Quality of life study in patients with unresectable locally advanced or metastatic pancreatic cancer treated with gemcitabine in combination with nab-paclitaxel versus gemcitabine alone:ax-panc-sy001: A phase II randomized study.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 346-346 ◽  
Author(s):  
Suayib Yalcin ◽  
Faysal Dane ◽  
Berna Oksuzoglu ◽  
Nuriye Yildirim ◽  
Abdurrahman Isikdogan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Disease Progression ◽  
Response Rate ◽  
Locally Advanced ◽  
Hazard Ratio ◽  
Combination Group ◽  
Combination Regimen ◽  
Free Survival

346 Background: Although clinical efficacy of gemcitabine in combination with nabpaclitaxel has been shown to be superior to single agent gemcitabine in a randomize phase 3 trial, data are lacking on the quality of life of this combination regimen as first-line therapy in patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma. Methods: We randomly assigned 125 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 to receive gemcitabine, 1000 mg/m2 plus nabpaclitaxel 125 mg/m2 or gemcitabine at a dose of 1000 mg per square meter weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks. Treatment continued until disease progression or unacceptable toxicity. The primary end point was 3-months deterioration-free rate (percentage of patients free from definitive deterioration) and quality of life of patients. Results: The median overall survival was 9.92 months in the gemcitabine plus nabpaclitaxel group as compared with 5.95 months in the gemcitabine group (hazard ratio for death, 0.642, 95% confidence interval, 0.422 to 0.866; p < 0.038). Median progression-free survival was 6.28 months in the combination group and 3.22 months in the gemcitabine group (hazard ratio for disease progression, 0.582; 95% CI, 0.391 to 0.866; p < 0.008). The objective response rate was 37.1% in the combination group versus 23.7% in the gemcitabine group (p < 0.009). Median time to deterioration was 3.68 months in the gemcitabine arm versus 5.36 months in the combination arm. More data on quality of life will be presented. Conclusions: As compared with gemcitabine, gemcitabine plus nabpaclitaxel was associated with an overall and progressive free survival advantage, with increased response rate, without increasing toxicity and deterioration of quality of life. Gemcitabine and nabpaclitaxel combination regimen with this form is a preferable option for the treatment of patients with advanced pancreatic cancer Clinical trial information: EudraCT: 2013-004180-32.

Intraoperative electrochemotherapy in locally advanced pancreatic cancer: Results and impact on quality of life. a single center experience.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16731-e16731
Author(s):  
Mariacristina Di Marco ◽  
Claudio Ricci ◽  
Riccardo Carloni ◽  
Elisa Grassi ◽  
Stefania De Lorenzo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Disease Progression ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
The Body ◽  
Locally Advanced Pancreatic Cancer ◽  
Long Term Results ◽  
The Mean

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.

scholarly journals Prolongation of survival time and improvement of the quality of life after treatment with irinotecan liposomal in the patient with metastatic pancreatic adenocarcinoma

Oncoreview ◽  
2021 ◽  
Vol 11 (3(43)) ◽  
pp. 77-79
Author(s):  
Wojciech Rogowski ◽  
Przemysław Będkowski
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Survival Time ◽  
Response Rate ◽  
Systemic Treatment ◽  
Advanced Disease ◽  
Locally Advanced ◽  
Malignant Neoplasms ◽  
Metastatic Pancreatic Adenocarcinoma

Pancreatic cancer is one of the malignant neoplasms with the worst prognosis. It is most often diagnosed at an advanced stage, which relates to unsatisfactory results of the therapy. Only about 15–20% of patients with pancreatic cancer qualify for surgery. The remaining patients are diagnosed with locally advanced disease or much more frequently in the generalized stage. Systemic treatment (chemotherapy) remains the mainstay of therapy in these patients, but both the response rate and progression-free time are unsatisfactory [1, 2]. This paper presents a case of a patient with metastatic pancreatic cancer, in whom three lines of systemic treatment were applied sequentially, which allowed to extend the survival time and improve the quality of life.

Systemic therapy with a loco-regional treatment in patients with locally advanced pancreatic cancer: The SMART study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS445-TPS445
Author(s):  
Shahid Ahmed ◽  
Osama Ahmed ◽  
Deborah Anderson ◽  
Gavin Beck ◽  
Haji I. Chalchal ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Cost Effectiveness ◽  
Disease Progression ◽  
Combination Chemotherapy ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Phase Iii

TPS445 Background: Pancreatic cancer is a major cause of cancer-related death. About 40% of patients with pancreatic cancer present with locally advanced disease and are not candidates for curative surgery. Most patients are treated with chemotherapy with a limited life expectancy. The role of local treatment such as radiation is not well defined. Other conventional ablative therapies, such as thermal or cryoablation have limited role due to the risk of collateral damage to the adjacent structures. Irreversible electroporation (IRE) is a novel non-thermal ablation technology that does not cause injury to nearby blood vessels, ducts, and bowel and has the potential to provide longer disease control and thereby better overall survival. We hypothesized that addition of IRE to combination chemotherapy in patients with locally advanced pancreatic cancer will improve their outcomes, and patients with undetectable 12-week post IRE circulating tumor cell DNA will have better prognoses. Methods: It is a prospective, multicenter, single-arm phase II study. The primary objective is to determine 12-month PFS rate of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE. Secondary objectives include identification of prognostic and predictive biomarkers, 24-months survival rate, quality of life of subjects, as well as cost-effectiveness and complication rates of IRE. Based on the assumption that treatment with IRE and chemotherapy would result in doubling of PFS versus chemotherapy alone a sample of n = 27 of patients with locally advanced pancreatic adenocarcinoma is estimated. Eligible patients will be recruited at the two major cancer centers in Saskatchewan. All IRE-eligible patients will receive 12 weeks of induction combination chemotherapy and will undergo IRE if there is no disease progression. An additional 12 weeks of chemotherapy will be recommended. Patients who are not eligible for IRE will receive chemotherapy at the discretion of treating oncologist until disease progression or until they become eligible for IRE. Circulating tumor DNA and a panel of genes will be examined using next-generation sequencing for their correlation with prognosis. Quality of life will be assessed, and cost-effectiveness analysis of IRE will be performed.The results of this study will be used to develop a future multicenter, national phase III trial. Clinical trial information: NCT04276857.

Randomized phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel combination therapy for locally advanced pancreatic cancer (JCOG1407).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4017-4017
Author(s):  
Masato Ozaka ◽  
Makoto Ueno ◽  
Hiroshi Ishii ◽  
Junki Mizusawa ◽  
Hiroshi Katayama ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Response Rate ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Free Survival ◽  
Randomized Phase Ii

4017 Background: FOLFIRINOX, consisting of leucovorin (LV), fluorouracil (FU), irinotecan (IRI) and oxaliplatin (L-OHP), and GnP, consisting of gemcitabine (GEM) plus nab-paclitaxel (nPTX), have shown superior efficacy over GEM in patients (pts) with metastatic pancreatic cancer. Although several studies have reported the efficacy of FOLFIRINOX or GnP for pts with locally advanced pancreatic cancer (LAPC), no randomized controlled trial to compare the two regimens has been conducted in those pts. To select the most promising chemotherapy for LAPC, a randomized phase II selection design trial (JCOG1407) was conducted to compare between modified FOLFIRINOX (FOLFIRINOX with dose reduction of IRI and without bolus FU; Arm A) and GnP (Arm B) for pts with LAPC. Methods: In Arm A, 85 mg/m2 of L-OHP, 200 mg/m2 of l-LV, 150 mg/m2 of IRI, followed by 2,400 mg/m2 of continuous FU over 46 hours are infused every 2 weeks. In Arm B, 125 mg/m2 of nPTX followed by 1,000 mg/m2 of GEM are infused on days 1, 8, and 15 every 4 weeks. The primary endpoint was overall survival (the proportion of 1-year OS), and secondary endpoints included progression-free survival (PFS), distant metastasis-free survival (MFS) and response rate in pts with target lesions. The planned sample size was 124 pts to select more effective regimen in 1-year OS with a probability of at least 0.85 and to test the null hypothesis of 53% in 1-year OS with a one-sided alpha of 5% and 80% Results: From 2015 to 2019, a total of 126 pts was enrolled from 29 Japanese institutions, and were allocated to Arm A (n = 62) or Arm B (n = 64). The median (range) age was 66 (44-75) years and 58.7% were male. At the analysis, after a median (range) follow-up of 1.52 (0.55-3.99) years, 75 (59.5%) pts died. The proportion of 1-year OS was better in Arm B, 77.4% [95% CI 64.9–86.0] vs. 82.5% [95% CI 70.7–89.9], but 2-year OS was better in Arm A, 48.2% [95% CI 33.3–61.7] vs. 39.7% [95% CI 28.6–52.5]. Median OS was 2.0 years [95% CI 1.6-2.7] in Arm A and 1.8 years [95% CI 1.5-2.0] in Arm B. 1-year PFS for Arm A/B was 47.5 % [95% CI 34.5-59.4]/40.2% [95% CI 27.8-52.3], and 1-year MFS was 64.2 % [95% CI 50.9-74.8]/57.3% [95% CI 43.9-68.6]. Arm A was better OS in pts with CA19-9 <1000 U/mL and the opposite trend was observed in pts with CA19-9>1000 U/mL. Response rate was 30.9% [95% CI 19.1-44.8] in Arm A, and 41.4% [95% CI 28.6-55.1]) in Arm B. Incidences of grade 3-4 non-hematological toxicities for Arm A and Arm B were 66.1% and 67.2%, respectively. There was no treatment-related death. Conclusions: This study was the first randomized trial comparing the two regimens. The 1-year OS of the primary endpoint in GnP was better than mFOLFIRINOX, but mFOLFIRINOX achieved longer survival in 2-year OS. It is required to confirm longer OS and safety profiles which regimen should be selected as a standard regimen in LAPC. Clinical trial information: jRCTs031180085.

Impact of stereotactic body radiation therapy on patient-reported quality of life in patients with unresectable or recurrent pancreatic cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 413-413
Author(s):  
Lauren M. Rosati ◽  
Zhi Cheng ◽  
Scott P. Robertson ◽  
Megan N. Kummerlowe ◽  
Amy Hacker-Prietz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Stereotactic Body Radiation Therapy ◽  
Locally Advanced ◽  
Future Health ◽  
Stereotactic Body Radiation ◽  
Patient Reported ◽  
The Impact

413 Background: The impact of fractionated stereotactic body radiation therapy (SBRT) on patient-reported quality of life (QOL) and physician-reported toxicity in patients with recurrent or locally advanced pancreatic cancer (PCA) was prospectively evaluated. Methods: Forty-two PCA patients were treated with 25-33 Gy using SBRT in 5 fractions on a single-institution study. Both patient- and physician-reported outcomes were evaluated prior to SBRT and 4-6 weeks post-SBRT. Eight outcomes were consistently evaluated among both groups—performance status, fatigue, pain, anorexia, nausea, vomiting, constipation, and diarrhea. Patient-reported QOL metrics were assessed using a 4-point Likert scale on the EORTC QLQ-C30 and QLQ-PAN26, while physician-reported toxicities were graded using the NCI CTCAE version 4.0. Comparisons between those with paired patient- and physician-reported outcomes collected prior to and 4-6 weeks after SBRT were made using the Wilcoxon signed-rank test. Results: Of the 42 patients currently enrolled onto the study, 29 had both patient- and physician-reported outcomes collected prior to and 4-6 weeks after SBRT. Fifty-five percent were female and 83% were Caucasian. The median age at diagnosis was 65.6 years (range, 40.8-86.6). There was no significant impairment of any of the 8 physician-reported toxicities, nor were significant changes observed in patient-reported overall health (p = 0.66) or QOL (p = 0.18) scores following SBRT. Patients felt less worried about their future health (mean change [mD] = -0.45, p = 0.02), and an improvement in feeling less attractive as a result of disease and treatment reached borderline significance (mD= 0.31, p = 0.09). However, patients felt limited in planning activities in advance (mD= 0.45, p = 0.02) and were more constipated (mD= 0.38, p = 0.01) 4-6 weeks post-SBRT. Conclusions: Although the numbers are small, patients with unresectable or locally recurrent PCA do not appear to suffer any detriment of overall health or QOL after receiving a five-day course of SBRT. Moreover, this regimen may lead to a more optimistic point of view on future health and/or level of physical attraction. Clinical trial information: NCT01781728.

Stereotactic body radiation therapy and patient-reported quality of life prospectively evaluated in patients with unresectable or recurrent pancreatic cancer.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 92-92
Author(s):  
Lauren M. Rosati ◽  
Zhi Cheng ◽  
Scott P. Robertson ◽  
Megan N. Kummerlowe ◽  
Amy Hacker-Prietz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Stereotactic Body Radiation Therapy ◽  
Locally Advanced ◽  
Future Health ◽  
Stereotactic Body Radiation ◽  
Patient Reported ◽  
The Impact

92 Background: The impact of fractionated stereotactic body radiation therapy (SBRT) on patient-reported quality of life (QOL) and physician-reported toxicity in patients with recurrent or locally advanced pancreatic cancer (PCA) was prospectively evaluated. Methods: Forty-two PCA patients were treated with 25-33 Gy using SBRT in 5 fractions on a single-institution study. Both patient- and physician-reported outcomes were evaluated prior to SBRT and 4-6 weeks post-SBRT. Eight outcomes were consistently evaluated among both groups—performance status, fatigue, pain, anorexia, nausea, vomiting, constipation, and diarrhea. Patient-reported QOL metrics were assessed using a 4-point Likert scale on the EORTC QLQ-C30 and QLQ-PAN26, while physician-reported toxicities were graded using the NCI CTCAE version 4.0. Comparisons between those with paired patient- and physician-reported outcomes collected prior to and 4-6 weeks after SBRT were made using the Wilcoxon signed-rank test. Results: Of the 42 patients currently enrolled onto the study, 29 had both patient- and physician-reported outcomes collected prior to and 4-6 weeks after SBRT. Fifty-five percent were female and 83% were Caucasian. The median age at diagnosis was 65.6 years (range, 40.8-86.6). There was no significant impairment of any of the 8 physician-reported toxicities, nor were significant changes observed in patient-reported overall health (p = 0.66) or QOL (p = 0.18) scores following SBRT. Patients felt less worried about their future health (mean change [mD] = -0.45, p = 0.02), and an improvement in feeling less attractive as a result of disease and treatment reached borderline significance (mD= 0.31, p = 0.09). However, patients felt limited in planning activities in advance (mD= 0.45, p = 0.02) and were more constipated (mD= 0.38, p = 0.01) 4-6 weeks post-SBRT. Conclusions: Although the numbers are small, patients with unresectable or locally recurrent PCA do not appear to suffer any detriment of overall health or QOL after receiving a five-day course of SBRT. Moreover, this regimen may lead to a more optimistic point of view on future health and/or level of physical attraction. Clinical trial information: NCT01781728.

Exenterative surgery to improve quality of life on men with locally advanced, symptomatic castration-resistant prostate cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 77-77
Author(s):  
Friederike Haidl ◽  
Florian Hartmann ◽  
David A. Pfister ◽  
Axel Heidenreich
Keyword(s):  
Quality Of Life ◽  
Statistical Tests ◽  
Symptom Relief ◽  
Locally Advanced ◽  
Well Being ◽  
Preoperative Imaging ◽  
Free Survival ◽  
Castration Resistant ◽  
Local Progression

77 Background: Invasion of the urinary bladder and/or the rectum by locally advanced castration sensitive (CSPC) or castration resistant PCA (CRPC) can result in debilitating symptoms with a significant negative impact on the patient’s well-being. Local progression might develop despite the application of new life prolonging agents. It was the purpose to retrospectively review the surgical and oncological outcome following pelvic exenteration surgery (PES) for locally advanced and symptomatic CRPC. Methods: Retrospective, single-centre, dual surgeon study of 103 men with symptomatic locally progressive and symptomatic CS- and CRPC treated between 2008 and 2019. Primary endpoint was symptomatic free survival (SFS) and the secondary endpoint were overall survival (OS) and complications defined by Clavien-Dindo criteria. Statistical tests were two-tailed with a p-value <0.05 considered to indicate significance. Symptom-free survival and cancer specific survival were calculated using Kaplan-Meier analysis. Results: 9 (8.7%), 71 (68.8%) and 21 (22.4%) patients underwent radical prostatectomy, radical cystoprostatectomy or anterior and posterior exenteration, resp. After a median follow-up of 36.5 (3 – 123) months, the SFS at 1 and 3 years was 89.2% (n=89) and 64.1% (n=66). The median SFS was 27.9 months. 78.6% of the patients were symptom-free during their remaining lifetime. OS at 1 and 3 years was 92.2% and 43.7%, respectively, and the median OS was 33.6 months. Clavien-Dindo grade 2, 3 and 4 complications developed in 31 (30.6%), 12 (12%) and 8 (8.1%), respectively. Conclusions: PES is a technically feasible approach in well-selected patients resulting in symptom relief of > 90% of patients which covered almost 80% of the remaining life time. Adequate preoperative imaging studies, endoscopic evaluation and extensive surgical experience is mandatory to achieving a benefit for the individual patient with improvement of quality of life.

scholarly journals Quality of life of locally advanced pancreatic cancer patients after FOLFIRINOX treatment

2021 ◽  
Author(s):  
Fleur van der Sijde ◽  
Laura Schafthuizen ◽  
Freek R. van ’t Land ◽  
Miranda Moskie ◽  
Hanneke W. M. van Laarhoven ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Cancer Patients ◽  
Sleep Duration ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Pain Scores ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

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.

scholarly journals A Case of Locally Advanced Pancreatic Cancer Successfully Resected after 14 Months Therapy with Gemcitabine and Meriva®

2016 ◽  
Vol 2 ◽  
pp. 1-4
Author(s):  
Caterina Soldà ◽  
Romeo Bardini ◽  
Francesca Zingales ◽  
Davide Pastorelli
Keyword(s):  
Pancreatic Cancer ◽  
Response Rate ◽  
Advanced Disease ◽  
Radical Surgery ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
New Drugs ◽  
Clinical Conditions ◽  
Disease Free

Pancreatic cancer (PC) is one of the leading cause of cancer death. Neoadjuvant therapy has been progressively used in the context of locally advanced/unresectable disease improve patients’ outcome. New drugs combination are associated with increased response rate but at the expense of higher toxicities. We presented a case of a patient with locally advanced disease treated who could undergo surgery after 14 cycles of therapy with gemcitabine and curcumin conjugated with phospholipids (Meriva®). Treatment was well tolerated without severe toxicities or impairment of quality of life. The patient is disease free at 9 month from surgery and 28 months from initial diagnosis and he still is in good clinical conditions. The combination of gemcitabine and Meriva® was effective in allowing radical surgery in a patient with locally advanced PC. Moreover, this results was obtained with minimally toxic regimen.

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