Efficacy and safety of endocrine therapy after mastectomy in patients with hormone receptor positive breast ductal carcinoma in situ: Retrospective cohort study

  1. Nan Niu
  2. Yinan Zhang
  3. Yang Bai
  4. Xin Wang
  5. Shunchao Yan
  6. Dong Song
  7. Hong Xu
  8. Tong Liu
  9. Bin Hua
  10. Yingchao Zhang
  11. Jinchi Liu
  12. Xinbo Qiao
  13. Jiaxiang Liu
  14. Xinyu Zheng  Is a corresponding author
  15. Hongyi Cao  Is a corresponding author
  16. Caigang Liu  Is a corresponding author
  1. Department of Oncology, Shengjing Hospital of China Medical University, China
  2. Department of Nursing, Shengjing Hospital of China Medical University, China
  3. Department of Breast Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, China
  4. Department of Breast Surgery, the First Hospital of Jilin University, China
  5. Department of Breast Surgery, Liaoning Cancer Hospital and Institute, China
  6. Department of Breast Surgery, Cancer Hospital of Harbin Medical University, China
  7. Department of General Surgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, China
  8. Department of Breast Surgery, the Second Hospital of Jilin University, China
  9. Department of Breast Surgery, the First Affiliated Hospital of China Medical University, China
  10. Department of Pathology, the First Affiliated Hospital of China Medical University and College of Basic Medical Sciences, China
3 figures, 4 tables and 2 additional files

Figures

Flowchart of the study.
The DFS of HR+ DCIS patients with or without post-mastectomy ET.

Kaplan-Meier analysis indicated that there was no significant difference in the DFS of HR+ DCIS patients between those with and without post-mastectomy ET. (A) There was no significant difference in the DFS of HR+ DCIS patients with age <50, (B) a larger tumor, (C) positive microinvasive, (D) higher tumor grade, (E) higher Ki67 level, (F) between those with and without post-mastectomy ET. HR, hormone receptor; DCIS, ductal carcinoma in situ; ET, endocrine therapy; DFS, disease-free survival. Source files available in Figure 2—source data 1.

Figure 2—source data 1

The disease-free survival of hormone receptor positive (HR+) ductal carcinoma in situ (DCIS) patients between endocrine therapy (ET) and non-ET groups.

https://cdn.elifesciences.org/articles/83045/elife-83045-fig2-data1-v1.xlsx
The frequency of patients with adverse effects between the ET and non-ET groups.

Data are expressed as % of cases with adverse events and real case numbers labeled and analyzed by Chi-squared test. *p<0.05, ***p<0.001. ET, endocrine therapy. Source files available in Figure 3—source data 1.

Figure 3—source data 1

Adverse events between the endocrine therapy (ET) and non-ET groups.

https://cdn.elifesciences.org/articles/83045/elife-83045-fig3-data1-v1.xlsx

Tables

Table 1
The demographic and clinical characteristics of patients.
ET (N=791)Non-ET (N=216)p-Value
Age (n, %)0.134
≤50448 (57%)110 (51%)
>50343 (43%)106 (49%)
Tumor size (n, %)0.839
≤20 mm459 (58%)127 (59%)
>20 mm332 (42%)89 (41%)
Microinvasive (n, %)0.322
Yes128 (16%)29 (13%)
No663 (84%)187 (87%)
Tumor grade (n, %)0.190
I-II565 (71%)164 (76%)
III226 (29%)52 (24%)
Ki67 (n, %)0.071
≥15%279 (35%)62 (29%)
<15%512 (65%)154 (71%)
Multifocal (n, %)0.310
Yes64 (8%)13 (6%)
No727 (92%)203 (94%)
  1. Notes: Data are n (%). ET, endocrine therapy. Source files available in Table 1—source data 1.

Table 1—source data 1

The demographic and clinical characteristics of patients.

https://cdn.elifesciences.org/articles/83045/elife-83045-table1-data1-v1.xlsx
Table 2
Tumor recurrence rates in patients with HR+ DCIS after mastectomy.
Tumor recurrenceET (N=19)Non-ET (N=4)
Invasive local recurrence4 (21%)0 (0%)
Contralateral breast cancer3 (16%)0 (0%)
Distant metastasis
Bone6 (32%)1 (25%)
Liver2 (11%)2 (50%)
Lung1 (5%)0 (0%)
Brain1 (5%)0 (0%)
Abdominal cavity1 (5%)1 (25%)
Lymph nodes1 (5%)0 (0%)
  1. Notes: Data are n (%). HR, hormone receptor; DCIS, ductal carcinoma in situ; ET, endocrine therapy.

  2. Source files available in Table 2—source data 1.

Table 2—source data 1

Tumor recurrences in patients with hormone receptor positive (HR+) ductal carcinoma in situ (DCIS) after mastectomy.

https://cdn.elifesciences.org/articles/83045/elife-83045-table2-data1-v1.xlsx
Table 3
Stratification analysis of tumor recurrence rates in patients with HR+ DCIS after mastectomy.
CharacteristicET (N=791)Non-ET (N=216)HR (95% CI)p-Value
Total19 (791)4 (216)1.30 (0.48–3.52)0.64
Age
≤5012 (448)1 (110)2.91 (0.74–11.47)0.28
>507 (343)3 (106)0.75 (0.18–3.17)0.67
Tumor size
≤20 mm6 (459)2 (127)0.82 (0.15–4.44)0.81
>20 mm13 (332)2 (89)1.75 (0.51–6.04)0.45
Microinvasive
Yes8 (128)0 (29)3.48 (0.60–20.02)0.16
No11 (663)4 (187)0.76 (0.22–2.59)0.64
Tumor grade
I-II10 (565)0 (164)3.64 (0.82–16.06)0.09
III9 (226)4 (52)0.51 (0.13–2.07)0.26
ER
1–10%4 (165)2 (40)0.47 (0.08–2.67)0.386
>10%15 (626)2 (176)2.14 (0.48–9.43)0.305
Ki67
≥15%7 (279)1 (62)0.88 (0.09–8.29)0.67
<15%12 (512)3 (154)1.42 (0.46–4.38)0.74
Multifocal
Yes3 (64)0 (13)3.34 (0.17–67.46)0.43
No16 (727)4 (203)1.11 (0.38–3.22)0.85
Surgery
Unilateral mastectomy19 (776)4 (215)1.32 (0.45–3.93)0.61
Bilateral mastectomy0 (15)0 (1)
  1. Notes: HR, hormone receptor; DCIS, ductal carcinoma in situ; ET, endocrine therapy.

  2. Source files available in Table 3—source data 1.

Table 4
Adverse events between TAM and AI in the ET group.
Adverse eventsTAM (N=551)AI (N=223)
Total212 (38%)76 (34%)
Musculoskeletal symptoms61 (11%)52 (23%)
Vasomotor symptoms42 (8%)12 (5%)
Gynecological events113 (21%)5 (2%)
Cardiovascular events26 (5%)12 (5%)
Abnormal liver function10 (2%)4 (2%)
  1. Notes: TAM, tamoxifen; AI, aromatase inhibitor; ET, endocrine therapy.

  2. Source files available in Table 4—source data 1.

Table 4—source data 1

Adverse events in the endocrine therapy (ET) group.

https://cdn.elifesciences.org/articles/83045/elife-83045-table4-data1-v1.xlsx

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  1. Nan Niu
  2. Yinan Zhang
  3. Yang Bai
  4. Xin Wang
  5. Shunchao Yan
  6. Dong Song
  7. Hong Xu
  8. Tong Liu
  9. Bin Hua
  10. Yingchao Zhang
  11. Jinchi Liu
  12. Xinbo Qiao
  13. Jiaxiang Liu
  14. Xinyu Zheng
  15. Hongyi Cao
  16. Caigang Liu
(2023)
Efficacy and safety of endocrine therapy after mastectomy in patients with hormone receptor positive breast ductal carcinoma in situ: Retrospective cohort study
eLife 12:e83045.
https://doi.org/10.7554/eLife.83045