Pyrotinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (PERSIST): A multicenter phase II trial
- Department of Thyroid and Breast Surgery, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, China
- Department of Thyroid and Breast Surgery, Ningbo Medical Center Lihuili Hospital, China
- Department of Breast Surgery, The First Affiliated Hospital of Wenzhou Medical University, China
- Department of Thyroid and Breast Surgery, Jinhua Municipal Central Hospital, China
- Department of Thyroid and Breast Surgery, Yiwu Central Hospital, China
- Department of Breast Surgery, Ningbo Women and Children's Hospital, China
- Department of Breast Surgery, Yiwu Maternity and Children Hospital, China
- Department of Surgical Oncology, Quzhou People's Hospital, China
- Department of Breast Surgery, The First Affiliated Hospital of Ningbo University, China
- Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, China
Figures
Figure 1
Study flowchart.
Figure 2
Kaplan–Meier estimates of invasive disease-free survival in the full analysis set.
Figure 3
Invasive disease-free survival in different subgroups.
Kaplan–Meier curves for invasive disease-free survival in (A) patients who received 6-month (n = 31) and 1-year pyrotinib treatment (n = 92), (B) patients with hormone receptor-positive breast cancer (n = 64) and hormone receptor-negative breast cancer (n = 77), (C) patients with lymph node-positive breast cancer (n = 107) and patients with lymph node-negative breast cancer (n = 34), and (D) patients who received adjuvant therapy with trastuzumab (n = 92) and trastuzumab plus pertuzumab (n = 49).
Tables
Table 1
Baseline characteristics of patients in the full analysis set.
| Variables | All (n = 141) |
|---|---|
| Age (years), median (range) | 50 (25–72) |
| T stage, n (%) | |
| T1 | 43 (30.5%) |
| T2 | 83 (58.9%) |
| T3 | 11 (7.8%) |
| T4 | 2 (1.4%) |
| Unable to determine | 2 (1.4%) |
| Nodal status, n (%) | |
| Negative | 34 (24.1%) |
| 1–3 positive nodes | 49 (34.8%) |
| >3 positive nodes | 58 (41.1%) |
| Hormone receptor status, n (%) | |
| Negative (ER and PR negative) | 77 (54.6%) |
| Positive (ER positive, PR positive, or both) | 64 (45.4%) |
| Ki-67, n (%) | |
| ≥20% | 119 (84.4%) |
| <20% | 22 (15.6%) |
| Previous neoadjuvant therapy, n (%) | 26 (17.7%) |
| Previous adjuvant therapy, n (%) | |
| Trastuzumab | 92 (65.2%) |
| Trastuzumab plus pertuzumab | 49 (34.8%) |
-
Tumors were assessed as being ER or PR positive with a threshold of 1%.
-
ER, estrogen receptor; PR, progesterone receptor.
Table 2
Treatment-emergent adverse events occurring in at least 10% of the patients.
| Events, n (%) | All (n = 141) | |
|---|---|---|
| Any grade | Grade 3 | |
| Diarrhea | 112 (79.4%) | 43 (30.5%) |
| Fatigue | 52 (36.9%) | 0 |
| Lymphocyte count decreased | 52 (36.9%) | 0 |
| Nausea | 47 (33.3%) | 0 |
| Hand-foot syndrome | 47 (33.3%) | 1 (0.7%) |
| Hyperuricemia | 33 (23.4%) | 0 |
| White blood cell count decreased | 26 (18.4%) | 0 |
| Dizziness | 26 (18.4%) | 0 |
| Anemia | 24 (17.0%) | 0 |
| Vomiting | 22 (15.6%) | 0 |
| Headache | 19 (13.5%) | 0 |
| Creatinine increased | 17 (12.1%) | 0 |
| Neutrophil count decreased | 16 (11.3%) | 0 |
Additional files
-
MDAR checklist
- https://cdn.elifesciences.org/articles/101724/elife-101724-mdarchecklist1-v1.docx
-
Source data 1
Processed raw data (with all private patient information removed).
- https://cdn.elifesciences.org/articles/101724/elife-101724-data1-v1.xlsx
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Pyrotinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (PERSIST): A multicenter phase II trial
eLife 13:RP101724.
https://doi.org/10.7554/eLife.101724.3
