCLC treated with curative-intent radiotherapy between April 1, 2021, and March 31, 2022, were included. Descriptive analyses were performed per the registered protocol. Group comparisons used Fisher's exact test, the chi-squared test, the Kruskal-Wallis test, and Pearson's chi-squared test.

Results: Among 273 patients, cCRT and sCRT were administered with equal frequency (37.7% each), followed by dRT (16.5%) and overlapping chemoradiotherapy (8.1%). Groups differed in performance status (PS) and age but not in Union for International Cancer Control-Tumor, Node, Metastasis (UICC-TNM) classification. PS and disease extent influenced the treatment choice. The cCRT was primarily chosen because of the tumor location, whereas sCRT was chosen mainly because of large tumor mass. Complication rates were similar, except for grade 3-4 hematologic toxicity, more frequent with cCRT.

Conclusion: In Poland, cCRT and sCRT are equally used. Treatment decisions are primarily driven by PS and tumor characteristics rather than UICC-TNM staging.