scholarly journals Anorexia, pain and peripheral neuropathy are associated with a decrease in quality of life in patients with advanced pancreatic cancer receiving outpatient chemotherapy — a retrospective observational study

Author(s):  
Hironori Fujii ◽  
Maaya Koda ◽  
Shiori Sadaka ◽  
Koichi Ohata ◽  
Hiroko Kato-Hayashi ◽  
...  

Abstract Background Cancer chemotherapy usually improves clinical outcomes in patients with advanced pancreatic cancer (APC), but can also cause moderate-to-severe adverse events (AEs). We investigated the relationship between moderate-to-severe AEs and quality of life (QOL) in patients with APC who received outpatient chemotherapy. Methods We recruited APC patients who received outpatient chemotherapy in Gifu University Hospital between September 2017 and December 2018. Adverse events related to chemotherapy were assessed by a pharmacist collaborating with a physician using common terminology criteria for AEs (CTCAE) ver 4.0, and QOL of patients was self-assessed by patients using the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L Japanese edition 2). Associations between the EQ-5D-5L utility value and serious AEs were assessed using proportional odds logistic regression. Results A total of 59 patients who received 475 chemotherapy cycles were included. The proportional odds logistic regression indicated that grade ≥ 2 anorexia, pain and peripheral neuropathy were significantly correlated with a decreased EQ-5D-5L utility value. Pharmaceutical intervention for these AEs significantly improved the patients’ EQ-5D-5L utility value. Conclusions Anorexia, pain and peripheral neuropathy were significantly associated with a decrease in QOL. It is assumed that appropriate pharmaceutical intervention with particular emphasis on these AEs can improve the QOL of pancreatic cancer patients receiving outpatient chemotherapy.

2020 ◽  
Vol 28 (12) ◽  
pp. 5943-5952
Author(s):  
Chiemi Hirose ◽  
Hironori Fujii ◽  
Hirotoshi Iihara ◽  
Masashi Ishihara ◽  
Minako Nawa-Nishigaki ◽  
...  

Abstract Background Outpatient cancer chemotherapy may lead to improved quality of life (QOL) by allowing treatment to continue without impairing the social lives of patients compared with hospitalization. However, the occurrence of serious adverse events may cause a decline in QOL. We investigated the relationship between outpatient chemotherapy–induced adverse events and QOL. Methods A single-center retrospective descriptive study was conducted in patients who received outpatient chemotherapy at Gifu University Hospital (Gifu, Japan) between September 2017 and December 2018. The utility values of QOL, type and severity of adverse events, type of cancer, chemotherapy regimen, and other patient demographics were analyzed. Adverse events were graded according to the Common Terminology Criteria for Adverse Events, version 4.0. QOL was evaluated using the Japanese version of the EuroQol 5 Dimension 5 Level (EQ-5D-5L). Associations between the EQ-5D-5L utility value and serious adverse events were assessed using adjusted (age and sex) odds ratios obtained with a proportional odds logistic regression model. Results Data from 1008 patients who received 4695 chemotherapy cycles were analyzed. According to proportional odds logistic regression, the adverse events that significantly correlated with a decreased EQ-5D-5L utility value were malaise, edema of the limbs, peripheral neuropathy, pruritus, and dry skin. Based on the proportional odds logistic analysis, neither cancer type nor anticancer drugs were significantly correlated with the EQ-5D-5L utility value in patients who received chemotherapy. Pharmaceutical care for peripheral neuropathy significantly improved patients’ EQ-5D-5L utility value from 0.747 to 0.776 (P < 0.01). Conclusions Adverse events (i.e., peripheral neuropathy, malaise, and edema of the limbs) are significantly correlated with a decrease in QOL, regardless of the type of cancer or anticancer drugs used. Pharmaceutical care provided by pharmacists in collaboration with physicians may improve QOL.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4053-4053
Author(s):  
Michael M. Vickers ◽  
Dongsheng Tu ◽  
Chee Lee ◽  
Paul Wheatley-Price ◽  
Wendy Parulekar ◽  
...  

4053 Background: There is insufficient information regarding the prognostic significance of baseline Quality of life (QoL) scores on overall survival (OS) and adverse events (AEs) in advanced pancreatic cancer. Methods: QoL was assessed prospectively using the EORTC QLQ-C30 and AEs were graded using the NCI Common Toxicity Criteria version 2.0 as part of the PA.3 trial of gemcitabine + erlotinib (G+E) vs. gemcitabine + placebo (G+P). Relevant clinical variables, ECOG performance status (PS), and QoL scores at baseline were analyzed by Cox stepwise regression to determine predictors of OS and AEs. QoL scores were transformed by square root. Results: 222 of 285 patients (pts) (78%) treated with G+E and 220 of 284 pts (77%) treated with G+P completed baseline QoL assessments. In a multivariate Cox analysis (MVA) combining all pts, better QoL physical function (PF) score independently and incrementally predicted longer OS (HR 0.91; CI: 0.83-1.00), as did non-white race (HR 0.62; CI: 0.42-0.91), PS 0-1 (vs. PS 2 - HR 0.64; CI: 0.49-0.84), locally advanced pancreatic cancer (LAPC) (vs. metastatic - HR 0.54; CI: 0.42-0.69) and G+E (vs. G+P - HR 0.79; CI: 0.64-0.98). More financial difficulty (HR 0.92; CI: 0.87-0.98) and PS 0-1 (HR: 0.36; CI: 0.17-0.77) predicted a lower risk of grade 3 or higher AEs. In a MVA of pts treated with G+E, pain intensity <20 (vs. ≥ 20 - HR 0.68; CI:0.52-0.88) and LAPC (HR 0.67; CI: 0.48-0.91) were associated with longer OS, while better QoL cognitive (HR 0.71; CI: 0.50-1.00), worse constipation (HR 0.89; CI: 0.81-0.98) and worse financial scores (HR 0.86; CI: 0.78-0.94), better dyspnea score (HR 0.82; CI: 0.71-0.93) and PS 0-1 (HR 0.21; CI: 0.05-0.78) predicted for lower risk of AEs. In a MVA of pts treated with G+P, better global QoL score (HR 0.91; CI:0.85-0.98) and LAPC (HR 0.57; CI: 0.40-0.82) were predictors of longer OS while no variables predicted grade 3 or higher AEs. Conclusions: In addition to clinical variables (including physician assessed PS), patient reported QoL scores added incremental predictive information regarding survival and adverse events for advanced pancreatic cancer patients treated with systemic chemotherapy.


2020 ◽  
Author(s):  
Kathrin Wode ◽  
Johanna Hök Nordberg ◽  
Gunver Sophia Kienle ◽  
Nils Elander ◽  
Britt-Marie Bernhardson ◽  
...  

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


2020 ◽  
Vol 19 ◽  
pp. 153473542094328
Author(s):  
Ester Oneda ◽  
Fausto Meriggi ◽  
Laura Zanotti ◽  
Elisabetta Zaina ◽  
Sara Bighè ◽  
...  

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse event of taxanes, with no effective prevention or treatment available and a highly negative impact on patient quality of life. The aim of this study is to asses that the constant application of cooled cuffs on the hands and feet prevent and mitigate CIPN. Methods: Patients with breast, gynecologic, and pancreatic cancer who received weekly paclitaxel (PTX), PTX/carboplatin, and nab-paclitaxel (nab-PTX)/gemcitabine for any indication at the therapeutic scheduled dosage were included in this prospective study. Hilotherm Chemo care device forms a closed-loop system with cuffs and tubes through which a coolant flows at a temperature of 10 °C. CIPN was monitored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (edition 3.0), and the tolerability and side effects were scored by using the Common Terminology Criteria for Adverse Events (T4.03 2017). Results: To date, we have enrolled 64 patients. Of these, 54 (84%) completed all cooling cycles. Continuous cooling was well tolerated by all patients. No patients had grade >2 CIPN or had serious or lasting adverse events as a result of Hilotherapy. The median time to CIPN onset was 77 days for the entire population. Conclusion: Hilotherapy has good effectiveness and tolerability and seems to be able to prevent or reduce the symptoms of CIPN. We are still recruiting patients to obtain more data and to collect data at 3 months after the end of chemotherapy. Prospective studies seem to be warranted.


2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 228-228
Author(s):  
Basile M. Njei ◽  
Ivo C. Ditah ◽  
Alexei Shimanovsky ◽  
Priscilla Owusu ◽  
John W Birk

228 Background: Even though gemcitabine monotherapy is commonly used as first-line treatment for metastatic pancreatic cancer, many novel treatment approaches have focused on combination chemotherapy. FOLFIRINOX, a combination of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin, has recently been shown to improve survival compared to gemcitabine. However, it is unclear whether survival benefits are counterbalanced by a poor quality of life due to the adverse effects. The aim of this study was to review emerging strategies that enhance treatment of patients with metastatic pancreatic cancer. Methods: Two authors independently conducted a comprehensive search of the Cochrane library PUBMED, and published proceedings from major oncologic and gastrointestinal cancer meetings from January 1980 to July 2012. Only published randomized controlled trials were eligible for inclusion. Our primary outcome measures were: progression-free survival (PFS), overall survival (OS) and serious adverse events (grade 3 or 4). Results: Thirty-one studies involving 7,957 patients were included in the analysis. There was an overall statistically significant increase in OS (RR 1.10, 95% CI 1.03-1.30) and PFS (RR 1.27, 95% CI 1.14-1.46) for the gemcitabine-based combination therapy group versus the gemcitabine monotherapy group. Subgroup analysis showed that only patients with fluoropyrimidine and platinum containing regimens showed prolonged survival: RR 1.33, 95% CI 1.04-1.76 and RR 1.38, 95% CI 1.08-1.76, respectively. The most common severe adverse event (neutropenia) was found in 45% of patients treated with FOLFIRINOX. Conclusions: Overall, gemcitabine in combination with fluoropyrimidine or platinum containing regimens can improve overall survival in patients with metastatic pancreatic cancer compared to gemcitabine alone. Even though, FOLFIRINOX therapy is associated with better survival outcomes than gemcitabine, the prolonged survival comes at the cost of poorer quality of life due to a higher incidence of adverse events. More data is needed from studies involving novel combination therapy such as hedgehog pathway inhibitors and radio-immunotherapy.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16731-e16731
Author(s):  
Mariacristina Di Marco ◽  
Claudio Ricci ◽  
Riccardo Carloni ◽  
Elisa Grassi ◽  
Stefania De Lorenzo ◽  
...  

e16731 Background: Locally advanced pancreatic cancer (LAPC) is usually treated with chemoradiotherapy with poor results, thus additional therapies have been proposed. Of the latter, electrochemotherapy (ECT) represents a non-thermal ablation method, which combines the administration of chemotherapeutic drugs with permeabilizing electric pulses for cell membrane electroporation. The present study is the first to assess the short and long-term results, and the quality of life of the patients who underwent ECT for LAPC. Methods: Observational study of patients affected by LAPC who underwent intraoperative ECT after chemoradiotherapy. The inclusion criteria were: 1- patients with LAPC (defined according to the National Comprehensive Cancer Network 2019), 2- previous chemoradiotherapy and 3- absence of disease progression at restaging. Data at diagnosis and at restaging were collected for each patient. The Quality of life was evaluated using the Euro Quality of Life Group Association Questionnaire (EQ-5D-5L). The questionnaire was administered to all patients before and after ECT. Results: From May 25, 2018 to November 26, 2019 five patients underwent ECT: in 4 cases, the tumors were located in the head and, in one, in the body of the pancreas. Preoperative chemotherapy consisted mainly of 6 cycles of modified folfirinox, while the radiotherapy consisted of 54 Gy (27 fractions). At restaging, the serum value of CA 19-9 and tumor size were reduced; however, the vascular involvement did not change. No downstaging was recorded. Intravenous bleomycin 15,000IU/m2 was given as a bolus, the ECT procedure was performed using at least 4 needles with a mean duration time of 27 minutes, (range 15-40). No postoperative mortality or major complications were reported. The mean length of stay was 8 days (range 5-14). Four patients were alive and well at the end of the study while one patient died from disease progression. The mean follow-up was 20.8 months (range 9-34) from diagnosis and 9.4 months (range 2-19) from ECT. The quality of life was good (EQ-5D-5L scale > 50 in all cases) and there was improvement in pain/discomfort with respect to the pre-treatment period in 3 out of 5 patients. Conclusions: Electrochemotherapy can be considered a simple, feasible and safe palliative additional treatment in LAPC without progression after chemoradiotherapy, and it seems to allow a good quality of life and pain improvement.


2020 ◽  
Vol 38 (4_suppl) ◽  
pp. TPS777-TPS777
Author(s):  
Stephanie Lelond ◽  
Harvey Chochinov ◽  
Paul Joseph Daeninck ◽  
Benjamin Adam Goldenberg ◽  
Lisa Lix ◽  
...  

TPS777 Background: Pancreatic cancer is lethal. Chemotherapy can improve survival by months; however, many patients experience an overwhelming burden of cancer-associated symptoms and poor quality of life (QOL). Early palliative care (EPC) alongside standard oncologic care results in improved QOL and survival in patients with lung cancer. Although international guidelines recommend EPC for patients with advanced pancreatic cancer (PANC), the benefit is not known. Objectives: The primary objective is to test for change in QOL between baseline (BL) and 16 weeks (wk). Secondary objectives are to test for change between BL and 16 wk in (a) symptom control; and (b) depression and anxiety. Methods: This prospective case-crossover study of patients with PANC provides EPC plus standard oncologic care. Primary oncology clinics refer patients to an EPC team led by a palliative care physician and a clinical nurse specialist. BL questionnaires are completed prior to initial EPC assessment, then every 4 wk until wk 16. EPC visits are every 2 wk for the first month, every 4 wk until wk 16, and then as needed. QOL, symptom control, anxiety and depression are measured using the FACT-Hep tool, ESAS-r, HADS and PHQ-9, respectively. A generalized linear model will test for statistically significant change in scores between BL and 16 wk; chemotherapy (yes/no) is included as a confounding covariate; model fit will be assessed. A sample size of 20 patients provides 80% power after controlling for covariate effects. 40 patients will be enrolled to account for missing data. To date, 28 patients have enrolled and 17 have completed the intervention. Significance: The benefit of EPC for patients with PANC is not known, however, EPC is increasingly recognized internationally by patients and stakeholders as a critical intervention which may improve both QOL and satisfaction with care. The Canadian Partnership Against Cancer’s report on the patient experience states “the best possible patient experience means all people with cancer have equitable access to high-quality person-centered palliative care”. This study offers access to EPC and provides an environment in which the benefit of an integrated approach is evaluated.


Author(s):  
Fleur van der Sijde ◽  
Laura Schafthuizen ◽  
Freek R. van ’t Land ◽  
Miranda Moskie ◽  
Hanneke W. M. van Laarhoven ◽  
...  

Abstract  Background Quality of life in cancer patients might be affected by chemotherapy-induced toxicity. Especially in patients with pancreatic ductal adenocarcinoma (PDAC), with a short life expectancy, fear of poor quality of life is often a reason for both patients and medical oncologists to refrain from further treatment. In this study, we investigated quality of life (QoL), pain, sleep, and activity levels in locally advanced pancreatic cancer (LAPC) patients after FOLFIRINOX treatment. Methods A total of 41 LAPC patients with stable disease or partial response were included after completion of at least four cycles of FOLFIRINOX. QoL was measured with the EORTC QLQ-C30 and NRS pain scores. Patients completed the Richards-Campbell Sleep Questionnaire (RCSQ) for five consecutive nights and wore a GENEActiv tri-axial accelerometer (Actiwatch) for 7 days, registering sleep duration, efficiency, and activity. Results Mean EORTC QLQ-C30 score for global health status was 78.3 (± 17.3), higher than reference values for cancer patients (P < 0.001) and general population (P = 0.045). LAPC patients reported few disease-related symptoms. Two patients (5%) reported pain scores > 3. Mean sleep duration was 8 h/night (± 1.2 h) and sleep efficiency 70% (± 9%) with high patient-reported quality of sleep (mean RCSQ score 72.0 ± 11.4). Mean duration of moderate-vigorous activity was 37 min/week (± 103 min/week). Conclusions QoL is very good in most LAPC patients with disease control after FOLFIRINOX, measured with validated questionnaires and Actiwatch registration. The fear of clinical deterioration after FOLFIRINOX is not substantiated by this study and should not be a reason to refrain from treatment. Trial registration Dutch trial register NL7578.


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