A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study.

Abstract

We carried out a retrospective observational study of 264 HER2-positive advanced breast cancer (ABC) patients to explore the efficacy of first-line treatment with pertuzumab/trastuzumab/taxane in real-world setting. Survival data were analyzed by Kaplan Meier curves and log rank test. Median follow-up, length of pertuzumab/trastuzumab/taxane treatment and of pertuzumab, trastuzumab maintenance were 21, 4 and 15 months, respectively. The response rate was 77.3%, and the clinical benefit rate 93.6%. Median progression-free survival (mPFS) was 21 months, and median overall survival (mOS) was not reached. When comparing patients by trastuzumab-pretreatment, similar PFS were observed, although a longer OS was reached in trastuzumab-naïve patients (p = 0.02). Brain metastases at baseline and their development in course of therapy were associated with significantly shorter PFS (p = 0.0006) and shorter OS, although at a not fully statistically relevant extent (p = 0.06). The addition of maintenance endocrine therapy (ET) to pertuzumab/trastuzumab maintenance was associated with longer PFS (p = 0.0001), although no significant differences were detected in OS (p = 0.31). Results were confirmed by propensity score analysis (p = 0.003 and p = 0.46, respectively). In multivariate models, longer PFS was related to lower Performance Status (PS) (p = 0.07), metastatic stage at diagnosis (p = 0.006) and single metastatic site (p < 0.0001). An OS advantage was observed with lower PS (p < 0.0001), single metastatic site (p = 0.004), no prior exposure to trastuzumab (p = 0.004) and response to pertuzumab-based treatment (p = 0.003). Our results confirm that trastuzumab/pertuzumab/taxane is the standard of care as first-line treatment of patients with HER2-positive ABC even in the real-world setting. Moreover, the double-maintenance therapy (HER2 block and ET) is strongly recommended when feasible.

• Authors: Teresa Gamucci, Laura Pizzuti, Clara Natoli, Lucia Mentuccia, Isabella Sperduti, Maddalena Barba, Domenico Sergi, Laura Iezzi, Marcello Maugeri-Saccà, Angela Vaccaro, Emanuela Magnolfi, Alain Gelibter, Giacomo Barchiesi, Valentina Magri, Loretta D'Onofrio, Alessandra Cassano, Ernesto Rossi, Andrea Botticelli, Luca Moscetti, Claudia Omarini, Maria Agnese Fabbri, Angelo Fedele Scinto, Domenico Corsi, Luisa Carbognin, Marco Mazzotta, Emilio Bria, Jennifer Foglietta, Riccardo Samaritani, Carlo Garufi, Luciano Mariani, Sandro Barni, Rosanna Mirabelli, Roberta Sarmiento, Vincenzo Graziano, Daniele Santini, Paolo Marchetti, Giuseppe Tonini, Luigi Di Lauro, Giuseppe Sanguineti, Giancarlo Paoletti, Silverio Tomao, Ruggero De Maria, Enzo Veltri, Ida Paris, Francesco Giotta, Agnese Latorre, Antonio Giordano, Gennaro Ciliberto, Patrizia Vici
• Journal: Cancer biology & therapy (Cancer Biol Ther) Vol. 20 Issue 2 Pg. 192-200 ( 2019) ISSN: 1555-8576 [Electronic] United States
• PMID: 30403909 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Taxoids
• pertuzumab
• Trastuzumab

Topics

• Antibodies, Monoclonal, Humanized (pharmacology, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (pharmacology, therapeutic use)
• Breast Neoplasms (drug therapy, pathology)
• Female
• Humans
• Middle Aged
• Retrospective Studies
• Taxoids (pharmacology, therapeutic use)
• Trastuzumab (pharmacology, therapeutic use)