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- Publisher Website: 10.1097/COC.0b013e318180baa3
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- PMID: 19307945
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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
Title | 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 |
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Authors | |
Keywords | Gefitinib K-ras Pancreatic adenocarcinoma Radiation |
Issue Date | 2009 |
Publisher | Lippincott 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? |
Abstract | OBJECTIVE:: 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 Identifier | http://hdl.handle.net/10722/157552 |
ISSN | 2023 Impact Factor: 1.6 2023 SCImago Journal Rankings: 0.711 |
ISI Accession Number ID | |
References |
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Olsen, CC | en_US |
dc.contributor.author | Schefter, TE | en_US |
dc.contributor.author | Chen, H | en_US |
dc.contributor.author | Kane, M | en_US |
dc.contributor.author | Leong, S | en_US |
dc.contributor.author | Mccarter, MD | en_US |
dc.contributor.author | Chen, Y | en_US |
dc.contributor.author | Mack, P | en_US |
dc.contributor.author | Eckhardt, SG | en_US |
dc.contributor.author | Stiegmann, G | en_US |
dc.contributor.author | Raben, D | en_US |
dc.date.accessioned | 2012-08-08T08:51:12Z | - |
dc.date.available | 2012-08-08T08:51:12Z | - |
dc.date.issued | 2009 | en_US |
dc.identifier.citation | American Journal Of Clinical Oncology: Cancer Clinical Trials, 2009, v. 32 n. 2, p. 115-121 | en_US |
dc.identifier.issn | 0277-3732 | en_US |
dc.identifier.uri | http://hdl.handle.net/10722/157552 | - |
dc.description.abstract | OBJECTIVE:: 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.language | eng | en_US |
dc.publisher | Lippincott Williams & Wilkins. The Journal's web site is located at http://www.amjclinicaloncology.com | en_US |
dc.relation.ispartof | American Journal of Clinical Oncology: Cancer Clinical Trials | en_US |
dc.subject | Gefitinib | - |
dc.subject | K-ras | - |
dc.subject | Pancreatic adenocarcinoma | - |
dc.subject | Radiation | - |
dc.subject.mesh | Adenocarcinoma - Blood - Pathology - Therapy | en_US |
dc.subject.mesh | Aged | en_US |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols - Therapeutic Use | en_US |
dc.subject.mesh | Combined Modality Therapy | en_US |
dc.subject.mesh | Dna Mutational Analysis | en_US |
dc.subject.mesh | Female | en_US |
dc.subject.mesh | Humans | en_US |
dc.subject.mesh | Imaging, Three-Dimensional | en_US |
dc.subject.mesh | Male | en_US |
dc.subject.mesh | Middle Aged | en_US |
dc.subject.mesh | Mutation - Genetics | en_US |
dc.subject.mesh | Neoplasm Staging | en_US |
dc.subject.mesh | Paclitaxel - Administration & Dosage | en_US |
dc.subject.mesh | Pancreatic Neoplasms - Blood - Pathology - Therapy | en_US |
dc.subject.mesh | Polymerase Chain Reaction | en_US |
dc.subject.mesh | Polymorphism, Restriction Fragment Length | en_US |
dc.subject.mesh | Prognosis | en_US |
dc.subject.mesh | Prospective Studies | en_US |
dc.subject.mesh | Proto-Oncogene Proteins - Blood | en_US |
dc.subject.mesh | Quinazolines - Administration & Dosage | en_US |
dc.subject.mesh | Radiotherapy, Conformal | en_US |
dc.subject.mesh | Survival Rate | en_US |
dc.subject.mesh | Tumor Markers, Biological - Blood | en_US |
dc.subject.mesh | Ras Proteins - Blood | en_US |
dc.title | 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 | en_US |
dc.type | Article | en_US |
dc.identifier.email | Chen, H:hlchen@hkucc.hku.hk | en_US |
dc.identifier.authority | Chen, H=rp00383 | en_US |
dc.description.nature | link_to_subscribed_fulltext | en_US |
dc.identifier.doi | 10.1097/COC.0b013e318180baa3 | en_US |
dc.identifier.pmid | 19307945 | - |
dc.identifier.scopus | eid_2-s2.0-67749113684 | en_US |
dc.relation.references | http://www.scopus.com/mlt/select.url?eid=2-s2.0-67749113684&selection=ref&src=s&origin=recordpage | en_US |
dc.identifier.volume | 32 | en_US |
dc.identifier.issue | 2 | en_US |
dc.identifier.spage | 115 | en_US |
dc.identifier.epage | 121 | en_US |
dc.identifier.isi | WOS:000265056900001 | - |
dc.publisher.place | United States | en_US |
dc.identifier.scopusauthorid | Olsen, CC=7201888559 | en_US |
dc.identifier.scopusauthorid | Schefter, TE=6508175207 | en_US |
dc.identifier.scopusauthorid | Chen, H=26643315400 | en_US |
dc.identifier.scopusauthorid | Kane, M=7202168131 | en_US |
dc.identifier.scopusauthorid | Leong, S=24824847100 | en_US |
dc.identifier.scopusauthorid | McCarter, MD=7004348297 | en_US |
dc.identifier.scopusauthorid | Chen, Y=40261235400 | en_US |
dc.identifier.scopusauthorid | MacK, P=7005725041 | en_US |
dc.identifier.scopusauthorid | Eckhardt, SG=7102944405 | en_US |
dc.identifier.scopusauthorid | Stiegmann, G=7003696681 | en_US |
dc.identifier.scopusauthorid | Raben, D=7005707918 | en_US |
dc.identifier.issnl | 0277-3732 | - |