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J. Cé Coelho
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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.01-043 - Molecular Testing for Non-Small Cell Lung Cancer in Latin American (ID 10391)
09:30 - 16:00 | Author(s): J. Cé Coelho
- Abstract
Background:
According to IALSC/CAP guidelines EGFR and ALK testing is recommended for all non-squamous advanced lung cancers. However, the real access to molecular test and treatment, especially in LATAN is unknown.
Method:
We conducted an online survey with medical oncologists from LATAN during May 2017. The survey has 20 questions about molecular test and target treatment, but also clinical practice in the management of advanced non-squamous NSCLC.
Result:
144 oncologists from 10 countries answer the survey, mostly of them (75%) from Brazil. Although 95% of the oncologists have access to EGFR mutation test and most of them can also test the ALK-fusion protein, only half of them test all patients. Usually these tests are supplied by the pharmaceutical industries (75% of EGFR and 78% of ALK). The mutation status are available in 2 weeks for the EGFR and in 3 weeks for the ALK. The main reason for not testing is lack of sufficient tissue (30% of oncologists), but also some difficulty in access and the long turn-around time where also an issue, 20% and 13% of the oncologist, respectively. Poor performance status and patient clinical characteristics were rarely considered a reason for not testing. Target therapy is available for mostly of the patients with private insurance, but only 50% in the public heath system have access to an anti-EGFR TKI and solely 20% can receive an anti-ALK TKI. New biopsies should be done in the progressive disease, but only 22% of the oncologists perform the procedure in more than 75% of their patient. Immunotherapy is a new treatment modality, especially in the develop countries, but it should be restricted as first line treatment to patients with high expression of PD-L1. In LATAN, immune checkpoints blockage is almost limited to the patients with private insurance (85%), being rare in the public heath system (15%). 83% of the oncologist considered to test the PD-L1 expression only after the results of EGFR /ALK are available.
Conclusion:
There are difficulties in the implementation of IALSC guidelines in LATAN. Mostly of the patients have access to EGFR mutation test, however the treatment is not available to everyone. It is clear the importance of the pharmaceutical industries in providing the molecular test by their voucher programs. The most important difficulty point out by the oncologists is the lack of tissue, but simple barriers as long time to get the results and access to the test should also be managed.
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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): J. Cé Coelho
- Abstract
Background:
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.
Method:
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.
Result:
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.
Conclusion:
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.
