Discussing treatment (Tx) and clinical trials for pancreatic cancer (PC): Learnings from the Pancreatic Cancer Action Network (PanCAN) survey.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 241-241
Author(s):  
Anitra Engebretson ◽  
Lynn Matrisian ◽  
Cara Thompson
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trials ◽  
Symptom Management ◽  
Primary Source ◽  
Support Service ◽  
Trial Participation ◽  
Realistic Option ◽  
The Us ◽  
Action Network

241 Background: In 2014, 46,420 patients (pts) in the US will be diagnosed with PC, and only 6.7% are expected to survive ≥ 5 years after diagnosis. Enrollment in clinical trials is recommended to improve pt outcomes. Methods: Funded by Celgene, PanCAN developed a 25-minute survey and distributed it online between 7/30/13 and 9/18/13 to pts with PC or caregivers whose loved ones were alive or had died of PC within the past 6 months. Results: Respondents included 184 pts (81 with metastatic PC) and 213 caregivers (145 for pts with metastatic PC). Pts and caregivers answered similarly with a few exceptions. Quality of life (QoL), extending survival, and symptom management were the 3 most important issues to all respondents. Caregivers placed statistically significantly more emphasis on QoL and managing symptoms vs pts (88% vs 71% and 68% vs 33%, respectively). A total of 196 respondents reported that Tx options were not offered at diagnosis, and 20% of these respondents stated that Tx options were never discussed with an MD. Most pts (95%) followed their doctors’ Tx recommendation, and 83% received chemotherapy. Almost half of respondents (49%) reported that their MD never discussed clinical trials; of those that did, oncologists (52%) were the primary source used to learn about possible clinical trial participation, followed by caregivers (16%) and loved ones (13%).Twelve percent of pts enrolled in clinical trials (> the US average of 4.6%; J Clin Oncol 31:3432-3438). Forty-eight percent of respondents were aware of the Pt and Liaison Services (PALS) program, a support service from PanCAN. PALS-aware respondents were more likely than others to report that the pt had undergone chemotherapy (89% vs 78%), surgery (64% vs 41%), or radiation (47% vs 32%) and more likely to state that the pt followed a Tx recommendation because it was the best/most realistic option (19% vs 11%). PALS-aware pts also participated more often in clinical trials (15% vs 9%). Conclusions: These results underscore the importance of discussing Tx options, clinical trials, and support services with pts. Such steps could increase Tx and enrollment in clinical trials, possibly improving QoL, survival, and symptom management.

scholarly journals The role of erenumab in the treatment of migraine

2020 ◽  
Vol 13 ◽  
pp. 175628642092711 ◽  
Author(s):  
Anna P. Andreou ◽  
Matteo Fuccaro ◽  
Giorgio Lambru
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
European Medicines Agency ◽  
Human Antibody ◽  
Subcutaneous Injections ◽  
Calcitonin Gene ◽  
The Us ◽  
Different Doses

Calcitonin gene related peptide (CGRP) monoclonal antibodies (mAbs) have been the first class of specifically developed preventive treatments for migraine. Clinical trials data suggest superiority of the CGRP mAbs to placebo in terms of prevention of migraine symptoms, migraine-specific quality of life and headache related disability. Treatment-related side effects overall did not differ significantly from placebo and discontinuation rate due to side effects has been low across the clinical trials, perhaps in view of their peripheral mode of action. Along with their route and frequency of administration, these novel class of drugs may constitute an improvement compared with the established arsenal of migraine treatments. Erenumab is a fully human antibody and the only mAb acting on the CGRP pathway by blocking its receptor. It is the first of the CGRP mAb class approved by the US Food and Drug Administration (May 2018) and the European Medicines Agency (July 2018). Erenumab exists in two different doses (70 mg and 140 mg) and it is administered with monthly subcutaneous injections. This review summarises erenumab pharmacological characteristics, clinical trials data, focusing on the potential role of this treatment in clinical practice.

Impact of study participation on survival of early-stage breast cancer patients: Results from the BRENDA study, a multicenter clinical cohort on quality of breast cancer care

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 521-521
Author(s):  
C. Kurzeder ◽  
J. König ◽  
A. Woeckel ◽  
G. Sauer ◽  
M. Wischnewsky ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Systemic Therapy ◽  
Early Stage ◽  
Trial Participation ◽  
Breast Cancer Patients ◽  
Study Participation ◽  
Neoadjuvant Systemic Therapy ◽  
Study Population

521 Background: Over the past two decades significant progress in treatment of early breast cancer has been accomplished through well designed, clinical trials (CTs). It has been hypothesized that trial participation could also be beneficial for the individual breast cancer patient. The BRENDA study group has been analysing quality of care provided by one university based and 16 regional breast cancer centers in south germany. In this study we investigated the impact of study participation on survival in an unselected clinical cohort of early stage breast cancer patients. Methods: The study population includes 5,966 patients who received primary therapy for early breast cancer between 1992 and 2005. Influence on survival by study participation was calculated by Cox proportional hazard analyses. Model adjustments include prognostic factors, type of treatment, age, risk group and time period. Guideline compliant treatment was assessed based on the St Gallen expert consensus recommendations and the German national S3 Guidelines. Results: A total of 738 patients (12%) received adjuvant (n = 552) or neoadjuvant (n = 186) systemic therapy within one out of 42 registered prospective multicenter phase II or III clinical trials. For patients not receiving neoadjuvant systemic therapy trial participation was associated with improved overall and disease free survival (hazard ratio [HR] = 0.75, 95% confidence interval [CI] 0.57–0.99, HR = 0.78, CI 0.63 - 0.97, respectively). The calculated effect was of similar magnitude after additional adjustment for co-existing morbidity of patients. Descriptional analysis revealed that guideline violations for locoregional or systemic treatment were more frequently found in patients receiving adjuvant treatment outside CTs. No significant effect on survival was calculated for 183 patients receiving neoadjuvant systemic therapy within CT protocols. Conclusions: In our study population participation in prospective clinical trials for adjuvant systemic therapy was associated with improved survival irrespective of treatment actually given. Intrinsic mechanisms within the framework of clinical trials can improve quality of breast cancer patient care. No significant financial relationships to disclose.

Willingness of patients with pancreatic cancer to participate in clinical trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4055-4055
Author(s):  
Pelin Cinar ◽  
Anitra W. Talley ◽  
Jimmy Hwang ◽  
Daniel Paul Dohan ◽  
Margaret A. Tempero
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cross Sectional Study ◽  
Trial Participation ◽  
Trial Recruitment ◽  
Chi Square ◽  
Cross Sectional ◽  
Recruitment Methods ◽  
Clinical Trial Recruitment

4055 Background: Recruitment of oncology patients into clinical trials continues to be a challenge as <5% of patients are accrued. Low accrual rates may be due to reduced awareness of trial availability and eligibility by physicians/patients. Our objective was to study the attitudes of patients with pancreatic cancer (PC) regarding clinical trial participation and to identify possible barriers to recruitment. Methods: In this cross-sectional study, we collaborated with Pancreatic Cancer Action Network (PanCAN) and invited patients with PC or their caregivers to complete a survey. The survey that was developed consisted of 22 questions and inquired about patients’ previous clinical trial enrollment experiences and their views on participation. The surveys were collected over a 6-month period via the PanCAN website and regional meetings. Comparison analyses between groups were done by Chi-square and Fisher’s test using STATA software. Results: Of the390 surveys received, 149 were included in the final analyses. 30% of the patients were offered to participate in a trial by their physicians. When asked to participate, 62% of the patients agreed. Of the patients who were not enrolled in a clinical trial, 61% were offered to participate in a trial but did not agree. This suggests that these patients were eligible to participate but declined. Conclusions: Majority of the patients with pancreatic cancer were not offered to participate in clinical trials by their physicians but would have agreed if asked. While low clinical trial recruitment rates for PC may be multifactorial, further research may focus on the important role of physicians in clinical trial recruitment efforts. [Table: see text]

Impact of organ function based standard exclusion criteria in diffuse large b-cell lymphoma (DLBCL) patients: Who gets left behind?

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14100-e14100
Author(s):  
Arushi Khurana ◽  
Raphael Mwangi ◽  
Grzegorz S. Nowakowski ◽  
Thomas Matthew Habermann ◽  
Stephen M. Ansell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
B Cell Lymphoma ◽  
Standard Of Care ◽  
Trial Participation ◽  
Newly Diagnosed ◽  
Organ Function ◽  
Exclusion Criteria ◽  
The Us ◽  
The Impact

e14100 Background: Only 3-5% of adult cancer patients in the US enroll in clinical trials. Patients with organ dysfunction are often excluded from clinical trials, regardless of specific drug metabolism or relative function of the organ. The ASCO and the US FDA recommend modernizing criteria related to baseline organ function and comorbidities. In hematological malignancies, often the disease itself is the reason for organ function derangement. In order to better inform clinical trial eligibility and improve participation in the future, we evaluated the impact of baseline organ function on the potential eligibility for clinical trial enrollment for real world patients with newly diagnosed DLBCL. Methods: Consecutive, newly diagnosed lymphoma patients were offered enrollment from 2002-2015 into the Molecular Epidemiology Resource (MER) of the University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence. This analysis is based on 1270 DLBCL patients receiving immunochemotherapy. Baseline organ function parameters were identified from the exclusion criteria for hemoglobin, absolute neutrophil count (ANC), platelet count, creatinine, and bilirubin reported in recent frontline trials in DLBCL (Table). Abstracted clinical labs from the MER were used to determine the percent of patients that would be excluded based on the criteria. Results: We determined that 11-23% of MER DLBCL patients receiving standard of care frontline therapy would have been excluded in the various trials utilizing baseline organ function alone (Table). Hemoglobin and renal function had the greatest impact on exclusion. Conclusions: Current national and international (phase II and III) trials are excluding up to 23% of patients from clinical trial participation based on organ function alone in DLBCL. These data will be useful in future clinical trial development to meet ASCO recommendations to increase trial accrual, while balancing the drug toxicities and patient safety. An online tool was developed based on these results to aid future trial development. [Table: see text]

Integrating Patient-Reported Outcomes Into Cancer Symptom Management Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

2007 ◽  
Vol 25 (32) ◽  
pp. 5070-5077 ◽  
Author(s):  
Jeff A. Sloan ◽  
Lawrence Berk ◽  
Joseph Roscoe ◽  
Michael J. Fisch ◽  
Edward G. Shaw ◽  
...  
Keyword(s):  
Clinical Trials ◽  
National Cancer Institute ◽  
Symptom Management ◽  
Patient Reported Outcomes ◽  
Draft Guidance ◽  
End Point ◽  
Patient Reported ◽  
The Us ◽  
Cancer Symptom Management ◽  
Made In

Patient-reported outcomes (PROs) are often the primary end point in symptom management trials. The scientific field of PROs is evolving, as evidenced by the US Food and Drug Administration's February 2007 release of a draft guidance for using PROs in effectiveness claims for drug labeling. This article presents issues encountered during use of PROs in National Cancer Institute–sponsored symptom management trials. Selected trials are presented that exemplify the challenges often seen in symptom management trials, and solutions are described. The examples presented include defining the appropriate end point, selecting and validating assessments, and answering the research questions through statistical analysis and interpretation. Progress has been made in addressing some of the unique challenges of PRO-based symptom management research. Many challenges still remain, but a foundational body of work now exists for more consistent and rigorous application of PROs into symptom management trials. There remains a need for more research in several methodologic aspects of design, analysis, and interpretation of symptom management trials.

Points to keep in mind when carrying out clinical trials in Japan on advanced pancreatic cancer cases without alternative treatments: Analysis of 367 cases.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 243-243
Author(s):  
Giichiro Tsurita ◽  
Hiroshi Yasui ◽  
Tomohiro Kurokawa ◽  
Yuichiro Yoshioka ◽  
Kentaro Yazawa
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
General Condition ◽  
Outpatient Clinic ◽  
Poor Prognosis ◽  
Medical Condition ◽  
Advanced Pancreatic Cancer ◽  
Screening Tests ◽  
Trial Participation

243 Background: We commenced a physician-led clinical trial to examine the efficacy of a combined treatment of peptide vaccine therapy for advanced pancreatic cancer that has no effective treatment. During this trial, there were inquiries from 367 cases, of which 145 cases (40%) were examined at our outpatient clinic. The purpose of this study was to examine these cases in detail and to consider the points to be noted in executing clinical trials for poor prognosis cases. Methods: We examined the timing of inquiry, medical condition, the person(s) they inquired, and other relevant information regarding the 367 subjects who made inquiries. For the 145 cases visited the outpatient clinic of our hospital, we examined their medical condition, treatment and whether or not they have participated in a clinical trial. Results: 140 of the 367 cases (38%) of inquiry were concentrated within the first two months after the start. During these two months, there was a concentration of patients who had completed standard treatments and were a few months into BSC, but were unable to participate in the clinical trial due to deterioration of their general condition. Many of the inquiries were made by family members (spouse or child) of the patients, around twice the number of inquiries made by patients themselves. Even among the 145 subjects that were examined in the outpatient clinic of our hospital, severe cases, in particular, were seen several months after the start of the study. There were many cases that required urgent hospitalization during outpatient visits or patients whose general condition rapidly deteriorated during the screening tests. 23 cases (16%) underwent the clinical trial. Conclusions: In clinical trials such as this one, which handles cases with poor prognosis, many of the subjects are in poor general condition at the inquiry stage, and most of these inquiries are concentrated immediately after the start of the study. Therefore, it is very important to deal with inquiries and make judgments during the outpatient examination on whether or not clinical trial participation is possible.

scholarly journals Who Needs What? Perceptions of Patients and Caregivers in Oncology Phase 1 Trials

2019 ◽  
Vol 7 (1) ◽  
pp. 27-33 ◽  
Author(s):  
Victoria Rezash ◽  
Janice Reed ◽  
Barbara Gedeon ◽  
Eric Parsons ◽  
Sandra Siedlecki ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase 1 ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Oncology Clinical Trial ◽  
Oncology Clinical Trials ◽  
Vulnerable Patient ◽  
Additional Support

Background: The study design and nature of oncology phase 1 clinical trials create a uniquely vulnerable patient population yet little research has been conducted to identify the added burden these trials create for both cancer patients and their caregiver(s). Objective: Examining the perceptions and needs of patients and their caregivers participating in phase 1 oncology clinical trials, the investigators tested the hypothesis that the caregiver will exhibit a higher level of burden and/or distress than the patient. Method: A mixed-methods exploratory process utilizing patient and caregiver interviews and quality-of-life questionnaires was used to assess the psychosocial burdens associated with oncology clinical trial participation. A qualitative and quantitative analysis of the responses were 8 performed. Result: Both patients and caregivers reported similar themes identifying the burdens and benefits related to phase 1 clinical trial participation. However, the caregivers’ expressed burden exceeded that of the patients’ validating the study’s hypothesis. Conclusion: The need for ongoing additional support services for not only the patient but also the caregiver was identified.

Quality-of-Life Assessment in the Symptom Management Trials of the National Cancer Institute-Supported Community Clinical Oncology Program

2005 ◽  
Vol 23 (3) ◽  
pp. 591-598 ◽  
Author(s):  
David R. Buchanan ◽  
Ann M. O'Mara ◽  
Joseph W. Kelaghan ◽  
Lori M. Minasian
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Clinical Oncology ◽  
National Cancer Institute ◽  
Symptom Management ◽  
Symptom Relief ◽  
Life Assessment ◽  
Specific Symptom ◽  
Community Clinical Oncology Program

Purpose To examine how quality of life (QOL) is prospectively conceptualized, defined, and measured in the symptom management clinical trials supported by the National Cancer Institute Community Clinical Oncology Program (CCOP). Methods All QOL research objectives, rationales, assessment instruments, symptoms treated, and types of interventions from the CCOP symptom management portfolio of clinical trials were extracted and analyzed. Results QOL assessments were proposed in 68 (52%) of the 130 total CCOP symptom management trials initiated since 1987. A total of 22 global QOL instruments were identified. Both the frequency of symptom management trials and the frequency of QOL assessment have increased significantly over time. The Functional Assessment of Cancer Therapy and Uniscale instruments were the most widely used QOL instruments, included in 55% of trials assessing QOL. The conceptual framework for QOL inclusion was limited to univariate relationships between symptom relief and global improvements in QOL. No consistent associations were found between QOL assessment and either the symptoms targeted or types of interventions. Conclusion To advance the state of the science, research protocols need to provide more explicit rationales for assessing QOL in symptom management trials and for the selection of the QOL instrument(s) to be used. Conceptual frameworks that specify the hypothesized links between the specific symptom(s) being managed, interactions with other symptoms, different domains of QOL, and global QOL also need to be more precisely described. Methodologic and conceptual advances in QOL symptom management trials are critical to fulfill the promise of alleviating suffering and improving the QOL of cancer patients.

Abstract 17202: Racial/Ethnic Minority Underreporting and Underrepresentation in Guideline-Driving Blood Cholesterol Clinical Trials

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Ashish Sarraju ◽  
Areli Valencia ◽  
Joshua Knowles ◽  
David J Maron ◽  
Fatima Rodriguez
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Census Data ◽  
The United States ◽  
Blood Cholesterol ◽  
Trial Participation ◽  
Atherosclerotic Cardiovascular Disease ◽  
The Us ◽  
Us Census ◽  
Racial Ethnic

Introduction: Cholesterol management is the cornerstone of atherosclerotic cardiovascular disease prevention. Diverse racial/ethnic participation in high-impact cholesterol trials is essential for the generalizability of trials and guidelines across the United States (US). Methods: We analyzed randomized clinical trials (RCTs) cited in the 2018 American Multi-society Guideline on the Management of Blood Cholesterol for reporting and representation of racial/ethnic minorities. We extracted participant level racial/ethnic data, including non-Hispanic White (NHW), Black, Hispanic, or Asian groups. For each race/ethnicity, we pooled trial data to assess overall representation compared to the general US population based on 2010 US Census and 2019 US Census American Community Survey estimates. Results: Among 71 cited RCTs from 1984 - 2017, 59.1% reported racial/ethnic data. NHW participation was reported in 58%, Black in 34%, Hispanic in 27%, and Asian in 17% (Figure). Four trials disaggregated Hispanic patients and none disaggregated Asians. Black trial representation was significantly lower than the US population per 2010 and 2019 Census data (trial: 5.5%, 2010: 12.6%, 2019: 13.4%, P <0.001). Hispanic trial representation was significantly lower compared to the US population (trial: 10.6%, 2010: 16.3%, 2019: 18.3%, P <0.001). NHW trial participation was lower compared to the US population (trial 69.2%; 2010: 72.4%; 2019: 76.5%, P <0.001), but with smaller relative differences compared to Black and Hispanic representation. Asian participation was higher than US census representation. Conclusion: Among guideline-driving cholesterol RCTs, Black and Hispanic participants are significantly underrepresented compared to the general U.S. population. Few studies disaggregate major racial/ethnic subgroups. These findings represent a source of systemic bias that may limit the generalizability of trials and guidelines and potentiate health inequities.

Comparison of Gemcitabine Versus the Matrix Metalloproteinase Inhibitor BAY 12-9566 in Patients With Advanced or Metastatic Adenocarcinoma of the Pancreas: A Phase III Trial of the National Cancer Institute of Canada Clinical Trials Group

2003 ◽  
Vol 21 (17) ◽  
pp. 3296-3302 ◽  
Author(s):  
M.J. Moore ◽  
J. Hamm ◽  
J. Dancey ◽  
P.D. Eisenberg ◽  
M. Dagenais ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Clinical Trials ◽  
Matrix Metalloproteinase ◽  
National Cancer Institute ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Matrix Metalloproteinase Inhibitor ◽  
Free Survival

Purpose: To compare the selective matrix metalloproteinase inhibitor BAY 12-9566 with the nucleoside analog gemcitabine in the treatment of advanced pancreatic cancer. Methods: Patients with advanced pancreatic adenocarcinoma who had not previously received chemotherapy were randomly assigned to receive BAY 12-9566 800 mg orally bid continuously or gemcitabine 1,000 mg/m2 administered intravenously on days 1, 8, 15, 22, 29, 36, and 43 for the first 8 weeks, and then days 1, 8, and 15 of each subsequent 28-day cycle. The primary end point was overall survival; secondary end points were progression-free survival, tumor response, quality of life, and clinical benefit. The planned sample size of the study was 350 patients. Two formal interim analyses were planned. Results: The study was closed to accrual after the second interim analysis on the basis of the recommendation of the National Cancer Institute of Canada Clinical Trials Group Data Safety Monitoring Committee. There were 277 patients enrolled onto the study, 138 in the BAY 12-9566 arm and 139 in the gemcitabine arm. The rates of serious toxicity were low in both arms. The median survival for the BAY 12-9566 arm and the gemcitabine arm was 3.74 months and 6.59 months, respectively (P < .001; stratified log-rank test). The median progression-free survival for the BAY 12-9566 and gemcitabine arms was 1.68 and 3.5 months, respectively (P < .001). Quality-of-life analysis also favored gemcitabine. Conclusion: Gemcitabine is significantly superior to BAY 12-9566 in advanced pancreatic cancer.

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