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

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 & 29 others 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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1-9
Number of pages9
JournalCancer Biology and Therapy
DOIs
Publication statusE-pub ahead of print - Nov 7 2018

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Taxoids
Observational Studies
Retrospective Studies
Breast Neoplasms
Maintenance
Therapeutics
Propensity Score
Survival
Trastuzumab
pertuzumab
Standard of Care
Disease-Free Survival
Neoplasm Metastasis
Brain

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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 and Therapy, 07.11.2018, p. 1-9.

Research output: Contribution to journalArticle

Gamucci, T, Pizzuti, L, Natoli, C, Mentuccia, L, Sperduti, I, Barba, M, Sergi, D, Iezzi, L, Maugeri-Saccà, M, Vaccaro, A, Magnolfi, E, Gelibter, A, Barchiesi, G, Magri, V, D'Onofrio, L, Cassano, A, Rossi, E, Botticelli, A, Moscetti, L, Omarini, C, Fabbri, MA, Scinto, AF, Corsi, D, Carbognin, L, Mazzotta, M, Bria, E, Foglietta, J, Samaritani, R, Garufi, C, Mariani, L, Barni, S, Mirabelli, R, Sarmiento, R, Graziano, V, Santini, D, Marchetti, P, Tonini, G, Di Lauro, L, Sanguineti, G, Paoletti, G, Tomao, S, De Maria, R, Veltri, E, Paris, I, Giotta, F, Latorre, A, Giordano, A, Ciliberto, G & Vici, P 2018, 'A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study', Cancer Biology and Therapy, pp. 1-9. https://doi.org/10.1080/15384047.2018.1523095
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. / A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study. In: Cancer Biology and Therapy. 2018 ; pp. 1-9.
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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-na{\"i}ve 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.",
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TY - JOUR

T1 - A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study

AU - Gamucci, Teresa

AU - Pizzuti, Laura

AU - Natoli, Clara

AU - Mentuccia, Lucia

AU - Sperduti, Isabella

AU - Barba, Maddalena

AU - Sergi, Domenico

AU - Iezzi, Laura

AU - Maugeri-Saccà, Marcello

AU - Vaccaro, Angela

AU - Magnolfi, Emanuela

AU - Gelibter, Alain

AU - Barchiesi, Giacomo

AU - Magri, Valentina

AU - D'Onofrio, Loretta

AU - Cassano, Alessandra

AU - Rossi, Ernesto

AU - Botticelli, Andrea

AU - Moscetti, Luca

AU - Omarini, Claudia

AU - Fabbri, Maria Agnese

AU - Scinto, Angelo Fedele

AU - Corsi, Domenico

AU - Carbognin, Luisa

AU - Mazzotta, Marco

AU - Bria, Emilio

AU - Foglietta, Jennifer

AU - Samaritani, Riccardo

AU - Garufi, Carlo

AU - Mariani, Luciano

AU - Barni, Sandro

AU - Mirabelli, Rosanna

AU - Sarmiento, Roberta

AU - Graziano, Vincenzo

AU - Santini, Daniele

AU - Marchetti, Paolo

AU - Tonini, Giuseppe

AU - Di Lauro, Luigi

AU - Sanguineti, Giuseppe

AU - Paoletti, Giancarlo

AU - Tomao, Silverio

AU - De Maria, Ruggero

AU - Veltri, Enzo

AU - Paris, Ida

AU - Giotta, Francesco

AU - Latorre, Agnese

AU - Giordano, Antonio

AU - Ciliberto, Gennaro

AU - Vici, Patrizia

PY - 2018/11/7

Y1 - 2018/11/7

N2 - 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.

AB - 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.

U2 - 10.1080/15384047.2018.1523095

DO - 10.1080/15384047.2018.1523095

M3 - Article

SP - 1

EP - 9

JO - Cancer Biology and Therapy

JF - Cancer Biology and Therapy

SN - 1538-4047

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