First Prospective Multicenter Italian Study on the Impact of the 21-Gene Recurrence Score in Adjuvant Clinical Decisions for Patients with ER Positive/HER2 Negative Breast Cancer

Dieci, Maria Vittoria; Guarneri, Valentina; Giarratano, Tommaso; Mion, Marta; Rossi, Costanza De; Gori, Stefania; Oliani, Cristina; Merlini, Laura; Pasini, Felice; Bonciarelli, Giorgio; Griguolo, Gaia; Orvieto, Enrico; Michieletto, Silvia; Saibene, Tania; Bianco, Paola Del; Salvo, Gian Luca De; Conte, Pierfranco

doi:10.1634/theoncologist.2017-0322

Cited by 7 publications

(16 citation statements)

References 30 publications

(58 reference statements)

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“…The results of the ROXANE study show that the availability of the RS test for use in clinical practice could lead to a change in adjuvant treatment recommendation in up to 30% of patients for whom the clinicians were initially unsure about treatment recommendation based on classical clinical and pathologic factors. This figure is different from the one of our previous Breast‐DX decision impact study (16% change in treatment decision), conducted in the same Italian region , and more similar to the results of other European cohorts . There are a number of differences among these studies and factors to be considered when interpreting the results.…”

Section: Discussioncontrasting

confidence: 97%

“…As an example, the proportion of N0 patients with grade 3 tumors was higher in the Italian studies (30% in Breast‐DX , 49% in ROXANE) as compared with other European studies (13% in the pooled analysis) . Moreover, most European studies focused on N0 patients, and only few included N1 patients, such as Breast‐DX and ROXANE . Nevertheless, in both Italian studies, the rate of pre‐RS recommendation to HT alone was similar or even higher versus other European studies (52% in Breast‐DX, 48% in ROXANE, 40%–55% in other studies) .…”

Section: Discussionmentioning

confidence: 71%

“…The population of patients enrolled in the Breast‐DX Italy and in the ROXANE studies showed higher risk features as compared with patients included in other decision impact European studies. As an example, the proportion of N0 patients with grade 3 tumors was higher in the Italian studies (30% in Breast‐DX , 49% in ROXANE) as compared with other European studies (13% in the pooled analysis) . Moreover, most European studies focused on N0 patients, and only few included N1 patients, such as Breast‐DX and ROXANE .…”

Section: Discussionmentioning

confidence: 90%

“…We previously discussed the tendency of Italian oncologists to frequently consider HT alone for patients with HR‐positive/HER2‐negative early breast cancer based on the evaluation of classical clinicopathological features, including Ki67 . The population of patients enrolled in the Breast‐DX Italy and in the ROXANE studies showed higher risk features as compared with patients included in other decision impact European studies.…”

Section: Discussionmentioning

confidence: 99%

“…In this study, all consecutive patients with estrogen receptor (ER)‐positive, HER2‐negative, N0–N1, T1–T3 early breast cancer who met the protocol‐defined criteria of “intermediate risk” (based on classical clinicopathological factors) were offered the RS test. Among the 250 enrolled patients, we reported a rate of treatment decision change of only 16% (mostly from CT + HT to HT) .…”

Section: Introductionmentioning

confidence: 97%

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Impact of 21-Gene Breast Cancer Assay on Treatment Decision for Patients with T1–T3, N0–N1, Estrogen Receptor-Positive/Human Epidermal Growth Receptor 2-Negative Breast Cancer: Final Results of the Prospective Multicenter ROXANE Study

et al. 2019

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Background The ROXANE Italian prospective study evaluated the impact of the 21‐gene Recurrence Score (RS) results on adjuvant treatment decision for patients with early breast cancer. Materials and Methods Nine centers participated. Physicians used the RS test whenever unsure about adjuvant treatment recommendation for patients with estrogen receptor‐positive/human epidermal growth receptor 2‐negative, T1–T3, N0–N1 early breast cancer. Pre‐RS and post‐RS treatment recommendations were collected. Results A total of 251 patients were included. N0 patients (61%) showed higher grade (p < .001) and higher Ki67 (p = .001) and were more frequently progesterone receptor negative (p = .012) as compared with N1 patients. RS results were as follows: <11, n = 63 (25.1%); 11–25, n = 143 (57%); and ≥26, n = 45 (17.9%). Higher RS was found in N0 vs. N1 patients (p = .001) and in cases of G3 (p < .001) and higher Ki67 (p < .001). The rate of change in treatment decision was 30% (n = 75), mostly from chemotherapy (CT) plus hormone therapy (CT + HT) to hormone therapy (HT; 76%, n = 57/75). The proportion of patients recommended to CT + HT was significantly reduced from pre‐RS to post‐RS (52% to 36%, p < .0001). CT use reduction was more evident for N1 patients (55% to 27%) than for N0 patients (50% to 42%) and was observed only in cases of RS ≤17. Conclusion Physicians predominantly used the 21‐gene assay in N0 patients with a more aggressive biology or in N1 patients showing more indolent biology. In this selected patient population, the use of RS testing led to a 30% rate of change in treatment decision. In the N1 patient subgroup, the use of RS testing contributed to reduce CT use by more than half. Implications for Practice This study shows that, even in a context in which physicians recommend a high proportion of patients to endocrine treatment alone before knowing the results of the Recurrence Score (RS) assay, the use of the RS test, whenever uncertainty regarding adjuvant treatment recommendation is present, significantly contributes in further reducing the use of chemotherapy, especially for N1 patients.

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Section: Discussioncontrasting

confidence: 97%

Section: Discussionmentioning

confidence: 71%

Section: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 97%

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Impact of 21-Gene Breast Cancer Assay on Treatment Decision for Patients with T1–T3, N0–N1, Estrogen Receptor-Positive/Human Epidermal Growth Receptor 2-Negative Breast Cancer: Final Results of the Prospective Multicenter ROXANE Study

et al. 2019

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Personalised medicine and the decision to withhold chemotherapy in early breast cancer with intermediate risk of recurrence – a systematic review and meta-analysis

Wallerstedt

Bagge

et al. 2020

Eur J Clin Pharmacol

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Purpose To assess the evidence for decision making, at the health care and the patient levels, regarding the use of gene expression assays to inform chemotherapy decisions in breast cancer patients with intermediate clinical risk of recurrence. Methods Systematic literature searches were performed (January 2002–April 2020) in Medline, Embase, PubMed, Cochrane Library, PsycINFO and HTA databases. Inclusion criteria: patients (P) were individuals with post-surgical breast cancer at intermediate clinical risk of recurrence; intervention (I)/comparison (C) was (i) use of, versus no use of, a gene expression assay and (ii) withholding versus providing chemotherapy; outcomes (O) were overall survival (OS), health-related quality of life (HRQL), and recurrence. Randomised controlled trials (RCTs) and non-RCTs were included. Random-effects meta-analyses were performed where possible. Results Three inconclusive non-RCTs, respectively, compared OS and recurrence with and without a gene expression assay. No studies investigated HRQL. Regarding the comparison withholding versus providing chemotherapy based on a gene expression assay, one RCT and four non-RCTs evaluated OS. In the RCT, 93.9% (I) versus 93.8% (C) were alive at 9 years. Three RCTs and seven non-RCTs evaluated recurrence. Three RCTs could be pooled regarding distant recurrence; 4.29% versus 3.88% had such an event (risk ratio: 1.12 (95% confidence interval: 0.90 to 1.39). Conclusion Regarding the use of gene expression assays in breast cancer, evidence on patient effects, informing patient-level chemotherapy decision making, is available. However, evidence for prioritisation at the overall health care level, i.e. use of, versus no use of, such assays, is largely lacking. Electronic supplementary material The online version of this article (10.1007/s00228-020-02914-z) contains supplementary material, which is available to authorized users.

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Prospective observational study on the impact of the 21-gene assay on treatment decisions and resources optimization in breast cancer patients in Lombardy: The BONDX study

et al. 2020

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Purpose Adjuvant treatment decisions in early breast cancer (eBC) have traditionally been driven by risk stratification based on clinical and pathological risk factors. The 21-gene Oncotype DX® assay has been validated as a predictive test for benefit from adjuvant chemotherapy (CT), hence assessing its impact in clinical decisions is of high interest. The objective of this study was to estimate the rate of adjuvant treatment decision modification impacted by the Recurrence Score® result, and the consequent budget impact. Methods The study was a multicentre, prospective, real-life experience in Lombardy (Italy) including consecutive patients with T1–T3, N0–N1a, and ER+/HER2-eBC with clinical-pathologic “intermediate risk” of relapse. The change in treatment recommendations was assessed before and after availability of Recurrence Score result. A budget model evaluated the implications of 21-gene testing in the study population. Results The overall proportion of CT recommendations was reduced from 24.6% to 15.2% after 21-gene testing, with a major impact in patients initially considered for CT plus hormone therapy (CHT). In these patients, the total budget was reduced, leading to a net saving of -€81,017. The greater the physician propensity to prescribe CHT, the higher the potential savings for the health system from sparing CT in most tested patients. Conclusions Our real-life experience suggests that all intermediate-risk ER+/HER2-eBC patients who are initially deemed candidates for CHT should be tested with the 21-gene test. The potential to spare CT in at least half of them offers relevant advantages for patients and national health services.

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First Prospective Multicenter Italian Study on the Impact of the 21-Gene Recurrence Score in Adjuvant Clinical Decisions for Patients with ER Positive/HER2 Negative Breast Cancer

Cited by 7 publications

References 30 publications

Impact of 21-Gene Breast Cancer Assay on Treatment Decision for Patients with T1–T3, N0–N1, Estrogen Receptor-Positive/Human Epidermal Growth Receptor 2-Negative Breast Cancer: Final Results of the Prospective Multicenter ROXANE Study

Impact of 21-Gene Breast Cancer Assay on Treatment Decision for Patients with T1–T3, N0–N1, Estrogen Receptor-Positive/Human Epidermal Growth Receptor 2-Negative Breast Cancer: Final Results of the Prospective Multicenter ROXANE Study

Personalised medicine and the decision to withhold chemotherapy in early breast cancer with intermediate risk of recurrence – a systematic review and meta-analysis

Prospective observational study on the impact of the 21-gene assay on treatment decisions and resources optimization in breast cancer patients in Lombardy: The BONDX study

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