P5-14-26: Results from a Prospective Clinical Study on the Impact of Oncotype DX on Adjuvant Treatment Decision Making in a Cohort of 142 UK Patients.

Abstract

Goals: International guidelines support the use of the Oncotype DX derived Recurrence Score (RS) to provide additional prognostic and predictive information in early breast cancer but experience in the UK is limited. In our prospective study we evaluate this test for the NHS and its impact on costs (subject of a separate abstract) and treatment recommendations by UK oncologists.Methods: 150 tests were made available to consecutive patients with ER+, pN0 or pN1mic early breast cancer who had no contraindication to adjuvant chemotherapy (CT) and who would accept chemotherapy if recommended. CT recommendations of oncologists based on Adjuvant! Online figures were recorded at an initial consultation and again after a second consultation once the RS was available.Results: Analysis is based on 142 patients. (150 tests performed, 3 failed to give a result, 3 repeated tests giving a result on the second block, one bilateral and one test stopped because the patient withdrew from the study). Initial treatment recommendations changed in 38 (26.8%) cases. Of the patients initially recommended CT + HT (total 57 patients), 26 (45.6%) patients were spared chemotherapy after review of the RS. Of the 85 patients initially recommended HT only (total 85 patients), 12 (14.1%) were changed to HT+CT. Further analysis shows that Grade and PR by IHC are correlated to RS. (Spearman rank correlation for grade is 0.05, 95%, Cl 0.36 to 0.61 and for PR by IHC is -0.49, 95%, Cl -0.60 to -0.35). If testing had been confined to patients initially recommended chemotherapy and patients with Grade 2/3 tumours plus a PR by IHC of 6 or less (84 patients) then 35 of the 38 (92.1%) changes in CT recommendations would have been included and the cost the test avoided in 58 (40.8%) of the patients. Conclusion:The results of our study suggest that Oncotype DX is applicable and feasible to perform in UK patients with a reduction in the use of adjuvant chemotherapy consistent with findings of other reported studies. RS added prognostic information beyond information provided by Adjuvant!

Prospective Study of the Effect of the 21-Gene Assay on Adjuvant Clinical Decision-Making in Japanese Women With Estrogen Receptor-Positive, Node-Negative, and Node-Positive Breast Cancer

“…17 We found an overall change rate of 33%. Change rates in the United Kingdom 25 and Australia 18 were somewhat lower with 27% and 24%, perhaps in part because the proportion of patients with an initial recommendation for chemotherapy in these studies was much lower (40% and 24%, respectively), than in our study (51%) and the other 3 cited. However, regardless of baseline tendencies to use either more conservative or aggressive treatment approaches across all studies to date, decision changes attributable to the 21-gene assay appear to occur in both directions-foregoing chemotherapy in many patients, and adding it in others.…”

The 21-Gene Recurrence Score Assay for Node-Positive, Early-Stage Breast Cancer and Impact of RxPONDER Trial on Chemotherapy Decision-Making: Have Clinicians Already Decided?

“…Most studies that involved trends in use of the RS assay involved either academic 40 or community facilities. [41][42][43] A recent meta-analysis of 23 studies revealed that 74% were conducted in academic centers, and the remainder in either community hospitals or mixed community and academic centers, but none compared RS assay trends across facilities. 21 Compared with patients treated at community centers, those treated at more comprehensive and academic centers were more likely to get tested with the RS assay.…”

21-Gene Recurrence Score Assay As a Predictor of Adjuvant Chemotherapy Administration for Early-Stage Breast Cancer: An Analysis of Use, Therapeutic Implications, and Disparity Profile

“…An overwhelming majority of previous studies involved either academic 16,18,35-37 or community facilities. [38][39][40] A recent metaanalysis of 23 studies revealed that 74% were conducted in academic centers, and the rest were conducted in either community hospitals or mixed community and academic centers, but none compared RS assay trends across facilities. 21 Our study revealed differences between community facilities and comprehensive community and academic facilities.…”