Scientific Program

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    P1.04 - Clinical Design, Statistics and Clinical Trials

    • Type: Poster Session with Presenters Present
    • Track: Clinical Design, Statistics and Clinical Trials
    • Moderators:
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      P1.04-003 - The International Lung Screen Trial: A Multi-Centre Study to Evaluate LDCT Screening Selection Criteria and Nodule Management

      09:30 - 16:00  |  Presenting Author(s): Kuan Pin Lim  |  Author(s): Fraser Brims, A. McWilliams, M. Tammemägi, C. Berg, H.M. Marshall, Emily Stone, R. Manser, K. Canfell, L. Connelly, J. Yee, Kwun M Fong, Stephen Lam

      • Abstract

      Background:
      There remain important knowledge gaps surrounding the optimal selection criteria of high-risk individuals for low-dose CT (LDCT) screening for lung cancer and the optimal management of screening-detected pulmonary nodules. The International Lung Screen Trial (ILST) is an international, multi-centre prospective cohort study with recruitment sites in Canada and Australia. The rationale and design for the study are presented here. The PLCO~m2012~ risk prediction model[1] may have higher sensitivity and positive predictive value in identifying individuals who develop lung cancer compared to the United States Preventive Services Task Force (USPSTF) criteria. The PanCan model[2] calculates malignancy probability in screen-detected nodules and provides a risk-based approach to managing pulmonary nodules. Both models will be prospectively tested in this study. Primary aims: (a) to define the optimal selection criteria for LDCT screening, (b) to evaluate pulmonary nodule management using the PanCan nodule risk calculator.

      Method:
      We aim to recruit 4,000 high-risk individuals with 5 years follow up. Eligible participants are current or former smokers, aged 55-80 years, with a PLCO~m2012~ lung cancer risk of ≥1.51% over 6 years or USPSTF criteria (age as above, plus ≥30 pack year history of smoking and smoking cessation <15 years ago). Exclusion criteria include: symptoms suspicious of lung cancer, severe co-morbidity, previous lung cancer and chest CT within the last 2 years. Baseline assessment includes interview, smoking status assessment and pulmonary function testing. Eligible individuals are offered a baseline screening LDCT and subsequent interval surveillance LDCTs dependent on the PanCan risk score. Participants with no nodules or nodule risk score of <1.5% will have biennial LDCT screening. Participants with nodule malignancy risk score ≥10%, or significant growth in subsequent scan will be considered suspicious for lung cancer and undergo clinical review for further investigation. The primary outcome is the proportion of lung cancers detected by either selection criteria. Secondary outcomes include: number needed to screen, cancer detection rate, lung cancer mortality, cancer stage distribution, resection rate, number of interval cancers, recall rate, invasive procedure rate, benign biopsy/surgery rate, screening-related adverse events and comprehensive healthcare economic evaluation.

      Result:
      This study is currently in its recruitment phase. Results will be reported in future conferences and peer-reviewed publications.

      Conclusion:
      The ILST trial will provide a clearer understanding on the optimum selection criteria for LDCT screening for lung cancer and prospective validation of the PanCan model. ClinicalTrials.gov number: NCT02871856 References: Tammemägi MC et al (2013). NEJM; 368:728-736. McWilliams A et al (2013). NEJM; 369:910-919.

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    PR 02 - Press Conference

    • 10:00 - 10:45
    • 10/16/2017
    • Location: Room 418
    • Type: Press Conference
    • Track:
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      PR 02.02 - RESPECT-MESO: An International Randomised Controlled Trial to Assess Early Specialist Palliative Care in Malignant Pleural Mesothelioma

      10:00 - 10:45  |  Presenting Author(s): Fraser Brims

      • Abstract

      Abstract not provided

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    OA 02 - Mesothelioma: Challenges For New Treatment

    • Type: Oral
    • Track: Mesothelioma
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      OA 02.05 - RESPECT-MESO: An International Randomised Controlled Trial to Assess Early Specialist Palliative Care in Malignant Pleural Mesothelioma

      11:00 - 12:30  |  Presenting Author(s): Fraser Brims  |  Author(s): S. Gunatilake, I. Lawrie, L. Marshall, C. Fogg, N. Maskell, K. Forbes, N. Rahman, S. Morris, S. Gerry, A. Chauhan

      • Abstract

      Background:
      Malignant pleural mesothelioma (MPM) has a high symptom burden and early specialist palliative care (SPC) may have a beneficial role for these patients. We examined the effect of early SPC in patients with MPM.

      Method:
      Participants with newly diagnosed MPM (within the last 6 weeks) were randomised to early SPC integrated with standard care, or standard care alone, in a 1:1 ratio. SPC visits were 4 weekly throughout the study period. Quality of life (QoL) and mood were assessed at baseline and every 4 weeks for up to 24 weeks with the EORTC QLQ–C30 questionnaire for QoL and General Health Questionnaire (GHQ-12) for anxiety/depression. The primary outcome was the change in EORTC C30 Global Health Status (GHS) QoL 12 weeks after randomisation.

      Result:
      174 participants underwent randomisation with 148 (85.1%) completing the primary outcome. The two groups were well matched after randomisation. Median (IQR) age was 72.6 (68.5-78.3) years and 139 (79.9%) were male. Epithelioid was the most common MPM subtype in 136 (78.2%) cases, ECOG PS was 0 in 66 (37.9%) and 1 in 108 (62.1%) participants. At randomisation, 134 (77.0%) participants reported dyspnoea and 100 (57.4%) had chest pain. At least 1 cycle of chemotherapy was completed in 103 (59.2%) participants. At 24 weeks 30 (17.2%) participants had died. Table 1 presents the primary and secondary outcome data. 68 (78.2%) participants in the intervention arm completed all scheduled monthly SPC visits at 12 weeks, and 46 (52.9%) at 24 weeks. 15 (17.2%) participants in the control arm were referred to SPC within 12 weeks, and 30 (34.5%) by 24 weeks.

      Table 1. Primary and secondary outcomes
      Control SPC Mean difference* p=
      Mean (SD) GHS QoL 12 weeks 59.5 (SD 21.2) 60.2 (23.6) 1.8 (95% CI -4.0 to 8.5) 0.60
      Mean (SD) GHS QoL 24 weeks 63.7 (SD 19.8) 61.3 (20.8) -2.0 (-8.8 to 4.6) 0.55
      Mean (SD) GHQ-12 anxiety / depression scores 12 weeks 2.6 (3.2) 2.2 (3.0) -0.6 (-1.5 to 0.4) 0.24
      Mean (SD) GHQ-12 anxiety / depression scores 24 weeks 2.1 (2.55) 1.75 (2.5) -0.4 (-1.2 to 0.4) 0.28
      Median (95% CI) survival (months) 12.6 (10.7-19.7) 11.5 (9.8-15.9) - 0.51
      Mean (SD) GHS QoL alive after 6 months of randomisation 60.9 (20.9) (n=66) 64.3 (19.9) (n=63) - -
      Mean (SD) GHS QoL in those who died within 6 months of randomisation 46.4 (21.4) (n=7) 38.9 (30.6) (n=12) 3.9 (-2.8 to 10.7)** 0.25
      * adjusted for baseline score; ** post hoc analysis SPC = specialist palliative care; SD = standard deviation; CI = confidence interval; GHS = Global Health Status (from EORTC QLQ–C30; higher score – better QoL); GHQ = General Health Questionnaire (higher score - higher depression/anxiety)


      Conclusion:
      Provision of early palliative care for all patients with recently diagnosed MPM is not associated with beneficial changes in quality of life as compared to palliative care review based on symptom burden.