Editor’s note: HER2-positive metastatic breast cancer (HER2+ MBC) has seen the emergence of several new drugs, but the combination of Pyrotinib with dual targeting therapy remains the preferred first-line option. Recently, ESMO Congress reported a multicenter real-world study that retrospectively analyzed the efficacy and safety of Pyrotinib combined with Trastuzumab (PyroH) compared to Pertuzumab combined with Trastuzumab (HP), providing new insights for clinical decision-making. During this year’s ESMO Congress, a Chinese multicenter study led by Dr. Biyun Wang from Fudan University-affiliated Cancer Hospital, the YOUNGBC-21 study, will be presented as a poster (Abstract No: 427P, titled “Pyrotinib plus trastuzumab versus pertuzumab plus trastuzumab in patients with HER2-positive metastatic breast cancer: A multicenter, retrospective study”).
Pyrotinib and Pertuzumab are both effective therapies for HER2-positive metastatic breast cancer (HER2+ MBC). However, there has been no direct comparison between Pyrotinib combined with Trastuzumab (PyroH) and Pertuzumab combined with Trastuzumab (HP) in the treatment of this condition.A retrospective analysis was conducted on HER2+ MBC patients treated with PyroH plus chemotherapy or HP plus chemotherapy at five Chinese institutions from 2017 to 2022 (NCT05572645), excluding patients with incomplete medical records. The primary endpoints of the study were progression-free survival (PFS) and treatment safety.
Research Findings:
In late first-line treatment, HP showed numerically better efficacy (median PFS 22.90 months vs. 14.46 months, P=0.057). However, in second-line and beyond advanced salvage treatment, there was no significant difference in PFS between the PyroH and HP groups (median PFS 8.67 vs. 7.92 months, P=0.286).
Figure 1 Survival curves for late first-line treatment (a) and second-line and beyond treatment (b).
In the overall patient population, although HP had a longer overall PFS (median PFS: 9.30 vs. 13.01 months, P=0.005), it was not an independent predictor of PFS in multivariate analysis (HR 1.134, 95% CI 0.710-1.811, P=0.598). In patients not receiving taxane chemotherapy, PyroH showed significantly better PFS compared to the HP group (median PFS: 10.12 vs. 8.15 months, P=0.017).
Figure 2 Survival curves for patients not receiving taxane chemotherapy (a) and those receiving taxane chemotherapy (b).
In the treatment of patients with brain metastases, PyroH and HP groups had similar PFS (median PFS: 9.03 vs. 8.15 months, p=0.955).
Figure 3 Survival curves for patients with brain metastases (a) and patients without brain metastases (b).
In terms of adverse events, the PyroH group had a significantly higher rate of grade 3/4 diarrhea compared to the HP group (34.3% vs. 3.0%), but the two groups had similar overall adverse events.
Research Conclusion:
In the real world, first-line treatment for HER2+ MBC patients more commonly involved the HP regimen, while patients who chose PyroH were often those with brain metastases or issues related to drug accessibility. The efficacy analysis showed that HP retained its first-line treatment position when combined with taxane chemotherapy, but PyroH demonstrated similar efficacy in second-line and subsequent treatments and in patients with brain metastases. Furthermore, when combined with non-taxane chemotherapy, PyroH even showed better efficacy. This study provides valuable insights for future clinical decision-making. It’s worth noting that the number of patients using PyroH in the first-line setting in this study was limited, and we look forward to prospective studies to validate these results.
Professor Bingyun Wang
Director of the Department of Breast and Urological Oncology, Fudan University-affiliated Cancer Hospital
Dr. Yizhao Xie
Resident Physician, Department of Oncology, Fudan University-affiliated Zhongshan Hospital
