scholarly journals The Management of Older Adults with Pancreatic Adenocarcinoma

Geriatrics ◽  
2018 ◽  
Vol 3 (4) ◽  
pp. 85 ◽  
Author(s):  
John Ogden ◽  
Hao Xie ◽  
Wen Ma ◽  
Joleen Hubbard
Keyword(s):  
Older Adults ◽  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Treatment Options ◽  
Karnofsky Performance Score ◽  
Nccn Guidelines ◽  
The Us ◽  
Localized Disease ◽  
Clinical Trial Enrollment ◽  
Current Guidelines

Pancreatic cancer is the eleventh most common cancer, yet it is the third leading cause of mortality. It is also largely a disease of older adults, with the median age of 71 at diagnosis in the US, with <1% of diagnoses occurring prior to age 50. Current NCCN guidelines recommend surgery for localized disease, followed by adjuvant therapy and/or consideration of enrollment in a clinical trial. For metastatic disease, current guidelines recommend clinical trial enrollment or systemic chemotherapy based on results from the landmark ACCORD-11 and MPACT trials. However, these trials focused heavily on younger, more fit patients, with the ACCORD-11 trial excluding patients over age 75 and the MPACT trial having 92% of its patients with a Karnofsky performance score >80. This article summarizes the available evidence in current literature in regards to the best treatment options for older adults, who represent the majority of pancreatic cancer diagnoses.

Racial disparities in comprehensive biomarker testing and clinical trial enrollment among patients with metastatic colorectal cancer (mCRC).

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 125-125
Author(s):  
Lisa M. Hess ◽  
Debora S. Bruno ◽  
Xiaohong Li ◽  
Eric Wen Su ◽  
Monaliben Patel
Keyword(s):  
Clinical Trial ◽  
Racial Disparities ◽  
Racial Differences ◽  
Significant Relationship ◽  
Trial Participation ◽  
Regression Analyses ◽  
Significant Difference ◽  
The Us ◽  
Biomarker Testing ◽  
Clinical Trial Enrollment

125 Background: Racial disparities may exist at many levels in the health care system; in oncology, yet little is known about racial disparities in biomarker testing and clinical trial enrollment among patients with mCRC. This study was designed to explore racial differences in comprehensive biomarker testing and clinical trial enrollment in the US using a large real-world database. Methods: This retrospective observational study utilized the Flatiron Health electronic health records database, which includes longitudinal data from patients diagnosed with mCRC. Patients with mCRC were eligible for this study if they had evidence of systemic therapy from 1/1/2017 through 10/30/2020 and were alive for at least 120 days after metastatic diagnosis. Unadjusted analyses summarized differences in biomarker testing and clinical trial enrollment between White and Black race, adjusted regression analyses were conducted using all baseline variables as covariates. These data are de-identified and are not considered human subjects research in accordance with the US Code of Federal Regulations (45 CFR Part 46). Results: A total of 7,879 patients were eligible: 4,803 (61.0%) were White and 838 (10.6%) were Black. Comprehensive testing by next-generation sequencing (NGS) was received by 51.6% and 41.8% of patients who were White and Black, respectively (p < 0.0001). There was no significant difference in clinical trial participation across all lines of therapy (2.9%, White and 2.9% Black). There was a statistically significant relationship between NGS-based testing and clinical trial enrollment (p < 0.0001), however, race was not identified a moderating factor in this relationship in adjusted regression analyses. The receipt of molecularly-targeted therapy was comparable between both races (11.9% and 9.7% for White and Black, respectively; p = 0.06). Patients received FOLFOX+bevacizumab most commonly in the first line (34.3% White; 40.5% Black), all other regimens were within 2 percentage points between racial groups. Targeted agents were each used by less than 7.4% of the study population. Conclusions: The use of NGS-based testing is significantly different by race in this database. The significant relationship between NGS testing and clinical trial enrollment at any time in the database did not appear to be moderated by race; however, descriptive analyses suggest that the ongoing analyses by line of therapy and considering timing of testing may better quantify these relationships. These data may not be generalizable to the entire US population as they are obtained from a single database that is limited to practices using this EHR system.

The mitochondrial metabolism inhibitor CPI-613 in combination with mFOLFIRINOX for pancreatic adenocarcinoma.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 264-264
Author(s):  
Angela Tatiana Alistar ◽  
Rodwige Desnoyer ◽  
Ralph D'Agostino
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Phase I ◽  
Response Rate ◽  
Treatment Options ◽  
Objective Response ◽  
Stage Iv ◽  
Phase I Clinical Trial ◽  
Glutamine Metabolism ◽  
Metastatic Pancreatic Cancer

264 Background: Stage IV pancreatic cancer is a lethal disease with limited treatment options. Current standard practice is combination chemotherapy with FOLFIRINOX or Gemcitabine + Abraxane. Despite these two new treatment options, the response rate and survival are limited in stage IV pancreatic cancer. The glycolic and mitochondrial metabolisms are aberrant in pancreatic cancer and translate into chemo-resistance. Inhibition of glutamine metabolism can potentially synergize with therapies that increase intracellular reactive oxygen species such as chemotherapy. CPI -613 is a novel anti-mitochondrial developed by Cornerstone Pharmaceuticals. Methods: A phase I clinical trial with mFOLFIRINOX+ CPI-613 in never treated for stage IV pancreatic cancer patients was initiated. The goals of this phase 1trial are: (1) To determine the Maximum Tolerated Dose (MTD) of CPI-613, when used in combination with mFOLFIRINOX, in patients with metastatic pancreatic cancer, (2) To assess the safety of CPI-613/ mFOLFIRINOX combination in patients with metastatic pancreatic cancer, and (3) To obtain preliminary data on efficacy of treatment with CPI-613/ mFOLFIRINOX Results: The MTD for CPI 613 was identified at 500mg/m2. The treatment combination is feasible and well-tolerated. The combination treatment was not found to have higher toxicity than FOLFIRINOX alone. The objective response rate was 53.9 % which is higher than FOLFIRINOX alone (reported as 31.6%). One patient has a complete radiologic and clinical response and two other patients have near complete responses. Conclusions: The preliminary efficacy data of this phase I clinical trial will inform a multi-institutional randomized phase II study of FOLFIRINOX vs. m FOLFIRINOX+ CPI613 in the near future. Clinical trial information: NCT01835041.

Feasibility of cancer clinical trial enrollment goals based on cancer incidence.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 20-20
Author(s):  
George Nhat Tran ◽  
Matthew Harker ◽  
Karen Chiswell ◽  
Joseph M. Unger ◽  
Mark Fleury ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cancer Diagnosis ◽  
Cancer Incidence ◽  
Recruitment Rate ◽  
Free Text ◽  
Medical Subject Headings ◽  
Cancer Society ◽  
The Us ◽  
Clinical Trial Enrollment ◽  
Suboptimal Design

20 Background: More than 20% of US clinical trials fail to accrue sufficient patients and terminate prematurely, impeding innovation and negating the valuable contributions of participating patients. The aim of this study is to estimate availability of patients for each trial opening in the national oncology clinical research portfolio to provide a benchmark for better understanding feasibility of clinical trial enrollment goals. Methods: The Database for Aggregate Analysis of ClinicalTrials.gov, up-to-date as of September 3, 2017, was used to identify actively-recruiting, interventional oncology trials at US sites. Observational studies were excluded as not all are registered. Trials were categorized via Medical Subject Headings or free text condition terms and sorted by cancer diagnosis. Trial slot availability was estimated between September 1, 2017, to August 31, 2018. Availability was estimated from total anticipated enrollment, assuming a constant recruitment rate. Estimates for studies with both foreign and US sites were pro-rated to calculate available enrollment in the US alone. The 2017 American Cancer Society cancer incidence estimates were used to approximate total US cancer diagnoses. Results: 4598 oncology trials were identified. Overall, an estimated 12.6 cancer patients are available for each clinical trial slot. The estimates by cancer diagnosis were: colorectal: 24.7 patients per trial slot; lung & bronchus: 20.1; prostate: 17.6; breast (female): 13.8; leukemia 11.6; and brain & other nervous system: 6.0. Conclusions: Across all diagnoses, 1 in 13 patients must enroll to meet accrual demands. This ratio varies by diagnosis. If cancer incidence is too low, trials with unrealistic accrual goals may be doomed at inception. In diagnoses with high disease burden, trial failure may be due to poor patient access or suboptimal design. [Table: see text]

scholarly journals Barriers to clinical trial enrollment of older adults with cancer: A qualitative study of the perceptions of community and academic oncologists

2020 ◽  
Vol 11 (2) ◽  
pp. 327-334 ◽  
Author(s):  
Mina S. Sedrak ◽  
Supriya G. Mohile ◽  
Virginia Sun ◽  
Can-Lan Sun ◽  
Bihong T. Chen ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trial ◽  
Qualitative Study ◽  
Clinical Trial Enrollment

scholarly journals Coming in the Air: Hypoxia Meets Epigenetics in Pancreatic Cancer

Cells ◽  
2020 ◽  
Vol 9 (11) ◽  
pp. 2353
Author(s):  
Claudia Geismann ◽  
Alexander Arlt
Keyword(s):  
Pancreatic Cancer ◽  
Immune Escape ◽  
Treatment Options ◽  
Tumor Development ◽  
Therapy Resistance ◽  
Ductal Adenocarcinoma ◽  
Epigenetic Alterations ◽  
Hypoxic Conditions ◽  
The Us ◽  
Desmoplastic Stroma

With a five-year survival rate under 9%, pancreatic ductal adenocarcinoma (PDAC) represents one of the deadliest tumors. Although the treatment options are slightly improving, PDAC is the second leading cause of cancer related death in 2020 in the US. In addition to a pronounced desmoplastic stroma reaction, pancreatic cancer is characterized by one of the lowest levels of oxygen availability within the tumor mass and these hypoxic conditions are known to contribute to tumor development and progression. In this context, the major hypoxia associated transcription factor family, HIF, regulates hundreds of genes involved in angiogenesis, metabolism, migration, invasion, immune escape and therapy resistance. Current research implications show, that hypoxia also modulates diverse areas of epigenetic mechanisms like non-coding RNAs, histone modifications or DNA methylation, which cooperate with the hypoxia-induced transcription factors as well as directly regulate the hypoxic response pathways. In this review, we will focus on hypoxia-mediated epigenetic alterations and their impact on pancreatic cancer.

Real-world data on treatment patterns of advanced CRC in third-line and beyond.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 56-56
Author(s):  
William A. Flood ◽  
Vlad Kozlovsky ◽  
Neil Margolis ◽  
Sandeep K. Reddy
Keyword(s):  
Clinical Trial ◽  
Treatment Options ◽  
Clinical Trial Data ◽  
Insurance Companies ◽  
Alternative Mechanism ◽  
Real World Data ◽  
Nccn Guidelines ◽  
Management Fees ◽  
Treatment Plans ◽  
Third Line

56 Background: NCCN guidelines state “regorafenib (Stivarga) [REG], and Trifluridine+Tipiracil (Lonsurf) [LON] are treatment options for patients who have progressed through all available regimens”. Available clinical trial data has not established whether recycling of prior regimens (oxaliplatin/irinotecan/5FU) with exchange of biologics (bevacizumab, ziv-aflibercept, cetuximab, panitumumab) is superior to changing class of therapy with oral well tolerated agents such as REG and LON. Methods: Data from a pre-authorization platform used by multiple commercial insurance companies in the US (Eviti) was analyzed. 6325 treatment plans of advanced CRC patients were evaluated. Analysis for request for use of REG and LON was limited to third-line and later of therapy in patients with a diagnosis of advanced CRC patients. Results: Of 394 treatment plans beyond second-line of therapy, REG was preferred over LON (239 v 155). Excluding growth factors, anti-emetics, and leucovorin, REG and LON were the 9th and 13th most frequently requested drugs in this clinical setting. Irinotecan was the most commonly requested drug in this setting at >10x the frequency of REG. Ramucirumab was requested more often than REG, and Pembrolizumab, Nivolumab, and Ziv-aflibercept were more requested than LON. HEOR models that included expected supportive care drugs and medication complication management fees estimated the cost of REG at $62,515 per patient versus LON at $26,596 with similar duration of therapy. Conclusions: Therapeutic preferences exist in third-line and later treatment of advanced CRC patients which cannot be fully explained by clinical trial outcome differences, HEOR cost differences, or NCCN guideline preferences. Recycling of chemotherapy and biologics in the late line setting is common and occurs more frequently than switching to a drug regimen with an alternative mechanism of action.

scholarly journals A Holistic View of the Biology of Pancreatic Cancer and Targeted Therapeutic Approaches to Treat the Cancer

2021 ◽  
Author(s):  
Sidra Munir ◽  
Shabir Ahmad ◽  
Ammara Gul
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Review Paper ◽  
Treatment Options ◽  
Gene Mutations ◽  
Tumor Formation ◽  
Therapeutic Approaches ◽  
Fatal Disease ◽  
Holistic View ◽  
Cellular Pathways

Pancreatic cancer is a fatal disease with mortality rate of 5% and a with a limited survival rate of 5 years. Despite of the extensive efforts that has been made to cure the disease it still has been considered as &lsquo;undruggable&rsquo;. It is characterized by epithelial to dense stromal tumor formation however due to lack of diagnosis options and treatment test available to detect the disease to the point at which resection of the tumor is possible, it makes it the fourth leading cause of cancer related death. The unavailable information regarding the early detection of biological markers along with the increased invasive tumor, the inherit chemoresistance against medication radiation and chemotherapy stubbornly fail the therapeutic options available. These associated problems made the scientists to reevaluate the approaches that are currently in practice and take a step back to fully understand the basic biological pathways that are involved in the pancreatic cancer, the heterogeneity of the tumor itself along with expression and a number of mutations that are observed at different locations. Clinical trial along with new approaches are nowadays focus of research to treat this tumor. The review paper describes the basic cellular pathways involved in pancreatic cancer, the gene mutations and their expression having effect on the pathology of the diseases along with treatment options that are available to treat the tumor. These efforts will help with the expansion of our knowledge to undergo the clinical trial and the synthesis of novel medicines for the prognosis of the disease.

scholarly journals ASO Visual Abstract: Access Denied—Inequities in Clinical Trial Enrollment for Pancreatic Cancer

2021 ◽  
Author(s):  
Mariam F. Eskander ◽  
Lindsay Gil ◽  
Eliza W. Beal ◽  
Yaming Li ◽  
Ahmad Hamad ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Clinical Trial Enrollment

Access Denied: Inequities in Clinical Trial Enrollment for Pancreatic Cancer

2021 ◽  
Author(s):  
Mariam F. Eskander ◽  
Lindsay Gil ◽  
Eliza W. Beal ◽  
Yaming Li ◽  
Ahmad Hamad ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Clinical Trial Enrollment

scholarly journals Pancreatic Adenocarcinoma, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology

2021 ◽  
Vol 19 (4) ◽  
pp. 439-457
Author(s):  
Margaret A. Tempero ◽  
Mokenge P. Malafa ◽  
Mahmoud Al-Hawary ◽  
Stephen W. Behrman ◽  
Al B. Benson ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Pancreatic Adenocarcinoma ◽  
Patient Outcomes ◽  
Advanced Disease ◽  
Treatment Options ◽  
Locally Advanced ◽  
Survival Rates ◽  
The United States ◽  
Nccn Guidelines

Pancreatic cancer is the fourth leading cause of cancer-related death among men and women in the United States. A major challenge in treatment remains patients’ advanced disease at diagnosis. The NCCN Guidelines for Pancreatic Adenocarcinoma provides recommendations for the diagnosis, evaluation, treatment, and follow-up for patients with pancreatic cancer. Although survival rates remain relatively unchanged, newer modalities of treatment, including targeted therapies, provide hope for improving patient outcomes. Sections of the manuscript have been updated to be concordant with the most recent update to the guidelines. This manuscript focuses on the available systemic therapy approaches, specifically the treatment options for locally advanced and metastatic disease.

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