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- J. Martin-Moreno
- R. Giuliani
- F. Perrone
1440PD - The European Cancer Patient Coalition’s white policy paper on the value of innovation in oncology (ID 2287)
- L. Makaroff
Abstract
Background
Each year, over 3 million Europeans are diagnosed with cancer, and over 1 million Europeans die from the disease. With a growing and ageing population, action is urgently needed to address this major global health and societal concern. Action is needed to help policy-makers understand how they can improve access to innovative cancer care and treatment. Aim: To produce a policy white paper that summarised the major recommendations to improve access to innovative cancer care and treatment for Europeans diagnosed with cancer.
Methods
The European Cancer Patient Coalition developed the white paper over a one-year period, in collaboration with Interel Public Affairs, oncology experts, and the patient organisations that form the membership of the European Cancer Patient Coalition.
Results
The “Value of Innovation in Oncology” white paper presented the position of the European Cancer Patient Coalition on innovation in oncology, and offered recommendations to help reduce variations in access to innovation and to involve patients in decision-making. It summarised the European Cancer Patient Coalition’s stance on topics related to innovation in oncology, with the overarching goal to shrink international variations in the time to patients’ access to innovation in oncology, while, at the same time, it considered the sustainability of health systems and how to ensure innovation is celebrated and accessed appropriately. Finally, the paper focused on recommendations to increase the involvement of patients in key aspects of innovation, including assessment and access.
Conclusions
More work is needed at the European and national level to improve the access of Europeans with cancer to innovative treatment and care and to ensure that people with cancer are actively involved in decisions throughout the care pathway.
Legal entity responsible for the study
European Cancer Patient Coalition
Funding
Bristol-Myers Squibb, Eli Lilly and Company, MSD, Novartis, Pfizer, and Roche.
Disclosure
L. Makaroff, A. Rek, I. Manneh-Vangramberen, F. Florindi: Employee of the European Cancer Patient Coalition F. De Lorenzo: President of the European Cancer Patient Coalition K. Apostolidis: Vice President of the European Cancer Patient Coalition J. Pelouchova: Secretary of the European Cancer Patient Coalition A. Winterbottom: Treasurer of the European Cancer Patient Coalition S. Chrostowski, D. Cimpoeru, N. Bolanos Fernandez: Board member of the European Cancer Patient Coalition L. Baker: Employee of Interel Public Affairs Belgium. Clients of Interel Public Affairs include some pharmaceutical companies. The European Cancer Patient Coalition has received support from Merck, Pfizer, Roche, MSD, Bristol-Myers Squibb, AbbVie, Amgen, AstraZeneca, Baxter, BI, Celgene, Helsinn, Ipsen, Lilly, & Novartis.
1441PD - Magnitude of clinical benefit of randomized controlled trials supporting US Food and Drug Administration approval of drugs for solid tumours (ID 2140)
- C. Molto Valiente
Abstract
Background
The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated and reproducible tool to assess the magnitude of clinical benefit from drugs for solid tumors. Here, we evaluate characteristics and outcomes of clinical trials supporting approval by the FDA and their association with ESMO-MCBS.
Methods
We searched the Drugs@FDA website for applications of anticancer drugs from January 2006 to December 2016. Drug labels and reports of registration trials were reviewed and study characteristics, efficacy, toxicity and quality of life outcomes as well as regulatory pathways were collected. For randomized controlled trials (RCTs) ESMO-MCBS grades were applied. Meaningful clinical benefit was defined as a grade of A or B for trials of neo/adjuvant intent and 4 or 5 for those of palliative intent. Comparisons between groups were assessed using Logistic regression and the Mann Whitney U test.
Results
We identified 137 studies; 109 (80%) of which were RCTs. These led to the approval of 63 individual drugs for 118 licensed indications. Among the 105 RCTs for which the ESMO-MCBS could be applied, 7 (6%) were in the neo/adjuvant setting and 98 (94%) in the palliative setting. Only 46 (44%) met the ESMO-MCBS clinically meaningful benefit threshold (100% of neo/adjuvant trials and 41% of palliative trials). In multivariable analysis of palliative therapy trials, meaningful ESMO-MCBS grades were associated with phase III trials (compared to phase II; OR 38.45, P = 0.004), those with overall survival as their primary endpoint (compared to intermediate endpoints; OR 8.28, P = 0.001) and trials of targeted drugs with companion diagnostics (OR 11.62, P < 0.001). Over time, there has been an increase in the number of trials meeting the ESMO-MCBS threshold (33% in 2006 vs. 67% in 2016, P for trend = 0.04). There was an insufficient number of neo/adjuvant studies to perform statistical analysis.
Conclusions
In patients with advanced solid tumours, fewer than half of RCTs supporting FDA approval meet the threshold for clinically meaningful benefit using validated scales.
Clinical trial identification
Not applicable
Legal entity responsible for the study
None
Funding
None
Disclosure
All authors have declared no conflicts of interest.
1442PD - Review on adherence to breast cancer guidelines in Europe (ID 4930)
- L. Neamtiu
Abstract
Background
Morbidity and mortality from breast cancer in Europe, as well as costs associated with the disease, remain high. Patients treated according to existing guidelines have better survival. The European Commission Initiative on Breast Cancer (ECIBC) aims to improve quality of care by developing evidence-based breast cancer guidelines and supporting their implementation via a quality assurance scheme for breast cancer services. The goal of this study is to give an overview on compliance with breast cancer guidelines in Europe.
Methods
Studies assessing adherence to guidelines on breast cancer screening, diagnosis, treatment and follow-up were searched via Pubmed. Studies published between 1990 and 2016 were included.
Results
In total, 127 studies (mainly observational, retrospective, prospective, and cross sectional) were analysed. The number of participants varied from 56 to 72 000—with studies based on cancer registry data typically including more than 10 000 patients. Overall, adherence to guidelines was variable. Regarding treatment, (e.g. chemotherapy) adherence ranged from 70% to 96% and was approximately 50% for follow-up. Additional or 'unnecessary' procedures were cited as the main causes of non-compliance to follow-up. On the other hand, adherence with respect to radiotherapy (e.g. compliance with technical guidelines) and some safety-related aspects (e.g. cardiac monitoring during adjuvant trastuzumab therapy and prophylaxis with colony-stimulating factors) was substantially lower. Elderly patients were treated less frequently according to existing guidelines. Professionals with less experience (i.e. < 8 years) complied better with guidelines. Use of computerised decision support systems (CDSS) and implementation of a multidisciplinary breast cancer pathway led to better compliance.
Conclusions
In Europe, adherence to guidelines is variable. Implementation of guidelines can help decrease variability in clinical practice, and improve treatment effectiveness and patient safety. Fortunately, adherence can be monitored through the use of quality assurance schemes (e.g., the ECIBC). Incorporating a CDSS within the clinical workflow could reduce the workload of physicians and thus increase their compliance with guidelines.
Clinical trial identification
Not applicable (review).
Legal entity responsible for the study
European Commission, Directorate General Joint Research Centre European Commission, Directorate General Joint Research Centre.
Funding
None
Disclosure
All authors have declared no conflicts of interest.
Invited Discussant 1440PD, 1441PD and 1442PD (ID 5892)
- R. Giuliani
Q&A led by Discussant (ID 5893)
1443PD - Analysis of compliance factors for colorectal cancer screening using a Bayesian network (ID 2356)
- F. Eisinger
Abstract
Background
Compared to standard explanatory analyses based on multivariate regressions, Bayesian network analyses enable multiple hypotheses and clear graphical representations of complex interactions. They provide visual descriptions of causal pathways to distinguish between direct/indirect factors. We compared multivariate regression and a Bayesian network to assess factors associated with colorectal cancer (CRC) screening.
Methods
The 5th French observational survey, EDIFICE 5, was conducted (Nov 22-Dec 7, 2016) by phone interviews of a representative sample of 1501 individuals (age, 50-75 y). The present analysis focuses on 1299 individuals with no history of cancer (50-74 y). Bayesian analysis was performed with the bnlearn R Package. Parameters of the Bayesian analysis were based on the literature and our own data (logistic regression). “Blacklist/whitelist”-type restrictions were used to reset current understanding of the correlations between variables. We also analyzed the network topology.
Results
In our sample, 36% (N = 469) declared never having undergone CRC screening (colonoscopy, fecal occult blood test) in their lifetime. The Bayesian model revealed 5 direct correlating factors: age, smoking status, social vulnerability, psychological reassurance in the screening test (PRST), and confidence in the efficacy of the test. The latter 2 account for 43% of the observed sum of the mutual informations. Other relevant factors typically seen in the literature and regression analysis had an indirect impact: level of education, self-perception of own risk of CRC, gender, temporal perspective, confidence in their physician and fear of the disease. Multiple regression analysis identified PRST (OR = 0.84, 95% CI 0.80-0.88, P < 0.01) and fear of the disease (OR = 0.90, 95% CI 0.84-0.96, P < 0.01) as the two main criteria.
Conclusions
We showed that Bayesian network analysis provides a novel representation of factors associated with CRC screening, and may explain why interventions focusing on indirect factors might be ineffective if the next step of the causal pathway remains unchanged. We suggest that Bayesian networks should be used more often to drive timely interventions (short term vs long term).
Legal entity responsible for the study
Kantar Health
Funding
Roche
Disclosure
F. Eisinger, J-Y. Blay, A. Cortot, L. Greillier, S. Couraud, J-F. Morere: Honorarium fees from Roche Edifice surveys were funded by Roche S.A. C. Lhomel: Employee of Roche. All other authors have declared no conflicts of interest.
1401PD - Fluctuating cancer screening uptake in France: results of the 5th EDIFICE survey (ID 2424)
- J. Viguier
Abstract
Background
The EDIFICE nationwide surveys assess attitudes to cancer screening in France. All 5 self-reported surveys (2005, 2008, 2011, 2014 and 2016) focused on breast (BC), colorectal (CRC), prostate cancer (PC) screening; the 4th and 5th editions also included cervical (CC) and lung cancer (LC) screening.
Methods
The 5th survey recruited a representative sample of 1299 subjects (men [M], women [F]; age, 50-74 y; no history of cancer) and focused on target populations of the national screening programs for BC and CRC (50-74 y), and on specific subpopulations for PC (M, 50-75 y), CC (F, 50-65 y) and LC (M and F, 55-74 y) screening. Participants were questioned about uptake of at least 1 lifetime screening test and compliance to recommended intervals. Data analysis encompassed nationwide screening programs, opportunistic screening, and vulnerability (assessed by the EPICES score).
Results
Rates for at least 1 lifetime BC screening test (screening rate) were 93%/94%/95%/97%/97% in 2005/2008/2011/2014/2016, respectively. In line with recommendations, 75%/83%/83%/81%/75% women reported having had a mammogram in the past 2 years (compliance), with a significant drop in 2016
Conclusions
In 2016, compliance to national programs was seen to be high for BC screening (despite a decline), and on the rise for CRC, possibly due to the use since 2015 of the new FIT test. Although a national program is due to be implemented in France, uptake of CC screening is on the decline.
Legal entity responsible for the study
Kantar Health
Funding
Roche France
Disclosure
S. Couraud, L. Greillier, J-Y. Blay, A. Cortot, J-F. Morere, F. Eisinger: Received honorarium fees from Roche/Edifice surveys were funded by Roche S.A. C. Lhomel: Employee of Roche. All other authors have declared no conflicts of interest.
Invited Discussant 1443PD and 1401PD (ID 5894)
- J. Martin-Moreno
Q&A led by Discussant (ID 5895)
1110PD_PR - Factors associated with reduced work ability in a nation-wide cohort of long-term cancer survivors treated in young adulthood (19-39 years): The NOR-CAYACS study (ID 3665)
- C. Kiserud
Abstract
Background
Young adulthood (19-39 years) is a phase of life focused on career development and establishment of a family. Cancer during these years may interfere considerably with solving these tasks. We examined factors associated with reduced work ability among cancer survivors treated in young adulthood (YACSs).
Methods
The Cancer Registry of Norway identified 3,617 YACSs alive at September 1, 2015 and diagnosed with cancer from 1985 to 2009, who were mailed a questionnaire. The response rate was 41% and we included 1,198 YACSs (198 melanoma, 494 breast cancer, 148 colorectal cancer, 222 non-hodgkin lymphoma and 136 leukemia), excluding YACSs who were in treatment, did not report on treatment, or had their last cancer diagnosed < 2 years before survey. Self-reported treatment was categorized in 6 groups by increasing intensity from minor surgery to 4-6 treatment modalities. The dataset was analyzed with block-wise linear regression analysis with current work ability (0=none to 10=optimal) as dependent variable.
Results
Mean age at diagnosis was 34 years, mean age at survey 50 years and 60% were in full time job. Our five steps block-wise model explained 54% of the variance in work ability. Late effects and cancer-related variables explained 16%, socio-demography 5%, self-reported health and somatic diseases 27%, mental distress 5%, and lifestyle 1%. Cancer diagnosis and treatment burden did not contribute significantly to the model, while cognitive problems, neuropathy, lymphedema, and radiation sequelae in skin, connective tissue and/or muscles contributed significantly to reduced work ability. The same was true for being female, having a low level of education, having poor self-rated health and cardiovascular disease including hypertension. Higher levels of anxiety, fatigue, depression and fear of recurrence were also significantly associated with poorer work ability. Drinking alcohol ≥ once a week was the only life-style variables with such association.
Conclusions
Among YACSs many psychosocial and somatic features, but not cancer type or treatment intensity, were significantly associated with reduced work ability.
Legal entity responsible for the study
National Advisory Unit for Late Effects
Funding
None
Disclosure
All authors have declared no conflicts of interest.
1111PD - Economic burden of cancer patients and the job assistance from the society (ID 2511)
- N. Koinuma
Abstract
Background
Cancer patients who face the financial difficulties and are obliged to retire for the treatment are increasing in number. It is urgently important that they keep working to receive the optimal treatment. We investigate the actual situation of the patients who retired for treatment and examine the feasible measures including the desirable balance of work and treatment.
Methods
The cancer patients and the attending doctors were surveyed in 40 cancer centers, university hospitals and regional hospitals in Japan.
Results
The number of replies from patients was 3.204. The ratio of patients who were at work before treatment was 50.7%. The ratio of employees was 89.7%. Of these, 31.8% of patients quitted their work for treatment. It was as the highest as 38.7% in lung cancer, and as the lowest as 27.1% in breast cancer. In case of retirees, the ratios of stage I, II, III and IV were 20.6%, 17.9%, 13.9% and 43.7% respectively. The ratio of stage IV was 26.8% in the whole patients, and therefore the retirees tend to be higher in stage. The annual out-of-pocket expense, including direct and indirect expense in the retirees was an average of 6,940 EUR. This was slightly smaller than that of the whole patients. The ratios of patients who felt heavy about the economic burden were 73.7% in retirees and 61.9% in the whole patients. 7.0% of retirees and 5.3% of the whole patients had to change or abandon the most suitable treatment due to the economic reasons. 58.5% of retirees answered that the income was decreased during the cancer treatment and this was significantly higher than that of the whole patients. The percentage of retirees whose tax-included annual income was less than 24,200 EUR was 48. 6%. This was 39.2% in the whole patients. 46.7% of retired employees had no choice but to quite the work, while 42.7% answered that they wanted to continue their work.
Conclusions
One of three patients with cancer is in a working generation, and it is important for patients to balance the treatment with the work. It became clear in the survey that one third of the patient who was working was obliged to retirement. In Japan, the Cancer Control Act was revised in December, 2016 and it became the efforts duty of the company to continue the employment of cancer patients.
Legal entity responsible for the study
Nobuo Koinuma
Funding
Ministry of Health, Labor and Welfare
Disclosure
All authors have declared no conflicts of interest.
1112PD_PR - Real-world productivity, healthcare resource utilization (HRU), and quality of life (QOL) in patients with advanced gastric cancer (GC) in Canada and Europe (ID 4132)
- G. Maglinte
Abstract
Background
As GC is the fifth most common cancer globally, it is important to better understand the impact of advanced disease on patient and caregiver productivity, HRU, and QOL.
Methods
Real-world data were collected through a cross-sectional survey administered to physicians and patients in France, Germany, Italy, Spain, the UK (EU5) and Canada (Nov 2016 to Mar 2017). Physicians provided patient data regarding disease history, characteristics, HRU, and caregiver burden. Health utility and overall health were assessed with the EQ-5D utility index (scores ranging 0 [dead] to 1.0 [full health]; scores <0 implying a health state worse than dead) and Visual Analog Scale (VAS; scores ranging 0 to100, higher scores indicating better overall health), respectively.
Results
A total of 265 physicians provided information for 724 patients currently on their third line active drug treatment for advanced GC. The average age of patients was 63 years (50% ≥65 years), most were male (65%), with ECOG PS of 1 (39%) or ≥ 2 (55%), had gastric vs. gastroesophageal (GEJ; 68% vs. 31%) for primary site of disease, no prior gastrectomy (78%), and ≥2 organs with metastases (65%). Most patients (74%) were retired, unemployed, or on sick leave; of these patients, 30% were unable to work due to their GC. 39% of patients had caregivers spending an average of 47.6 hours of care/week (SD = 46.2). Many caregivers were partners/spouses (76%) who were unable to work or were working less in order to care for the patient (82%). Advanced GC also had an impact on HRU and EQ-5D scores. In the prior 12 months, patients made an average of 13.4 visits to an oncologist (SD = 8.1) and had 0.76 GC-related hospitalizations (SD = 2.34). Relative to EU5 general population norms for ages 65-74 (EQ-5D index, 0.78-0.90; VAS, 67.8-77.3), patients had worse health utility (mean EQ-5D index score=0.61; SD = 0.35) and overall health (mean VAS score=50.6; SD = 20.4).
Conclusions
As indicated by real-world data, advanced GC is associated with productivity loss for both patients and caregivers, significant HRU, and meaningful reductions in patients’ QOL. Novel treatment options are needed to reduce the overall burden of this disease.
Clinical trial identification
Not applicable
Legal entity responsible for the study
Bristol-Myers Squibb
Funding
Bristol-Myers Squibb
Disclosure
G. Maglinte: Employee and stock holder of Bristol-Myers Squibb. M. Contente: Employee and stock option holder at Bristol Myers Squibb. E. Calvo: Consulting/Research funding/Speakers Bureau from various companies. All other authors have declared no conflicts of interest.
Invited Discussant 1110PD, 1111PD and 1112PD (ID 5896)
- F. Perrone
Q&A led by Discussant (ID 5897)
1113PD - Using the ASCO’s quality oncology practice initiative (QOPI) metrics and standards to improve value, meaningful use of resources and reduce waste (ID 4816)
- C. Pinto
Abstract
Background
The Institute of Oncology (IOV) is using the ASCO’s QOPI since 2013 in Brazil. QOPI is a retrospective analysis by data abstraction submited to a database pulling over 180 quality measures based on care guidelines and expert consensus. Data collection are twice a year and provides reports based on practice wide data sample comparing overall quality score for the practice and for the participants aggregate.
Methods
IOV participates in rounds at least once a year. At each round current performance is reviewed and select gaps are translated into improvement projects that focus on meaningful use of resources, safety, accountability of care, and value. Meaningful use of PET-CT; lab tests; and G-CSF are samples of specific projects the past. IOV's Patient Navigation System (PNS) was adapted to track QOPI standards/measures that are monitored by clinical navigators as checkpoints in real time transitions of care and handovers. Potentially hazardous checkpoints are actively chased using a daily signaling process.
Results
Between Feb/2016 and Mar/2017, the PNS checked 9,372 patient iteractions (surgery, exams, outside appointments, optimal sequencing of care); 138 (1.5%) potentially hazardous events were identififed and managed in advance: missing “readiness to care data” and lab tests (36%); delayed radiation or chemo (38%); delayed surgery (7%); and missing echocardiogram for patients using cardiotoxic drugs (6%). The Pain Management Navigation System was created to meet another set of QOPI measures that also translated into 17% reduction of emergency room admissions for 141 patients involved. A dedicated flow was created to meet oral chemo standards, and patient satisfaction improved from 67% to 93% by reducing door-to-door time from 40 to 12 minutes, including check in, interview, drug refill and reconciliation.
Conclusions
One of the big challenges of healthcare is how to introduce changes that translates into real improvements. The use of evidence-based measures and standards to evaluate quality of care provides a clear and straight path to deliver higher value; meaningful use of resources; focus and alignment for improvements initiatives where it matters most: patient care and outcomes.
Legal entity responsible for the study
Instituto de Oncologia do Vale
Funding
None
Disclosure
C.F. Pinto: Board Member at Institute of Oncology. All other authors have declared no conflicts of interest.
1444PD - Cancer Clinical Practice Guidelines: Evaluation of ESMO, NICE and SIGN diversity (ID 1726)
- E. Pallari
Abstract
Background
This research study is on the critical appraisal of the impact of cited research evidence underpinning the development of cancer clinical practice guidelines (CCPGs) by the professional bodies of the European Society for Medical Oncology (ESMO), the National Institute for Health and Care Excellence (NICE) and the Scottish Intercollegiate Guidelines Network (SIGN).
Methods
A total of 101 CCPGs were identified from ESMO, NICE and SIGN websites across 13 cancer sites. Their 9,486 cited references were downloaded from the Web of Science© Clarivate Group database and analysed on Excel© (2016) using VBA macros.
Results
ESMO CCPGs mostly cited research from Western Europe while the NICE and SIGN ones from the UK, Canada, Australia and Scandinavian countries. The ESMO CCPGs cited more recent and basic research (e.g. genetics), in comparison to NICE and SIGN CCPGs where older and more clinical research (e.g. drugs treatment) papers were referenced. This chronological difference in the evidence-base is also in line with that ESMO has a shorter gap between the publication of the research and its citation on the CCPGs. It was demonstrated that ESMO CCPGs report more chemotherapy research while the NICE and SIGN more surgery, with the results being statistically significant. Also, breast cancer research was explored individually across the analysed evidence-base, with a similar pattern to overall oncology CCPGs. Additionally, the volume of breast cancer research cited by ESMO was slightly higher than the fraction of the oncology population suffering from breast cancer in Europe; for the NICE and SIGN the citation percentage was twice as much as the UK disease burden, indicating a potential preference on breast cancer among other oncology types.
Conclusions
This study showed that ESMO, NICE & SIGN differ in their evidence-base. Healthcare professionals should be aware of this heterogeneity in effective decision-making of tailored-treatments to patients irrespective of geographic location across Europe. Considering the potential of the United Kingdom exiting the European Union, a closer collaboration between these professional bodies can lead to the use of more evidence-based, relevant and updated clinical practice guidelines.
Legal entity responsible for the study
Elena Pallari, King's College London
Funding
None
Disclosure
All authors have declared no conflicts of interest.
Invited Discussant 1113PD and 1444PD (ID 5898)
- M. Aapro