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A phase I/II multisite study of nivolumab and carboplatin/paclitaxel with radiation therapy (RT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC) [Meeting Abstract]

Wu, J J; Atkinson, E C; Leichman, L P; Patel, H; Iqbal, S; Lee, Du K; Bizekis, C; Goldberg, J D; Thomas, C R; Cohen, D J; Becker, D J; Siolas, D; Beri, N; Oberstein, P E; Ku, G Y
Background: Preoperative chemoRT is a standardof- care as shown in the CROSS trial (N Engl J Med 2012;366:2074-2084), Surgery is sometimes deferred in pts with clinical CR (cCR) based on lack of overall survival benefit (J Clin Oncol 2005;23:2310-2317, J Clin Oncol2007;25:1160-1168). Nivolumab has activity in advanced ESCC (Lancet Oncol 2017;18:631-639), and adding it to chemoRT may improve outcomes.
Method(s): This phase I/II study was designed to assess the safety and tolerability and efficacy of nivolumab added to chemoRT (6 weekly carboplatin AUC 2, paclitaxel 50mg/m2, RT 50.4 Gy in 1.8 Gy fractions 5/7 days) for pts with TanyN1-3 or T3-4N0M0 ESCC. The phase I primary endpoint is 'unacceptable toxicity' at 28 days after the last dose of chemotherapy. The phase II primary endpoints are cCR (endoscopy + PET/CT) and pCR rates for pts undergoing surgery. Nivolumab is given q2W x2, then concurrent chemoRT with nivolumab q2W x3. If no cCR, pt proceeds to esophagectomy, then adjuvant nivolumab q2W x3; if cCR, pt has an option of no surgery but receives nivolumab q2W x3.
Result(s):From 7/20/17 to 12/27/18, 6 pts were enrolled. No unacceptable or grade 5 toxicities were observed. The most common grade 1/2 AEs in >1 pt were anorexia, myelosuppression, elevated AST and nausea. Grade 3/4 AEs in >1 pt were lymphopenia and leukocytopenia. 2 pts required hospitalizations (dyspnea 1, colitis 1). All pts completed therapy; 1 pt had dose delay due to grade 2 esophagitis; 2 pts progressed, 4 achieved cCR. Of 4 pts with cCR, 2 pts chose surgery and both achieved pCR. None of the 4 pts recurred.
Conclusion(s): ChemoRT with nivolumab is tolerable with manageable toxicities in locally advanced ESCC. Enrollment to the phase II portion ended because of slow accrual. Adverse Events. Grade 1 &2 in > 1 pt: 4/6: Anorexia & Anemia 3/6: Leukocytopenia Neutropenia Thrombocytopenia Nausea & Elevated AST 2/6: Hypomagnesemia Hypokalemia Grade 3 & 4 in > 1 pt: 5/6: Lymphopenia, 2/6: Leukocytopenia
EMBASE:630962197
ISSN: 1527-7755
CID: 4326192

Resection of an Ectopic Parathyroid Adenoma via Video-Assisted Mediastinoscopy

Spear, Charlotte; Geraci, Travis; Bizekis, Costas; Zervos, Michael
PMID: 30735709
ISSN: 1532-9488
CID: 3632502

LIQUID NITROGEN SPRAY CRYOTHERAPY FOR PALLIATION OF INVASIVE ESOPHAGEAL CARCINOMA: RESULTS FROM A MULTICENTER US REGISTRY [Meeting Abstract]

Ramay, Fariha H.; Shaheen, Nicholas J.; Kaul, Vivek; Nieto, Jose; Joshi, Virendra; Litle, Virginia; Fernando, Hiran C.; Fukami, Norio; Hoffman, Brenda J.; Bizekis, Costas; McKinley, Matthew; Habr, Fadlallah; Nishioka, Norman S.; Tsai, Franklin; Coyle, Walter J.; Pleskow, Douglas K.; Greenwald, Bruce D.
ISI:000435509900430
ISSN: 0016-5107
CID: 3646462

Therapeutic Treatment Of High-Grade Squamous Dysplasia Of The Airway With Spray Cryotherapy [Meeting Abstract]

Yaffee, DW; Pass, H; Zervos, M; Bizekis, C
ISI:000400372506599
ISSN: 1535-4970
CID: 2591312

Robot-assisted complete thymectomy for mediastinal ectopic parathyroid adenomas in primary hyperparathyroidism

Ward, Alison F; Lee, Timothy; Ogilvie, Jennifer B; Patel, Kepal N; Hiotis, Karen; Bizekis, Costas; Zervos, Michael
One to two percent of ectopic parathyroid adenomas are found in the lower mediastinum and often these are best accessed via a sternotomy or thoracotomy. Video-assisted thoracoscopic surgery (VATS) is an alternative approach with less surgical trauma, decreased morbidity, shorter hospital stays, and superior cosmetic results. Ten years after the first VATS resection of an ectopic mediastinal parathyroid, a robot-assisted thoracoscopic approach was described. Here we describe a series of five robot assisted complete thymectomies in patients with primary hyperparathyroidism due to mediastinal ectopic parathyroid adenomas. A single surgeon, single institution case series of five consecutive robotic-assisted mediastinal parathyroidectomies was performed between March 2013 and September 2015. The patients' ages ranged from 31 to 65, 80 % were female, and all had primary hyperparathyroidism due to an ectopic parathyroid located in the lower mediastinum. Pre-operative imaging workup included Technetium 99-sestimibi parathyroid scan and CT scan of the chest. An ectopic parathyroid adenoma was successfully removed in all five cases, with intraoperative iOPTH decreasing ~50 % from baseline after 10 minutes. A hypercellular parathyroid was confirmed on pathologic exam in all specimens. Post-operative discharge and follow up calcium levels all returned to normal. There were no intraoperative complications, including no recurrent laryngeal nerve injuries, no postoperative morbidity, and no mortalities. This case series demonstrates that a robot-assisted complete thymectomy for mediastinal parathyroid adenomas causing primary hyperparathyroidism provides excellent visualization of the mediastinum, is effective at reducing PTH and calcium levels, and is safe with no morbidity or mortality.
PMID: 27771850
ISSN: 1863-2491
CID: 2288552

CUMALATIVE BIOMARKER MODEL PREDICTS 3-YEAR RECURRENCE IN RESECTED STAGE I ADENOCARCINOMA OF THE LUNG [Meeting Abstract]

Donington, Jessica; Hirsch, Nathalie; Levine, Joseph; Harrington, Ryan; Crawford, Bernard; Zervos, Micheal; Bizekis, Costas; Pass, Harvey
ISI:000339624902138
ISSN: 1556-1380
CID: 1317582

SEX-BASED DIFFERERNCES IN MORBIDITY AND MORTALITY ASSOCIATED WITH NON-SMALL CELL LUNG CANCER RESECTIONS [Meeting Abstract]

Pendleton, Audrey; Pass, Harvey; Gonzalez, Gerardo; Goldberg, Judith; Harrington, Ryan; Crawford, Bernard; Zervos, Micheal; Bizekis, Costas; Donington, Jessica
ISI:000339624905200
ISSN: 1556-1380
CID: 1317622

Current readings: endoesophageal management of early esophageal cancer and dysplastic barrett esophagus: a review of recent and influential studies

Towe, Christopher W; Bizekis, Costas S
PMID: 24216531
ISSN: 1043-0679
CID: 626972

Bronchoscopic techniques including endobronchial ultrasound

Chapter by: Levin, J; Bizekis, C; Zervos, M
in: Cardiothoracic Surgery Review by
pp. 929-932
ISBN: 9781451154153
CID: 2229012

Endoscopic ablational therapies and stenting

Chapter by: Zervos, M; Bizekis, C
in: Principles and Practice of Lung Cancer: The Official Reference Text of the International Association for the Study of Lung Cancer (IASLC) by
pp. 891-900
ISBN: 9781451152968
CID: 2171132