PANHER study: a 20-year treatment outcome analysis from a multicentre observational study of HER2-positive advanced breast cancer patients from the real-world setting.
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Pizzuti Laura, Krasniqi Eriseld, Sperduti Isabella, Barba Maddalena, Gamucci Teresa, Mauri Maria, Veltri Enzo Maria, Meattini Icro, Berardi Rossana, Di Lisa Francesca Sofia, Natoli Clara, Pistelli Mirco, Iezzi Laura, Risi Emanuela, D'Ostilio Nicola, Tomao Silverio, Ficorella Corrado, Cannita Katia, Riccardi Ferdinando, Cassano Alessandra, Bria Emilio, Fabbri Maria Agnese, Mazzotta Marco, Barchiesi Giacomo, Botticelli Andrea, D'Auria Giuliana, Ceribelli Anna, Michelotti Andrea, Russo Antonio, Salimbeni Beatrice Taurelli, Sarobba Giuseppina, Giotta Francesco, Paris Ida, Saltarelli Rosa, Marinelli Daniele, Corsi Domenico, Capomolla Elisabetta Maria, Sini Valentina, Moscetti Luca, Mentuccia Lucia, Tonini Giuseppe, Raffaele Mimma, Marchetti Luca, Minelli Mauro, Ruggeri Enzo Maria, Scavina Paola, Bacciu Olivia, Salesi Nello, Livi Lorenzo, Tinari Nicola, Grassadonia Antonino, Fedele Scinto Angelo, Rossi Rosalinda, Valerio Maria Rosaria, Landucci Elisabetta, Stani Simonetta, Fratini Beatrice, Maugeri-Saccà Marcello, De Tursi Michele, Maione Angela, Santini Daniele, Orlandi Armando, Lorusso Vito, Cortesi Enrico, Sanguineti Giuseppe, Pinnarò Paola, Cappuzzo Federico, Landi Lorenza, Botti Claudio, Tomao Federica, Cappelli Sonia, Bon Giulia, Pelle Fabio, Cavicchi Flavia, Fiorio Elena, Foglietta Jennifer, Scagnoli Simone, Marchetti Paolo, Ciliberto Gennaro, Vici Patrizia
Аннотация
METHODS: The observational PANHER study included 1,328 HER2-positive advanced BC patients treated with HER2 blocking agents since June 2000 throughout July 2020. Endpoints of efficacy were progression-free survival (PFS) and overall survival (OS).
RESULTS: Patients who received a first-line pertuzumab-based regimen showed better PFS (p < 0.0001) and OS (p = 0.004) than those receiving other treatments. Median PFS and mOS from second-line starting were 8 and 28 months, without significant differences among various regimens. Pertuzumab-pretreated patients showed a mPFS and a mOS from second-line starting not significantly affected by type of second line, that is, T-DM1 or lapatinib/capecitabine (p = 0.80 and p = 0.45, respectively). Conversely, pertuzumab-naïve patients receiving second-line T-DM1 showed a significantly higher mPFS compared with that of patients treated with lapatinib/capecitabine (p = 0.004). Median OS from metastatic disease diagnosis was higher in patients treated with trastuzumab-based first line followed by second-line T-DM1 in comparison to pertuzumab-based first-line and second-line T-DM1 (p = 0.003), although these data might be partially influenced by more favorable prognostic characteristics of patients in the pre-pertuzumab era. No significant differences emerged when comparing patients treated with 'old' or 'new' drugs (p = 0.43), even though differences in the length of the follow-up between the two cohorts should be taken into account.
CONCLUSION: Our results confirmed a relevant impact of first-line pertuzumab-based treatment and showed lower efficacy of second-line T-DM1 in trastuzumab/pertuzumab pretreated, as compared with pertuzumab-naïve patients. Our findings may help delineate a more appropriate therapeutic strategy in HER2-positive metastatic BC. Prospective randomized trials addressing this topic are awaited.