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.

A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study / Gamucci, Teresa; Pizzuti, Laura; Natoli, Clara; Mentuccia, Lucia; Sperduti, Isabella; Barba, Maddalena; Sergi, Domenico; Iezzi, Laura; Maugeri-Saccà, Marcello; Vaccaro, Angela; Magnolfi, Emanuela; Gelibter, Alain; Barchiesi, Giacomo; Magri, Valentina; D'Onofrio, Loretta; Cassano, Alessandra; Rossi, Ernesto; Botticelli, Andrea; Moscetti, Luca; Omarini, Claudia; Fabbri, Maria Agnese; Scinto, Angelo Fedele; Corsi, Domenico; Carbognin, Luisa; Mazzotta, Marco; Bria, Emilio; Foglietta, Jennifer; Samaritani, Riccardo; Garufi, Carlo; Mariani, Luciano; Barni, Sandro; Mirabelli, Rosanna; Sarmiento, Roberta; Graziano, Vincenzo; Santini, Daniele; Marchetti, Paolo; Tonini, Giuseppe; Di Lauro, Luigi; Sanguineti, Giuseppe; Paoletti, Giancarlo; Tomao, Silverio; De Maria, Ruggero; Veltri, Enzo; Paris, Ida; Giotta, Francesco; Latorre, Agnese; Giordano, Antonio; Ciliberto, Gennaro; Vici, Patrizia. - In: CANCER BIOLOGY & THERAPY. - ISSN 1538-4047. - 20:2(2019), pp. 192-200. [10.1080/15384047.2018.1523095]

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

Pizzuti, Laura;Mentuccia, Lucia;Sperduti, Isabella;Barba, Maddalena;Gelibter, Alain;Barchiesi, Giacomo;Magri, Valentina;Botticelli, Andrea;Fabbri, Maria Agnese;Mazzotta, Marco;Santini, Daniele;Marchetti, Paolo;Tomao, Silverio;
2019

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.
HER2; endocrine therapy; first-line treatment; maintenance; metastatic breast cancer; pertuzumab; trastuzumab
01 Pubblicazione su rivista::01a Articolo in rivista
A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study / Gamucci, Teresa; Pizzuti, Laura; Natoli, Clara; Mentuccia, Lucia; Sperduti, Isabella; Barba, Maddalena; Sergi, Domenico; Iezzi, Laura; Maugeri-Saccà, Marcello; Vaccaro, Angela; Magnolfi, Emanuela; Gelibter, Alain; Barchiesi, Giacomo; Magri, Valentina; D'Onofrio, Loretta; Cassano, Alessandra; Rossi, Ernesto; Botticelli, Andrea; Moscetti, Luca; Omarini, Claudia; Fabbri, Maria Agnese; Scinto, Angelo Fedele; Corsi, Domenico; Carbognin, Luisa; Mazzotta, Marco; Bria, Emilio; Foglietta, Jennifer; Samaritani, Riccardo; Garufi, Carlo; Mariani, Luciano; Barni, Sandro; Mirabelli, Rosanna; Sarmiento, Roberta; Graziano, Vincenzo; Santini, Daniele; Marchetti, Paolo; Tonini, Giuseppe; Di Lauro, Luigi; Sanguineti, Giuseppe; Paoletti, Giancarlo; Tomao, Silverio; De Maria, Ruggero; Veltri, Enzo; Paris, Ida; Giotta, Francesco; Latorre, Agnese; Giordano, Antonio; Ciliberto, Gennaro; Vici, Patrizia. - In: CANCER BIOLOGY & THERAPY. - ISSN 1538-4047. - 20:2(2019), pp. 192-200. [10.1080/15384047.2018.1523095]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1187945
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