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L. Greillier
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OA22 - Novel Trials and Biomarkers in Malignant Pleural Mesothelioma (ID 403)
- Event: WCLC 2016
- Type: Oral Session
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:H. Pass, N. Van Zandwijk
- Coordinates: 12/07/2016, 14:20 - 15:50, Strauss 3
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OA22.02 - Nintedanib plus Pemetrexed/Cisplatin in Patients with MPM: Phase II Findings from the Placebo-Controlled LUME-Meso Trial (ID 4191)
14:30 - 14:40 | Author(s): L. Greillier
- Abstract
- Presentation
Background:
Standard first-line treatment for patients with unresectable malignant pleural mesothelioma (MPM) is pemetrexed/cisplatin, yielding a median overall survival (OS) of only ~1 year, thus new approaches are required. As demonstrated by the bevacizumab MAPS study, inhibition of the VEGF pathway is of interest as a treatment approach for MPM. Nintedanib is an oral, triple angiokinase inhibitor of VEGFR, PDGFR and FGFR. This study will evaluate the efficacy and safety of nintedanib plus pemetrexed/cisplatin in patients with advanced MPM.
Methods:
Patients with unresectable MPM (chemo-naïve, ECOG PS 0–1) were stratified by histology (epithelioid/biphasic) and randomised (1:1) to receive up to 6 cycles of pemetrexed (500 mg/m[2])/cisplatin (75 mg/m[2]) on Day 1 plus nintedanib (200 mg bid)/placebo on Days 2–21. Patients without disease progression received maintenance treatment with nintedanib/placebo. The primary endpoint was progression-free survival (PFS).
Results:
87 patients were randomised to receive pemetrexed/cisplatin, plus nintedanib/placebo. Patient characteristics were comparable between the groups. PFS was longer in the nintedanib vs the placebo arm, in both the overall study population and in epithelioid patients (Table 1). Preliminary OS data also favour nintedanib. All patients experienced at least one adverse event (AE, any grade), with 7% of patients in the nintedanib arm discontinuing due to AEs, vs 15% with placebo. Serious AEs occurred in 36% vs 42% of patients in the nintedanib and placebo arms, respectively. The most common ≥grade 3 AEs occurring in nintedanib vs placebo patients were neutropenia (34% vs 10%), ALT increase (14% vs 2%) and gamma glutamyltransferase increase (14% vs 0%).
Conclusion:
Nintedanib plus pemetrexed/cisplatin demonstrated clinical efficacy with improved PFS and a tolerable safety profile in patients with unresectable MPM. Based on these promising findings, this Phase II study was extended to a confirmatory Phase III trial, which is currently enrolling patients. Clinical trial identifier: NCT01907100.
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P1.01 - Poster Session with Presenters Present (ID 453)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Epidemiology/Tobacco Control and Cessation/Prevention
- Presentations: 2
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.01-010 - Awareness of Lung Cancer Risk Factors among Lay Persons and Physicians (ID 4686)
14:30 - 14:30 | Author(s): L. Greillier
- Abstract
Background:
Tobacco consumption, and more specifically active smoking, remains the main risk factor for lung cancer (LC) and continues to be the target of awareness campaigns worldwide. However, in recent decades, other risk factors have been identified, including passive smoking, atmospheric pollution and occupational exposure. This analysis focuses on awareness of LC risk factors among the lay population and physicians.
Methods:
The 4th French nationwide observational survey, EDIFICE 4, was conducted by phone interviews of a representative sample of 1602 subjects, aged between 40 and 75 years, from June 12 to July 10, 2014. A mirror survey was also conducted by phone among physicians between July 9 and August 8, 2014. Both surveys were conducted using the quota method on representative samples of 1602 lay persons and 301 physicians. The following analyzes were conducted amongst 1463 lays persons with no history of cancer and 301 physicians. Interviewees were asked to cite the five main risk factors for LC.
Results:
LC risk factors associated with tobacco in general were widely cited in first position by both physicians and the lay population (100% and 96%, respectively; P≤0.01), with the role of active smoking (100% vs 94%, P≤0.01) and passive smoking (77% vs. 68%, P≤0.01) clearly identified. Twice as many physicians cited asbestos as a risk factor, ranking it in second place, compared with the lay population (77% vs. 30%, P≤0.01). Atmospheric pollution was cited to the same degree by physicians and the lay population (49% vs. 43%, P=0.05), the latter ranking it second. Heredity and family history came fourth (32% vs. 13%, P≤0.01) and alcohol fifth (13% vs. 10%, not statistically significant), in both populations. Infections and other respiratory disorders were cited by less than one person in ten (7%). Poor dietary habits were very rarely cited by either physicians or the lay population (<1% vs 4%, respectively, P≤0.01).
Conclusion:
The awareness of risk factors for lung cancer is broadly consistent with the established risk factors, among both physicians and the lay persons in our survey. As expected, tobacco was ranked first, followed by atmospheric pollution and asbestos, though the latter is less present in the mind of the lay population compared to physicians. It is noteworthy that even among physicians, a history of respiratory disorders was only marginally acknowledged.
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P1.01-017 - The Dramatic Shift of Lung Cancer toward Young in Prisons (ID 5149)
14:30 - 14:30 | Author(s): L. Greillier
- Abstract
Background:
Although prisoners could be at higher risk for lung cancers, very few studies focused on that particular population. In a previous cohort study (Carbonnaux et al. Oncology 2013;85:370–377), we found an early onset of lung cancer in imprisoned patients. The aim of the CARCAN study was to assess epidemiological characteristics, management, prognosis and incidence of lung cancer among prisoners compared to general population.
Methods:
We designed a multi-centric observational case-control study. Cases were lung cancer diagnosed in prison in 3 penitentiary medical units (PMU) of France from 2005 to 2013 (Lyon / Marseille / Toulouse). Up to 3 controls were selected for each case from hospital databases. Controls were randomly matched to cases for center, sex, and year of diagnosis. Overall and age-specific cumulated incidences were calculated in the penitentiary area covered by the 3 participating PMU and in the French population using national statistics.
Results:
Overall, 170 controls and 72 cases met the inclusion criteria and were analyzed. Cases were mainly men (99%). Mean age at diagnosis was 52.9 (±11.0) in prisoners and 64.3 (±10.1) in controls patients (P<10-4). Most of prisoners were current smokers compared to controls (83% vs 53%; P<10-4). We did not find significant difference in histologic type or TNM stage at diagnosis between the two groups. Also, there was no significant difference in first-line treatment type in both groups; especially there was no difference in the rate of patient undergoing supportive care only. Median time from first symptoms to first treatment was 3.3 months [2.7-3.9] in controls compared to 3.6 months [2.7-4.4] in prisoners (P=0.947). We found no significant difference in progression free and overall survival between the two groups. Cumulated incidence (2008-2013) in men was dramatically increased in prisons in each age category compared to the French incidence. Incidence was 4.5 fold higher in prisons than in the general population among 30-40 years old peoples; 3.4 fold higher in 40-50 yo and 1.4 fold higher in 50-60 and 60+ yo categories.
Conclusion:
There is a dramatic shift of lung cancer toward young peoples in prisons. However, presentation, management and prognosis are similar in prisoners compared to controls. These finding should justify a specific screening policy in that high-risk population.
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P1.03 - Poster Session with Presenters Present (ID 455)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.03-040 - Beliefs Surrounding Lung Cancer Screening among Physicians and Lay Populations: Results from the EDIFICE Survey (ID 4436)
14:30 - 14:30 | Author(s): L. Greillier
- Abstract
Background:
The National Lung Cancer Screening Trial has shown that lung cancer screening (LCS) with an annual low-dose chest CT-scan reduces specific mortality in both former and current heavy smokers. However, organizational issues have yet to be solved before it can be systematically implemented. We investigated the perceptions of the population at large as well as those of physicians with regard to the efficacy of LCS, and target populations in terms of tobacco use.
Methods:
The 4th French nationwide observational survey, EDIFICE 4, was conducted by phone interviews of a representative sample of 1602 subjects, aged between 40 and 75 years, from June 12 to July 10, 2014. A mirror survey was also conducted by phone among physicians between July 9 and August 8, 2014. Both surveys were conducted using the quota method on representative samples of 1463 lay persons and 301 physicians with no history of cancer.
Results:
For 53% of lay persons and 33% of physicians interviewed (P<0.01), generalization of LCS is potentially an effective way to reduce lung cancer mortality. For the majority of interviewees (58% of lay persons and 55% of physicians; difference not statistically significant [NS]), offering LCS to the whole population would not encourage smokers to continue smoking. The table shows lay persons’ and physicians’ replies concerning possible target populations within the whole population and among smokers. Figure 1
Conclusion:
Lay persons are more inclined to suggest generalizing LCS to the whole population, independently of current smoking status or quitting issues. Lay persons and physicians alike agree with generalizing LCS to all smokers, regardless of their tobacco consumption.
