Publications by authors named "Kenneth Meredith"

73 Publications

Comparative outcomes of transthoracic versus transhiatal esophagectomy.

Surgery 2021 07 22;170(1):263-270. Epub 2021 Apr 22.

Sarasota Memorial Institute for Cancer Care, Florida State University College of Medicine, Sarasota, FL. Electronic address:

Background: Surgical resection has become a mainstay of therapy for locally advanced esophageal cancer and can increase survival significantly. With the advancement of minimally invasive surgery, there is still debate on the best approach for esophagectomy. We report a modern analysis of outcomes with transthoracic versus transhiatal esophagectomy.

Methods: A prospectively managed esophagectomy database was queried for patients undergoing transthoracic or transhiatal esophagectomy between 1996 and 2016. Continuous variables were compared using the Kruskal-Wallis or the analysis of variance tests as appropriate. Pearson χ test was used to compare categorical variables. All statistical tests were 2-sided and an α (type I) error < .05 was considered statistically significant.

Results: A total of 846 patients underwent esophagectomy with a median age of 66 (28-86) years. There was no difference in estimated blood loss for transthoracic and transhiatal, but mean operating room times were longer for transthoracic versus transhiatal (P < .001), and the number of retrieved lymph nodes was higher for transthoracic versus transhiatal (P < .002). Postoperative complications occurred in 207 (29%) transthoracic patients vs 59 (44.7%) transhiatal patients, (P < .001). The most common complications in transthoracic versus transhiatal techniques, respectively, were anastomotic leaks: 4.3% vs 9.8%; (P = .01), anastomotic stricture 7% vs 26.5%; (P < .001), and pneumonia 12.6% vs 22.7%; (P < .002). Median survival significantly improved in patients undergoing transthoracic (62 months) vs transhiatal (39 months) P = .03.

Conclusion: We found that a transthoracic approach was associated with lower pneumonias, anastomotic leaks, wound infections, and strictures, with an improvement in nodal harvest. Survival was also significantly improved in patients who underwent transthoracic esophagectomy.
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http://dx.doi.org/10.1016/j.surg.2021.02.036DOI Listing
July 2021

The Florida Pancreas Collaborative Next-Generation Biobank: Infrastructure to Reduce Disparities and Improve Survival for a Diverse Cohort of Patients with Pancreatic Cancer.

Cancers (Basel) 2021 Feb 15;13(4). Epub 2021 Feb 15.

Department of Gastrointestinal Oncology, Brian Jellison Cancer Institute, Sarasota Memorial Hospital, Sarasota, FL 34239, USA.

: Well-annotated, high-quality biorepositories provide a valuable platform to support translational research. However, most biorepositories have poor representation of minority groups, limiting the ability to address health disparities. : We describe the establishment of the Florida Pancreas Collaborative (FPC), the first state-wide prospective cohort study and biorepository designed to address the higher burden of pancreatic cancer (PaCa) in African Americans (AA) compared to Non-Hispanic Whites (NHW) and Hispanic/Latinx (H/L). We provide an overview of stakeholders; study eligibility and design; recruitment strategies; standard operating procedures to collect, process, store, and transfer biospecimens, medical images, and data; our cloud-based data management platform; and progress regarding recruitment and biobanking. : The FPC consists of multidisciplinary teams from fifteen Florida medical institutions. From March 2019 through August 2020, 350 patients were assessed for eligibility, 323 met inclusion/exclusion criteria, and 305 (94%) enrolled, including 228 NHW, 30 AA, and 47 H/L, with 94%, 100%, and 94% participation rates, respectively. A high percentage of participants have donated blood (87%), pancreatic tumor tissue (41%), computed tomography scans (76%), and questionnaires (62%). : This biorepository addresses a critical gap in PaCa research and has potential to advance translational studies intended to minimize disparities and reduce PaCa-related morbidity and mortality.
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http://dx.doi.org/10.3390/cancers13040809DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7919015PMC
February 2021

Multi-agent neoadjuvant chemotherapy improves response and survival in patients with resectable pancreatic cancer.

J Gastrointest Oncol 2020 Oct;11(5):1078-1089

Florida State University College of Medicine, Tallahassee, FL, USA.

Background: We sought to examine the impact of neoadjuvant chemotherapy (NCT), single agent (SA) or multi-agent (MA) chemotherapy, and chemoradiation (NCRT) on response and survival in pancreatic cancer.

Methods: Utilizing the National Cancer Database, we identified patients who underwent resection of the pancreatic head for adenocarcinoma [2006-2013]. Overall survival (OS) analysis was performed using the Kaplan-Meier method. Multivariable cox proportional hazard models (MVA) and propensity score matching (PSM) were developed to identify predictors of survival. For upfront surgery (UFS), OS was limited to receipt of adjuvant treatment.

Results: We identified 26,563 patients who underwent pancreatic head resection: UFS =23,877, NCRT =1,482, and NCT =1,204. MA-NCT was utilized in 77% and after PSM, 52%. There was improved R0 resections and 30-day mortality associated with neoadjuvant therapy compared to UFS. Overall response rate to neoadjuvant therapy was 24%. The highest response rate seen with MA-NCRT. Response rates for SA-NCT, MA-NCT, SA-NCRT, and MA-NCRT were 11.5%, 18.1%, 27.5%, and 33.1% (P=0.01). However, OS was improved with neoadjuvant therapy regardless of response compared to UFS (P=0.03). After PSM, the median OS for UFS, SA-NCT, MA-NCT, SA-NCRT, and MA-NCRT was 21.9, 21.5, 29.8, 25.3, and 25.8 months in all patients (P=0.001). MVA after PSM demonstrated that only MA-NCT was associated with decreased mortality while increasing age, higher Charlson-Deyo index, N1, higher grade, tumor size, and positive margins were associated with higher mortality.

Conclusions: There was improved OS associated with MA-NCT in pancreatic cancer patients compared to UFS with adjuvant therapy. OS was improved regardless of response to therapy.
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http://dx.doi.org/10.21037/jgo.2019.12.03DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657841PMC
October 2020

Neoadjuvant therapy and pancreatic cancer: a national cancer database analysis.

J Gastrointest Oncol 2019 Aug;10(4):663-673

Department of Surgical Oncology, Sarasota Memorial Hospital, Sarasota, FL, USA.

Background: We sought to examine the impact of neoadjuvant chemotherapy (NCT), single agent or multiagent chemotherapy, and neoadjuvant chemoradiation (NCRT) on survival in pancreatic cancer.

Methods: Utilizing the National Cancer Database, we identified patients who underwent pancreatic resection for adenocarcinoma (2006 to 2013). Overall survival (OS) analysis was performed using the Kaplan-Meier method. Multivariable cox proportional hazard models (MVA) and propensity score matching (PSM) were developed to identify predictors of survival. For upfront surgery (UFS), OS was limited to receipt of adjuvant treatment.

Results: We identified 26,563 patients who underwent pancreatic resection: UFS =23,877, NCRT =1,482, and NCT =1,204. Multiagent chemotherapy was utilized in 77% of NCT and 42% of NCRT. There was improved R0 resections associated with neoadjuvant therapy compared to UFS, however, there was no difference between NCT and NCRT. In addition, the was improved R0 with MA-NCT (P<0.001) but not for single agent NCT (P=0.26). After PSM, the median OS for UFS, SA-NCT, MA-NCT, SA-NCRT, and MA-NCRT was 21.9, 21.5, 29.8, 25.3, and 25.8 months in all patients (P=0.001), and 23.6, 23.9, 31.6, 25.9, and 26.6 months in R0 patients (P=0.03), respectively. There was no difference in OS in patients with R1/2 resection. MVA after PSM demonstrated that only MA-NCT was associated with decreased mortality while increasing age, higher Charlson-Deyo index, N1, higher grade, tumor size, and positive margins were associated with higher mortality.

Conclusions: There was improved OS associated with MA-NCT in pancreatic cancer patients compared to UFS with adjuvant therapy.
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http://dx.doi.org/10.21037/jgo.2019.02.09DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6657333PMC
August 2019

Comparative Perioperative Outcomes by Esophagectomy Surgical Technique.

J Gastrointest Surg 2020 06 13;24(6):1261-1268. Epub 2019 Jun 13.

Radiation Oncology, University of Central Florida, Orlando, FL, USA.

Introduction: Surgical resection is vital in the curative management of patients with esophageal cancer. However, a myriad of surgical procedures exists based on surgeon preference and training. We report on the perioperative outcomes based on esophagectomy surgical technique.

Methods: A prospectively managed esophagectomy database was queried for patients undergoing esophagectomy from 1996 and 2016. Basic demographics, tumor characteristics, operative details, and post-operative outcomes were recorded and analyzed by comparison of transhiatal vs Ivor-lewis and minimally invasive (MIE) vs open procedures.

Results: We identified 856 patients who underwent esophagectomy. Neoadjuvant therapy was administered in 543 patients (63.4%). There were 504 (58.8%) open esophagectomies and 302 (35.2%) MIE. There were 13 (1.5%) mortalities and this did not differ among techniques (p = 0.6). While there was no difference in overall complications between MIE and open, complications occurred less frequently in patients undergoing RAIL and MIE IVL compared to other techniques (p = 0.003). Pulmonary complications also occurred less frequently in RAIL and MIE IVL (p < 0.001). Anastomotic leaks were less common in patients who underwent IVL compared to trans-hiatal approaches (p = 0.03). MIE patients were more likely to receive neoadjuvant therapy (p = 0.001), have lower blood loss (p < 0.001), have longer operations (p < 0.001), and higher lymph node harvests (p < 0.001) compared to open patients.

Conclusion: Minimally invasive and robotic Ivor Lewis techniques demonstrated substantial benefits in post-operative complications. Oncologic outcomes similarly favor MIE IVL and RAIL.
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http://dx.doi.org/10.1007/s11605-019-04269-yDOI Listing
June 2020

Comparative outcomes of minimally invasive and robotic-assisted esophagectomy.

Surg Endosc 2020 02 10;34(2):814-820. Epub 2019 Jun 10.

Florida Hospital Cancer Institute, Orlando, USA.

Objective: Minimally invasive esophagectomy (MIE) has demonstrated superior outcomes compared to open approaches. The myriad of techniques has precluded the recommendation of a standard approach. The addition of robotics to esophageal resection has potential benefits. We sought to examine the outcomes with MIE to include robotics.

Methods: Utilizing a prospective esophagectomy database, we identified patients who underwent (MIE) Ivor Lewis via thoracoscopic/laparoscopic (TL), transhiatal (TH), or robotic-assisted Ivor Lewis (RAIL). Patient demographics, tumor characteristics, and complications were analyzed via ANOVA, χ, and Fisher exact where appropriate.

Results: We identified 302 patients who underwent MIE: TL 95 (31.5%), TH 63 (20.8%), and RAIL 144 (47.7%) with a mean age of 65 ± 9.6. The length of operation was longer in the RAIL: TL (299 ± 87), TH (231 ± 65), RAIL (409 ± 104 min), p < 0.001. However, the EBL was lower in the patients undergoing transthoracic approaches (RAIL + TL): TL (189 ± 188 ml), TH (242 ± 380 ml), RAIL (155 ± 107 ml), p = 0.03. Conversion to open was also lower in these patients: TL 7 (7.4%), TH 8 (12.7%), RAIL 0, p < 0.001. The R0 resection rate and lymph node (LN) harvest also favored the RAIL cohort: TL 86 (93.5%), TH 60 (96.8%), and RAIL 144 (100%), p = 0.01; LN: TL 14 ± 7, TH 9 ± 6, and RAIL 20 ± 9, p < 0.001. The overall morbidity was lower in MIE patients that underwent a transthoracic approach vs. transhiatal: TL 29 (30.5%), TH 39 (61.9%), RAIL 34 (23.6%), p < 0.001.

Conclusions: Patients undergoing MIE via thoracoscopic/laparoscopic and robotic transthoracic approaches demonstrated lower EBL, morbidity, and conversion to open compared to the transhiatal approach. Additionally the oncologic outcomes measured by R0 resections and LN harvest also favored the patients who underwent a transthoracic approach.
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http://dx.doi.org/10.1007/s00464-019-06834-7DOI Listing
February 2020

The accuracy of neutrophil to lymphocyte ratio and platelet to lymphocyte ratio as a marker for gastrointestinal malignancies.

J Gastrointest Oncol 2018 Oct;9(5):972-978

Department of Gastrointestinal Oncology, Sarasota Memorial Healthcare System, Sarasota, FL, USA.

Background: Accurate predictors of locally advanced and recurrence disease in patients with gastrointestinal cancer are currently lacking. Neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) have emerged as possible markers for predicting recurrence in these patients. In this study, we sought to evaluate the utility of NLR and PLR in predicting the presence of regional nodal disease, metastasis and systemic recurrence in patients with gastrointestinal malignancies.

Methods: We queried a comprehensive gastrointestinal oncology database to identify patients who had undergone surgery for a GI malignancy. NLR and PLR values were determined via a complete blood count (CBC). In patients treated with neoadjuvant therapy (NT) the NLR and PLR were calculated from CBCs before and after NT and in patients proceeding to surgery within 2 weeks pre-operatively. The associations between NLR and PLR and the clinicopathologic parameters (sex, age, tumor size, differentiation, positive lymph nodes, and metastatic disease) were assessed via χ or Fisher's exact tests where appropriate. All the tests were two-sided, and P<0.05 was considered statistically significant.

Results: We identified 116 patients diagnosed with gastrointestinal malignancies. There were 76 (65.5%) males and 40 (34.5%) females with an average age of 69.4±10.7 years. The mean follow up was 14.1±15.5 months. We identified 49 (42.2%) esophageal, 34 (29.3%) pancreatic, 14 (12.1%) colorectal, 13 (11.2%) gastric, and 6 (5.2%) biliary cancers. There were 36 (31.0%) patients with node negative disease, 52 (44.8%) with node positive and 28 (24.2%) with metastatic disease at surgery. Of the metastatic patients 4 (3.4%) were found at staging laparoscopy and 24 (20.6%) were diagnosed pre-operatively. The median NLR for LN- patient's was 1.78 (0.23-8.2) and for LN+ and metastatic patients was 4.69 (2.27-36), P<0.001. The median PLR for LN- patient's was 123.03 (14-257.69) and for LN+ and metastatic patients was 212.42 (105.45-2,185.18), P<0.001. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for a NLR >2.25 was 98.8%, 72.2%, 89%, and 96% respectively. The sensitivity, specificity, PPV, and NPV for PLR >140 was 95%, 78%, 90%, and 88% respectively. Utilizing both NLR and PLR the sensitivity, specificity, PPV and NPV was increased.

Conclusions: Elevation of NLR and PLR can be used to help identify patients with advanced disease GI malignancies and recurrences after surgery. Additionally, failure of normalization of NLR and PLR 3-month post-surgical resection may indicate early recurrence or persistent disease. Individually, NLR has a higher sensitivity and negative predictive value while PLR has a higher specificity and positive predictive value for distinguishing metastatic disease and node positivity. The combination of NLR and PLR has the highest accuracy of predicting advanced disease among all gastrointestinal malignancies.
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http://dx.doi.org/10.21037/jgo.2018.08.05DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6219984PMC
October 2018

Outcomes associated with robotic approach to pancreatic resections.

J Gastrointest Oncol 2018 Oct;9(5):936-941

Department of Gastrointestinal Oncology, Sarasota Memorial Hospital, Sarasota, FL, USA.

Minimally invasive techniques have improved post-operative outcomes, however, the majority of pancreatic surgery, known for its complexity, is still performed via open approaches. The development of robotics has improved dexterity which may allow for application in more complex surgeries. We queried a prospectively maintained robotic database to identify patients who underwent robotic pancreatic resection by a single surgeon between 2012 and 2016. Patient demographics and operative outcomes were compared using Mann-Whitney U, Kruskal Wallis and Pearson's Chi-square test as appropriate. We identified 119 patients; 65 Whipples [Robotic Whipple (RW)], 43 distal pancreatectomies, 4 total pancreatectomies, 6 pancreatic enucleations, and 1 robotic cyst gastrostomy with a median age of 71 [24-91], median body mass index (BMI) of 27.6 (16.8-40.2), and American society of anesthesiologists (ASA) of 3. The median estimated blood loss (EBL) was 125 [25-800] and loss of heterozygosity (LOH) 6 [1-34]. Mean operative time for RW decreased after 15 cases (578 457 minutes, P<0.004). Conversions to open occurred in 5 (4.2%) patients. In total of 117 (98.3%) patients underwent R0 resections and the median lymph node (LN) harvest was 16 [0-37]. The 30 and 90 days mortality was 1 (0.8%). Major complications (Clavien-Dindo grade 3-5) were seen in 16 (13.4%) cases (20.3%) but decreased steadily as volume increased (case 30). Pancreatic leaks occurred in 14 (11.8%): A, 8 (6.7%); B, 4 (3.4%); and C, 2 (1.7%). Robotic assisted approaches to pancreatic resections is feasible. However, it takes approximately 15 cases before a decrease in operative time and 30 cases before major complications are decreased. These trends in complications are associated with surgeon experience and volume are critical to consider in robotic pancreatic surgery.
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http://dx.doi.org/10.21037/jgo.2018.08.04DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6219977PMC
October 2018

Correlation of tumor size and survival in pancreatic cancer.

J Gastrointest Oncol 2018 Oct;9(5):910-921

Department of Gastrointestinal Oncology, Sarasota Memorial Healthcare System, Sarasota, FL, USA.

Background: Neoadjuvant therapy (NT) for resectable pancreatic adenocarcinoma (PAC) continues to be debated. We sought to establish the relationship between pancreatic tumor size, neoadjuvant chemotherapy (NCT), neoadjuvant chemoradiation (NCRT), and definitive surgery (DS) on survival.

Methods: Utilizing the National Cancer Database we identified patients with PAC who underwent NT and DS. Patient characteristics and survival were compared with Mann-Whitney U, Pearson's Chi-square, and the Kaplan-Meier method. Multivariable analysis (MVA) was developed to identify predictors of survival. All tests were two-sided and α <0.05 was significant.

Results: We identified 11,707 patients: 9,722 patients with tumors >2 cm and 1,985 with tumors ≤2 cm. There were 523 patients treated with NCT, 559 treated with NCRT, and 10,625 DS. Patients with tumors >2 cm were more likely to have higher T-stage, P<0.001, positive lymph nodes, P<0.001, poor histologic grade, P<0.001, and R1 resections, P<0.001. The median survival for patients with tumors ≤2 cm was 30.6 months compared to 20.5 months for those whose tumors were >2 cm, P<0.001. In the >2 cm groups the median survival for NCT, NCRT, and DS was 22.9, 25.8 and 21.3 months, P=0.01. MVA revealed that age, Charlson/Deyo score, N-stage, grade, tumor size >2 cm, R0 resection, and NT were predictors of survival. Ninety-day mortality was worse in both the NCT and NCRT compared to DS, P<0.001.

Conclusions: The size of pancreatic cancer correlates to pathologic stage and overall survival. Tumors >2 and <2 cm benefited from a NT. However, the 90-operative mortality was significantly worse in those patients receiving NT.
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http://dx.doi.org/10.21037/jgo.2018.08.06DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6219973PMC
October 2018

Esophagectomy from then to now.

J Gastrointest Oncol 2018 Oct;9(5):903-909

Department of Gastrointestinal Oncology, Sarasota Memorial Healthcare System, Sarasota, FL, USA.

We have come a long way from the onset of surgery for esophageal cancer. Surgical resection is pivotal for the long-term survival in patients with locally advanced esophageal cancer. Moreover, advancements in post-operative care and surgical techniques have contributed to reductions in morbidity. More recently minimally invasive esophagectomy has been increasingly used in patients undergoing esophageal cancer resection. Potential advantages of MIE include: the decreased pulmonary complications, lower post-operative wound infection, decreased post-operative pain, and decreased length of hospitalization. The application of robotics to esophageal surgery is becoming more widespread. Robotic esophageal surgery has potential advantages over the known limitations of laparoscopic and thoracoscopic approaches to esophagectomy while adhering to the benefits of the minimally invasive approach. This paper is a review of the evolution from open esophagectomy to the most recent robotic approach.
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http://dx.doi.org/10.21037/jgo.2018.08.15DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6219976PMC
October 2018

Anastomotic leak and neoadjuvant chemoradiotherapy in esophageal cancer.

J Gastrointest Oncol 2018 Oct;9(5):894-902

Division of Surgical Oncology, Sarasota Memorial Hospital, Sarasota, FL, USA.

Background: Anastomotic leaks (AL) cause significant morbidity after esophagectomy. Most patients receive neoadjuvant chemoradiation (NCR) prior to esophagectomy which has been associated with increase perioperative complications and mortality. We report on a comparison of AL rates in upfront surgical (UFS) and NCR patients.

Methods: An esophagectomy database was queried for UFS and NCR patients treated between 1996 and 2015. Predictors of AL rate were identified using univariate and multivariate (MVA) analysis and propensity score matching (PSM).

Results: We identified 820 patients (UFS, 288; NCR, 532). Overall AL rate was 5.4%. Decreased AL rate was observed in NCR patients on MVA (8.0% 4.1%; P=0.02) but no difference was seen after PSM (7.7% 4.2%; P=0.14). MVA of factors associated with decreased AL in UFS patients included distal esophageal tumors and body mass index (BMI) >25. Age, gender, year of surgery, histology, anastomotic location, and diabetes were not prognostic. Before PSM, MVA of NCR patients of factors associated with decreased AL revealed that only thoracic anastomosis was prognostic. However, this was not observed after PSM. MVA of factors associated with decreased AL in all patients revealed thoracic anastomosis, NCR, and BMI 25-30. After PSM, only distal esophageal tumors and thoracic anastomosis were prognostic for decreased AL.

Conclusions: There is no difference in the AL rate between UFS and NCR patients. Decreased AL rate was observed in patients with distal esophageal tumors and thoracic anastomosis.
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http://dx.doi.org/10.21037/jgo.2018.04.09DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6219963PMC
October 2018

Accuracy of endoscopic ultrasound staging for T2N0 esophageal cancer: a National Cancer Database analysis.

J Gastrointest Oncol 2018 Oct;9(5):887-893

Division of Surgical Oncology, Sarasota Memorial Hospital, Sarasota, FL, USA.

Background: To determine accuracy of clinical staging of T2N0 esophageal cancer from the National Cancer Database (NCDB).

Methods: The NCDB was accessed to identify patients with T2N0M0 esophageal cancer (adenocarcinoma or squamous cell carcinoma) treated between 2004-2013 that underwent esophagectomy. Pathologic staging was compared to clinical stage. Univariate (UVA) and multivariate analysis (MVA) was performed to identify factors related to pathologic upstaging using Cox proportional hazard ratio.

Results: We identified 1,840 patients with T2N0 esophageal cancer who underwent esophagectomy as first line therapy. The median age was 67 years. The vast majority of patients were male and had distal adenocarcinomas. Clinical staging in was accurate pathologically in 30.7% of patients. While there was a trend for worse accuracy with increasing year of diagnosis, there rate of pT0-2N0 was stable. Tumor length >3 cm was significantly associated with tumor upstaging, while poor differentiation was significantly associated with nodal upstaging. UVA and MVA identified younger age, tumor length >3 cm, and poor differentiation were significantly associated with overall upstaging. Gender, tumor location, and tumor histology were not prognostic.

Conclusions: Clinical staging for T2N0M0 esophageal cancer continues to remain highly inaccurate, however, rates of pT0-2N0 have steadily remained over 50%. Tumor length >3 cm and poor differentiation are strongly associated with pathologic upstaging.
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http://dx.doi.org/10.21037/jgo.2018.01.16DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6219972PMC
October 2018

Clinical fate of T0N1 esophageal cancer: results from the National Cancer Database.

J Gastrointest Oncol 2018 Oct;9(5):880-886

Sarasota Memorial Hospital, Florida State University College of Medicine, Sarasota, FL, USA.

The long-term survival for patients with locally advanced esophageal cancer (EC) remains poor despite improvements in multi-modality care. Neoadjuvant chemoradiation (NCR) followed by surgical resection remains pivotal in the management of patients with EC. However, the outcome of patients whose primary tumor exhibits a complete response with residual regional nodal disease (T0N1) remains unclear as well as the role for adjuvant therapy.Utilizing the National Cancer Database we identified patients with EC who underwent NCR followed by esophagectomy who had subsequent pathology of T0N1. Baseline univariate comparisons of patient characteristics were made for continuous variables using both the Mann-Whitney U and Kruskal Wallis tests as appropriate. Pearson's Chi-square test was used to compare categorical variables. Unadjusted survival analyses were performed using the Kaplan-Meier method comparing survival curves with the log-rank test. All statistical tests were two-sided and α (type I) error <0.05 was considered statistically significant.We identified 7,116 patients diagnosed with EC; 6,235 (87.6%) adenocarcinoma (AC), 881 (12.4%) squamous cell carcinoma (SCC) with a median age of 62 [21-88] years. There were 6,031 (84.8%) males and 1,085 (15.2%) females. R0 resections were achieved in 6,668 (93.7%) patients and this correlated to improved median survival 39.5 (R0) and 20.1 (R1) months respectively, P<0.001. The median nodes harvested were 13 [0-83] with a mean positive LN's of 1.4±2.9. Pathologic complete response (pCR) was achieved in 1,334 (18.7%), partial response (pPR) 2,812 (39.5%) and non-response (pNR) 2,970 (41.7%). There were 230 (3.2%) patients deemed as pathologic T0N1. The median survival of patients with pCR was 61.7 months compared to 32.1 months in the T0N1 patients P<0.001. T0N1 patients did not demonstrate an improved survival over T1/2 patients who had a median survival of 30.5 months, P=0.79. However, T0N1 did reveal an improved survival over T3/4 patients who had a median survival of 24.6 months, P=0.02. Adjuvant chemotherapy in T0N1 did not provide a benefit in survival, median survival adjuvant versus no adjuvant 30.8 32.1 months respectively, P=0.08. Multivariate analysis in T0N1 patients demonstrated only number of LN's positive, and histology SCC ACC as predictive of survival, HR, 1.22, 95% CI: 1.10-1.36, P<0.001; HR, 0.43, 95% CI: 0.24-0.75, P=0.003, respectively.Patients with EC who exhibit a pathologic T0N1 after NCR have oncologic fates similar to node positive patients. Patients with pCR of the primary tumor and regional lymph nodes continue to demonstrate significant survival benefits over all remaining pathologic cohorts.
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http://dx.doi.org/10.21037/jgo.2018.08.08DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6219970PMC
October 2018

Management of foregut malignancies and hepatobiliary tract and pancreas malignancies.

Authors:
Kenneth Meredith

J Gastrointest Oncol 2018 Oct;9(5):878-879

Professor, Florida State University College of Medicine, Tallahassee, FL, USA.

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http://dx.doi.org/10.21037/jgo.2018.08.16DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6219965PMC
October 2018

Adjuvant radiation provides survival benefit for resected pancreatic adenocarcinomas of the tail.

J Gastrointest Oncol 2018 Jun;9(3):487-494

Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL, USA.

Background: The appropriate adjuvant treatment for resected pancreatic cancer remains a controversy. We sought to determine the effect of adjuvant treatment on overall survival (OS) in patients with pancreatic tail adenocarcinoma.

Methods: Retrospective review of patients with upfront surgically resected pancreatic tail cancer treated at our institution between 2000-2012 was performed to determine outcomes of patients treated with and without adjuvant radiation therapy (RT). Survival curves were calculated according to the Kaplan-Meier method. Univariate analysis (UVA) and multivariate analysis (MVA) were performed using the Cox proportional hazards model.

Results: Thirty-four patients met inclusion criteria. 79% received adjuvant chemotherapy, either concurrent with RT or alone. The groups were well matched, with the only significant difference being patient sex. On both UVA and MVA there was significantly worse survival in patients with a post-op CA19-9 >90 [hazard ratio (HR) 5.55; 95% confidence interval (CI): 1.20-25.7, P=0.03] and improved survival in patients treated with adjuvant RT (HR 0.15; 95% CI: 0.04-0.58, P=0.006). The median and 2-year OS were 21.6 months and 47% for patients treated with adjuvant RT compared with 11.3 months and 21% for those treated without RT.

Conclusions: Although few in patient numbers, this data suggests integration of adjuvant RT in resected pancreatic tail adenocarcinoma may improve OS.
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http://dx.doi.org/10.21037/jgo.2018.02.02DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6006031PMC
June 2018

CT-based assessment of visceral adiposity and outcomes for esophageal adenocarcinoma.

J Gastrointest Oncol 2017 Oct;8(5):833-841

Department Gastrointestinal Oncology, Florida State University, Sarasota Memorial Hospital, Sarasota, FL, USA.

Background: Various methods of quantifying and correlating obesity to outcomes for patients with esophageal adenocarcinoma (EA) have been evaluated. Published data suggest that quantification of adiposity may be more accurate than body mass index (BMI) as a prognostic factor. We report our analysis of adiposity as a prognostic factor in a series of patients with EA.

Methods: This single institution retrospective review included patients with EA who underwent esophagectomy from 1994-2008. Patients with BMI <20 were excluded. Using the preoperative CT scan, the visceral (VFA), subcutaneous (SFA), and total abdominal fat (TFA) areas were calculated. Each was contoured on a Siemens Leonardo workstation at the level of the iliac crest (L4/5). The Hounsfield threshold was -30 to -130. Outcomes were analyzed using Kaplan-Meier method and log-rank analysis. Multivariate analysis (MVA) was performed using the Cox proportion hazard regression model.

Results: We identified 126 patients for the analysis. There were no statistically significant differences in overall survival or disease-free survival between groups above and below the medians for TFA, SFA, or VFA/SFA ratio. However, an increase in VFA was significantly associated with worsened OS and DFS when we further classified patients into quartiles. Patients with VFA ≥182 cm had larger tumor size (P=0.016), fewer involved lymph nodes (P=0.047), longer operating times (P=0.032), and were more likely to be males (P=0.042).

Conclusions: Published data have demonstrated an association between treatment outcomes and degree of adiposity; our study found a correlation between VFA and OS and DFS in patients with EA. Median TFA, SFA, and VFA/SFA were not prognostic on MVA. While VFA >182 cm was associated with larger tumors, there were also fewer lymph nodes harvested in this group.
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http://dx.doi.org/10.21037/jgo.2017.07.03DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5674266PMC
October 2017

Adjuvant chemotherapy and outcomes in esophageal carcinoma.

J Gastrointest Oncol 2017 Oct;8(5):816-824

Department of Gastrointestinal Oncology H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.

Background: Standard treatment for locally advanced esophageal cancer is neoadjuvant chemoradiation followed by surgery. The role of postoperative chemotherapy is unclear. We sought to determine the indications, patterns, and outcomes for adjuvant chemotherapy in esophageal carcinoma.

Methods: This single institution retrospective review included patients with esophageal cancer who received neoadjuvant chemoradiation and surgery at Moffitt. We identified patients in this cohort who additionally received adjuvant chemotherapy. Medical records were reviewed for demographic/clinical information. Survival was estimated using the Kaplan-Meier method and compared by log-rank. Case-control analysis was performed using a 2:1 nearest neighbor propensity score matching algorithm, which included 92 without adjuvant chemotherapy and 46 with adjuvant chemotherapy.

Results: We identified 382 patients, 46 of whom received adjuvant chemotherapy. Patients who received adjuvant chemotherapy were younger (60.2 . 63.8 years; P=0.047), more likely to have adenocarcinoma (91% . 85%; P=0.034), had more advanced ypT and ypN classifications (P<0.001), less response to neoadjuvant therapy (P<0.001), and more margin positivity (15% . 4%; P=0.007). With propensity score matching analysis, no variables were significantly different between the two matched groups. Median follow-up times for the entire cohort and for case-control analysis were 2.9 and 2.4 years, respectively. There were no significant differences in overall or recurrence-free survival (RFS) between groups in either analysis.

Conclusions: The role of adjuvant chemotherapy following neoadjuvant chemoradiation and surgery in esophageal cancer is unclear. We found no significant difference in survival based on adjuvant chemotherapy. Future prospective studies should further investigate potential survival benefits and morbidity.
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http://dx.doi.org/10.21037/jgo.2017.07.10DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5674263PMC
October 2017

Outcomes of adjuvant radiotherapy and lymph node resection in elderly patients with pancreatic cancer treated with surgery and chemotherapy.

J Gastrointest Oncol 2017 Oct;8(5):758-765

Surgical Oncology, Sarasota Memorial Health Care System, Florida State University College of Medicine, Sarasota, FL, USA.

Background: We sought to determine the effects of post-operative radiation therapy (PORT) and lymph node resection (LNR) on survival in patients ≥70 years with pancreatic cancer treated with surgery and chemotherapy.

Methods: An analysis of patients ≥70 years with surgically resected pancreatic cancer who received chemotherapy from the SEER database between 2004-2008 was performed to determine association of PORT and LNR on survival.

Results: We identified 961 patients who met inclusion criteria. There was a trend towards increased survival associated with PORT in all patients (P=0.052) and N1 patients (P=0.060) but no benefit in N0 patients (P=0.161). There was no difference in OS based on number of lymph nodes removed in all (P=0.741), N0 (P=0.588), and N1 (P=0.070) patients. MVA for all patients revealed that higher T stage, N1, and high grade tumors were prognostic for increased mortality, while there was decreased mortality with PORT and mild benefit with increased lymph nodes resected (P=0.084).

Conclusions: PORT demonstrated no benefit in survival of pancreatic cancer patients ≥70 who are resected and treated with adjuvant chemotherapy. Future investigation will need to address age as a stratification factor for pancreatic cancer in the adjuvant setting.
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http://dx.doi.org/10.21037/jgo.2017.08.05DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5674250PMC
October 2017

Robotic-assisted Ivor Lewis esophagectomy: technique and early outcomes.

Robot Surg 2017 27;4:93-100. Epub 2017 Sep 27.

Florida State University, FL, USA,

Esophagectomy is pivotal for the long-term survival in patients with early stage and advanced esophageal cancer, and improved perioperative care and advanced surgical techniques have contributed to reduced postoperative morbidity. However, despite these advances, esophagectomy continues to be associated with significant morbidity and mortality. Minimally invasive esophageal surgery (MIE) has been increasingly used in patients undergoing surgery for esophageal cancer. Potential advantages of MIE include the decreased postoperative pain; lower postoperative wound infection, decreased pulmonary complications, and decreased length of hospitalization. Robotic esophageal surgery has the ability to overcome some of the limitations of laparoscopic and thoracoscopic approaches to esophagectomy while maintaining the benefits of the minimally invasive approach. In this article, we will review the clinical efficacy and outcomes associated with robotic-assisted Ivor Lewis esophagectomy (RAIL).
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http://dx.doi.org/10.2147/RSRR.S99537DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6193432PMC
September 2017

Small caliber covered self-expanding metal stents in the management of malignant dysphagia.

J Gastrointest Oncol 2016 Jun;7(3):411-9

1 Florida State University, USA ; 2 Florida Digestive Health, USA ; 3 Moffitt Cancer Center, USA ; 4 University of Central Florida, USA.

Background: Use of large caliber [≥18 mm body diameter (BD)] self-expanding metal stents (SEMS) for management of malignant dysphasia is associated with substantial adverse event (AE) and mortality rates (MRs). We sought to determine dysphagia response, stent migration rates, and AE and MRs, for small caliber covered SEMS (sccSEMS) with BDs between 10-16 mm in malignant dysphagia.

Methods: Thirty-one patients underwent direct endoscopic placement of 50 sccSEMS between January 2008 and March 2011. Patients were monitored for change in dysphagia score (DS), stent migration, AEs, and death through May 2011.

Results: DS improved in 30 of 31 patients (97%). The median DS decreased from 3 to 2 (P<0.0001). The median effective duration of first sccSEMS placement was 116 (95% CI: 75-196) days. Major and minor AE rates were 6.5% and 19.4% respectively. No stent related deaths were encountered. The overall migration rate was 36% (18/50). The anticipated migration rate was 45.7% (16/35) and the unanticipated migration rate was 13.3% (2/15) (P=0.052). Positive effective clinical outcome occurred in 93.5% (29/31) of cases.

Conclusions: In malignant dysphagia, direct endoscopic sccSEMS placement provided acceptable dysphagia control and migration rates with substantial reductions in stent related AEs and MRs compared to those reported for large caliber SEMS.
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http://dx.doi.org/10.21037/jgo.2015.12.03DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4880758PMC
June 2016

Determining the optimal number of lymph nodes harvested during esophagectomy.

J Gastrointest Oncol 2016 Jun;7(3):387-94

Department of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida 334612, USA.

Background: We examined the impact of the number of lymph nodes (LNs) removed during esophagectomy on outcomes in esophageal cancer (EC).

Methods: From a comprehensive EC database we identified patients who underwent curative resection from 1994 to 2011. The impact of total LNs retrieved on disease-free survival (DFS) and overall survival (OS) was investigated.

Results: In total, 635 patients were identified. Patients were divided on the basis of total number of LNs removed (<8, 9-12, 13-20, and >20). The 5-year OS and DFS rates for the group by LN category were (43%, 42%, 55%, and 36%, P=0.1836) and (44%, 37%, 46%, and 36%, P=0.5166), respectively. Total number of LNs assessed did not correlate with reduced risk of recurrence or improved survival. On multivariate analysis controlling for age, sex, histology, neoadjuvant therapy, only removal of 13-20 LN's correlated to improved oncologic outcomes.

Conclusions: In a tertiary cancer center, we demonstrated that only removal of 13-20 LNs during esophagectomy correlated to improved survival. While the importance of standardized pathologic examination and adequate nodal staging is of utmost importance for patients with EC undergoing esophagectomy the optimum number of LNs removed clearly warrants further investigation.
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http://dx.doi.org/10.21037/jgo.2015.12.02DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4880760PMC
June 2016

Effect of body mass index on operative outcome after robotic-assisted Ivor-Lewis esophagectomy: retrospective analysis of 129 cases at a single high-volume tertiary care center.

Dis Esophagus 2017 01;30(1):1-7

Department of Surgery, University of Wisconsin Hospital and Clinics, Madison, WI, USA

The impact of body weight on outcomes after robotic-assisted esophageal surgery for cancer has not been studied. We examined the short-term operative outcomes in patients according to their body mass index following robotic-assisted Ivor-Lewis esophagectomy at a high-volume tertiary-care referral cancer center and evaluated the safety of robotic surgery in patients with an elevated body mass index. A retrospective review of all patients who underwent robotic-assisted Ivor-Lewis esophagectomy between April 2010 and June 2013 for pathologically confirmed distal esophageal cancer was conducted. Patient demographics, clinicopathologic data, and operative outcomes were collected. We stratified body mass index at admission for surgery according to World Health Organization criteria; normal range is defined as a body mass index range of 18.5-24.9 kg/m2. Overweight is defined as a body mass index range of 25.0-29.9 kg/m2 and obesity is defined as a body mass index of 30 kg/m2 and above. Statistics were calculated using Pearson's Chi-square and Pearson's correlation coefficient tests with a P-value of 0.05 or less for significance. One hundred and twenty-nine patients (103 men, 26 women) with median age of 67 (30-84) years were included. The majority of patients, 76% (N = 98) received neoadjuvant therapy. When stratified by body mass index, 28 (22%) were normal weight, 56 (43%) were overweight, and 45 (35%) were obese. All patients had R0 resection. Median operating room time was 407 (239-694) minutes. When stratified by body mass index, medians of operating room time across the normal weight, overweight and obese groups were 387 (254-660) minutes, 395 (310-645) minutes and 445 (239-694), respectively. Median estimated blood loss (EBL) was 150 (25-600) cc. When stratified by body mass index, medians of EBL across the normal weight, overweight and obese groups were 100 (50-500) cc, 150 (25-600) cc and 150 (25-600), respectively. Obesity significantly correlated with longer operating room time (P = 0.05) but without significant increased EBL (P = 0.348). Among the three body mass index groups there was no difference in postoperative complications including thrombotic events (pulmonary embolism and deep venous thrombosis) (P = 0.266), pneumonia (P = 0.189), anastomotic leak (P = 0.090), wound infection (P = 0.390), any cardiac events (P = 0.793) or 30 days mortality (P = 0.414). Our data study demonstrates that patients with esophageal cancer and an elevated body mass index undergoing robotic-assisted Ivor-Lewis esophagectomy have increased operative times but no significantly increased EBL during the procedure. Other potential morbidities did not differ with the robotic approach.
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http://dx.doi.org/10.1111/dote.12484DOI Listing
January 2017

Perioperative outcomes associated with robotic Ivor Lewis esophagectomy in patient's undergoing neoadjuvant chemoradiotherapy.

J Gastrointest Oncol 2016 Apr;7(2):206-12

1 Department of Radiation Oncology, Florida Hospital Orlando, Orlando, FL, USA ; 2 Department of Surgical Oncology, 3 Department of Radiation Oncology, 4 Department of Gastrointestinal Oncology, Moffitt Cancer Center, Tampa, FL, USA ; 5 Department of Gastrointestinal and Surgical Oncology, Sarasota Memorial Hospital, Sarasota, FL, USA.

Background: Neoadjuvant chemoradiotherapy (NCR) for the treatment of esophageal cancer has been associated with increased perioperative morbidity and mortality. Minimally invasive procedures utilizing robotic techniques have been shown to reduce perioperative complications and length of hospitalization (LOH). The purpose of this study is to compare perioperative outcomes between patients undergoing NCR and robotic-assisted Ivor Lewis esophagectomy (RAIL) versus upfront RAIL.

Methods: A database of esophagectomy patients was queried to identify RAIL patients. Differences in perioperative outcomes were analyzed between NCR and non NCR patients.

Results: Eighty-nine patients were identified who underwent RAIL Seventy-seven patients (87%) had NCR and 22 patients did not (13%). The median age was 66 (range, 44-83). The median age of the patients treated with NCR was younger {69 [44-83] vs. 64 [46-81] years respectively, P=0.05}. The patients who underwent NCR had a higher BMI then those who went straight to esophagectomy (31 vs. 27; P=0.001). There were no conversions to open laparotomy or thoracotomy in either group. There were no statistically significant differences in the mean operative times and estimated blood loss (EBL) between both groups. Complications occurred in 17 (19.1%) patients. There were no statistically significant differences in the rates of any complications between patients receiving NCR and those that did not receive NCR (P=0.11). There were no deaths in either group. The total number of days in hospital and total number of intensive care unit (ICU) days were also similar in both groups (P=0.25). There was no statistically significant difference in the mean number of lymph nodes harvested in the patients treated with NCR compared with those treated without NCR.

Conclusions: We have demonstrated that RAIL is a safe and feasible option for patients with esophageal cancer. The administration of NCR to RAIL did not result in an increase in perioperative morbidity and mortality. The number of lymph nodes harvested and the completeness of resection was also similar between patients who received NCR and those who did not. Longer follow-up is required in order to determine long term oncologic outcome.
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http://dx.doi.org/10.3978/j.issn.2078-6891.2015.104DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4783744PMC
April 2016

AKT expression is associated with degree of pathologic response in adenocarcinoma of the esophagus treated with neoadjuvant therapy.

J Gastrointest Oncol 2016 Apr;7(2):158-65

1 Department of Gastrointestinal Oncology, 2 Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL, USA ; 3 Department of Surgery, College of Medicine Florida State University, FL, USA.

Background: Neoadjuvant chemoradiation (NCRT) has become standard in the treatment of locally advanced esophageal adenocarcinoma (EAC) with survival correlated to degree of pathologic response. The phosphatidyl inositol 3 kinase (PI3K)/protein kinase B (AKT)/mTOR pathway plays an important role in tumorgenesis and resistance. We sought to elucidate the role of this pathway in patients with EAC who received NCRT.

Methods: After IRB approval, a prospective trial was initiated in which patients with EAC underwent endoscopic biopsies of normal and tumor tissue prior to instituting NCRT. Patients then proceeded to esophagectomy. The pre-treatment tissues underwent gene expression profiling. SAM method was used to analyze expression of AKT within normal and tumor tissue. Expression was then correlated to degree of pathologic response.

Results: One-hundred patients were consented for the study, of which 67 met final eligibility. Nineteen patient's tumors ultimately underwent gene expression profiling via microarray. The differential expression of all AKT isoforms in tumor tissue was markedly overexpressed compared to normal tissue (P=6×10(-5)). There were 3 patients designated as pNR, 6 as pPR, and 10 as pCR. Partial and non-responders had higher expressions of AKT compared to pCR with the non-responders consistently illustrated the highest expression of AKT (P=0.02). There was a significant correlation between individual isoforms of AKT-1, AKT-2, and AKT-3 and degree of pathologic response (P=0.002, 0.04, and 0.04 respectively).

Conclusions: AKT is overexpressed in patients with AC of the esophagus. Moreover, pathologic response to NCRT may be correlated with degree of AKT expression. Additional data is needed to clarify this relationship to potentially add targeted therapies to the neoadjuvant regimen.
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http://dx.doi.org/10.3978/j.issn.2078-6891.2015.067DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4783740PMC
April 2016

Correlation Between Standardized Uptake Value in Preneoadjuvant and Postneoadjuvant Chemoradiotherapy and Tumor Regression Grade in Patients With Locally Advanced Esophageal Cancer.

Am J Clin Oncol 2018 03;41(3):254-258

Departments of Gastrointestinal Oncology.

Purpose: To investigate whether positron emission tomography/computed tomography (PET/CT) initial and restaging imaging predicts for pathologic response measured by tumor regression grade (TRG) after preoperative chemoradiotherapy (CRT) in patients with locally advanced esophageal cancer.

Methods: A retrospective review of 220 patients with stage II-III esophageal cancer treated with neoadjuvant CRT followed by surgery was performed. In total, 187 patients were eligible for statistical analysis. Pretreatment and posttreatment PET/CT scans were reviewed. Maximum standard uptake value (SUV) at the site of the primary tumor was recorded before and 6 weeks after neoadjuvant therapy. Upon completion of surgery, TRG was determined by a specialized site-specific gastrointestinal pathologist. Spearman correlation was used to compare pre, post, and change in maximum SUV, TRG, and overall survival.

Results: The median follow-up was 24 months. Although no significant correlation was found between pretreatment SUV and TRG (r=0.073, P=0.32), post-CRT SUV, however, showed a significant positive correlation with TRG (r=0.374, P<0.01). There was no significant correlation between the absolute change in fluorodeoxyglucose uptake after CRT and TRG (r=0.057, P=0.44); however, the rate of SUV change showed a significant correlation with TRG (r=0.178, P=0.017). Similar to previous studies, our study showed a significant difference in overall survival between TRG groups (log-rank test, P=0.019). Patients with TRG 3 showed prominently worse survival with median survival of 27.4 months. Patients with favorable pathologic responses were those whose scans demonstrated a metabolic response defined as a decrease in SUV≥70%.

Conclusions: Changes in SUV uptake on PET/CT scans after CRT have prognostic value in predicting pathologic response of esophageal cancer after neoadjuvant therapy. Further studies are needed to validate the integration of PET/CT as a decision-making tool.
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http://dx.doi.org/10.1097/COC.0000000000000258DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7810133PMC
March 2018

Body Mass Index and Perioperative Complications After Esophagectomy for Cancer.

Ann Surg 2015 Oct 22. Epub 2015 Oct 22.

*Department of Surgery, New York University Medical School, New York †Divisions of Gastrointestinal Oncology, Moffitt Cancer Center, Tampa, Florida ‡Cancer Prevention and Control, Moffitt Cancer Center, Tampa, Florida §Division of General Surgery, Medical College of Georgia, Augusta, Georgia.

Background: Given the increasing rate of obesity, the effects of excessive body weight on surgical outcomes constitute a relevant quality of care concern. Our aim was to determine the relationship between preoperative body mass index (BMI) on perioperative complications after esophagectomy for cancer.

Methods: From our comprehensive esophageal cancer database consisting of 510 patients, we identified 166 obese (BMI ≥30), 176 overweight (BMI 25-29), and 148 normal-weight (BMI 20-24) patients. Malnourished patients (BMI of <20) were excluded. Incidence of preoperative risk factors and perioperative complications in each group were analyzed.

Results: The patient group consists of 420 men and 70 women with a mean age at time of surgery were 64 years (range 28-86 years). The categories of patients (obese, overweight, and normal-weight) were similar in terms of demographics and comorbidities, with the exception of a younger age (62.5 years vs 66.2 years vs 65.3 years, P = 0.002), and a higher incidence of diabetes (23.5% vs 11.4% vs 10.1%, P = 0.001) and hiatal hernia (28.3% vs 14.8% vs 20.3%, P = 0.01) for obese patients. More patients with BMI >24 were found with adenocarcinoma, compared with the normal-weight group (90.8% vs 90.9% vs 82.5%, P = 0.03). Despite similar preoperative stage, obese patients were less likely to receive neoadjuvant treatment (47.6% vs 54.5% vs 66.2%, P = 0.004). The type of surgery performed, overall blood loss, extent of lymphadenectomy, rate of resections with negative margins, and postoperative complications were not influenced by BMI on univariate and multivariate analysis.

Conclusions: In our experience, BMI did not affect number of harvested lymph-nodes, rates of negative margins, and morbidity and mortality after esophagectomy for cancer. In our experience, esophagectomy could be performed safely and efficiently in mildly obese patients.
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http://dx.doi.org/10.1097/SLA.0000000000000242DOI Listing
October 2015

Outcomes of resected pancreatic cancer in patients age ≥70.

J Gastrointest Oncol 2015 Oct;6(5):498-504

1 University of South Florida Morsani College of Medicine, Tampa, FL, USA ; 2 Department of Radiation Oncology, 3 Gastrointestinal Tumor Program, 4 Senior Adult Oncology Program, Moffitt Cancer Center, Tampa, FL, USA ; 5 Gastrointestinal Oncology, Sarasota Memorial Hospital, Sarasota, FL, USA.

Objective: To determine outcomes of patients ≥70 years with resected pancreatic cancer.

Methods: A study was conducted to identify pancreatic cancer patients ≥70 years who underwent surgery for pancreatic carcinoma from 2000 to 2012. Patients were excluded if they had neoadjuvant therapy. The primary endpoint was overall survival (OS).

Results: We identified 112 patients with a median follow-up of surviving patients of 36 months. The median patient age was 77 years. The median and 5 year OS was 20.5 months and 19%, respectively. Univariate analysis (UVA) showed a significant correlation for increased mortality with N1 (P=0.03) as well as post-op CA19-9 >90 (P<0.001), with a trend towards decreased mortality with adjuvant chemoradiation (P=0.08). Multivariate analysis (MVA) showed a statistically significant increased mortality associated with N1 (P=0.008), post-op CA19-9 >90 (P=0.002), while adjuvant chemoradiation (P=0.04) was associated with decreased mortality.

Conclusions: These data show that in patients ≥70, nodal status, post-op CA19-9, and adjuvant chemoradiation, were associated with OS. The data suggests that outcomes of patients ≥70 years who undergo upfront surgical resection are not inferior to younger patients.
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http://dx.doi.org/10.3978/j.issn.2078-6891.2015.038DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4570916PMC
October 2015

Robotic Whipple Procedure for Pancreatic Cancer: The Moffitt Cancer Center Pathway.

Cancer Control 2015 Jul;22(3):340-51

Department of Gastrointestinal Oncology, Moffitt Cancer Center, Tampa, FL 33612, USA.

Background: Resection of malignancies in the head and uncinate process of the pancreas (Whipple procedure) using a robotic approach is emerging as a surgical option. Although several case series of the robotic Whipple procedure have been reported, detailed descriptions of operative techniques and a clear pathway for adopting this technology are lacking.

Methods: We present a focused review of the procedure as it applies to pancreatic cancer and describe our clinical pathway for the robotic Whipple procedure used in pancreatic cancer and review the outcomes of our early experience. A systematic review of the literature is provided, focusing on the indications, variations in surgical techniques, complications, and oncological results of the robotic Whipple procedure.

Results: A clinical pathway has been defined for preoperative training of surgeons, the requirements for hospital privileges, patient selection, and surgical techniques for the robotic Whipple procedure. The robotic technique for managing malignant lesions of the pancreas head is safe when following well-established guidelines for adopting the technology. Preliminary data demonstrate that perioperative convalescence may exceed end points when compared with the open technique.

Conclusions: The robotic Whipple procedure is a minimally invasive approach for select patients as part of multidisciplinary management of periampullary lesions in tertiary centers where clinicians have developed robotic surgical programs. Prospective trials are needed to define the short- and long-term benefits of the robotic Whipple procedure.
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http://dx.doi.org/10.1177/107327481502200313DOI Listing
July 2015

Outcomes of Therasphere Radioembolization for Colorectal Metastases.

Clin Colorectal Cancer 2015 Sep 16;14(3):146-53. Epub 2015 Feb 16.

Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL.

Introduction: The liver is the most common site for colorectal cancer (CRC) metastases. Radioembolization with yttrium-90 (Y90) represents an alternative approach in the management of unresectable hepatic colorectal metastases. The objective of this study was to evaluate outcomes after treatment with Y90.

Materials And Methods: A retrospective review of patients undergoing Y90 glass microsphere treatment for metastatic CRC from 2009 to 2013 was conducted. Multivariable analysis (MVA) of factors related to overall survival (OS) was performed using the Cox proportional hazard and OS estimates were calculated using the Kaplan-Meier method.

Results: We identified 68 patients. Median and 2-year OS were 11.6 months and 34%. For patients with ≤ 25% hepatic burden of disease (HBD) and 1 chemotherapy regimen, 2-year OS was 63%. Median and 2-year OS for patients with ≤ 25% versus > 25% HBD were 19.6 months and 42% versus 3.4 months and 0% (P < .0001). Univariate analysis revealed that higher HBD, ≥ 3 lines of chemotherapy received, and higher carcinoembryonic antigen (CEA) were found to be significant predictors of worse OS. MVA revealed age, > 25% HBD, ≥ 3 lines of chemotherapy, and higher CEA were independently prognostic for increased mortality, and resected status of the primary tumor was associated with decreased mortality. The presence of extrahepatic metastases was not prognostic. Toxicities were mild and only 5 patients experienced Grade 3/4 biochemical toxicity.

Conclusion: Yttrium-90 was associated with acceptable OS with minimal morbidity in this series. Minimal exposure to chemotherapy and low HBD were found to be associated with better OS, however, even patients with chemotherapy-refractory disease received a benefit from treatment.
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http://dx.doi.org/10.1016/j.clcc.2015.02.002DOI Listing
September 2015

Concurrent chemoradiotherapy with protracted infusion of 5-fluorouracil (5-FU) and cisplatin for locally advanced resectable esophageal cancer.

J Gastrointest Oncol 2015 Feb;6(1):39-44

1 Department of Gastrointestinal Oncology, 2 Department of Radiation Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL 33612, USA.

Background: Neoadjuvant concurrent chemoradiotherapy (CCRT) has become the standard treatment for esophageal cancer (EC) in North America. The cisplatin/5-flurouracil (5-FU) combination has been the most commonly used regimen. For the last 15 years we incorporated a daily continuous infusion of 5-FU and 2 doses of cisplatin into our neoadjuvant CCRT for potentially resectable EC.

Patients And Methods: Between July 1997 and June 2012, 129 patients with locally advanced EC (T3 or N1 and higher), received neoadjuvant CCRT with cisplatin 75 mg/m(2) on day 1 and day 29 and continuous infusion of 5-FU (225 mg/m(2)/day) on the days of radiation.

Results: The median age of patients was 63 years, 85% had adenocarcinoma, 29, 74 and 26 patients had stage II, III and IVa disease respectively, 110 patients had N1 disease based on the American Joint Committee on Cancer (AJCC) 6(th) edition, 118 patients experienced weight loss during treatment. All patients completed treatment. Treatment was well tolerated with 14% of patients having ≥ grade 3 toxicity and 18 patients requiring hospital admission. Sixty-four percent of patients had surgical resection following CCRT, with disease progression and patient refusal being the most common reasons for not proceeding with surgery. An R0 resection was achieved in 96% of patients. A pathological complete response (pCR) was achieved in 45% of patients. With a median follow up of 26 months (1.2-144 months), 48/129 patients recurred and 60/129 died of their disease.

Conclusions: Our study has its limitation, however, and compared to the conventional chemotherapy regimens containing the cisplatin/5-FU doublet, our treatment strategy for locally advanced EC CCRT seems to be feasible and well tolerated.
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http://dx.doi.org/10.3978/j.issn.2078-6891.2014.101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4294830PMC
February 2015
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