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Pancreatic Neoplasms: HELP
Articles by Peter J. Hosein
Based on 14 articles published since 2010
(Why 14 articles?)
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Between 2010 and 2020, P. J. Hosein wrote the following 14 articles about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 Review FOLFIRINOX for locally advanced pancreatic cancer: a systematic review and patient-level meta-analysis. 2016

Suker, Mustafa / Beumer, Berend R / Sadot, Eran / Marthey, Lysiane / Faris, Jason E / Mellon, Eric A / El-Rayes, Bassel F / Wang-Gillam, Andrea / Lacy, Jill / Hosein, Peter J / Moorcraft, Sing Yu / Conroy, Thierry / Hohla, Florian / Allen, Peter / Taieb, Julien / Hong, Theodore S / Shridhar, Ravi / Chau, Ian / van Eijck, Casper H / Koerkamp, Bas Groot. ·Department of Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands. · Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA. · Department of Hepatogastroenterology, Antoine Beclère Hospital, Assistance publique-Hôpitaux de Paris, Paris Sud University, Clamart, France. · Department of Hematology-Oncology, Massachusetts General Hospital, Boston, MA, USA. · Department of Radiation Oncology, H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA. · Department of Hematology and Medical Oncology, Emory University, Atlanta, GA, USA. · Department of Medicine, Washington University School of Medicine, Saint Louis, MO, USA. · Department of Medicine, Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA. · Department of Medicine, Division of Medical Oncology, University of Kentucky-Markey Cancer Center, Lexington, KY, USA. · Department of Medicine, The Royal Marsden National Health Service Foundation Trust, London and Surrey, UK. · Department of Medical Oncology, Institut de Cancérologie de Lorraine and Lorraine University, Vandoeuvre-lès-Nancy, France. · Department of Hematology, Medical Oncology, Hemostasis, Rheumatology and Infectious Diseases, Paracelsus Medical University of Salzburg, Salzburg, Austria. · Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, Assistance publique-Hôpitaux de Paris, Sorbonne Paris Cité, Paris Descartes University, Cancer Research Personalized Medicine (CARPEM), Paris, France. · Department of Radiation Oncology, Florida Hospital Cancer Institute, Orlando, FL, USA. · Department of Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands. Electronic address: b.grootkoerkamp@erasmusmc.nl. ·Lancet Oncol · Pubmed #27160474.

ABSTRACT: BACKGROUND: 35% of patients with pancreatic cancer have unresectable locally advanced disease at diagnosis. Several studies have examined systemic chemotherapy with FOLFIRINOX (leucovorin and fluorouracil plus irinotecan and oxaliplatin) in patients with locally advanced pancreatic cancer. We aimed to assess the effectiveness of FOLFIRINOX as first-line treatment in this patient population. METHODS: We systematically searched Embase, MEDLINE (OvidSP), Web of Science, Scopus, PubMed Publisher, Cochrane, and Google Scholar from July 1, 1994, to July 2, 2015, for studies of treatment-naive patients of any age who received FOLFIRINOX as first-line treatment of locally advanced pancreatic cancer. Our primary outcome was overall survival. Secondary outcomes were progression-free survival; rates of grade 3 or 4 adverse events; and the proportion of patients who underwent radiotherapy or chemoradiotherapy, surgical resection after FOLFIRINOX, and R0 resection. We evaluated survival outcomes with the Kaplan-Meier method with patient-level data. Grade 3 or 4 adverse events, and the proportion of patients who underwent subsequent radiotherapy or chemoradiotherapy or resection, were pooled in a random-effects model. FINDINGS: We included 13 studies comprising 689 patients, of whom 355 (52%) patients had locally advanced pancreatic cancer. 11 studies, comprising 315 patients with locally advanced disease, reported survival outcomes and were eligible for patient-level meta-analysis. Median overall survival from the start of FOLFIRINOX ranged from 10·0 months (95% CI 4·0-16·0) to 32·7 months (23·1-42·3) across studies with a pooled patient-level median overall survival of 24·2 months (95% CI 21·7-26·8). Median progression-free survival ranged from 3·0 months (95% CI not calculable) to 20·4 months (6·5-34·3) across studies with a patient-level median progression-free survival of 15·0 months (95% 13·8-16·2). In ten studies comprising 490 patients, 296 grade 3 or 4 adverse events were reported (60·4 events per 100 patients). No deaths were attributed to FOLFIRINOX toxicity. The proportion of patients who underwent radiotherapy or chemoradiotherapy ranged from 31% to 100% across studies. In eight studies, 154 (57%) of 271 patients received radiotherapy or chemoradiotherapy after FOLFIRINOX. The pooled proportion of patients who received any radiotherapy treatment was 63·5% (95% CI 43·3-81·6, I(2) 90%). The proportion of patients who underwent surgical resection for locally advanced pancreatic cancer ranged from 0% to 43%. The proportion of patients who had R0 resection of those who underwent resection ranged from 50% to 100% across studies. In 12 studies, 91 (28%) of 325 patients underwent resection after FOLFIRINOX. The pooled proportion of patients who had resection was 25·9% (95% CI 20·2-31·9, I(2) 24%). R0 resection was reported in 60 (74%) of 81 patients. The pooled proportion of patients who had R0 resection was 78·4% (95% CI 60·2-92·2, I(2) 64%). INTERPRETATION: Patients with locally advanced pancreatic cancer treated with FOLFIRINOX had a median overall survival of 24·2 months-longer than that reported with gemcitabine (6-13 months). Future research should assess these promising results in a randomised controlled trial, and should establish which patients might benefit from radiotherapy or chemoradiotherapy or resection after FOLFIRINOX. FUNDING: None.

2 Review Percutaneous Approach to Irreversible Electroporation of the Pancreas: Miami Protocol. 2015

Venkat, Shree / Hosein, Peter J / Narayanan, Govindarajan. ·Department of Radiology, University of Miami-Miller School Of Medicine, Miami, FL. Electronic address: vshree@med.miami.edu. · Department of Internal Medicine, Division of Medical Oncology, University of Kentucky, Markey Cancer Center, Lexington, KY. · Department of Radiology, University of Miami-Miller School Of Medicine, Miami, FL. ·Tech Vasc Interv Radiol · Pubmed #26365545.

ABSTRACT: Despite advances in the treatment of unresectable locally advanced pancreatic cancer, outcomes remain poor. Irreversible electroporation is a nonthermal ablative modality whose role in the management of locally advanced pancreatic cancer is being studied. This review highlights patient selection, preparation, and follow-up as well as discusses the techniques to achieve safe and effective tumor ablation in this challenging location.

3 Clinical Trial A phase II, open-label, multicenter study to evaluate the antitumor efficacy of CO-1.01 as second-line therapy for gemcitabine-refractory patients with stage IV pancreatic adenocarcinoma and negative tumor hENT1 expression. 2014

Li, D / Pant, S / Ryan, D P / Laheru, D / Bahary, N / Dragovich, T / Hosein, P J / Rolfe, L / Saif, M W / LaValle, J / Yu, K H / Lowery, M A / Allen, A / O'Reilly, E M. ·Memorial Sloan Kettering Cancer Center, New York, NY, USA. · Peggy and Charles Stephenson Oklahoma Cancer Center, Oklahoma City, OK, USA. · Massachussetts General Hospital, Boston, MA, USA. · The Sydney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA. · University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA. · University of Arizona Cancer Center, Tucson, AZ, USA. · Sylvester Comprehensive Cancer Center, Miami, FL, USA. · Clovis Oncology, Cambridge, UK; Clovis Oncology, San Francisco, CA, USA. · Columbia University College of Physicians and Surgeons, New York, NY, USA. · Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: oreillye@mskcc.org. ·Pancreatology · Pubmed #25278310.

ABSTRACT: BACKGROUND: Nucleotide transporters such as human equilibrative nucleoside transporter-1 (hENT1) play a major role in transporting gemcitabine into cells. CO-1.01 (gemcitabine-5'-elaidate) is a novel cytotoxic agent consisting of a fatty acid derivative of gemcitabine, which is transported intracellularly independent of hENT1. CO-1.01 was postulated to have efficacy as a second-line treatment in gemcitabine-refractory pancreatic adenocarcinoma in patients with negative tumor hENT1 expression. METHODS: Eligibility criteria included patients with either a newly procured or archival biopsy tumor confirming the absence of hENT1 and either gemcitabine-refractory metastatic pancreas adenocarcinoma or with progression of disease following resection during or within 3 months of adjuvant gemcitabine therapy. Patients were treated with intravenous infusion of CO-1.01 dosed at 1250 mg/m(2) on Days 1, 8, and 15 of a 4-week cycle. The primary end point was disease control rate (DCR). RESULTS: Nineteen patients were enrolled of which 18 patients were evaluable for efficacy assessment. Thirteen patients (68%) had liver metastases, 6 (32%) had lymph node metastases, and 10 (53%) had lung metastases. Two of 18 patients (11%) achieved disease control. The median survival time was 4.3 (95% CI 2.1-8.1) months. All patients experienced at least one treatment-related adverse event with the majority of events being mild or moderate. CONCLUSION: This study did not meet its primary endpoint and no efficacy signal was identified for CO-1.01 in treating progressive metastatic pancreas adenocarcinoma.

4 Clinical Trial A phase II trial of nab-Paclitaxel as second-line therapy in patients with advanced pancreatic cancer. 2013

Hosein, Peter J / de Lima Lopes, Gilberto / Pastorini, Vitor H / Gomez, Christina / Macintyre, Jessica / Zayas, Gloria / Reis, Isildinha / Montero, Alberto J / Merchan, Jaime R / Rocha Lima, Caio M. ·*Department of Medicine, Division of Hematology/Oncology, Miller School of Medicine, University of Miami, Miami, FL †Department of Oncology, Johns Hopkins Singapore International Medical Center, Singapore, Republic of Singapore. ·Am J Clin Oncol · Pubmed #22307213.

ABSTRACT: OBJECTIVE: nab-Paclitaxel has been shown to disrupt pancreatic cancer stroma and was effective in combination with gemcitabine in a phase I/II trial. This study was designed to determine the efficacy of nab-paclitaxel monotherapy in previously treated pancreatic cancer patients. METHODS: In this phase II trial, patients with advanced pancreatic cancer who progressed on gemcitabine-based therapy, received nab-paclitaxel 100 mg/m over 30 minutes on days 1, 8, and 15 of a 28-day cycle. The primary endpoint was 6-month overall survival (OS). Secondary endpoints were response rate (by Response Evaluation Criteria In Solid Tumors), progression-free survival, safety, and toxicity profile. RESULTS: Among 19 patients treated, the median age was 61 years, 9 (47%) were male patients and 18 (95%) had stage-IV disease. The primary endpoint of the study was reached with a 6-month OS of 58% [95% confidence interval (95% CI), 33%-76%] and an estimated median OS of 7.3 months (95% CI, 2.8-15.8 mo). The median progression-free survival was 1.7 months (95% CI, 1.5-3.5 mo). One patient had a confirmed partial response and 6 (32%) had stable disease as their best response. Nonhematological toxicities were generally mild with grades 1-2 nausea, anorexia, hypocalcemia, and vomiting occurring in 63%, 47%, 37%, and 26% of patients, respectively. Grades 3-4 neutropenia, neutropenic fever, and anemia occurred in 32%, 11%, and 11% of patients, respectively. Only 2 of 15 available tumors stained positive for secreted protein acid rich in cysteine, and neither of these patients benefited from the therapy. CONCLUSIONS: nab-Paclitaxel was well tolerated, and it demonstrated preliminary evidence of activity in a subset of patients who progressed on gemcitabine-based therapy.

5 Clinical Trial Percutaneous irreversible electroporation for downstaging and control of unresectable pancreatic adenocarcinoma. 2012

Narayanan, Govindarajan / Hosein, Peter J / Arora, Geetika / Barbery, Katuzka J / Froud, Tatiana / Livingstone, Alan S / Franceschi, Dido / Rocha Lima, Caio M / Yrizarry, Jose. ·Department of Radiology, Division of Vascular/Interventional Radiology, University of Miami Miller School of Medicine, 1475 NW 12th Ave., Miami, FL 33136, USA. gnarayanan@med.miami.edu ·J Vasc Interv Radiol · Pubmed #23177107.

ABSTRACT: PURPOSE: Treatment of unresectable locally advanced pancreatic cancer (LAPC) usually includes chemotherapy and/or radiation therapy in an attempt to downstage these tumors to the extent of resectability, but outcomes remain poor. Irreversible electroporation (IRE) is an ablative modality that may be useful in this population. The aim of this study was to evaluate the safety of percutaneous IRE in patients with pancreatic adenocarcinoma. MATERIALS AND METHODS: IRE was performed in patients with pancreatic cancer whose tumors remained unresectable after, or who were intolerant of, standard therapy. The procedures were all done percutaneously under general anesthesia. Patients were then followed for adverse events, tumor response, and survival. RESULTS: Fifteen IRE procedures were performed in 14 patients (one was treated twice). Three patients had metastatic disease and 11 had LAPC. All patients had received chemotherapy previously, and 11 had received radiation. The median tumor size was 3.3 cm (range, 2.5-7 cm). Immediate and 24-hour postprocedural scans demonstrated patent vasculature in the treatment zone in all patients. Two patients underwent surgery 4 and 5 months after IRE, respectively. Both had margin-negative resections, and one had a pathologic complete response; both remain disease-free after 11 and 14 months, respectively. Complications included spontaneous pneumothorax during anesthesia (n = 1) and pancreatitis (n = 1), and both patients recovered completely. There were no deaths directly related to the procedure. All three patients with metastatic disease at IRE died from progression of their disease. CONCLUSIONS: Percutaneous IRE for pancreatic adenocarcinoma is feasible and safe. A prospective trial is being planned.

6 Article DNA damage repair deficiency as a predictive biomarker for FOLFIRINOX efficacy in metastatic pancreatic cancer. 2019

Palacio, Sofia / McMurry, Hannah S / Ali, Robert / Donenberg, Talia / Silva-Smith, Rachel / Wideroff, Gina / Sussman, Daniel A / Rocha Lima, Caio M S / Hosein, Peter J. ·Department of Medicine, University of Miami Miller School of Medicine, and Sylvester Comprehensive Cancer Center, Miami, FL, USA. · Wake Forest School of Medicine, Wake Forest, NC, USA. ·J Gastrointest Oncol · Pubmed #31949930.

ABSTRACT: Patients with pathogenic germline and somatic variants in DNA damage repair (DDR) genes may derive greater benefit with platinum-based chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC). This study investigates the role of DDR genes as a predictive biomarker for response to first-line platinum chemotherapy with FOLFIRINOX in metastatic PDAC patients. Demographic, clinical, and pathologic variables were collected for patients with metastatic PDAC who received FOLFIRINOX as frontline treatment and who had germline and somatic genetic testing. Kaplan-Meier analysis of overall survival (OS) and progression free survival (PFS) were correlated to the presence of DDR pathogenic variants. Forty patients with metastatic PDAC met inclusion criteria. Germline genetic testing revealed germline pathogenic variants in DDR genes in 5 patients (12%), and somatic pathogenic variants in DDR genes in 4 patients (10%). Median PFS was significantly longer in patients with any (germline or somatic) pathogenic variant in DDR genes than in those without alterations 18.5

7 Article Complete response to ipilimumab and nivolumab therapy in a patient with extensive extrapulmonary high-grade small cell carcinoma of the pancreas and HIV infection. 2018

Husnain, Muhammad / Park, Wungki / Ramos, Juan Carlos / Johnson, Thomas E / Chan, Joseph / Dasari, Arvind / Mudad, Raja / Hosein, Peter J. ·Department of Medicine, Division of Oncology, University of Miami Miller School of Medicine and Sylvester Comprehensive Cancer Center, 1475 NW 12th Ave. Suite 3400, Miami, FL, 33136, USA. · Department of Ophthalmology, University of Miami Miller School of Medicine and Bascom Palmer Eye Institute, Miami, USA. · Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Mount Sinai Medical Center, Miami, USA. · MD Anderson Cancer Center, Houston, USA. · Department of Medicine, Division of Oncology, University of Miami Miller School of Medicine and Sylvester Comprehensive Cancer Center, 1475 NW 12th Ave. Suite 3400, Miami, FL, 33136, USA. phosein@med.miami.edu. ·J Immunother Cancer · Pubmed #29986769.

ABSTRACT: BACKGROUND: Immune checkpoint inhibitors (CPIs) have shown promising results in many solid tumors. There are limited data on the safety and efficacy of these drugs in HIV infected patients as they have traditionally been excluded from CPIs clinical trials. CASE PRESENTATION: We present a case of an HIV-positive patient with extensive extrapulmonary high-grade small cell carcinoma who was treated with dual CPIs (nivolumab and ipilimumab) with a complete response to therapy and with a manageable safety profile. We performed a comprehensive literature review identifying 62 total HIV positive cases treated with CPIs showing this to be a potentially safe option in HIV-positive patients. CONCLUSION: HIV infection is not an absolute contraindication to CPI therapy. Our case and others provide justification for ongoing trials of CPI therapy in patients with HIV infection, a group that has traditionally been excluded from clinical trials.

8 Article Neoadjuvant 2018

Peterson, Shawn L / Husnain, Muhammad / Pollack, Terri / Pimentel, Agustin / Loaiza-Bonilla, Arturo / Westendorf-Overley, Colleen / Ratermann, Kelley / Anthony, Lowell / Desimone, Philip / Goel, Gaurav / Kudrimoti, Mahesh / Dineen, Sean / Tzeng, Ching-Wei D / Hosein, Peter J. ·University of Louisville, James Graham Brown Cancer Center, Louisville, KY, U.S.A. · University of Miami, Sylvester Comprehensive Cancer Center, Miami, FL, U.S.A. · Cancer Treatment Centers of America, Philadelphia, PA, U.S.A. · University of Kentucky Markey Cancer Center, Lexington, KY, U.S.A. · University of Pittsburgh, Hillman Cancer Center, Pittsburgh, PA, U.S.A. · Moffitt Cancer Center, Tampa, FL, U.S.A. · The University of Texas, MD Anderson Cancer Center, Houston, TX, U.S.A. · University of Miami, Sylvester Comprehensive Cancer Center, Miami, FL, U.S.A. phosein@miami.edu. ·Anticancer Res · Pubmed #29970528.

ABSTRACT: BACKGROUND/AIM: Combination nab-paclitaxel/gemcitabine (AG) is superior to gemcitabine in patients with metastatic pancreatic cancer (PC). There are limited data for AG in borderline resectable (BR) or locally advanced pancreatic cancer (LAPC). Herein, we report our experience with neoadjuvant AG for BR/LAPC in patients ineligible for FOLFIRINOX. PATIENTS AND METHODS: This retrospective series, included patients with BR/LAPC who received AG as neoadjuvant therapy for 3-4 months followed by radiation, then re-evaluation for surgery. RESULTS: Between 10/2013-2/2018, 32 patients (22 BR, 10 LAPC) were treated with this approach. Median age was 70 years. Nine patients were converted to resectability by imaging; six had R0 resections (19%), five (16%) achieved a partial response and 24 (75%) had stable disease. CONCLUSION: In this small series, the R0 resection rate and response rate were 19% and 16% respectively. These data suggest that neoadjuvant AG may be an alternate option for patients ineligible for FOLFIRINOX.

9 Article The 2018

Palacio, Sofia / Hosein, Peter J / Reis, Isildinha / Akunyili, Ikechukwu I / Ernani, Vinicius / Pollack, Terri / Macintyre, Jessica / Restrepo, Maria H / Merchan, Jaime R / Rocha Lima, Caio M. ·Department of Medicine, University of Miami Miller School of Medicine and Sylvester Comprehensive Cancer Center, Miami, FL, USA. · Department of Medicine, University of Nebraska Medical Center, Omaha, NE, USA. · Division of Oncology, Gibbs Comprehensive Cancer Center and Research Institute, Spartanburg, SC, USA. ·J Gastrointest Oncol · Pubmed #29564179.

ABSTRACT: The phase III MPACT trial for metastatic pancreatic cancer (PC) showed improved overall survival (OS), progression free survival (PFS) and response rates (RRs) for first-line

10 Article Effect of complications on oncologic outcomes after pancreaticoduodenectomy for pancreatic cancer. 2017

Le, Anh-Thu / Huang, Bin / Hnoosh, Dima / Saeed, Hayder / Dineen, Sean P / Hosein, Peter J / Durbin, Eric B / Kudrimoti, Mahesh / McGrath, Patrick C / Tzeng, Ching-Wei D. ·Department of Surgery, University of Kentucky, Lexington, Kentucky. · Department of Biostatistics, University of Kentucky, Lexington, Kentucky. · Department of Internal Medicine, University of Kentucky, Lexington, Kentucky. · Department of Internal Medicine, University of Kentucky, Lexington, Kentucky; Department of Medicine, Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida. · Department of Radiation Medicine, University of Kentucky, Lexington, Kentucky. · Department of Surgery, University of Kentucky, Lexington, Kentucky; Department of Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: CDTzeng@mdanderson.org. ·J Surg Res · Pubmed #28624029.

ABSTRACT: BACKGROUND: Although adjuvant therapy (AT) is a necessary component of multimodality therapy for pancreatic ductal adenocarcinoma (PDAC), its application can be hindered by post-pancreaticoduodenectomy (PD) complications. The primary aim of this study was to evaluate the impact of post-PD complications on AT utilization and overall survival (OS). METHODS: Patients undergoing PD without neoadjuvant therapy for stages I-III PDAC at a single institution (2007-2015) were evaluated. Ninety-day postoperative major complications (PMCs) were defined as grade ≥3. Records were linked to the Kentucky Cancer Registry for AT/OS data. Early AT was given <8 wk; late 8-16 wk. Initiation >16 wk was not considered to be AT. Complication effects on AT timing/utilization and OS were evaluated. RESULTS: Of 93 consecutive patients treated with surgery upfront with AT data, 64 (69%) received AT (41 [44%] early; 23 [25%] late). There were 32 patients (34%) with low-grade complications and 24 (26%) with PMC. With PMC, only six of 24 patients (25%) received early AT and 13 of 24 (54%) received any (early/late) AT versus 35 of 69 (51%) early AT and 51 of 69 (74%) any AT without PMC. PMCs were associated with worse median OS (7.1 versus 24.6 mo, without PMC, P < 0.001). Independent predictors of OS included AT (hazard ratio [HR]: 0.48), tumor >2 cm (HR: 3.39), node-positivity (HR: 2.16), and PMC (HR: 3.69, all P < 0.02). CONCLUSIONS: Independent of AT utilization and biologic factors, PMC negatively impacted OS in patients treated with surgery first. These data suggest that strategies to decrease PMC and treatment sequencing alternatives to increase multimodality therapy rates may improve oncologic outcomes for PDAC.

11 Article Percutaneous Image-Guided Irreversible Electroporation for the Treatment of Unresectable, Locally Advanced Pancreatic Adenocarcinoma. 2017

Narayanan, Govindarajan / Hosein, Peter J / Beulaygue, Isabelle C / Froud, Tatiana / Scheffer, Hester J / Venkat, Shree R / Echenique, Ana M / Hevert, Elizabeth C / Livingstone, Alan S / Rocha-Lima, Caio M / Merchan, Jaime R / Levi, Joseph U / Yrizarry, Jose M / Lencioni, Riccardo. ·Department of Interventional Radiology, University of Miami Miller School of Medicine, 1475 NW 12th Avenue, C-080, Miami, FL 33136. Electronic address: gnarayanan@med.miami.edu. · Division of Medical Oncology, Department of Medicine, University of Kentucky, Lexington, Kentucky. · Department of Interventional Radiology, University of Miami Miller School of Medicine, 1475 NW 12th Avenue, C-080, Miami, FL 33136. · Department of Radiology and Nuclear Medicine, VU University Medical Center Amsterdam, Amsterdam, The Netherlands. · Department of Radiology, Jackson Memorial Hospital, Miami, Florida. · Department of Medicine, Sylvester Comprehensive Cancer Center, and Department of Surgery, University of Miami Miller School of Medicine, 1475 NW 12th Avenue, C-080, Miami, FL 33136. · Division of Oncology, Gibbs Cancer Center & Research Institute, Spartanburg, South Carolina. · Division of Medical Oncology, University of Miami Miller School of Medicine, 1475 NW 12th Avenue, C-080, Miami, FL 33136. ·J Vasc Interv Radiol · Pubmed #27993507.

ABSTRACT: PURPOSE: To describe safety and effectiveness of percutaneous irreversible electroporation (IRE) for treatment of unresectable, locally advanced pancreatic adenocarcinoma (LAPC). MATERIALS AND METHODS: This retrospective study included 50 patients (23 women, 27 men; age range, 46-91 y; median age, 62.5 y) with biopsy-proven, unresectable LAPC who received percutaneous computed tomography (CT)-guided IRE. The primary objective was to assess the safety profile of the procedure; the secondary objective was to determine overall survival (OS). All patients had prior chemotherapy (1-5 lines, median 2), and 30 (60%) of 50 patients had prior radiation therapy. Follow-up included CT at 1 month and at 3-month intervals thereafter. RESULTS: There were no treatment-related deaths and no 30-day mortality. Serious adverse events occurred in 10 (20%) of 50 patients (abdominal pain [n = 7], pancreatitis [n = 1], sepsis [n = 1], gastric leak [n = 1]). Median OS was 27.0 months (95% confidence interval [CI], 22.7-32.5 months) from time of diagnosis and 14.2 months (95% CI, 9.7-16.2 months) from time of IRE. Patients with tumors ≤ 3 cm (n = 24) had significantly longer median OS than patients with tumors > 3 cm (n = 26): 33.8 vs 22.7 months from time of diagnosis (P = .002) and 16.2 vs 9.9 months from time of IRE (P = .031). Tumor size was confirmed as the only independent predictor of OS at multivariate analysis. CONCLUSIONS: Percutaneous image-guided IRE of unresectable LAPC is associated with an acceptable safety profile.

12 Article Defining the optimal timing of adjuvant therapy for resected pancreatic adenocarcinoma: A statewide cancer registry analysis. 2016

Saeed, Hayder / Hnoosh, Dima / Huang, Bin / Durbin, Eric B / McGrath, Patrick C / Desimone, Philip / Maynard, Erin / Anthony, Lowell B / Dineen, Sean P / Hosein, Peter J / Tzeng, Ching-Wei D. ·Department of Internal Medicine, University of Kentucky Medical Center, Lexington, Kentucky. · Department of Surgery, University of Kentucky Medical Center, Lexington, Kentucky. · Department of Biostatistics, College of Public Health, Lexington, Kentucky. · Kentucky Cancer Registry, Markey Cancer Center, Lexington, Kentucky. · Department of Surgery, Oregon Health and Science University, Portland, Oregon. ·J Surg Oncol · Pubmed #27238300.

ABSTRACT: BACKGROUND: Long-term results of the ESPAC-3 trial suggest that while completing adjuvant therapy (AT) is necessary after resection of pancreatic ductal adenocarcinoma (PDAC), early initiation (within 8 weeks) may not be associated with improved overall survival (OS). The primary aim of this study was to evaluate the OS impact of early versus late AT in a statewide analysis. METHODS: Patients with stages I-III PDAC in the Kentucky Cancer Registry (KCR) from 2004 to 2013, were evaluated. Those undergoing pancreatectomy were stratified into two groups ("early," <8 weeks, vs. "late," 8-16 weeks). RESULTS: Of 2,221 diagnosed patients with stages I-III, 831 (37.4%) underwent pancreatectomy upfront. Of these, only 420 (50.5%) received AT. Initiation date of AT was not associated with OS (median OS: early, 20.2 vs. late, 19.0 months, P = 0.97). On multivariate analysis, factors that affected OS included stage (II, HR-1.82, P = 0.017; III, HR-3.77, P < 0.001), node positivity (HR-1.51, P = 0.004), poorly/undifferentiated grade (HR-1.34; P = 0.011), but not AT initiation date. CONCLUSIONS: In this statewide analysis, there was no difference in OS between early and late AT initiation for resected PDAC. The ideal window for AT initiation remains unknown as tumor biology continues to trump regimens from the past decade. J. Surg. Oncol. 2016;114:451-455. © 2016 Wiley Periodicals, Inc.

13 Article Full dose neoadjuvant FOLFIRINOX is associated with prolonged survival in patients with locally advanced pancreatic adenocarcinoma. 2015

Khushman, Moh'd / Dempsey, Naomi / Maldonado, Jennifer Cudris / Loaiza-Bonilla, Arturo / Velez, Michel / Carcas, Lauren / Dammrich, Daniel / Hurtado-Cordovi, Jorge / Parajuli, Ritesh / Pollack, Terri / Harwood, Ana P / Macintyre, Jessica / Tzeng, Ching-Wei D / Merchan, Jaime R / Restrepo, Maria H / Akunyili, Ikechukwu I / Ribeiro, Afonso / Narayanan, Govindarajan / Portelance, Lorraine / Sleeman, Danny / Levi, Joe U / Lima, Caio M S Rocha / Hosein, Peter J. ·University of Miami, Sylvester Comprehensive Cancer Center, Miami, FL, USA. · Pontificia Universidad Javeriana, Bogota, CO, USA. · University of Pennsylvania, Abramson Cancer Center, Philadelphia, PA, USA. · Memorial Cancer Institute, Hollywood, FL, USA. · Florida Cancer Care, Boca Raton, FL, USA. · University of Kentucky, Markey Cancer Center, Lexington, KY, USA. · University of Kentucky, Markey Cancer Center, Lexington, KY, USA. Electronic address: Peter.Hosein@uky.edu. ·Pancreatology · Pubmed #26412296.

ABSTRACT: BACKGROUND: The efficacy of FOLFIRINOX for metastatic pancreatic cancer has led to its use in patients with earlier stages of disease. This study retrospectively analyzed a cohort of patients with locally-advanced pancreatic cancer (LAPC) treated with FOLFIRINOX. METHODS: Between 2008 and 2013, 51 treatment-naïve patients with LAPC at a single institution received first-line FOLFIRINOX with neoadjuvant intent, at the full dose as described in the PRODIGE 4/ACCORD 11 study. Combined chemoradiation was administered for those who remained unresectable after maximum response to chemotherapy. The primary outcome measure was overall survival (OS), and secondary outcomes were progression-free survival (PFS) and margin-negative (R0) resection rate, and toxicity profile. RESULTS: A total of 429 cycles of FOLFIRINOX were given with a median of 8 cycles (range 2-29) per patient; 66% of cycles were full dose. After chemotherapy, 27 (53%) received chemoradiation. The median OS was 35.4 months (95% CI 25.8-45). Ten (4 borderline resectable and 6 unresectable) patients had successful R0 resections; those who had R0 resections had a significantly longer survival than those who did not (3-year OS rate 67% versus 21%, log rank p = 0.042). Increasing number of full-dose cycles was significantly associated with increased survival. The toxicity profile was similar to previous reports of this regimen. CONCLUSIONS: FOLFIRINOX is feasible as neoadjuvant therapy for LAPC. Although the R0 resection rate was only 20%, the median OS of almost 3 years appears promising. Dose intensity and duration were associated with increased survival in this study, arguing against dose attenuated versions of this regimen.

14 Article A retrospective study of neoadjuvant FOLFIRINOX in unresectable or borderline-resectable locally advanced pancreatic adenocarcinoma. 2012

Hosein, Peter J / Macintyre, Jessica / Kawamura, Carolina / Maldonado, Jennifer Cudris / Ernani, Vinicius / Loaiza-Bonilla, Arturo / Narayanan, Govindarajan / Ribeiro, Afonso / Portelance, Lorraine / Merchan, Jaime R / Levi, Joe U / Rocha-Lima, Caio M. ·Department of Medicine, Division of Hematology/Oncology, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL, USA. phosein@med.miami.edu ·BMC Cancer · Pubmed #22642850.

ABSTRACT: BACKGROUND: 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (FOLFIRINOX) is superior to gemcitabine in patients with metastatic pancreatic cancer who have a good performance status. We investigated this combination as neoadjuvant therapy for locally advanced pancreatic cancer (LAPC). METHODS: In this retrospective series, we included patients with unresectable LAPC who received neoadjuvant FOLFIRINOX with growth factor support. The primary analysis endpoint was R0 resection rate. RESULTS: Eighteen treatment-naïve patients with unresectable or borderline resectable LAPC were treated with neoadjuvant FOLFIRINOX. The median age was 57.5 years and all had ECOG PS of 0 or 1. Eleven (61 %) had tumors in the head of the pancreas and 9 (50 %) had biliary stents placed prior to chemotherapy. A total of 146 cycles were administered with a median of 8 cycles (range 3-17) per patient. At maximum response or tolerability, 7 (39 %) were converted to resectability by radiological criteria; 5 had R0 resections, 1 had an R1 resection, and 1 had unresectable disease. Among the 11 patients who remained unresectable after FOLFIRINOX, 3 went on to have R0 resections after combined chemoradiotherapy, giving an overall R0 resection rate of 44 % (95 % CI 22-69 %). After a median follow-up of 13.4 months, the 1-year progression-free survival was 83 % (95 % CI 59-96 %) and the 1-year overall survival was 100 % (95 % CI 85-100 %). Grade 3/4 chemotherapy-related toxicities were neutropenia (22 %), neutropenic fever (17 %), thrombocytopenia (11 %), fatigue (11 %), and diarrhea (11 %). Common grade 1/2 toxicities were neutropenia (33 %), anemia (72 %), thrombocytopenia (44 %), fatigue (78 %), nausea (50 %), diarrhea (33 %) and neuropathy (33 %). CONCLUSIONS: FOLFIRINOX followed by chemoradiotherapy is feasible as neoadjuvant therapy in patients with unresectable LAPC. The R0 resection rate of 44 % in this population is promising. Further studies are warranted.