title: The impact of the Oncotype DX Recurrence Score on treatment decisions and clinical outcomes in patients with early breast cancer: the Maccabi Healthcare Services experience with a unified testing policy.
abstract: The Oncotype DX Recurrence Score is a validated prognosticator in oestrogen receptor positive (ER+) breast cancer. Our retrospective analysis of a prospectively defined cohort summarises the clinical implications associated with Oncotype DX testing according to the Maccabi Healthcare Services (MHS) policy. The MHS eligibility criteria for testing included ER+ N0/pN1mic invasive tumours, discussion of test implications with an oncologist, ductal carcinoma 0.6-1 cm Grade 2-3, HER2 negative ductal carcinomas with 1.1-4.0 cm Grade 1-2, or lobular carcinoma. Large (> 1 cm) Grade 3 tumours could have grade reassessed. We linked Recurrence Score results with patients' information and used chi-squared tests to assess the associations thereof. Between January 2008 and December 2011, tests were performed on 751 patients (MHS-eligible, 713); 54%, 38%, and 8% of patients had low, intermediate, and high Recurrence Score results, respectively. Recurrence Score distribution varied significantly with age (P = 0.002), with increasing Recurrence Score values with decreasing age. The proportion of patients with high Recurrence Score results varied by grade/size combination and histology, occurring in 32% of small (≤ 1 cm) Grade 3 and 3% of larger (1.1-4 cm) Grade 1 ductal tumours and only in 2% of lobular carcinomas. Chemotherapy was administered to 1%, 13%, and 61% of patients with low, intermediate, and high Recurrence Score results, respectively (P < 0.0001), but only to 2% of intermediate score patients ≥ 65 years. Luteinising-hormone-releasing hormone agonists with tamoxifen were used in 27% of low Recurrence Score patients ≤ 50 years. With a median follow-up of 26 months, no systemic recurrences were documented, whereas four patients exhibited locoregional recurrences. In summary, in this low-to-moderate risk patient population, testing identified 46% of patients as intermediate/high risk. Treatment decisions were influenced by Recurrence Score results and patients' age. The current MHS policy seems to achieve the goal of promoting chemotherapy use according to the test results in a prespecified patient population.
authors.affiliation: Maccabi Healthcare Services, 27 Hamered Street, Tel Aviv 68125, Israel.
authors.forename: Nava
authors.initials: N
authors.lastname: Siegelmann-Danieli
authors.affiliation: Maccabi Healthcare Services, 27 Hamered Street, Tel Aviv 68125, Israel.
authors.forename: Barbara
authors.initials: B
authors.lastname: Silverman
authors.affiliation: Hadassah Medical Center, Ein Kerem, Jerusalem 91120, Israel.
authors.forename: Aviad
authors.initials: A
authors.lastname: Zick
authors.affiliation: Maccabi Healthcare Services, 27 Hamered Street, Tel Aviv 68125, Israel.
authors.forename: Anat
authors.initials: A
authors.lastname: Beit-Or
authors.affiliation: Maccabi Healthcare Services, 27 Hamered Street, Tel Aviv 68125, Israel.
authors.forename: Itzhak
authors.initials: I
authors.lastname: Katzir
authors.affiliation: Maccabi Healthcare Services, 27 Hamered Street, Tel Aviv 68125, Israel.
authors.forename: Avi
authors.initials: A
authors.lastname: Porath
keywords: biomarker; breast cancer; chemotherapy; health policy; personalised medicine