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G.R. Oxnard
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OA04 - Epidemiology and Prevention of Lung Cancer (ID 370)
- Event: WCLC 2016
- Type: Oral Session
- Track: Epidemiology/Tobacco Control and Cessation/Prevention
- Presentations: 1
- Moderators:L. Petruželka, S. Shastri
- Coordinates: 12/05/2016, 11:00 - 12:30, Schubert 4
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OA04.07 - Clinical Characteristics of Lung Adenocarcinoma in the Young: Results from the Genomics of Young Lung Cancer Study (ID 5578)
12:05 - 12:15 | Author(s): G.R. Oxnard
- Abstract
- Presentation
Background:
Background: Lung cancer is increasingly recognized as a heterogeneous disease comprised of genomically defined subtypes with distinct targetable genomic alterations. However, it is unknown whether established lung cancer risk factors differ between these genomically distinct subtypes. In this study of the genomics of young lung cancer (GoYLC), we present preliminary results of lifestyle risk factors by specific genomic alteration to better characterize lung cancer in the young.
Methods:
Methods: Beginning in July of 2014, patients diagnosed with a bronchogenic lung cancer under the age of 40 were recruited to the GoYLC study. Informed consent was obtained in-person and virtually (online), allowing patients to participate globally, regardless of proximity to study sites (https://www.openmednet.org/site/alcmi-goyl). To date, this study has accrued a total of 101 cases, of which 85 are adenocarcinoma (AC). Stage 4 AC is the focus of this analysis.
Results:
Results: Among the 63 stage 4 AC cases, the most common genomic alterations were ALK rearrangements (n=28; 44% of stage 4 AC cases) and EGFR mutations (n=17; 27%) while the other genomic alterations (n=18; 29%) include ROS1, BRCA2, HER2, P53, RET and ATM. The prevalence of active smoking and/or exposure to passive smoking was highest among those with ALK (64%), intermediate for those with EGFR (47%) and lowest for those with other genomic alterations (39%). However, the prevalence of only active smoking was lowest among those with ALK (28%), followed by EGFR (35%) and highest for those with other genomic alterations (39%). The majority of patients with ALK rearrangements or EGFR mutations reported no family history of lung cancer (82% and 88%, respectively), compared with 67% among those with other genomic alterations.
Conclusion:
Conclusion: These preliminary results suggest that lifestyle characteristics and family history in young lung cancer patients may differ by genomic alteration. Passive smoke exposure was more prevalent among those with ALK rearrangements or EGFR mutations. Those with other genomic alterations, albeit, a heterogeneous group, were least likely to be exposed to passive smoking and more likely to be active smokers. We are continuing to enroll participants and are expanding the epidemiologic characterization to all study patients to evaluate if risk factors also differ by tumor stage and histology (Data to be presented). Importantly, this analysis lays the groundwork for the development of our more comprehensive epidemiology of young lung cancer study that may identify potential lifestyle and environmental risk factors related to specific genomic alterations.
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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-077 - Osimertinib Expanded Access Program for Previously Treated Patients With Advanced EGFR T790M Mutation-Positive NSCLC (ID 4923)
14:30 - 14:30 | Author(s): G.R. Oxnard
- Abstract
Background:
The US AZD9291 Expanded Access Program (EAP) was conducted to provide compassionate access to osimertinib for previously treated patients with advanced/metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
Methods:
Patients (≥18 years old) with EGFR T790M mutation-positive NSCLC and a WHO Performance Status of 0–2 who had received ≥1 prior lines of therapy that included an EGFR tyrosine kinase inhibitor (TKI) or progressed during EGFR TKI treatment, were eligible. Patients received osimertinib at 80mg oral, once-daily, until dose reduction, discontinuation or EAP completion following FDA approval (November 2015). Patient demographics, T790M testing, safety and tolerability including serious adverse events (SAEs) were collected. Patient response was collected at investigator discretion, but not mandated by the EAP protocol. For required T790M diagnostics, various testing methods were permitted.
Results:
Osimertinib was provided to 248 EGFR T790M mutation-positive patients through the EAP (May 2015 to November 2015). Of the 244 patients with reported T790M method data, the majority were enrolled based on samples from tissue (n=187) and blood (n=48), whereas others were based on pleural fluid (n=5) or urine (n=4). Use of noninvasive (ie, liquid biopsy) T790M testing varied across the 25 participating sites: 5 sites (20%) enrolled no patients using liquid biopsy, 2 (8%) enrolled all patients based on liquid biopsy, and 18 (72%) enrolled based on different methods. Median age was 65 years old (range, 31–91), 69% of patients were female, and 85% of patients received ≥2 prior cancer treatments. Prior erlotinib therapy was reported in 96% of patients. Starting daily dose of 80mg osimertinib was maintained throughout the study in 238 patients (96%) and reduced to 40mg in 10 patients because of AEs/intolerance. Once commercially available, most patients (n=205; 83%) continued on osimertinib, thus completing the EAP. Reasons for EAP withdrawal prior to conversion included disease progression (7%) or death (5%). A total of 19 (8%) deaths were reported during the EAP, mostly attributed to lung cancer/disease progression and/or respiratory complications (n=16; 84%). Five (2%) patients reported drug-related SAEs, including dyspnea, deep vein thrombosis, femur fracture, increased alanine aminotransferase, and pneumonitis.
Conclusion:
In a real-world setting, US AZD9291 EAP demonstrated that osimertinib was well tolerated in previously treated patients with EGFR T790M mutation-positive NSCLC, and most converted to commercial therapy following FDA approval. This EAP suggests early uptake of non-invasive T790M testing at some centers.
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P3.06 - Poster Session with Presenters Present (ID 492)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Trial Design/Statistics
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.06-008 - Employing Remote Web Consenting and Social Media to Facilitate Enrollment to an International Trial on Young Lung Cancer (ID 4180)
14:30 - 14:30 | Author(s): G.R. Oxnard
- Abstract
Background:
In 2014, the Addario Lung Cancer Medical Institute (ALCMI) launched a prospective study to characterize somatic and germline genomics of adolescents and young adult (AYA) patients under the hypothesis that lung cancer diagnosis at younger ages (<40) are more likely to have targetable genomic alterations. It is estimated that less than 2% of those newly diagnosed with lung cancer globally are AYA, thus presenting a striking recruitment challenge.
Methods:
The study workflow includes a dedicated website enabling e-consenting so patients can participate remotely from anywhere in the world, including the underserved, and employs social media to share our trial. We have an integrated data and bio repository that allows for seamless communication and completion of study activities including routing of blood and tumor specimens. ALCMI's "sister" foundation, the Bonnie J. Addario Lung Cancer Foundation, played a key role in educating patient and caregiver communities, including a social media campaign.
Results:
Accrual opened July 23, 2014. In the first 5 weeks of the study, 37 subjects consented versus the 5 projected. Of the 37 initially consented, 35 enrolled via the remote web-portal. As of June 15 2016, 104 subjects are enrolled (128 consented) in the study from 10 countries following a social media campaign of 89 discrete postings resulting in 21,062 active users out of 391,222 individual viewers and 675,680 impressions. Of the 104 subjects enrolled to date, 49% entered the study via the remote study portal with the balance recruited locally by participating ALCMI study sites. 45% of total accruals to date resulted from the education outreach by patient advocacy and patient to patient social networking.Figure 1
Conclusion:
This study clearly demonstrates the utility, speed and feasibility of remote, web-based screening and consenting platforms supported by patient-centric, advocate-driven social media efforts as novel approaches to "bringing research to the patient" for global clinical trials.
