scholarly journals Active Hexose Correlated Compound For Patients With Resectable/Borderline Resectable Pancreatic Cancer Treated By Neoadjuvant Therapy: A Study Protocol For A Double-Blind Randomized Phase II Trial

2021 ◽  
Author(s):  
Daisuke Hashimoto ◽  
Sohei Satoi ◽  
Hideki Ishikawa ◽  
Yasuhiro Kodera ◽  
Keiko Kamei ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adjuvant Chemotherapy ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Preoperative Chemotherapy ◽  
Phase Ii Trial ◽  
Dose Intensity ◽  
Ductal Adenocarcinoma ◽  
Adverse Event Profile ◽  
Borderline Resectable ◽  
Before And After

Abstract Background: The prognosis of pancreatic ductal adenocarcinoma remains very poor. One possible reason for the short survival of patients with this disease is malnutrition, which can be present at the initial diagnosis, and continue after pancreatectomy. Then, it is important to improve nutritional status and to decrease adverse events during neoadjuvant and adjuvant chemotherapy. Active hexose correlated compound (AHCC) is a standardized extract of cultured Lentinula edodes mycelia, and is considered a potent biological response modifier in the treatment of cancer. To evaluate the survival impact of AHCC on the patients with pancreatic ductal adenocarcinoma, we plan to perform this trial.Methods: This is a prospective multicenter phase II trial in patients with resectable/borderline resectable pancreatic ductal adenocarcinoma to investigate the efficacy of AHCC regarding survival. Patients will begin taking AHCC or placebo on the first day of neoadjuvant therapy. AHCC or placebo will be continued until 2 years after surgery. The primary endpoint will be 2-year disease-free survival. The secondary endpoints are the completion rate, dose intensity, and adverse event profile of preoperative chemotherapy; response rate to preoperative chemotherapy; rate of decrease in tumor marker (carbohydrate antigen 19-9, carcinoembryonic antigen) concentrations during preoperative chemotherapy; entry rate, completion rate, dose intensity, and adverse event profile of adjuvant chemotherapy; safety of the protocol therapy (adverse effect of AHCC); 2-year overall survival rate; and nutrition score before and after preoperative chemotherapy, and before and after adjuvant chemotherapy. We will enroll 230 patients, and the study involves eight leading Japanese institutions that are all high-volume centers in pancreatic surgery.Discussion: AHCC is expected to function as a supportive food in patients with pancreatic ductal adenocarcinoma, and to reduce the proportion of severe adverse events related to neoadjuvant chemotherapy and to increase the completion proportion of multimodal treatments, resulting in improved survival. Trial registration: The trial protocol has been registered in the protocol registration system at the Japan Registry of Clinical Trials (Trial ID: jRCTs051200029). At the time of the submission of this paper (October 2020), the protocol version is 2.0. The completion date is estimated to be November 2024.

scholarly journals Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy as neoadjuvant chemotherapy for resectable/borderline resectable pancreatic ductal adenocarcinoma (PDAC-GS/GA-rP2, CSGO-HBP-015)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Daisaku Yamada ◽  
Shogo Kobayashi ◽  
Hidenori Takahashi ◽  
Hirofumi Akita ◽  
Terumasa Yamada ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Combination Therapy ◽  
Survival Time ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Curative Resection ◽  
Phase Ii Study ◽  
Ductal Adenocarcinoma ◽  
Borderline Resectable ◽  
Randomized Phase Ii

Abstract Background Pancreatic ductal adenocarcinoma (PDAC) is a lethal disease, and multimodal strategies, such as surgery plus neoadjuvant chemotherapy (NAC)/adjuvant chemotherapy, have been attempted to improve survival in patients with localized PDAC. To date, there is one prospective study providing evidence for the superiority of a neoadjuvant strategy over upfront surgery for localized PDAC. However, which NAC regimen is optimal remains unclear. Methods A randomized, exploratory trial is performed to examine the clinical benefits of two chemotherapy regimens, gemcitabine plus S-1 (GS) and gemcitabine plus nab-paclitaxel (GA), as NAC for patients with planned PDAC resection. Patients are enrolled after the diagnosis of resectable or borderline resectable PDAC. They are randomly assigned to either NAC regimen. Adjuvant chemotherapy after curative resection is highly recommended for 6 months in both arms. The primary endpoint is tumor progression-free survival time, and secondary endpoints include the rate of curative resection, the completion rate of protocol therapy, the recurrence type, the overall survival time, and safety. The target sample size is set as at least 100. Discussion This study is the first randomized phase II study comparing GS combination therapy with GA combination therapy as NAC for localized pancreatic cancer. Trial registration UMIN Clinical Trials Registry UMIN000021484. This trial began in April 2016.

scholarly journals Is surgery after neoadjuvant chemoradiotherapy feasible for elderly patients with resectable or borderline resectable pancreatic ductal adenocarcinoma?

2020 ◽  
Author(s):  
Hironobu Suto ◽  
Keiichi Okano ◽  
Minoru Oshima ◽  
Yasuhisa Ando ◽  
Hiroyuki Matsukawa ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Elderly Patients ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Neoadjuvant Chemoradiotherapy ◽  
The Elderly ◽  
Elderly Group ◽  
Ductal Adenocarcinoma ◽  
Borderline Resectable ◽  
Pancreas Resection

Abstract Background The benefit and safety of pancreas resection for pancreatic ductal adenocarcinoma for elderly patients, especially after preoperative adjuvant therapy, is still unknown. This study attempted to evaluate perioperative and long-term outcomes after pancreas resection in elderly patients with pancreatic ductal adenocarcinoma and to detect the potential impact of neoadjuvant chemoradiotherapy. Methods One hundred and thirty-four consecutive patients undergoing curative resection for resectable and borderline resectable pancreatic ductal adenocarcinoma between March 2008 and February 2018 at our institution were analyzed. Patients were divided into two groups: patients older than or equal to 75 years (the elderly group, n=46) and those younger than 75 years (the younger group, n= 88). Results There were no significant differences both in overall survival and relapse free survival between the two groups (P=0.270, P=0.699). Although the induction rate of adjuvant chemotherapy was not significantly different (P=0.458), the completion rate was significantly lower in elderly group than that in younger group (35% and 56%; P=0.022). Neoadjuvant chemoradiotherapy was performed for 82 patients (61%), and the induction and completion rates were not significantly different (P=0.668, P=0.794) between the two groups. The elderly patients with completion of adjuvant chemotherapy had significantly better overall survival than those without it (P=0.032). Neoadjuvant chemoradiotherapy did not significantly affect overall survival in elderly patients, however, there was a trend toward longer overall survival in patients who had neoadjuvant chemoradiotherapy (P=0.072). Conclusions Neoadjuvant chemoradiotherapy could be introduced and completed even for elderly patients without serious complications and might lead to improved prognosis for those who are difficult to complete postoperative adjuvant chemotherapy.

Predicting Surgical Margins in Patients With Borderline Resectable and Locally Advanced Pancreatic Cancer Undergoing Resection

2021 ◽  
pp. 000313482110111
Author(s):  
Weizheng Ren ◽  
Dimitrios Xourafas ◽  
Stanley W. Ashley ◽  
Thomas E. Clancy
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Univariate Analysis ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Ductal Adenocarcinoma ◽  
Resection Margins ◽  
Borderline Resectable ◽  
Stepwise Selection ◽  
R1 Resection ◽  
Positive Resection Margins

Background Many patients with borderline resectable/locally advanced pancreatic ductal adenocarcinoma (borderline resectable [BR]/locally advanced [LA] pancreatic ductal adenocarcinoma [PDAC]) undergoing resection will have positive resection margins (R1), which is associated with poor prognosis. It might be useful to preoperatively predict the margin (R) status. Methods Data from patients with BR/LA PDAC who underwent a pancreatectomy between 2008 and 2018 at Brigham and Women’s Hospital were retrospectively reviewed. Logistic regression analysis was used to evaluate the association between R status and relevant preoperative factors. Significant predictors of R1 resection on univariate analysis ( P < .1) were entered into a stepwise selection using the Akaike information criterion to define the final model. Results A total of 142 patients with BR/LA PDAC were included in the analysis, 60(42.3%) had R1 resections. In stepwise selection, the following factors were identified as positive predictors of an R1 resection: evidence of lymphadenopathy at diagnosis (OR = 2.06, 95% CI: 0.99-4.36, P = .056), the need for pancreaticoduodenectomy (OR = 3.81, 96% CI: 1.15-15.70, P = .040), extent of portal vein/superior mesenteric vein involvement at restaging (<180°, OR = 3.57, 95% CI: 1.00-17.00, P = .069, ≥180°, OR = 7,32, 95% CI: 1.75-39.87, P = .010), stable CA 19-9 serum levels (less than 50% decrease from diagnosis to restaging, OR = 2.27, 95% CI: 0.84-6.36 P = .107), and no preoperative FOLFIRINOX (OR = 2.17, 95% CI: 0.86-5.64, P = .103). The prognostic nomogram based on this model yielded a probability of achieving an R1 resection ranging from <5% (0 factors) to >70% (all 5 factors). Conclusions Relevant preoperative clinicopathological characteristics accurately predict positive resection margins in patients with BR/LA PDAC before resection. With further development, this model might be used to preoperatively guide surgical decision-making in patients with BR/LA PDAC.

A High C-Reactive Protein Level on Postoperative Day 7 is Associated with Poor Survival of Patients with Pancreatic Ductal Adenocarcinoma after Resection

2021 ◽  
pp. 000313482110234
Author(s):  
Masaji Tani ◽  
Hiroya Iida ◽  
Hiromitsu Maehira ◽  
Haruki Mori ◽  
Toru Miyake ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Median Overall Survival ◽  
Cox Regression ◽  
Ductal Adenocarcinoma ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Retrospective View ◽  
Node Metastases ◽  
Common Malignancy

Introduction Pancreatic ductal adenocarcinoma (PDAC) is a common malignancy. While inflammation-related biomarkers influence patient survival after resection, it has not been known whether postoperative inflammations affect the survival of PDAC patients or not. Methods It was investigated whether the universal biomarkers on postoperative day (POD) 7 affect the survival of PDAC patients in the retrospective view, and univariate and multivariate analyses were performed via the Cox regression method. Results Overall, 108 consecutive patients underwent resection; 98 (90.7%) had T3 disease and 73 (67.6%) had lymph node metastases. Thirty-four patients (31.5%) experienced postoperative complications. Compared with preoperative values, the white blood cell count and C-reactive protein (CRP) level on POD 7 were significantly elevated ( P < .001 for both); conversely, the lymphocyte count was significantly reduced ( P < .001). Among 108 patients, 72 received adjuvant chemotherapy. The median overall survival was 21.0 months; the 5-year survival rate was 22.3%. On multivariate analysis, receiving adjuvant chemotherapy and low CRP levels on POD 7 (<7.6 mg/dL) were prognosticators of better survival. However, the CD classification was not a prognosticator of survival after resection. Conclusions Adjuvant chemotherapy and postoperative low CRP levels on POD 7 were prognosticators of better survival of PDAC patients after resection. Surgeons should be aware of managing postoperative infections because a high postoperative CRP level is related with unfavorable survival.

scholarly journals PancREatic Cancer and Individualised Supervised Exercise (PRECISE): a feasibility trial protocol for patients with resectable pancreatic ductal adenocarcinoma

2020 ◽  
Vol 2 ◽  
pp. 22
Author(s):  
Dominic O'Connor ◽  
Malcolm Brown ◽  
Roy Bowdery ◽  
Martin Eatock ◽  
Claire Hulme ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adjuvant Chemotherapy ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Exercise Intervention ◽  
Feasibility Trial ◽  
Ductal Adenocarcinoma ◽  
Moderate Intensity ◽  
Moderate Intensity Exercise ◽  
Supervised Exercise ◽  
Health And Social Care

Background: Patients with resectable pancreatic ductal adenocarcinoma (PDAC), undergoing adjuvant chemotherapy can experience an array of complications including fatigue, pain and the loss of physical function. Accumulating evidence from largely early stage breast cancer studies supports exercise as an adjunct therapy to help mitigate treatment complications. However, there is a lack of evidence of its feasibility in pancreatic cancer. The purpose of this study is to explore the initial feasibility of delivering a supervised, individualized, and progressive concurrent exercise intervention to individuals with resectable PDAC who are undergoing adjuvant therapy. Methodology: Ten patients with resectable PDAC undergoing adjuvant chemotherapy will be recruited. Clinical care teams will screen patients against inclusion criteria to determine eligibility. All enrolled participants will complete a 16-week, supervised, tailored, moderate intensity exercise intervention consisting of aerobic and muscle strengthening activities. The primary outcome will be feasibility of delivering a supervised exercise intervention. Secondary outcomes will include measures of physical fitness, fatigue, and quality of life. Outcomes will be measured at baseline (T1), 16 weeks (T2) and 3 months (T3). The feasibility, acceptability and potential utility of the supervised exercise intervention will be explored qualitatively through semi-structured interviews with key stakeholders (e.g. active participants, eligible participants that declined participation and the research staff including exercise physiologists and recruiting clinicians).  The use of health and social care services, medications and personal expenses incurred during the trial will also be used to determine cost-effectiveness of this intervention and a potential further RCT in PDAC. Discussion: The overall aim of this study is to determine the utility of a supervised, tailored, moderate intensity exercise intervention in PDAC patients undergoing adjuvant chemotherapy.  This feasibility study will help inform the design of future randomised controlled trials to determine the efficacy of the exercise intervention in PDAC.

scholarly journals Complete Radiologic Response of Metastatic Pancreatic Ductal Adenocarcinoma to Microwave Ablation Combined with Second-Line Palliative Chemotherapy

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Hakon Blomstrand ◽  
Karin Adolfsson ◽  
Per Sandström ◽  
Bergthor Björnsson
Keyword(s):  
Adjuvant Chemotherapy ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Palliative Chemotherapy ◽  
Lung Metastases ◽  
Performance Status ◽  
Progression Free Survival ◽  
Disease Recurrence ◽  
Ductal Adenocarcinoma ◽  
Second Line ◽  
First Line

Pancreatic ductal adenocarcinoma (PDAC) has a bleak prognosis, especially for the majority of patients diagnosed with metastatic disease. The primary option for palliative treatment is chemotherapy, and responses beyond first-line treatment are rare and typically short. Here, we report a case of a 63-year-old woman with PDAC in the head of the pancreas who was initially successfully treated by pancreaticoduodenectomy followed by adjuvant chemotherapy with gemcitabine. However, disease recurrence with liver and para-aortic lymph node metastases was detected only two months after the completion of adjuvant chemotherapy. First-line palliative chemotherapy with gemcitabine-nab/paclitaxel was commenced. The results were discouraging, with disease progression (liver and lung metastases) detected at the first evaluation; the progression-free survival was just two months (64 days). Surprisingly, the response to second-line palliative chemotherapy with 5-fluorouracil-oxaliplatin was excellent; in combination with the ablation of a liver metastasis, this treatment regimen resulted in a complete radiological response and an 11-month treatment-free interval with a sustained good performance status.

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