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Noelle O'Rourke
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P2.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 187)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.16-11 - ADVANCE-1: Development and Feasibility Testing of a Benchmarking Approach for Quality Improvement in Lung Cancer Care (Now Available) (ID 280)
10:15 - 18:15 | Author(s): Noelle O'Rourke
- Abstract
Background
Benchmarking is successfully utilized in industry to improve working process and productivity. In its original sense benchmarking is a systematic process for comparing performances, functions or processes of organisations against the best in the world.
However, the majority of research within lung cancer is focused on prevention, diagnosis and treatment rather than examining infrastructure or processes of managing lung cancer patients.
ADVANCE-1 is a European Respiratory Society (ERS) funded pilot study with the aim of creating a benchmarking tool that can easily document and reflect the structure and process within a lung cancer centre and its associated registry and how these processes impact on the pathway of a patient through the individual centres.
Method
The ADVANCE-1 study group was constituted by the two ERS fellowship-holders and senior lung cancer specialists from the two participating lung cancer services in the Beatson West of Scotland Cancer Centre, Glasgow, Scotland, and the Lungenklinik Heckeshorn in the Helios Klinikum Emil von Behring, Berlin, Germany. We created the study design with direct cooperation of the German Benchmarking Centre as well as the University of Glasgow. Final results were externally reviewed by the German Society for Quality Management in Health Care.
Result
Two benchmarking tools were created; the first for documentation of the service provided at each centre, the underlying cancer registry and a test of the robustness and comprehensiveness of information and data collecting resources available at each centre. Secondly; a patient pathway tool to reflect the journey of a patient through each of the relevant centres. Patient satisfaction surveys and staff satisfaction surveys were also created.
Prospective testing of these benchmarking tools in Glasgow and Berlin will allow a comparison between the two centres in order to ascertain best practice and learning from each centre in a so called ‘collaborative’ benchmarking approach.
Conclusion
This unique study has created a benchmarking tool that can easily document the service of a lung cancer centre and the pathway of a patient through that service. With comparison and learning from each other using this tool we aim to improve the patient care and journey through a lung cancer service.
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PL02 - Presidential Symposium including Top 7 Rated Abstracts (ID 89)
- Event: WCLC 2019
- Type: Plenary Session
- Track:
- Presentations: 1
- Moderators:Giorgio Vittorio Scagliotti, Ramon Rami-Porta
- Coordinates: 9/09/2019, 08:00 - 10:15, Barcelona (2005)
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PL02.09 - National Lung Matrix Trial (NLMT): First Results from an Umbrella Phase II Trial in Advanced Non-Small Cell Lung Cancer (NSCLC) (ID 2282)
08:00 - 10:15 | Author(s): Noelle O'Rourke
- Abstract
Background
Oncogene-addicted NSCLC can achieve substantial clinical benefit with single-agent targeted therapy. Seeking to extend this paradigm to other more genetically complex NSCLC, we report first results of NLMT, an umbrella phase II trial whereby a bespoke next-generation sequencing screening panel (Stratified Medicine Programme 2) stratifies NSCLC patients to rationally selected targeted therapies. Uniquely we present results across the entirety of the platform to enable an assessment of the potential to further stratify medicine in advanced NSCLC. Novel methodology is used to ensure that the integrity of this ongoing platform trial is not jeopardised.
Method
NLMT uses a Bayesian adaptive design to screen currently 8 targeted drugs for signals of activity in 22 molecularly defined cohorts. For single agents, pre-specified clinically relevant outcomes are either median progression-free survival (mPFS) >3 months or objective response rate (ORR) and/or durable clinical benefit rate at 24 weeks (DCBR) >30%. Target recruitment for each cohort is 30 with futility analyses at 15. Recruitment continues in 19 cohorts. We report posterior probabilities (PP) of a clinically relevant outcome for closed cohorts and Bayesian predictive probability of success (PPoS) given observed data for open cohorts. This novel approach provides insight into the drug-biomarker combinations that have the strongest potential for further research.
Result
Over a 4 year period to end of March 2019, NLMT has recruited 286 patients from >4000 screened. Of 6 palbociclib cohorts (all proficient Rb): mPFS in KRAS mutation (n=30) is 5.8 months (PP>0.99); CDKN2A loss/non-squamous (n=27) passed its interim analysis; we predict >75% PPoS, given current data, in CDKN2A loss/squamous (n=16) and CCND1 amplification (n=13). Data for crizotinib show >90% PPoS in ROS1 gene fusions (n=8) and MET exon 14 skipping mutation (n=8), with less clear signal for MET amplification (n=9). Responses to selumetinib/docetaxel in NF1 mutation (n=16) warrant continuation. Recruitment to vistusertib was halted at interim for LKB1 single mutation (ORR=0/15, PP=0.003; DCBR=1/15, PP=0.026), but DCBR in LKB1/KRAS double mutation (n=23) warrant continuation. 4 cohorts receive capivasertib (n=22): data in PIK3CA amplifications (n=9) indicate <15% PPoS.
Conclusion
These first results from the largest stratified medicine dataset in NSCLC indicate further molecular stratifications could benefit from targeted therapies. Reporting interim outputs for all cohorts will allow reappraisal of the global stratified medicine strategy in cancer.
