Research Within LCA. Dr Mary O Brien

Size: px

Start display at page:

Download "Research Within LCA. Dr Mary O Brien"

Grace Chandler
5 years ago
Views:

1 Research Within LCA Dr Mary O Brien

2 Agenda Align with NCRN trials Scope what is ongoing in LCA Directory of PIs, research nurses, trial coordinators, data managers AIM 1. Increase recruitment to ongoing studies 2. Only initiate studies that are doable..

3 The problems with research Trials that do not recruit or too slow We need to do SURVEYS to see is randomisation or approach accept surgery v SBRT? Or would lung patient post surgery accept OAFU? Too long to get set up in centre Does every centre need to open every trial especially if only 1-2 patient/year eg. alk-met? Could one data manager do set up for one protocol for all centres in LCA? This task would rotate so each centre is doing one extra protocol Funding if extra central we need to use it If local we need carefully and more cleverly use current resources Research must address patient experience formally and potentially have health benefits overall.

4 Order? AUDIT research SERVICE Research SERVICE audit SERVICE audit research Service Early detection, patient experience, improving outcomes

5 What is changing? From 9 NIHR CRN Coordinating Centres To 1 NIHR CRN Coordinating Centre with thematic leadership 102 Local Research Networks 15 Local Clinical Research Networks Inconsistent national coverage with complex geographical configuration Inconsistent and complex structures leading to fragmented workforce coordination and funding allocation for research delivery across geographic areas Simplified national coverage across all therapy areas Single more responsive strategic model providing consistent and simple structures and funding allocation for the delivery of research across all therapy and geographic areas

6 An integrated area-based model 15 Local Clinical Research Networks in operation from April 2014 NIHR CRN Coordinating Centre Local NIHR CRNs Mapped to Academic Health Science Network boundaries One host organisation per area Hosts will work to an operating framework setting out functions and responsibilities 5 year contracts, with one year operational plans

7 NIHR CRN National Coordinating Centre Theme 1 Theme 2 Theme 3 Theme 4 Etc.. Theme 1 Theme 2 Theme 3 Theme 4 Etc.. Performance Management Local CRN Exec Team Local Theme Leadership Team COO Exec of Host Org. Clinical Lead Theme Clinical Lead Theme Manager Theme Management Team Business Support Business Support Teams Local CRN Local CRN delivery model Research Delivery Staff

8 Networks from 102 including the cancer research Network, to 15 local Networks. 3 Research Networks in London with the South-West merging with South-East. Chief operating officer, clinical lead and theme lead, april Integrated portfolios have been put together for breast and UGI Super-host

9 Areas 1. Early detection GPs (TWR, 62 days,?90day + symptoms?pk/years pharmacy - research Pneumonia audit, - last 10 cases of pneu,metabol Smoking prevention services 2. Early detection of relapse audit 3. SBRT v surgery scoping/audit/case conference N2 remove/debulk 3 versus 2 therapies 4. Neoadjuvant/Adjuvant study 5. Rare subgroups SCLC/Meso/patients with mutations 6. TOFFI

of COPD and lung cancer, direct referral pathway from community pharmacy into secondary care respiratory

10 To increase awareness of the signs and symptoms of lung cancer and lung disease (pharmacist/patients) To promote healthy lifestyles by signposting to local smoking cessation services To facilitate early diagnosis of COPD and lung cancer, direct referral pathway from community pharmacy into secondary care respiratory services Support reductions in the inequalities gap between the more and less affluent parts of South West London

11 Phase 2 confirm pilot Hypothesis from pilot: There are patients who do not access GP over a 6 month period, 50 at-risk patients referred for investigation a 20% incidence of undetected airways disease requiring further investigation. (1 in 5 patients) Increase in coverage and duration: 4 boroughs- Croydon, Wandsworth, Sutton & Merton 43 pharmacies October 2012-March 2013

12 Early detection Pharmacy ongoing project Management of pneumonia guidelines on follow-up of high risk patients should come from LCA audit of current practice e.g. each centre describes 5 last cases Screening how many CTs do high risk COPD patients get in 5 years after diagnosis? are we doing stealth screening? Smoking prevention services blood bank

13 Survival (%) Overall Survival Stage IIIA- early detection of relapse make a difference to outcome or patient experience? Experimental RT Conventional RT 58% alive and 42% dead at 1 yr 30% alive and 70% dead at 2 yrs >6 Time from randomization (Years)

14 Early detection of relapse - why FU? RMH audit N= 42 patients radical chemo/rt In first 2 years Chest X-Ray (CXR) - 93 Chest CT - 4 PET/CT Each patient had at least 2 CTs and 3 CXRs Therefore propose OAFU + 2 CTs and 3 CXRs v current practice? Same for patients post surgery

15 Areas Early detection GPs pharmacy - research Pneumonia audit, - last 10 cases of pneumonia, metabolomics Smoking prevention services Early detection of relapse audit SBRT v surgery scoping/audit/case conference N2 remove/debulk 3 versus 2 therapies Neoadjuvant/Adjuvant study Rare subgroups SCLC/Meso TOFFI

Adjuvant Carbo Cisplatin Median PFS (mo)15.4 11.

16 Adjuvant Carbo Cisplatin Median PFS (mo) % CI (mo) HR 0.8 Carbo Cisplatin Median OS (yr) 3.6 Not reached 95% CI (yr) Not reached HR (95% CI) 1.12 ( )

17 Diagnosis of patient with Stage 2-3 adenocarcinoma NSCLC; Conform to eligibility criteria Screening Patients who harbour EGFR mutation but do not meet adenocarcinoma (eg NSCLC-NOS) or smoking criteria (eg ongoing smoker or >10 pack-year history) and otherwise confirm to eligibility criteria Operable patients with EGFR mutation neoadjuvant study REMNANT CONSENT: for EGFR genotyping and surgery QA project Dr Popat Genotype at EGFR CONSENT: surgery QA project EGFR wild type or uninformative result EGFR Mutation CONSENT for rand Q RANDOMISATION OFF PROTOCOL: SURGERY Arm 1: Immediate surgery SURGERY WITH CURATIVE INTENT Arm 2: AFATINIB 40mg once daily for 12 weeks SURGERY WITH CURATIVE INTENT DATA CAPTURED FOR SURGICAL QA STUDY Central pathology review of resection specimens for secondary endpoint (baseline ct vs pt) 1 (T descriptor down staging - baseline ct to 12 week ct) Follow-up for secondary outcome measures of progression-free and overall survival

18 Areas Early detection GPs pharmacy - research Pneumonia audit, - last 10 cases of pneumonia, metabolomics Smoking prevention services Early detection of relapse audit SBRT v surgery scoping/audit/case conference N2 remove/debulk 3 versus 2 therapies Neoadjuvant/Adjuvant study Rare subgroups SCLC/Meso TOFFI

19 Rare subgroups/situations - Audits small numbers 3 rd line pemetrexed 18 patients - RR Docetaxel 60 v 75 with or without GCSF toxicity Collect and register specific subgroups Process for LCA audit and service evaluation

20 Areas Early detection GPs pharmacy - research Pneumonia audit, - last 10 cases of pneumonia, metabolomics Smoking prevention services Early detection of relapse audit SBRT v surgery scoping/audit/case conference N2 remove/debulk 3 versus 2 therapies Neoadjuvant/Adjuvant study Rare subgroups SCLC/Meso TOFFI

21 TOFFI TOo (old) Frail For Investigations Dementia can they consent for CT scan? If patient does not want treatment should they be investigated? Should Dr go out on GPs request? Collect cases at MDM labelled TOFFI Community physicians or GP follow

22 QOL - QTIPs Questionnaire + analysis Questionnaire only No questionnaire All assessed 6 weeks later of treatment.

23 Order AUDIT research SERVICE Research SERVICE audit SERVICE audit research

24 Any Questions?

25 Contact details Dr Mary O Brien Consultant Medical Oncologist and Head of Lung Unit, Royal Marsden Mary.obrien@rmh.nhs.uk

LCA Lung Clinical Forum. 21 st October 2014

LCA Lung Clinical Forum. 21 st October 2014 LCA Lung Clinical Forum 21 st October 2014 Welcome Dr Liz Sawicka Chair - LCA Lung Pathway Group Succession planning Dr Kate Haire Consultant in Public Health Medicine, LCA Commissioning Intentions for