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Article: Results of a phase i trial of 12 patients with locally advanced pancreatic carcinoma combining gefitinib, paclitaxel, and 3-dimensional conformal radiation: Report of toxicity and evaluation of circulating k-ras as a potential biomarker of response to therapy

TitleResults of a phase i trial of 12 patients with locally advanced pancreatic carcinoma combining gefitinib, paclitaxel, and 3-dimensional conformal radiation: Report of toxicity and evaluation of circulating k-ras as a potential biomarker of response to therapy
Authors
Issue Date2009
PublisherLippincott Williams & Wilkins. The Journal's web site is located at http://www.amjclinicaloncology.com
Citation
American Journal Of Clinical Oncology: Cancer Clinical Trials, 2009, v. 32 n. 2, p. 115-121 How to Cite?
AbstractOBJECTIVE:: To evaluate the toxicity of daily gefitinib, an epidermal growth factor receptor-tyrosine kinase inhibitor, with concurrent chemoradiation (CRT) in patients with locally advanced pancreatic adenocarcinoma and prospectively evaluate plasma k-ras as a potential marker of response to gefitinib and CRT. METHODS:: Eleven of 12 eligible patients enrolled received a 7-day induction of gefitinib (250 mg PO) followed by daily gefitinib with concurrent CRT. Patients received 50.4 Gy/28 fractions of external beam radiation with weekly paclitaxel (40 mg/m IV) followed by maintenance on gefitinib. Plasma k-ras codon 12 mutations were detected using a two-stage restriction fragment length polymorphism-polymerase chain reaction assay on patients' plasma both before and after therapy. Mutations were confirmed by direct sequencing. RESULTS:: Common adverse events included grade 1 skin rash (63%), grade 1 to 2 gastrointestinal symptoms including anorexia, nausea, vomiting, and diarrhea occurred in 63% of patients, grade 3 nausea occurred in 45% of patients. Three patients did not complete therapy, only one was possibly associated with study drug. K-ras mutations were detected in the pre-gefitinib plasma of 5/11 patients and in the matched tumor tissue of 3/4 patients. In patients where k-ras mutations were undetectable post-treatment, survival times were favorable. CONCLUSIONS:: Combination of daily gefitinib with concurrent CRT in this locally advanced pancreatic cancer population was reasonably tolerated. Rapid changes in serum k-ras may provide critical information as to the efficacy of a novel agent and assist in tailoring treatment for cancers of the pancreas. © 2009 by Lippincott Williams & Wilkins.
Persistent Identifierhttp://hdl.handle.net/10722/157552
ISSN
2015 Impact Factor: 2.977
2015 SCImago Journal Rankings: 0.846
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorOlsen, CCen_US
dc.contributor.authorSchefter, TEen_US
dc.contributor.authorChen, Hen_US
dc.contributor.authorKane, Men_US
dc.contributor.authorLeong, Sen_US
dc.contributor.authorMccarter, MDen_US
dc.contributor.authorChen, Yen_US
dc.contributor.authorMack, Pen_US
dc.contributor.authorEckhardt, SGen_US
dc.contributor.authorStiegmann, Gen_US
dc.contributor.authorRaben, Den_US
dc.date.accessioned2012-08-08T08:51:12Z-
dc.date.available2012-08-08T08:51:12Z-
dc.date.issued2009en_US
dc.identifier.citationAmerican Journal Of Clinical Oncology: Cancer Clinical Trials, 2009, v. 32 n. 2, p. 115-121en_US
dc.identifier.issn0277-3732en_US
dc.identifier.urihttp://hdl.handle.net/10722/157552-
dc.description.abstractOBJECTIVE:: To evaluate the toxicity of daily gefitinib, an epidermal growth factor receptor-tyrosine kinase inhibitor, with concurrent chemoradiation (CRT) in patients with locally advanced pancreatic adenocarcinoma and prospectively evaluate plasma k-ras as a potential marker of response to gefitinib and CRT. METHODS:: Eleven of 12 eligible patients enrolled received a 7-day induction of gefitinib (250 mg PO) followed by daily gefitinib with concurrent CRT. Patients received 50.4 Gy/28 fractions of external beam radiation with weekly paclitaxel (40 mg/m IV) followed by maintenance on gefitinib. Plasma k-ras codon 12 mutations were detected using a two-stage restriction fragment length polymorphism-polymerase chain reaction assay on patients' plasma both before and after therapy. Mutations were confirmed by direct sequencing. RESULTS:: Common adverse events included grade 1 skin rash (63%), grade 1 to 2 gastrointestinal symptoms including anorexia, nausea, vomiting, and diarrhea occurred in 63% of patients, grade 3 nausea occurred in 45% of patients. Three patients did not complete therapy, only one was possibly associated with study drug. K-ras mutations were detected in the pre-gefitinib plasma of 5/11 patients and in the matched tumor tissue of 3/4 patients. In patients where k-ras mutations were undetectable post-treatment, survival times were favorable. CONCLUSIONS:: Combination of daily gefitinib with concurrent CRT in this locally advanced pancreatic cancer population was reasonably tolerated. Rapid changes in serum k-ras may provide critical information as to the efficacy of a novel agent and assist in tailoring treatment for cancers of the pancreas. © 2009 by Lippincott Williams & Wilkins.en_US
dc.languageengen_US
dc.publisherLippincott Williams & Wilkins. The Journal's web site is located at http://www.amjclinicaloncology.comen_US
dc.relation.ispartofAmerican Journal of Clinical Oncology: Cancer Clinical Trialsen_US
dc.subject.meshAdenocarcinoma - Blood - Pathology - Therapyen_US
dc.subject.meshAgeden_US
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols - Therapeutic Useen_US
dc.subject.meshCombined Modality Therapyen_US
dc.subject.meshDna Mutational Analysisen_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshImaging, Three-Dimensionalen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshMutation - Geneticsen_US
dc.subject.meshNeoplasm Stagingen_US
dc.subject.meshPaclitaxel - Administration & Dosageen_US
dc.subject.meshPancreatic Neoplasms - Blood - Pathology - Therapyen_US
dc.subject.meshPolymerase Chain Reactionen_US
dc.subject.meshPolymorphism, Restriction Fragment Lengthen_US
dc.subject.meshPrognosisen_US
dc.subject.meshProspective Studiesen_US
dc.subject.meshProto-Oncogene Proteins - Blooden_US
dc.subject.meshQuinazolines - Administration & Dosageen_US
dc.subject.meshRadiotherapy, Conformalen_US
dc.subject.meshSurvival Rateen_US
dc.subject.meshTumor Markers, Biological - Blooden_US
dc.subject.meshRas Proteins - Blooden_US
dc.titleResults of a phase i trial of 12 patients with locally advanced pancreatic carcinoma combining gefitinib, paclitaxel, and 3-dimensional conformal radiation: Report of toxicity and evaluation of circulating k-ras as a potential biomarker of response to therapyen_US
dc.typeArticleen_US
dc.identifier.emailChen, H:hlchen@hkucc.hku.hken_US
dc.identifier.authorityChen, H=rp00383en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1097/COC.0b013e318180baa3en_US
dc.identifier.pmid19307945-
dc.identifier.scopuseid_2-s2.0-67749113684en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-67749113684&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume32en_US
dc.identifier.issue2en_US
dc.identifier.spage115en_US
dc.identifier.epage121en_US
dc.identifier.isiWOS:000265056900001-
dc.publisher.placeUnited Statesen_US
dc.identifier.scopusauthoridOlsen, CC=7201888559en_US
dc.identifier.scopusauthoridSchefter, TE=6508175207en_US
dc.identifier.scopusauthoridChen, H=26643315400en_US
dc.identifier.scopusauthoridKane, M=7202168131en_US
dc.identifier.scopusauthoridLeong, S=24824847100en_US
dc.identifier.scopusauthoridMcCarter, MD=7004348297en_US
dc.identifier.scopusauthoridChen, Y=40261235400en_US
dc.identifier.scopusauthoridMacK, P=7005725041en_US
dc.identifier.scopusauthoridEckhardt, SG=7102944405en_US
dc.identifier.scopusauthoridStiegmann, G=7003696681en_US
dc.identifier.scopusauthoridRaben, D=7005707918en_US

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