scholarly journals A pilot trial of early specialty palliative care for patients with advanced pancreatic cancer: Challenges encountered and lessons learned.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 110-110 ◽  
Author(s):  
Yael Schenker ◽  
Nathan Bahary ◽  
Rene Claxton ◽  
Julie Childers ◽  
Dio Kavalieratos ◽  
...  

110 Background: Palliative care trials face implementation barriers. We describe challenges encountered in a pilot trial of early specialty palliative care for patients with pancreatic cancer. Methods: We conducted a mixed-methods pilot randomized controlled trial of early specialty physician-led palliative care in advanced pancreatic cancer. Recently diagnosed patients with borderline, locally-advanced, or metastatic pancreatic cancer and their caregivers (total N=60) were recruited from clinic at a comprehensive cancer center and randomized (2:1) to receive monthly specialty palliative care visits for 3 months in addition to standard oncology care vs. standard oncology care alone. Feasibility assessments included enrollment and intervention completion rates. Acceptability and perceived effectiveness were assessed via drop-out rates and semi-structured participant interviews. Results: The enrollment target was reached after 50 weeks, with a randomized: approached rate of 27%. Mean patient age was 63 (SD 11) and 50% were male. Mean caregiver age was 62 (SD 12), 47% were male, and 80% were the spouse or partner of a patient. 70% of participants in the intervention group completed at least one specialty palliative care visit and 15% completed 3 palliative care visits within the 3-month time period. Two patients and 3 caregivers withdrew, and 4 patients died prior to 3 months. Enrollment barriers included patients not planning to continue receiving care from a participating oncologist and feeling too overwhelmed at the time of diagnosis to consider research participation. In semi-structured interviews, patients and caregivers noted that long travel times to the cancer center, difficulty scheduling palliative care visits at a convenient time, and lengthy study assessments posed burdens. Oncologists and palliative care physicians recommended more in-person communication between clinicians and tailoring palliative care visit content and schedules to match patient needs. Conclusions: Future palliative care intervention trials must consider implementation challenges related to recruitment, retention, intervention fidelity, and participant burden. Clinical trial information: NCT01885884.

Medicina ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 77
Author(s):  
Nathalie Rosumeck ◽  
Lea Timmermann ◽  
Fritz Klein ◽  
Marcus Bahra ◽  
Sebastian Stintzig ◽  
...  

Background and Objectives: An increasing number of patients (pts) with locally advanced pancreatic cancer (LAPC) are treated with an intensive neoadjuvant therapy to obtain a secondary curative resection. Only a certain number of patients benefit from this intention. The aim of this investigation was to identify prognostic factors which may predict a benefit for secondary resection. Materials and Methods: Survival time and clinicopathological data of pts with pancreatic cancer were prospective and consecutively collected in our Comprehensive Cancer Center Database. For this investigation, we screened for pts with primarily unresectable pancreatic cancer who underwent a secondary resection after receiving induction therapy in the time between March 2017 and May 2019. Results: 40 pts had a sufficient database to carry out a reliable analysis. The carbohydrate-antigen 19-9 (CA 19-9) level of the pts treated with induction therapy decreased by 44.7% from 4358.3 U/mL to 138.5 U/mL (p = 0.001). The local cancer extension was significantly reduced (p < 0.001), and the Eastern Cooperative Oncology Group (ECOG) performance status was lowered (p = 0.03). The median overall survival (mOS) was 20 months (95% CI: 17.2–22.9). Pts who showed a normal CA 19-9 level (<37 U/mL) at diagnosis and after neoadjuvant therapy or had a Body Mass Index (BMI) below 25 kg/m2 after chemotherapy had a significant prolonged overall survival (29 vs. 19 months, p = 0.02; 26 vs. 18 months, p = 0.04; 15 vs. 24 months, p = 0.01). Pts who still presented elevated CA 19-9 levels >400 U/mL after induction therapy did not profit from a secondary resection (24 vs. 7 months, p < 0.001). Nodal negativity as well as the performance of an adjuvant therapy lead to better mOS (25 vs. 15 months, p = 0.003; 10 vs. 25 months, p < 0.001). Conclusion: The pts in our investigation had different benefits from the multimodal treatment. We identified the CA 19-9 level at time of diagnosis and after neoadjuvant therapy as well as the preoperative BMI as predictive factors for overall survival. Furthermore, diagnostics of presurgical nodal status should gain more importance as nodal negativity is associated with better outcome.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 413-413 ◽  
Author(s):  
Sofia Palacio ◽  
Ikechukwu Immanuel Akunyili ◽  
Vinicius Ernani ◽  
Jessica Macintyre ◽  
Jaime R. Merchan ◽  
...  

413 Background: The combination of nab-P and Gem improves survival compared to Gem alone in first-line therapy of metastatic pancreatic cancer. Efficacy data with this doublet in previously treated pts are scant. Our group presented preliminary results on 10 pts treated with this two-drug combination in the second and third line setting and herein present updated data on 59 pts. Methods: This IRB approved analysis identified all pts diagnosed with advanced refractory pancreatic cancer, treated with second-line Gem and nab-P at University of Miami and Sylvester Comprehensive Cancer Center between September 2010 and June 2014. Response by RECIST, CA19-9, and symptomatic improvement were assessed. Progression-free survival (PFS) and overall survival (OS) were calculated from the start of Gem + nab-P and were analyzed using the Kaplan-Meier method. Clinical benefit was defined as the percentage of patients with a partial response (PR) or stable disease (SD). Results: Data from59 pts were analyzed. The median age was 60; 55% were male; 54% received Gem + nab-P as second line therapy and 46% received it as third-line or beyond. Five (10%) pts had confirmed PR, 23 (47%) SD and 21 (43%) progressed. Among the 31 (52%) pts who received prior Gem, 18 (58%) had clinical benefit, 3 PR and 15 SD. The median OS was 3.9 months. The median PFS was 3 months. Toxicity appears similar to what has been reported on the MPACT trial with the combination. Conclusions: The clinical benefit seen withGem and nab-P in this group of pretreated pancreatic cancer pts suggests that it can be considered as an option. Additionally, prior Gem treatment appears not to decrease Gem and nab-P benefit in this population. Since nab-P monotherapy has modest activity in pre-treated pancreatic cancer pts, our data suggests a positive interaction between Gem and nab-P that may overcome resistance to Gem. [Table: see text]


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 7041-7041 ◽  
Author(s):  
Gary Rodin ◽  
Carmine Malfitano ◽  
Anne Rydall ◽  
Christopher Lo ◽  
Aaron David Schimmer ◽  
...  

7041 Background: Individuals diagnosed with AL may experience severe physical and psychological distress due to the illness and its treatment, the threat of relapse and treatment failure, and a high risk of mortality. To alleviate psychological and physical distress in this population, we developed a novel, 8-week, manualized intervention called EASE. This includes: 1) EASE-psy- a tailored psychotherapeutic component to reduce psychological distress; and 2) EASE-phys-symptom screening, with moderate to severe physical symptoms triggering early palliative care. Methods: To assess the feasibility and preliminary efficacy of EASE, patients were recruited within 2 weeks of admission to a comprehensive cancer center and randomized to receive either EASE or usual care (UC). Physical and psychological symptoms were assessed at baseline, 4, 8 (primary endpoint), and 12 weeks. Intervention patients received 6-10 psychotherapy sessions over 8 weeks, weekly assessment of physical symptoms, and consultation and follow-up by palliative care, when needed. One-way ANOVA was performed to assess mean change scores over time between groups. Results: Forty-two patients were randomized to EASE (n = 22) or UC (n = 20). Predefined feasibility outcomes were all met: > 86% (19/22) of EASE participants (goal > 64%) completed > 50% of proposed EASE-psy sessions; 64% (14/22) completed symptom screenings (goal > 50%); and 100% of those with moderate to severe symptoms had > 1 meeting with the EASE-phys team (goal 100%). There were statistically significant findings favoring EASE vs. UC for satisfaction with care at 8 and 12 weeks (Δ: -3.12 vs 7.39, p < 0.04; -6.1910 vs 0.0125 p < 0.03). There were trends favoring EASE vs. UC for traumatic stress symptoms, depressive symptoms, quality of life, attachment security, and number, severity, and distress related to physical symptoms at 4, 8, and 12 weeks. Conclusions: Although not powered for statistical significance, this randomized pilot trial of EASE for AL showed promising reductions in psychological and physical distress and supports the feasibility and need for a larger randomized controlled trial. Clinical trial information: NCT02353559.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15744-e15744 ◽  
Author(s):  
Anup Kasi ◽  
Akshay Middinti ◽  
An Cao ◽  
Pratikkumar Vekaria ◽  
Devangi Patel ◽  
...  

e15744 Background: FOLFIRINOX (FFN) and Gemcitabine plus nab-paclitaxel (GN) have been established as first line chemotherapy in advanced pancreatic cancer (PC). But there is no head-to-head randomized trial data available to support preferable first line choice between these two regimens. Methods: We retrospectively evaluated 154 chemotherapy-naïve locally advanced and metastatic PC patients treated with FFN or GN at KU Cancer Center between January 2011 and November 2016. FFN consisted of Oxaliplatin 85mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 as a bolus and 2,400 mg/m2over 46 hour on days 1 and 15 every 4 weeks. GN consisted of Gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 day1,8,15 every 4 weeks. We compared characteristics, efficacy and adverse events between FFN and GN. Results: 107 patients were treated with FFN and 47 patients with GN as first line therapy. Demographic and baseline characteristics (FFN/GN) were as follows: Median age 61/63 years, ECOG performance status (0-1): 90% / 83%, Gender (male): 57% / 54%, distant metastases: 52%/70%, biliary stenting: 41%/20%, locally advanced tumor: 48%/30%, pancreatic head tumors: 63%/55%, median number of cycles: 4/4 respectively. Objective response rate (13% vs. 10%), Stable disease rate (76% vs 82%) and disease control rate (89% vs. 92%, p = 0.5) were similar in FFN and in GN. Median PFS was 11.7 months (95% CI: 7.2-16.1) in FFN and 5.7 months (95% CI: 2.7-8.8) in GN [p = 0.07]. Median OS was 15.9 months (95% CI: 13.7-18.1) in FFN and 10.8 months (95% CI: 7.1 – 14.5) in GN [p = 0.17]. Incidences of grade 3 or higher adverse effects were neutropenia (33% vs. 17%), anemia (14% vs 31%), thrombocytopenia (28% vs 6%), elevated creatinine (2.8% vs 4%), elevated transminases (3.7% vs 6%), diarrhea (5% vs. 0%), and peripheral neuropathy (6% vs. 6%) respectively. Conclusions: Patients treated with FFN showed statistically better PFS compared to GN. However this difference in PFS did not translate into statistically significant difference in OS. Response rates were similar. Incidences of adverse events were relatively more with FFN compared to GN as expected.


2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 163-163
Author(s):  
Matthew Anaka ◽  
Minji Lee ◽  
Sunita Ghosh ◽  
Winson Y. Cheung ◽  
Jennifer L. Spratlin

163 Background: Cancer care in Northern Alberta (Canada) is delivered at a single tertiary cancer centre, and 11 regional and community cancer centres (RCCC). We compared outcomes and care patterns for patients with advanced pancreatic cancer (APC; locally advanced or metastatic) in Northern Alberta treated with palliative chemotherapy at either the tertiary centre or an RCCC. Methods: This is a retrospective cohort analysis of APC patients treated with palliative chemotherapy from 2012-2015 in Northern Alberta (Canada). Data were obtained from outpatient medical oncology and palliative care notes and the provincial cancer registry. Survival analysis used a multivariate Cox-regression model. All other tests were Chi-squared/Fisher’s Exact. Results: We identified 106 patients, 90 treated in the tertiary centre, and 16 in a RCCC. Baseline characteristics were not significantly different. There were significant differences in first line chemotherapy regimen use (P = 0.037), with patients treated at RCCC more likely to receive gemcitabine during the study period (68.8% vs 36.6%), and less likely gemcitabine/nab-paclitaxel (12.5% vs 36.5%) or FOLFIRINOX (18.8% vs 28.7%). Patients treated at RCCC were less likely to see an outpatient palliative care physician (P = 0.020, 6.3% vs 35.6%), or have a documented goals of care designation (P = 0.005, 12.5% vs 52.2%). There was no significant difference in overall survival in a multivariate analysis (median 199 vs 232 days, HR = 1.080, 95% CI 0.594 – 1.966). Conclusions: We found that survival was not different for APC patients treated at the tertiary vs RCCC in Northern Alberta. However there were significant differences in the use of palliative care resources and 1st line chemotherapy regimens, which represent important disparities that should be the focus for future quality improvement.


2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 683-683
Author(s):  
Matthew Anaka ◽  
Minji Lee ◽  
Elisa Lim ◽  
Sunita Ghosh ◽  
Winson Y. Cheung ◽  
...  

683 Background: Discussion of goals of care (GoC) is a key part of quality care for patients with palliative cancer. Numerous studies have shown that documentation of GoC in this population remains low. In 2014, Alberta Health Services launched a health-system wide initiative to provide patients with physical copies of their GoC designation intended to be available at all health-system interactions. Here we describe rates of GoC documentation in the period surrounding this initiative. Methods: This is a retrospective cohort analysis of 240 patients with locally advanced or metastatic pancreatic cancer treated with palliative chemotherapy from 2012-2015 in Alberta, Canada. Data were obtained from outpatient electronic medical record documentation and the provincial cancer registry. Results: 63.8% (153/240) of patients had a documented GoC discussion, with 60.4% (145/240) receiving a specific GoC designation. 59.6% (143/240) of patients were referred to palliative care, with 32.5% (78/240) seen by palliative care physician. Of 334 individual GoC discussions documented, 38.6% (129/334) were by medical oncologists, 2.3% (10/334) were by radiation oncologists, 27.2% (91/334) were by palliative care, and 19.2% (64/334) were by other inpatient physicians during hospital admissions. At least 9.6% (32/334) referenced discussions that occurred prior to initial consultation with an oncology physician. Conclusions: The majority of pancreatic cancer patients undergoing palliative chemotherapy had a documented GoC designation during the study period. Providing patients with physical copies of their GoC designation may therefore represent a simple but effective means of increasing GoC documentation in the outpatient oncology setting.


2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 63-63
Author(s):  
Bethany Lockwood ◽  
Olanipekun Lanny Ntukidem ◽  
Sarah Ehrman ◽  
Maryam B. Lustberg ◽  
Bhavana Bhatnagar ◽  
...  

63 Background: Adolescent and young adults (AYA) diagnosed with cancer have distinct physical, developmental and psychosocial needs that are often unmet during oncology treatment. Such needs are further intensified for AYA patients with an advanced cancer diagnosis. Palliative Care (PC), specialized care for patients and families with serious illness, can address these needs throughout the disease trajectory including symptom management, supportive communication, and advance care planning. The incorporation of PC remains suboptimal despite evidence that palliative services can improve quality of life. In an effort to identify strategies to advance access to PC for the AYA population at our institution, the referral pattern to PC was studied. Methods: A retrospective chart review was performed to identify referral patterns to PC in the AYA population (ages 18-39) from July 2017 through June 2019 at a National Cancer Institute designated comprehensive cancer center. Descriptive statistics were utilized to summarize referral patterns and trends. Results: In the past 2 years, 1,894 AYA patients established oncology care at our institution. The most common AYA cancer diagnoses included hematologic 20.8% (n=944), thyroid 10.8% (n=490), brain 9.9% (n=451) and breast 9.1% (n=414). There were 311 (16%) referrals placed to PC, mostly in the inpatient setting (81.4%). Less than half (43%) of the inpatient referrals had a post-discharge follow-up appointment in the PC clinic. Multiple disease-specific service lines were represented including leukemia (40%), colorectal (14.5%), sarcoma (9%) and breast (9%). Quarterly volumetric trends remained static over the 2 years (average number of referrals: 54/quarter). The average age at cancer diagnosis in the AYA population was 30 years and 32.7 years (range 19-39) at time of PC referral. This was consistent with the average length of time from initial diagnosis to PC referral of 2.8 years. Conclusions: Comprehensive oncology care in the AYA population should include PC. Yet, involvement of PC in the AYA population during oncologic treatment was limited. Future research will investigate optimal models of integrative PC to address the unique needs of AYA cancer.


2013 ◽  
Vol 18 (5) ◽  
pp. 543-548 ◽  
Author(s):  
Jason E. Faris ◽  
Lawrence S. Blaszkowsky ◽  
Shaunagh McDermott ◽  
Alexander R. Guimaraes ◽  
Jackie Szymonifka ◽  
...  

2018 ◽  
Vol 21 (1) ◽  
pp. 28-36 ◽  
Author(s):  
Yael Schenker ◽  
Nathan Bahary ◽  
Rene Claxton ◽  
Julie Childers ◽  
Edward Chu ◽  
...  

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