scholarly journals Gemcitabine Alone Versus Gemcitabine Plus Radiotherapy in Patients With Locally Advanced Pancreatic Cancer: An Eastern Cooperative Oncology Group Trial

2011 ◽  
Vol 29 (31) ◽  
pp. 4105-4112 ◽  
Author(s):  
Patrick J. Loehrer ◽  
Yang Feng ◽  
Higinia Cardenes ◽  
Lynne Wagner ◽  
Joanna M. Brell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Pancreatic Cancer ◽  
Rank Test ◽  
Unresectable Pancreatic Cancer ◽  
To Receive

Purpose The purpose of this trial was to evaluate the role of radiation therapy with concurrent gemcitabine (GEM) compared with GEM alone in patients with localized unresectable pancreatic cancer. Patients and Methods Patients with localized unresectable adenocarcinoma of the pancreas were randomly assigned to receive GEM alone (at 1,000 mg/m2/wk for weeks 1 to 6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m2/wk for weeks 1 to 5, then 4 weeks later 1,000 mg/m2 for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8 Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional Assessment of Cancer Therapy–Hepatobiliary questionnaire was also performed. Results Of 74 patients entered on trial and randomly assigned to receive GEM alone (arm A; n = 37) or GEM plus radiation (arm B; n = 34), patients in arm B had greater incidence of grades 4 and 5 toxicities (41% v 9%), but grades 3 and 4 toxicities combined were similar (77% in A v 79% in B). No statistical differences were seen in quality of life measurements at 6, 15 to 16, and 36 weeks. The primary end point was survival, which was 9.2 months (95% CI, 7.9 to 11.4 months) and 11.1 months (95% CI, 7.6 to 15.5 months) for arms A and B, respectively (one-sided P = .017 by stratified log-rank test). Conclusion This trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer, with acceptable toxicity.

Quality of life and acute radiation toxicity following hypofractionated stereotactic body radiation therapy with concurrent full-dose gemcitabine for unresectable pancreatic adenocarcinoma.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 336-336
Author(s):  
Marie Kate Gurka ◽  
Gary Tse ◽  
Keith Robert Unger ◽  
Nadim G Haddad ◽  
John Marshall ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Stereotactic Body Radiation Therapy ◽  
Locally Advanced ◽  
Radiation Toxicity ◽  
Unresectable Pancreatic Cancer ◽  
Eortc Qlq ◽  
Acute Radiation Toxicity

336 Background: Quality of life (QoL) is of paramount importance when cure is not obtainable. The aim of this study is to report QoL outcomes and acute radiation toxicity in patients with pancreatic cancer treated with stereotactic body radiation therapy (SBRT) and concurrent gemcitabine. Methods: This prospective study reviewed the charts of 10 patients with locally advanced, unresectable pancreatic cancer treated with SBRT and 6 cycles of gemcitabine. The primary tumor and adjacent para-aortic nodes received a total dose of 2500 cGy in 500 cGy fractions on consecutive days between cycles 1 and 2 of gemcitabine. QoL was assessed on the 1st day of each cycle using the EORTC QLQ-C30 and EORTC QLQ-PAN26 questionnaires. Wilcoxon rank sum test was used to determine statistical significance between QoL scores. Toxicity was graded by NCI Common Terminology Criteria for Adverse Events, Version 3.0. Results: The median age was 62.5 years. All patients completed the prescribed SBRT. Median overall survival was 13 months (range 5- 17). QoL scores at baseline compared to immediately after SBRT showed an increase in the following symptoms: fatigue, nausea/vomiting (N/V) and anorexia, which were statistically significant (P < 0.05). These were not statistically different from baseline by cycle 3 except N/V. No symptoms were significantly improved after radiation therapy; however, there was a trend towards improvement in back pain, night pain and abdominal discomfort. Functional scales declined after treatment, but not significantly. Global QoL did not significantly change from baseline. There were no grade 3 or 4 acute toxicities related to SBRT. Conclusions: Hypofractionated SBRT with concurrent gemcitabine is feasible for locally advanced, unresectable pancreatic cancer. There is a temporary increase in selected symptoms due to radiation which resolve within one month. This may be an improvement compared to conventional fractionated radiation due to shorter duration of symptoms related to radiation treatment.

Effects of gemcitabine and stereotactic body radiotherapy on quality of life in locally advanced pancreatic cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 278-278
Author(s):  
Avani Satish Dholakia ◽  
Daniel Tandel Chang ◽  
Karyn A. Goodman ◽  
Elizabeth Sugar ◽  
Amy Hacker-Prietz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Body Image ◽  
Radiation Therapy ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Role Functioning

278 Background: Existing literature on the impact of radiation therapy for locally advanced pancreatic cancer (LAPC) on quality of life (QoL) is limited and is specific to standard chemoradiation. We prospectively investigated patient-reported QoL after treatment with fractionated stereotactic body radiation therapy (SBRT). Methods: Forty-nine patients with LAPC treated were prospectively enrolled in a clinical trial at 3 institutions. Participants received a total of 33 Gy in 6.6 Gy daily fractions using SBRT either upfront (N=5) or after a single induction cycle of gemcitabine (N=44), followed by post-SBRT gemcitabine until evidence of disease progression. Two validated questionnaires, the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and pancreatic cancer-specific QLQ-PAN26, were administered to patients prior to SBRT and at 4-weeks and 3 to 4-months following SBRT. Results: QoL questionnaires were available for 43 patients (88%) in the clinical trial at enrollment, of which 38 (88%) and 22 (51%) also had data at 4-weeks and 3 to 4-months following SBRT, respectively. There was no significant change in global QoL scores from enrollment at 4-weeks (p=0.682) and 4-months (p>0.999) following SBRT. Patients demonstrated a significant improvement in pancreatic pain (p=0.001), body image (p=0.007) and jaundice (p=0.001) scores from the pre-SBRT values at 4 weeks following SBRT. The initial 4-week results were similar when restricted to those patients with both 4-week and 4-month QoL data (p=0.020) and jaundice (p=0.004); however, these symptoms had returned to enrollment levels by the 4-month follow-up. An improvement in body image (p=0.016) and decline in role functioning (p=0.002) were observed in patients with 4-month follow-up QoL questionnaires. Conclusions: LAPC patients undergoing SBRT experience no impairment in global QoL and have short-term improvements in symptoms commonly bothersome to this population including pancreatic pain, body image, and jaundice. Patients also experience a delay in impaired role functioning several months after treatment. These results warrant further investigation of SBRT for LAPC. Clinical trial information: NCT01146054.

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.

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.

Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline

2016 ◽  
Vol 34 (22) ◽  
pp. 2654-2668 ◽  
Author(s):  
Edward P. Balaban ◽  
Pamela B. Mangu ◽  
Alok A. Khorana ◽  
Manish A. Shah ◽  
Somnath Mukherjee ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Group Performance ◽  
Performance Status ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Unresectable Pancreatic Cancer ◽  
Free Survival ◽  
American Society ◽  
Comorbidity Profile

Purpose To provide evidence-based recommendations to oncologists and others for treatment of patients with locally advanced, unresectable pancreatic cancer. Methods American Society of Clinical Oncology convened an Expert Panel of medical oncology, radiation oncology, surgical oncology, gastroenterology, palliative care, and advocacy experts and conducted a systematic review of the literature from January 2002 to June 2015. Outcomes included overall survival, disease-free survival, progression-free survival, and adverse events. Results Twenty-six randomized controlled trials met the systematic review criteria. Recommendations A multiphase computed tomography scan of the chest, abdomen, and pelvis should be performed. Baseline performance status and comorbidity profile should be evaluated. The goals of care, patient preferences, psychological status, support systems, and symptoms should guide decisions for treatments. A palliative care referral should occur at first visit. Initial systemic chemotherapy (6 months) with a combination regimen is recommended for most patients (for some patients radiation therapy may be offered up front) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile. There is no clear evidence to support one regimen over another. The gemcitabine-based combinations and treatments recommended in the metastatic setting (eg, fluorouracil, leucovorin, irinotecan, and oxaliplatin and gemcitabine plus nanoparticle albumin-bound paclitaxel) have not been evaluated in randomized controlled trials involving locally advanced, unresectable pancreatic cancer. If there is local disease progression after induction chemotherapy, without metastasis, then radiation therapy or stereotactic body radiotherapy may be offered also with an Eastern Cooperative Oncology Group performance status ≤ 2 and an adequate comorbidity profile. If there is stable disease after 6 months of induction chemotherapy but unacceptable toxicities, radiation therapy may be offered as an alternative. Patients with disease progression should be offered treatment per the ASCO Metastatic Pancreatic Cancer Treatment Guideline. Follow-up visits every 3 to 4 months are recommended. Additional information is available at www.asco.org/guidelines/LAPC and www.asco.org/guidelines/MetPC and www.asco.org/guidelineswiki .

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.

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 Assessment of Nutritional Status, Digestion and Absorption, and Quality of Life in Patients with Locally Advanced Pancreatic Cancer

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
J. E. Witvliet-van Nierop ◽  
C. M. Lochtenberg-Potjes ◽  
N. J. Wierdsma ◽  
H. J. Scheffer ◽  
G. Kazemier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Nutritional Status ◽  
Handgrip Strength ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Serum Vitamin ◽  
Fat Free Mass ◽  
Locally Advanced Pancreatic Cancer

Background and Aim.To provide a comprehensive quantitative assessment of nutritional status, digestion and absorption, and quality of life (QoL) in patients with locally advanced pancreatic cancer (LAPC).Methods.Sixteen patients with LAPC were prospectively assessed for weight loss (WL), body mass index (BMI), fat-free mass index (FFMI), handgrip strength (HGS), dietary macronutrient intake, serum vitamin levels, resting and total energy expenditure (REE and TEE, indirect calorimetry), intestinal absorption capacity and fecal losses (bomb calorimetry), exocrine pancreatic function (fecal elastase-1 (FE1)), and gastrointestinal quality of life (GIQLI).Results.Two patients had a low BMI, 10 patients had WL > 10%/6 months, 8 patients had a FFMI < P10, and 8 patients had a HGS < P10. Measured REE was 33% higher (P=0.002) than predicted REE. TEE was significantly higher than daily energy intake (P=0.047). Malabsorption (<85%) of energy, fat, protein, and carbohydrates was observed in, respectively, 9, 8, 12, and 10 patients. FE1 levels were low (<200 μg/g) in 13 patients. Total QoL scored 71% (ample satisfactory).Conclusion.Patients with LAPC have a severely impaired nutritional status, most likely as a result of an increased REE and malabsorption due to exocrine pancreatic insufficiency. The trial is registered with PANFIRE clinicaltrials.govNCT01939665.

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