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Alex A Adjei
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IASLC General Assembly (ID 364)
- Event: WCLC 2019
- Type: General Assembly
- Track:
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/10/2019, 08:00 - 08:45, Tokyo (1982)
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GA01.01 - Welcome (Now Available) (ID 3909)
08:00 - 08:45 | Presenting Author(s): Alex A Adjei
- Abstract
- Presentation
Abstract not provided
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IBS09 - Challenges in Translating Small Cell and Neuroendocrine Tumor Research into Clinical Practice (Ticketed Session) (ID 40)
- Event: WCLC 2019
- Type: Interactive Breakfast Session
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 07:00 - 08:00, Seoul (2007)
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IBS09.01 - Challenges in Translating Small Cell and Neuroendocrine Tumor Research into Clinical Practice (Now Available) (ID 3341)
07:00 - 08:00 | Presenting Author(s): Alex A Adjei
- Abstract
- Presentation
Abstract
Challenges in Translating Small Cell and Neuroendocrine Tumor Research into Clinical Practice
Alex A. Adjei, MD;PhD
Mayo Clinic, Rochester, MN, USA
According to World Health Organization (WHO) classification of lung tumors in 2015, small cell lung cancer (SCLC) is one of four lung tumors of neuroendocrine origin. Key morphological features of SCLC are dense sheets of small cells, scant cytoplasm, ill-defined cell borders and distinctive nuclear quality. These tumors are typically high grade, manifesting a high proliferation rate, apoptosis and necrosis. Ki-67 is typically 50-100%, and there is neuroendocrine differentiation documented by expression of synaptophysin, chromogranin A, NCAM1 and insulinoma-associated protein 1 (INSM1). These tumors are very aggressive with high metastatic potential. While they are very responsive to initial therapy, there is invariably relapse and 5 year survival overall is less than 10%. A number of agents thought to be very promising, including the antibody drug conjugate Rova-T, and PARP inhibitors have yielded negative results. In this presentation we will review some of these studies to discern any lessons that can be learned from the failed studies. We will discuss promising new agents such as lurbinectedin, and EZH2 inhibitors and DNA damage response modifiers.
A number of molecular vulnerabilities of SCLC have been identified. These include
loss of TP53 and RB function, expression of the ASCL1, MYC, and Notch signaling pathways and unique neuronal characteristics. In addition, SCLC subtypes defined by differential expression of four key transcription regulators, the achaete-scute homologue 1 (ASCL1), neurogenic differentiation factor 1 (NeuroD1), yes-associated protein 1 (YAP1) and POU class 2 homeobox 3 (POU2F3), have been described. These new insights will be discussed in this presentation. The most significant advancements in the last year shown in Figure 1 below will be described
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IBS22 - JTO Workshop: How to Get Your Manuscript Published (Ticketed Session) (ID 53)
- Event: WCLC 2019
- Type: Interactive Breakfast Session
- Track: Young Investigators
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/10/2019, 07:00 - 08:00, Tokyo (1982)
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IBS22.01 - JTO Workshop: How to Get Your Manuscript Published (Now Available) (ID 3382)
07:00 - 08:00 | Presenting Author(s): Alex A Adjei
- Abstract
- Presentation
Abstract not provided
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MA06 - Challenges in the Treatment of Early Stage NSCLC (ID 124)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Now Available
- Moderators:Florentino Hernando-Trancho, Ayten Kayi Cangir
- Coordinates: 9/08/2019, 13:30 - 15:00, Colorado Springs (1994)
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MA06.07 - E1505: Adjuvant Chemotherapy +/- Bevacizumab for Early Stage NSCLC: Updated Chemotherapy Subset Analysis (Now Available) (ID 2885)
13:30 - 15:00 | Author(s): Alex A Adjei
- Abstract
- Presentation
Background
Adjuvant chemotherapy (chemo) for resected early stage NSCLC provides modest survival benefit with limited comparison data between regimens. From this trial we previously reported that adding bevacizumab (B) to adjuvant chemo failed to improve either disease free survival (DFS) or overall survival (OS). Here we update outcomes by chemotherapy regimen with an additional 30 months of follow-up.
Method
Enrolled patients with resected early stage NSCLC, stratified by stage, histology, sex, and chemo option, were randomized 1:1 to chemo alone or with B (15 mg/kg every 3 weeks for up to 1 year). Chemo consisted of a planned 4 cycles of every 3 week cisplatin with either vinorelbine (V), docetaxel (D), gemcitabine (G) or pemetrexed (P).
Result
From July 2007 to September 2013, 1501 patients were enrolled with this distribution of chemo: V 25.0%, D 22.9%, G 18.9% and P 33.2%. P was added in 2009 and restricted to non-squamous (NSq) pts. Chemo regimen was chosen (not randomized). Arms were well balanced for known prognostic factors; 28% had Sq histology. Median f/up per chemo group is: V 83.5 months(m); D 89.9m; G 87.8m; P 71.9m. In pooled analysis DFS differed by histology ranging from 29.9m(G)-43.5m(V) for NSq and 59.4m(V)-77.3m(G) for Sq. OS also differed by histology ranging from 80m(D)-98.8m(P) for NSq and 98m(G)-119m(V) for Sq. A non-significant decline in both DFS and OS was seen when B was added to D or V regimens, regardless of histology. Conversely, the addition of B to P improved both DFS (HR 0.74, p= .00994) and OS (HR 0.65, p= .00368). We thus compared outcomes across non-B regimens and though numerical differences were seen in median DFS and OS, these failed to reach statistical significance. Toxicity details were presented previously.
Conclusion
B did not improve OS when added to adjuvant chemo for patients with surgically resected early stage NSCLC, though variable DFS and OS outcomes by chemotherapy regimen have emerged with longer-term follow-up. These include a significant positive improvement in DFS and OS with B combined with P and trends of worse outcomes when B was added to other regimens. Ongoing molecular analysis of samples will hopefully elucidate the etiology of these differences.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MTE01 - Meet the JTO Editor (ID 385)
- Event: WCLC 2019
- Type: Educational Session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 14:00 - 15:30, Amsterdam (2011)
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MTE01.01 - Meet the Editor (ID 4055)
14:00 - 15:30 | Author(s): Alex A Adjei
- Abstract
Abstract not provided
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P1.12 - Small Cell Lung Cancer/NET (ID 179)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.12-11 - Exploring Sex Differences in Small Cell Lung Cancer: Is This a Hormonal Issue? (ID 605)
09:45 - 18:00 | Author(s): Alex A Adjei
- Abstract
Background
Small cell lung cancer (SCLC) accounts for about 10% to 15% of lung cancers among women and men. Though heavily associated with smoking, its incidence in women is rapidly increasing despite a decline in cigarette exposure. Given the changing demographics of SCLC and hormonal factors associated with other forms of lung cancer, we studied differences between sexes in SCLC.
Method
Utilizing the National Cancer Database, we identified all incident SCLC cases from 2004 to 2014. Patients were classified as limited (LS) or extensive stage (ES). Women were stratified by menopausal status (≥55 years = postmenopausal). Kaplan-Meier method and Cox regression were used for overall survival (OS) and multivariable analysis.
Result
161,978 patients were identified. No significant sociodemographic differences were observed between sexes. The majority of patients were non-Hispanic whites (89.1%), followed by non-Hispanic blacks (7.5%). Men were more likely to be diagnosed with ES disease than women (63% vs. 56%). Both sexes initiated treatment within a similar time frame from diagnosis (chemotherapy, median 18 days, IQR 8-32). Women had better median OS compared to men in both LS (15.2 vs. 12.7 months, HR: 0.85, 95% CI 0.83-0.86, p < 0.0001) and ES (6.4 vs. 5.7 months, HR: 0.88, 95% CI 0.87-0.90, p < 0.0001). No racial or ethnic disparities in OS were observed, overall and when examined within sex and disease stage groups. Differences between sexes in OS were also observed when comparing patients within the same racial/ethnic group (women having better OS). When divided by menopausal status, postmenopausal women with LS and ES had worse OS than premenopausal women (14.7 vs. 22 months, HR: 1.50, 95% CI 1.44-1.56; 6.1 vs. 9.8 months, HR: 1.41, 95% CI: 1.37-1.46, respectively). We also observed worse OS in older men when divided by age (<55 years and ≥55 years). In multivariable analysis, older age, postmenopausal status, and Medicaid as primary insurance were associated with worse OS for both LS and ES.
Conclusion
In this large cohort, women with SCLC had better OS compared to men. Post-menopausal women had worse OS compared to pre-menopausal women. Since older men had a similar trend of worse survival compared to younger men, age might exert a more significant influence on survival than hormonal status in SCLC. Further studies with data on sexual hormone levels are necessary to better understand their role in women with SCLC.
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P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.16-14 - Effects of an Artificial Intelligence (AI) System on Clinical Trial Enrollment in Lung Cancer (ID 548)
09:45 - 18:00 | Author(s): Alex A Adjei
- Abstract
Background
Clinical trials offer cancer patients access to the latest promising therapies and improve the overall quality and safety of cancer care. However, few patients participate, due in part to the time and effort associated with traditional manual ad hoc screening methods. IBM Watson Health’s Clinical Trials Matching (CTM) is an artificial intelligence (AI) system that employs natural language processing to abstract patient and trial data from unstructured sources and machine learning to match patients to trials. This study compared the clinical trial enrollment rates of lung cancer patients before and after deployment of CTM.
Method
CTM was trained for lung cancer and adopted in an academic outpatient oncology clinic using a phased implementation approach beginning July 2018. Clinical trials included ~42 therapeutic, supportive care, and observational trials. Clinical research coordinators validated Watson-derived clinical trial matches on the day prior to patient clinic visits. Oncologists were provided with a list of potentially eligible trials for each patient to facilitate evaluation at point of care. The average monthly enrollment rates for therapeutic trials were compared 6 months before and after CTM deployment. Average enrollment rates per active clinical trial were reported.
Result
Clinical trial matches were validated and delivered to lung oncology providers in 69% (1818/2637) of patients’ visits during the 6-month phased implementation. Enrollment of patients in lung cancer therapeutic clinical trials occurred at a rate of 3.83 patients/month after CTM deployment, as compared to 1.83 patients/month prior to CTM deployment; a 109% enrollment increase. When adjusted for the average number of active clinical trials before (30) and after (39) CTM implementation, the enrollment was 0.097 patients/trial using CTM, compared to 0.061 patients/trial using traditional methods; a 58.4% enrollment increase.
Conclusion
Use of IBM Watson Health’s Clinical Trials Matching (CTM) system with screening coordinators facilitated an increase in clinical trial enrollment and promoted awareness of clinical trial opportunities within the lung oncology practice.
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P2.18 - Treatment of Locoregional Disease - NSCLC (ID 191)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.18-01 - A Multicenter, Double-Blind, Randomized, Controlled Study of Bintrafusp Alfa (M7824) in Unresectable Stage III NSCLC (Now Available) (ID 2200)
10:15 - 18:15 | Author(s): Alex A Adjei
- Abstract
Background
The TGF-β pathway promotes tumor immunosuppression, and its inhibition may enhance the antitumor activity of PD-(L)1 monoclonal antibodies and reduce radiation-induced lung fibrosis. Bintrafusp alfa is an innovative first-in-class bifunctional fusion protein composed of the extracellular domain of TGF-βRII (a TGF-β “trap”) fused to a human IgG1 mAb blocking PD-L1. In a phase 1 study, second-line bintrafusp alfa therapy demonstrated promising antitumor activity in advanced non-small cell lung cancer (NSCLC) (NCT02517398). In preclinical studies, bintrafusp alfa plus radiotherapy showed enhanced antitumor activity compared with radiotherapy alone in mouse models. This study is evaluating the efficacy and safety of bintrafusp alfa with concurrent chemoradiation (cCRT) followed by bintrafusp alfa vs cCRT plus placebo followed by durvalumab in patients with unresectable stage III NSCLC.
Method
This global, multicenter, double-blind, randomized, controlled study of bintrafusp alfa (NCT03840902) includes adults with histologically documented stage III locally advanced, unresectable NSCLC, ECOG performance status ≤1, adequate pulmonary function, and life expectancy ≥12 weeks. Patients with tumors with actionable mutations (EGFR, ALK translocation, ROS-1 rearrangement) are also eligible. Mixed small cell lung cancer and NSCLC histology; pleural effusions greater than minimal, exudative, or cytologically positive; significant acute or chronic infections; prior chemotherapy or immune checkpoint inhibitor therapy for NSCLC; and current use of immunosuppressive medication are exclusion criteria. Patients are randomized to receive either bintrafusp alfa 1200 mg IV every 2 weeks (Q2W) with cCRT for 6 weeks followed by bintrafusp alfa 1200 mg IV Q2W (arm A) or placebo with cCRT for 6 weeks followed by durvalumab 10 mg/kg IV Q2W (arm B) until confirmed disease progression, unacceptable toxicity, or treatment ≤1 year. The primary endpoint is progression-free survival; secondary endpoints include overall survival, safety, lung function assessment, objective response, duration of response, pharmacokinetics, and immunogenicity. This phase 2 trial was activated on April 2, 2019 and first patient in is anticipated for May 22, 2019. Target enrollment: 350 patients.
Result
Section not applicable
Conclusion
Section not applicable
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PR02 - Press Conference (ID 387)
- Event: WCLC 2019
- Type: Press Conference
- Track: Immuno-oncology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 10:30, CC7.1 A&B
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PR02.03 - Announcement of JTO Clinical and Research Reports (ID 4072)
09:45 - 10:30 | Presenting Author(s): Alex A Adjei
- Abstract
Abstract not provided
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YI02 - Clinical Trials (ID 108)
- Event: WCLC 2019
- Type: Young Investigator Session
- Track: Young Investigators
- Presentations: 1
- Now Available
- Moderators:Laura Mezquita, Frances Shepherd
- Coordinates: 9/07/2019, 09:00 - 10:30, Dublin (1997)
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YI02.05 - Principles to Get Your Paper Published (Now Available) (ID 3700)
09:00 - 10:30 | Presenting Author(s): Alex A Adjei
- Abstract
- Presentation
Abstract
How to get your Manuscript Published
Alex A. Adjei, MD;PhD
Mayo Clinic, Rochester, MN, USA
Scientific publication is the backbone of academic research. Findings by investigators need to be disseminated to the community so that results can influence human health and well-being as well lay groundwork for future research.
In spite of the central role of publishing in academic life described above, there are very few formal courses or seminars teaching academics, particularly physician scientists on how to publish their work. The table below outlines reasons for rejection of manuscripts, coming out of a survey of a number of journal editors
Using information from this survey as a starting point, we will discuss the “fatal flaws” that lead to outright rejection of manuscripts, and outline strategies on how to write a manuscript of high impact, which is likely to be accepted for publication.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
