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Paul L. Mitchell



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    MA04 - Health Policy and the Real World (ID 217)

    • Event: WCLC 2020
    • Type: Mini Oral
    • Track: Health Services Research/Health Economics
    • Presentations: 1
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      MA04.09 - Impacts of Multidisciplinary Meeting Presentation: Drivers and Outcomes from a Population Registry Retrospective Cohort Study (ID 2037)

      16:45 - 17:45  |  Author(s): Paul L. Mitchell

      • Abstract
      • Presentation
      • Slides

      Introduction

      Evaluation of lung cancer is complex and discussion in a multidisciplinary context is recommended. The benefits of Multidisciplinary Meeting (MDM) presentation have been demonstrated in case series however its population-based impacts demand evaluation. We evaluated the drivers, likelihood of receipt of treatment and survival impacts of MDM presentation in the population-based Victorian Lung Cancer Registry (VLCR).

      Methods

      Patients in the VLCR (Non-Small Cell and Small Cell Lung Cancer), prospectively captured following diagnosis between 2011 to 2020, were categorised as MDM-presented or non-presented based on medical record documentation. The association of patient, disease and hospital characteristics with likelihood of MDM discussion was determined via logistic regression. Median survival was compared using Kaplan-Meier method and mortality risk was assessed using cox-regression modelling. Propensity score matching, landmark analysis (excluding deaths within 6 weeks of diagnosis), and sensitivity analyses with interaction terms were performed to evaluate these results.

      Results

      Of 9,628 patients, 5,900 (61.3%) were discussed at MDM, 3,728 (38.7%) were not. Patients in the non-MDM group were more likely to be ≥80 years old (p<0.001), with poorer performance status (p<0.001) and advanced stage at diagnosis (43.4% vs. 34.0% clinical stage IV, p<0.001). Non-MDM patients were less likely to undergo surgery (22.1 vs 31.2%, p<0.001), chemotherapy (44.7 vs 49.0%, p<0.001) or radiotherapy (34.2 vs 44.4%, p<0.001). They were less likely to be referred from a sub-acute vs acute facility (p<0.001), private vs public hospital (p<0.001) or inner regional vs major city hospital (p<0.001).

      Patients were less likely to be presented at MDM if clinical stage IV (OR 0.34, p<0.001), referred from an inner regional (OR 0.52, p<0.001), subacute facility (OR 0.57, p<0.001) or private hospital (OR 0.18, p<0.001)

      MDM-presented patients overall had better median survival (1.70 vs 0.75 years, p<0.001) and a 25% reduced overall mortality risk (HR 0.75 (0.71 to 0.80), p<0.001), MDM presentation was strongly associated with receipt of treatment (surgery 0.30 (0.27-0.33), p<0.001; chemotherapy 0.55 (0.52-0.59) p<0.001; radiotherapy 0.88 (0.83-0.93) <0.001). This protective effect was confirmed on propensity score analyses and consistent across hospital types and locations. Factors associated with a higher mortality were age >80 years (HR 1.63, p>0.001), male gender (HR 1.17, p<0.001), ECOG 4 (HR 6.04, p<0.001), clinical stage IV (HR 6.55, p<0.001) and referral from subacute hospital (HR 1.60, p<0.001).

      Non-documentation of ECOG status, tumour histopathology and clinical stage were associated with significantly lower likelihoods of MDM discussion (OR 0.34, 0.35, 0.29 respectively, p<0.001) and higher mortality (HR 1.51, 1.34 and 2.90 respectively, p<0.001).

      Conclusion

      In this population-based lung cancer registry, being male, ≥80 years of age, of high ECOG, advanced clinical stage and poor documentation of clinical characteristics were associated with lower likelihood of MDM discussion, lower likelihood of treatment and a higher mortality risk. MDM presentation conferred survival benefit in lung cancer across all hospital types and locations. This study supports the use of MDM presentation as a crucial component of lung cancer management and identifies patient subgroups where discrepancies in care exist and urgent action is needed.

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    OA04 - New Data from Rare EGFR Alterations (ID 223)

    • Event: WCLC 2020
    • Type: Oral
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 1
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      OA04.04 - Amivantamab in Post-platinum EGFR Exon 20 Insertion Mutant Non-small Cell Lung Cancer (ID 3031)

      11:45 - 12:45  |  Author(s): Paul L. Mitchell

      • Abstract
      • Presentation
      • Slides

      Introduction

      Despite sharing similar tumor biology to other epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) tumors, no targeted therapies have been approved for NSCLC harboring EGFR Exon 20 insertion mutations (Exon20ins). The standard of care remains platinum-based chemotherapy for the front-line, with no clear subsequent options available. Amivantamab (JNJ-61186372) is a novel, fully human EGFR-MET bispecific antibody with immune cell-directing activity that targets activating and resistance EGFR mutations, as well as MET mutations and amplifications, and has received FDA Breakthrough Therapy Designation for the treatment of patients with EGFR Exon20ins NSCLC after platinum-based chemotherapy. Here we present updated results on the Exon20ins cohort from the CHRYSALIS study (NCT02609776).

      Methods

      The dose escalation phase enrolled patients with advanced NSCLC to determine the recommended phase 2 dose (RP2D) of 1050 mg (1400 mg for ≥80 kg) amivantamab. The dose expansion phase assessed the safety and efficacy of amivantamab in patients with EGFR- and MET-mutant NSCLC treated at the RP2D. Disease response was assessed by the investigator per RECIST v1.1 and is presented for those patients with Exon20ins NSCLC who had progressed on prior platinum-based chemotherapy, were treated at the RP2D, and had at least 3 post-baseline disease assessments (18 weeks) or discontinued, progressed, or died prior to the 3rd assessment (the Post-Platinum Cohort). The data cutoff date was 8 Jun 2020.

      Results

      In the Post-Platinum Cohort (n=81), median age was 62 (42 – 84), 59% were women, 49% were Asian, median prior lines of therapy was 2 (1 – 7), and 53% were never-smokers. At a median follow-up of 6.5 months (1.1 – 29.3), investigator-assessed overall response rate (ORR) was 36% (29/81; 95% CI, 25 – 47), with all responders achieving partial response (PR). The clinical benefit rate (≥PR or stable disease ≥11 weeks) was 73% (59/81; 95% CI, 62 – 82). Responses were durable at a median of 6.8 months (95% CI, 5.0 – not reached) with ongoing responses in 18/29 (longest at 16+ months). Median progression-free survival was 8.3 months (95% CI, 5.5 – 12.7) and median overall survival was 22.8 months (95% CI, 14.0 – not reached).

      Among all phase 1 patients, across a variety of EGFR genomic alterations and lines of therapy, treated with amivantamab monotherapy at the RP2D (n=258), the most common adverse events (AEs) were rash (78%), infusion related reaction (IRR; 65%), and paronychia (40%). Additional EGFR-related AEs were stomatitis (19%), pruritus (19%), and diarrhea (11%). Grade ≥3 AEs were reported in 39% of patients; 14% were considered treatment-related, with rash (3%) and IRR (2%) being most frequent. No treatment-related deaths were reported. The incidence of treatment-related AEs leading to dose reduction and discontinuation was 10% and 3%, respectively.

      Conclusion

      Amivantamab treatment led to promising efficacy with durable responses in patients with EGFR Exon20ins NSCLC post-platinum doublet and continues to demonstrate a manageable safety profile in over 250 patients treated at the RP2D. A phase 3 study, PAPILLON, evaluating amivantamab in combination with chemotherapy in the front-line setting is in planning stages.

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    OA05 - Value and Quality in Lung Cancer (ID 216)

    • Event: WCLC 2020
    • Type: Oral
    • Track: Health Services Research/Health Economics
    • Presentations: 1
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      OA05.06 - Lessons Learned from the Victorian Lung Cancer Registry: Opportunities for Quality Improvement in Lung Cancer Management and Outcomes (ID 1455)

      15:30 - 16:30  |  Author(s): Paul L. Mitchell

      • Abstract
      • Presentation
      • Slides

      Introduction

      The development of clinical quality registries (CQR) is a strategy promoted by the Australian Commission on Safety and Quality in Health Care to systematically monitor the quality of health care within specific clinical domains by routinely collecting, analysing and reporting health-related information. Strategic objectives include confirmation of safety, improvement in quality and value of patient-centred health care, improving compliance with evidence-based guidelines and to provide evidence-based support for the development of future guidelines and standards.

      Lung cancer is a disease that meets key criteria for registry development in that evidence based, well executed sequences of care improve patient outcomes, the consequences of poor quality care provide serious risk to patients and the condition is associated with a high cost to the health system.

      Objectives: This report describes the development, preliminary results and lessons learned from the development of the VLCR.

      cqr.png

      Methods

      Design: This is an observational, narrative description of a CQR for monitoring, describing and driving quality improvement in the management of lung cancer in Victoria, Australia. Setting: The VLCR recruits from 19 Victorian health services, 44 hospitals, including metropolitan, regional, public and private hospitals. A Danish surgical resection registry cohort was evaluated to provide international survival benchmarking. Participants: All patients with newly diagnosed primary lung cancer (NSCLC and SCLC) at institutions participating in the VLCR. This report describes 8,180 registrations between 2011-2018. Intervention: Implementation of a CQR for population-based capture and reporting of risk adjusted, bench-marked quality indicators in lung cancer management.

      Results

      Between 2011-2018 a total of 8,180 patients (NSCLC 6,548, SCLC 891) with newly diagnosed lung cancer were registered, mean age 70 years, 57% male. Supportive care screening (28%), palliative care referral (stage IV) within 8 weeks of diagnosis (38%), provision of adjuvant chemotherapy following stage II resection (39%), proportion of lung cancer resections with ³5 lymph nodes resected (59%) and Multi-Disciplinary Meeting presentation (69%) provide opportunities for quality improvement. Reassurance is provided by high levels of pathological diagnostic confirmation (91%), low levels of aggressive end of life chemotherapy (5%) and 90 mortality following resection (3%).

      Conclusion

      The implementation of a population-based registry with >80% population coverage is feasible. Reporting demonstrates significant variation from clinical practice guidelines, variation in practice between metropolitan and regional as well as public and private hospitals and identifies clear actionable targets for quality improvement. The VLCR identifies important quality improvement opportunities and provides a model for a national lung cancer CQR.

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