Personalizing Neoadjuvant Chemotherapy: The Impact of BRCA Variants on Pathologic Complete Response in Luminal B Breast Cancer
Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Patient Characteristics
- History of synchronous or previous systemic malignant cancer;
- Previous ipsilateral or contralateral breast cancer;
- Stage IV at diagnosis;
- Evidence of metastatic spread during NACT;
- Indication for hormonal neoadjuvant therapy.
2.2. Treatment Plan
2.3. Endpoints
2.4. Statistical Analysis
3. Results
3.1. Epidemiological Characteristics
3.2. Radiological Assessment
3.3. Surgical Treatment
3.4. Pathological Evaluation
3.5. Follow-Up Outcomes
3.6. Oncological Outcomes
3.7. Univariate and Multivariable Analysis
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
NACT | neoadjuvant chemotherapy |
pCR | pathologic complete response |
BRCA PVs | pathogenic variants in the BRCA gene |
BRCA WT | BRCA wild-type gene |
LR-DFS | locoregional disease-free survival |
DDFS | distant disease-free survival |
OS | overall survival |
MDT | multidisciplinary team |
References
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Characteristics | 495 Patients | BRCA WT 442 (89.3%) | BRCA PV 53 (10.7%) | p-Value |
---|---|---|---|---|
Epidemiological Characteristics | ||||
Age (years) | 50 ± 10.6 (58.9; 42.3–56.2) | 50.9 ± 10.3 (49.9; 43.8–57.5) | 41.7 ± 9.5 (40.2; 34.7–46.5) | p < 0.0001 |
Menopausal status | 236 (47.7%) | 226 (51.1%) | 10 (18.9%) | p < 0.0001 |
BMI (Kg/m2) | 25.3 ± 5 (24.2; 22.0–27.3) | 25.4 ± 5 (24.3; 22.2–27.4) | 24.5 ± 4.7 (23.9; 21.1–26.9) | p = 0.234 |
Biological Characteristics | ||||
Histotype | p = 0.871 | |||
- Ductal | 316 (63.8%) | 283 (64.0%) | 33 (62.3%) | |
- Lobular | 39 (7.9%) | 34 (7.7%) | 5 (9.4%) | |
- Other | 140 (28.3%) | 125 (28.3%) | 15 (28.3%) | |
Grading | p = 0.371 | |||
- G1 | 1 (0.2%) | 1 (0.2%) | 0 (0%) | |
- G2 | 183 (37.0%) | 167 (37.8%) | 16 (30.2%) | |
- G3 | 311 (62.8%) | 274 (62.0%) | 37 (69.8%) | |
Estrogen Receptor | p = 0.135 | |||
- Negative | 19 (3.8%) | 15 (3.4%) | 4 (7.5%) | |
- Positive | 476 (96.2%) | 427 (96.6%) | 49 (92.5%) | |
Progesterone Receptor | p = 0.839 | |||
- Negative | 72 (14.5%) | 64 (14.5%) | 8 (15.1%) | |
- Positive | 423 (85.5%) | 378 (85.5%) | 45 (84.9%) | |
Androgen Receptor | p = 0.837 | |||
- Negative | 71 (14.3%) | 63 (14.3%) | 8 (15.1%) | |
- Positive | 424 (85.7%) | 379 (85.7%) | 45 (84.9%) | |
Ki67 | p = 0.160 | |||
- <20% | 4 (0.8%) | 4 (0.9%) | 0 (0%) | |
- 20–50% | 306 (61.8%) | 279 (63.1%) | 27 (50.9%) | |
- >50% | 185 (37.4%) | 159 (36.0%) | 26 (49.1%) | |
HER2 | p = 0.698 | |||
- 0 | 175 (36.0%) | 154 (35.4%) | 21 (41.2%) | |
- 1+ | 166 (34.2%) | 149 (34.3%) | 17 (33.3%) | |
- 2+ | 145 (29.8%) | 132 (30.3%) | 13 (25.5%) |
Characteristics | 495 Patients | BRCA WT 442 (89.3%) | BRCA PV 53 (10.7%) | p-Value |
---|---|---|---|---|
Baseline | ||||
Cancer size (mm) | 39.7 ± 20.2 (35; 25.0–50.0) | 39.7 ± 20.1 (35; 26.0–50.0) | 40.1 ± 21.6 (35; 25.0–50.0) | p = 0.881 |
Multifocality/Multicentricity | 227 (45.9%) | 205 (46.4%) | 22 (41.5%) | p = 0.561 |
Clinical T stage | p = 0.143 | |||
- cT0 | 3 (0.6%) | 3 (0.7%) | 0 (0%) | |
- cT1 | 52 (10.5%) | 42 (9.5%) | 10 (18.9%) | |
- cT2 | 301 (60.8%) | 273 (61.8%) | 28 (52.8%) | |
- cT3 | 86 (17.4%) | 74 (16.7%) | 12 (22.6%) | |
- cT4 | 53 (10.7%) | 50 (11.3%) | 3 (5.7%) | |
Clinical N stage | p = 0.738 | |||
- cN0 | 152 (30.7%) | 134 (30.3%) | 18 (34.0%) | |
- cN1 | 229 (46.3%) | 206 (46.6%) | 23 (43.4%) | |
- cN2 | 95 (19.2%) | 86 (19.5%) | 9 (17.0%) | |
- cN3 | 19 (3.8%) | 16 (3.6%) | 3 (5.7%) | |
Stage of cancer | p = 0.064 | |||
- 1A | 14 (2.8%) | 9 (2.0%) | 5 (9.4%) | |
- 1B | 30 (6.1%) | 26 (5.9%) | 4 (7.5%) | |
- 2A | 98 (19.8%) | 88 (19.9%) | 10 (18.9%) | |
- 2B | 164 (33.1%) | 150 (33.9%) | 14 (26.4%) | |
- 3A | 118 (23.8%) | 105 (23.8%) | 13 (24.5%) | |
- 3B | 51 (10.3%) | 48 (10.9%) | 3 (5.7%) | |
- 3C | 20 (4.0%) | 16 (3.6%) | 4 (7.5%) | |
Radiological Features Post-NACT | ||||
RECIST criteria | p = 0.003 | |||
- Complete response | 126 (26.2%) | 106 (24.7%) | 20 (38.5%) | |
- Partial response | 230 (47.8%) | 202 (47.1%) | 28 (53.8%) | |
- Stable disease | 114 (23.7%) | 111 (25.9%) | 3 (5.8%) | |
- Progressive disease | 11 (2.3%) | 10 (2.3%) | 1 (1.9%) | |
Overall Response Rate | 356 (74.0%) | 308 (71.8%) | 48 (92.3%) | p = 0.001 |
Residual cancer size (mm) | 18.4 ± 18.3 (15; 0.03–46.0) | 19.1 ± 18.2 (16; 3.1–28.0) | 12.5 ± 17.6 (8.5; 0–17.3) | p = 0.014 |
Characteristics | 495 Patients | BRCA WT 442 (89.3%) | BRCA PV 53 (10.7%) | p-Value |
---|---|---|---|---|
Breast Surgery | ||||
Type of Surgery: | p < 0.0001 | |||
- Lumpectomy/Quadrantectomy | 208 (42.0%) | 201 (45.5%) | 7 (13.2%) | |
- Level II Oncoplastic Surgery | 71 (14.3%) | 68 (15.4%) | 3 (5.7%) | |
- Conservative Mastectomy | 164 (33.1%) | 124 (28.1%) | 40 (75.5%) | |
- Radical Mastectomy | 52 (10.5%) | 49 (11.1%) | 3 (5.7%) | |
Axillary Surgery | ||||
Sentinel Node Biopsy | 385 (77.8%) | 342 (77.4%) | 43 (81.1%) | p = 0.604 |
Axillary Dissection | 329 (66.5%) | 302 (68.3%) | 27 (50.9%) | p = 0.014 |
Characteristics | 495 Patients | BRCA WT 442 (89.3%) | BRCA PV 53 (10.7%) | p-Value |
---|---|---|---|---|
Breast | ||||
pCR | 59 (11.9%) | 48 (10.9%) | 11 (20.8%) | p = 0.044 |
Breast pCR | 83 (16.8%) | 68 (15.4%) | 15 (28.3%) | p = 0.030 |
Node pCR * | 67 (13.5%) | 55 (12.4%) | 12 (22.6%) | p = 0.054 |
ypT | p = 0.005 | |||
- 0 | 83 (16.8%) | 68 (15.4%) | 15 (28.3%) | |
- 1 | 279 (56.4%) | 248 (56.1%) | 31 (58.5%) | |
- 2 | 106 (21.4%) | 102 (23.1%) | 4 (7.5%) | |
- 3 | 21 (4.2%) | 20 (4.5%) | 1 (1.9%) | |
- 4 | 6 (1.2%) | 4 (0.9%) | 2 (3.8%) | |
Axillary | ||||
Sentinel Node Biopsy | ||||
- Removed lymph nodes | 4.69 (5; 1–7) | 4.70 (5; 1–7) | 4.69 (5; 2–7) | p = 0.827 |
- Positive lymph nodes | 0.71 (0; 0–6) | 0.73 (0; 0–6) | 0.61 (0; 0–5) | p = 0.652 |
Axillary Dissection | ||||
- Removed lymph nodes | 14.01 (13; 8–45) | 14 (13; 8–45) | 14.08 (13; 9–25) | p = 0.943 |
- Positive lymph nodes | 3.39 (2; 0–33) | 3.5 (2; 4.24–33) | 2.08 (1; 0–16) | p = 0.095 |
ypN | p = 0.061 | |||
- 0 | 153 (30.9%) | 131 (29.6%) | 22 (41.5%) | |
- 1 | 228 (46.1%) | 202 (45.7%) | 26 (49.1%) | |
- 2 | 94 (19.0%) | 90 (20.4%) | 4 (7.5%) | |
- 3 | 20 (4.0%) | 19 (4.3%) | 1 (1.9%) |
Characteristics | 495 Patients | BRCA WT 442 (89.3%) | BRCA PV 53 (10.7%) | p-Value |
---|---|---|---|---|
Locoregional recurrence | ||||
Total | 51 (10.3%) | 39 (8.8%) | 12 (22.6%) | p = 0.006 |
- Axilla | 20 (4.0%) | 17 (3.8%) | 3 (5.7%) | |
- Breast | 25 (5.1%) | 18 (4.1%) | 7 (13.2%) | |
- Both Axilla and Breast | 6 (1.2%) | 4 (0.9%) | 2 (3.8%) | |
Systemic recurrence | ||||
95 (19.2%) | 85 (19.2%) | 10 (18.9%) | p = 1.000 | |
Exitus | ||||
62 (12.5%) | 55 (12.4%) | 7 (13.2%) | p = 0.828 |
Characteristics | Univariate Analysis | Multivariable Analysis | ||||
---|---|---|---|---|---|---|
OR | p-Value | 95% CI | OR | p-Value | 95% CI | |
Age (years) | 0.969 | 0.027 | 0.943–0.996 | 0.735 | ||
Menopausal Status | ||||||
- No | Ref. | Ref. | Ref. | |||
- Yes | 0.725 | 0.253 | 0.417–1.259 | |||
BRCA PV | 0.738 | |||||
- No | Ref. | Ref. | Ref. | |||
- Yes | 2.150 | 0.039 | 1.038–4.454 | |||
Histotype | 0.965 | |||||
- DIC | 0.923 | 0.789 | 0.513–1.659 | |||
- LIC | 0.010 | 0.998 | 0.002–0.001 | |||
- IC NST | Ref. | Ref. | Ref. | |||
Grading | 0.102 | |||||
- 1 | Ref. | Ref. | Ref. | |||
- 2 | 0.001 | 1.000 | 0.002–0.001 | |||
- 3 | 0.001 | 1.000 | 0.002–0.001 | |||
Estrogen Receptor | ||||||
- Negative | 3.684 | 0.011 | 1.342–10.100 | 6.053 | 0.038 | 1.103–33.224 |
- Positive | Ref. | Ref. | ||||
Progesterone Receptor | ||||||
- Negative | 2.028 | 0.036 | 1.048–3.925 | 0.342 | ||
- Positive | Ref. | |||||
Androgen Receptor | ||||||
- Negative | 1.077 | 0.855 | 0.488–2.377 | |||
- Positive | Ref. | |||||
Ki67 | 1.037 | <0.0001 | 1.023–1.052 | 1.037 | <0.0001 | 1.017–1.057 |
cT | 0.002 | 0.096 | ||||
- 0 | Ref. | |||||
- 1 | 0.889 | 0.926 | 0.075–10.526 | |||
- 2 | 0.315 | 0.351 | 0.028–3.557 | |||
- 3 | 0.024 | 0.018 | 0.001–0.526 | |||
- 4 | 0.001 | 0.997 | 0.001–0.002 | |||
cN | 0.120 | |||||
- 0 | Ref. | |||||
- 1 | 0.515 | 0.033 | 0.280–0.947 | |||
- 2 | 0.570 | 0.158 | 0.261–1.243 | |||
- 3 | 0.269 | 0.211 | 0.034–2.107 | |||
Stage | 0.001 | 0.618 | ||||
- 1A | Ref. | |||||
- 1B | 0.485 | 0.287 | 0.128–1.838 | |||
- 2A | 0.342 | 0.071 | 0.106–1.098 | |||
- 2B | 0.124 | 0.001 | 0.038–0.410 | |||
- 3A | 0.123 | 0.001 | 0.036–0.427 | |||
- 3B | 0.001 | 0.997 | 0.000 – | |||
- 3C | 0.070 | 0.022 | 0.007–0.681 | |||
Radiological Assessment (RECIST) | <0.0001 | <0.0001 | ||||
- Complete Response | Ref. | Ref. | ||||
- Partial Response | 0.084 | <0.0001 | 0.042–0.171 | 0.081 | <0.0001 | 0.036–0.182 |
- Stable Disease | 0.015 | <0.0001 | 0.002–0.110 | 0.015 | <0.0001 | 0.002–0.121 |
- Progressive Disease | 0.000 | 0.999 | 0.000 – | 0.000 | 0.999 | 0.000 |
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Di Leone, A.; Franco, A.; Castagnetta, V.; Silenzi, M.; Accetta, C.; Carnassale, B.; D’Archi, S.; De Lauretis, F.; Di Guglielmo, E.; Gagliardi, F.; et al. Personalizing Neoadjuvant Chemotherapy: The Impact of BRCA Variants on Pathologic Complete Response in Luminal B Breast Cancer. Cancers 2025, 17, 1619. https://doi.org/10.3390/cancers17101619
Di Leone A, Franco A, Castagnetta V, Silenzi M, Accetta C, Carnassale B, D’Archi S, De Lauretis F, Di Guglielmo E, Gagliardi F, et al. Personalizing Neoadjuvant Chemotherapy: The Impact of BRCA Variants on Pathologic Complete Response in Luminal B Breast Cancer. Cancers. 2025; 17(10):1619. https://doi.org/10.3390/cancers17101619
Chicago/Turabian StyleDi Leone, Alba, Antonio Franco, Virginia Castagnetta, Marta Silenzi, Cristina Accetta, Beatrice Carnassale, Sabatino D’Archi, Flavia De Lauretis, Enrico Di Guglielmo, Federica Gagliardi, and et al. 2025. "Personalizing Neoadjuvant Chemotherapy: The Impact of BRCA Variants on Pathologic Complete Response in Luminal B Breast Cancer" Cancers 17, no. 10: 1619. https://doi.org/10.3390/cancers17101619
APA StyleDi Leone, A., Franco, A., Castagnetta, V., Silenzi, M., Accetta, C., Carnassale, B., D’Archi, S., De Lauretis, F., Di Guglielmo, E., Gagliardi, F., Magno, S., Moschella, F., Natale, M., Sanchez, A. M., Scardina, L., Masetti, R., & Franceschini, G. (2025). Personalizing Neoadjuvant Chemotherapy: The Impact of BRCA Variants on Pathologic Complete Response in Luminal B Breast Cancer. Cancers, 17(10), 1619. https://doi.org/10.3390/cancers17101619