Microwave ablation with AMICA® probe for unresectable locally advanced pancreatic cancer. Quality of life and performance status.

2015 ◽  
Vol 41 (1) ◽  
pp. S3-S4
Author(s):  
V. Sciascia ◽  
A. Febbraro ◽  
G. Benincasa ◽  
E. Di Gaeta ◽  
G. Perillo ◽  
...  
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.


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.


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.


2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 408-408
Author(s):  
Jon Kroll Bjerregaard ◽  
Morten Ladekarl ◽  
Anna-Lene Fromm ◽  
Per Pfeiffer

408 Background: Locally advanced pancreatic cancer (LAPC) is often a mix of borderline and never-resectable tumors. Multimodality treatment might downstage these tumors to allow a potential radical resection, especially the borderline group. In this ongoing phase II study we examined the feasibility of FOLFIRINOX with or without CRT followed by surgery for both borderline and never-resectable tumors (NCT-01397019). Methods: Patients in performance status 0-1, with initially non-resectable stage II/III pancreatic cancer were offered FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5FU 400 mg/m2+ 2400 mg/m2) every 14 days. Every 4th series the patients were evaluated and offered CRT (50.4 Gy/27F & capecitabine) if deemed potentially resectable. Resections were performed if deemed possible by the MDT. Results: Between August 2012 and present, 58 patients have been recruited with a median observation time of 14.5 months. Median age was 65(range 38-75) years, with 47%/53% stage II/III distribution. Median CA19-9 was 299(range 2-13,432). Two-hundred-seventy-four courses of FOLFIRINOX have been given, with a median of 6.5 per patient, with a median of 2 without dose modifications. Presently twenty-one patients have been treated with CRT. Twelve patients have been resected, of which 7 received prior CRT. Median survival for all patients was 15.6 months (11-NR) with a 1-year survival of 70% (49-84). For patients not resected the median survival was 12.8 months (9-16) for resected the median survival has not yet been reached. The FOLFIRINOX was associated with adverse events similar to what is expected in metastatic patients. Conclusions: FOLFIRINOX with or without CRT in patients with LAPC shows promising efficacy in patients with both borderline and never-resectable tumors. Unmodified FOLFIRINOX had acceptable toxicity, however dose reductions are often needed. CRT following initial FOLFIRINOX was feasible and without unexpected toxicity. Clinical trial information: NCT-01397019.


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.


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.


Author(s):  
Hedy Lee Kindler

Overview: Since 1996, the cornerstone of chemotherapy for advanced pancreatic cancer has been gemcitabine, which has a genuine, but modest effect on survival and quality of life. It has been remarkably difficult to improve on these outcomes. Many phase III studies of gemcitabine doublets have been uniformly negative, with the exception of a trial of gemctabine plus erlotinib, which provided only marginal benefit. In 2010, the FOLFIRINOX regimen (bolus and infusional 5-fluorouracil, irinotecan, and oxaliplatin) emerged as a major treatment advance for patients with metastatic pancreatic cancer. In a trial with 342 patients, FOLFIRINOX yielded a longer median overall survival (11.1 vs. 6.8 months, hazard ratio [HR] 0.57, p < 0.001), a superior progression-free survival (6.4 vs. 3.3 months, HR 0.47, p < 0.001), a higher objective response rate (31.6% vs. 9.4%, p < 0.001), and a significant increase in time until definitive deterioration in quality of life, compared with gemcitabine. FOLFIRINOX is also more cost-effective than gemcitabine. Because of higher rates of grade 3 to 4 neutropenia (46% vs. 21%), febrile neutropenia (5% vs. 1%), and diarrhea (13% vs. 2%) with FOLFIRINOX, vigilant patient selection, education, and monitoring are essential. Retrospective single-institution series confirm the substantial activity of FOLFIRINOX in metastatic, locally advanced, and previously-treated patients; demonstrate its safety in individuals with biliary stents; and elucidate how physicians routinely modify drug doses without clear evidence or guidelines. Ongoing and planned studies will prospectively evaluate FOLFIRINOX in the adjuvant, locally advanced, and borderline resectable settings, will add targeted agents to FOLFIRINOX, and will evaluate how to adjust doses to ameliorate toxicity.


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