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T. Berghmans
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MA03 - Epidemiology, Risk Factors and Screening (ID 374)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Epidemiology/Tobacco Control and Cessation/Prevention
- Presentations: 1
- Moderators:N. Bilir, H. Olschewski
- Coordinates: 12/05/2016, 14:20 - 15:50, Lehar 3-4
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MA03.07 - Discussant for MA03.05, MA03.06, MA03.07 (ID 7073)
14:20 - 15:50 | Author(s): T. Berghmans
- Abstract
- Presentation
Abstract not provided
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P1.07 - Poster Session with Presenters Present (ID 459)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.07-040 - Prognostic Factors in Extensive Disease (ED) Small Cell Lung Cancer (SCLC): An ELCWP Phase III Randomised Trial (ID 4738)
14:30 - 15:45 | Author(s): T. Berghmans
- Abstract
Background:
Main prognostic factors for survival in SCLC patients are performance status, disease extent, age or gender, as previously reported by the European Lung Cancer Working Party (ELCWP) (Paesmans et al, Eur Respir J 2011). Based on a previous meta-analysis (Mascaux et al, Lung Cancer 2000) showing a survival advantage for regimens including cisplatin (CDDP) or etoposide (VP16), the ELCWP designed a phase III trial to determine if addition of CDDP to VP16 would improve survival in comparison with VP16 combination without CDDP in a population of ED SCLC. The aim of this work was to search for prognostic factors for survival.
Methods:
Untreated patients with ED (limited (LD) not amenable to radiotherapy or stage IV disease) SCLC, Karnofsky performance status (PS) ≥60, adequate haematological, hepatic, renal and cardiac functions, were centrally randomised to receive either CDDP-VP16 (CE) or ifosfamide-VP16-epirubicin (IVE). According to statistical considerations, 315 deaths had to occur before analysis. Univariate and multivariate tests were performed for prognostic factors analyses.
Results:
346 eligible patients were randomised (176 in CE and 170 in IVE arms) between 2000 and 2013. At the time of analysis, 329 deaths occurred. No statistically significant imbalance was observed regarding age, gender, PS, disease extent (LD vs stage IV), neutrophil count and weight loss. No statistically significant difference was observed between CE and IVE groups according to main evaluation criteria: best response rate (60% vs 59%, p=0.88), progression-free survival (median 5.1 vs 5.3 months; p=1) and overall survival times with medians of 9.6 months and 10 months and 2-year rates of 5 % and 9 % (p=0.16), respectively. The following variables were statistically significantly associated with survival in univariate analysis: age (continuous evaluation) (HR=1.02, p=0.002), gender (male as reference) (HR=0.69, p=0.008), PS (PS ≤ 70 as reference) (HR=0.60, p=0.0001), weight loss (≤5% as reference) (HR=1.28, p=0.05) and neutrophil count (≤7500/mm3 as reference) (HR=1.46, p=0.003). In addition, variables with a p-value < 0.2 in univariate analysis were also included in the multivariate analysis: disease extent (LD as reference) (HR=1.38, p=0.10), WBC count (≤10000/mm3 as reference) (HR=1.23, p=0.08) and treatment arm (CE as reference) (HR=0.84, p=0.16). Two variables retained their statistical significance in multivariate analysis: gender (HR=0.69, 95% CI 049-0.97; p=0.03) and PS (HR=0.53, 95% CI 0.49-0.97; p<0.0001).
Conclusion:
Adding CDDP to VP16 failed improving survival in ED SCLC. In this population, gender and performance status confirmed their prognostic value for survival.
