Page 120 - EJMO-9-3

Eurasian Journal of
Medicine and Oncology Zercepac + pyrotinib versus pertuzumab in HER2+ BC
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2. Materials and methods • Py (Jiangsu Hengrui, China): 400 mg orally once daily
(eight patients).
2.1. Study population
A retrospective analysis was performed on clinical data 2.2.3. Monitoring and supportive care
from 62 patients with HER2-positive breast cancer who (i) Tumor response was assessed through ultrasound at
received neoadjuvant therapy (Zercepac combined each cycle, with supplemental breast magnetic resonance
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with Py or pertuzumab and chemotherapy), followed by imaging conducted at baseline and before surgery.
surgical resection at the Breast Diagnosis and Treatment (ii) Pretreatment laboratory tests (complete blood count,
Center of Anhui Cancer Hospital between February 2021 hepatic/renal function, electrolytes) were mandatory
and December 2023. before each treatment cycle. Chemotherapy was
(i) Inclusion criteria: Only patients with previously administered only if no contraindications were
untreated HER2-positive breast cancer were included identified.
(excluding those who had received radiotherapy or (iii) Granulocyte colony-stimulating factor was
targeted therapy before neoadjuvant treatment); administered according to the National Comprehensive
(ii) Exclusion criteria: Patients who received fewer than Cancer Network guidelines for hematologic support.
six treatment cycles (n=3) or experienced surgical (iv) Surgery was performed 14 days after completion of
delays exceeding 4 weeks (n=2) were excluded; neoadjuvant therapy, followed by 1 year of adjuvant-
(iii) Grouping basis: Treatment regimens were determined targeted therapy.
by a multidisciplinary team based on guideline (v) Left ventricular ejection fraction (LVEF) was
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recommendations and were not selected by the measured before initiating Zercepac (HLX02)
patients. treatment and monitored regularly during therapy.
Zercepac (HLX02) treatment was discontinued for
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2.2. Neoadjuvant treatment regimens and surgical at least 4 weeks under the following conditions, with
approaches LVEF re-evaluated every 4 weeks:
2.2.1. Neoadjuvant Therapy protocols (a) If the absolute value of LVEF decreased by ≥16%
from baseline. If LVEF returned to the normal
Treatment regimens and dosages were administered in range or the decrease was ≤15% within 4 – 8 weeks,
accordance with institutional guidelines and the drug Zercepac (HLX02) could be resumed.
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manufacturer’s specifications. The NAT regimens included: (b) The use of Zercepac (HLX02) should be stopped
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(i) TCbHP (29 cases): Docetaxel + carboplatin + permanently if LVEF continued to decline for
trastuzumab (H) + pertuzumab (P) more than 8 weeks, or if treatment was interrupted
(ii) TCbHPy (eight cases): Docetaxel + carboplatin + more than 3 times due to cardiotoxicity.
trastuzumab (H) + Py (vi) During Zercepac (HLX02) treatment, LVEF was
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(iii) THP (nine cases): Docetaxel + trastuzumab (H) + assessed every 3 months and again at the end of the
pertuzumab (P) therapy. Following completion of treatment, LVEF
(iv) TCbH (16 cases): Docetaxel + carboplatin + was monitored every 6 months for at least 2 years.
trastuzumab (H)
All patients received six treatment cycles at 21-day 2.2.4. Py-specific diarrhea prophylaxis
intervals. Patients receiving Py were administered triple antidiarrheal
therapy:
2.2.2. Drug administration details
(i) Bifidobacterium: One sachet 3 times daily.
• Docetaxel (Qilu Pharmaceutical, China): 75 mg/m (ii) Montmorillonite powder: One sachet 3 times daily.
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(all patients). (iii) Loperamide: Two tablets as needed (maximum six
• Carboplatin (Qilu Pharmaceutical, China): 400 – tablets per day).
500 mg/m (53 patients).
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• Anti-HER2 agents: 2.3. Efficacy evaluation
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• Zercepac (S20200019, Shanghai Fosun Pharma, Clinical efficacy was assessed according to Response
China): Initial dose 8 mg/kg, reduced to 6 mg/kg in Evaluation Criteria in Solid Tumors, version 1.1.
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subsequent cycles (all patients). Pathological response post-neoadjuvant therapy was
• Pertuzumab (S20180029, Shanghai Roche, China): evaluated using the Miller–Payne (MP) grading system,
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Initial dose 840 mg, adjusted to 420 mg after the which categorizes tumor regression based on histological
loading dose (38 patients). examination of surgical specimens.

Volume 9 Issue 3 (2025) 112 doi: 10.36922/EJMO025100044