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J. Van Meerbeeck
Moderator of
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Malignant pleural mesothelioma (ID 28)
- Event: ELCC 2017
- Type: Educational session
- Track:
- Presentations: 4
- Moderators:J. Van Meerbeeck, D. Waller
- Coordinates: 5/07/2017, 14:45 - 16:15, Room C
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Combined modality therapy (ID 115)
15:45 - 16:05 | Author(s): J. Van Meerbeeck
- Abstract
Abstract not provided
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Genetics of mesothelioma (ID 112)
14:45 - 15:05 | Author(s): M. Carbone
- Abstract
- Presentation
Abstract not provided
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Prognostic indices (ID 113)
15:05 - 15:25 | Author(s): A. Curioni-Fontecedro
- Abstract
- Presentation
Abstract not provided
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Surgical approach: P/D versus EPP (ID 114)
15:25 - 15:45 | Author(s): D. Waller
- Abstract
- Presentation
Abstract not provided
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Author of
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Malignant pleural mesothelioma (ID 28)
- Event: ELCC 2017
- Type: Educational session
- Track:
- Presentations: 1
- Moderators:J. Van Meerbeeck, D. Waller
- Coordinates: 5/07/2017, 14:45 - 16:15, Room C
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Combined modality therapy (ID 115)
15:45 - 16:05 | Author(s): J. Van Meerbeeck
- Abstract
Abstract not provided
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Poster Display Session (ID 63)
- Event: ELCC 2017
- Type: Poster Display Session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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170TiP - LUME-Meso: Randomised phase II/III study of nintedanib (N) + pemetrexed/cisplatin (PEM/CIS) followed by maintenance N or placebo (P) in chemo-naïve patients with malignant pleural mesothelioma (MPM) (ID 274)
12:30 - 12:30 | Author(s): J. Van Meerbeeck
- Abstract
Background:
PEM/CIS is the standard first-line treatment for MPM, with median overall survival (OS) of ∼1 year. N 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, as well as Src and Abl kinases. VEGF and PDGF overexpression are associated with poor prognosis in MPM, and N has demonstrated efficacy in preclinical MPM models. We performed a randomised Phase II trial of N or P + PEM/CIS in MPM followed by maintenance N or P; progression-free survival (PFS) was the primary endpoint. An internal Data Monitoring Committee recommended the study be expanded to include a confirmatory Phase III part. With regulatory authority guidance, the Phase II data were unblinded, demonstrating a PFS benefit with N (hazard ratio 0.56, 95% confidence interval 0.34–0.91; p = 0.017); these data assisted in planning the Phase III part including sample size estimation, and N was granted U.S. Food & Drug Administration orphan drug designation for the treatment of MPM in December 2016. The Phase III part (NCT01907100) is recruiting.
Trial design:
For Phase III, 450 chemo-naïve patients worldwide (>100 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 6 21-day cycles of PEM (500 mg/m[2])/CIS (75 mg/m[2]) on Day 1 plus N or P (200 mg twice daily, Days 2–21), followed by N or P monotherapy until disease progression or undue toxicity. The primary endpoint is PFS; the key secondary endpoint is 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/severity of adverse events and health-related quality of life will also be assessed. An exploratory analysis of predictive/prognostic biomarkers is planned.
Clinical trial identification:
NCT01907100
Legal entity responsible for the study:
Boehringer Ingelheim Pharma GmbH & Co. KG
Funding:
Boehringer Ingelheim Pharma GmbH & Co. KG
Disclosure:
S. Popat: Acknowledges NHS funding to the NIHR Biomedical Research Centre at The Royal Marsden and the ICR, and is consultant to and has received honoraria from Boehringer Ingelheim and Eli Lilly. A. Nowak: Acknowledges funding from the National Health and Medical Research Council of Australia to the National Centre for Asbestos Related Diseases. A. Tsao: Received honoraria from Eli Lilly, Roche, Novartis, AstraZeneca, Ariad, Boehringer Ingelheim, Genentech, BMS, Seattle Genetics, and has received research funding from Eli Lilly, AstraZeneca, Millennium, BMS, Seattle Genetics, and Polaris. J. Van Meerbeeck: Received institutional funding through research grants from the Belgian Foundation against Cancer and Flemish Kom op tegen Kanker Fund. N. Vogelzang: Received an honorarium from Boehringer lngelheim for services on the steering committee of this study. D. Velema: Employee of Boehringer Ingelheim. N. Morsli: Employee of Boehringer Ingelheim. G. Scagliotti: Consultant for Eli Lilly and has received honoraria from Eli Lilly, Roche, Pfizer, Novartis, AstraZeneca, and Clovis Oncology. All other authors have declared no conflicts of interest.
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SCLC and early stage NSCLC (ID 62)
- Event: ELCC 2017
- Type: Proffered Paper session
- Track:
- Presentations: 1
- Moderators:S. Popat, P. Van Schil
- Coordinates: 5/07/2017, 09:00 - 10:30, Room C
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LBA2_PR - Use of G-CSF and prophylactic antibiotics with concurrent chemo-radiotherapy in limited-stage small cell lung cancer: Results from the Phase III CONVERT trial (ID 501)
10:03 - 10:15 | Author(s): J. Van Meerbeeck
- Abstract
- Presentation
Background:
Concurrent chemo-radiotherapy (CTRT) is the optimal treatment for limited-stage small cell lung cancer. The use of granulocyte colony stimulating-factor (G-CSF) in this context is controversial and its routine use is not recommended after a report of higher toxicity but the safety data is scarce. The use of prophylactic antibiotics is also not standardised.
Methods:
In a phase 3 trial, 547 patients (pts) were randomised between once-daily RT (66Gy 33 fractions) or twice-daily (45Gy 30 fractions) with chemotherapy (cisplatin/etoposide). The use of prophylactic G-CSF and antibiotics was permitted.
Results:
33% of pts received at least 1 cycle of prophylactic G-CSF and 41% received prophylactic and/or therapeutic G-CSF. Its use increased from 11% at cycle 1 to 27% at cycle 4. Prophylactic antibiotics were used in 48% of pts but its use decreased from 41% to 20%. The use of antibiotics and/or G-CSF was similar in both arms. The incidence of grade 3/4 thrombocytopenia was higher in pts with G-CSF (29.4% vs. 13%; p
Conclusions:
The use of G-CSF with modern radiotherapy techniques during CTRT does not result in an increased risk of severe acute esophagitis or pneumonitis. Despite an increased incidence of severe thrombocytopenia and anaemia, the use of G-CSF was not detrimental in PFS or OS.
Clinical trial identification:
ISRCTN91927162 / NCT00433563
Legal entity responsible for the study:
The Christie NHS Foundation Trust
Funding:
The Christie NHS FT, Cancer Research UK, EORTC, GECP, GFPC, IFCT.
Disclosure:
All authors have declared no conflicts of interest.
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