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



            Table 2. Univariate logistic regression analysis of factors   Table 3. Multivariate logistic regression analysis of total
            associated with total pathological complete response  pathological complete response predictors
            Variable                Univariate logistic regression  Variable        Multivariate logistic regression
                                    OR     95% CI      p                         Adjusted OR   95% CI     p
            Age (years)                                        Model 1: Full input method N=62
             ≤50                    Ref       -       0.022     Age (years)
                                                                  ≤50               Ref          -       0.999
             >50                   3.491   1.196 – 10.190
                                                                  >50               ≈ 0         0 – 0
            cT
                                                                cN
             1 – 2                  Ref       -       0.492
                                                                  0                 Ref          -       0.962
             3                     0.617   0.156 – 2.447
                                                                  1 – 3             1.067    0.073 – 15.678
            cN                                                  cTNM
             0                      Ref       -       0.001       IIa               Ref          -       0.074
             1 – 3                 0.100   0.025 – 0.401          IIb – IIIc        0.105    0.009 – 1.247
            cTNM                                                HR
             IIa                    Ref       -      <0.001       Negative          Ref          -       0.134
             IIb – IIIc            0.094   0.026 – 0.335          Positive          0.373    0.102 – 1.356
                                                                Menstrual status
            Histological grade
                                                                  Pre-menstrual     Ref          -       0.999
             II                     Ref       -       0.128
                                                                  Post-menstrual     ≈0         0 – 0
             III                   0.179   0.020 – 1.637
                                                               Model 2: Backward screening method N=62
            HR                                                  Age (years)
             Negative               Ref       -       0.037       ≤50               Ref          -       0.034
             Positive              0.311   0.104 – 0.933          >50               3.820    1.104 – 13.225
            Menstrual status                                    cTNM
             Pre-menstrual          Ref       -       0.093       IIa               Ref          -      <0.001
             Post-menstrual        2.516   0.856 – 7.392          IIb – IIIc        0.088    0.023 – 0.338
            BNAT Ki-67                                         Abbreviations: CI: Confidence interval; cN: Clinical lymph node
                                                                                                 th
                                                               staging  (American  Joint  Committee  on  Cancer  8   edition);  cTNM:
             ≤20%                   Ref       -       0.689    Tumor-node-metastasis classification stage; HR: Hormone receptor;
             >20%                  1.383   0.283-6.764         Ki-67: Antigen Kiel 67; OR: Odds ratio; Ref: Reference.
            Abbreviations: BNAT: Baseline assessment before neoadjuvant   chemotherapy, consistent with the aforementioned studies.
            chemotherapy; CI: Confidence interval; cN: Clinical lymph node staging                 ®
                                           th
            (American Joint Committee on Cancer [AJCC] 8  edition); cT: Clinical   This suggests that the efficacy of Zercepac  in treating
                              th
            tumor size staging (AJCC 8  edition); cTNM: Tumor-node-metastasis   HER2-positive breast cancer is essentially equivalent to
            classification stage; HR: Hormone receptor; Ki-67: Antigen Kiel 67;    that of Herceptin. Previous studies  have also confirmed
                                                                                           5,13
            OR: Odds ratio; Ref: Reference.                                                              ®
                                                               that neoadjuvant treatment combining Zercepac  or
                                                               Herceptin with pertuzumab and chemotherapy yields
            scale KRISTINE  study compared six cycles of TCbHP   comparable efficacy and safety profiles. Moreover, a model-
                         12
            (docetaxel, carboplatin, trastuzumab, and pertuzumab)   based economic evaluation in China in 2022 showed that
            with ado-trastuzumab emtansine plus neoadjuvant    Zercepac  is more cost-effective than Herceptin, making
                                                                      ®
            treatment. The tpCR rate in the TCbHP group was 55.7%   it more accessible to patients and aligning with financial
            (123/221), superior to the 44.4% (99/223) observed in the   constraints in healthcare. 14
            control group, thus validating both the efficacy and safety
                                                                                                   ®
            of the TCbHP regimen. In our study, the overall tpCR rate   In addition to these advantages, Zercepac  offers other
            among all patients was 50% (31/62). The highest tpCR rate   benefits. Notably, it does not contain benzyl alcohol as a
            was  55.2%  (16/29),  observed  in  the  group  treated with   preservative, while the 440 mg formulation of Herceptin
                   ®
            Zercepac  (a trastuzumab biosimilar) plus pertuzumab in   available in China still does. Studies have shown that benzyl
            combination with six cycles of docetaxel carboplatin (TCb)   alcohol may reduce the efficacy of protein-based drugs and

            Volume 9 Issue 3 (2025)                        115                         doi: 10.36922/EJMO025100044
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