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Conference Paper: The PARSC trial, a prospective study for the assessment of recurrence risk in stage II colon cancer patients using ColoPrint

TitleThe PARSC trial, a prospective study for the assessment of recurrence risk in stage II colon cancer patients using ColoPrint
Authors
KeywordsMedical sciences
Oncology medical sciences
Radiology and nuclear medicine pharmacy and pharmacology biology
Cytology and histology
Issue Date2012
PublisherAmerican Society of Clinical Oncology. The Journal's web site is located at http://www.jco.org/
Citation
The 2012 Annual Meeting of the American Society of Clinical Oncology® (ASCO 2012), Chicago, IL., 1-5 June 2012. In Journal of Clinical Oncology, 2012, v. 30 n. 15 suppl., abstract no. TPS10632 How to Cite?
AbstractBACKGROUND: An 18-gene expression profile, ColoPrint, has been developed for identifying colon cancer patients more likely to develop recurrent disease and who would be candidates for adjuvant chemotherapy. The gene signature was validated in public datasets and independent patient cohorts (stage II and III patients). Uni-and multivariate analysis was performed on the pooled stage II patient set (n=320) (median follow-up 70 months). ColoPrint classifies 65% of stage II patients as Low Risk. The 3-year RFS was 91% for Low Risk and 74% for High Risk patients with a HR of 2.9 (p=0.001). ColoPrint was the only significant prognostic marker in the subgroup of patients with T3-MSS phenotype (Tabernero, ASCO GI 2012). METHODS: A blinded prospective trial, PARSC (Prospective study for the Assessment of Recurrence risk in Stage II colon cancer patients) using ColoPrint has been initiated. Objectives are: (1)To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage II colon cancer. (2) To compare the risk assessment in stage II patients using the ColoPrint profile vs a clinical risk assessment based on Investigator’s assessment of risk and ASCO high-risk recommendations. (3) To investigate therapy as a potential confounding factor for ColoPrint results. (4) To assess the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage III colon cancer. Inclusion criteria: age ≥ 18 years, adenocarcinoma of the colon, stage II and III, no prior neo-adjuvant therapy, no synchronous tumors, fresh tumor sample, and written informed consent. The treatment of the patient is at the discretion of the physician adhering to National Comprehensive Cancer Network (NCCN)-approved regimens or a recognized alternative (blinded for ColoPrint result). The trial started in Sept. 2008 with currently 32 participating sites in 11 countries. Thus far, 340 eligible stage II and 280 stage III patients have been enrolled. The aim is to enroll 575 stage II patients. Clinical trial registry number: NCT00903565.
DescriptionGeneral Poster Session - Tumor Biology: abstract no. TPS10632 - http://meetinglibrary.asco.org/content/97780-114
Persistent Identifierhttp://hdl.handle.net/10722/153149
ISSN
2015 Impact Factor: 20.982
2015 SCImago Journal Rankings: 9.204

 

DC FieldValueLanguage
dc.contributor.authorSalazar, Ren_US
dc.contributor.authorMarshall, Jen_US
dc.contributor.authorCapdevila, Jen_US
dc.contributor.authorGlimelius, Ben_US
dc.contributor.authorde Waard, JWen_US
dc.contributor.authorVan Der Hoeven, Jen_US
dc.contributor.authorKlaase, Jen_US
dc.contributor.authorBibeau, Fen_US
dc.contributor.authorBachleitner-Hofmann, Ten_US
dc.contributor.authorMidgley, RAen_US
dc.contributor.authorLevine, EAen_US
dc.contributor.authorLaw, WLen_US
dc.contributor.authorAsano, Men_US
dc.contributor.authorChang, GJen_US
dc.contributor.authorCohen, SMen_US
dc.contributor.authorBeart, RWen_US
dc.contributor.authorGoldfarb, PMen_US
dc.contributor.authorMcCarter, Men_US
dc.contributor.authorStork-Sloots, Len_US
dc.contributor.authorRosenberg, Ren_US
dc.date.accessioned2012-07-16T09:58:07Z-
dc.date.available2012-07-16T09:58:07Z-
dc.date.issued2012en_US
dc.identifier.citationThe 2012 Annual Meeting of the American Society of Clinical Oncology® (ASCO 2012), Chicago, IL., 1-5 June 2012. In Journal of Clinical Oncology, 2012, v. 30 n. 15 suppl., abstract no. TPS10632en_US
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/10722/153149-
dc.descriptionGeneral Poster Session - Tumor Biology: abstract no. TPS10632 - http://meetinglibrary.asco.org/content/97780-114-
dc.description.abstractBACKGROUND: An 18-gene expression profile, ColoPrint, has been developed for identifying colon cancer patients more likely to develop recurrent disease and who would be candidates for adjuvant chemotherapy. The gene signature was validated in public datasets and independent patient cohorts (stage II and III patients). Uni-and multivariate analysis was performed on the pooled stage II patient set (n=320) (median follow-up 70 months). ColoPrint classifies 65% of stage II patients as Low Risk. The 3-year RFS was 91% for Low Risk and 74% for High Risk patients with a HR of 2.9 (p=0.001). ColoPrint was the only significant prognostic marker in the subgroup of patients with T3-MSS phenotype (Tabernero, ASCO GI 2012). METHODS: A blinded prospective trial, PARSC (Prospective study for the Assessment of Recurrence risk in Stage II colon cancer patients) using ColoPrint has been initiated. Objectives are: (1)To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage II colon cancer. (2) To compare the risk assessment in stage II patients using the ColoPrint profile vs a clinical risk assessment based on Investigator’s assessment of risk and ASCO high-risk recommendations. (3) To investigate therapy as a potential confounding factor for ColoPrint results. (4) To assess the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage III colon cancer. Inclusion criteria: age ≥ 18 years, adenocarcinoma of the colon, stage II and III, no prior neo-adjuvant therapy, no synchronous tumors, fresh tumor sample, and written informed consent. The treatment of the patient is at the discretion of the physician adhering to National Comprehensive Cancer Network (NCCN)-approved regimens or a recognized alternative (blinded for ColoPrint result). The trial started in Sept. 2008 with currently 32 participating sites in 11 countries. Thus far, 340 eligible stage II and 280 stage III patients have been enrolled. The aim is to enroll 575 stage II patients. Clinical trial registry number: NCT00903565.-
dc.languageengen_US
dc.publisherAmerican Society of Clinical Oncology. The Journal's web site is located at http://www.jco.org/-
dc.relation.ispartofJournal of Clinical Oncologyen_US
dc.subjectMedical sciences-
dc.subjectOncology medical sciences-
dc.subjectRadiology and nuclear medicine pharmacy and pharmacology biology-
dc.subjectCytology and histology-
dc.titleThe PARSC trial, a prospective study for the assessment of recurrence risk in stage II colon cancer patients using ColoPrinten_US
dc.typeConference_Paperen_US
dc.identifier.emailLaw, WL: lawwl@hkucc.hku.hken_US
dc.identifier.authorityLaw, WL=rp00436en_US
dc.description.naturelink_to_OA_fulltext-
dc.identifier.hkuros201000en_US
dc.identifier.volume30-
dc.identifier.issue15 suppl.-
dc.publisher.placeUnited States-

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