Consensus Report of the National Cancer Institute Clinical Trials Planning Meeting on Pancreas Cancer Treatment

Duke University, Durham, North Carolina, United States
Journal of Clinical Oncology (Impact Factor: 18.43). 10/2009; 27(33):5660-9. DOI: 10.1200/JCO.2009.21.9022
Source: PubMed

ABSTRACT Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of cancer mortality, despite significant improvements in diagnostic imaging and operative mortality rates. The 5-year survival rate remains less than 5% because of microscopic or gross metastatic disease at time of diagnosis. The Clinical Trials Planning Meeting in pancreatic cancer was convened by the National Cancer Institute's Gastrointestinal Cancer Steering Committee to discuss the integration of basic and clinical knowledge in the design of clinical trials in PDAC. Major emphasis was placed on the enhancement of research to identify and validate the relevant targets and molecular pathways in PDAC, cancer stem cells, and the microenvironment. Emphasis was also placed on developing rational combinations of targeted agents and the development of predictive biomarkers to assist selection of patient subsets. The development of preclinical tumor models that are better predictive of human PDAC must be supported with wider availability to the research community. Phase III clinical trials should be implemented only if there is a meaningful clinical signal of efficacy and safety in the phase II setting. The emphasis must therefore be on performing well-designed phase II studies with uniform sets of basic entry and evaluation criteria with survival as a primary endpoint. Patients with either metastatic or locally advanced PDAC must be studied separately.

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    • "Our group previously established a primary pancreatic cancer explant model by implanting and propagating surgically resected tumour tissues in SCID mice (Hylander et al, 2005; Philip et al, 2009). The primary tumours were maintained in vivo without passage through cell line phase and the model has been shown to closely mirror the biology of the donor patients' tumours (Philip et al, 2009). This platform has been used by us and others (Hylander et al, 2005; Rubio-Viqueira et al, 2006) in evaluating anti-cancer drugs preclinically. "
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    British Journal of Cancer 12/2013; 110(2). DOI:10.1038/bjc.2013.754 · 4.82 Impact Factor
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    • "Pancreatic cancer, the fourth largest cause of cancer death in the world, is one of the most aggressive cancers [22] [23]. Although there have been substantial advances in the therapeutic modalities for pancreatic cancer, including systemic chemotherapies using gemcitabine (GEM), S-1 (tegaful , gimeracil, and oteracil potassium), and/or moleculartargeted agents, the prognosis of advanced pancreatic cancer patients still remains dismal [22] [23]. Therefore, development "
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    ABSTRACT: Juzentaihoto (JTT) is a well-known Japanese herbal medicine, which has been reported to modulate immune responses and enhance antitumor immunity in animal models. However, it is not clear whether JTT has similar effects on humans. In particular, there is little information on the effects of JTT in antigen-specific immunity in cancer patients. Here we conducted a randomized clinical study to investigate whether combined usage of JTT could affect antigen-specific immunity and clinical findings in advanced pancreatic cancer patients undergoing personalized peptide vaccination (PPV), in which HLA-matched vaccine antigens were selected based on the preexisting host immunity. Fifty-seven patients were randomly assigned to receive PPV with (n = 28) or without (n = 29) JTT. Unexpectedly, JTT did not significantly affect cellular or humoral immune responses specific to the vaccine antigens, which were determined by antigen-specific interferon-γ secretion in T cells and antigen-specific IgG titers in plasma, respectively. Nevertheless, JTT prevented deterioration of patients' conditions, such as anemia, lymphopenia, hypoalbuminemia, plasma IL-6 elevation, and reduction of performance status, which are frequently observed in advanced cancers. To our knowledge, this is the first clinical study that examined the immunological and clinical effects of JTT in cancer patients undergoing immunotherapy in humans.
    Evidence-based Complementary and Alternative Medicine 06/2013; 2013:981717. DOI:10.1155/2013/981717 · 1.88 Impact Factor
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    • "Pancreatic adenocarcinoma continues to be one of the deadliest cancer-related diseases in the world [30]. Little progress has been made since the past introduction of the chemotherapeutic agent gemcitabine, which remains the first-line chemotherapeutic agent in pancreatic cancer. "
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