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Reasons why patients accept or decline clinical trials within the gastrointestinal team
ABSTRACTS acceptable toxicity for patients not suitable for surgery. Data base is set up at Guildford for a prospective audit. http://dx.doi.org/10.1016/j.ejso.2016.07.056
104. OPTIMA: a prospective randomised trial to validate the predictive utility and cost-effectiveness of gene expression testdirected chemotherapy decisions Robert Stein1, Andreas Makris2, Luke Hughes-Davies3, Iain Macpherson4, Andrea Marshall5, Amy Campbell5, Peter Hall6, David Cameron6, Helena Earl7, Adele Francis8, Sarah Pinder9, Christopher Poole10, Daniel Rea11, John Bartlett12, Adrienne Morgan13, Leila Rooshenas14, Carmel Conefrey14, Jenny Donovan14, Claire Hulme15, Christopher McCabe16, Victoria Harmer17, Helen Higgins5, Janet Dunn5, on behalf of the OPTIMA Trial Management Group 1 University College London, UK 2 East and North Hertfordshire NHS Trust, UK 3 Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, UK 4 University of Glasgow, UK 5 University of Warwick, UK 6 University of Edinburgh, UK 7 University of Cambridge, UK 8 University Hospitals Birmingham NHS Foundation Trust, UK 9 Kings College London, Guy’s Hospital, UK 10 University Hospitals Coventry and Warwickshire NHS Trust, UK 11 Cancer Research UK Institute for Cancer Studies, UK 12 Ontario Institute for Cancer Research, Canada 13 Independent Cancer Patients’ Voice, London, UK 14 University of Bristol, UK 15 University of Leeds, UK 16 University of Alberta, Canada 17 Imperial College Healthcare Trust, UK Background: Multi-parameter gene expression assays (MPAs) are used to estimate individuals’ residual risk and guide chemotherapy use in hormone-sensitive HER2-negative node-negative early breast cancer. OPTIMA aims to prospectively validate the use of MPA testing to additionally predict chemotherapy sensitivity in a largely node-positive breast cancer population. Method: OPTIMA is a partially blinded multi-centre, phase 3 RCT with an adaptive two-stage design. The preliminary phase (OPTIMA-prelim) evaluated the performance of MPAs for use in the main efficacy trial and assessed the feasibility and acceptability of a large UK trial. It demonstrated that a large-scale study is feasible in the UK. It showed that research on MPA-directed therapy, especially with Prosigna, should be of substantial value to the NHS. The OPTIMA patient population is women aged 40 years or men with resected early stage ER-positive, HER2-negative breast cancer, who either 1e9 have involved nodes or tumours 30 mm. Randomisation is to standard management (chemotherapy then endocrine therapy) or MPA-directed treatment. Those with a tumour categorised as “high-risk” by the test have standard management whilst those at “low-risk” receive endocrine therapy alone. OPTIMA-prelim used Oncotype DX as the discriminator; OPTIMA use Prosigna (PAM50). Coprimary outcomes are invasive disease free survival and cost-effectiveness. Tumour blocks from all consenting participants will be banked allowing the performance of alternative MPA technologies to be evaluated. An integrated qualitative study, undertaken with support from theme II of the MRC ConDuCT-II methodology hub, will aim to optimise recruitment and informed consent. A 4500 patient study allows the demonstration of 3% non-inferiority of MPA-directed
S229 treatment with 5% significance and 85% power. Inclusion of OPTIMA-prelim patients allows assessment of non-inferiority with 2.5% significance. Results: Recruitment commenced in 2016. Conclusion: OPTIMA is a prospective RCT validating MPA-directed therapy in node-positive hormone-sensitive early breast cancer and will have a global impact on patient treatment. http://dx.doi.org/10.1016/j.ejso.2016.07.057 105. Reasons why patients accept or decline clinical trials within the gastrointestinal team Cyper Allan, Sarah Brown University of Sheffield, UK Background: Over the last two decades some studies have attempted to examine the reasons for low recruitment uptake; Taylor (1987), CookGotay (1991) and Fallowfield (1997) all agreed that strict eligibility trial criteria, lack of staff support and randomisation are the reasons. As there are no new studies available, this survey investigated the reasons why patients were accepting or declining entry to clinical trials. Method: The survey utilized in this study was designed to provide some demographic data. Purposive sampling was employed in this survey. This sample type is also referred to as judgment, selective or subjective sampling is a non-probability sampling method that is characterised by a deliberate effort to gain representative samples by including groups or typical areas in a sample. The researcher relied on their judgment to select sample group members. Results: The survey was carried out from November 2015 to February 2016 to all GI patients. 172 patients with GI cancer and eligible to participate in any clinical trials were invited to join the survey. Patients who were eligible comprised of newly diagnosed, already on treatment or on their follow-up. One hundred and twelve (65%) returned the questionnaires with SCOT (12.5%) and GI160 (12.5%) trial patients, STO3 (10.7%), FOxTROT (8.9%) and STO3 PET (8.9%) trial patients forming 53.5% of the total sample. Overall, 105/112 (94%) patients accepted entry to a clinical trial and 7/112 (6%) declined. The gender frequency distribution of all participants with male respondents (70%) outnumbered female patients (30%) who responded to the questionnaire survey. Conclusion: Trust in the doctor and altruism are seen as the most important reasons for accepting entry to a trial. A total of 26 different kinds of trial were included in this survey and they are trials involving chemotherapy, standard or novel treatment, non-drug clinical trials involving blood samples and scanning of patients. http://dx.doi.org/10.1016/j.ejso.2016.07.058 116. The NCRI future of surgery initiative: Defining a research agenda for outcomes of surgical randomized controlled trials Angus McNair1, Kristian Brock2, Terry Jones3, Adele Francis2, Jane Blazeby1, Simon Bach2, Kerry Avery1, Kathrine Fairhurst1, Richard Shaw3 1 University of Bristol, UK 2 University of Birmingham, UK 3 University of Liverpool, UK Background: Randomized controlled trials (RCT) outcomes are a critical component of evaluating novel cancer surgeries. There are, however, unique challenges in selecting, measuring and reporting surgical outcomes that need to be addressed. This national workshop aimed to define future surgical outcomes research in this area. Method: Key stakeholders across all cancer surgical specialties were invited to participate in a one day workshop in May 2016 including consumers, surgeons, clinical academics, methodologists, trialists, funding
104. OPTIMA: a prospective randomised trial to validate the predictive utility and cost-effectiveness of gene expression testdirected chemotherapy decisions Robert Stein1, Andreas Makris2, Luke Hughes-Davies3, Iain Macpherson4, Andrea Marshall5, Amy Campbell5, Peter Hall6, David Cameron6, Helena Earl7, Adele Francis8, Sarah Pinder9, Christopher Poole10, Daniel Rea11, John Bartlett12, Adrienne Morgan13, Leila Rooshenas14, Carmel Conefrey14, Jenny Donovan14, Claire Hulme15, Christopher McCabe16, Victoria Harmer17, Helen Higgins5, Janet Dunn5, on behalf of the OPTIMA Trial Management Group 1 University College London, UK 2 East and North Hertfordshire NHS Trust, UK 3 Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, UK 4 University of Glasgow, UK 5 University of Warwick, UK 6 University of Edinburgh, UK 7 University of Cambridge, UK 8 University Hospitals Birmingham NHS Foundation Trust, UK 9 Kings College London, Guy’s Hospital, UK 10 University Hospitals Coventry and Warwickshire NHS Trust, UK 11 Cancer Research UK Institute for Cancer Studies, UK 12 Ontario Institute for Cancer Research, Canada 13 Independent Cancer Patients’ Voice, London, UK 14 University of Bristol, UK 15 University of Leeds, UK 16 University of Alberta, Canada 17 Imperial College Healthcare Trust, UK Background: Multi-parameter gene expression assays (MPAs) are used to estimate individuals’ residual risk and guide chemotherapy use in hormone-sensitive HER2-negative node-negative early breast cancer. OPTIMA aims to prospectively validate the use of MPA testing to additionally predict chemotherapy sensitivity in a largely node-positive breast cancer population. Method: OPTIMA is a partially blinded multi-centre, phase 3 RCT with an adaptive two-stage design. The preliminary phase (OPTIMA-prelim) evaluated the performance of MPAs for use in the main efficacy trial and assessed the feasibility and acceptability of a large UK trial. It demonstrated that a large-scale study is feasible in the UK. It showed that research on MPA-directed therapy, especially with Prosigna, should be of substantial value to the NHS. The OPTIMA patient population is women aged 40 years or men with resected early stage ER-positive, HER2-negative breast cancer, who either 1e9 have involved nodes or tumours 30 mm. Randomisation is to standard management (chemotherapy then endocrine therapy) or MPA-directed treatment. Those with a tumour categorised as “high-risk” by the test have standard management whilst those at “low-risk” receive endocrine therapy alone. OPTIMA-prelim used Oncotype DX as the discriminator; OPTIMA use Prosigna (PAM50). Coprimary outcomes are invasive disease free survival and cost-effectiveness. Tumour blocks from all consenting participants will be banked allowing the performance of alternative MPA technologies to be evaluated. An integrated qualitative study, undertaken with support from theme II of the MRC ConDuCT-II methodology hub, will aim to optimise recruitment and informed consent. A 4500 patient study allows the demonstration of 3% non-inferiority of MPA-directed
S229 treatment with 5% significance and 85% power. Inclusion of OPTIMA-prelim patients allows assessment of non-inferiority with 2.5% significance. Results: Recruitment commenced in 2016. Conclusion: OPTIMA is a prospective RCT validating MPA-directed therapy in node-positive hormone-sensitive early breast cancer and will have a global impact on patient treatment. http://dx.doi.org/10.1016/j.ejso.2016.07.057 105. Reasons why patients accept or decline clinical trials within the gastrointestinal team Cyper Allan, Sarah Brown University of Sheffield, UK Background: Over the last two decades some studies have attempted to examine the reasons for low recruitment uptake; Taylor (1987), CookGotay (1991) and Fallowfield (1997) all agreed that strict eligibility trial criteria, lack of staff support and randomisation are the reasons. As there are no new studies available, this survey investigated the reasons why patients were accepting or declining entry to clinical trials. Method: The survey utilized in this study was designed to provide some demographic data. Purposive sampling was employed in this survey. This sample type is also referred to as judgment, selective or subjective sampling is a non-probability sampling method that is characterised by a deliberate effort to gain representative samples by including groups or typical areas in a sample. The researcher relied on their judgment to select sample group members. Results: The survey was carried out from November 2015 to February 2016 to all GI patients. 172 patients with GI cancer and eligible to participate in any clinical trials were invited to join the survey. Patients who were eligible comprised of newly diagnosed, already on treatment or on their follow-up. One hundred and twelve (65%) returned the questionnaires with SCOT (12.5%) and GI160 (12.5%) trial patients, STO3 (10.7%), FOxTROT (8.9%) and STO3 PET (8.9%) trial patients forming 53.5% of the total sample. Overall, 105/112 (94%) patients accepted entry to a clinical trial and 7/112 (6%) declined. The gender frequency distribution of all participants with male respondents (70%) outnumbered female patients (30%) who responded to the questionnaire survey. Conclusion: Trust in the doctor and altruism are seen as the most important reasons for accepting entry to a trial. A total of 26 different kinds of trial were included in this survey and they are trials involving chemotherapy, standard or novel treatment, non-drug clinical trials involving blood samples and scanning of patients. http://dx.doi.org/10.1016/j.ejso.2016.07.058 116. The NCRI future of surgery initiative: Defining a research agenda for outcomes of surgical randomized controlled trials Angus McNair1, Kristian Brock2, Terry Jones3, Adele Francis2, Jane Blazeby1, Simon Bach2, Kerry Avery1, Kathrine Fairhurst1, Richard Shaw3 1 University of Bristol, UK 2 University of Birmingham, UK 3 University of Liverpool, UK Background: Randomized controlled trials (RCT) outcomes are a critical component of evaluating novel cancer surgeries. There are, however, unique challenges in selecting, measuring and reporting surgical outcomes that need to be addressed. This national workshop aimed to define future surgical outcomes research in this area. Method: Key stakeholders across all cancer surgical specialties were invited to participate in a one day workshop in May 2016 including consumers, surgeons, clinical academics, methodologists, trialists, funding