title: Impact of the 12-Gene Colon Cancer Assay on Clinical Decision Making for Adjuvant Therapy in Stage II Colon Cancer Patients.
abstract: OBJECTIVE
  To evaluate the impact of the 12-gene Colon Cancer Recurrence Score Assay-a clinically validated prognosticator in stage II colon cancer after surgical resection-on adjuvant treatment decisions in T3 mismatch repair proficient (MMR-P) stage II colon cancer in clinical practice.
  
  
  METHODS
  This retrospective analysis included all patients with T3 MMR-P stage II colon cancer (Clalit Health Services members) with Recurrence Score results (time frame January 2011 to May 2012). Treatment recommendations pretesting were compared with the treatments received. Changes were categorized as decreased (to observation alone/removing oxaliplatin from the therapy) or increased (from observation alone/adding oxaliplatin to the therapy) intensity.
  
  
  RESULTS
  The analysis included 269 patients; 58%, 32%, and 10% of the values were in the low (<30), intermediate (30-40), and high (≥41) score groups, respectively. In 102 patients (38%), treatment changed post-testing (decreased/increased intensity 76/26 patients). The overall impact was decreased chemotherapy use (45.0% to 27.9%; P < 0.001). Treatment changes occurred in all score groups, but more frequently in the high (change rate 63.0%; 95% confidence interval [CI] 42.3%-80.6%) than in the intermediate (30.6%; 95% CI 21.0%-41.5%) and low (37.6%; 95% CI 30.0%-45.7%) score groups. The direction of the change was consistent with the assay result, with increased intensity more common in higher score values and decreased intensity more common in lower score values.
  
  
  CONCLUSIONS
  Testing significantly affected adjuvant treatment in T3 MMR-P stage II colon cancer in clinical practice. The study is limited by its design, which compared treatment recommendations pretesting to actual treatments received post-testing, lack of a control group, and nonassessment of confounding factors that may have affected treatment decisions.
authors.affiliation: Institute of Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, affiliated with Sackler School of Medicine, Tel Aviv, Israel. Electronic address: brennerb@clalit.org.il.
authors.forename: Baruch
authors.initials: B
authors.lastname: Brenner
authors.affiliation: Division of Oncology, Sourasky Medical Center, Tel Aviv, Israel.
authors.forename: Ravit
authors.initials: R
authors.lastname: Geva
authors.affiliation: Genomic Health Inc., Redwood City, CA, USA.
authors.forename: Megan
authors.initials: M
authors.lastname: Rothney
authors.affiliation: Department of Oncology, Rambam Medical Center, Haifa, Israel.
authors.forename: Alexander
authors.initials: A
authors.lastname: Beny
authors.affiliation: Oncology Department, Meir Medical Center, Kfar Saba, Israel.
authors.forename: Ygael
authors.initials: Y
authors.lastname: Dror
authors.affiliation: Department of Oncology, Carmel Hospital, Haifa, Israel.
authors.forename: Mariana
authors.initials: M
authors.lastname: Steiner
authors.affiliation: Sharett Institute of Oncology, Hadassah-Hebrew University Hospital, Jerusalem, Israel.
authors.forename: Ayala
authors.initials: A
authors.lastname: Hubert
authors.affiliation: Institute of Oncology, Kaplan Medical Center, Rehovot, Israel.
authors.forename: Efraim
authors.initials: E
authors.lastname: Idelevich
authors.affiliation: Department of Clinical Oncology and Radiology, Soroka University Medical Center, Beer Sheva, Israel.
authors.forename: Alexander
authors.initials: A
authors.lastname: Gluzman
authors.affiliation: Institute of Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, affiliated with Sackler School of Medicine, Tel Aviv, Israel.
authors.forename: Ofer
authors.initials: O
authors.lastname: Purim
authors.affiliation: Department of Oncology, Sheba Medical Center, Ramat Gan, Israel.
authors.forename: Einat
authors.initials: E
authors.lastname: Shacham-Shmueli
authors.affiliation: Oncology Unit, Hillel Yaffe Medical Center, Hadera, Israel.
authors.forename: Katerina
authors.initials: K
authors.lastname: Shulman
authors.affiliation: Oncology Department, Meir Medical Center, Kfar Saba, Israel.
authors.forename: Moshe
authors.initials: M
authors.lastname: Mishaeli
authors.affiliation: Department of Clinical Oncology and Radiology, Soroka University Medical Center, Beer Sheva, Israel.
authors.forename: Sophia
authors.initials: S
authors.lastname: Man
authors.affiliation: Oncotest-Teva Pharmaceutical Industries Ltd., Shoham, Israel.
authors.forename: Lior
authors.initials: L
authors.lastname: Soussan-Gutman
authors.affiliation: Genomic Health Inc., Redwood City, CA, USA.
authors.forename: Haluk
authors.initials: H
authors.lastname: Tezcan
authors.affiliation: Genomic Health Inc., Redwood City, CA, USA.
authors.forename: Calvin
authors.initials: C
authors.lastname: Chao
authors.affiliation: Department of Oncology, Sheba Medical Center, Ramat Gan, Israel.
authors.forename: Adi
authors.initials: A
authors.lastname: Shani
authors.affiliation: Community Division, Clalit Health Services, Tel Aviv, Israel.
authors.forename: Nicky
authors.initials: N
authors.lastname: Liebermann
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D000066491:Clinical Decision-Making; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000601:surgery; D003131:Combined Modality Therapy; D053843:DNA Mismatch Repair; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis* / Q000235:genetics*; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D000077150:Oxaliplatin; D016133:Polymerase Chain Reaction; D012189:Retrospective Studies; D057832:Watchful Waiting
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil
keywords: 12-gene colon cancer assay; Oncotype DX; Recurrence Score; adjuvant chemotherapy; colon cancer; decision impact