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The impact and indications for Oncotype DX on adjuvant treatment recommendations when third-party funding is
L Chin-Lenn1,2, R H De Boer1, E Segelov1
1The Royal Melbourne Hospital, Parkville, VIC, Australia.
Objectives:
Industry-supported decision impact studies demonstrate that Oncotype Dx (ODX) changes treatment recommendations (TR) in 24-40% of hormone receptor+/HER2- patients. ODX is not reimbursed by third-party payers in Australia, potentially resulting in more selective use. We sought to evaluate the impact of self-funded ODX on TRs.
Methods:
Data collected included demographics, tumor characteristics, indication for ODX and pre- and post-recurrence score (RS) TR. Primary endpoint was frequency of TR change and associations with TR change were sought.
Results:
Eighteen physicians contributed 382 patients (median age 54). A total of 232 (61%) of tumors were T1 and were grade 1, 2 and 3 in 49 (13%), 252 (66%) and 79 (21%). A total of 257 (67%) were node negative. Assay indications were: confirm need for chemotherapy (CT) (36%), confirm omission of CT (40%) and genuine equipoise (24%). RS was low (≤17) in 55%, intermediate (18-31) in 36% and high (≥32) in 9%. Thirty-eight percent of patients had TR change post-ODX. Sixty-five percent of patients recommended CT pre-ODX changed to hormone therapy alone (HT)-more likely if lower grade and if ER and/or PR > 10%. Fourteen percent of patients with pre-ODX TR for HT added CT-more likely if ER and/or PR ≤10% and if Ki67 > 15% Overall, TR for CT decreased from 47% to 24%.
Conclusion:
Patient-funded ODX changed TRs in 38% of patients, de-escalating 65% from CT to HT and adding CT to 14% of those recommended HT. These changes were greater than an industry-funded study suggesting that physicians can identify situations where the assay may influence decisions.
Insights
Patient-funded Oncotype Dx (ODX) testing significantly altered treatment recommendations in 38% of hormone receptor-positive, HER2-negative breast cancer patients. This led to de-escalation of chemotherapy in many cases, demonstrating the assay's value in clinical decision-making.
Area of Science:
- Oncology
- Genomics
- Clinical Decision Support
Background:
- Industry-supported Oncotype Dx (ODX) studies show treatment recommendation changes in 24-40% of hormone receptor-positive/HER2-negative patients.
- ODX is not reimbursed by Australian third-party payers, potentially influencing its selective utilization.
Purpose of the Study:
- To evaluate the impact of self-funded ODX on treatment recommendations (TR) in hormone receptor-positive/HER2-negative breast cancer patients.
- To determine the frequency of TR changes and associated factors following ODX testing.
Main Methods:
- Retrospective analysis of 382 patients undergoing ODX testing, with data on demographics, tumor characteristics, and pre- and post-recurrence score (RS) TR.
- Primary endpoint: frequency of TR change. Secondary analysis: associations between TR change and clinical/pathological factors.
Main Results:
- Thirty-eight percent of patients experienced a TR change post-ODX.
- Of those initially recommended chemotherapy (CT), 65% shifted to hormone therapy (HT) alone.
- Of those initially recommended HT, 14% were recommended to add CT.
- Overall TR for CT decreased from 47% to 24%.
Conclusions:
- Patient-funded ODX testing significantly altered TRs in 38% of cases.
- The study observed de-escalation from CT to HT in 65% and escalation to CT in 14% of relevant patient groups.
- These findings suggest physicians can identify specific clinical scenarios where ODX influences treatment decisions, even when self-funded.
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