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Eurasian Journal of
Medicine and Oncology Zercepac + pyrotinib versus pertuzumab in HER2+ BC
®

Table 5. Treatment‑related adverse events by regimen
Regimen TCbH (n=16) TCbHP (n=29) TCbHPy (n=8) THP (n=9) χ 2 p
Adverse cardiac events (n [%])
ST-segment changes 3 (18.75%) 1 (3.45%) 1 (12.50%) 0 (0%) 4.30 0.23
Clockwise or counterclockwise rotation 2 (12.50%) 3 (10.34%) 0 (0%) 0 (0%) 2.12 0.55
Premature atrial/ventricular contractions 1 (6.25%) 2 (25.00%) 0 (0%) 2 (22.22%) 8.14 0.04
Sinus arrhythmia a 2 (12.50%) 5 (17.24%) 0 (0%) 0 (0%) 3.21 0.36
Conduction block 3 (18.75%) 0 (0%) 0 (0%) 0 (0%) 9.06 0.03
Low QRS voltage 1 (6.25%) 1 (3.45%) 0 (0%) 0 (0%) 1.04 0.79
Left axis deviation 0 (0%) 0 (0%) 1 (12.50%) 1 (11.11%) 5.50 0.14
Left ventricular hypertrophy 2 (12.50%) 1 (3.45%) 0 (0%) 0 (0%) 3.03 0.39
Adverse reactions (n [%])
Alopecia 15 (93.75%) 25 (86.21%) 8 (100%) 9 (100%) 2.85 0.42
Nausea 5 (31.25%) 17 (58.62%) 3 (37.50%) 5 (55.56%) 3.66 0.30
Diarrhea 0 (0%) 1 (3.45%) 8 (100%) 1 (11.11%) 48.29 < 0.001
Abdominal pain 1 (6.25%) 4 (13.80%) 0 (0%) 0 (0%) 2.85 0.42
Low white blood cell count 1 (6.25%) 5 (17.24%) 2 (25.00%) 0 (0%) 3.49 0.32
Low hemoglobin 5 (31.25%) 2 (6.90%) 0 (0%) 0 (0%) 9.09 0.03
Low platelet count 3 (18.75%) 5 (17.24%) 0 (0%) 0 (0%) 3.49 0.32
Abnormal liver function 3 (18.75%) 9 (31.03%) 1 (12.50%) 1 (11.11%) 2.46 0.48
Arthralgia 2 (12.50%) 3 (10.34%) 0 (0%) 1 (11.11%) 1.04 0.79
Anemia 2 (12.50%) 14 (48.28%) 3 (37.50%) 3 (33.33%) 5.80 0.12
Notes: Sinus arrhythmia refers to irregular heart rhythm or tachycardia. Data are presented as n (%). Statistical method: Chi-square test.
a
Abbreviations: TCbH: Docetaxel + carboplatin + trastuzumab; TCbHP: Docetaxel + carboplatin + trastuzumab + pertuzumab; TCbHPy: Docetaxel +
carboplatin +trastuzumab + pyrotinib; THP: Docetaxel + trastuzumab + pertuzumab.

ongoing. As early as 2020, Xuhong et al. conducted a phase response to adverse reactions such as diarrhea, thus affecting
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II clinical trial involving 19 patients, reporting a tpCR rate treatment efficacy. In a study involving 267 patients with
of 73.7% for Py combined with the EC-TH (epirubicin/ advanced HER2-positive breast cancer, the PHOEBE
20
cyclophosphamide followed by docetaxel/trastuzumab) trial confirmed that the median progression-free survival
regimen in the neoadjuvant treatment of HER2-positive (PFS) was significantly longer in the Py group compared
locally advanced breast cancer. The main adverse reactions to the lapatinib group (median PFS: 12.5 months versus
were diarrhea and leukopenia. Mao et al. found that 6.8 months; hazard ratio [HR] = 0.39, p<0.001). The ORR
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among 97 patients treated with Py-based neoadjuvant was also higher in the Py group than in the lapatinib group
therapy, the tpCR rate was 48.5%. The incidence of grade 3 (67.2% versus 51.5%, p=0.016), with the median duration
or higher adverse reactions was 35.1%, with diarrhea being of the response being 11.1 months versus 7.0 months,
the most common, occurring in 63.9% of patients. A real- respectively. Subgroup analysis revealed that among
world study by Fu et al. reported a tpCR rate of 44.7% patients with brain metastases, PFS remained significantly
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in the trastuzumab + Py group. The lower rate compared prolonged in the Py group (HR = 0.32). In addition, the
to the first prospective cohort study, and its similarity to Phase II PERMEATE study, which targeted patients with
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the retrospective cohort study, may be attributed to dose asymptomatic brain metastases, confirmed that Py could
reductions or treatment discontinuation caused by grade 3 effectively cross the blood–brain barrier, achieving an ORR
or higher adverse reactions. The study further confirmed of 74.6% and improving the prognosis of patients with
that there was a statistically significant difference in tpCR brain metastases from HER2-positive breast cancer.
rates based on Py dose reductions and the occurrence of
grade 3 or higher adverse reactions in the trastuzumab + Py In our study, the tpCR rate for the trastuzumab + Py
group. In addition, patient compliance was lower in real- group combined with six cycles of TCb chemotherapy was
world settings than in strictly controlled clinical studies; 37.5% (3/8), which was lower than the rates reported in
some patients reduced or discontinued medication in the aforementioned prospective and real-world studies.

Volume 9 Issue 3 (2025) 117 doi: 10.36922/EJMO025100044