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The Importance of a Multidisciplinary Approach to Lung Cancer Patients in the Era of Immuno-Oncology - A Case Report of Multi-Organ Toxicity with Checkpoint Inhibitor Treatment [Meeting Abstract]

Weintraub, S.; Newman, J.; Thomas, R.; Seetharamu, N.
ISI:000792480403219
ISSN: 1073-449x
CID: 5339682

Forming the Hematology-Oncology Collaborative Videoconferencing (CO-VID) Learning Initiative: Experiential Lessons Learned From a Novel Trainee-Led Multidisciplinary Virtual Learning Platform

Martin, Richard L; Grant, Michael J; Kimani, Stephen; Midha, Shonali; May, Jori; Patell, Rushad; Collier, Emily; Furfaro, David; Bodine, Charles; Reap, Leo; Shah, Nikesh; DeLaune, Jess; Brusca, Samuel; Olazagasti, Coral; Goyal, Shreya; Rubinstein, Samuel; Hakim, Nausheen; Qin, Shuai; Browning, Sabrina L; Sena, Laura; Gilbert, Jill; Davidson, Mario; Lovly, Christine M; Seetharamu, Nagashree; Rangachari, Deepa; Murphy, Martina; Chatwal, Monica; Paschal, Rita; Henry, Elizabeth; Collichio, Frances; Green, Jennifer R
PURPOSE/UNASSIGNED:COVID-19 challenged medical practice and graduate medical education. Building on previous initiatives, we describe and reflect on the formative process and goals of the Hematology-Oncology Collaborative Videoconferencing Learning Initiative, a trainee-led multi-institutional virtual COVID-19 learning model. METHODS/UNASSIGNED:Clinical fellows and faculty from 13 US training institutions developed consensus needs, goals, and objectives, recruited presenters, and generated a multidisciplinary COVID-19 curriculum. Weekly Zoom conferences consisted of two trainee-led instructional segments and a trainee-moderated faculty Q&A panel. Hematology-oncology training program faculty and trainees were the targeted audience. Leadership evaluations consisted of anonymized baseline and concluding mixed methods surveys. Presenter evaluations consisted of session debriefs and two structured focus groups. Conference evaluations consisted of attendance, demographics, and pre- or postmultiple-choice questions on topic learning objectives. RESULTS/UNASSIGNED:In 6 weeks, the initiative produced five conferences: antivirals, anticoagulation, pulmonology, provider resilience, and resource scarcity ethics. The average attendance was 100 (range 57-185). Among attendees providing both pre- and postconference data, group-level knowledge appeared to increase: antiviral (n = 46) pre-/postcorrect 82.6%/97.8% and incorrect 10.9%/2.2%, anticoagulation (n = 60) pre-/postcorrect 75%/93.3% and incorrect 15%/6.7%, and pulmonary (n = 21) pre-/postcorrect 66.7%/95.2% and incorrect 33.3%/4.8%. Although pulmonary management comfort appeared to increase, comfort managing of antivirals and anticoagulation was unchanged. At the conclusion of the pilot, leadership trainees reported improved self-confidence organizing multi-institutional collaborations, median (interquartile range) 58.5 (50-64) compared with baseline 34 (26-39), but did not report improved confidence in other educational or leadership skills. CONCLUSION/UNASSIGNED:During crisis, trainees built a multi-institutional virtual education platform for the purposes of sharing pandemic experiences and knowledge. Accomplishment of initiative goals was mixed. Lessons learned from the process and goals may improve future disaster educational initiatives.
PMID: 34242082
ISSN: 2688-1535
CID: 4933632

A Phase 1b/2 Study of Pepinemab in Combination with Avelumab in Advanced Non-Small Cell Lung Cancer

Shafique, Michael; Fisher, Terrence Lee; Evans, Elizabeth E; Leonard, John E; Pastore, Desa Rae Electa; Mallow, Crystal L; Smith, Ernest S; Mishra, Vikas; Schröder, Andreas; Chin, Kevin; Beck, J Thaddeus; Baumgart, Megan Ann; Govindan, Ramaswamy; Gabrail, Nashat Y; Spira, Alexander I; Seetharamu, Nagashree; Lou, YanYan; Mansfield, Aaron S; Sanborn, Rachel E; Goldman, Jonathan W; Zauderer, Maurice
PURPOSE/OBJECTIVE:The CLASSICAL-Lung clinical trial tested the combination of pepinemab, an IgG4 humanized monoclonal antibody targeting semaphorin 4D, with the PD-L1 inhibitor avelumab to assess the effects of coupling increased T cell infiltration and reversal of immune suppression via pepinemab with sustained T cell activation via checkpoint inhibition. PATIENTS AND METHODS/METHODS:This phase 1b/2, single arm study was designed to evaluate the safety, tolerability and efficacy of pepinemab in combination with avelumab in 62 patients with advanced NSCLC, including immunotherapy-naïve (ION) patients and patients whose tumors progressed following anti-PD-1/L1 monotherapy (IOF). The main objectives were to evaluate safety / tolerability, establish a RP2D, obtain a preliminary evaluation of anti-tumor activity and investigate candidate biomarker activity. RESULTS:The combination was well tolerated with no major safety signals identified. Pepinemab, 10mg/kg with avelumab, 10mg/kg, Q2W, was selected as the RP2D. Among 21 evaluable ION patients, 5 patients experienced partial responses (PR), 4 patients evidenced clinical benefit {greater than or equal to} 1 year, and the DCR was 81%. Notably, ORR with the combination therapy was higher than previously reported for single agent avelumab in the PD-L1 negative / low population. Among 29 evaluable IOF patients, the combination resulted in a DCR of 59%, including 2 PR and 7 patients with durable clinical benefit of {greater than or equal to} 23 weeks. Biomarker analysis of biopsies demonstrated increased CD8 T cell density correlating with RECIST response criteria. CONCLUSIONS:The combination of pepinemab with avelumab was well tolerated in NSCLC and showed signs of antitumor activity in immunotherapy resistant and PD-L1 negative / low tumors.
PMID: 33820783
ISSN: 1557-3265
CID: 4839032

Malignant struma ovarii with late recurrence harbouring high microsatellite instability [Case Report]

Chung, Su Yun; Chi, Jeffrey; Park, Jennifer; John, Veena; Seetharamu, Nagashree
Struma ovarii (SO) is a rare ovarian teratoma containing abundant mature thyroid tissue. Malignant transformation is even less common and distant metastasis is documented in about 5%-10%. The time from diagnosis of primary SO to metastatic disease varies. As malignant SO is rare, there are no uniform diagnostic criteria or treatment guidelines. Management is usually extrapolated from that of thyroid malignancy. We report a patient who relapsed 12 years from the initial diagnosis and metastasised to the lungs 5 years after the first recurrence. Our patient was treated with total thyroidectomy followed by radioactive iodine, and retreated on progression in the lungs. The tumour harboured high microsatellite instability and treatment with programmed cell death protein 1 inhibitor was initiated. This case shows the long latency of SO with the rare phenomenon of metastasis. It also highlights the importance of molecular testing for rare cancers such as this.
PMID: 34127502
ISSN: 1757-790x
CID: 4911482

A real world analysis of first line treatment of advanced EGFR mutated non-small cell lung cancer: A multi-center, retrospective study

Lee, Chung-Shien; Ahmed, Iman; Miao, Emily; Chung, Shirley; Patel, Khilna; Kohn, Nina; Seetharamu, Nagashree
INTRODUCTION/BACKGROUND:TKIs. METHODS:therapy between 2014 and 2019 were included. Patients were dichotomized based on front-line TKI (osimertinib vs. other). PFS, OS, and time-to-discontinuation were evaluated. RESULTS:TKI group, respectively (p < 0.0036).Estimated OS at 6, 12, and 18 months was similar for both groups: 94.2%, 94.2%, 80.2% and 95.7%, 93.9%, 84.1%, respectively [Adjusted HR = 0.95 (95% CI, 0.37-2.44; p < 0.9128]. CONCLUSION/CONCLUSIONS:TKIs. This finding is consistent with results of the FLAURA trial. However, unlike FLAURA, there were no differences in estimated OS between the two groups in our study. Further research to evaluate optimal sequencing strategies in the real world of first, second and third generation TKIs is needed.
PMID: 34120514
ISSN: 1477-092x
CID: 4911202

Impact of stereotactic body radiation therapy on geriatric assessment and management for older patients with head and neck cancer using G8

Gogineni, Emile; Rana, Zaker; Wotman, Michael; Karten, Jessie; Riegel, Adam; Marrero, Mihaela; Maduro, Luis; Kamdar, Dev; Frank, Douglas; Paul, Doru; Seetharamu, Nagashree; Ghaly, Maged
PURPOSE/OBJECTIVE:Management of head and neck cancers (HNC) in older adults is a common but challenging clinical scenario. We assess the impact of Stereotactic Body Radiation Therapy (SBRT) on survival utilizing the Geriatric-8 (G8) questionnaire. MATERIALS AND METHODS/METHODS:171 HNC patients, deemed medically unfit for definitive treatment, were treated with SBRT ± systemic therapy. G8 questionnaires were collected at baseline, at 4-6 weeks, and at 2-3 months post-treatment. Patients were stratified according to their baseline G8 score: <11 as 'vulnerable', 11-14 as 'intermediate', and >14 as 'fit'. Overall survival (OS) was assessed through univariate Kaplan Meier analysis. Repeated measures ANOVA was used to determine if baseline characteristics affected G8 score changes. RESULTS:Median follow-up was seventeen months. 60% of patients presented with recurrent HNC, 30% with untreated HNC primaries, and 10% with metastatic non-HNC primaries. Median age was 75 years. Median Charlson Comorbidity Index score was 2. 51% of patients were 'vulnerable', 37% were 'intermediate', and 12% were 'fit' at baseline, with median survival of 13.2, 24.3, and 41.0 months, respectively (p = .004). Patients who saw a decrease in their follow-up G8 score (n = 69) had significantly lower survival than patients who had stable or increased follow-up G8 scores (n = 102), with median survival of 8.6 vs 36.0 months (p < .001). CONCLUSION/CONCLUSIONS:The G8 questionnaire may be a useful tool in upfront treatment decision-making to predict prognosis and prevent older patients from receiving inappropriate anti-cancer treatment. Decline in follow-up G8 scores may also predict worse survival and aid in goals of care following treatment.
PMID: 32593669
ISSN: 1879-4076
CID: 4503692

Epidemiology and clinicopathological features of lung cancer in patients with prior history of breast cancer

Wang, Kevin Y; Newman, James; Lee, Chung-Shien; Seetharamu, Nagashree
Breast cancer is the most common malignancy in women, and lung cancer, the leading cause of cancer-related mortality in the United States, is the most common subsequent primary cancer among breast cancer survivors. In this review, we examine the risk factors that cause subsequent primary lung cancer after breast cancer (referred to herein as BCLC patients) as well as the prognostic factors that may affect survival. Notable clinicopathological features include patient characteristics such as age, smoking history, and the presence of EGFR or BRCA mutations, as well as factors related to the treatment of breast cancer such as radiation, surgery, chemotherapy, stage, anti-estrogen therapy, and ER/PR/HER2 status.
PMCID:8155786
PMID: 34104436
ISSN: 2050-3121
CID: 4899872

Back to the well: Can patients with advanced non-small cell lung cancer benefit from changing PD-1/PD-L1 inhibitors after progression? [Meeting Abstract]

Newman, James; Lee, Chung-Shien; McGovern, Kerri; Seetharamu, Nagashree
ISI:000708120305161
ISSN: 0732-183x
CID: 5339692

Burden of Proof: Evaluating the Efficacy of Tumor Mutational Burden (TMB) in Predicting Response to Immune Checkpoint Inhibitors

Newman, James; Seetharamu, Nagashree; Saif, Muhammad Wasif
PMCID:7769129
PMID: 33377136
ISSN: n/a
CID: 4731812

Simple parameters to solve a complex issue: predicting response to checkpoint inhibitor therapy in lung cancer

Newman, James; Preeshagul, Isabel; Kohn, Nina; Devoe, Craig; Seetharamu, Nagashree
Background/UNASSIGNED:Noninvasive biomarkers predicting immune checkpoint inhibitor (ICI) response are urgently needed. We evaluated the predictive value of pretreatment neutrophil-to-lymphocyte ratio (NLR), smoking history, smoking intensity, BMI and programmed death ligand 1 (PD-L1) expression in non-small-cell lung cancer (NSCLC) patients treated with ICIs. Materials & methods/UNASSIGNED:Single-center retrospective study included 137 patients from July 2015 to February 2018. Outcomes included 3-month disease control rate, progression-free survival, and overall survival. Predictive value of biomarkers was assessed independently and in a multivariable model. Results/UNASSIGNED:NLR was associated with all outcomes. Smoking history was predictive of progression-free survival and smoking intensity was predictive of disease control rate. BMI and PD-L1 were not associated with any outcome. High BMI was associated with low NLR. Conclusion/UNASSIGNED:Simple clinical biomarkers can predict response to ICIs. A score incorporating both clinical factors and established tissue/serum biomarkers may be useful in identifying NSCLC patients who would benefit from ICIs.
PMCID:8162145
PMID: 34084210
ISSN: 1758-1974
CID: 4892022