• 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-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; Giordano, Antonio|0000-0002-5959-016X (2019-02-01)
      © 2018, © 2018 The Author(s). Published by Taylor & Francis. 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 Real-World Multicentre Retrospective Study of Paclitaxel-Bevacizumab and Maintenance Therapy as First-Line for HER2-Negative Metastatic Breast Cancer

      Gamucci, T; Mentuccia, L; Natoli, C; Sperduti, I; Cassano, A; Michelotti, A; Di Lauro, L; Sergi, D; Fabi, A; Sarobba, MG; Marchetti, P; Barba, M; Magnolfi, E; Maugeri-Saccà, M; Rossi, E; Sini, V; Grassadonia, A; Pellegrini, D; Astone, A; Nisticò, C; Angelini, F; Vaccaro, A; Pellegrino, A; De Angelis, C; Palleschi, M; Moscetti, L; Bertolini, I; Buglioni, S; Giordano, A; Pizzuti, L; Vici, P; Giordano, Antonio|0000-0002-5959-016X (2017-06-01)
      © 2016 Wiley Periodicals, Inc. Bevacizumab in combination with taxanes in HER2-negative metastatic breast cancer (MBC) patients has shown improved progression-free survival (PFS), despite the lack of clear overall survival (OS) benefit. We performed a retrospective analysis to evaluate the impact of paclitaxel-bevacizumab and of maintenance therapy with bevacizumab (BM) and endocrine therapy (ET) in the real-world practice. We identified 314 HER2-negative MBC patients treated in 12 cancer centers. Overall, the median PFS and OS were 14 and 40 months, respectively. Among the 254 patients potentially eligible for BM, 183 received BM after paclitaxel discontinuation until progression/toxicity. PFS and OS were improved in patients who had received BM in comparison with those potentially eligible but who did not receive BM (P< 0.0001 and P = 0.001, respectively). Results were confirmed when adjusting for propensity score. Among the 216 hormone-receptor positive patients eligible for BM, a more favorable PFS and OS were observed when maintenance ET was administered (P < 0.0001). Multivariate analysis showed that PS, BM, number of disease sites and maintenance ET were related to PFS, while response and maintenance ET were related to OS. In hormone-receptor positive patients, BM produced a significant PFS and a trend towards OS benefit only in absence of maintenance ET (P = 0.0007 and P = 0.06, respectively). In the triple-negative subgroup, we observed a trend towards a better OS for patients who received BM (P = 0.06), without differences in PFS (P = 0.21). Our results confirmed the efficacy of first-line paclitaxel-bevacizumab in real-world practice; both BM and maintenance ET significantly improved PFS and OS compared to no maintenance therapies. J. Cell. Physiol. 232: 1571–1578, 2017. © 2016 Wiley Periodicals, Inc.