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V.A. Memoli
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MINI 01 - Pathology (ID 93)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:W.A. Franklin, A.G. Nicholson
- Coordinates: 9/07/2015, 10:45 - 12:15, Mile High Ballroom 2c-3c
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MINI01.12 - Implementation of a Molecular Tumor Board: The Impact on Treatment Decisions for NSCLC Patients Evaluated at Dartmouth-Hitchcock in One Year (ID 2719)
10:45 - 12:15 | Author(s): V.A. Memoli
- Abstract
- Presentation
Background:
Genetic profiling of tumors is a powerful approach to predict drug sensitivity and resistance. Definitive interpretation of the clinical significance of somatic mutations is possible for only a few well studied mutations. For the majority, prediction of clinical significance is challenging. We established a Molecular Tumor Board (MTB) at our Cancer Center to interpret individual patients’ tumor genetic profiles and provide treatment recommendations.
Methods:
DNA from tumor specimens was sequenced in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory to identify coding mutations in a 50-gene panel. Cases were evaluated by a MTB composed of molecular and anatomic pathologists, medical oncologists, basic research scientists, and genetic counselors.
Results:
35 cases were evaluated in 1 year by the MTB including 8 metastatic NSCLC cases. The most common reason for MTB referral was for recommendations on targeted therapies (91.9%), and for potential germline mutations. Tumors exhibited genetic heterogeneity: 71 different mutations were found across 300 genes (for NSCLC 18 mutations across 10 genes). In 18/32 of advanced/metastatic cases, MTB recommended non-standard therapy with a specific targeted agent (11 clinical trials; 7 off-label use), 4 of the 18 patients were subsequently treated with a MTB-recommended targeted therapy. The remaining 14 patients continued on current therapy because disease was stable (n=4), were treated with non-MTB-recommended standard therapy (n=4), declined conventional therapy (n=5), or died prior to receiving further therapy (n=1). For 4 out of the 8 NSCLC cases MTB recommended a BRAF inhibitor (1), RET inhibitor (1), or MET inhibitor (2). One patient received a BRAF inhibitor, 6 continued on current standard of care therapy, one declined therapy.
Conclusion:
Case evaluation by a multidisciplinary group of individuals in the context of a MTB frequently shapes treatment options and decisions. Importantly, anticipated obstacles to capitalizing on the benefits of a MTB such as access to drugs were rarely encountered in the entire cohort and in the NSCLC patients. Instead, the most commonly encountered reasons that MTB-recommended therapy was not administered stemmed from patient preferences, and genetic profiling at a very late stage of disease.
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MINI 22 - New Technology (ID 134)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
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MINI22.11 - A Clinical Platform for Examining Mechanism-Driven Chemotherapeutic Agents (ID 724)
16:45 - 18:15 | Author(s): V.A. Memoli
- Abstract
- Presentation
Background:
There is a clinical need to establish whether those pathways activated in vitro and in animal models, are also activated in human lung cancer. We established a window-of-opportunity clinical trial platform in lung cancer where novel agents are administered in the preoperative period. Intratumoral drug concentrations are correlated with molecular marker changes. Our four completed window-of-opportunity clinical trials established that optimal intratumoral drug concentrations are needed for the desired pharmacodynamic effects, providing direction for optimal dose and schedule. To further evaluate the value of this window-of-opportunity platform, we investigate the impact on standard postoperative outcome measures.
Methods:
39 consecutive patients enrolled under the window-of-opportunity platform were matched to 39 contemporary patients undergoing the same operation by the same surgeon. Co-morbidities and stage of lung cancer and postoperative complications were compared using univariate and multivariate analysis. Wilcoxon Scores (Rank Sums) for variable data elements and Fisher’s Exact Test was used for analysis.
Results:
When comparing window-of-opportunity patients to control patients, there was no difference in age, pack years of smoking, or incidence of comorbidities including diabetes, coronary artery disease, hypertension, chronic obstructive pulmonary disease, and previous cancer. There was no difference in the stage distribution, (stage I: 28 vs. 22, stage II: 5 vs. 3, stage III: 5 vs. 2 stage IV: 1 vs. 1, p=0.1642). There was also no difference in the incidence of postoperative pneumonia (4 vs. 9, p=0.2235), other infection (2 vs. 3, p=0.8208), atelectasis (2 vs. 4, p=0.6748), myocardial infarction (0 vs. 0, p=1.000), reoperation for bleeding (1 vs. 1, p=1.000), pulmonary embolism (1 vs. 2, p=1.000) or number patients experiencing any complication (14 vs. 8, p=0.131118). There was no difference in the distribution of survival at 2 years (27 vs. 30) or 5 years (10 vs. 15), p=0.2266.
Conclusion:
The window of opportunity platform does not increase the perioperative risk of complications in early stage NSCLC patients undergoing surgery. By evaluating drug effect and the potential toxicities, window-of-opportunity trials validate mechanisms established in the laboratory and facilitate bi-directional translation research.
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