The impact and indications for Oncotype DX on adjuvant treatment recommendations when third‐party funding is unavailable

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...

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Published in:	Asia-Pacific journal of clinical oncology Vol. 14; no. 6; pp. 410 - 416
Main Authors:	Chin‐Lenn, L., Boer, R. H., Segelov, E., Marx, G. M., Hughes, T. M., McCarthy, N. J., White, S. C., Foo, S. S., Rutovitz, J. J., Della‐Fiorentina, S., Jennens, R., Antill, Y. C., Tsoi, D., Cronk, M. F., Lombard, J. M., Kiely, B. E., Chirgwin, J. H., Gorelik, A., Mann, G. B.
Format:	Journal Article
Language:	English
Published:	Australia Wiley Subscription Services, Inc 01-12-2018
Subjects:	adjuvant chemotherapy Adjuvant therapy Australia Breast Neoplasms - drug therapy Breast Neoplasms - economics Breast Neoplasms - genetics Carcinoma, Ductal, Breast - drug therapy Carcinoma, Ductal, Breast - economics Carcinoma, Ductal, Breast - genetics Carcinoma, Lobular - drug therapy Carcinoma, Lobular - economics Carcinoma, Lobular - genetics Chemotherapy Chemotherapy, Adjuvant Decision Making Demography ErbB-2 protein Female Gene Expression Profiling - economics Gene Expression Profiling - methods HER2‐negative early breast cancer hormone receptor‐positive Humans Middle Aged multigene assay Patients Practice Patterns, Physicians' - standards Prognosis treatment decision Tumors Australia multigene assay adjuvant chemotherapy HER2-negative early breast cancer hormone receptor-positive treatment decision
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1743-7555 1743-7563
DOI:	10.1111/ajco.13075