scholarly journals Substantial Reduction in Adjuvant Chemotherapy With the Use of the 21-Gene Test to Manage Early Breast Cancer in a Public Hospital in Brazil

2021 ◽  
pp. 1003-1011
Author(s):  
André Mattar ◽  
Guilherme R. Fonseca ◽  
Murilo B. A. Romão ◽  
Jorge Y. Shida ◽  
Vilmar M. de Oliveira ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Substantial Reduction ◽  
Recurrence Score ◽  
Treatment Recommendations ◽  
Public Hospitals ◽  
Test Results ◽  
Node Positive ◽  
Gene Testing ◽  
Gene Test ◽  
The Impact

PURPOSE We evaluated the impact of 21-gene test results on treatment decisions for patients with early-stage breast cancer treated under the public health care system in Brazil, Sistema Único de Saúde. METHODS Eligible patients treated at Hospital Pérola Byington and Santa Casa de Misericórdia de São Paulo in Brazil were required to have the following characteristics: postsurgery with hormone receptor–positive, human epidermal growth factor 2–negative, node-negative and node-positive, and T1/T2 breast cancer and patients with these characteristics were candidates for adjuvant systemic therapy. Treatment recommendations, chemotherapy plus hormonal therapy (CT + HT) or HT alone, were captured before and after 21-gene test results. RESULTS From August 2018 to April 2019, 179 women were enrolled. The mean age was 58 years (29-86 years), 135 (76%) were postmenopausal, and 58 (32%) had node-positive breast cancer. Most patients (61%) had a tumor > 2 cm, including 7% with tumors > 4 cm. Using Recurrence Score (RS) result cut points on the basis of the TAILORx trial, 40 (22%) had RS 0-10, 91 (51%) had RS 11-25, and 48 (27%) had RS 26-100. Before 21-gene testing, 162 of 179 (91%) patients were recommended for CT. After testing, 117 of 179 patients (65%) had changes in CT recommendation: 112 (63%) who were initially recommended CT received HT alone and five (3%) who were initially recommended HT alone received CT + HT. After 21-gene testing, 99% of physicians reported strong confidence in their treatment recommendations. CONCLUSION The change in clinical practice at these public hospitals was greater than expected: 66% of initial treatment recommendations were changed to omit CT with 21-gene test results. Clinicopathologic features did not correlate well with 21-gene test results and did not adequately identify those most likely to benefit from CT.

scholarly journals Practice-Changing Use of the 21-Gene Test for the Management of Patients With Early-Stage Breast Cancer in Latin America

2021 ◽  
pp. 1364-1373
Author(s):  
Henry L. Gomez ◽  
Juan E. Bargallo-Rocha ◽  
Roberto J. Billinghurst ◽  
Aníbal R. Núñez De Pierro ◽  
Federico A. Coló ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Latin America ◽  
Recurrence Score ◽  
Treatment Decisions ◽  
Test Results ◽  
Node Negative ◽  
Node Positive ◽  
Gene Testing ◽  
Before And After ◽  
Gene Test

PURPOSE We present a physician survey of the impact of 21-gene Breast Recurrence Score test results on treatment decisions in clinical practice in Latin America. METHODS This prospective survey enrolled consecutive patients at 14 sites in Argentina, Colombia, Mexico, and Peru who had routine 21-gene testing. Physician surveys captured patient and tumor characteristics and treatment decisions before and after 21-gene test results. The survey spanned the period before and after Trial Assigning Individualized Options for Treatment (TAILORx) results reported (June 2018). Overall net percent change in adjuvant chemotherapy recommendations was estimated, and asymptotic 95% CIs with continuity correction were calculated. The proportion with a change between pretest treatment recommendation and actual treatment received was calculated overall and by Recurrence Score groups per TAILORx. RESULTS Between March 2015 and December 2019, the survey was completed for 647 patients; 20% were node-positive. The mean patient age was 54 years (24-85 years); 55% were postmenopausal; 17%, 63%, and 20% had grade 1, 2, and 3 tumors, respectively; and 30% had tumors > 2 cm. Recurrence Score (RS) results were as follows: 20% RS 0-10, 56% RS 11-25, and 24% RS 26-100. Overall, chemotherapy recommendations fell by a relative proportion of 39% (95% CI, 33.4 to 44.3) after 21-gene testing (33% decrease in node-negative and 55% decrease in node-positive). Among node-negative patients, the relative decrease in chemotherapy recommendations was 28% (95% CI, 18.9 to 39.5) before TAILORx and 36% (95% CI, 28.4 to 43.7) after. CONCLUSION To our knowledge, this large survey of 21-gene test practice patterns was the first conducted in Latin America and showed the relevance of 21-gene testing in low- and medium-resource countries to minimize chemotherapy overuse and underuse in breast cancer. The results showed substantial reductions in chemotherapy use overall—especially after TAILORx reported—indicating the practice-changing potential of that study.

Practice-changing use of 21-gene oncotype DX breast recurrence score assay in a public hospital in Brazil: Results of 155 cases.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12518-e12518
Author(s):  
Andre Mattar ◽  
Guilherme Ribeiro Fonseca ◽  
Murilo Barato Agudo Romão ◽  
Jorge Yoshinori Shida ◽  
Monica Maria Agata Stiepcich ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Public Hospital ◽  
Recurrence Score ◽  
Treatment Recommendations ◽  
Clinical Risk ◽  
Post Surgery ◽  
Gene Assay ◽  
Gene Test ◽  
Score Result ◽  
The Impact

e12518 Background: The 21-gene assay estimates risk of recurrence expressed as a Recurrence Score result between 0 and 100. The assay is clinically validated to predict chemotherapy (CT) benefit in node-negative (N0) and node-positive (up to three axillary nodes, N1) hormone receptor-positive (HR+) early-stage breast cancer (ESBC). The TAILORx study, which randomized 6711 women with N0 ESBC and Recurrence Score result 11-25 to hormonal therapy (HT) ± CT, demonstrated that patients older than 50 years derived no benefit from CT+HT, although younger patients with Recurrence Score result 16-25 may derive some benefit. The 21-gene assay has been incorporated in practice guidelines worldwide, based on evidence of clinical utility in N0 and N1 ESBC. We evaluated the impact of the 21-gene test on treatment decisions for patients with N0 and N1 ESBC at Sistema Único de Saúde in Brazil. Methods: Eligible patients were post-surgery with T1/T2 tumors, had HR+, HER2−, N0 or N1 ESBC, and were candidates for adjuvant systemic therapy. Treatment recommendations, CT+HT or HT alone, were captured before and after 21-gene test results. All patients were seen at Pérola Byington Hospital, a public hospital in São Paulo, Brazil. TAILORx results were used to guide decisions for or against CT for each patient. Results: From 08/2018 to 04/2019, 155 women were enrolled. Patient mean age was 57.6 years (29-78), 116 (75%) were postmenopausal, and 53 (34%) had N1 breast cancer. Based on clinical data alone, 151 patients had pre-assay recommendations of CT. Post-assay, 106 of 151 patients (70%) had changes in CT recommendation: 104 (69%) initially recommended CT received HT alone, and 2 (1%) initially recommended HT alone received CT+HT (Table). Using the modified Adjuvant!Online criteria for clinical risk classification, 109 of 155 patients (70%) had high risk, 48 (44%) of whom received CT. Of 46 patients with low clinical risk, 10 (22%) received CT. CT use trended with histologic grade: 11% with grade 1, 69% with grade 2, and 61% with grade 3. Most of our patients had tumor bigger than 2 cm (61%) with 8% bigger than 4 cm. Conclusions: The change in clinical practice at this public hospital was greater than expected: 69% of initial treatment recommendations were changed with the Recurrence Score result to omit CT. Clinicopathologic criteria did not correlate well with Recurrence Score results and did not identify those most likely to benefit from CT. A cost-effectiveness study is underway at our institution. [Table: see text]

Practice-changing use of the 21-gene oncotype DX breast recurrence score test in Latin American hospitals.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12539-e12539
Author(s):  
Henry Leonidas Gomez ◽  
Juan Enrique Bargallo-Rocha ◽  
Roberto Jorge Billinghurst ◽  
Aníbal Roberto Núñez de Pierro ◽  
Federico Andrés Coló ◽  
...  
Keyword(s):  
Latin America ◽  
Latin American ◽  
Early Stage ◽  
Recurrence Score ◽  
Treatment Decisions ◽  
Treatment Recommendation ◽  
Physician Survey ◽  
Gene Testing ◽  
Gene Test ◽  
The Impact

e12539 Background: The 21-gene test is clinically validated to predict chemotherapy (CT) benefit in node-negative (N0) and node-positive (up to 3 axillary nodes, N+) HR+, HER2− early-stage breast cancer (ESBC). TAILORx showed no CT benefit overall in N0 patients with RS 0-25, but younger patients with RS 16-25 might have some. Clinical guidelines worldwide incorporate the 21-gene test; still, the impact of the test on treatment decisions is unclear in Latin America, where patients often present younger and with more advanced disease. We present a physician survey of the impact of Recurrence Score results on treatment decisions in clinical practice in Latin America. Methods: This multicenter, non-therapeutic, prospective survey enrolled consecutive patients who had 21-gene testing during routine care at 14 community and academic sites in Argentina, Colombia, Mexico, and Peru. Tests were paid for by patients. The physician survey captured patient and tumor characteristics and treatment decisions by physicians pre- and post-assay result. The survey included patients treated before and after TAILORx results reported in 6/2018. Overall net percent change in CT recommendation and 95% Clopper Pearson confidence intervals (CI) were estimated. The proportion with a change between pre-assay treatment recommendation and actual treatment received was calculated overall and by Recurrence Score groups per TAILORx. Results: Between 3/2015 and 12/2019, the survey was completed for 647 patients. 20% had N+ ESBC. Mean patient age was 54 y (24-85 y); 55% were postmenopausal. 17%/63%/20% had grade 1/2/3 tumors; 70%/30% had tumors ≤2/ > 2 cm in size. Recurrence Score results were: 20% RS 0-10, 56% RS 11-25, and 24% RS 26-100. Overall, CT recommendations fell from 325 patients pre-assay to 199 patients post-assay, a 39% decrease (95% CI 33.4 to 44.3) (36% decrease in N0; 46% decrease in N+). The direction of change was consistent with Recurrence Score results. Among N0 patients, the decrease in CT recommendations was 28% (95% CI 18.9 to 39.5) before TAILORx reported and 36% (95% CI 28.4 to 43.7) after. Conclusions: This large survey of 21-gene test practice patterns was the first conducted in Latin America and showed the relevance of 21-gene testing in low- and medium-resource countries to minimize CT over- and underuse in ESBC. Our results showed substantial reductions in CT use overall. After TAILORx, CT use was further reduced, indicating the practice-changing potential of that study.

A prospective clinical utility study of the impact of the 21-gene recurrence score assay (Oncotype DX) in estrogen receptor positive (ER+) node negative (pN0) breast cancer in academic Canadian centers.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 549-549
Author(s):  
James Ashley Davidson ◽  
Ian Cromwell ◽  
Susan Ellard ◽  
Caroline A. Lohrisch ◽  
Karen A. Gelmon ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Recurrence Score ◽  
Decisional Conflict ◽  
The United States ◽  
Treatment Recommendations ◽  
Oncotype Dx ◽  
Treatment Recommendation ◽  
Treatment Preferences ◽  
Node Negative ◽  
The Impact

549^ Background: The Oncotype DX 21-gene Recurrence Score assay (RS) can potentially predict the magnitude of chemotherapy benefit in patients with stage I-II, node-negative, ER+ disease who will be treated with tamoxifen for 5 years. While use in the United States has grown significantly since its introduction, it is not yet routinely ordered by oncologists in most parts of Canada. The primary purpose of this study was to measure the impact of the Oncotype DX test on the physician’s treatment recommendation in ER+ pN0 breast cancer in British Columbia. Methods: After providing informed consent, patients and medical oncologists completed respective pre-RS questionnaires indicating their treatment preferences and level of confidence and a decisional conflict scale (patients only). At a subsequent visit, after the RS result was known and discussed, the patient and oncologist completed a second set of questionnaires. The proportion of physician treatment recommendations that changed from baseline to follow-up (post RS) were calculated with 95% confidence interval (CI). A prospective health economic (HE) analysis was also performed. Results: From May 2010 to July 2011, two participating BCCA centres enrolled 156 patients. Of the 150 for whom successful RS assay results were obtained, physicians changed their chemotherapy recommendation in 45 cases (30%; 95% CI 22.8-38.0%); either to add (10%; 95% CI 5.7-16.0%) or omit (20%; 95% CI 13.9-27.3%) adjuvant chemotherapy. As a secondary end-point, in 84 cases (56%; 95% CI 47.7-64.1%) there was a change in either the planned chemo and/or endocrine therapy recommendation. There was an overall significant improvement in physician confidence post RS (p < 0.001). Patient decisional conflict also significantly decreased following the RS assay (p < 0.001). The HE analysis is ongoing and will be presented separately. Conclusions: Within the context of a publicly funded health care system, the RS assay significantly affects adjuvant treatment recommendations in ER+ node negative breast cancer, in addition to reducing patient decisional conflict.

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