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Marko Jakopovic
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P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.01-08 - Gender Differences in Lung Cancer Survival (ID 12441)
12:00 - 13:30 | Presenting Author(s): Marko Jakopovic
- Abstract
Background
Lung cancer death rate in women rose in the past years surpassing breast cancer as the main cause of cancer mortality. The rise in lung cancer mortality in women appears to corelate with the increased prevalence of smoking. Adenocarcinoma has become the most frequent histologic subtype in both genders, and women present with adenocarcinoma in a higher proportion than men do.
a9ded1e5ce5d75814730bb4caaf49419 Method
Medical records of the patients diagnosed with lung cancer in Clinical hospital center Zagreb, Department for respiratory diseases Jordanovac during the year 2012 were retrospectively collected and reviewed. Baseline data were reported using descriptive statistics. Survival analysis was measured and analyzed using the Kaplan-Meier and log-rank test.
4c3880bb027f159e801041b1021e88e8 Result
During the year 2012 there were 661 patients diagnosed with lung cancer in our Department. 482 (73%) were men and 179 (27%) were women. Median age at diagnosis was 64 (37-90). Total lifetime amount smoked varied from 2 to 200 pack/years in the smokers, with median 41 pack/years. The most predominant histological type was adenocarcinoma (287 patients, 43%), followed by squamous cell carcinoma (185; 28%) and microcellular carcinoma (79; 12%). Women had proportionally more adenocarcinoma and less squamous cell carcinoma than men. Cumulative exposure of smoking (as measured by pack-years of cigarettes) is significantly different with 33,6% of men smoking more than 50 pack years compared to 11,7% of women (p < 0.01). No significant difference in stage was observed across genders (p = 0.40). There were no significant differences in treatment between genders. Median overall survival (mOS) for all diagnosed lung cancer patients was 9 months. 1-year survival for all lung cancer patients is 39%, and 5-year survival is 8.1%. Female patients had significantly better survival rates. 1-year survival for female patients is 46% versus male patients 37%. 5-year survival rate for female patients is 11% versus male patients 7%.
8eea62084ca7e541d918e823422bd82e Conclusion
Male gender has been reported as a significant independent negative prognostic factor for patients with lung cancer in previous studies. Our results are similar to these findings. Over the last 20 years there were changes in the epidemiology of lung cancer between men and women. Characteristics of our patient population reflect the current trends of lung cancer epidemiology. Female patients smoke less but seem more susceptible to develop lung cancer. Although adenocarcinoma is the most common subtype in both genders, women have proportionally more adenocarcinomas than men do. Women have better survival than men.
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PL02 - Presidential Symposium - Top 5 Abstracts (ID 850)
- Event: WCLC 2018
- Type: Plenary Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 08:15 - 09:45, Plenary Hall
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PL02.09 - Nintedanib + Pemetrexed/Cisplatin in Patients with Unresectable MPM: Phase III Results from the LUME-Meso Trial (ID 11192)
09:15 - 09:25 | Author(s): Marko Jakopovic
- Abstract
- Presentation
Background
Nintedanib targets VEGFR 1–3, PDGFR α/β, FGFR 1–3, Src and Abl kinases, all implicated in malignant pleural mesothelioma (MPM) pathophysiology. This global Phase II/III, randomised, double-blind study investigated pemetrexed/cisplatin in combination with nintedanib or pemetrexed/cisplatin in combination with placebo, followed by nintedanib or placebo maintenance, in patients with unresectable MPM. In the double-blind, randomised Phase II part, nintedanib plus pemetrexed/cisplatin improved PFS vs placebo (HR=0.56; 95% CI: 0.34–0.91; p=0.017; median 9.4 vs 5.7 months).
In Phase III, chemotherapy-naïve patients with epithelioid MPM (ECOG PS 0–1) were randomised 1:1 to receive up to six cycles of pemetrexed (500 mg/m2)/cisplatin (75 mg/m2) on Day 1, plus nintedanib (200 mg bid) or matched placebo on Days 2–21. After combination treatment, patients without disease progression received nintedanib or placebo maintenance. The primary endpoint (PFS by investigator assessment) and key secondary endpoint (OS) were planned to be analysed by hierarchical testing, with an interim OS analysis at the time of the primary PFS analysis. PFS was also assessed by independent central review. Based on the assumed treatment effect (HR=0.63), the study had 90% power to detect a statistically significant and clinically meaningful improvement in PFS.
In total, 458 patients were randomised. Baseline patient characteristics and oncological history were similar between treatment arms. Median duration of nintedanib or placebo administration was 5.3 and 5.1 months, respectively. After 250 events, there was no difference in PFS between nintedanib and placebo arms (HR=1.01; 95% CI: 0.79–1.30; p=0.91; median 6.8 vs 7.0 months, respectively). PFS by central independent review was similar (242 events; HR=0.99; 95% CI: 0.77–1.28; p=0.96; median 6.8 months in each arm). In the interim OS analysis (127 deaths [28% of events]), median OS was 14.4 vs 16.1 months (nintedanib vs placebo; HR=1.12; 95% CI: 0.79–1.58; p=0.54). There were no unexpected safety findings. The proportion of patients with Grade ≥3 AEs was higher with nintedanib than with placebo (72% vs 62%). The most frequently reported Grade ≥3 AE by medical concept in both treatment arms was neutropenia (nintedanib: 32%; placebo: 24%). The proportion of deaths due to serious AEs was 4.0% (nintedanib) and 7.5% (placebo).
The primary endpoint of the Phase III part of LUME-Meso was not met ‒ Phase II findings were not confirmed. The reported safety profile was consistent with the known safety profiles of nintedanib and pemetrexed/cisplatin.
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