Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection.
OBJECTIVE
The 21-gene Recurrence Score (RS) assay has been validated to quantify the risk of distant recurrence in tamoxifen-treated patients with lymph node-negative, estrogen receptor-positive breast cancer and predict magnitude of chemotherapy benefit. This multicenter study was designed to prospectively examine whether RS affects physician and patient adjuvant treatment selection and satisfaction.


METHODS
Before and after obtaining the 21-gene RS assay, medical oncologists stated their adjuvant treatment recommendation and confidence in it. Patients also indicated their treatment choice pre- and post-RS assay. Patients completed measures for decisional conflict, anxiety, and quality of life.


RESULTS
Seventeen medical oncologists at one community and three academic practices consecutively enrolled 89 assessable patients. The medical oncologist treatment recommendation changed for 28 patients (31.%). Twenty-four patients (27%) changed their treatment decision. The largest change after the RS results was conversion from the medical oncologist's pretest recommendation for chemotherapy plus hormonal therapy (CHT) to post-test recommendation for hormone therapy (HT) in 20 cases (22.5%). Nine patients (10.1%) changed their treatment decision from CHT to HT. RS results increased medical oncologist confidence in their treatment recommendation in 68 cases (76%). Patient anxiety and decisional conflict were significantly lower after RS results.


CONCLUSIONS
The results of this study indicate that the RS assay impacts medical oncologist adjuvant treatment recommendations, patient treatment choice, and patient anxiety.
Lo
Shelly S
SS
Loyola University Medical Center, Cardinal Bernardin Cancer Center, 2160 S First Ave, Maywood, IL 60153, USA. shlo@lumc.edu
Mumby
Patricia B
PB
Norton
John
J
Rychlik
Karen
K
Smerage
Jeffrey
J
Kash
Joseph
J
Chew
Helen K
HK
Gaynor
Ellen R
ER
Hayes
Daniel F
DF
Epstein
Andrew
A
Albain
Kathy S
KS
D000328:Adult; D000368:Aged; D001007:Anxiety / Q000209:etiology; D001943:Breast Neoplasms / Q000235:genetics* / Q000523:psychology / Q000628:therapy*; D003657:Decision Making; D005260:Female; D020869:Gene Expression Profiling; D006801:Humans; D008495:Medical Oncology; D008875:Middle Aged; D057240:Patient Preference; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life