Randomised Phase I/II trial assessing the safety and efficacy of radiolabelled anti-carcinoembryonic antigen I131KAb201 antibodies given intra-arterially or intravenously in ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2009-02-25

AUTHORS

Asma Sultana, Susannah Shore, Michael GT Raraty, Sobhan Vinjamuri, Jonathan E Evans, Catrin Tudur Smith, Steven Lane, Seema Chauhan, Lorraine Bosonnet, Conall Garvey, Robert Sutton, John P Neoptolemos, Paula Ghaneh

ABSTRACT

BackgroundAdvanced pancreatic cancer has a poor prognosis, and the current standard of care (gemcitabine based chemotherapy) provides a small survival advantage. However the drawback is the accompanying systemic toxicity, which targeted treatments may overcome. This study aimed to evaluate the safety and tolerability of KAb201, an anti-carcinoembryonic antigen monoclonal antibody, labelled with I131 in pancreatic cancer (ISRCTN 16857581).MethodsPatients with histological/cytological proven inoperable adenocarcinoma of the head of pancreas were randomised to receive KAb 201 via either the intra-arterial or intravenous delivery route. The dose limiting toxicities within each group were determined. Patients were assessed for safety and efficacy and followed up until death.ResultsBetween February 2003 and July 2005, 25 patients were enrolled. Nineteen patients were randomised, 9 to the intravenous and 10 to the intra-arterial arms. In the intra-arterial arm, dose limiting toxicity was seen in 2/6 (33%) patients at 50 mCi whereas in the intravenous arm, dose limiting toxicity was noted in 1/6 patients at 50 mCi, but did not occur at 75 mCi (0/3).The overall response rate was 6% (1/18). Median overall survival was 5.2 months (95% confidence interval = 3.3 to 9 months), with no significant difference between the intravenous and intra-arterial arms (log rank test p = 0.79). One patient was still alive at the time of this analysis.ConclusionDose limiting toxicity for KAb201 with I131 by the intra-arterial route was 50 mCi, while dose limiting toxicity was not reached in the intravenous arm. More... »

PAGES

66

References to SciGraph publications

  • 2005-07. Current status of cancer therapy with radiolabeled monoclonal antibody in ANNALS OF NUCLEAR MEDICINE
  • 2005-09-07. Monoclonal antibody therapy of cancer in NATURE BIOTECHNOLOGY
  • 1987-12. Transport of molecules across tumor vasculature in CANCER AND METASTASIS REVIEWS
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    http://scigraph.springernature.com/pub.10.1186/1471-2407-9-66

    DOI

    http://dx.doi.org/10.1186/1471-2407-9-66

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1045014395

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/19243606


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