Long term survival in IMAGE 1 (Immune Modulation And Gemcitabine Evaluation 1), a randomized, open-label phase II trial comparing gemcitabine with and without IMM-101 in advanced pancreatic cancer.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 3051-3051
Author(s):  
Angus George Dalgleish ◽  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Ii ◽  
Immune Modulation ◽  
Phase Ii Trial ◽  
Advanced Pancreatic Cancer ◽  
Open Label ◽  
Term Survival ◽  
Long Term Survival ◽  
Open Label Phase

scholarly journals Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer

2016 ◽  
Vol 115 (7) ◽  
pp. 789-796 ◽  
Author(s):  
Angus G Dalgleish ◽  
Justin Stebbing ◽  
Douglas JA Adamson ◽  
Seema Safia Arif ◽  
Paolo Bidoli ◽  
...  
Keyword(s):  
Phase Ii ◽  
Immune Modulation ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Similar Rate ◽  
Adverse Event Reporting ◽  
Ductal Adenocarcinoma ◽  
Open Label ◽  
Open Label Phase ◽  
Intent To Treat

Abstract Background: Immune Modulation and Gemcitabine Evaluation-1, a randomised, open-label, phase II, first-line, proof of concept study (NCT01303172), explored safety and tolerability of IMM-101 (heat-killed Mycobacterium obuense; NCTC 13365) with gemcitabine (GEM) in advanced pancreatic ductal adenocarcinoma. Methods: Patients were randomised (2 : 1) to IMM-101 (10 mg ml−l intradermally)+GEM (1000 mg m−2 intravenously; n=75), or GEM alone (n=35). Safety was assessed on frequency and incidence of adverse events (AEs). Overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) were collected. Results: IMM-101 was well tolerated with a similar rate of AE and serious adverse event reporting in both groups after allowance for exposure. Median OS in the intent-to-treat population was 6.7 months for IMM-101+GEM v 5.6 months for GEM; while not significant, the hazard ratio (HR) numerically favoured IMM-101+GEM (HR, 0.68 (95% CI, 0.44–1.04, P=0.074). In a pre-defined metastatic subgroup (84%), OS was significantly improved from 4.4 to 7.0 months in favour of IMM-101+GEM (HR, 0.54, 95% CI 0.33–0.87, P=0.01). Conclusions: IMM-101 with GEM was as safe and well tolerated as GEM alone, and there was a suggestion of a beneficial effect on survival in patients with metastatic disease. This warrants further evaluation in an adequately powered confirmatory study.

scholarly journals Factors Associated With Long-Term Survival in Gemcitabine-Concurrent Proton Radiotherapy For Non-Metastatic Locally Advanced Pancreatic Cancer: a Single-Center Retrospective Study

2021 ◽  
Author(s):  
Yuta Ogura ◽  
Kazuki Terashima ◽  
Yoshihide Nanno ◽  
SungChul Park ◽  
Masaki Suga ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Median Survival ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Proton Radiotherapy ◽  
Term Survival ◽  
Long Term Survival ◽  
Factors Associated ◽  
Pancreatic Body

Abstract Background: Factors associated with long-term survival in gemcitabine-concurrent proton radiotherapy (GPT) for non-metastatic locally advanced pancreatic cancer (LAPC) remain unclear. This study aimed to determine the factors associated with long-term survival in GPT for non-metastatic LAPC.Methods: The medical records of 123 patients with LAPC treated with GPT between February 2009 and December 2019 at Hyogo Ion Beam Medical Center were retrospectively reviewed to assess the factors associated with long-term survival outcomes.Results: The median survival time of the total cohort treated with GPT was 18.7 months. The 1- and 2-year overall, local progression-free, and progression-free survival rates were 70.4% and 35.7%, 78.2% and 59.0%, and 38.6% and 20.8%, respectively. Multivariate analysis revealed that LAPCs at the pancreatic body-tail and those without anterior peripancreatic invasion were independently associated with longer overall survival (P = 0.040 and P = 0.015, respectively). The median survival times of patients with LAPC at the pancreatic body-tail and those with LAPC without anterior peripancreatic invasion were 24.1 and 28.1 months, respectively. LAPCs at the pancreatic body-tail had a higher volume ratio irradiated over 60 Gy equivalents at gross tumor volume than those at the pancreatic head (P < 0.001). LAPCs with anterior peripancreatic invasion had more peritoneal recurrence within 6 months than those without anterior peripancreatic invasion (P = 0.039).Conclusions: GPT is a promising treatment option for patients with LAPC at the pancreatic body-tail and those with LAPC without anterior peripancreatic invasion.

scholarly journals A patient with unresectable advanced pancreatic cancer achieving long-term survival with Gemcitabine chemotherapy

2008 ◽  
Vol 14 (43) ◽  
pp. 6876 ◽  
Author(s):  
Yoshiki Okamoto ◽  
Takashi Maeba ◽  
Keitarou Kakinoki ◽  
Keiichi Okano ◽  
Kunihiko Izuishi ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Advanced Pancreatic Cancer ◽  
Term Survival ◽  
Long Term Survival

Prognostic factors associated with long term survival in chemotherapy-treated advanced pancreatic cancer: A Canadian multicenter analysis.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 416-416
Author(s):  
Christina Kim ◽  
Shahid Ahmed ◽  
Dawn Elizabeth Armstrong ◽  
Tayyba Baig ◽  
Miguel Cardoso ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Logistic Regression ◽  
Primary Tumor ◽  
Advanced Pancreatic Cancer ◽  
Term Survival ◽  
Long Term Survival ◽  
Factors Associated ◽  
Multivariable Logistic Regression ◽  
Head Of The Pancreas

416 Background: The outcomes of patients (pts) with advanced pancreatic cancer (APC) are poor. With the use of currently available multi-agent regimens, median overall survival (mOS) remains < 12 months. Select pts, however, experience a protracted survival. Little is known about the clinical, pathologic and treatment characteristics associated with long term survival (LTS) in APC. Methods: Pooled individual level data from six Canadian cancer centers of pts diagnosed with APC from 2012 to 2016 who received at least one cycle of chemotherapy (CT) were analyzed. Clinical, pathologic and treatment characteristics, as well as survival, were compared between pts who lived < and ≥ 18 months. Multivariable logistic regression was used to identify independent predictors of survival. Results: Of 455 pts, 96% had metastatic disease and 88 (19%) survived ≥ 18 months. Compared to pts who survived < 18 months, those with LTS had lower WBC (p = 0.0025), CA 19-9 (p < 0.001), ALP (p < 0.001) and LDH (p = 0.007) at baseline. Pts with LTS also had higher albumin (p < 0.001) and BMI (p = 0.0268). In addition, they had better ECOG (p < 0.001) and were more likely to have tumors in the head of the pancreas (p = 0.0204). LTS pts were more likely to have a complete response (CR) or partial response (PR) to 1L CT (p < 0.001). The mOS seen with LTS was 29.2 months, compared to 4.3 months (p < 0.001). On multivariable logistic regression, independent predictors of LTS included: primary tumor in the head of the pancreas (OR 3.42 95% CI 1.2-9.76); experiencing a CR or PR to 1L CT (OR 9.19 95% CI 3.78-22.32); and receipt of 2L doublet CT (OR 2.72 95% CI 1.05 to 7.08). Conversely, factors associated with lower likelihood of LTS included: ECOG ≥ 2 (OR 0.32 95% CI 0.11-0.95); and elevated CA 19-9 (OR 0.43 95% CI 0.21-0.9). Conclusions: A select proportion of pts with APC experience LTS and have clinical features which differentiate them from those without LTS. The use of performance status, primary tumor location, pre-treatment CA 19-9, 2L CT type and radiologic response may help identify LTS and inform discussions regarding treatment and prognosis.

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