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 ◽  
...  

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.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS445-TPS445
Author(s):  
Shahid Ahmed ◽  
Osama Ahmed ◽  
Deborah Anderson ◽  
Gavin Beck ◽  
Haji I. Chalchal ◽  
...  

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.


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 ◽  
...  

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.


2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 346-346 ◽  
Author(s):  
Suayib Yalcin ◽  
Faysal Dane ◽  
Berna Oksuzoglu ◽  
Nuriye Yildirim ◽  
Abdurrahman Isikdogan ◽  
...  

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.


2016 ◽  
Vol 16 (3) ◽  
pp. 285-294 ◽  
Author(s):  
Mirko D’Onofrio ◽  
Stefano Crosara ◽  
Riccardo De Robertis ◽  
Giovanni Butturini ◽  
Roberto Salvia ◽  
...  

Aim: The objective of this study was to evaluate the efficacy of percutaneous radiofrequency ablation of locally advanced pancreatic cancer located in the pancreatic body. Materials and Methods: Patients with biopsy-proven locally advanced pancreatic adenocarcinoma were considered for percutaneous radiofrequency ablation. Postprocedural computed tomography studies and Ca19.9 tumor marker evaluation were performed at 24 hours and 1 month. At computed tomography, treatment effect was evaluated by excluding the presence of complications. The technical success of the procedure is defined at computed tomography as the achievement of tumoral ablated area. Results: Twenty-three patients have been included in the study. Five of the 23 patients were excluded. At computed tomography, the mean size of the intralesional postablation necrotic area was 32 mm (range: 15-65 mm). Technical success of the procedure has been obtained in 16 (93%) of the 18 cases. None of the patients developed postprocedural complications. Mean Ca19.9 serum levels 1 day before, 1 day after, and 1 month after the procedure were 285.8 U/mL (range: 16.6-942.0 U/mL), 635.2 U/mL (range: 17.9-3368.0 U/mL), and 336.0 U/mL (range: 7.0-1400.0 U/mL), respectively. Follow-up duration was less than 6 months for 11 patients and more than 6 months for 7 patients. At the time of the draft of this article, the mean survival of the patients included in the study was 185 days (range: 62-398 days). Conclusion: Percutaneous radiofrequency ablation of locally advanced adenocarcinoma has a high technical success rate and is effective in cytoreduction both at imaging and laboratory controls.


Author(s):  
D. A. Ionkin ◽  
N. A. Karelskaya ◽  
Yu. A. Stepanova ◽  
V. M. Zemskov ◽  
M. N. Kozlova ◽  
...  

Aim. To improve quality and duration of life in patients with locally advanced pancreatic cancer. Material and methods. Cryosurgery through laparotomy has been performed in 36 patients with locally advanced pancreatic cancer since 2012. There were 14 (38.9%) men and 22 (61.1%) women (mean age 58 ± 6.8 years). Dimensions of pancreatic tumors were from 4 to 10 cm. Domestic devices “CRYO-MT”, “CRYO-01”, “ELAMED” and cryoapplicators with a diameter 2–5 cm were applied. Target temperature was about 186 °С, time of exposure – 3–5 min. There were 1–5 sessions of cryoablation (mean 2.4) and their number depended on tumor dimensions. Local cryodestruction was supplemented by bypass anastomoses in 18 patients (50%). All patients subsequently underwent adjuvant chemotherapy with additional regional chemoembolization in 10 of them. Results. There were no lethal outcomes during cryodestruction and in postoperative period. Early postoperative complications occurred in 14 (38.8%) patients, severe complications – in 13.6%. Cryodestruction was followed by complete regression (39.2%) or significant improvement (41.6%) of pain syndrome. 6-, 12-, 24- and 36-month survival was 92%, 84%, 48% and 14%, respectively. Median survival was 18.2 months. Conclusion. Cryodestruction is able to improve patients’ quality of life due to reduced pain syndrome in case of locally advanced pancreatic cancer. Certain increase of survival was observed in additional chemotherapy.


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