Virtual Library
Start Your Search
L. Lacerda Landry
Author of
-
+
P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
-
+
P2.04-014 - Computing the Impact of Immunotherapy on NSCLC Landscape: The Advanced Non-Small Cell Lung Cancer Holistic Registry (ANCHoR) (ID 9505)
09:30 - 09:30 | Author(s): L. Lacerda Landry
- Abstract
Background:
Anti-PD-1 and anti-PD-L1 antibodies including pembrolizumab, nivolumab and atezolizumab have entered clinical practice in the management of metastatic NSCLC as monotherapy and immunotherapy-based combinations. We have established a real-world Advanced Non-Small Cell Lung Cancer Holistic Registry (ANCHoR) to understand how the emergence of immunotherapy impacts choice of treatment, clinical outcomes, and patient reported outcomes (PROs) in the different histo-molecular subtypes of metastatic NSCLC. The objectives of ANCHoR are to determine the treatment choice and treatment sequence by PD-L1 status in the various histo-molecular categories of NSCLC and to understand the impact of such treatment choice on response rates, progression-free survival (PFS), and overall survival (OS). Additionally we will measure the impact the treatment choices have on the PROs by utilizing the validated instruments, EuroQol-5D version 5L (EQ-5D-5L) and MD Anderson Symptom Inventory module specific to lung cancer (MDASI-LC).
Method:
The study will enroll patients with metastatic NSCLC diagnoses who are treated at MD Anderson Cancer Center (MDA) between January 1, 2017 and December 31, 2020. The study period will end on June 30, 2021 to allow a minimum of six months of follow-up. Trained abstractors will collect demographic, diagnostic, clinical, molecular (biomarker and PD-L1), treatment (regimens utilized in sequence and reason for discontinuation), response and survival (including PFS and OS), health care resource utilization and PRO (EQ-5D-5L and MDASI-LC) information that will be integrated in a comprehensive database. Information from the MDA electronic medical record will be extracted and populated in the GEnomic Marker-guided therapy INItiative (GEMINI) database and the PRO database which are linked. EQ-5D-5L followed by MDASI-LC will be completed directly by the patients and these will be automatically populated in the web-based PRO database at treatment initiation, at the time of response assessments and when switching lines of therapy.
Result:
Interim analysis will be conducted every six months to measure the impact of immunotherapy over time. Study results will be presented using descriptive statistics for continuous variables (mean, standard deviation, median, and interquartile range), categorical variables (frequency and proportions), and time-to-event variables (Kaplan-Meier). Regression models will be used for estimating the relationship between dependent variable and one or more predictors. Cox proportional hazards model will be used to estimate hazard ratios for time-to-event outcomes.
Conclusion:
The ANCHoR study is the first comprehensive registry of its kind that will enable the quantification of the changing impact of immunotherapy on the real-world NSCLC treatment landscape.
-
+
P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
-
+
P2.07-062a - Single Institutional Experience of the Use of PD-1 Inhibitors to Non-Small Cell Lung Cancer Patients with Preexisting Autoimmune Diseases (ID 10307)
09:30 - 09:30 | Author(s): L. Lacerda Landry
- Abstract
Background:
Safety of PD-1/PD-L1 pathway inhibitors in patients with preexisting autoimmune disease is not well defined since these patients are generally excluded from immunotherapy trials. In this study we aimed to provide our institutional experience for the safety of PD-1 inhibitors in NSCLC patients with a history of autoimmune diseases.
Method:
In a retrospective study we collected genomic, demographic, clinical and pathologic data from patients with a history of autoimmune disease who received PD-1 inhibitors for their stage IV NSCLC as standard of care at MD Anderson Cancer Center (MDACC). Qualifying autoimmune diseases included autoimmune thyroiditis, rheumatologic, neurologic and dermatologic autoimmune conditions.
Result:
Between March 2016 and February 2017, 975 NSCLC patients were treated with PD-1 inhibitors, as standard of care at MDACC and 14 of those patients had preexisting autoimmune disease (5 rheumatoid arthritis, 3 seronegative arthritis, 3 psoriasis, 2 hashimoto thyroiditis, and 1 polymyalgia rheumatica). Three patients experienced flare of the autoimmune disease (2 psoriasis, and 1 rheumatoid arthritis) while on therapy and two of those patients were symptomatic from their preexisting autoimmune disease prior to the treatment. Median duration of exposure to therapy prior to flare was 21.4 weeks (range 7-48 weeks). These patients did not require treatment break or steroid use for autoimmune disease flare. 35% (5/14) of patients developed at least one immune related adverse effect (irAEs, one grade 2 and four grade 3) unrelated to the underlying autoimmune disease. There were no grade 4-5 irAEs observed. Updated results from larger patient cohort will be reported at the conference.
Conclusion:
In our single center experience, symptomatic flare of underlying autoimmune diseases was uncommon. However, patients with history of immune disease may be at higher risks for immune related toxicities during therapy with PD-1 pathway inhibitor. Further studies are needed to identify the safety profile of the PD-1 directed therapies in patient subsets with preexisting autoimmune diseases.
