Pyrotinib in the first-line treatment of HER2-positive advanced breast cancer: Results from the PRETTY study.
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e13016 Background: Pyrotinib is an irreversible tyrosine kinase inhibitor that inhibits EGFR, HER2, and HER4. Multiple studies have demonstrated the efficacy and safety of pyrotinib in HER2-positive advanced breast cancer. The phase 3 PHILA study demonstrated that pyrotinib combined with trastuzumab and chemotherapy achieved promising efficacy in the first-line treatment of HER2-positive advanced breast cancer. Here we supplemented real-world evidence on first-line use of pyrotinib. Methods: The PRETTY study was a nationwide, prospective observational study conducted at 61 sites in China from August 2019 to November 2021, enrolling 1129 patients with HER2-positive advanced breast cancer treated with pyrotinib-based regimens. The primary outcome was real-world progression-free survival (rwPFS). This analysis focused on the effectiveness data of patients in the first-line group. Results: A total of 437 patients receiving first-line pyrotinib treatment were included, of whom 81 (18.5%) received pyrotinib-trastuzumab-based therapy and 356 (81.5%) received pyrotinib-based therapy without trastuzumab. Among them, 304 patients (69.6%) had previously been treated with trastuzumab, and 55 (12.6%) had received both trastuzumab and pertuzumab. In univariable analysis, patients with de novo disease (p < 0.001), visceral metastases (p < 0.001), brain metastases (p = 0.004), or a treatment-free interval from previous adjuvant therapy (TFI) ≥24 months (p = 0.003) were more likely to receive pyrotinib-trastuzumab based therapy. Multivariable logistic regression showed that patients with a TFI ≥24 months were more likely to receive pyrotinib-trastuzumab based therapy (odds ratio: 0.32, 95% CI, 0.13-0.77, p = 0.01), while trastuzumab-treated patients were more likely to receive pyrotinib-based therapy (odds ratio: 2.62, 95% CI, 1.28-5.37, p = 0.008). By the data cutoff date on May 29, 2022, the median follow-up duration was 11.8 (IQR, 7.2-16.9) months, the median rwPFS for the overall first-line population was 17.8 months (95% CI, 15.2-24.9). The rwPFS was not reached (NR) (95% CI, NR-NR) with pyrotinib-trastuzumab based therapy and 17.8 months (95% CI, 14.5-21.2) with pyrotinib-based therapy. In trastuzumab-treated patients, the median rwPFS was 19.9 months (95% CI, 17.1-22.7), and in trastuzumab-pertuzumab-treated patients, the median rwPFS was 24.9 months (95% CI, NR-NR). Conclusions: In real world, patients who received first-line pyrotinib-trastuzumab-based regimens achieved favorable effectiveness. With the continuous development of anti-HER2 therapy in the early stage, further exploration of pyrotinib-based regimens in the first-line treatment of HER2-positive advanced breast cancer is warranted. Clinical trial information: NCT04158505 .
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Pyrotinib in the first-line treatment of HER2-positive advanced breast cancer: Results from the PRETTY study.
- Date Crossref
- 01/06/2025
- Éditeur
- American Society of Clinical Oncology (ASCO)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
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Chinese Academy of Medical Sciences & Peking Union Medical College pays non établi dans la noticeUniversité ou école supérieure
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Tianjin Medical University Cancer Institute and Hospital pays non établi dans la noticeÉtablissement de santé
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Hubei Cancer Hospital pays non établi dans la noticeÉtablissement de santé
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Hunan Cancer Hospital pays non établi dans la noticeÉtablissement de santé
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Harbin Medical University pays non établi dans la noticeUniversité ou école supérieure
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Third Affiliated Hospital of Harbin Medical University pays non établi dans la noticeÉtablissement de santé
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Soochow University Department of Oncology pays non établi dans la noticeUniversité ou école supérieure
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First Affiliated Hospital of Soochow University pays non établi dans la noticeÉtablissement de santé
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Shandong University Department of Medical Oncology pays non établi dans la noticeUniversité ou école supérieure
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Shandong Tumor Hospital pays non établi dans la noticeÉtablissement de santé
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Shandong First Medical University pays non établi dans la noticeUniversité ou école supérieure
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Xuzhou Medical College pays non établi dans la noticeUniversité ou école supérieure
Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin Medical University Cancer Institute and Hospital et Hubei Cancer Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.