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

Laura Pizzuti, Eriseld Krasniqi, Isabella Sperduti, Maddalena Barba, Teresa Gamucci, Maria Mauri, Enzo Maria Veltri, Icro Meattini, Rossana Berardi, Francesca Sofia Di Lisa, Clara Natoli, Mirco Pistelli, Laura Iezzi, Emanuela Risi, Nicola D’Ostilio, Silverio Tomao, Corrado Ficorella, Katia Cannita, Ferdinando Riccardi, Alessandra CassanoEmilio Bria, Maria Agnese Fabbri, Marco Mazzotta, Giacomo Barchiesi, Andrea Botticelli, Giuliana D’Auria, Anna Ceribelli, Andrea Michelotti, Antonio Russo, Beatrice Taurelli Salimbeni, Giuseppina Sarobba, Francesco Giotta, Ida Paris, Rosa Saltarelli, Daniele Marinelli, Domenico Corsi, Giuseppe Tonini, Marcello Maugeri-Saccà, Angela Maione, Armando Orlandi, Vito Lorusso, Giuseppe Sanguineti, Paola Pinnarò, Federico Cappuzzo, Claudio Botti, Federica Tomao, Giulia Bon, Paolo Marchetti, Gennaro Ciliberto, Patrizia Vici

Research output: Contribution to journalArticlepeer-review


Background: The evolution of therapeutic landscape of human epidermal growth factor receptor-2 (HER2)-positive breast cancer (BC) has led to an unprecedented outcome improvement, even if the optimal sequence strategy is still debated. To address this issue and to provide a picture of the advancement of anti-HER2 treatments, we performed a large, multicenter, retrospective study of HER2-positive BC patients. 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.

Original languageEnglish
JournalTherapeutic Advances in Medical Oncology
Publication statusPublished - Nov 2021


  • advanced breast cancer
  • HER2-positive
  • lapatinib
  • pertuzumab
  • sequence
  • T-DM1

ASJC Scopus subject areas

  • Oncology


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