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J.P. Van Meerbeeck
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P1.09 - Mesothelioma (ID 695)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Mesothelioma
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.09-011 - LUME-Meso Phase II/III Study: Nintedanib + Pemetrexed/Cisplatin in Chemo-Naïve Patients with Malignant Pleural Mesothelioma (ID 7937)
09:30 - 09:30 | Author(s): J.P. Van Meerbeeck
- Abstract
Background:
Pemetrexed/cisplatin is the standard first-line treatment for unresectable malignant pleural mesothelioma (MPM), with median overall survival (OS) of ~1 year. Nintedanib is a triple angiokinase inhibitor of vascular endothelial growth factor (VEGF) receptors 1–3, platelet-derived growth factor (PDGF) receptors α/β and fibroblast growth factor receptors 1–3. VEGF and PDGF overexpression are associated with poor prognosis in MPM, and nintedanib has demonstrated efficacy in preclinical MPM models. Nintedanib also targets the Src and Abl kinases, which are involved in MPM cell migration. A randomised Phase II trial of nintedanib or placebo + pemetrexed/cisplatin in MPM followed by maintenance nintedanib or placebo, with progression-free survival (PFS) as the primary endpoint, was performed. With regulatory authority guidance, the Phase II data were unblinded. At the primary analysis, PFS benefit was observed with nintedanib, and confirmed at the updated analysis (hazard ratio [HR]=0.54, 95% confidence interval [CI]: 0.33–0.87; p=0.010; median PFS: nintedanib 9.4 months vs placebo 5.7 months). A strong signal towards improved OS also favoured nintedanib (HR=0.77, 95% CI: 0.46–1.29; p=0.319; median OS: 18.3 vs 14.2 months). The study was expanded to include a confirmatory Phase III part based on the primary PFS results, and the Phase II data assisted in planning of the Phase III part, including sample size estimation. Nintedanib was granted US Food and Drug Administration orphan drug designation for the treatment of MPM in December 2016.
Method:
The Phase III part of the study (NCT01907100) is currently recruiting participants. Four hundred and fifty chemotherapy-naïve patients worldwide (~140 sites in 27 countries), aged ≥18 years with unresectable MPM of epithelioid histology and Eastern Cooperative Oncology Group performance score 0–1 will be randomised 1:1 to receive up to six 21-day cycles of pemetrexed (500 mg/m[2])/cisplatin (75 mg/m[2]) on Day 1 + nintedanib or placebo (200 mg twice daily, Days 2–21), followed by nintedanib or placebo monotherapy until disease progression or undue toxicity. The primary endpoint is PFS with the key secondary endpoint being OS. An adaptive design will be used at the time of the primary PFS analysis to reassess the number of OS events for sufficient OS power. Other secondary endpoints are objective response and disease control (using modified Response Evaluation Criteria in Solid Tumors). The frequency and severity of adverse events, as well as health-related quality of life, will also be assessed. An exploratory analysis of predictive/prognostic biomarkers is planned.
Result:
Section not applicable
Conclusion:
Section not applicable
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P3.13 - Radiology/Staging/Screening (ID 729)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.13-008 - Lung Cancer Associated with Cystic Airspaces: Clinical, Imaging, Histopathological and Molecular Correlation (ID 8202)
09:30 - 09:30 | Author(s): J.P. Van Meerbeeck
- Abstract
Background:
“Lung cancer associated with cystic airspaces” is a rare radiological entity that is becoming more frequently encountered on imaging studies and has been gaining more attention since the widespread use of CT for lung cancer screening. The goal of this retrospective study is to investigate and correlate clinical, imaging, histopathological and molecular findings in patients presenting with this type of lung cancer.
Method:
Between January 2014 and April 2017, 13 patients presented at the Multidisciplinary Thoracic Oncology Tumour Board with this rare entity. Clinical, histopathological and molecular data were collected and imaging studies were reviewed for the presence of emphysema, size, morphologic classification and findings on [18]F-FDG-PET.
Result:
Median age at the time of diagnosis was 69 years (53-86 years) with a male/female ratio of 8:5. Ten out of 13 patients were smokers. Eleven patients (11/13) had no previous oncological history. Two patients with previous oncological history both had a history of head-and-neck and stage IA lung cancer. Imaging findings showed emphysema in 7 cases. Four patients had type I, 1 patient type II, 4 type III and 4 type IV morphology. Median diameter for the type I, II, III and IV lesions was 20 mm (17-43), 20 mm, 60 mm (25-67) and 46 mm (37-77) respectively. Lesions were more frequent in the right upper (4/13) and lower lobe (4/13). FDG-PET-scan was available in 11 patients and showed high uptake in all patients who presented with a solid aspect of the associated tumour. Four patients (4/13) presented with stage IV at diagnosis. Other stages varied: IA (4/10), IB (1/10), IIA (1/10), IIIA (2/10) and IIIB (1/10). Adenocarcinoma was found in 11 patients (11/13) and squamous cell carcinoma in 2 (2/13). Molecular genotyping for EGFR, ALK and ROS-1 was available in 10 patients (10/13). None of the patients showed positivity for ALK-immunohistochemistry. A single patient showed an exon-18 mutation in the EGFR gene. One patient showed a translocation at the 6q22 breakpoint of the ROS-1 gene. In one patient, a p.Gly469Ala B-RAF mutation was present. Two patients showed a mutation in the exon 2 of the KRAS gene (exon2 c/35G>C;p.Gly 12Ala and c/35G>T;p.Gly 12Val).
Conclusion:
In this series, 5 out of 10 patients with a “lung cancer associated with cystic airspaces” showed a molecular alteration. This suggests that targeted molecular profiling is mandatory in this subgroup. Larger series are needed to confirm these findings.
