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Pancreatic Neoplasms: HELP
Articles by Jeffrey M. Hardacre
Based on 13 articles published since 2008
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Between 2008 and 2019, Jeffrey Hardacre wrote the following 13 articles about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 Guideline Pancreatic Adenocarcinoma, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology. 2017

Tempero, Margaret A / Malafa, Mokenge P / Al-Hawary, Mahmoud / Asbun, Horacio / Bain, Andrew / Behrman, Stephen W / Benson, Al B / Binder, Ellen / Cardin, Dana B / Cha, Charles / Chiorean, E Gabriela / Chung, Vincent / Czito, Brian / Dillhoff, Mary / Dotan, Efrat / Ferrone, Cristina R / Hardacre, Jeffrey / Hawkins, William G / Herman, Joseph / Ko, Andrew H / Komanduri, Srinadh / Koong, Albert / LoConte, Noelle / Lowy, Andrew M / Moravek, Cassadie / Nakakura, Eric K / O'Reilly, Eileen M / Obando, Jorge / Reddy, Sushanth / Scaife, Courtney / Thayer, Sarah / Weekes, Colin D / Wolff, Robert A / Wolpin, Brian M / Burns, Jennifer / Darlow, Susan. · ·J Natl Compr Canc Netw · Pubmed #28784865.

ABSTRACT: Ductal adenocarcinoma and its variants account for most pancreatic malignancies. High-quality multiphase imaging can help to preoperatively distinguish between patients eligible for resection with curative intent and those with unresectable disease. Systemic therapy is used in the neoadjuvant or adjuvant pancreatic cancer setting, as well as in the management of locally advanced unresectable and metastatic disease. Clinical trials are critical for making progress in treatment of pancreatic cancer. The NCCN Guidelines for Pancreatic Adenocarcinoma focus on diagnosis and treatment with systemic therapy, radiation therapy, and surgical resection.

2 Editorial Preface. 2016

Hardacre, Jeffrey M. ·Associate Professor of Surgery, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106, USA. Electronic address: jeffrey.hardacre@uhhospitals.org. ·Surg Clin North Am · Pubmed #27865289.

ABSTRACT: -- No abstract --

3 Review Surgical Therapy for Pancreatic and Periampullary Cancer. 2016

Ammori, John B / Choong, Kevin / Hardacre, Jeffrey M. ·Division of Surgical Oncology, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106, USA. Electronic address: john.ammori@uhhospitals.org. · Division of Surgical Oncology, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106, USA. ·Surg Clin North Am · Pubmed #27865277.

ABSTRACT: Surgery is the key component of treatment for pancreatic and periampullary cancers. Pancreatectomy is complex, and there are numerous perioperative and intraoperative factors that are important for achieving optimal outcomes. This article focuses specifically on key aspects of the surgical management of periampullary and pancreatic cancers.

4 Review Organ-sparing pancreatectomy for synchronous pancreatic intraductal papillary mucinous neoplasms. 2014

Fathi, Amir H / Uhm, Suji / Hardacre, Jeffrey M. ·Department of Surgery, University Hospitals Case Medical Center and Case Western Reserve University, Cleveland, Ohio, USA. ·Am Surg · Pubmed #25513902.

ABSTRACT: -- No abstract --

5 Clinical Trial Addition of algenpantucel-L immunotherapy to standard adjuvant therapy for pancreatic cancer: a phase 2 study. 2013

Hardacre, Jeffrey M / Mulcahy, Mary / Small, William / Talamonti, Mark / Obel, Jennifer / Krishnamurthi, Smitha / Rocha-Lima, Caio S / Safran, Howard / Lenz, Heinz-Joseph / Chiorean, E Gabriela. ·Department of Surgery, University Hospitals Seidman Cancer Center and Case Western Reserve University, 11100 Euclid Avenue, Cleveland, OH 44106, USA. jeffrey.hardacre@UHhospitals.org ·J Gastrointest Surg · Pubmed #23229886.

ABSTRACT: BACKGROUND: Despite continued investigation, limited progress has been made in the adjuvant treatment of resected pancreatic cancer. Novel or targeted therapies are needed. METHODS: Multi-institutional, open-label, dose-finding, phase 2 trial evaluating the use of algenpantucel-L (NewLink Genetics Corporation, Ames, IA) immunotherapy in addition to chemotherapy and chemoradiotherapy in the adjuvant setting for resected pancreatic cancer (ClinicalTrials.gov identifier, NCT00569387). The primary outcome was 12-month disease-free survival. Secondary outcomes included overall survival and toxicity. RESULTS: Seventy patients were treated with gemcitabine and 5-fluorouracil-based chemoradiotherapy as well as algenpantucel-L (mean 12 doses, range 1-14). After a median follow-up of 21 months, the 12-month disease-free survival was 62 %, and the 12-month overall survival was 86 %. The most common adverse events were injection site pain and induration. CONCLUSIONS: The addition of algenpantucel-L to standard adjuvant therapy for resected pancreatic cancer may improve survival. A multi-institutional, phase 3 study is ongoing (ClinicalTrials.gov identifier, NCT01072981).

6 Article Surgery for Localized Pancreatic Cancer: The Trend Is Not Improving. 2016

Strohl, Madeleine P / Raigani, Siavash / Ammori, John B / Hardacre, Jeffrey M / Kim, Julian A. ·From the *School of Medicine, Case Western Reserve University; and †Division of Surgical Oncology, Department of Surgery, University Hospitals Seidman Cancer Center, Cleveland, OH. ·Pancreas · Pubmed #26491905.

ABSTRACT: OBJECTIVES: The aim of this study was to examine the trend in the use of surgery for localized pancreatic adenocarcinoma for the past 2 decades using the Surveillance, Epidemiology, and End Results database. METHODS: We identified a cohort of patients who received a diagnosis of localized pancreatic adenocarcinoma between 1988 and 2010 in the United States. Univariate and multivariate methods were used to determine factors associated with not receiving surgery. Cox proportional hazards regression modeling was used to determine factors associated with survival. RESULTS: Of 6742 patients with a diagnosis of localized pancreatic adenocarcinoma, 1715 patients (25.4%) underwent surgery. There was no significant change in use of surgery over time. Patients were less likely to undergo surgery if they were older than 50 years, black, unmarried, and located outside the East and had pancreatic head or body lesions, higher tumor grades, or tumor size greater than 2 cm (P < 0.0001). Receiving surgery had the most significant impact on the hazard of disease-specific death (hazards ratio, 1.41; 95% confidence interval, 1.29-1.53; P < 0.0001). CONCLUSIONS: In contrast to recent studies that suggest an increasing use of surgery, the present study demonstrates that there has been no change in the rate of use of surgery in patients with localized pancreatic disease.

7 Article Starting a High-Quality Pancreatic Surgery Program at a Community Hospital. 2015

Hardacre, Jeffrey M / Raigani, Siavash / Dumot, John. ·Division of Surgical Oncology, University Hospitals Case Medical Center, 11100 Euclid Avenue, Cleveland, OH, 44106, USA. jeffrey.hardacre@UHhospitals.org. · Case Western Reserve University School of Medicine, Cleveland, OH, USA. · Division of Gastroenterology, University Hospitals Ahuja Medical Center, Beachwood, OH, USA. ·J Gastrointest Surg · Pubmed #26358277.

ABSTRACT: BACKGROUND: Most literature suggests that pancreatic resections should be done by high-volume surgeons at high-volume hospitals to optimize patient outcomes. However, patient preference and insurance requirements may restrict hospital location. After careful planning, a high-volume pancreatic surgeon started performing pancreatectomies at a community hospital. METHODS: Sixty pancreatectomies were performed at an academic medical center and 28 at a 144-bed community, non-teaching hospital. Sixty-day outcomes were recorded. RESULTS: There were no statistically significant differences between the academic medical center and community hospital with regard to the median age of the patients (66 vs. 61 years), the gender distribution (57 vs. 64 % female), or the median BMI (28 vs. 26 kg/m(2)). There was a significant difference in the American Society of Anesthesiologists class distribution between the academic medical center and community hospital (1; 0 vs. 4 %, 2; 7 vs. 21 %, 3; 88 vs. 75 %, 4; 5 vs. 0 %, p = 0.006). The median length of stay (LOS) for 17 pancreaticoduodenectomy/total pancreatectomy patients at the community hospital was significantly less than for 39 patients at the academic medical center (5 vs. 7 days, p = 0.006). Eleven distal pancreatectomy/splenectomy patients at the community hospital tended to have a shorter median LOS than 21 patients at the academic medical center (4 vs. 5 days, p = 0.25). Accordion ≥ 3 complications (7 vs. 27 %) and readmissions (11 vs. 22 %) tended to be lower at the community hospital than the academic medical center. Greater than 80 % of patients with adenocarcinoma at both hospital settings who were recommended to receive adjuvant therapy started their treatment within 60 days of surgery. CONCLUSIONS: With appropriate planning and careful patient selection, high-quality pancreatic surgery can be performed at a community hospital by a high-volume pancreatic surgeon.

8 Article Trends in the treatment of resectable pancreatic adenocarcinoma. 2014

Raigani, Siavash / Ammori, John / Kim, Julian / Hardacre, Jeffrey M. ·Department of Surgery, Division of Surgical Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, 11100 Euclid Avenue, Cleveland, OH, 44106, USA. ·J Gastrointest Surg · Pubmed #24002769.

ABSTRACT: BACKGROUND: Multiple prospective, randomized trials have demonstrated that the addition of adjuvant therapy after surgical resection of pancreatic cancer improves survival compared to surgery alone. However, the optimal type of adjuvant therapy, chemotherapy alone, or chemotherapy combined with chemoradiation therapy remains controversial. Our aim was to examine the treatment trends for surgically resectable (stages I and II) pancreatic cancer in the USA using the National Cancer Database. METHODS: The National Cancer Database (NCDB) is a national oncology outcomes database for over 1,500 Commission on Cancer accredited cancer programs. Patients diagnosed with stage I-II pancreatic adenocarcinoma between 2003 and 2010 were selected from the NCDB Hospital Comparison Benchmark Reports. Attention was paid to the initial treatment regimen, such as surgery alone, surgery plus chemotherapy, or surgery plus chemoradiation. In addition, data on hospital setting (teaching hospitals vs. community hospitals) were collected and analyzed. The Cochran-Armitage test for trend was used to assess changes in treatment over time. RESULTS: Fifty-nine thousand ninety-four patients with stage I-II pancreatic adenocarcinoma were included in the analysis. Between 2003 and 2010, the use of surgery alone as first course treatment of stage II disease decreased significantly at both teaching hospitals and community hospitals among patients who underwent surgery (P < 0.0001 for both cases). In the same period, the use of chemotherapy in addition to surgery as treatment of stage I and II disease increased at least twofold at both hospital settings (P < 0.0001 for all cases). Treatment with surgery plus chemoradiation decreased significantly for both stages in both hospital settings (P < 0.0001 for all cases). Nonsurgical treatment for stage II disease was surprisingly high and significantly increased over time (P < 0.001 for both hospital types), ranging from approximately 30-37 % at teaching hospitals and 39-47 % at community hospitals. CONCLUSION: Data from the NCDB from 2003 to 2010 illustrate changes in the adjuvant treatment of pancreatic cancer. The use of chemotherapy alone as adjuvant therapy increased whereas the use of multimodality therapy decreased. In addition, there remains an alarmingly high rate of nonsurgical therapy for stage I and II disease.

9 Article A dual-institution randomized controlled trial of remnant closure after distal pancreatectomy: does the addition of a falciform patch and fibrin glue improve outcomes? 2013

Carter, Timothy I / Fong, Zhi Ven / Hyslop, Terry / Lavu, Harish / Tan, Wei Phin / Hardacre, Jeffrey / Sauter, Patricia K / Kennedy, Eugene P / Yeo, Charles J / Rosato, Ernest L. ·Department of Surgery and the Jefferson Pancreas, Biliary and Related Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA. ·J Gastrointest Surg · Pubmed #22798186.

ABSTRACT: OBJECTIVE: The objective of the study was to assess the efficacy of two pancreatic remnant closure techniques following distal pancreatectomy: (1) stapled or sutured closure versus (2) stapled or sutured closure plus falciform patch and fibrin glue reinforcement in the setting of a prospective randomized trial, with the primary endpoint being pancreatic fistula. Pancreatic stump leak following left-sided pancreatic resection (distal pancreatectomy) remains common. Despite multiple and varied techniques for closure, the reported leak rate varies up to 30 %. A retrospective analysis by Iannitti et al. (J Am Coll Surg 203(6):857-864, 2006) detected a decreased leak rate in patients receiving a traditional closure buttressed with an autologous falciform ligament patch and fibrin glue. METHODS: Between April 2008 and October 2011, all willing patients scheduled to undergo distal pancreatectomy at the authors' institutions were consented and enrolled at the preoperative office visit. Patients were intraoperatively stratified as having hard or soft glands and randomized to one of two groups: (1) closure utilizing stapling or suturing (SS) versus (2) stapled or sutured plus falciform ligament patch and fibrin glue (FF). The trial design and power analysis (α = 0.05, β = 0.2, power 80 %, chi-square test) hypothesized that the FF intervention would reduce the primary endpoint (pancreatic fistula) from 30 % to 15 % and targeted an accrual goal of 190 patients. Secondary endpoints included length of postoperative hospital stay, 30-day mortality, hospital readmission, and ISGPF fistula grade (A, B, and C). RESULTS: The trial accrued 109 patients, 55 in the SS group and 54 in the FF group. Enrollment was closed prior to the target accrual, following an interim analysis and futility calculation. Due to insufficient enrollment, patients stratified as having a hard gland were excluded (n = 8) from analysis, leaving 101 patients in the soft stratum. The overall pancreatic leak rate was 19.8 % (20 patients) for patients with soft glands. Patients randomized to the FF group had a leak rate of 20 %, as compared with 19.6 % in the SS group (p = 1.000). Fistula grades in both groups were identical: 1A, 8B, and 1C in the FF group as compared to 1A, 8B, and 1C in the SS group. Complication rates were comparable between the two groups. The median length of postoperative hospital stay was 5 days in both groups. There was a trend towards a higher 30-day readmission rate in the FF group (28 % vs. 17.6 %, p = 0.243). CONCLUSION: The addition of a falciform ligament patch and fibrin glue to standard stapled or sutured remnant closure did not reduce the rate or severity of pancreatic fistula in patients undergoing distal pancreatectomy (ClinicalTrials.gov NCT00889213).

10 Article Stereotactic body radiation therapy for nonresectable tumors of the pancreas. 2012

Goyal, Kush / Einstein, Douglas / Ibarra, Rafael A / Yao, Min / Kunos, Charles / Ellis, Rod / Brindle, James / Singh, Deepjot / Hardacre, Jeffrey / Zhang, Yuxia / Fabians, Jeffrey / Funkhouser, Gary / Machtay, Mitchell / Sanabria, Juan R. ·Department of Surgery, University Hospitals-Case Medical Center, Case Western Reserve University, Cleveland, Ohio 44106, USA. ·J Surg Res · Pubmed #21937061.

ABSTRACT: BACKGROUND: Stereotactic body radiation therapy (SBRT) has emerged as a potential treatment option for local tumor control of primary malignancies of the pancreas. We report on our experience with SBRT in patients with pancreatic adenocarcinoma who were found not to be candidates for surgical resection. METHODS: The prospective database of the first 20 consecutive patients receiving SBRT for unresectable pancreatic adenocarcinomas and a neuroendocrine tumor under an IRB approved protocol was reviewed. Prior to SBRT, cylindrical solid gold fiducial markers were placed within or around the tumor endoscopically (n = 13), surgically (n = 4), or percutaneously under computerized tomography (CT)-guidance (n = 3) to allow for tracking of tumor during therapy. Mean radiation dose was 25 Gray (Gy) (range 22-30 Gy) delivered over 1-3 fractions. Chemotherapy was given to 68% of patients in various schedules/timing. RESULTS: Patients had a mean gross tumor volume of 57.2 cm(3) (range 10.1-118 cm(3)) before SBRT. The mean total gross tumor volume reduction at 3 and 6 mo after SBRT were 21% and 38%, respectively (P < 0.05). Median follow-up was 14.57 mo (range 5-23 mo). The overall rate of freedom from local progression at 6 and 12 mo were 88% and 65%. The probability of overall survival at 6 and 12 mo were 89% and 56%. No patient had a complication related to fiducial markers placement regardless of modality. The rate of radiation-induced adverse events was: grade 1-2 (11%) and grade 3 (16%). There were no grade 4/5 adverse events seen. CONCLUSION: Our preliminary results showed SBRT as a safe and likely effective local treatment modality for pancreatic primary malignancy with acceptable rate of adverse events.

11 Article Pancreatic resection in octogenarians. 2009

Hardacre, Jeffrey M / Simo, Kerri / McGee, Michael F / Stellato, Thomas A / Schulak, James A. ·Department of Surgery, University Hospitals Case Medical Center, Cleveland, OH 44106-5047, USA. jeffrey.hardacre@UHhospitals.org ·J Surg Res · Pubmed #19592032.

ABSTRACT: BACKGROUND: Few studies exist that evaluate outcomes of pancreatectomy in patients > or =80 y of age, an age group increasing in size in the United States. This study analyzes the outcomes of pancreatectomy in patients > or =80 y of age. METHODS: The medical records of 32 patients > or =80 y of age undergoing pancreatectomy at our institution from April 1995 through October 2008 were reviewed, and outcomes were analyzed. RESULTS: The median patient age was 82 y, and 75% were ASA Class 3. Eighty-one percent of the resections were pancreaticoduodenectomies. There were no operative deaths. Sixty-six percent of patients suffered at least one complication. The median length of stay was 11 d. Eighty-one percent of the resections were performed for cancer. Median survival for all patients was 14.4 mo. Median survival for patients with cancer was 12 mo versus 103 mo for patients without cancer, P = 0.017. CONCLUSIONS: Pancreatectomy in patients > or =80 y of age can be performed with a low risk of mortality but with significant morbidity.

12 Article The impact of resection margin status and postoperative CA19-9 levels on survival and patterns of recurrence after postoperative high-dose radiotherapy with 5-FU-based concurrent chemotherapy for resectable pancreatic cancer. 2008

Kinsella, Timothy J / Seo, Yuji / Willis, Joseph / Stellato, Thomas A / Siegel, Christopher T / Harpp, Deborah / Willson, James K / Gibbons, Joseph / Sanabria, Juan R / Hardacre, Jeffrey M / Schulak, James P. ·Department of Radiation Oncology, University Hospitals Case Medical Center, Cleveland, OH 44106-6068, USA. timothy.kinsella@uhhospitals.org ·Am J Clin Oncol · Pubmed #18838880.

ABSTRACT: OBJECTIVES: To analyze the impact of surgical margins and other clinicopathological data on treatment outcomes on 75 patients treated from 1999 to 2006 by initial potentially curative surgery (+/- intraoperative radiotherapy), followed by high-dose 3-dimensional conformal radiation therapy and concomitant fluoropyrimidine-based chemoradiotherapy. MATERIALS AND METHODS: All clinical and pathologic data on this patient cohort were analyzed by actuarial Kaplan-Meier survival methodology and by univariate and multivariate Cox proportional hazards methods to measure effects on survival and patterns of failure. RESULTS: With a median follow-up of 28 months, the median, 2-year and 5-year overall survival (OS) rates were 18.1 month, 41% and 23.6%, respectively. Disease-free survival (DFS) rates were of 11.4 months, 35% and 20%, respectively. Only 2 clinicopathological features, positive (< or =1 mm) surgical margins (P < 0.05) and a 2-fold (>70 U/mL) elevation of the postoperative serum CA19-9 (P < 0.001) impacted OS and disease-free survival. In patients with negative (>1 mm) surgical margins and a low (< or =70 U/mL) postoperative CA19-9, the projected 2- and 5-year OS were 80% and 65%, respectively, compared with 40% and 10% with positive surgical margins and a low CA19-9 and to 10% and 0% with positive or negative surgical margins and a high (>70 U/mL) CA19-9. Positive surgical margins (P < 0.001) and an elevated postoperative CA19-9 (P < 0.001) also predicted early development of distant metastases, whereas isolated loco-regional failure was less common and not affected by these or other clinicopathological features. CONCLUSIONS: Using this fluoropyrimidine-based chemoradiotherapy regimen after surgical resection (+/- intraoperative radiotherapy), positive surgical margins and an elevated (2-fold) postoperative serum CA19-9 level predicted for reduced survival and early development of distant metastatic disease.

13 Article Early experience with intraoperative radiotherapy in patients with resected pancreatic adenocarcinoma. 2008

Messick, Craig / Hardacre, Jeffrey M / McGee, Michael F / Siegel, Christopher T / Stellato, Thomas A / Sanabria, Juan R / Kinsella, Timothy J / Schulak, James A. ·Department of Surgery, University Hospitals Case Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH 44106-5047, USA. ·Am J Surg · Pubmed #18207129.

ABSTRACT: BACKGROUND: The use of intraoperative radiotherapy (IORT) in patients with resected pancreatic adenocarcinoma has not been clearly defined. METHODS: The medical records of our first 22 patients receiving IORT for resected pancreatic adenocarcinoma (2001 to 2006) were reviewed and compared with the records of 27 consecutive patients not receiving IORT for resected pancreatic adenocarcinoma (2004 to 2006). RESULTS: There were no 30-day mortalities in either group, and complication rates were similar. Local recurrence occurred in 18% in the IORT group (median 14 months) and 12% in the no-IORT group (median 7 months). Distant recurrence occurred in 47% in the IORT group (median 11 months) and 32% in the no-IORT group (median 6.5 months). Median overall, stage-specific, and location-specific survival did not differ between the groups. CONCLUSIONS: Although limited in size and follow-up, our experience showed that complications, recurrence, and survival were not affected by IORT, but time to recurrence may be longer with IORT.