In the Era of Genomics, Should Tumor Size Be Reconsidered as a Criterion for Neoadjuvant Chemotherapy?

Pivot, Xavier; Mansi, Laura; Chaigneau, L.; Montcuquet, P.; Thiery-Vuillemin, A.; Bazán, Fernando; Dobi, Erion; Sautiere, Jean Loup; Rigenbach, Frederic; Algros, M.-P.; Butler, Steve; Jamshidian, Farid; Febbo, Phillip G.; Svedman, Christer; Paget‐Bailly, Sophie; Bonnetain, Franck; Villanueva, Christian

doi:10.1634/theoncologist.2014-0198

Cited by 21 publications

(7 citation statements)

References 27 publications

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“…The TransNEOS findings complement those of previous studies suggesting that the Recurrence Score test may help guide decisions about neoadjuvant chemotherapy [27–33]. In the Pivot and Yardley studies of neoadjuvant chemotherapy, the rate of pathologic CR was 26% ( p = 0.02) and 30% ( p = 0.002), respectively, among patients with RS ≥ 31 but 0% among patients with RS < 18 [30, 31]. Recently, Bear and colleagues assessed the feasibility of using Recurrence Score results to guide neoadjuvant systemic therapy [27].…”

Section: Discussionsupporting

confidence: 76%

Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study

Iwata

Masuda

Yamamoto

et al. 2018

Breast Cancer Res Treat

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Purpose The Recurrence Score test is validated to predict benefit of adjuvant chemotherapy. TransNEOS, a translational study of New Primary Endocrine-therapy Origination Study (NEOS), evaluated whether Recurrence Score results can predict clinical response to neoadjuvant letrozole. Methods NEOS is a phase 3 clinical trial of hormonal therapy ± adjuvant chemotherapy for postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer, after six months of neoadjuvant letrozole and breast surgery. TransNEOS patients had tumors ≥ 2 cm and archived core-biopsy samples taken before neoadjuvant letrozole and subsequently sent for Recurrence Score testing. The primary endpoint was to evaluate clinical (complete or partial) response to neoadjuvant letrozole for RS < 18 versus RS ≥ 31. Secondary endpoints included evaluation of clinical response and rate of breast-conserving surgery (BCS) by continuous Recurrence Score result, ESR1 and PGR single-gene scores, and ER gene-group score. Results Of 295 TransNEOS patients (median age 63 years; median tumor size 25 mm; 66% grade 1), 53.2% had RS < 18, 28.5% had RS18–30, and 18.3% had RS ≥ 31. Clinical response rates were 54% (RS < 18), 42% (RS18–30), and 22% (RS ≥ 31). A higher proportion of patients with RS < 18 had clinical responses ( p < 0.001 vs. RS ≥ 31). In multivariable analyses, continuous Recurrence Score result ( p < 0.001), ESR1 score ( p = 0.049), PGR score ( p < 0.001), and ER gene-group score ( p < 0.001) were associated with clinical response. Recurrence Score group was significantly associated with rate of BCS after neoadjuvant treatment (RS < 18 vs. RS ≥ 31, p = 0.010). Conclusion The Recurrence Score test is validated to predict clinical response to neoadjuvant letrozole in postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer. Electronic supplementary material The online version of this article (10.1007/s10549-018-4964-y) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 76%

Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study

Iwata

Masuda

Yamamoto

et al. 2018

Breast Cancer Res Treat

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“…Although two reports showed there was no statistically significant association between tumor response and RS (26,27), some studies support the correlation between RS and tumor response to neoadjuvant systemic therapy (28)(29)(30)(31)(32)(33)(34). In univariate analyses of predictive factors for the ≥50%TR achievement from our study (Table 7), none of the models were statistically significant.…”

Section: Correlation Between Ms and Rscontrasting

confidence: 63%

“…RS has been proposed to also select HR+ HER2-BC patients who will benefit from NCT. The correlation between multi-gene assays such as Oncotype DX® RS from pretreatment biopsy tissue and tumor response to neoadjuvant therapy has been studied previously (26)(27)(28)(29)(30)(31)(32)(33)(34).…”

Section: Introductionmentioning

confidence: 99%

The Correlation of Magee EquationsTM and Oncotype DX® Recurrence Score From Core Needle Biopsy Tissues in Predicting Response to Neoadjuvant Chemotherapy in ER+ and HER2- Breast Cancer

Soran

Tane

Sezgın

et al. 2020

Eur J Breast Health

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Objective: Oncotype DX® recurrence score (RS) can be predicted from Magee Equations TM (MS) postoperatively. The aim of this study is to investigate correlation of MS with RS from pretreatment core needle biopsy (CNB) tissues, and their clinical usefulness in prediction of response to neoadjuvant chemotherapy (NCT) in estrogen receptor-positive and human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer (BC). Materials and Methods:Pretreatment CNB tissue samples from 60 patients with ER+/HER2-invasive BC were analyzed for MS and RS correlation. MS and RS were categorized as follows: low (<18), intermediate (18-30), and high (≥ 31). Percentage Tumor size Reduction (%TR) was used to assess tumor response to NCT, and substantial %TR was defined as at least 50% reduction (≥50%TR). Correlation between MS and RS, and predictive factors for the ≥50%TR achievement were assessed.Results: MS and RS represented a strong correlation (Spearman's correlation; r=0.58, p<0.0001) as a continuous variable. As a categorical variable, the concordance between MS and RS was 43.3%, and it increased to 80% (r=0.61, p=0.003) with the exclusion of the intermediate risk categories. Although, there was pathologic complete response (pCR), MS showed the highest predictive power for the ≥50% TR achievement, none of the factors were statistically significant (p≥0.07). Conclusion:Our study demonstrated that there was a strong correlation between MS and RS from pretreatment biopsy tissue samples in ER+ and HER2-invasive BC.

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“…It is important to note the concordance of low pathological response found in both studies in patients with lower Recurrence Score results (RS 0–25), suggesting these patients will not benefit from NAC despite having clinical criteria of NAC. Pivot el al [ 29 ] showed a similar effect in patients selected for NAC primarily based on large tumor size, in that patients with low RS results, with minimal if any expected long-term clinical benefit to NAC, were unlikely to achieve pCR.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, there have been multiple small studies incorporating the Oncotype DX® test in the neoadjuvant setting. These studies have shown that pCR or clinical complete response (cCR) to chemotherapy almost never occurs in patients with a low Recurrence Score result by Oncotype DX [ [10] , [11] , [12] , [13] ]. Using other genomic signatures in the NAC setting, very few or no pathological responses were observed among patients with a low risk of recurrence (ROR) based on the PAM50 [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Selection of neoadjuvant treatment based on the 21-GENE test results in luminal breast cancer

et al. 2021

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Neoadjuvant chemotherapy (NAC) is an optimal option in early breast cancer, but in ER-positive/HER2-negative (luminal) is still controversial, although a survival benefit has recently been observed when a histological response by Symmans’ method type 0 or I is achieved. The 21-gene Oncotype DX Breast Recurrence Score® assay (Oncotype DX®) is a validated test to assess the survival benefit of adjuvant chemotherapy in these patients but its role in the neoadjuvant setting is less established. We analyzed the results of the Oncotype DX® test in a cohort of 122 consecutive patients selected to receive NAC based on classical clinicopathological parameters and the correlation between the Oncotype DX® results and the pathological response assessed by Symmans’ method. Median age was 56.5 (range 31–84) years. Initial tumor size was T1 (<20 mm) in 46 patients (37.7%), 57 (46.7%) had a T2 tumor (20–50 mm), and 19 (15.6%) had a tumor size more than 50 mm. 59 (48.4%) had axillary node involvement. The median expression estrogen and progesteron receptors by immunohistochemistry was 280 and 120 respectively and median Ki67 index was 28%. The Recurrence Score (RS) results were <11 in 21 patients (17.2%) patients, RS 11 to 25 in 58 (47.5%), and RS > 25 in 43 (35.2%). Considering the Oncotype DX test results, neoadjuvant chemotherapy was administered to 60 patients (49%), 11 (9%) received adjuvant chemotherapy and 51 (42%) no chemotherapy. Testing with the assay has therefore led to 42% fewer chemotherapy treatments. Among 60 patients receiving NAC, pathologic response was achieved for 5 patients (8.3%) with RCB-0 and 15 RCB-1 (25%). We did not find any pathological response RCB-0 and RCB-I in the 20 patients who received NAC and had a Recurrence Score result <21 for the premenopausal group, or a RS result <25 for the postmenopausal group. For patients with highest Recurrence Score results (RS > 21 or 25 according to menopausal status) it was 12% (5/40) RCB-0 and 40% (16/40) RCB-I. Conclusions The Oncotype DX test could be a useful tool to select patients candidates for neoadjuvant chemotherapy in luminal breast cancer. Neoadjuvant chemotherapy could be avoided in 42% of patients. We found a correlation between Recurrence Score results and pathological response with 14% of RCB-0 and a total of 47% of significant pathological response type RCB-0 and RCB-I in patients with highest Recurrence Score results. Interestingly, patients with a Recurrence Score result inferior to 32 did not get any histological response type 0 and only 5% RCB-I.

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In the Era of Genomics, Should Tumor Size Be Reconsidered as a Criterion for Neoadjuvant Chemotherapy?

Cited by 21 publications

References 27 publications

Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study

Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study

The Correlation of Magee EquationsTM and Oncotype DX® Recurrence Score From Core Needle Biopsy Tissues in Predicting Response to Neoadjuvant Chemotherapy in ER+ and HER2- Breast Cancer

Selection of neoadjuvant treatment based on the 21-GENE test results in luminal breast cancer

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