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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
P1.01-063 - Are the Real World Patients with Advanced Non-Small Cell Lung Cancer Represented in Phase III Immunotherapy Trials? (ID 9801)
09:30 - 16:00 | Author(s): G. Geib
Several randomized phase III trials with immune checkpoints inhibitors have accrued patients with metastatic non-small cell lung cancer (NSCLC). These trials employed strict patient selection criteria, and it is currently unknown how it represents the ‘real-world’ population.
From January 2011 to December 2016, all patients with metastatic NSCLC referred for first oncological evaluation at two University Hospitals in South of Brazil were identified by electronic database and included in the analysis. Twelve pre-defined eligibility criteria, all used in the recent first line phase III immunotherapy trial, were analyzed. OS and PFS were estimated by Kaplan-Meier curves. Multivariate analysis was performed to identify factors associated with survival. Statistical analysis was performed with SPSS 22.0.
Three hundred and nine patients were collected for this analysis. Patient characteristics revealed a mean age of 63.73 ± 09.47 years, 56% male and 65% had adenocarcinoma. One hundred ninety-seven (64%) patients did not meet one or more eligible criteria at first evaluation. ECOG performance status ≥2 (118 patients) and active brain metastasis (69 patients) accounted alone for 79.7% of non-eligibility cases. One hundred (50.76%), 53 (26.9%), 30 (15.22%) and 14 (7.1%) had 1, 2, 3 or 4 non-eligible criteria respectively. The median survival after the diagnosis of metastatic disease was 6.34 (95% IC, 5.59 to 7.08) months in the non-eligible group and 11.07 (95% IC, 8.65 to 13.48; p<0.001) in the eligible group. The hazard ratio of 1.90 (95% IC, 1.46 to 2.47) to mortality in the non-eligible group should reflect the worse baseline prognostic features in this group.
To our knowledge, this is the first report of metastatic NSCLC patients analyzed regarding the eligible criteria of the phase III trials. It is clear that clinical trials do not represent the “real world” population and its outcomes have an important selection bias. Phase III clinical trials eligibility criteria should be reviewed to better represent the NSCLC population.
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