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P. Dumont
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OA11 - Angiogenesis in Advanced Lung Cancer (ID 387)
- Event: WCLC 2016
- Type: Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:L.M. Montuenga, J. Heymach
- Coordinates: 12/06/2016, 11:00 - 12:30, Stolz 2
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OA11.01 - Prolonged OS of Patients Exposed to Weekly Paclitaxel and Bevacizumab: Impact of the Cross-Over in the IFCT-1103 ULTIMATE Study (ID 4988)
11:00 - 11:10 | Author(s): P. Dumont
- Abstract
- Presentation
Background:
Overall survival (OS) is considered as the gold standard for evaluating efficacy of antineoplastic treatments, including chemotherapy and targeted therapies. In randomized trials, allowing patients to cross-over to the other arm usually prevents demonstration of a survival benefit. However, it may provide important information with clinical relevance.
Methods:
The phase III IFCT-1503 ULTIMATE study compared weekly paclitaxel and bevacizumab (wPB) vs. docetaxel (DOC) as second- or third-line therapy in non-squamous NSCLC. At progression, patients were allowed to cross over to the other arm. Date of progression was collected for patients who crossed over to the other arm and for those who did not cross over but received a post-discontinuation treatment within 60 days following progression. Post-discontinuation progression-free survival (PFS2) and OS2 were calculated from day 1 of post-discontinuation treatment.
Results:
The study met its primary endpoint, PFS, which was significantly improved in the wPB arm (medians 5.4 vs. 3.9 mo, hazard ratio (HR) 0.62, p=0.006). No overall survival was observed (medians 9.9 vs. 11.4 mo, HR 1.18, p=0.4). Out of patients treated with DOC (n=55), those who crossed over to wPB (n=21, 38.2%) had a median PFS2 of 4.9 mo [3.1-6.2] and a median OS2 of 12.5 mo (7.0-NR), whereas those who did not cross over but received a post-discontinuation treatment (n=13, 23.7%) had a median PFS2 of 1.7 mo [1.1-2.2] and a median OS2 of 4.1 mo [2.1-5.9]. Out of patients treated with wPB (n=111), median PFS2 was 1.9 mo [1.2-2.2] for those who crossed over to DOC (n=9, 8.3%) and median PFS2 and OS2 were 1.9 mo [1.7-2.6] and 5.0 m [3.4-9.0] for those who did not cross over but received a post-discontinuation treatment (n=57, 52.3%).
Conclusion:
Allowing patients to cross over to the other arm demonstrated benefit of wPB following progression on docetaxel and explains the absence of OS benefit.
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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: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.01-038 - Prognosis Value of Body Mass Index (BMI) and Weight Loss at Diagnosis in Primary Lung Cancer: Results of KBP-2010-CPHG Study (ID 4373)
14:30 - 14:30 | Author(s): P. Dumont
- Abstract
Background:
We studied the relationship between 1-year mortality and weight at diagnostic in 6,965 adult patients followed for primary lung cancer in 104 general hospitals.
Methods:
Patients were classified into 5 groups: Group 1, underweight with recent weight loss; Group 2, underweight without recent weight loss; Group 3, normal weight; Group 4, overweight; Group 5, obese. Kaplan-Meier method (1-year mortality) and Cox multivariate analysis (independent risk-factors) were used.
Results:
Respectively, 11%, 4%, 45%, 29%, and 12% of patients belonged to Groups 1, 2, 3, 4, and 5. One-year survival was lower in Group 1 (27% [24%-30%]) and higher in Group 4 (50% [48%-52%]) or 5 (53% [50%-57%]) than in Group 2 (47% [41%-53%]) or 3 (43% [42%-45%]) (Fig. 1). As compared with normal weight, overweight was an independent protective factor. Independent protective/risk factors are presented in Table 1. Interaction analyses showed that overweight was a significant independent protective factor for stage IIIA and IIIB cancer (HR=0.77 [0.6-0.99], p=0.038; HR=0.75 [0.59-0.97], p=0.029, respectively). Figure 1Variable HR 95%CI P BMI (group) 3 1 1 1.06 0.96-1.17 0.26 2 1.03 0.85-1.23 0.789 4 0.92 0.85-0.99 0.036 5 0.9 0.81-1.01 0.061 Age (years) <=40 1 41-50 1.07 0.74-1.54 0.714 51-60 1.02 0.72-1.46 0.899 61-70 1.05 0.74-1.49 0.796 71-80 1.11 0.78-1.59 0.553 >80 1.54 1.07-2.22 0.02 Sex Men 1 Women 0.81 0.74-0.88 <0.001 Smoking Never-smoker 1 Former-smoker 1.19 1.06-1.35 0.004 Current-smoker 1.27 1.13-1.44 <0.001 PS PS0 1 PS1 1.58 1.45-1.73 <0.001 PS2 2.66 2.4-2.95 <0.001 PS3 5.6 4.95-6.34 <0.001 PS4 10.61 8.62-13.05 <0.001 Stage <=IIB 1 IIIA 1.89 1.61-2.21 <0.001 IIIB 3 2.56-3.52 <0.001 IV 4.71 4.13-5.38 <0.001
Conclusion:
In 2010, in France, in real life conditions, 1-year survival was low in lung cancer patients with low BMI at diagnosis and recent weight loss. Overweight appeared to be a protective factor in particular for stage IIIA and IIIB cancers.