G17DT+gemcitabine [Gem] versus placebo+Gem in untreated subjects with locally advanced, recurrent, or metastatic adenocarcinoma of the pancreas: Results of a randomized, double-blind, multinational, multicenter study

Shapiro, James; Marshall, J.; Karásek, Petr; Figer, A.; Oettle, Helmut; Couture, Félix; Jeziorski, Krzysztof; Broome, P.; Hawkins, R. A.

doi:10.1200/jco.2005.23.16_suppl.lba4012

Cited by 36 publications

(21 citation statements)

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“…Two of those were excluded as KaplanMeier survival curves were not presented [11,12] and seven further abstracts have not been included as since then the related studies have been published in peer-review journals and they had been identified through our literature search.…”

Section: Resultsmentioning

confidence: 99%

Excess premature (3-month) mortality in advanced pancreatic cancer could be related to fatal vascular thromboembolic events. A hypothesis based on a systematic review of phase III chemotherapy studies in advanced pancreatic cancer

Sgouros

Maraveyas

2008

Acta Oncologica

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Section: Resultsmentioning

confidence: 99%

Excess premature (3-month) mortality in advanced pancreatic cancer could be related to fatal vascular thromboembolic events. A hypothesis based on a systematic review of phase III chemotherapy studies in advanced pancreatic cancer

Sgouros

Maraveyas

2008

Acta Oncologica

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“…A borderline significant survival benefit was seen with G17DT compared to placebo (median survival 150 vs 83 days; Wilcoxon P ¼ 0.047), although there was a lower incidence of metastatic stage IV disease in the G17DT arm (73 vs 84%, respectively) (Gilliam et al, 2004). However, when G17DT was combined with gemcitabine in an RCT of 383 patients, the combination did not produce a survival advantage over gemcitabine alone (P ¼ 0.1) (Shapiro et al, 2005). In our trial A, gastrazole was associated with a longer survival compared to placebo (P ¼ 0.02).…”

Section: Discussionmentioning

confidence: 96%

Gastrazole (JB95008), a novel CCK2/gastrin receptor antagonist, in the treatment of advanced pancreatic cancer: results from two randomised controlled trials

et al. 2006

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Gastrin has been shown to be a growth stimulant in pancreatic cancer cells. Gastrazole is a potent and selective gastrin receptor antagonist. Two randomised blinded trials were conducted to assess the effect of gastrazole in advanced pancreatic cancer. Patients with biopsy-proven, inoperable pancreatic carcinoma were recruited. Trial A compared protracted venous infusion (PVI) gastrazole with PVI placebo, whereas trial B compared PVI gastrazole with PVI fluorouracil (5-FU). Eighteen patients were randomised in trial A. Gastrazole produced significantly better survival compared to placebo (median 7.9 months vs 4.5 months; 1-year survival: 33 vs 11%, respectively; log rank P ¼ 0.02). No difference in toxicity was seen between gastrazole and placebo, except central venous catheter and pump complications. Ninety-eight patients were randomised in trial B. No significant survival difference was detected between gastrazole and 5-FU (median: 3.6 vs 4.2 months; 1-year survival: 13.2 vs 26.2%, respectively; log rank P ¼ 0.42). Toxicity of gastrazole was mild with significantly less diarrhoea (P ¼ 0.03), stomatitis (Po0.001) and hand -foot syndrome (Po0.001) compared to 5-FU. Quality of life (QoL) assessment showed similar QoL between gastrazole and 5-FU at baseline and no significant differences occurred with treatment either between arms or within arms. Compared to placebo, patients with advanced pancreatic cancer treated with gastrazole appeared to live longer, albeit in a very small trial and will require confirmation with large-scale randomised data. However, it did not produce survival advantage over PVI 5-FU. Lack of toxicity for gastrazole may allow its combination with cytotoxic drugs.

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“…Again, the survival benefit was significantly dependent on the anti-G17DT response [79]. Negative results were reported by Shapiro et al [80] in advanced PDAC treatment for the combination of gemcitabine plus G17DT (median OS 5.8 months) compared to gemcitabine plus placebo (median OS 6.6 months). The final results of a phase III trial in advanced PDAC patients treated with sequentially administered G17DT or placebo are pending (NCT02118077).…”

Section: Vaccination Strategies In Pdac and Extrahepatic Btcmentioning

confidence: 99%

Immunotherapy: Pancreatic Cancer and Extrahepatic Biliary Tract Cancer

2019

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Pancreatic ductal adenocarcinoma (PDAC) and extrahepatic biliary tract cancer (BTC) are among the malignancies with the highest morbidity and mortality. Despite increasing knowledge on biology and novel therapies, outcome remains poor in these patients. Recent progress in immunotherapies created new hopes in the treatment of PDAC and extrahepatic BTC. Several trials tested immunotherapies in various therapeutic situations as monotherapies or in combinations. Although responses were seen in some of the trials, the value of immunotherapy in PDAC and extrahepatic BTC remains unclear in the current situation, especially regarding the complex biological characteristics with a high stroma component, intrinsic resistance mechanisms and an immunosuppressive, hypoxic microenvironment. These major hurdles have to be taken into account and overcome if immunotherapies should be successful in these tumor entities. Thereby, combinational approaches that allow on the one hand targeted therapy and on the other restore or boost the function of immune cells are promising.

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G17DT+gemcitabine [Gem] versus placebo+Gem in untreated subjects with locally advanced, recurrent, or metastatic adenocarcinoma of the pancreas: Results of a randomized, double-blind, multinational, multicenter study

Cited by 36 publications

References 0 publications

Excess premature (3-month) mortality in advanced pancreatic cancer could be related to fatal vascular thromboembolic events. A hypothesis based on a systematic review of phase III chemotherapy studies in advanced pancreatic cancer

Excess premature (3-month) mortality in advanced pancreatic cancer could be related to fatal vascular thromboembolic events. A hypothesis based on a systematic review of phase III chemotherapy studies in advanced pancreatic cancer

Gastrazole (JB95008), a novel CCK2/gastrin receptor antagonist, in the treatment of advanced pancreatic cancer: results from two randomised controlled trials

Immunotherapy: Pancreatic Cancer and Extrahepatic Biliary Tract Cancer

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