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

Authors

Ramon Salazar

Ramon Salazar

Institut Catala d'Oncologia, Barcelona, Spain

Ramon Salazar , John Marshall , Jaume Capdevila , Bengt Glimelius , Jan Willem de Waard , Jacobus Van Der Hoeven , Joost Klaase , Frédéric Bibeau , Thomas Bachleitner-Hofmann , Rachel A Midgley , Edward Allen Levine , Wai Lun Law , Michio Asano , George J. Chang , Stephen M Cohen , Robert W. Beart , Paul M. Goldfarb , Martin McCarter , Lisette Stork-Sloots , Robert Rosenberg

Organizations

Institut Catala d'Oncologia, Barcelona, Spain, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, Vall d'Hebron University Hospital, Barcelona, Spain, Akademiska University Hospital, Uppsala, Sweden, Westfries Gasthuis, Hoorn, Netherlands, Medical Center Alkmaar, Alkmaar, Netherlands, Medisch Spectrum Twente, Enschede, Netherlands, Pathology Depatment, CRLC Val d'Aurelle, Montpellier, France, Medizinische Universitaet Wien, Vienna, Austria, Department of Clinical Pharmacology, Oxford, United Kingdom, Wake Forest School of Medicine, Winston-Salem, NC, Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong, Matsuda Hospital, Hamamatsu, Japan, University of Texas M. D. Anderson Cancer Center, Houston, TX, Atlanta Colon and Rectal Surgery, Atlanta, GA, Glendale Memorial Hospital, Glendale, CA, Scripps, San Diego, CA, University of Colorado Health Science Center, Aurora, CO, Agendia, Amsterdam, Netherlands, Department of Surgery, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany

Research Funding

Pharmaceutical/Biotech Company
Background: 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.

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Abstract Details

Meeting

2012 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Tumor Biology

Track

Tumor Biology

Sub Track

Genomic and Epigenomic Biomarkers

Clinical Trial Registration Number

NCT00903565

Citation

J Clin Oncol 30, 2012 (suppl; abstr TPS10632)

DOI

10.1200/jco.2012.30.15_suppl.tps10632

Abstract #

TPS10632

Poster Bd #

54A

Abstract Disclosures

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