Leon Auditorium (Hall 3) Poster Discussion session
Date
29.09.2019
Time
10:15 - 11:45
Location
Leon Auditorium (Hall 3)
Chairs
  • Jose Maria Borras (Barcelona, Spain)
  • Jose M. Martin-Moreno (Valencia, Valencia, Spain)
  • Barbara Melosky (Vancouver, British Columbia, Canada)
  • Francesco Perrone (Napoli, Italy)
Poster Discussion - Public policy Poster Discussion session

1631PD_PR - Clinical benefit and prices of cancer drugs in the US and Europe (ID 2162)

Presentation Number
1631PD_PR
Lecture Time
10:15 - 10:15
Speakers
  • Kerstin N. Vokinger (Zurich, Switzerland)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

Given rising cancer drug costs, US Medicare recently proposed to tie some drug prices to average prices paid by comparable countries. To understand the potential scope of this policy, we assessed differences in cancer drug prices in the US and European countries. We also evaluated the correlation between drug prices and their clinical benefit, as measured by two value frameworks: the American Society of Clinical Oncology Value Framework v2 (ASCO VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale v1.1 (ESMO-MCBS).

Methods

We identified all new drugs for adult solid and hematologic cancers, approved by the FDA from 2009-2017 and that have also been approved by the EMA by December 31, 2018. US average sales prices (and if not available, wholesale acquisition costs) were extracted as of February 1, 2019, and compared to comparable currency-adjusted ex-factory drug costs in England, France, Germany, and Switzerland. ASCO VF and ESMO-MCBS scores were assessed for pivotal trials supporting solid tumor drugs; in case of multiple trials, we focused on the highest score. Consistent with the developers of the rating scales, “high benefit” was defined as scores of A-B (neo/adjuvant setting) and 4-5 (palliative setting) on the ESMO-MCBS scale and scores ≥45 on the ASCO VF. Linear regression models and non-parametric Kruskal-Wallis test and were used to assess the association between drug prices and benefit scores.

Results

The study cohort included 63 drugs approved by the FDA and the EMA during the study period. 46 (73%) were approved for solid tumors, and 17 (27%) were approved for hematologic malignancies. Overall, median cancer drug prices in Europe were 52% (interquartile range: 37-72%) lower than US prices. There was no association between monthly treatment cost and ASCO-VF or ESMO-MCBS scores in any country. There was also no association between price differential between US and median European drug prices and either ASCO-VF (P = 0.599) or ESMO-MBCS (P = 0.321) scores.

Conclusions

Drug prices of cancer drugs were not associated with clinical benefit in the US or in European countries. Cancer drug prices in the US were significantly higher than in the compared European countries.

Legal entity responsible for the study

University of Zurich.

Funding

Swiss Cancer League.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

1632PD - Determinants of the cancer drug funding process in Canada (ID 4743)

Presentation Number
1632PD
Lecture Time
10:15 - 10:15
Speakers
  • Joanna Gotfrit (Ottawa, Canada)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

Canada has a publicly-funded healthcare system with a complex drug funding process. After Health Canada approval to market a drug, the pan-Canadian Oncology Drug Review (pCODR) makes a non-binding funding recommendation to the Canadian provinces (except Quebec), which each then decide whether the drug will be publicly funded. We identified the determinants of funding in this process.

Methods

We analyzed drugs for advanced lung (n = 15), breast (n = 8), colorectal (CRC) (n = 7), melanoma (n = 10), and neuroendocrine (NET) (n = 3) cancer undergoing the funding decision process from 2011-2019. Determinants of funding assessed in the model included list price, cancer type, drug class, and pCODR recommendation. The primary outcome was the correlation between list price and time-to-funding (TTF: Health Canada approval to first provincial funding). Secondary outcomes included an exploratory analysis of predictors of drug funding.

Results

We analyzed 43 drugs: targeted agents 72%, immunotherapy 20%, chemotherapy 7%. 72% were funded in at least 1 province. Median TTF was 379 days (IQR 203-601). Median list price (28-day course) was $8213 (IQR 5391-9445). Higher list price was not correlated with TTF (correlation coefficient -0.20, p = 0.28). There was no association between list price and pCODR recommendation, or the decision to fund in at least 1 province. A positive pCODR recommendation correlated with the provinces’ funding decisions (p < 0.001), where 89% of drugs with a positive recommendation were funded and 100% of drugs with a negative recommendation were not funded. Tumour type was predictive of TTF (p < 0.001): CRC drugs slowest at a median of 2541 days (IQR 702-4379), and NET drugs quickest at a median of 0 days (IQR 0-502). Cancer type predicted decision to fund in at least 1 province (p = 0.005), with funding for 100% of NET drugs at the high end and 29% of CRC drugs at the low end. Drug class was predictive of TTF (p = 0.01): 465 days (IQR 245-702) for targeted agents, 443 days (IQR 298-587) for chemotherapy, and 339 days (IQR 164-446) for immunotherapy.

Conclusions

Determinants of drug funding include cancer type, drug class, and pCODR recommendation, but not list price. Factors other than cost are more heavily weighted in the funding decisions of cancer drugs in Canadian provinces.

Legal entity responsible for the study

Paul Wheatley-Price and Joanna Gotfrit.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

1633PD - Biosimilar substitution: European prescriber perspectives (ID 6081)

Presentation Number
1633PD
Lecture Time
10:15 - 10:15
Speakers
  • Michael S. Reilly (Alexandria, United States of America)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

As countries seek to control health costs and expand access to biologic therapies, biosimilars are a valuable tool. With the automatic subsitution of biosimilars banned in much of Europe, building physician confidence in biosimilars is critical to promoting their uptake and reaping their cost savings benefits. This study is a refresh of a study done in 2013, and documents the perspectives of European prescribers regarding biosimilar substitution and related issues, to serve as a guide to policymakers.

Methods

579 prescribers were recruited from France, Germany, Italy, Spain, Switzerland, UK. Drawn from Dermatology, Endocrinology, Gastrointestinal, Hematology oncology, Immunology, Nephrology, Neurology, Oncology, Ophthalmology, Rheumatology. 15 minute web-based survey, offered in multiple languages. The data was collected in March 2019.

Results

Respondents consider it very important or critical that there are multiple suppliers for government tenders. They also consider it important/critical that tenders include factors besides price. Sole prescription authority is considered very important/critical, as is authority to prevent a substitution. Physicians are more comfortable switching bio-naïve patient to biosimilar, but less comfortable switching a stable patient. Physicians are more comfortable switching a patient for non-medical reasons, but less so when switching is done by a third-party.

Conclusions

In countries with a government tender, physicians consider it important to have several therapeutic options available, and consider factors beyond price to be important. As physicians’ familiarity has increased since the 2013 survey, so has the percentage of physicians characterizing sole prescription authority as "very important or critical". The percentage of prescribers characterizing the ability to prevent/deny a substitution very important or critical has also risen. While comfortable making biosimilar substitutions- including for cost reasons- with new/bio-naive patients, physicians remain cautious about doing so with stable patients. Physicians remain uncomfortable with third-party switching of patients for non-medical (e.g. cost) reasons.

Legal entity responsible for the study

Alliance for Safe Biologic Medicines.

Funding

Alliance for Safe Biologics which receives some funding from manufacturers of originators and biosimilars.

Disclosure

The author has declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

1634PD - Cost avoided in drugs derived from participation in clinical trials in colorectal cancer (ID 1218)

Presentation Number
1634PD
Lecture Time
10:15 - 10:15
Speakers
  • Luis Sánchez- Rubio Ferrández (Madrid, Spain)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

Colon cancer presents at high incidence and its treatment generates an important economic impact in hospitals. In Spain, it is mandatiory for the sponsors of clinical trials to supply the investigational drugs without charge to the national health system. Avoided cost is defined as the cost that would have had to be paid if the patient did not participate in a clinical trial with the free contribution of the drugs. The objective of the main study was to calculate the cost avoided in drugs derived from the participation of patients in clinical trials of colon cancer in a university hospital.

Methods

This was a retrospective observational study. A data cut was made in April 2018 and the active clinical trials in colon cancer were selected. All patients who had participated in them were included, regardless of the date of inclusion. Sources of data collection: Pharmacy Service database, Farmis Oncofarm® electronic Citostatic prescription program, and Clinical Records. The cost of the cycles received in the investigation was estimated for each patient and the cost of the standard treatment during the same period was calculated. For this, the following variables were collected: name of the trial, drug in research, number of cycles, duration, cost of treatment in the experimental arm and in the comparator or standard therapy. The costs of the medication associated with chemotherapy were not taken into account.

Results

Four clinical trials in colon cancer have been included, where a total of 16 patients with a mean age of 60.9 years participated and 5 investigational drugs were studied. The average duration of each patient’s treatment within the trial was 6.7 months. The global avoided cost in the 4 trials is 269,074.85 Euros, which means an average avoided cost per patient of 16,817.17 Euros and an average avoided cost for each trial in colon cancer of 67,268.71 Euros.

Conclusions

Clinical trials contribute to scientific advances, help the sustainability of the Public Health System and allow patients access to novel treatments. It is necessary to promote clinical research since it has proven to be favorable for patients, as well as for clinicians and institutions.

Legal entity responsible for the study

Hospital Universitario La Paz.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

Invited Discussant 1631PD_PR, 1632PD, 1633PD and 1634PD (ID 6918)

Lecture Time
10:15 - 10:30
Speakers
  • Barbara Melosky (Vancouver, British Columbia, Canada)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45
Poster Discussion - Public policy Poster Discussion session

Q&A led by Discussant (ID 6925)

Lecture Time
10:30 - 10:37
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45
Poster Discussion - Public policy Poster Discussion session

1635PD - Accessibility and affordability to trastuzumab for breast cancer patients: Voices of the global oncology community from ONCOLLEGE 001 survey, part 2 (ID 3453)

Presentation Number
1635PD
Lecture Time
10:37 - 10:37
Speakers
  • Sara C. Altuna (Caracas, Venezuela)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

ONCOLLEGE-001 project surveyed the global accessibility (ACC)/ affordability (AFF) to HER2-testing (H2T) & medicines for breast cancer (BC). The 1st analysis showed critical issues of ACC & AFF of H2T in lower- middle income countries. Part 2 of the survey focuses on ACC, AFF and prioritization of anti-HER2 medicines; here, we present the data for trastuzumab (T).

Methods

An internet-based survey was developed by the international ONCOLLEGE working group. Data were analyzed per country-income (World Bank groupings) and World Health Organization Regions. Responders authorized for the use of the data.

Results

Responses were received from 210 providers (78% medical or clinical oncologists) across 45 countries (all income groups, all regions). 8% of providers reported no T available in their setting, of which 60% are from low and low-middle income countries (LMICs) and the remaining from upper- middle (UMIC). Where T was available, 15% of the responders reported ACC only as out of pocket expenditure (OOP) for patients, of which almost 70% from LMICs. More than 2/3 of the responders described to order the H2T regardless ACC to affordable trastuzumab for patients, retaining the prognostic information of HER2- overexpression to inform treatment decision- making (e.g. risk grouping for early breast cancer). The patterns of reimbursement for T influenced the percentage of eligible HER2 patients receiving the anti-HER2 drug: T is received in more than 50% of the eligible population in 8%, 41% and 74% in LMIC, UMIC and HIC (high- income) settings, respectively. In 71% of settings where trastuzumab is provided only as OOP, <1/4 of the eligible patients could access affordable T.

Conclusions

The heterogeneous pattern of ACC and AFF of H2T & anti-HER2 medicines influenced the chance of breast cancer patients to receive T. Data on the use of trastuzumab biosimilars and other HER2 blockers is under analysis. International systematized cross-cutting and comprehensive efforts across the cancer continuum are warranted to inform and shape the areas of research implementation for cancer - aiming to optimize the cure and care for all cancer patients and prevent catastrophic OOP.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

1636PD - Analysis of 105,000 cancer patients: Have they been discussed in oncologic multidisciplinary team meetings? A nationwide population-based study in the Netherlands (ID 3302)

Presentation Number
1636PD
Lecture Time
10:37 - 10:37
Speakers
  • Janneke E. Walraven (Nijmegen, Netherlands)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

For optimal oncological care it is recommended to discuss every patient with cancer in a multidisciplinary team meeting (MDTM). Due to increasing incidence and prevalence of cancer and emergence of dedicated tumour specific MDTMs, the number of patients that needs to be discussed rises, and the time- and financial burden is growing. This leads to a growing demand to change the current workflow. We aimed to investigate the number of patients discussed in current daily practice of MDTMs and aimed to identify characteristics that associate with not being discussed.

Methods

Data of patients with a newly diagnosed solid malignant tumour in 2015 and 2016 were analyzed through the nationwide population-based Netherlands Cancer Registry (NCR). We clustered all different tumour types in 8 groups that were frequently discussed within a tumour specific MDTM; 1. upper gastro-intestinal- , 2. hepato-pancreatic-biliary- , 3. colorectal-, 4. gynaecological- , 5.central nervous system-, 6. head and neck-, 7. breast- and 8. prostate cancers. Tumour types without information about MDTMs in the NCR were excluded. Multivariable logistic regression analyses were used to analyze which factors were associated with not being discussed in a MDTM.

Results

Out of 105.305 patients, 91% were discussed in a MDTM; varying from 74%-99% between the different tumour groups. Significantly less frequently discussed were patients aged ≥ 75 years (OR = 0.7, 95%CI=0.6-0.7), diagnosed with disease stage I (OR = 0.5, 95%CI=0.5-0.6), IV (OR = 0.4, 95%CI=0.4-0.4) or unknown (OR = 0.2, 95%CI=0.2-0.2), and patients that received no treatment (OR = 0.3, 95%CI=0.3-0.3). Patients that received a multidisciplinary treatment were more likely to be discussed compared to patients with a monodisciplinary treatment (OR = 4.6, 95%CI=4.2-5.1).

Conclusions

In general most cancer patients are actually discussed in a MDTM in the Netherlands, although differences were observed between tumour groups. Factors associated with not being discussed may, at least partially, reflect the absence of a multidisciplinary question. These results form a starting point for debate towards a more durable and efficient new MDTM strategy.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

V.E.P.P. Lemmens: Research grant / Funding (institution): Roche. R.H.A. Verhoeven: Research grant / Funding (self): Roche; Research grant / Funding (self): Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

1637PD - Reaching sustainable oncology care via the National Cancer Control Program (NCCP) (ID 5246)

Presentation Number
1637PD
Lecture Time
10:37 - 10:37
Speakers
  • Branko Zakotnik (Ljubljana, Slovenia)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

The NCCP is a program of activities for efficient action in the field of cancer control adopted by our Government and based on recommendations of WHO and European Partnership Action Against Cancer. It was initiated due to high cancer incidence and mortality in our country. We report achievements of our 3 organized, population-based screening programs (SP).

Methods

1. Cervical Cancer (CerC) SP, started 2003, conventional cytology, 3 years interval, age 20–64, participation 72%. 2. Colorectal Cancer (CRC) SP, started 2009, immunochemical fecal occult blood test, follow up colonoscopy if positive, age 50-74, 2 years interval, participation 62%. 3. Breast Cancer (BC) SP, started 2008 in central region, countrywide in 2018, mammography every 2 years, age 50-69, participation 73%. Outcome measures: 1. Incidence for CerC and CRC for all pts diagnosed in Slovenia from SP start. 2. Stage distribution, net survival and hazard ratio (HR) of death for screen vs not screen detected cancers diagnosed with CerC, CRC and BC from 2011-2015 for all invited patients to the SPs.

Results

CerC incidence was reduced from 2003 to 2017 by 62% (from 211 cases/year to 85), CRC from 2010 to 2015 by 21% (from 1729 cases/year to 1357). A significant (p < 0.0001) stage shift in screen detected vs not screen detected cancers was achieved. The stage shift percentages (screen detected/not screen detected) for the three SP are: for CerC stage I 81/41; stage II 16/30; stage III 3/19; stage IV 1/10, for CRC stage I 45/14; stage II 19/24; stage III 29/33; stage IV 8/30 and for BC stage I 66/40; stage II 26/35 stage III 8/18; stage IV 1/7. 5-year net survival for screen detected pts with CerC, CRC and BC was 92.1%, 88.4% and 100% and in not screen detected 63.7%, 57.1%, 85.3% respectively. The risk of death described by hazard ratio is in screened detected cancers 4-5 times lower: CerC HR 0.18 (0.11 – 0.28), CRC HR 0.26 (0.23-0.29) and BC HR 0.17 (0.10-0.31).

Conclusions

High quality SPs have a significant impact on incidence, stage and survival and are the basis of sustainable oncology care. They are even more essential in countries with limited human and financial resources. Pts with screen detected cancers are diagnosed in earlier stages and have lower probability to die from cancer.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

Invited Discussant 1635PD, 1636PD and 1637PD (ID 6919)

Lecture Time
10:37 - 10:52
Speakers
  • Jose Maria Borras (Barcelona, Spain)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45
Poster Discussion - Public policy Poster Discussion session

Q&A led by Discussant (ID 6924)

Lecture Time
10:52 - 10:59
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45
Poster Discussion - Public policy Poster Discussion session

1638PD - Changing landscape of clinical cancer trials in Germany (ID 5586)

Presentation Number
1638PD
Lecture Time
10:59 - 10:59
Speakers
  • Susen Burock (Berlin, Germany)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

The development of new therapeutic options for cancer patients due to a better understanding of tumor biology has profound effects on the design and conduct of modern clinical cancer research especially with respect to clinical trial design. Until recently, cancer drugs have been investigated in clinical trials for a definitive histological tumor type but this approach is slowly changing and recently drugs have been approved rather histology agnostic based on genomic alterations in various histological tumor types. Here we investigated the changes in the landscape of clinical cancer trials in Germany from 2000-2016.

Methods

Clinical trials gov database was queried in 2017 for interventional clinical cancer trials running in Germany with study start between 01/01/2000 and 31/12/2016. Data extracted from the database included the conditions, interventions, study phase, Sponsor/Collaborators, funder type, study design, outcome measures and number enrolled.

Results

Overall, 2977 trials matching the criteria were extracted. Number of studies heavily increased within the first decade from 32 studies in 2000 to 214 studies in 2010, remained thereafter relatively stable (with 260 in 2011, 243 in 2012, 236 in 2013, 252 in 2014, 274 in 2015 to 224 in 2016). There was a clear change in the study design over the years towards more trials with a placebo. Furthermore, the number of entities investigated within one clinical trial (from 1 tumor entity, 2-5 tumor entities, 6-10 tumor entities and >10 tumor entities (including clinical trials targeting events from various entities) increased over the years. With respect to sponsorship, there was an increase of industry-alone sponsorship over the years.

2000 - 20042005 - 20092010 - 20142015 - 2016
Masking
open label78%75%73%77%
single blind1%3%3%4%
double blind12%20%18%12%
quadruple1%2%6%6%
Missing9%0%0%1%
Placebo
Placebo - no95%82%80%85%
Placebo - yes5%18%20%15%
Number of entities
188%91%89%85%
2 - 56%3%4%5%
6 - 100%0%0%1%
> 106%5%7%10%
Sponsorship
Industrie alone43%68%65%64%
other57%32%35%36%

Conclusions

Cancer clinical trials have changed with respect to trial design and sponsorship during the last decade to cope with recent development of new cancer therapeutics.

Legal entity responsible for the study

Charité Universitätsmedizin Berlin.

Funding

Has not received any funding.

Disclosure

T. Füreder: Honoraria (self), Honoraria (institution), Research grant / Funding (institution): Norvartis; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Merck Darmstadt; Honoraria (self), Honoraria (institution), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Honoraria (institution), Research grant / Funding (institution): Sanofi; Honoraria (self), Honoraria (institution), Research grant / Funding (institution): Accord; Honoraria (institution), Research grant / Funding (institution): Celegene; Honoraria (institution), Research grant / Funding (institution): Ipsen; Honoraria (institution), Research grant / Funding (institution): Astellas; Non-remunerated activity/ies: President elect Austrian Head and Neck cancer society; Full / Part-time employment: Medical University of Vienna; Honoraria (institution): Johnson and Johnson ; Research grant / Funding (institution): Amgen. U. Keilholz: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Advisory / Consultancy: Serono; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD Oncology; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Pfizer; Honoraria (self), Speaker Bureau / Expert testimony: Novartis; Honoraria (self), Speaker Bureau / Expert testimony: Glycotope GmbH. All other authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

1639PD - Comparison between phase III randomized clinical trials and their preceeding phase II studies (ID 5192)

Presentation Number
1639PD
Lecture Time
10:59 - 10:59
Speakers
  • Ivan Lyra-Gonzalez (Toronto, Canada)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

Few studies have assessed the differences in outcomes between phase II versus III landmark studies in gastrointestinal (GI) malignancies. The primary aim of this study was to determine differences in overall survival (OS) and overall response rate (ORR) between phase III studies and their preceeding phase II studies and to assess for differences in reported grade 3 and 4 toxicities.

Methods

A PubMed search was performed and reports of phase III randomized clinical trials (RCTs) evaluating systemic therapies in GI malignancies, published between 2008 and 2018 in JAMA, NEJM, JCO, Ann Oncol, Lancet, and Lancet Oncol were included. Preceeding phase II studies were identified by searching in PubMed and Medline using author and group names from the phase III studies. Phase II studies could be published in any journal. Hazard ratios (HRs) for OS, ORR, and incidence of grade 3/4 adverse events (AEs) were collected and compared between available phase III and phase II pairs via meta-analysis.

Results

Out of 788 phase III studies identified, 91 met our inclusion criteria. Corresponding phase II studies were found in 43 cases (47%). The most studied tumour sites were colorectal, gastric and pancreas cancer. Fifty-five (60.4%) phase III studies were entirely funded by industry and 44 (80%) focused on metastatic disease. In the localized disease setting, only 5 (21.7%) studies were preceeded by a phase II trial, while in the metastatic setting this occurred in 38 (55.9%) studies. Comparisons between phase III and their phase II trials, showed no difference in ORR (p = 0.191) and a hazard ratio increase in phase III OS (p = 0.028). Additionally, we observed no difference in AEs (p = 0.203), where only 52 (57%) of the phase III studies clearly stated the overall incidence of grade 3/4 toxicities.

Conclusions

Lack of preceeding phase II studies in 48 (52.7%) phase III studies published in high impact journals suggests there may be insufficient background data for the performance of pivotal trials. The reported ORRs and grade 3/4 toxicities were similar between phase III and II studies, however, phase III studies show an increment in HRs for OS of 19.7% (2.0-40.5 95%CI) compared to phase II studies.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

1640PD - Projecting overall survival data for health-economic models in oncology: Do maturity levels impact uncertainty? (ID 5811)

Presentation Number
1640PD
Lecture Time
10:59 - 10:59
Speakers
  • Isabelle Borget (Villejuif, France)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

A lifetime horizon is recommended for health-economic evaluation of anticancer drugs. If overall survival (OS) data is immature, extrapolation of the Kaplan-Meier (KM) curve using distributions is done to obtain long-term data. Depending on OS maturity, the distribution chosen may impact estimation of life expectancy (LE) and of life years gained (LYG) between treatments. This study aimed to estimate the error (on LE and LYG) induced by the choice of extrapolation distributions, for 2 levels of OS maturity (30% and 50%), as compared to LE and LYG at full maturity.

Methods

Fifteen phase III trials published between 2013 and 2017 containing OS KM curves were selected if maturity > 70% (Full). To test 2 maturity levels, each KM curve was truncated at 30% and 50%. A 3-step process was performed: i) KM was digitalized, ii) individual patient-data was reproduced using the Guyot algorithm, and iii) 5 parametric survival distributions were fit using the R-Survival package. For each study, the process was done for each treatment arm and each of the 3 maturity levels on the same time horizon, equal to the maximum follow-up of the study. For each curve, the best distribution was chosen by a board of 2 oncologists and 2 health-economists, based on visual inspection, Akaike/Bayesian Information criteria, and external validity.

Results

Based on the board review of the 90 KM curves, main chosen distributions were Weibull (33%), Log-logistic (32%) and Log-normal (27%). As compared to LE at full maturity, LE was overestimated in 23% and 40% at 30% and 50% maturity, respectively. Mean absolute error was 2.12 months at 30% maturity, and decreased to 0.88 months at 50% maturity, i.e. estimation was 2.4 times better from 30% to 50% maturity. On average, at 30% maturity versus full, mean percentage of error in LYG was 126.4% and 62.4% at 50% maturity versus full.

Conclusions

The use of immature OS data increases the risk of error when projecting long-term LE. Even marginal gains in OS maturity can be translated in more accurate estimations and guide health-economist in developing models.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

Invited Discussant 1638PD, 1639PD and 1640PD (ID 6920)

Lecture Time
10:59 - 11:14
Speakers
  • Francesco Perrone (Napoli, Italy)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45
Poster Discussion - Public policy Poster Discussion session

Q&A led by Discussant (ID 6923)

Lecture Time
11:14 - 11:21
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45
Poster Discussion - Public policy Poster Discussion session

1641PD - Implementation frameworks to effectively transition complex research interventions into clinical practice in oncology, nuclear medicine, diagnostic and interventional radiology: A scoping systematic review (ID 1801)

Presentation Number
1641PD
Lecture Time
11:21 - 11:21
Speakers
  • Gayathri Delanerolle (Cambridge, United Kingdom)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

Clinical research is considered as a cross-disciplinary specialty in modern day medicine merging science and clinical arenas to better public health. The rapidly changing clinical research landscape has led to an array of treatments moving towards a precision medicine platform involving complex interventions. Thus, clear processes to conduct and transition research interventions into clinical practice are more important than ever. Theoretically, implementation of novel interventions require clear methods as part of a fit for purpose framework comprising of effective adaptation processes and practice policies. However, from a practical perspective, implementation of new interventions is more complex especially in specialties such as oncology, NM, IR and DR. This is the first study to systematically scope and review implementation frameworks to understand it’s applicability in clinical specialties.

Methods

We searched 17 databases including PubMed, Medline/OvidSP, Science Direct, PROSPERO, PRISMA, PubMed Health, Embase, EBSCOhost, SciELO, TRIP, ProQuest, Academic search complete, Ageline, Cochrane, Web-of-Science and BIOSIS using a comprehensive search strategy to review publications from January 1st1980 to 31stMarch 2019 in English. We selected 20 publications as per the inclusion/exclusion criteria developed under a review protocol registered with PROSPERO (CRDG42019124020).

Results

There were no publications indicating a validated framework or a specific system used to implement complex interventions within oncology, IR, NM and DR. However, there were generalized implementation processes and adaptation models available. Furthermore, validation studies were not conducted against these frameworks to review their applicability and viability in healthcare especially in the UK.

Conclusions

It is evident there is a research implementation gap in healthcare especially in the UK and additional operational research is required to address this issue. Better alignment between academic theories and healthcare practice is also required to enable better implementation of novel interventions.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

1642PD - Measuring the cancer burden in Europe: The European Cancer Information System (ECIS) (ID 5003)

Presentation Number
1642PD
Lecture Time
11:21 - 11:21
Speakers
  • Manola Bettio (Ispra, Italy)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

The European Commission has a long-term commitment to reducing cancer burden in the EU. Evaluation of the effectiveness of measures implemented is dependent on accurate and comparable data allowing derivation of cancer indicators (incidence, mortality, survival). For this purpose, the EC Joint Research Centre (JRC) in close collaboration with DG SANTE is maintaining a comprehensive cancer information system for Europe.

Methods

Population-based cancer registries (CRs) are the information source for the computation of cancer burden indicators. In response to the call from the Council to the Commission to act further in harmonising EU cancer registration, the JRC since 2012 has taken an active role in supporting the activities and exploiting the data of the CRs affiliated to the European Network of Cancer Registries (ENCR).

Results

The JRC has developed and launched in February 2018 the European Cancer Information System (ECIS) as a web-based tool to report and disseminate cancer burden indicators. The ECIS displays historical time series and projections of cancer incidence and mortality, as well as cancer survival indicators. Statistics in the ECIS are derived from the data of about 150 CRs in 34 European countries, detailing up to 58 cancers sites. The database feeding the ECIS is dynamic and is updated as new data become available.

Conclusions

ECIS permits the exploration of geographical patterns and temporal trends of cancer burden indicators at national and/or regional level. It constitutes an essential tool to promote awareness on cancer burden, to assess and monitor its magnitude and follow trends and changes over time. ECIS is an important step forward in informing the citizens, assisting political decision making and supporting epidemiological research.

Legal entity responsible for the study

European Commission.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

1643PD - Association between socioeconomic factors and one-month mortality after cancer-directed surgery in solid tumours (ID 702)

Presentation Number
1643PD
Lecture Time
11:21 - 11:21
Speakers
  • Zeting Qiu (Shantou, China)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45

Abstract

Background

Cancer-directed surgery is the principal therapy for solid tumors. One-month mortality after surgery remains an important criterion for evaluating the quality of surgical treatment. Socioeconomic factors play important roles in the modern biopsychosocial medical model. Here we studied the relationship between socioeconomic factors and one-month mortality after surgery in 17 primary solid tumors.

Methods

Based on the Surveillance, Epidemiology, and End Results database between 2004 and 2014, we focused on the socioeconomic factors, containing ethnicity, marital status, insurance status, household income, educational level, residence, unemployment level, and poverty level. The top 17 common cancer sites were selected, including bladder, breast, cervix, colorectum, esophagus, kidney, liver, lung, melanoma, oral cavity, ovary, pancreas, small intestine, stomach, testis, thyroid, uterine. The primary outcome was that patients died within one month after surgery. The control group was patients surviving beyond one month. We performed multivariable logistic regression model and subgroup analysis to detect the association.

Results

There were 24,233 (1.6%) patients dying within one month after surgery among 1,550,375 persons with primary solid cancers. Adjusted by age, gender and stage, patients with a unmarried state (aOR [adjusted odds ratio] 1.550, 95% CI [confidence interval] 1.504-1.597), Medicaid/uninsured (aOR 1.563, 95% CI 1.491-1.639), a low-income level (aOR 1.100, 95% CI 1.044-1.158), a low educational level (aOR 1.107, 95% CI 1.061-1.155), or a high poverty level (aOR 1.089, 95% CI 1.041-1.140), had significantly high risks of one-month mortality (All p values < 0.001). No significant association was found as for ethnicity, residence or unemployment. In the subgroup analysis by different cancer sites, it was found that the effects of the above-mentioned factors on mortality were almost consistent with overall.

Conclusions

Socioeconomically disadvantaged people tend to have high risks of one-month mortality after cancer-directed surgery. Especially in patients with unmarried or Medicaid/uninsured status, the risks were much higher than other factors.

Legal entity responsible for the study

Wei Sun.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion - Public policy Poster Discussion session

Invited Discussant 1641PD, 1642PD and 1643PD (ID 6921)

Lecture Time
11:21 - 11:36
Speakers
  • Jose M. Martin-Moreno (Valencia, Valencia, Spain)
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45
Poster Discussion - Public policy Poster Discussion session

Q&A led by Discussant (ID 6922)

Lecture Time
11:36 - 11:43
Location
Leon Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
Date
29.09.2019
Time
10:15 - 11:45