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B. Goulart
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P1.03 - Poster Session with Presenters Present (ID 455)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.03-036 - Adherence to Eligibility Criteria for Low-Dose CT Screening in an Academic Center (ID 4957)
14:30 - 14:30 | Author(s): B. Goulart
- Abstract
Background:
The United States Preventive Services Task Force (USPSTF), Centers for Medicare and Medicaid Services (CMS), and the National Comprehensive Cancer Network (NCCN) recommend low dose computed tomography (LDCT) lung cancer screening for high risk patients, defined as those between age 55-77 (CMS) or 55-80 (USPSTF), with ≥30 pack-year smoking history who currently smoke or quit within the past 15 years. The NCCN guidelines also recommend screening for patients over 50 years with ≥20 pack-year smoking history and at least one additional lung cancer risk factor. To better understand community practices, we describe adherence to screening eligibility criteria for the population screened at the Seattle Cancer Care Alliance (SCCA).
Methods:
The SCCA developed a multidisciplinary LDCT screening program that executes LDCT screening orders when patients’ regional primary care providers deem them eligible for screening, and provides follow-up evaluations based on screening results. From a prospective registry study of patients screened at the SCCA, we collected baseline sociodemographic, smoking history, and clinical data to retroactively assess patients’ screening eligibility based on USPSTF, CMS, and NCCN criteria, respectively. We define adherence as the proportion of patients meeting at least 1 set of guidelines criteria for screening and used univariate logistic regression to identify potential sociodemographic predictors of adherence, excluding age and smoking history.
Results:
Of 252 patients screened between 5/8/2012 and 8/19/2015, 111 (44%) consented to participate in the study. Median age was 63, 67% were male, 89% were white, 99% were insured, median household income was $75,000, 56% were current smokers, and median cigarette use was 36 pack-years. Of 106 patients with complete eligibility data, 61 (58%), 60 (57%), and 60 (57%) met the USPSTF, CMS, and NCCN screening criteria, respectively. Seventy-nine (75%) patients met eligibility criteria for at least one guideline. Of the 27 patients ineligible by any guidelines, 17 (63%) had <20 pack-years smoking history and 5 (19%) were under age 50. White patients were more likely to meet eligibility for at least one guideline (Odds Ratio= 7.3; 95% CI = 1.9-27.8).
Conclusion:
In this single-center registry study, 25% of patients did not meet screening eligibility criteria when primary care providers were responsible for identifying screening candidates. In response to these results, the program employed a coordinator to pro-actively review screening orders to confirm guideline compliance. An opportunity exists to prioritize LDCT screening to high risk patients through patient counseling, provider education and pro-active review of screening CT orders.
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-061 - A Phase II Study of Nab-Paclitaxel (Nab-P) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR Mutations (ID 4337)
14:30 - 14:30 | Author(s): B. Goulart
- Abstract
Background:
Patients with NSCLC harboring a sensitizing EGFR mutation have effective targeted therapy options initially but most patients eventually need to receive cytotoxic chemotherapy. We previously reported our institutional experience with taxane based therapy in this patient population and this provided the rationale for the currently ongoing phase II study (NCT01620190).
Methods:
Patients with EGFR mutation positive NSCLC who were refractory to tyrosine kinase inhibitor (TKI) therapy and chemotherapy naive received nab-P at 125mg/m2 on days 1, 8 and 15 in a 28-day cycle. The primary endpoint was response rate which was assessed using RECIST v1.1.
Results:
As of data cut-off of March 14 2016, 22 patients were enrolled and received therapy (19 evaluable, 2 not yet evaluable, 1 patient excluded due to not being eligible). Median age was 65 (range 54-77), 75% of patients were women, 40% did not have a smoking history and majority (65%) of patients had an ECOG performance status of 1. Tumor histology consisted mostly of adenocarcinoma (90%); 55% of patients harbored exon 21 L858R and 45% harbored exon deletion 19 mutations. Confirmed partial response was documented in 8 of 19 (42%) patients with a median duration of response of 4.3 months (range 3.3-9.5) and stable disease was documented in 4 of 19 (21%) patients with a disease control rate of 63%. Median progression free survival was 4.4 months (95% CI 1.8-5.5 months). The most common grade 3 treatment-related adverse events (AE) were peripheral neuropathy (10%), fatigue (10%) and neutropenia (15%). There were no treatment-related grade 4 AEs.
Conclusion:
Single agent nab-P has promising activity in patients with EGFR mutation positive NSCLC. The AE profile was consistent with previously reported AEs in the literature. Accrual of patients continues and updated data will be presented Figure 1
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P3.03 - Poster Session with Presenters Present (ID 473)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.03-063 - Phase 1/2 Trial of WT1 TCR-Transduced Central Memory and Naïve CD8+T Cells for Patients with Mesothelioma and Non-Small Cell Lung Cancer (ID 5740)
14:30 - 14:30 | Author(s): B. Goulart
- Abstract
Background:
The Wilms’ tumor gene (WT1) is important in cell survival and overexpressed in mesothelioma and lung cancer, providing rationale for WT1-targeted strategies.
Methods:
Patients with metastatic/unresectable, previously-treated mesothelioma or non-small cell lung cancer, HLA-A0201+, receive two infusions of WT1 TCR-transduced CD8+T cells at a central memory(T~CM~): naïve(T~N~) 1:1 ratio comprising each infusion. The first infusion is 1x10[9]/m[2 ]cells, to assess tolerability. The second infusion is given two weeks later at 1x10[10]/m[2], preceded by cyclophosphamide 300mg/m2/day x 2 days, and followed by interleukin-2 250,000 IU/m2 subcutaneously b.i.d x 14 days.
Results:
Figure 1Figure 2Six pleural mesothelioma patients have been treated to date. Four patients are evaluable; two are in progress. All patients experienced grade 1-3 cytokine release syndrome and grade 3/4 lymphopenia, which resolved. At 12 weeks, there was 1 partial response (Fig.1), 1 stable disease, and 2 with progressive disease. WT1+T cells were detectable in the peripheral blood of all 4 patients post-infusions, however only the partial responder had long-term T cell persistence to day 70 and ongoing (Fig.2). Evaluation of phenotypic/functional T cell markers and the relative persistence of T~CM ~:T~N ~subpopulations in peripheral blood is underway.
Conclusion:
Targeting WT1 with TCR-engineered CD8+T cells demonstrates early evidence of tolerability and anti-tumor activity in mesothelioma.
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P3.07 - Poster Session with Presenters Present (ID 493)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Regional Aspects/Health Policy/Public Health
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.07-013 - Determining EGFR and ALK Status in a Population-Based Cancer Registry: A Natural Language Processing Validation Study (ID 5061)
14:30 - 14:30 | Author(s): B. Goulart
- Abstract
Background:
Population-based data on Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) gene test status can inform about real-world molecular testing practices and their impact on treatment decisions and outcomes. Yet no efficient methods are available for population-based cancer registries to ascertain molecular testing data of non-squamous non-small cell lung cancer (NS-NSCLC) from electronic pathology (e-path) records. We sought to validate natural language processing (NLP) systems to accurately ascertain EGFR and ALK test use and results in patients with stage IV NS-NSCLC included in the Fred Hutchinson Cancer Research Center’s Cancer Surveillance System (CSS), a part of the U.S. Surveillance, Epidemiology, and End Results (SEER) program.
Methods:
We identified 4,279 e-path reports available in the CSS corresponding to 1,634 patients diagnosed with stage IV NS-NSCLC between 09/1/2011 and 12/31/2013. Using a random sample of 426 (10%) reports, we developed and trained an NLP system to detect EGFR mutation and ALK gene rearrangement test use (test result reported vs. not reported), and test results (positive vs. negative among reported tests). Two oncologists reviewed all e-path reports and resolved discrepancies by consensus to determine the gold-standard classification of test use and results. We report preliminary estimates of the NLP sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for EGFR and ALK test use based on a second random sample of 426 reports (testing subsample).
Results:
Of 1,634 patients, mean age was 68 years, 815 (50%) were male, 1424 (87%) were white, and 1,347 (82%) had adenocarcinoma histology. Based on the gold-standard classification, in the training subsample, 126 (30%) and 103 (24%) reports contained information about EGFR and ALK test results, respectively. In the testing subsample, 139 (32%) and 115 (27%) had information about EGFR and ALK test results, respectively. In the testing subsample, the NLP system correctly detected 135 reports that contained EGFR test results and 285 that did not (sensitivity=97%; specificity=99%; PPV=99%; NPV=99%), respectively. The NLP system correctly detected 113 reports that contained ALK test results and 307 that did not (sensitivity=98%; specificity=99%; PPV=97%; NPV=99%), respectively.
Conclusion:
NLP is likely a valid method for capture of EGFR and ALK test use from e-path reports. Ongoing analyses include the NLP validity for ascertainment of test results among reported EGFR and ALK tests in this initial dataset and in a separate validation dataset of 3,427 pathology reports, all of which will be reported subsequently.
