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

被引：23

作者：

Pizzuti, Laura ^{[1
]}

Giordano, Antonio ^{[2
]}

Michelotti, Andrea ^{[3
]}

Mazzotta, Marco ^{[4
]}

Natoli, Clara ^{[5
]}

Gamucci, Teresa ^{[6
,7
]}

De Angelis, Claudia ^{[3
]}

Landucci, Elisabetta ^{[3
]}

Diodati, Lucrezia ^{[3
]}

Iezzi, Laura ^{[5
]}

Mentuccia, Lucia ^{[6
]}

Fabbri, Agnese ^{[8
]}

Barba, Maddalena ^{[1
]}

Sanguineti, Giuseppe ^{[9
]}

Marchetti, Paolo ^{[4
,10
]}

Tomao, Silverio ^{[11
]}

Mariani, Luciano ^{[12
]}

Paris, Ida ^{[13
]}

Lorusso, Vito ^{[14
]}

Vallarelli, Simona ^{[14
]}

Cassano, Alessandra ^{[15
]}

Airoldi, Francesca ^{[15
]}

Orlandi, Armando ^{[15
]}

Moscetti, Luca ^{[16
]}

Sergi, Domenico ^{[1
]}

Sarobba, Maria Giuseppina ^{[17
]}

Tonini, Giuseppe ^{[18
]}

Santini, Daniele ^{[18
]}

Sini, Valentina ^{[19
]}

Veltri, Enzo ^{[20
]}

Vaccaro, Angela ^{[5
]}

Ferrari, Laura ^{[5
]}

De Tursi, Michele ^{[4
]}

Tinari, Nicola ^{[4
]}

Grassadonia, Antonino ^{[4
]}

Greco, Filippo ^{[21
]}

Botticelli, Andrea ^{[2
]}

La Verde, Nicla ^{[22
]}

Zamagni, Claudio ^{[23
]}

Rubino, Daniela ^{[23
]}

Cortesi, Enrico ^{[24
]}

Magri, Valentina ^{[24
]}

Pomati, Giulia ^{[24
]}

Scagnoli, Simone ^{[24
]}

Capomolla, Elisabetta ^{[25
]}

Kayal, Ramy ^{[26
]}

Scinto, Angelo Fedele ^{[27
]}

Corsi, Domenico ^{[27
]}

Cazzaniga, Marina ^{[28
]}

Laudadio, Lucio ^{[29
]}

机构：

[1] IRCCS Regina Elena Natl Canc Inst, Div Med Oncol 2, Via Elio Chianesi 53, I-00144 Rome, Italy

[2] Sapienza Univ Rome, Azienda Osped St Andrea, Dept Clin & Mol Med, Rome, Italy

[3] Azienda Osped Univ Pisana, Dipartimento Oncol Dei Trapianti & Nuove Tecnol, UO Oncol Med I, Osped S Chiara, Pisa, Italy

[4] Ctr Sci Invecchiamento & Med Traslazionale CeSI M, Chieti, Italy

[5] Loc San Marciano Hosp, SS Trinita Hosp, Med Oncol Unit, Sora, Frosinone, Italy

[6] SS Trinita Hosp, Med Oncol Unit, Sora, Italy

[7] Sandro Pertini Hosp, Med Oncol, Rome, Italy

[8] Belcolle Hosp, Med Oncol Unit, Viterbo, Italy

[9] IRCCS Regina Elena Natl Canc Inst, Rome, Italy

[10] Sapienza Univ Rome, A Oncol Div, Dept Clin & Mol Med, Rome, Italy

[11] Univ Roma La Sapienza, A Oncol Div, Dept Clin & Mol Med, Rome, Italy

[12] IRCCS Regina Elena Natl Canc Inst, Dept Gynaecol Oncol, HPV Unit, Rome, Italy

[13] Univ Cattolica Sacro Cuore, Gynecol Oncol Unit, Rome, Italy

[14] Giovanni Paolo II Hosp, IRCCS, Div Med Oncol, Bari, Italy

[15] Univ Cattolica Sacro Cuore, Dept Med Oncol, Rome, Italy

[16] Univ Hosp Modena, Dept Hematol & Oncol, Div Med Oncol, Modena, Italy

[17] Osped San Francesco, Div Med Oncol, Nuoro, Italy

[18] Univ Campus Biomed Rome, Dept Oncol, Rome, Italy

[19] Santo Spirito Hosp, Oncol Unit, ASL Roma 1, Rome, Italy

[20] Osped S Maria Goretti, Div Med Oncol, Latina, Italy

[21] ASST Fatebenefratelli Sacco Fatebenefratelli, Dept Oncol, Milan, Italy

[22] ASST Fatebenefratelli Sacco Fatebenefratelli, Dept Oncol, Milan, Italy

[23] St Orsola Marcello Malpighi Hosp, SSD Oncol Med Addarii, Bologna, Italy

[24] Univ Rome, Policlin Umberto I, Med Oncol, Rome, Italy

[25] Osped Parodi Delfino, Med Oncol, Colleferro, Italy

[26] IRCCS Regina Elena Natl Canc Inst, Dept Radiol, Rome, Italy

[27] Osped San Pietro Fatebenefratelli, Med Oncol Unit, Rome, Italy

[28] ASST Monza, Oncol Unit, Monza, Italy

[29] Osped Renzetti, Med Oncol, Lanciano, Italy

[30] Mater Salutis Hosp, ULSS21, Dept Pathol Surg & Oncol, Verona, Italy

[31] ASST Bergamo Ovest, Oncol Unit, Dept Oncol, Treviglio, Italy

[32] Regina Margherita Hosp, Med Oncol Unit, Rome, Italy

[33] Tor Vergata Univ Hosp, Tor Vergata Clin Ctr, Univ Hosp, Med Oncol Unit,Dept Syst Med, Rome, Italy

[34] Univ Palermo, Sect Med Oncol, Dept Surg Oncol & Oral Sci, Palermo, Italy

[35] Univ Aquila, S Salvatore Hosp, Med Oncol Dept, Laquila, Italy

[36] Univ Politecn Marche, Azienda Osped Univ Ospedali Riuniti Clin Oncol, Ancona, Italy

[37] Univ Cattolica Sacro Cuore, Inst Gen Pathol, Rome, Italy

[38] IRCCS Regina Elena Natl Canc Inst, Biostat Unit, Via Elio Chianesi 53, I-00144 Rome, Italy

[39] IRCCS Regina Elena Natl Canc Inst, Sci Direct, Rome, Italy

来源：

JOURNAL OF CELLULAR PHYSIOLOGY | 2019年 / 234卷 / 06期

关键词：

advanced breast cancer; hormonal therapy; endocrine resistance; palbociclib; real-world setting; 1ST-LINE TREATMENT; FULVESTRANT; COMBINATION; LETROZOLE; EFFICACY; SAFETY; MULTICENTER; ABEMACICLIB; PLACEBO; WOMEN;

D O I：

10.1002/jcp.27832

中图分类号：

Q2 [细胞生物学];

学科分类号：

071009 ; 090102 ;

摘要：

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.

引用

页码：7708 / 7717

页数：10

共 30 条

[1] [Anonymous], 2018, N Engl J Med, V379, P2582, DOI 10.1056/NEJMx180043
[2] Arnedos M., 2017, SAN ANT BREAST CANC
[3] Efficacy and safety of palbociclib in heavily pretreated patients with HR+/HER2-metastatic breast cancer
Ban, Marija
Mise, Branka Petric
Majic, Ana
Drazic, Ivanka
Vrdoljak, Eduard
[J]. FUTURE ONCOLOGY, 2018, 14 (06) : 537 - 544
[4] Brufsky A, 2018, CANCER RES, V78
[5] Chiu J, 2017, ANN ONCOL, V28
[6] Clifton K. K., 2017, SAN ANT BREAST CANC
[7] Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial
Cristofanilli, Massimo
Turner, Nicholas C.
Bondarenko, Igor
Ro, Jungsil
Im, Seock-Ah
Masuda, Norikazu
Colleoni, Marco
DeMichele, Angela
Loi, Sherene
Verma, Sunil
Iwata, Hiroji
Harbeck, Nadia
Zhang, Ke
Theall, Kathy Puyana
Jiang, Yuqiu
Bartlett, Cynthia Huang
Koehler, Maria
Slamon, Dennis
[J]. LANCET ONCOLOGY, 2016, 17 (04) : 425 - 439
[8] Overcoming endocrine resistance in metastatic hormone receptor-positive breast cancer
D'Souza, Anishka
Spicer, Darcy
Lu, Janice
[J]. JOURNAL OF HEMATOLOGY & ONCOLOGY, 2018, 11
[9] Efficacy of Palbociclib Combinations in Hormone Receptor-Positive Metastatic Breast Cancer Patients After Prior Everolimus Treatment
Dhakal, Ajay
Matthews, Christina M.
Levine, Ellis Glenn
Salerno, Kilian Elizabeth
Zhang, Fan
Takabe, Kazuaki
Early, Amy P.
Edge, Stephen B.
O'Connor, Tracy
Khoury, Thaer
Young, Jessica S.
Opyrcha, Mateusz
[J]. CLINICAL BREAST CANCER, 2018, 18 (06) : E1401 - E1405
[10] Efficacy of palbociclib plus fulvestrant after everolimus in hormone receptor-positive metastatic breast cancer
du Rusquec, Pauline
Palpacuer, Clement
Campion, Loic
Patsouris, Anne
Augereau, Paule
Gourmelon, Carole
Robert, Marie
Dumas, Laurence
Caroline, Folliard
Campone, Mario
Frenel, Jean-Sebastien
[J]. BREAST CANCER RESEARCH AND TREATMENT, 2018, 168 (02) : 559 - 566

← 1 2 3 →