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J Cell Physiol. 2019 Jun;234(6):7708-7717. doi: 10.1002/jcp.27832. Epub 2018 Dec 10.

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

Author information

1
Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
2
Department of Clinical and Molecular Medicine, "Sapienza" University of Rome, Azienda Ospedaliera Sant'Andrea, Rome, Italy.
3
UO Oncologia Medica I, Ospedale S. Chiara, Dipartimento di Oncologia, Dei Trapianti e Delle Nuove Tecnologie, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.
4
Department of Medical, Oral and Biotechnological Sciences, Centro Scienze Dell'Invecchiamento e Medicina Traslazionale-CeSI-MeT, Chieti, Italy.
5
Medical Oncology Unit, SS Trinità Hospital, Loc. San MarcianoHospital, Sora, Frosinone, Italy.
6
Medical Oncology Unit, SS Trinità Hospital, Sora, Italy.
7
Medical Oncology, Sandro Pertini Hospital, Rome, Italy.
8
Medical Oncology Unit, Belcolle Hospital, Viterbo, Italy.
9
Department of Radiation Oncology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
10
Department of Clinical and Molecular Medicine, A Oncology Division, "Sapienza" University of Rome, Rome, Italy.
11
Department of Clinical and Molecular Medicine, A Oncology Division, La "Sapienza" University of Rome, Rome, Italy.
12
HPV Unit, Department of Gynaecologic Oncology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
13
Gynecology Oncology Unit, Catholic University of the Sacred Heart, Rome, Italy.
14
Division of Medical Oncology, IRCCS, Giovanni Paolo II Hospital, Bari, Italy.
15
Department of Medical Oncology, Catholic University of Sacred Heart, Rome, Italy.
16
Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy.
17
Division of Medical Oncology, Ospedale San Francesco, Nuoro, Italy.
18
Department of Oncology, University Campus Biomedico of Rome, Rome, Italy.
19
Oncology Unit, ASL Roma 1, Santo Spirito Hospital, Rome, Italy.
20
Division of Medical Oncology, Ospedale S. Maria Goretti, Latina, Italy.
21
ASST Fatebenefratelli Sacco PO Fatebenefratelli, Department of Oncology, Milan, Italy.
22
Department of Oncology, ASST Fatebenefratelli Sacco PO Fatebenefratelli, Milan, Italy.
23
SSD Oncologia Medica "Addarii", S. Orsola-Malpighi Hospital, Bologna, Italy.
24
Medical Oncology, Policlinico Umberto I, Sapienza, University of Rome, Rome, Italy.
25
Medical Oncology, Ospedale "Parodi-Delfino", Colleferro, Italy.
26
Department of Radiology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
27
Medical Oncology Unit, Ospedale San Pietro Fatebenefratelli, Rome, Italy.
28
Oncology Unit, ASST Monza, Monza, Italy.
29
Medical Oncology, Ospedale F. Renzetti, Lanciano, Italy.
30
Department of Pathology, Surgery and Oncology, "Mater Salutis" Hospital, ULSS21, Verona, Italy.
31
Department of Oncology, Oncology Unit, ASST Bergamo Ovest, Treviglio, Italy.
32
Medical Oncology Unit, "Regina Margherita" Hospital, Rome, Italy.
33
Medical Oncology Unit, Department of Systems Medicine, Tor Vergata Clinical Center University Hospital, Tor Vergata University Hospital, Rome, Italy.
34
Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy.
35
Medical Oncology Department, S. Salvatore Hospital, University of L'Aquila, L'Aquila, Italy.
36
Azienda Ospedaliero Universitaria Ospedali Riuniti Clinica di Oncologia, Università Politecnica delle Marche, Ancona, Italy.
37
Institute of General Pathology, Catholic University of the Sacred Heart, Rome, Italy.
38
Bio-statistics Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
39
Scientific Direction, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Abstract

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.

KEYWORDS:

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

PMID:
30536609
DOI:
10.1002/jcp.27832

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