Impact Of Oncotype DX Research Articles

Abstract PO1-28-03: Impact of the Oncotype DX® test over time and association with clinicopathological characteristics of Peruvian patients with early breast cancer: Experience in the last 15 years

Abstract Introduction: Gene expression assays provide prognostic and therapy-predictive information that complements management of early breast cancer patients. Oncotype DX® had showed prognostic and prediction of adjuvant chemotherapy benefit. The present study evaluates the impact of Oncotype DX® on therapeutic decision-making for 15 years and explores the association of clinicopathological characteristics with the Recurrence Score (RS) in Peruvian patients with early breast cancer. Material and methods: A retrospective multicenter analysis of 759 breast cancer patients treated in three oncological centers in Lima-Peru (Instituto Nacional de Enfermedades Neoplásicas, Oncosalud and Ricardo Palma) between 2007 and 2022 was conducted. Risk groups were classified according to Oncotype DX® result and menopausal status. For premenopausal women ≤ 50 years: low (RS=0-20), intermediate (RS=21-25) and high-risk (RS=26-100). A descriptive analysis was evaluated to observe the trend and profile of the patients who used the Oncotype test in 5 time periods (2007-2009, 2010-2013, 2014-2016, 2017-2019, 2020-2022). Subsequently, chi-square, t-test, analysis of variance and Poisson linear regression tests were applied to compare clinicopathological features with RS. Finally, univariate and multivariate analyses were performed using Cox logistic regression to identify the probability of association with the high-risk group. Results: 642 patients were included, 78.5% were postmenopausal, and 64.2% had clinical stage (CS) I. Overall, 63.4% had no recommendation for chemotherapy and only 5.6% had recurrence. 74.8% were classified as low-risk according to the Oncotype DX® result. Postmenopausal patients had negative lymph nodes (95.4%), the majority had undergone conservative surgery (71.8%) and had a low rate of breast reconstruction (11.9%). An increase in the use of Oncotype DX® was observed over time, especially in premenopausal patients (from 4.5% in 2007 to 36.9% in 2022). A significant association was found between luminal B subtype (p < 0.0001), histological grade 3 (p < 0.0001) and T3 vs. T1/2 (p=0.025). In univariate analysis, luminal B subtype (vs. luminal A, OR=5.56, 95% CI, 2.80-12.3, p< 0.001), T3 (vs. T1/2, OR=2.84, 95% CI, 0.13-30.0, p=0.006), histological grade 3 (vs. 1/2, OR=13.1, 95% CI, 5.35-39.6, p< 0.001) and histology (other vs. ductal/lobulillar/mucinous, OR=2.94, 95% CI, 0.57-13.5, p=0.003) provided a higher probability of obtaining a high-risk RS result. Similar results were found in multivariate analysis. Conclusion: The use of the Oncotype DX® had a significant impact on therapeutic decision-making in Peruvian patients with early breast cancer, with an increase of use in the last 15 years. A high-risk RS was associated with luminal B subtype, histological grade 3 and T3 tumor size, which could facilitate risk stratification and provide valuable information for the need of adjuvant chemotherapy. Keywords: Early breast cancer, Oncotype DX®, clinicopathological characteristics, Recurrence Score (RS), Peru Oncotype PERU Table Citation Format: Steffi Katheryne Gonzalez Bocanegra, Guillermo valencia Mesías, Yomali Aroa Ferreyra Chombo, Karoll Tatiana Meza Garcia, Mariano Lopez-Pereyra, Jorge Torres Maldonado, Edgar Fermín Yan Quiroz, Zaida Morante Cruz, Jose Cotrina-Concha, Henry Gómez, Gabriela Calderon Valencia, Mauricio León Rivera. Impact of the Oncotype DX® test over time and association with clinicopathological characteristics of Peruvian patients with early breast cancer: Experience in the last 15 years [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-28-03.

Comparing practice patterns and outcomes for early-stage hormone receptor-positive and node-positive breast cancer patients with high-intermediate-risk Oncotype Dx scores in the National Cancer Database.

e12520 Background: Oncotype Dx (ODX) is a commercial diagnostic test primarily used to predict the likely benefit from chemotherapy in ER+, HER2-, and node negative breast cancer. The prognostic value (recurrence risk) has also been demonstrated to apply to early stage lymph node positive (LN+) disease in a number of retrospective and prospective studies. The ongoing RxPONDER trial aims to clarify the predictive value of RS in LN+ population. In light of the initial results, we analyzed the practice patterns and outcomes for HR+/Her2 -/node positive breast cancer patients receiving ODX testing in the years from 2010-2017 with RS 14-25 in a retrospective observational study of the NCDB. Methods: Women with HR+/Her2 -/node positive breast cancer receiving ODX testing from 2010-2017 were identified in the NCDB using TAILORx and RxPONDER patients’ inclusion criteria: ages 18-75, 6-50mm invasive tumors, N1, M0, ER+/HER2 -. The impact of ODX results in the high-intermediate range (14-25) and other clinico-pathologic variables on the receipt of chemotherapy were compared. Additionally, we examined the impact of chemotherapy on overall survival (OS). Frequencies, Kaplain-Meier analysis, and changepoint analysis using the Contal and O’Quigley method were utilized. Results: There were 109,652 T1-2 and N1 patients of whom 32,506 (29.6%) received ODX testing. 13,461 (41.4%%) women had scores in the high-intermediate (14-25) range. The majority tended to have only 1 LN involved (1LN: 77.2%, 2LNs: 17.5%, 3LNs: 5.3%), had a mean age of 57.8y, were Caucasian (86.4%), and were preferentially tested at academic or comprehensive community cancer programs (79.2%). 6,610 (49.3%) patients were recommended chemotherapy, the median ODX score for all women who were recommended chemotherapy was 20 compared to 17 for those whom chemotherapy was not recommended. 5,068 (76.7%) women had documentation of receiving chemotherapy which correlated with improved OS regardless of age. Conclusions: In the group of women with HR+/Her2 -/node positive breast cancer, clinicians appear to utilize ODX testing in less than one-third of patients, possibly finding RS to be most useful in guiding adjuvant therapy recommendations when only 1LN is involved. Both the recommendation and receipt of chemotherapy correlated linearly with increasing RS, as expected based on the current NCCN guideline recommendations. We identified an OS benefit when chemotherapy was administered, regardless of patient age. Long-term follow-up in the RxPONDER trial will likely continue to clarify the predictive value of RS < 25 in the ER+/HER2-/node positive breast cancer population.

Implications of the 21-gene recurrence score assay (Oncotype DX) on adjuvant treatment decisions in ER-positive early-stage breast cancer patients: Experience of Kuwait Cancer Control Center.

e12582Background: To evaluate the impact of Oncotype DX as a tool for adjuvant treatment decision of ER-positive, early stage breast cancer patients diagnosed in Kuwait and to determine which clini...

Abstract P4-12-11: Cost effectiveness of oncotype Dx for early stage breast cancer under National health insurance

Abstract Background : Oncotype Dx is being used increasingly for risk stratification to identify for patients with estrogen receptor-positive (ER+), node negative early-stage breast cancer who are most likely to benefit from adjuvant chemotherapy. In Korea, all citizens are covered by national health insurance (NHI), besides patients just pay 5% of hospital bill, if who diagnosed with cancer. NHI can help solve the financial burden for cancer patients. So the acquisition costs of the Oncotype DX test are sometimes a barrier to its widespread use. This study was conducted for existing cost-effectiveness analyses of Oncotype DX in Korea. Methods : We analyzed the hospital expenses of patients who diagnosis with LN-negative ER-positive early-stage breast cancer from October 2010 to October 2016 in Seoul National University Hospital. All patients are possible candidates for adjuvant chemotherapy. Among them 273 patients were tested Oncotype Dx. A cost-utility analysis (CUA) was performed. We analyzed the hospital expenses of chemotherapy by regimens who underwent adjuvant chemotherapy patients, and costs of accompanying adverse event. Each costs of therapy were derived from the hospital administration and expressed by USD. (KRW convert into USD) We also analyzed every patient charges and real expense. Result : Of 273 patients, 39(14.3%) were underwent adjuvant chemotherapy. The patients proportion by regimens are FAC(56.4%), AC(10.3%), AC followed by weekly paclitaxel (5.1%), TC(10.3%), AC followed by docetaxel (5.1%), TC and CMF etc. Each patient's hospital expense are roughly 3,000 USD (2,200 – 4,000 USD), it including all costs of laboratory test, computer tomography, chest x-ray, chemoagents and other medications. Of these costs, patients should pay only 5% so it could be around 150 USD (110-200USD). Disccusion ; The economic benefits of Oncotype DX are modelled by an overall reduction in chemotherapy usage, thus avoiding associated costs and disutility, and an increase in chemotherapy usage in the high RS group, reducing the risk of recurrence and improving health outcomes. Several studies shows Oncotype DX has been proposed to better estimate baseline risk and response to chemotherapy, to appropriately target chemotherapy to higher risk patients. In the costeffectiveness model, decision making with Oncotype DX in addition to standard decision-making tools is compared with standard decision making without Oncotype DX. From this study, most patient (234 of 273, 85.7%) who are possible candidates for adjuvant chemotherapy avoiding the treatment. A number of studies have looked at the impact of Oncotype DX on clinical decision making. But under the special environment of Korea that most costs who diagnosed with cancer covered by National Insurance health, it relatively expensive than other conturies. So it deserve much consideration that necessity of further studies and reaserches to develop new tools that could be more reasonable in cost in Korea. Citation Format: Kim Y, Han W. Cost effectiveness of oncotype Dx for early stage breast cancer under National health insurance [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P4-12-11.

The impact of Oncotype DX® recurrence score of paraffin-embedded core biopsy tissues in predicting response to neoadjuvant chemotherapy in women with breast cancer

Oncotype DX®test is beneficial in predicting recurrence free survival in estrogen receptor positive (ER+) breast cancer. Ability of the assay to predict response to neoadjuvant chemotherapy (NCT) is less well-studied. We hypothesize a positive association between the Oncotype DX®recurrence score (RS) and the percentage tumor response (%TR) after NCT. Pre-therapy RS was measured on core biopsies from 60 patients with ER+, HER2- invasive breast cancer (IBC) who then received NCT. Pre-therapy tumor size was measured using imaging. %TR, partial response (PR; >50%), pathologic complete response (pCR) and breast conserving surgery (BCS) rates were measured. Median RS was 20 (2-69). Median %TR was 42 (0-97)%. PR was observed in 43% of patients. There was no association between %TR and pre-NCT tumor size, age, Nottingham score or nodal status (p > 0.05). No statistically significant association with %TR was seen with RS as a categorical or continuous variable (p = 0.21 and 0.7, respectively). Response to NCT improved as ER (p = 0.02) by RT-PCR decreased. Lower ER expression by IHC correlated with response (p = 0.03). In patients with ER+ IBC receiving NCT, RS did not predict response to NCT using %TR. The benefit of the assay prior to NCT requires further study.

Abstract P5-15-02: Indications for, and impact of oncotype DX on adjuvant treatment recommendations when third party funding is unavailable

Abstract Background: An Australian industry-funded decision impact study demonstrated that Oncotype Dx (ODX) changed treatment recommendations (TR) in 24% of hormone receptor+/HER2- patients. ODX is available in Australia, but is self-funded by patients (∼USD 4175), so its use is limited. We sought to evaluate the impact of self-funded ODX on TRs. A high proportion of TR changes would imply a benefit to the broader community if ODX testing were available to all appropriately selected patients. Methods: All Australian physicians who had ordered >5 ODX were invited to participate. Data collected included demographics, tumor characteristics, indication for ODX (confirm need for chemotherapy (CT), confirm omission of CT, or genuine equipoise). Pre- and post Recurrence Score (RS) TRs (CT recommended versus hormone therapy alone (HT)) were also collected. The primary endpoint was the frequency and predictors of TR change. Relationships between categorical variables were assessed using Chi2 test and logistic regression analysis determined factors associated with TR change post-ODX. Results: 382 patients with median age 54 (range 31-76) were included. 18 physicians contributed a median of 17 (5-87) patients. Tumor characteristics were: T1 232 (61%); ≥T2 150 (39%); grade 1 49 (13%), grade 2 252 (66%) and grade 3 79 (21%) and Ki67>15% in 131/231 (49%). 257 (67%) were node negative (N0). Assay indications were: confirm need for CT in 36%, confirm omission of CT in 40% and genuine equipoise in 24%. RS was low in 55%, intermediate in 36% and high in 9%. Of 355 patients with a TR recorded pre-ODX, 38% had TR change post-ODX. 109/168 patients (65%) recommended CT pre-ODX changed to HT alone, and this was more likely if lower grade (82.1% vs 50.8% p<0.001) and less likely if ER and/or PR≤10% (12% vs 25% p=0.03). 27/187 (14%) with pre-ODX TR for HT alone changed to CT, and this was more likely if ER and/or PR≤10% (27.6% vs 11.5% p=0.02) and if Ki67 >15% (27.5% vs 9.8% p=0.015). Overall, TR for CT decreased from 47% to 24%. Influence of adverse prognostic factors (defined as ≥T2, grade 3, ER and/or PR <10%, nodal macrometastasis) on TR is tabulated. In 348 patients with complete data, TR changed in 31% (72/234) of N0 and 53% (60/114) of node positive (N+) patients. Number of "adverse factors"01234N0 (n=234)Number of patients90116244 RS median (range)16 (0-40)17 (0-41)26 (5-52)31 (22-40) TR change19/90 (21%)45/116 (39%)6/24 (25%)2/4 HT to CT7/71 (10%)10/61 (16%)2/11 (18%)1/2 CT to HT12/19 (63%)35/55 (64%)4/13 (31%)1/2 N+ (n=114)Number of patients22424181 RS median (range)14 (5-34)16 (0-38)14 (0-32)24 (12-50)39 TR change11/22 (50%)21/42 (50%)25/41 (42%)3/8 (38%)0/1 HT to CT3/13 (23%)3/14 (21%)0/12NANA CT to HT8/9 (89%)18/28 (64%)25/29 (86%)3/7 (43%)0/1 Conclusions: Patient self-funded ODX changed TRs in 38%. 65% who would have been recommended CT pre-ODX were spared CT post-ODX, suggesting that traditional histopathological indications for CT in ER+ patients has led to many receiving CT unnecessarily. Where the pre ODX TR was HT alone, only 14% changed to adding CT, suggesting that the indication was reassurance that CT could be omitted. Consideration could be made for third party funding in select patient groups. Citation Format: Chin-Lenn L, Segelov E, De Boer R, Marx G, Hughes TM, McCarthy N, White S, Foo S, Rutovitz J, Della Fiorentina S, Jennens R, Antill Y, Tsoi D, Cronk M, Lombard J, Kiely BE, Chirgwin J, Gorelik A, Mann GB. Indications for, and impact of oncotype DX on adjuvant treatment recommendations when third party funding is unavailable. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-15-02.

Abstract P2-08-15: Impact of OncotypeDX on treatment decision for early stage, hormone-receptor-positive breast cancer

Abstract BACKGROUND and OBJECTIVE The OncotypeDX multigene assay analyzes the individual biology of an invasive breast cancer by examining the activity of 16 breast cancer related genes and 5 reference genes in the tumour tissue. It is used in patients with early hormone-receptor-positive breast cancer with up to 3 positive lymphnodes. The results of the analysis are fed into a formula that calculates a Recurrence Score® (RS) result. The RS result is a number between 0 and 100, and can provide information about how likely your breast cancer is to recur within 10 years of diagnosis. Since becoming available, the test is successfully validated in 18 studies for both N0 and N1. The primary study objective was to evaluate the impact of the RS on physicians' adjuvant therapy decision-making in a cohort of consecutive patients with early ER+, HER2-negative, N0/N1 (until two positive lymph-nodes) breast cancer in our multidisciplinary team (MDT). Secondary study objectives were to assess the impact of the RS on patients' decisional conflict. PATIENTS and METHODS This prospective clinical study was carried out in the Breast Cancer Center at the AGAPLESION Markus Hospital. 140/890 (15,7%) patients were enrolled between 02/2013 and 04/2015 with early ER+, HER2-negative (IHC or FISH), N0/N1, T1-3, histological grade 1-3. We kept records from the treatment decision before and after having the result of OncotypeDX. Further inclusion criteria were age >18 years and no contraindication for receiving systemic chemoendocrine therapy. Also, the treating physician and the enrolled patient had to confirm that she was principally willing to consider her initial recommendation and decision. Each patient's case was discussed twice within the respective institution's MDT. In the first meeting, adjuvant treatment was recommended based on available clinical and histopathological data according to the guidelines. In a second meeting, the case was rediscussed and treatment was recommended with the RS result as an additional piece of information. RESULTS 100/140 (71,4%) patients were node negative (N0), whereas 40/140 (28,6%) were node positive (N+). Treatment recommendation changed in overall 34,3% of the cases (N0 33%, N+ 35%). In 48% of all patients (N0 43.5%, N+ 52%) with an initial recommendation for chemoendocrine therapy, the post-RS recommendation changed into endocrine therapy, in 25% (N0 30%, N+ 6.7%) of the cases with an initial recommendation for endocrine therapy only to combined chemoendocrine therapy, respectively. Only 48% of the patients with an inital endocrine therapy recommendation followed post-RS recommendation change to chemoendocrine therapy. On the other hand, 100% of the patients with an initial chemoendocrine therapy recommendation followed the post-RS recommendation change to endocrine therapy. CONCLUSION Our results show that OncotypeDX has an impact on the initial treatment decision on node positive as well as node negative patients. A substantial therapy change was evident in 34,3% of the cases. The data confirm, that OncotypeDX can help the doctor to formulate an individually treatment plan for patients with conflicting combination of clinical and pathological parameters. Citation Format: Anastasiadou L, Schneider M, Barinoff J, Khandan F, Falk S, Thill M. Impact of OncotypeDX on treatment decision for early stage, hormone-receptor-positive breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P2-08-15.

Abstract P3-07-18: Utilization and impact of oncotype DX 21- gene breast cancer assay in clinical practice across the US: 2010-2012 National cancer data base analysis

Abstract Oncotype DX (OD), initially used for early stage estrogen receptor-positive (ER+), node-negative (LN-) invasive breast cancers (BC) and later also for ER+ and 1-3 LN+BC, provides a low, intermediate or high 10-year risk recurrence score (LRS, IRS or HRS) for BC. Based on the score, the addition of adjuvant chemotherapy (AC) to endocrine therapy is recommended for HRS; no benefit for LRS, and unclear benefits for IRS. The test has been in use since 2004. Payment for OD was approved by the Centers for Medicare&Medicaid Services in 2006. Patient selection for OD use remains unclear, and data on utilization and impact of the assay in clinical practice across the US are lacking. The utilization and impact of OD across the US is presented in a retrospective observational study of National Cancer Data Base (NCDB) patients (represents 75% of the US population) from 2010-2012. This time period encompasses the beginning of required recording of molecular assays and the latest data released by NCDB in 4/2015. Demographic and clinical variables of all patients that had OD results were analyzed using frequency statistics, chi-square and logistic regression analysis. 513080 patients had BC; 406525 were ER+. 86409 patients with known OD results were analyzed (23.7% of ER+). Patients age range from 19-90 (mean 58.8, median 59 years); 99.1% were females. Demographic and clinicopathologic characteristics of OD tested patientsCharacteristicsOD 86409=100%Age 18-403429=4%41-6455313=64%65-90+27667=32%Race White75749=87.7%Black6616=7.7%Other4044=4.6%Comorbidities 073901=85.5%110643=12.3%≥21865=2.2%Median Income Quartiles 2008-2012Missing 634=0.7%$<3800010430=12.1%$38000-4799917346=20.1%$48000-6299923273=26.9%$>6300034726=40.2%US geographic location CT MA ME NH RI VT5404=6.3%NJ NY PA15781=18.3%DC DE FL GA MD NC SC VA WV18984=22%IL IN MI OH WI16542=19.1%AL KY MS TN4704=5.4%IA KS MN MO ND NE SD7256=8.4%AR LA OK TX4342=5%AZ CO ID MT NM NV UT WY4757=5.5%AK CA HI OR WA8639=10%Urban vs ruralMissing 2264=2.6%Urban79642=92.2%Rural4503=5.2%ERMissing 190=0.2%ER+85018=98.4%ER-1181=1.4%ER borderline20=0.0002%Cancer stageUnknown 626=0.7%I58614=67.8%II25907=30%III1134=1.3%IV128=0.2%Tumor size (mm)Missing 723=0.8%1-52825=3.3%6-1017997=20.8%11-5063509=73.5%51-9001355=1.6%LN+Missing 2147=2.4%070165=81.2%110322=12%2-33113=3.6%4-39662=0.8%Histologic gradeUnknown 4178=4.8%G123142=26.8%G244451=51.4%G3&G414638=17% 57.9% of tests followed National Comprehensive Network (NCCN)-defined intermediate risk guidelines (ER+/LN- tumors >1cm), while 15.5% of tests included N1 disease and 25.7% included T1a, T1b and T3 tumors. LRS had 90.1% negative predictive value (NPV) for no AC administration. IRS had 47.4% positive predictive value (PPV) and HRS had 88.9% PPV for AC administration. OD score and chemotherapy administration ChemotherapyChemotherapyTotalOD scoreNoYes LRS42600=90.1%4014=9.9%46614IRS12740=52.6%11520=47.4%7591HRS840=11.1%6751=88.9%78465 The OD is obtained in almost ¼ of ER+BC patients across the US. Its application across geographic and racial groups is fair. Factors influencing patient selection for OD test and AC administration upon obtaining IRS results require further study. Citation Format: Orucevic A, Heidel RE, Bell JL. Utilization and impact of oncotype DX 21- gene breast cancer assay in clinical practice across the US: 2010-2012 National cancer data base analysis. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P3-07-18.

P172. Impact of Oncotype DX on the decision for adjuvant chemotherapy: Retrospective analysis of the Salford Royal Foundation Trust cohort

P172. Impact of Oncotype DX on the decision for adjuvant chemotherapy: Retrospective analysis of the Salford Royal Foundation Trust cohort

Abstract P6-06-15: Cost impact of oncotype Dx® breast cancer assay use in a fully integrated healthcare delivery system

Abstract Background: The Oncotype Dx Breast Cancer Assay (ODX) provides relevant information on the risk of distant recurrence and the treatment effect for adjuvant chemotherapy (ACT) in early stage breast cancer. However, no studies to date have evaluated the impact of ODX use on total and oncology specific costs. The objective of this study was to explore the impact of ODX use on total and oncology specific costs within the Group Health Cooperative health plan. Methods: Our study sample included women diagnosed between 2004-2012 with ER positive, node negative, early stage (I, IIA, or IIB) breast cancer. Data were collected from SEER and automated health plan data. We used multiple logistic regression to model receipt of adjuvant chemotherapy as a function of OncotypeDx Breast Cancer Assay receipt. Further, we used multiple linear regression to model total and oncology specific one-year costs as a function of OncotypeDx Breast Cancer Assay receipt. In both analyses, we adjusted for key patient, tumor, and health system factors. Results: The study population consisted of 1510 women, 13% of which received the ODX test. The groups were similar across relevant clinical and demographic characteristics with the exception of age at diagnosis, stage, tumor grade and drug benefits. In the logistic regression analysis, patients who received ODX were 51% less likely to receive adjuvant chemotherapy versus those who did not receive the test. In the multiple linear regression analysis, those who received ODX had fewer total and oncology specific one-year costs (total costs difference: -$9,149 (95% CI: -$13,818, -$4,481, P-Value: <0.001); oncology specific cost difference: -$1,380 (95% CI: -$2,361, -$400, P-Value: <0.006). Study Results ODX vs. No ODX95% CIP-valueTotal cost difference*-$9,149-$13,818 to -$4,481<0.000Oncology cost difference*-$1,380-$2,361 to -$4000.006Adjuvant chemotherapy use (OR)*0.490.33 to 0.73<0.000* Model covariates: stage, Charlson comorbidity score, age at diagnosis, tumor size, tumor grade, race, and pharmacy benefits Conclusions: Our results are the first to report on the impact of the ODX test directly on total and oncology specific costs. In accordance with previous studies that used modeled cost estimates, i.e. through cost projections focusing solely on the adjuvant chemotherapy reductions, we found a statistically significant difference in both total and oncology specific costs. These data further bolster the evidence that suggests the ODX lowers total and oncology specific costs. Further evidence is needed to evaluate the impact of ODX on clinical outcomes. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-06-15.

The impact of the Oncotype Dx breast cancer assay in clinical practice: a systematic review and meta-analysis

The impact of the Oncotype Dx (ODX) breast cancer assay on adjuvant chemotherapy (ACT) treatment decisions has been evaluated in many previous studies. However, it can be difficult to interpret the collective findings, which were conducted in diverse settings with limited sample sizes. We conducted a systematic review and meta-analysis to synthesize the results and provide insights about ODX utility. Studies, identified from PubMed, Embase, ASCO, and SABCS, were included if patients had ER+, node -, early-stage breast cancer, reported use of ODX to inform actual ACT decisions. Information was summarized and pooled according to: (1) distribution of ODX recurrence scores (RS), (2) impact of ODX on ACT recommendations, (3) impact of ODX on ACT use, and (4) proportion of patients following the treatment suggested by the ODX RS. A total of 23 studies met inclusion criteria. The distribution of RS categories was 48.8 % low, 39.0 % intermediate, and 12.2 % high (21 studies, 4,156 patients). ODX changed the clinical-pathological ACT recommendation in 33.4 % of patients (8 studies, 1,437 patients). In patients receiving ODX, receipt of ACT were: 28.2 % overall, 5.8 % low, 37.4 % intermediate, and 83.4 % high. Low RS patients were significantly more likely to follow the treatment suggested by ODX versus high RS patients RR: 1.07 (1.01–1.14) [corrected].The pooled results are consistent with most individual studies to date. The increased proportion of intermediate scores relative to original estimates may have implications for the clinical utility and cost impacts of testing. In addition, low versus high RS patients were significantly more likely to follow the ODX results, suggesting a tendency toward less aggressive treatment, despite a high ODX RS. Finally, there was a lack of studies on the impact of ODX on ACT use versus standard approaches, suggesting that additional studies are warranted.

Impact of Oncotype DX on Treatment Decisions in ER-Positive, Node-Negative Breast Cancer with Histologic Correlation

Oncotype DX, a gene-expression profiling assay, provides stratification of patients with estrogen-receptor positive, lymph-node-negative early breast cancer into risk groups based on recurrence score, which are associated with distant recurrence and response to chemotherapy. This study aims to determine whether Oncotype DX influences clinicians' treatment decisions, and whether assay results correlate with histologic assessment. Fifty patients with estrogen-receptor positive, node-negative early breast cancer analyzed by Oncotype DX and operated on by two breast surgeons were included. To assess effect on treatment decisions, clinical vignettes were created by retrospective chart review. Physicians were then presented with the clinical vignettes and instructed to make a treatment decisions (i.e., hormone therapy alone versus hormone therapy combined with chemotherapy) both before and after knowledge of the recurrence score. To assess correlation with histologic assessment, a prospective, blinded review of tumor slides was performed by two pathologists. Based on this review, tumors were placed into low, intermediate and high risk groups for comparison with Oncotype DX assay results. Treatment decisions were changed based on Oncotype DX results in 36 and 18% of cases by breast surgeons and medical oncologists, respectively. All tumors categorized as high risk by Oncotype DX were categorized as high risk based on histologic assessment, and 96% of cases categorized as low risk by recurrence score were categorized as low or intermediate risk by histologic assessment. Oncotype DX significantly influences management of estrogen-receptor positive, lymph-node-negative early breast cancer. Further studies are needed to assess association of histologic categorization to assay results.

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 Objectives: 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, pN1itc or pN1mic early breast cancer who had no contraindication to adjuvant chemotherapy (CT) and who would accept CT + hormone therapy (HT) if recommended. CT recommendations of oncologists based on Adjuvant! Online figures were recorded at an initial consultation. Eligible patients were consented to Oncotype DX testing and review arranged once the result was available. After a second consultation a final decision on adjuvant therapy was recorded. 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 with the RS. Of the 85 patients initially recommended HT only 12 (14.1%) were changed to HT + CT. Further analysis shows that Grade, estrogen receptor status by immunohistochemistry (ER by IHC) and progesterone receptor by immunohistochemistry (PR by IHC) are correlated to RS but in our cohort age, size and node status were not. (Spearman rank correlation for grade is 0.05, 95%, Cl 0.36 to 0.61; for ER by IHC is −0.36, Cl −0.49 to −0.20; and for PR by IHC is −0.49, 95%, Cl −0.60 to −0.35). Apart from HER2 positive patients who are already recognized to return a high RS, further analysis of our series shows no clear combination of currently available prognostic factors that would predict RS and therefore reliably avoid testing of any subset of 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 reported studies. RS added prognostic information beyond information provided by Adjuvant! Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-14-26.

P1-10-04: Cost-Utility of the 21-Gene Breast Cancer Assay (Oncotype DX®) in the Irish Healthcare Setting.

Abstract Objective: The Oncotype DX® Breast Cancer Test is a validated 21-gene assay that predicts the likelihood of benefit from adjuvant chemotherapy in early-stage, node-negative and up to 3-node-positive, ER+ breast cancer as well as the likelihood of distant recurrence at 10-years. Study objective was to investigate the cost-utility (incremental cost per QALY gained) of using Oncotype DX® in early stage, node-negative, ER+ breast cancer patients, from the perspective of the Irish Healthcare system. Methods: A cost-utility analysis was performed over the lifetime of the patient using a state transition model (Markov), which simulated the costs and quality-adjusted survival associated with and without the use of Oncotype DX® to inform adjuvant chemotherapy decisions. The model included 3 health states: no recurrence, recurrence and death. Transition probabilities between health states, utility scores associated with each of the health state, patient cohort characteristics and impact of Oncotype DX® on chemotherapy decisions data were derived from published sources. Direct medical costs associated with chemotherapy were collected from a representative panel of 5 hospitals in Ireland. Costs and outcomes were discounted at 4% per annum and the analysis was conducted over 30 years (lifetime horizon). Probabilistic and one-way sensitivity analyses were conducted. Results: Costs associated with adjuvant chemotherapy (4 cycles of TC) included the following costs: drug (€1,002); administration and monitoring (€1,646); adverse event prevention (€3,561) and adverse event management (€756). The average total cost of chemotherapy across hospitals therefore summed up to €6,965. The base case incremental cost per QALY gained with ODX testing was estimated to be €9,462. There was a 74% chance for ODX to be cost-effective at a willingness to pay threshold of €20,000. Conclusions: Using Oncotype DX® as a decision tool to inform adjuvant chemotherapy in node-negative, ER+ breast cancer patients, is likely to be cost-effective in the Irish healthcare setting. This estimate is probably conservative as the cost and disutility associated with long-term impact of chemotherapy related adverse events (i.e. such as cardiotoxicity, secondary leukaemia and potential cognitive impairment) have not been considered. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P1-10-04.

P196 Results from a prospective clinical study on the impact of Oncotype DX on adjuvant treatment decision and risk classification by Nottingham prognostic index (NPI) and recurrence score (RS)

P196 Results from a prospective clinical study on the impact of Oncotype DX on adjuvant treatment decision and risk classification by Nottingham prognostic index (NPI) and recurrence score (RS)