scholarly journals Are population‐based patient‐reported outcomes associated with overall survival in patients with advanced pancreatic cancer?

2019 ◽  
Vol 9 (1) ◽  
pp. 215-224 ◽  
Author(s):  
Wei Fang Dai ◽  
Jaclyn Beca ◽  
Helen Guo ◽  
Wanrudee Isaranawatchai ◽  
Deborah Schwartz ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Patient Reported Outcomes ◽  
Advanced Pancreatic Cancer ◽  
Population Based ◽  
Patient Reported

Are real-world patient-reported outcomes associated with survival in patients with advanced pancreatic cancer?

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 205-205
Author(s):  
Wei Fang Dai ◽  
Jaclyn Marie Beca ◽  
Helen Guo ◽  
Lucy Qiao ◽  
Wanrudee Isaranuwatchai ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Symptom Score ◽  
Patient Reported Outcomes ◽  
Cox Model ◽  
Advanced Pancreatic Cancer ◽  
Symptom Burden ◽  
Physical Symptoms ◽  
Funding Program ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale

205 Background: Advanced pancreatic cancer (APC) patients often have a substantial symptom burden. In Ontario, patients visiting cancer clinics routinely complete the Edmonton Symptom Assessment Scale (ESAS), which screens for 9 symptoms (scale: 0-10). Using ESAS, we explored the association between baseline patient-reported outcomes and overall survival (OS). Methods: APC Patients with ESAS records prior to receiving publicly-funded drugs from November 2008 to March 2016 were identified from Cancer Care Ontario’s New Drug Funding Program and Symptom Management databases. We examined 3 baseline composite ESAS scores: Total Symptom Distress Score (TSDS: all 9 symptoms), Physical Symptom Score (PHS: 6/9 symptoms), and Psychological Symptom Score (PSS: 2/9 symptoms); Composite scores greater than a threshold (defined as number of symptoms in composite score multiplied by clinically relevant score (≥4)) were categorized as High Symptom Burden (TSDS ≥ 36, PHS ≥ 24, PSS ≥ 8). The primary endpoint, OS, was assessed using Kaplan-Meier. Multivariable Cox models were used to adjust for age, gender, income, prior therapies (surgery, adjuvant gemcitabine, radiation), and Charlson's comorbidity. Analysis was repeated in a sub-cohort with identifiable ECOG status and stage. Results: We identified 2,199 APC patients (mean age 64 years, 55% male) with ESAS records prior to receiving gemcitabine (54%), FOLFIRINOX (40%) or gemcitabine/nab-paclitaxel (6%). Crude median survival was 4.5 and 7.3 months for patients with high and low TSDS burden, respectively (HR = 1.50, 95% CI: 1.36, 1.66). After adjustment with multivariable Cox model, high TSDS burden was associated with lower OS (HR = 1.47, 95% CI: 1.33, 1.63). Similar trends were observed for PHS and PSS. When adjusting for both PHS and PSS in a Cox model, only the effect of PHS remained significant. In the sub-cohort (n = 393), high TSDS burden (HR = 1.34, 95% CI: 1.04, 1.73) was associated with lower OS, after adjusting for ECOG and stage. Conclusions: Among APC patients, a higher burden of patient-reported symptoms, via ESAS, at baseline was associated with reduced OS. The effect was prominent for physical symptoms, even after adjusting for treatment, stage and ECOG.

A multicenter, phase IV study of the effectiveness of palliative gemcitabine in patients with advanced pancreatic cancer.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 46-46
Author(s):  
David Wallace ◽  
Jina Zhang-Salomons ◽  
Christopher M. Booth ◽  
William J. Mackillop
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Clinical Practice ◽  
Clinical Benefit ◽  
Single Agent ◽  
Advanced Pancreatic Cancer ◽  
Well Being ◽  
Routine Clinical Practice ◽  
Assessment System ◽  
Patient Reported

46 Background: Randomized controlled trials (RCTs) have shown that palliative gemcitabine provides clinical benefit and prolongs survival in patients with advanced pancreatic cancer. The purpose of this study was to determine if the efficacy of palliative gemcitabine demonstrated in RCTs has translated into effectiveness in routine clinical practice in Ontario. Methods: This was a retrospective cohort study of all patients with exocrine cancer of the pancreas treated with first line, single agent, palliative gemcitabine at all 13 provincial cancer centres in Ontario between 2008 and 2011. These patients were identified by linking electronic records of treatment from all cancer centres and hospitals in Ontario to the Ontario Cancer Registry. Patient-reported well-being and symptoms were captured by the Edmonton Symptom Assessment System, which has been in routine use at these centres since 2008. The effectiveness of gemcitabine was measured in terms of clinical benefit at two months and overall survival. Patients were classified as having achieved clinical benefit if they had not discontinued gemcitabine and their self-reported well-being was stable or improved at two months. Results: The study population included 423 patients. Their median age was 65 and 50% were women. Fifty-seven percent had stage IV disease, 17% had stage III disease, and 10% had recurrence after earlier treatment for stage I or II disease. Patients included in this study were older than, but otherwise similar to, patients enrolled in four relevant RCTs that used gemcitabine in the experimental or control arm. At two months, 36.9% (95% CI 29.6-44.2%) of patients in this study achieved clinical benefit, which was within the range of 24% to 56% observed in patients in these trials. Median overall survival was 5.7 months (95% CI 4.7-6.1), which was within the range of 5.4 to 6.9 months reported in the trials. Conclusions: The efficacy of gemcitabine demonstrated in RCTs has translated into effectiveness in routine clinical practice in Ontario. The approach described above could readily be used to study the effectiveness of other palliative interventions.

scholarly journals Induction Chemotherapy for Primarily Unresectable Locally Advanced Pancreatic Adenocarcinoma—Who Will Benefit from a Secondary Resection?

Medicina ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 77
Author(s):  
Nathalie Rosumeck ◽  
Lea Timmermann ◽  
Fritz Klein ◽  
Marcus Bahra ◽  
Sebastian Stintzig ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Neoadjuvant Therapy ◽  
Induction Therapy ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Pancreatic Cancer ◽  
Comprehensive Cancer Center ◽  
Secondary Resection ◽  
Number Of Patients

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.

scholarly journals Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multi-centre, parallel group, double-blind, randomised controlled clinical trial (MISTRAL)

2020 ◽  
Author(s):  
Kathrin Wode ◽  
Johanna Hök Nordberg ◽  
Gunver Sophia Kienle ◽  
Nils Elander ◽  
Britt-Marie Bernhardson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Overall Survival ◽  
Cancer Patients ◽  
Advanced Pancreatic Cancer ◽  
Health Related Quality ◽  
Mistletoe Extract ◽  
Related Quality ◽  
Health Related

Abstract Background Most pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and optimisation of health-related quality of life. In a recent open-label trial of mistletoe extract for advanced pancreatic cancer patients not eligible for chemotherapy, promising results on improved overall survival and better health-related quality of life were reported. The objective of the present study is to assess the value of mistletoe extract as a complement to standard 18 treatment (palliative chemotherapy or best supportive care) in advanced pancreatic cancer patients with 19 regard to overall survival and health-related quality of life. Methods The trial is prospective, randomised, double-blind, multicentre, parallel group and placebo-controlled. In total 290 participants are randomly assigned to placebo or mistletoe extract given subcutaneously in increasing dosage from 0.01mg to 20mg three times per week for nine months. Stratification is performed for site and palliative chemotherapy. Main inclusion criteria are advanced pancreatic cancer and Eastern Cooperative Oncology Group performance status zero to two; main exclusion criteria are life expectancy less than four weeks and neuroendocrine tumour of the pancreas. Two ancillary studies on sub-sets of participants are nested in the trial: a biomarker study collecting blood samples and a cross-sectional qualitative study with semi-structured face-to-face interviews. Discussion To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer. The presented trial with its two nested ancillary studies exploring biomarkers and patient experiences is expected to give new insights into the treatment of advanced pancreatic cancer. Trial registration EU Clinical Trial Register, EudraCT Number 2014-004552-64. Registered 19 January 2016, https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-004552-64/SE

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