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-naive 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, T.; Pizzuti, L.; Natoli, C.; Mentuccia, L.; Sperduti, I.; Barba, M.; Sergi, D.; Iezzi, L.; Maugeri-Sacca, 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, M. A.; Scinto, A. F.; 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.. - In: CANCER BIOLOGY & THERAPY. - ISSN 1555-8576. - 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

Vaccaro A.;Omarini C.;Santini D.;
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-naive 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.
2019
20
2
192
200
A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study / Gamucci, T.; Pizzuti, L.; Natoli, C.; Mentuccia, L.; Sperduti, I.; Barba, M.; Sergi, D.; Iezzi, L.; Maugeri-Sacca, 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, M. A.; Scinto, A. F.; 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.. - In: CANCER BIOLOGY & THERAPY. - ISSN 1555-8576. - 20:2(2019), pp. 192-200. [10.1080/15384047.2018.1523095]
Gamucci, T.; Pizzuti, L.; Natoli, C.; Mentuccia, L.; Sperduti, I.; Barba, M.; Sergi, D.; Iezzi, L.; Maugeri-Sacca, 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, M. A.; Scinto, A. F.; 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.
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