Room for improvement? The adoption of multimodal esophageal cancer care in the United States.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 78-78
Author(s):  
R. P. Merkow ◽  
K. Y. Bilimoria ◽  
M. McCarter ◽  
A. Stewart ◽  
W. B. Chow ◽  
...  

78 Background: Consensus guidelines recommend neoadjuvant chemo- or chemoradiation therapy as the preferred treatment for locally advanced esophageal adenocarcinoma; however, it is unknown if this recommendation has been widely adopted in the U.S. Our objective was to examine esophageal cancer multimodal therapy and identify factors associated with the use of neoadjuvant therapy. Methods: From the National Cancer Data Base, patients with middle third, lower third and GE junction (GEJ) adenocarcinomas were identified. Patients who were clinical stage I-III and underwent surgical resection were included. Separate logistic regression models were developed to identify predictors of neoadjuvant therapy utilization and outcomes. Results: From 1998 to 2007, 8,051 patients underwent surgical resection for esophageal cancer: 16.3% stage I, 45.0% stage II and 38.7% stage III. For stage II/III tumors, neoadjuvant use increased (49.0% to 77.8%, p<0.001). After adjustment, factors associated with underuse of neoadjuvant therapy in stage II/III patients were older age, Black or Hispanic ethnicity, more severe comorbidities, tumor location (GEJ and middle vs. lower third), tumor size ≥ 2cm, stage II (vs. III) and geographic region. Stage II/III patients not receiving neoadjuvant had an over two fold increased risk of positive lymph nodes (OR 2.14. 95% CI 1.79 – 2.55, p<0.001). In addition, the positive surgical margin rate increased almost three fold (OR 2.80 95% CI 2.17-3.62, p<0.001) but 30-day postoperative mortality risk was not significantly affected (OR 1.50 95% CI 0.94-2.39; p=0.090). For stage I patients, neoadjuvant therapy decreased over time (38.0% to 11.4%, p<0.001). The overuse of neoadjuvant therapy was associated with higher tumor grade, larger tumor size, and low surgical case volume (all p<0.05). Conclusions: The adoption of neoadjuvant therapy has increased in the past decade; however, opportunity exists to improve guideline treatment for locally advanced esophageal cancer. Registry-based feedback to individual hospitals, such as benchmark comparison tools, could help institutions provide care in concordance with national guidelines. No significant financial relationships to disclose.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 173-173
Author(s):  
Camille Baumrucker ◽  
Dido Franceschi ◽  
Alan S Livingstone ◽  
Francis Igor Macedo

173 Background: Esophageal cancer (EC) is historically a male-predominant disease. Current available evidence on the impact of gender on clinical presentation and survival outcomes of EC is limited by small sample size or single institutional series. Methods: Patients with EC (stage I-III) were identified in the National Cancer Data Base (NCDB, 2004-2016). Clinicopathologic and treatment characteristics of male and female patients were compared using Chi-square analysis. Overall survival (OS) was estimated using Kaplan-Meier method and Cox proportional hazards regression. Results: Of 62,893 patients included, male gender was predominant (77.7% vs 22.3%). Adenocarcinoma was the most common subtype (66.7%); however, squamous cell carcinoma was more predominant in females (57.1% vs. 26.5%, p<0.001). Females were significantly older (68.5 vs. 66.1 years; p<0.001) and more likely African American (AA) (14% vs. 8.1%; p<0.001). Females were more likely to present with local disease (stage I, 19.6% vs. 18.2%; p<0.001), while males presented more likely with locoregional disease (LRD, stage II/III, 80.4% vs 81.8%, p<0.001). Females had worse OS compared to males (18.1 vs. 19.7 mo; p=0.001; cI: 23.5 vs. 31.9mo, p<0.001; cII/III: 17.2 vs 18.3mo, p=0.473). White females had worse OS than white males (18.6 vs. 20.4mo, p<0.001), while AA females had better OS (13.5 vs. 12.6mo, p=0.001). Among patients with LRD, females less frequently received chemotherapy (CT, 75.4% vs. 82.9%, p<0.001), radiation therapy (RT, 78.9% vs. 82.6%, p<0.001), and esophagectomy (28% vs. 40.5%, p<0.001). Females who underwent esophagectomy had improved OS over males (40.3 vs. 32.7mo; p<0.001). More specifically, white females who underwent esophagectomy had improved OS over white males (47.6 vs 38mo, p<0.001); however, AA males and females who underwent esophagectomy had similar OS (33.8 vs 32.6mo, p=0.452). Female gender, advanced age, AA race, high comorbidity score and clinical stage, and lack of access to CT, RT, and esophagectomy were independent predictors of mortality (Table). Conclusions: Females with EC seem to have less access to CT, RT and esophagectomy, which is associated with worse OS compared to males. Healthcare policies should be implemented to increase access to standard of care treatment for female patients with EC. [Table: see text]


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 521-521
Author(s):  
Timur Mitin ◽  
Shearwood McClelland ◽  
Jess Hatfield ◽  
Catherine Degnin ◽  
Yiyi Chen

521 Background: The widely accepted standard of care in treating primary breast angiosarcoma involves surgical resection, often followed by adjuvant therapy (radiation and/or chemotherapy). The rarity of this disease has precluded large-scale analyses. The question regarding the impact of resection extent on survival has yet to be examined on a nationwide scale. Methods: The National Cancer Data Base (NCDB) from 2004-2014 identified primary breast angiosarcoma patients throughout the United States having undergone surgical resection. The extent of resection (mastectomy versus lumpectomy) was adjusted for several variables (including patient age, race, income, primary payer for care, tumor size, adjuvant therapies, and medical comorbidities) to assess its impact on breast angiosarcoma-related mortality. Results: Over this eleven-year span, 826 resected primary breast angiosarcoma patients were identified in the United States. Mastectomy was by far the most common surgical modality for primary breast angiosarcoma (86% of patients). Increasing tumor size was predictive for mastectomy over lumpectomy (p < 0.0001), and for involvement of adjuvant radiation therapy (p = 0.001). The extent of surgical resection was inversely predictive of radiation usage (p = 0.017). However, surgical modality was not significantly predictive of breast angiosarcoma-related mortality. Conclusions: Despite the frequent preference of mastectomy for primary breast angiosarcoma treatment (more than 6 of every 7 patients), there is no survival benefit of mastectomy versus lumpectomy. This lack of benefit should be discussed with patients, given the reduced operative morbidity of lumpectomy versus mastectomy. The Class IIB evidence provided from this analysis represents the highest level of evidence to-date governing management of this disease.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4035-4035
Author(s):  
Amy Catherine Moreno ◽  
Ning Zhang ◽  
Steven H. Lin ◽  
Sharon Hermes Giordano

4035 Background: The aim of this study was to examine current patterns of care and associated outcomes for patients with stage I esophageal cancer (EC) treated in the United States. Methods: The National Cancer Data Base (NCDB) was queried for patients diagnosed with clinical stage T1-2N0 EC from 2004-2012. Patients were categorized into four treatment groups: observation without definitive therapy (Obs), chemoradiotherapy (CRT), local excision (LE), and esophagectomy (Eso). Patient, tumor, and treatment parameters were compared between groups. Kaplan-Meier 5-year overall survival (OS) estimates, postoperative 30- and 90-day mortality comparisons, and multivariate Cox proportional hazards modeling are reported. Results: A total of 5,460 patients met the criteria. Of these, 21% were observed, 14% underwent CRT, 23% LE, and 42% Eso. Median age and follow up were 67 years and 28 months, respectively. Eso was the primary treatment for patients of age ≤ 80 while 48% of patients age > 80 were observed. Age, race, comorbidity score, tumor location within the esophagus, type of medical insurance, median income, type of facility (academic vs. non-academic), and distance from treating facility were significant factors for predicting receipt of local therapy over observation. Postoperative 30-day mortality between the LE and Eso groups was 0.5% and 2.9%, respectively ( P< .001), which increased to 1.4% and 5.5% at 90 days ( P< .001). Five-year OS was 21% for Obs, 26% CRT, 64% LE, and 63% Eso ( P < .001). Multivariate analyses demonstrated improved OS with any form of local definitive therapy: CRT ( HR: 0.54, 95% CI [0.48 - 0.61], P< .001), LE ( HR: 0.24, [0.20 - 0.27], P< .001), Eso (HR: 0.31, [0.28 - 0.35], P< .001). Age, comorbidity score, facility type, distance, median income quartile, and insurance status were also independently associated with OS. Conclusions: Management of stage I EC is influenced by several demographic and socioeconomic factors. Clinical observation yields suboptimal outcomes compared to any local therapy, and a surgical approach should be considered over CRT whenever feasible.


2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 723-723
Author(s):  
Richard John Cassidy ◽  
En Cheng ◽  
Jeffrey M. Switchenko ◽  
Renjian Jiang ◽  
Jaymin Jhaveri ◽  
...  

723 Background: Elderly patients have been underrepresented in randomized clinical trials of rectal cancer, and the value and tolerance of treatment options in this population remain unclear. We used the National Cancer Data Base (NCDB) to assess the incidence, treatment patterns, and overall survival (OS) outcomes of patients 80 years or older with newly diagnosed non-metastatic rectal adenocarcinomas. Methods: 5076 patients 80 years and older diagnosed with non-metastatic rectal adenocarcinomas from 2004 to 2013 were identified. Univariable and multivariable (MVA) analysis were performed to identify patient, tumor, and treatment characteristics associated with receipt of standard of care therapy (SOCT) and factors predictive of OS. SOCT was defined as surgical resection for Stage I patients and receipt of neoadjuvant therapy followed by surgical resection for Stage II/III patients. Kaplan-Meier curves were generated to assess the effect of stage and treatment received on overall survival. Results: At presentation, 935 (18.5%) were TXN0, 1557 (30.8%) were Stage I, 1552 (30.6%) were Stage II, and 1,032 (20.1%) were Stage III. The rates of patients receiving no therapy were: 29.6% for TXN0, 22.6% for Stage I, 16.5% for Stage II, and 12.2% for Stage III. The rates of patients not receiving SOCT were: 22.6% for Stage I, 51.4% for Stage II and 39.4% for Stage III cases. Survival was significantly worse for patients not receiving standard of care therapy: Stage I (52.1% receiving SOCT vs. 7.6% not receiving SOCT; p < 0.01), Stage II (49.8% receiving SOCT vs. 14.5% not receiving SOCT; p < 0.01), and Stage III (47.5% receiving SOCT vs. 10.2% not receiving SOCT; p < 0.01). On MVA of patient, tumor, and treatment variables, receipt of SOCT was associated with improved OS for the entire cohort (p < 0.01) and when examined by stage (p < 0.01). Conclusions: In this nationwide sample of patient’s ≥ 80 years old with rectal cancer, there was a high rate of patients receiving no therapy. Those that did receive standard therapy achieved reasonable outcomes, suggesting avoidance of guideline care in this population should not be advised.


2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 172-172
Author(s):  
Francis Igor Macedo ◽  
Kristin Kelly ◽  
Danny Yakoub ◽  
Dido Franceschi ◽  
Alan S Livingstone ◽  
...  

172 Background: Neoadjuvant chemotherapy (NAC) is the gold standard approach for locally advanced esophageal cancer (EC), however the addition of radiation remains largely controversial. We sought to investigate the role of neoadjuvant radiation in resectable EC by comparing outcomes of patients who underwent neoadjuvant chemotherapy with (NACR) or without radiation (NAC) using a large nationwide cohort. Methods: National Cancer Data Base (NCDB) was queried for patients with non-metastatic EC between 2010 and 2014. Kaplan-Meier, log-rank and Cox multivariable regression analysis were performed to calculate overall survival (OS). Logistic regression was used to identify factors associated with 90-day mortality and complete pathological response (pCR). Results: A total of 12,546 EC patients who underwent neoadjuvant therapy were included: the majority were males (84%), Caucasians (90.3%), and had adenocarcinoma (81.1%), cT3 (60.6%) and cN1 (49.1%). 11,269 (89.8%) patients had NACR, whereas 969 (7.7%), NAC alone. pCR rate was 14.1% (19.2%, NACR vs. 6.3%, NAC, p < 0.001). Neoadjuvant radiation was an independent predictor for improved pCR [HR 0.305, 95% CI 0.205-0.454, p < 0.001], however OS was similar in patients undergoing NAC with or without radiation (35.9 vs. 37.6 months, respectively, p = 0.393). This persisted regardless of tumor staging. There was a trend towards worse 90-day mortality after radiation (8.2%, NACR vs. 7.7%, NAC; HR 1.410, 95% CI 0.975-2.038, p = 0.068). In Cox regression, controlling for patient and disease-related factors, neoadjuvant radiation was an independent predictor of worse OS (HR 1.322, 965% CI 1.177-1.485, p < 0.001). Conclusions: This is the largest study comparing NACR versus NAC in resected EC. The addition of radiation to neoadjuvant chemotherapy is associated with improved pathological response rates, however it had deleterious effects in long-term and possibly, short-term survival. Our findings suggest that NAC without radiation may be the optimal neoadjuvant therapy in resectable EC, however further evidence with randomized clinical trials is warranted.


2020 ◽  
Vol 28 (1) ◽  
pp. 138-151
Author(s):  
Kelly A. Stahl ◽  
Elizabeth J. Olecki ◽  
Matthew E. Dixon ◽  
June S. Peng ◽  
Madeline B. Torres ◽  
...  

Gastric cancer is the third most common cause of cancer deaths worldwide. Despite evidence-based recommendation for treatment, the current treatment patterns for all stages of gastric cancer remain largely unexplored. This study investigates trends in the treatments and survival of gastric cancer. The National Cancer Database was used to identify gastric adenocarcinoma patients from 2004–2016. Chi-square tests were used to examine subgroup differences between disease stages: Stage I, II/III and IV. Multivariate analyses identified factors associated with the receipt of guideline concordant care. The Kaplan–Meier method was used to assess three-year overall survival. The final cohort included 108,150 patients: 23,584 Stage I, 40,216 Stage II/III, and 44,350 Stage IV. Stage specific guideline concordant care was received in only 73% of patients with Stage I disease and 51% of patients with Stage II/III disease. Patients who received guideline consistent care had significantly improved survival compared to those who did not. Overall, we found only moderate improvement in guideline adherence and three-year overall survival during the 13-year study time period. This study showed underutilization of stage specific guideline concordant care for stage I and II/III disease.


2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 335-335
Author(s):  
Mark Yarchoan ◽  
Qingfeng Zhu ◽  
Jennifer N. Durham ◽  
Nicole Gross ◽  
Soren Charmsaz ◽  
...  

335 Background: Only 10-15% of newly diagnosed HCC patients are candidates for a potentially curative resection, and most patients who receive resection eventually recur. Historical systemic therapies including sorafenib, as well as locoregional therapies, have not demonstrated benefit in the perioperative setting. Novel combinations of targeted therapies and immunotherapies demonstrate higher response rates than sorafenib in HCC. Here, we report the feasibility and efficacy of neoadjuvant combination therapy with cabozantinib plus nivolumab, followed by surgical resection, in patients with borderline resectable or locally advanced HCC. Methods: We conducted an open-label, single-arm, phase I study in patients with HCC with borderline resectable or locally advanced HCC (including multinodular disease, portal vein involvement, or other high-risk features). Patients received 8 weeks of therapy with cabozantinib 40 mg oral daily plus nivolumab 240 mg IV every two weeks, followed by restaging and possible surgical resection. The primary endpoint was feasibility, defined by the percentage of patients experiencing a treatment-related adverse event that precluded continuing on to surgery within 60 days of the planned date for surgical evaluation. Results: We enrolled 15 patients of whom 14 patients completed neoadjuvant therapy and underwent surgical evaluation. Adverse events were consistent with prior experience with these agents, and the trial met its primary endpoint, with no patients experiencing a treatment-related adverse event that precluded timely surgical assessment. Of patients completing neoadjuvant therapy, 1 patient declined surgery, 1 tumor could not be resected, and 12 patients underwent successful R0 surgical resection. 5/12 (41.7%) resected patients had a major or complete pathologic response. At a median follow up of one year, 4/5 pathologic responders are without recurrence. We performed an in-depth profiling of the surgical resection biospecimens and identified an enrichment of IFNγ+ effector memory CD4+ and granzyme B+ effector CD8+ T cells as well as tertiary lymphoid aggregates in the pathologic responders. We further analyzed the spatial relationships of cell types in responders and non-responders, which identified distinct spatial arrangement of B cells in responders, and proximity of arginase-1 expressing myeloid cells to T cells in nonresponders. Conclusions: This study is, to our knowledge, the first use of a targeted therapy in combination with an immune checkpoint inhibitor in the neoadjuvant setting in HCC, and the first use of modern systemic therapies to expand surgical resection criteria. Neoadjuvant cabozantinib and nivolumab is feasible, and may result in pathologic responses and long-term disease-free survival in a group of patients who may be outside traditional resection criteria. Clinical trial information: NCT03299946.


2019 ◽  
Author(s):  
Francis Igor Macedo ◽  
Danny Yakoub ◽  
Vikas Dudeja ◽  
Nipun B. Merchant

The incidence of pancreatic cancer continues to rise, and it is now the third-leading cause of cancer-related deaths in the United States. Only 15 to 20% of patients are eligible to undergo potentially curative resection, as most tumors are deemed unresectable at the time of diagnosis because of either locally advanced disease or distant metastases. Improvements in preoperative CT imaging have enabled better determination of the extent of disease and allowed for better operative planning. Based on their relationship to the surrounding vasculature and structures and presence or absence of distant disease, pancreatic tumors are classified into four categories: resectable, borderline resectable pancreatic cancer (BRPC), locally advanced pancreatic cancer (LAPC), and metastatic. With the recent advent of more effective chemotherapy regimens, efforts have focused on using neoadjuvant therapy approaches to increase the likelihood of achieving an R0 in patients with BRPC and possibly convert unresectable, locally advanced tumors to potentially resectable tumors. Response with neoadjuvant therapy regimens has resulted in increased number of patients eligible for resection, many times requiring vascular resection. Herein, we describe recent changes in the classification, important surgical and pathologic considerations and updated multimodal therapeutic options in the complex management of BRPC and LAPC.  This review contains 5 figures, 2 tables, and 78 references. Key Words: borderline resectable pancreatic cancer, CA 19-9, FOLFIRINOX, locally advanced pancreatic cancer, nab-paclitaxel, neoadjuvant chemotherapy, pancreatectomy, portal vein resection, radiation therapy, gemcitabine


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