Clinical Evidence in Neoadjuvant Setting

Clinical Highlights | TransNEOS Study | WSG ADAPT Trial

Why use the Oncotype DX Breast Recurrence Score® test in the neoadjuvant setting?

Neoadjuvant therapy administered before surgery may:1

  • Improve the likelihood of successful breast-conserving surgery through tumor shrinkage
  • Downstage the nodal status in the axilla
  • Help assess primary tumor response to systemic therapy

To help patients reach these outcomes, the Breast Recurrence Score® test is a proven predictor of response to neoadjuvant treatment among postmenopausal, node-negative women and provides useful information to guide systemic treatment decisions:2-7

 

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Patients with lower Recurrence Score® results experienced greater clinical responses from neoadjuvant hormonal therapy compared to patients with higher Recurrence Score results.

 

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Patients with higher Recurrence Score results experienced greater clinical and pathologic responses from neoadjuvant chemotherapy compared to patients with lower Recurrence Score results.

 

A predictor of response to neoadjuvant chemotherapy

The National Cancer Database was used to identify all patients with T1-T3, ER-positive, HER2-negative primary breast cancer from 2010 to 2015 who had the Breast Recurrence Score test performed and received neoadjuvant chemotherapy (N=989). Recurrence Score results were strongly associated with the likelihood of pathologic complete response.8

Graph pCR

Distribution by RS Group:

  • RS 0-17:   23.0%
  • RS 18-30:  45.5%
  • RS 31-100:  31.5%

pCR achieved:

  • 2.2% with RS 0-17
  • 1.6% with RS 18-30
  • 9.6% with RS 31-100, P<0.001

 

In a similar manner, the National Cancer Database was used to identify all patients with T1-T2, clinically N1/N2, ER-positive, HER2-negative invasive ductal carcinoma of the breast from 2010 to 2015 who had the Breast Recurrence Score test performed and received neoadjuvant chemotherapy (N=158). Recurrence Score results were significantly associated with the likelihood of pathologic complete response in the axilla.9

Graph Axillary pCR

Distribution by RS Group:

  • RS 0-17:   35.4%
  • RS 18-30:  39.2%
  • RS 31-100:  25.3%

Axillary pCR achieved:

  • 10.7% with RS 0-17
  • 9.7% with RS 18-30
  • 27.5% with RS 31-100, P=0.0268

 

 

TransNEOS study: neoadjuvant endocrine therapy and Breast Recurrence Score test7

Patients in the TransNEOS study (a translational study of NEOS) had tumors ≥2 cm and archived core-biopsy samples taken before neoadjuvant letrozole and subsequently sent for Breast Recurrence Score® testing.

Study endpoints were:

Primary: Evaluate clinical (complete or partial) response to neoadjuvant letrozole for RS <18 vs RS ≥31

Secondary: Evaluate clinical response and rate of breast-conserving surgery (BCS) by continuous Recurrence Score test result

A total of 295 patients were included in TransNEOS. Recurrence Score (RS) result group (RS 0-17 vs RS 31-100) and was significantly associated with the rate of clinical response (χ2 test P<0.001). With the Recurrence Score result 18-30 group included, Recurrence Score result group remained significantly associated with the rate of clinical response (Cochran–Armitage trend test, P<0.001)

Clinical Response to 24 Weeks Neoadjuvant Letrozole by RS

 

Clinical Response, n

Recurrence Score<18

Recurrence Score 18-30

Recurrence Score >=31

Total

CR + PR

86

35

12

133

SD

70

46

33

149

PD

1

3

9

13

Total

157

84

54

295

Percent clinical response to neoadjuvant letrozole by Recurrence Score Group (N = 295); CR = complete response; PD = progressive disease; PR = partial response; SD = stable disease

 

The Recurrence Score result group was not associated with breast-conserving surgery candidacy before neoadjuvant letrozole but was significantly associated with breast-conserving surgery received after treatment. Among patients with Recurrence Score results 0-17, pretreatment surgery recommendation significantly differed from posttreatment surgery received (McNemar’s test P<0.001), whereas there was no significant change among patients with Recurrence Score results 31-100 (P=0.075).

 

Recurrence Score Group

No

Yes

p value*

BCS candidacy before neoadjuvant letrozole

Test result <18

60 (38%)

97 (62%)

0.878

Test result >=31

20 (37%)

34 (63%)

 

BCS received after neoadjuvant letrozole

Test result <18

31 (21%)

118 (79%)

0.009

Test result >=31

19 (40%)

29 (60%)

 

BCS = breast-conserving surgery

*Based on x2 test

Among patients with nonmissing information on surgery received.

 

The authors concluded that the TransNEOS study validates the Recurrence Score result as a significant predictor of clinical response to neoadjuvant letrozole in postmenopausal women with ER+, HER2-, clinically node-negative breast cancer. Patients with RS 0-17 were significantly more likely than patients with RS 31-100 to respond to neoadjuvant letrozole and undergo BCS.

Patients with a low Recurrence Score result (0-17) may be candidates for neoadjuvant endocrine therapy to elicit a clinical response and conversion from mastectomy to lumpectomy.

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WSG ADAPT trial: neoadjuvant chemotherapy studies with the Breast Recurrence Score test

The WSG ADAPT HR+/HER2− trial used clinicopathologic features, Recurrence Score result (static biomarker), and Ki-67 levels after a short course of preoperative endocrine therapy to assign treatment for patients with HR+, HER2- invasive breast cancer. Patients received either adjuvant endocrine therapy or chemotherapy (either in the adjuvant or neoadjuvant setting) followed by adjuvant endocrine therapy.10 For patients who were cN0-1, assignment to chemotherapy was based on one of the following findings: Recurrence Score results 12-25 and Ki-67post-ET >10% or Recurrence Score results 26-100. Of the 2241 eligible women assigned chemotherapy in the trial, a total of 864 (including 577 with evaluable Recurrence Score results) received their chemotherapy in the neoadjuvant setting.

Among patients with Recurrence Score results, the rate of pCR was significantly higher in the group with Recurrence Score results 26-100 than with Recurrence Score results 12-25:10

Graph pCR 95

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View clinical utility in the locoregional and late-recurrence setting 

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