Abstract 1096
Background
OncotypeDX (ODX®) can enhance prediction of breast cancer recurrence, guiding adjuvant treatment options. However, the opportunity to access this test is not always possible. The aim of this study is to investigate the correlation between phenotypical tumor characteristics, quantitative classical immunohistochemistry (IHC) and recurrent score (RS) resulting from ODX®.
Methods
All breast cancer patients who underwent ODX® between 2014 and 2018 were retrospectively included in the study. The data selected for analysis were age, menopausal status, pathological and IHC features. IHC was performed with standardized quantitative methods. Dataset was split into two subsets (70% for training and 30% for internal validation). Logistic models were built with statistically significant features for predicting RS ≤ 25 or ≤ 20. An external validation set, provided by another center, was used to test reliability of prediction models.
Results
The internal dataset included 407 patients (Table) who underwent ODX®. Mean age was 53.7 (31-80) and 222 patients (54.55%) were > 50 years old. ODX® results showed: 67 patients (16.6%) between 0-10, 272 patients between 11-25 (66.8%) and 68 pts > 26 (16.6%). At the logistic regression analysis, RS score was significantly associated with ER (p = 0.004), PgR (p < 0.001), and Ki67% (p < 0.001) with the threshold equal to 25. Above patients with RS ≤ 25, the generalized linear regression resulted in a well calibrated model with an AUC of 92.2% (sensitivity 84.2%; specificity 80.1%). External validation set included 180 patients and confirmed the model performance with an AUC of 82.3% and good calibration. A nomogram predicting RS score ≤25 was generated.Table:
261P Tumor characteristics training set + internal test set
Training + internal test set – Tumor characteristics | ||
---|---|---|
Histological subtype classification | Invasive Ductal Carcinoma | 318 pts (78,1%) |
Invasive Lobular Carcinoma | 47 pts (11,5%) | |
Other | 42 pts (10,3%) | |
Grading | 1 | 28 pts (6.8%) |
2 | 268 pts (65,8%) | |
3 | 111 pts (27,3%) | |
pT | 1a | 3 pts (0,7%) |
1b | 38 pts (9,3%) | |
1c | 216 pts (53,1%) | |
2 | 143 pts (35,1%) | |
3 | 6 pts (1,5%) | |
4 | 1 pt (0,3%) | |
pN | 0 | 233 pts (57,2%) |
0i+ | 12 pts (3%) | |
1mic | 43 pts (10,6%) | |
1 | 108 pts (26,5%) | |
NA | 11 pts (2,7%) | |
Mean T diameter [cm] | 1.9 (Range 0,2-8,5) | |
Mean Sentinel Lymph Node (SLN) diameter [mm] | 1.7 (Range 0-40) | |
Mean Axillary Lymph Node (ALN) diameter [mm] | 0.8 (Range 0-25) | |
Mean N Ratio | 0.14 (0.00 – 1.00) | |
SLN involvement [n° of nodes] | 0 | 261 pts (64,1%) |
1 | 112 pts (27,5%) | |
2 | 24 pts (5,8%) | |
3 | 1 pt (0,2%) | |
NA | 9 pts (2,2%) | |
ALN involvement [n° of nodes] | 0 | 338 pts (83%) |
0i+ | 4 pts (1%) | |
1mic | 3 pts (0,7%) | |
1 | 31 pts (7,6%) | |
2 | 8 pts (2%) | |
3 | 5 pts (1,2%) | |
5 | 1 pt (0,2%) | |
NA | 17 pts (4,1%) | |
Multifocality | Yes | 97 pts (23,8%) |
No | 300 pts (73,7%) | |
NA | 10 pts (2.5%) | |
Multicentricity | Yes | 20 pts (4,9%) |
No | 376 pts (92,4%) | |
NA | 11 pts (2,7%) | |
PVI | Absent | 242 pts (59,4%) |
Focal | 51 pts (12,5%) | |
Moderate | 32 pts (7,8%) | |
Massive | 59 pts (14,5%) | |
NA | 23 pts (5,6%) | |
Mean ER expression | 87,9% (Range 1-100) | |
Mean PgR expression | 62.2% (Range 0-100) | |
Mean AR expression | 7.7% (Range 0-90) | |
Mean Ki67% expression | 29.8% (Range 0-90) | |
Her2 Expression | 0 | 187 pts (46%) |
1 | 112 pts (27,5%) | |
2 | 104 pts (25,5%) | |
NA | 4 pts (0,9%) | |
Fluorescence in situ hybridization (FISH) for HER-2 | Not determined | 300 pts (73,7%) |
Not amplificated | 100 pts (23,7%) | |
Undetermined | 1 pt (0,2%) | |
Equivocal | 1 pt (0,2%) |
Conclusions
Quantitative IHC presents a good correlation with RS score in patients with RS ≤ 25, also in external validation set. A nomogram for physician that enhances a cost/effectiveness clinical approach practice has been developed. Prospective clinical application will be tested in further studies.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Fabio Marazzi.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
3180 - Genomic analysis of hepatobiliary lithiasis associated cholangiocarcinoma revealed a distinct subtype feature.
Presenter: Lunda Gu
Session: Poster Display session 2
Resources:
Abstract
4891 - Comparison of the impact of stereotactic body radiation therapy vs. radiofrequency ablation on liver function in patients with single hepatocellular carcinoma: A propensity score matching analysis
Presenter: Masayuki Ueno
Session: Poster Display session 2
Resources:
Abstract
3203 - Exploratory analysis based on tumor location and early metabolic tumor response of REACHIN, a randomized double-blinded placebo-controlled phase II trial of regorafenib after failure of gemcitabine/platinum-based chemotherapy for advanced and metastatic biliary tract tumors.
Presenter: Anne Demols
Session: Poster Display session 2
Resources:
Abstract
1602 - Predictive Value of Neutrophil-Lymphocyte Ratio (NLR) And Platelet-Lymphocyte Ratio (PLR) In Hepatocellular Carcinoma (HCC) Patients Treated with Nivolumab (N)
Presenter: Sirish Dharmapuri
Session: Poster Display session 2
Resources:
Abstract
2848 - Preliminary Safety and Pharmacokinetics of a New Lysosomotropic Oral Agent, GNS561, in a First-in-Human Study in Advanced Primary Liver Cancer Patients
Presenter: Ahmad Awada
Session: Poster Display session 2
Resources:
Abstract
1396 - A phase 1b trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) in unresectable hepatocellular carcinoma (uHCC): updated results
Presenter: Josep Llovet
Session: Poster Display session 2
Resources:
Abstract
1139 - Multicentric prospective study of validation of angiogenesis-related gene polymorphisms in HCC patients treated with sorafenib: Final results of INNOVATE study
Presenter: Andrea Casadei-gardini
Session: Poster Display session 2
Resources:
Abstract
4688 - Prognostic and predictive factors from the phase 3 CELESTIAL trial of cabozantinib (C) versus placebo (P) in previously treated advanced hepatocellular carcinoma (aHCC)
Presenter: Tim Meyer
Session: Poster Display session 2
Resources:
Abstract
1492 - A phase Ib study of pembrolizumab following trans-arterial chemoembolization (TACE) in hepatocellular carcinoma (HCC): PETAL.
Presenter: David Pinato
Session: Poster Display session 2
Resources:
Abstract
3159 - Anlotinib for advanced hepatocellular carcinoma: interim results from the phase II ALTER0802 study
Presenter: AiPing Zhou
Session: Poster Display session 2
Resources:
Abstract