Journal of Cancer Policy最新文献

Importance

Understanding the factors that are associated with new molecular entity (NME) cancer drug approvals as a single agent and in combination, and European Society for Medical Oncology (ESMO) scores, can aid in identifying suitable factors to consider in trial designs for future drugs. In addition, the association between the various outcomes can aid in determining benefit when surrogate outcomes are used in approval consideration.

Objective

This study aims to (1) use the measures used in evaluating clinical trials by ESMO scores to determine the differences in the characteristics of 2013–2022 Food and Drug Administration (FDA) oncology NME drug approvals for those approved for use in combination or as a monotherapy, and (2) analyze the association between survival outcomes and the response rate for monotherapy NME drugs and/or drugs approved in combination.

Design

Cross-sectional analysis.

Setting

US FDA Oncology Drug Approvals (2013–2022)

Participants

US FDA Oncology Drug Approvals (2013–2022)

Exposures

Trial-level characteristics (tumor types, basis of approval, randomized or not, phase) and associations between overall survival (OS), progression-free survival (PFS), or overall response rate (ORR) and whether NME drugs were approved as monotherapy or in combination .

Results

Drugs approved for use as a monotherapy are less likely to be approved using a randomized study (p < 0.001) and more likely to be approved via the accelerated pathway (p = 0.012) and be open-label (p < 0.001). Drugs approved for use as a combination or monotherapy significantly differed on their approval basis (p = 0.002), phase of trial at the time of approval (p = 0.02), and ESMO scores (p = 0.02). There was low correlation between response rate and either PFS or OS metrics. However, nearly all of the drugs with large improvements in OS (> 5months) were drugs with robust ORR.

Conclusions and relevance

Drugs approved as monotherapy with a low response rate are likely to have marginal benefit in OS and PFS.

In India the cancer burden for 2021 was 26.7 million disability-adjusted life years (DALYs), and this is expected to increase to 29.8 million in 2025 (Kulothungan et al., 2022). According to the World Health Organisation (WHO), cancer is a leading cause of death worldwide, accounting for one in six deaths. As per WHO, palliative care is a strategy that assists both adults and children along with their families in dealing with life-threatening illnesses. Currently, only 14% of those in need of pain and palliative (P&P) care receive it globally (WHO, 2020). Financial toxicity (FT) is the term used to describe the negative effects that an excessive financial burden resulting from cancer have on patients, their families, and society (Desai and Gyawali, 2020). Addressing this gap will require significant adjustments to both demand- and supply-side policies to ensure accessible and equitable cancer care in India (Caduff et al., 2019). Measuring FT along with health-related quality of life (HRQoL) represents a clinically relevant and patient-centred approach (de Souza et al., 2017).

Aim and objective

To estimate FT and its association with quality of life (QoL).

Materials and methods

This was an observational descriptive study conducted among cancer patients recommended for P&P care. Scores were estimated from September 2022 to February 2023 using official tools: the Functional Assessment for Chronic illness Treatment Compressive Score for Financial Toxicity (FACIT-COST) and the European Organisation for Research and Treatment of Cancer (EORTC) Quality of life Questionnaires for Cancer (QLQ30).

Results

From 150 patients (70 males and 80 females, mean age 54.96 ± 13.5 years), 92.6% suffered from FT. Eleven patients (7.3%) were under FT grade 0, 41 (27.3%) were FT grade 1, 98 (65.3%) were FT grade 2, and no patients were under FT grade 3. At criterial alpha 0.05 (95%CI), FT and the global score for HRQoL showed an association. Among inpatient department (IPD) expenses, medication bills contributed the greatest expense at 33%, and among outpatient department (OPD) expenses treatment expenses contributed 50% of the total. Breast cancer (30 cases, 20%) and oral cancer (26 cases, 17.3%) were the most frequent cancers.

Conclusion

FT measured using the COST tool showed an association with HRQoL.

Policy summary

This paper refers to the insurance policies available for cancer patients irrespective of P&P care treatment.

Background

In 2012, the Brazilian government launched a radiotherapy (RT) expansion plan (PER-SUS) to install 100 linear accelerators. This study assesses the development of this program after eight years.

Methods

Official reports from the Ministry of Health (MoH) were reviewed. RT centres projects status, timeframes, and cost data (all converted to US dollars) were extracted. The time analysis was divided into seven phases, and for cost evaluation, there were five stages. The initial predicted project time (IPPT) and costs (estimated by the MoH) for each phase were compared between the 18 operational RT centres (able to treat patients) and 30 non-operational RT centres using t-tests, ANOVA, and the Mann-Whitney U. A p-value < 0.05 indicates statistical significance.

Results

A significant delay was observed when comparing the IPPT with the overall time to conclude each 48 RT centres project (p < 0.001), with considerable delays in the first five phases (p < 0.001 for all). Moreover, the median time to conclude the first 18 operational RT centres (77.4 months) was shorter compared with the 30 non-operational RT centres (94.0 months), p < 0.001. The total cost of 48 RT services was USD 82,84 millions (mi) with a significant difference in the per project median total cost between 18 operational RT centres, USD1,34 mi and 30 non-operational RT centres USD2,11 mi, p < 0.001. All phases had a higher cost when comparing 30 non-operational RT centres to 18 operational RT centres, p < 0.001. The median total cost for expanding existing RT centres was USD1,30 mi versus USD2,18 mi for new RT services, p < 0.0001.

Conclusion

After eight years, the PER-SUS programs showed a substantial delay in most projects and their phases, with increased costs over time.

Policy summary

Our findings indicate a need to act to increase the success of this plan. This study may provide a benchmark for other developing countries trying to expand RT capacity.

Background

Cancer poses significant challenges for healthcare professionals across the disease pathway including cancer imaging. This study constitutes part of the user requirement definition of INCISIVE EU project. The project has been designed to explore the full potential of artificial intelligence (AI)-based technologies in cancer imaging to streamline diagnosis and management. The study aimed to map cancer care pathways (breast, prostate, colorectal and lung cancers) across INCISIVE partner countries, and identify bottle necks within these pathways.

Methods

Email interviews were conducted with ten oncology specialised healthcare professionals representing INCISIVE partner countries: Greece, Cyprus, Spain, Italy, Finland, the United Kingdom (UK) and Serbia. A purposive sampling strategy was employed for recruitment and data was collected between December 2020 and April 2021. Data was entered into Microsoft Excel spreadsheet to allow content examination and comparative analysis.

Results

The analysed pathways all shared a common characteristic: inequalities in relation to delays in cancer diagnosis and treatment. All the studied countries, except the UK, lacked official national data about diagnostic and therapeutic delays. Furthermore, a considerable variation was noted regarding the availability of imaging and diagnostic services across the seven countries. Several concerns were also noted for inefficiencies/inequalities with regards to national screening for the four investigated cancer types.

Conclusions

Delays in cancer diagnosis and treatment are an ongoing challenge and a source for inequalities. It is important to have systematic reporting of diagnostic and therapeutic delays in all countries to allow the proper estimation of its magnitude and support needed to address it. Our findings also support the orientation of the current policies towards early detection and wide scale adoption and implementation of cancer screening, through research, innovation, and technology. Technologies involving AI can have a great potential to revolutionise cancer care delivery.

Policy summary

This study highlights the widespread delay in cancer diagnosis across Europe and supports the need for, systematic reporting of delays, improved availability of imaging services, and optimised national screening programs. The goal is to enhance cancer care delivery, encourage early detection, and implement research, innovation, and AI-based technologies for improved cancer imaging.

Introduction

Patients diagnosed with ovarian cancer from more deprived areas may face barriers to accessing timely, quality healthcare. We evaluated the literature for any association between socioeconomic group, treatments received and hospital delay among patients diagnosed with ovarian cancer in the United Kingdom, a country with universal healthcare.

Methods

We searched MEDLINE, EMBASE, CINAHL, CENTRAL, SCIE, AMED, PsycINFO and HMIC from inception to January 2023. Forward and backward citation searches were conducted. Two reviewers independently reviewed titles, abstracts, and full-text articles. UK-based studies were included if they reported socioeconomic measures and an association with either treatments received or hospital delay. The inclusion of studies from one country ensured greater comparability. Risk of bias was assessed using the QUIPS tool, and a narrative synthesis was conducted. The review is reported to PRISMA 2020 and registered with PROSPERO [CRD42022332071].

Results

Out of 2876 references screened, ten were included. Eight studies evaluated treatments received, and two evaluated hospital delays. We consistently observed socioeconomic inequalities in the likelihood of surgery (range of odds ratios 0.24–0.99) and chemotherapy (range of odds ratios 0.70–0.99) among patients from the most, compared with the least, deprived areas. There were no associations between socioeconomic groups and hospital delay.

Policy summary

Ovarian cancer treatments differed between socioeconomic groups despite the availability of universal healthcare. Further research is needed to understand why, though suggested reasons include patient choice, health literacy, and financial and employment factors. Qualitative research would provide a rich understanding of the complex factors that drive these inequalities.

Background

Horizon scanning (HS) is the systematic identification of emerging therapies to inform policy and decision-makers. We developed an agile and tailored HS methodology that combined multi-criteria decision analysis weighting and Delphi rounds. As secondary objectives, we aimed to identify new medicines in melanoma, non-small cell lung cancer and colorectal cancer most likely to impact the Australian government’s pharmaceutical budget by 2025 and to compare clinician and consumer priorities in cancer medicine reimbursement.

Method

Three cancer-specific clinician panels (total n = 27) and a consumer panel (n = 7) were formed. Six prioritisation criteria were developed with consumer input. Criteria weightings were elicited using the Analytic Hierarchy Process (AHP). Candidate medicines were identified and filtered from a primary database and validated against secondary and tertiary sources. Clinician panels participated in a three-round Delphi survey to identify and score the top five medicines in each cancer type.

Results

The AHP and Delphi process was completed in eight weeks. Prioritisation criteria focused on toxicity, quality of life (QoL), cost savings, strength of evidence, survival, and unmet need. In both curative and non-curative settings, consumers prioritised toxicity and QoL over survival gains, whereas clinicians prioritised survival. HS results project the ongoing prevalence of high-cost medicines. Since completion in October 2021, the HS has identified 70 % of relevant medicines submitted for Pharmaceutical Benefit Advisory Committee assessment and 60% of the medicines that received a positive recommendation.

Conclusion

Tested in the Australian context, our method appears to be an efficient and flexible approach to HS that can be tailored to address specific disease types by using elicited weights to prioritise according to incremental value from both a consumer and clinical perspective.

Policy summary

Since HS is of global interest, our example provides a reproducible blueprint for adaptation to other healthcare settings that integrates consumer input and priorities.

Childhood cancer presents significant acute and long-term challenges for patients,families, communities, and health systems. Although meaningful strides have been made in research and treatment, severe outcome disparities prevail between low- and middle-income countries (LMICs) and high-income countries (HICs), with childhood cancer survival rates lower than 20% in LMICs, as compared with over 80% across many HICs. In recent years, greater emphasis has been placed on health system strengthening as a means to develop domestic policy and capacity for sustainable improvements in childhood cancer outcomes in LMICs. In pursuit of a systems approach to childhood cancer in LMICs, our research team developed the Paediatric Oncology System Integration Tool (POSIT)—the first comprehensive framework for the design and evaluation of childhood cancer systems. Since its development, POSIT has been applied in an exploration of key determinants of access to essential childhood cancer medicines across two separate multi-site studies. In this commentary, we explore the value of the POSIT framework and toolkit as a constructive systems-level guide for examining interactions between childhood cancer-specific programs and encompassing health system. socio-political, and economic contexts.

Background

The number of international migrants is increasing worldwide. The four major non-western ethnic groups in the Netherlands are Turkish, Moroccan, Surinamese, and Dutch-Caribbean. This review examined the scientific literature on the views of cancer patients from these four ethnic groups on cancer diagnosis, treatment, and prognosis.

Methods

A systematic literature review was conducted using the databases EMBASE, Medline Web of Science, and Cochrane Central Register. Studies with patients who were of Turkish, Moroccan, Surinamese, and Dutch-Caribbean descent were included. Both qualitative and quantitative studies were included, and thematic analysis was performed. The methodological quality was assessed using the Mixed Methods Appraisal Tool.

Results

Thirteen studies were conducted in Turkey on Turkish cancer patients, while three were conducted in the Netherlands on Turkish and Moroccan cancer patients. Four themes emerged from the included studies: disclosure of diagnosis, communication, information provision, and decision-making. The majority of cancer patients in Turkey wanted information regarding their diagnosis and treatment. However, disclosure of a cancer diagnosis was rarely discussed with cancer patients in Turkey, whereas in the Netherlands it was provided directly. Family members in both the host and native countries had a strong influence on communication and decision-making. No literature on this topic for Surinamese or Dutch-Caribbean cancer patients was found.

Conclusion

Although major ethnic groups live in host countries, there is a lack of knowledge on optimal communication and information disclosure on cancer to patients and their families.

Policy summary

Further research into the views of ethnic groups on how to communicate about cancer is essential to ensuring that every patient receives optimal care and treatment.

Women in Nigeria have a high burden of diseases, such as cancer and HIV. Nigerian women also have inadequate access to health information, especially for disease prevention and health promotion. Researchers have indicated that living with HIV can be particularly harmful to the health and survival of cancer survivors. However, there is a dearth of research on Nigerian women cancer survivors’ knowledge of cancer and HIV linkage and their access to HIV health information. This knowledge gap may have negative health consequences. Therefore, there is a need to ensure HIV prevention among Nigerian women cancer survivors by improving access to health information. This study used a qualitative descriptive method to examine HIV knowledge and access to health information among women cancer survivors in Nigeria. Semi-structured interviews were conducted with a purposive sample of 30 women cancer survivors from Abuja, Nigeria. We identified three themes from the data, illuminating women’s knowledge of the connection between HIV and cancer. The themes include: (a) perception of HIV versus cancer which described views of HIV and cancer as distinct health conditions, (b) perceived effect of HIV on cancer given that HIV can worsen cancer outcomes, and (c) sourcing for HIV health information which highlighted issues of inadequate or inaccessible HIV-cancer information. Our findings showed that targeted health education interventions are required to address the lack of HIV information among cancer survivors.

Introduction

Lung cancer is a major cause of death in the United States. Social determinants of health (SDOH) are important factors that impact the treatment and prognosis of lung cancer. The social vulnerability index (SVI) is a validated measure of SDOH. This cross-sectional study aimed to investigate the impact of the SVI on lung cancer mortality using descriptive epidemiology.

Methods

Mortality data for lung malignancies from 2014 to 2018 was obtained from the CDC database and was age-adjusted and standardized to the population in the year 2000. The SVI for the same years was obtained from the CDC Agency for Toxic Substances and Disease Registry database. Age-adjusted mortality rates (AAMR) were estimated for each SVI quartile (SVI-Q) and demographic subgroup.

Results

We found that counties in SVI-Q4 (most vulnerable) had a higher cumulative AAMR compared to counties in SVI-Q1 (least vulnerable), accounting for a 4.48 excess death rate per 100,000 person-years. AAMR among males in SVI-Q4 was higher compared to SVI-Q1, accounting for a 9.96 excess death rate per 100,000 person-years, whereas no mortality differences were observed for female populations between SVI-Q4 and SVI-Q1. AAMR in SVI-Q4 was higher for both Hispanic and non-Hispanic populations, except for American Indian/Alaska Native populations. Similar trends were observed in both metropolitan and non-metropolitan counties.

Conclusion

Our study suggests that the SVI may play a significant role in lung cancer mortality and highlights the need for interventions targeting vulnerable populations to improve outcomes.