1. The impact and indications for Oncotype DX on adjuvant treatment recommendations when third-party funding is unavailable
- Author
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Stephen Della-Fiorentina, Gavin Marx, R De Boer, J. J Rutovitz, Janine M. Lombard, Laura Chin-Lenn, Shane White, T M Hughes, Alexandra Gorelik, Belinda E Kiely, Nicole McCarthy, M F Cronk, D Tsoi, S S Foo, Jacquie Chirgwin, Yoland Antill, Ross Jennens, G B Mann, and Eva Segelov
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Decision Making ,Breast Neoplasms ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Carcinoma ,Clinical endpoint ,Humans ,030212 general & internal medicine ,Practice Patterns, Physicians' ,Chemotherapy ,Third party ,medicine.diagnostic_test ,business.industry ,Gene Expression Profiling ,Carcinoma, Ductal, Breast ,Australia ,General Medicine ,Middle Aged ,Prognosis ,medicine.disease ,Node negative ,Carcinoma, Lobular ,Oncology ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Female ,Hormone therapy ,business ,Oncotype DX ,Adjuvant - Abstract
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.
- Published
- 2018
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