Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor-positive, advanced breast cancer: A real-world experience

Laura Pizzuti, Antonio Giordano, Andrea Michelotti, Marco Mazzotta, Clara Natoli, Teresa Gamucci, Claudia De Angelis, Elisabetta Landucci, Lucrezia Diodati, Laura Iezzi, Lucia Mentuccia, Agnese Fabbri, Maddalena Barba, Giuseppe Sanguineti, Paolo Marchetti, Silverio Tomao, Luciano Mariani, Ida Paris, Vito Lorusso, Simona VallarelliAlessandra Cassano, Francesca Airoldi, Armando Orlandi, Luca Moscetti, Domenico Sergi, Maria Giuseppina Sarobba, Giuseppe Tonini, Daniele Santini, Valentina Sini, Enzo Veltri, Angela Vaccaro, Laura Ferrari, Michele De Tursi, Nicola Tinari, Antonino Grassadonia, Filippo Greco, Andrea Botticelli, Nicla La Verde, Claudio Zamagni, Daniela Rubino, Enrico Cortesi, Valentina Magri, Giulia Pomati, Marina Cazzaniga, Maria Mancini, Silvia Carpano, Ruggero De Maria, Isabella Sperduti, Gennaro Ciliberto, Patrizia Vici

Research output: Contribution to journalArticlepeer-review


Data from 423 human epidermal growth factor receptor 2-negative (HER2−), hormone receptor-positive (HR+) advanced breast cancer (aBC) patients treated with palbociclib and endocrine therapy (ET) were provided by 35 Italian cancer centers and analyzed for treatment outcomes. Overall, 158 patients were treated in first line and 265 in second/later lines. We observed 19 complete responses and 112 partial responses. The overall response rate (ORR) was 31% (95% confidence interval [CI], 26.6–35.4) and clinical benefit was 52.7% (95% CI, 48–57.5). ORR was negatively affected by prior exposure to everolimus/exemestane (p = 0.002) and favorably influenced by early line-treatment (p < 0.0001). At 6 months, median progression-free survival was 12 months (95% CI, 8–16) and median overall survival was 24 months (95% CI, 17–30). More favorable outcomes were associated with palbociclib in early lines, no visceral metastases and no prior everolimus/exemestane. The main toxicity reported was neutropenia. Our results provide further support to the use of palbociclib with ET in HER2−, HR+ aBC. Differences in outcomes across patients subsets remain largely unexplained.

Original languageEnglish
JournalJournal of Cellular Physiology
Publication statusAccepted/In press - Jan 1 2018


  • advanced breast cancer, hormonal therapy
  • endocrine resistance
  • palbociclib
  • real-world setting

ASJC Scopus subject areas

  • Physiology
  • Clinical Biochemistry
  • Cell Biology


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