Palbociclib combined with endocrine therapy in heavily pretreated HR+/HER2- advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP)

被引：9

作者：

Manso, Luis ^{[1
]}

Hernando, Cristina ^{[2
]}

Galan, Maria ^{[3
]}

Oliveira, Mafalda ^{[4
]}

Cabrera, Miguel A. ^{[5
]}

Bratos, Raquel ^{[6
]}

Rodriguez, Cesar A. ^{[7
]}

Ruiz-Borrego, Manuel ^{[8
]}

Blanch, Salvador ^{[9
]}

Llombart-Cussac, Antonio ^{[10
]}

Delgado-Mingorance, Juan I. ^{[11
]}

Alvarez-Busto, Inaki ^{[12
]}

Gallegos, Isabel ^{[13
]}

Gonzalez-Cortijo, Lucia ^{[14
]}

Morales, Serafin ^{[15
]}

Aguirre, Elena ^{[16
]}

Hernando, Blanca A. ^{[17
]}

Ballesteros, Ana ^{[18
]}

Ales-Martinez, Jose E. ^{[19
]}

Reboredo, Cristina ^{[20
]}

Oltra, Amparo ^{[21
]}

Gonzalez-Cao, Maria ^{[22
]}

Santisteban, Marta ^{[23
]}

Malon, Diego ^{[24
]}

Echeverria, Isabel ^{[25
]}

Garcia-Garre, Elisa ^{[26
]}

Vega, Estela ^{[27
]}

Servitja, Sonia ^{[28
]}

Andres, Raquel ^{[29
]}

Robles, Carlos E. ^{[30
]}

Lopez, Rafael ^{[31
]}

Galve, Elena ^{[32
]}

Echarri, Maria J. ^{[33
]}

Legeren, Marta ^{[34
]}

Moreno, Fernando ^{[35
]}

机构：

[1] Hosp Univ 12 Octubre, Madrid, Spain

[2] Hosp Clin Univ Valencia, Valencia, Spain

[3] Hosp Univ Son Llatzer, Palma De Mallorca, Spain

[4] Hosp Univ Vall DHebron, Barcelona, Spain

[5] Hosp Univ Nuestra Senora Candelaria, Santa Cruz De Tenerife, Spain

[6] Hosp MD Anderson Canc Ctr, Madrid, Spain

[7] Hosp Univ Salamanca, Madrid, Spain

[8] Hosp Univ Virgen Rocio, Seville, Spain

[9] Inst Valenciano Oncol, Valencia, Spain

[10] Hosp Arnau Vilanova, Valencia, Spain

[11] Hosp Univ Badajoz, Badajoz, Spain

[12] Hosp Univ Miguel Servet, Zaragoza, Spain

[13] Hosp Gen Segovia, Segovia, Spain

[14] Hosp Univ Quironsalud, Madrid, Spain

[15] Hosp Arnau Vilanova, Lleida, Spain

[16] Hosp Quironsalud, Zaragoza, Spain

[17] Hosp Univ Burgos, Burgos, Spain

[18] Hosp Univ La Princesa, Madrid, Spain

[19] Hosp Nuestra Senora Sonsoles, Avila, Spain

[20] Complejo Hosp Univ A Coruna, La Coruna, Spain

[21] Hosp Virgen Los Lirios, Alicante, Spain

[22] Hosp Univ Dexeus, Barcelona, Spain

[23] Clin Univ Navarra, Pamplona, Spain

[24] Hosp Univ Fuenlabrada, Madrid, Spain

[25] Hosp Gen Univ Gregorio Maranon, Madrid, Spain

[26] Hosp Gen Univ Morales Meseguer, Murcia, Spain

[27] Hosp Univ HM Sanchinarro, Madrid, Spain

[28] Hosp Mar, Barcelona, Spain

[29] Hosp Clin Univ Lozano Blesa, Zaragoza, Spain

[30] Hosp Univ Virgen Valme, Seville, Spain

[31] Hosp Clin Univ Santiago, Santiago De Compostela, Spain

[32] Hosp Univ Basurto, Bilbao, Spain

[33] Hosp Univ Severo Ochoa, Madrid, Spain

[34] Hosp Univ Clin San Cecilio, Granada, Spain

[35] Hosp Clin San Carlos, Madrid, Spain

来源：

BREAST | 2020年 / 54卷

关键词：

Advanced breast cancer; Palbociclib; CDK4/6; inhibitors; Endocrine therapy; Compassionate use program; FULVESTRANT; COMBINATION; MULTICENTER; EFFICACY; SAFETY; WOMEN; PLACEBO;

D O I：

10.1016/j.breast.2020.11.005

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: This study evaluated efficacy and safety of palbociclib, a CDK4/6 inhibitor, in heavilypretreated hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/ HER2(-)) metastatic breast cancer (mBC) patients during the compassionate use program in Spain from February 2015 to November 2017. Patients and methods: Patient data were collected retrospectively from 35 hospitals in Spain. Patients with HR+/HER2(-) mBC who had progressed on >= 4 treatments for advanced disease were eligible. Results: A total of 219 patients received palbociclib in combination with aromatase inhibitors (110; 50.2%), fulvestrant (87; 39.7%), tamoxifen (8; 3.6%) or as single agent (10; 4.6%). Mean age of the patients was 58 years; 31 patients (16.1%) were premenopausal and 162 (83.9%) were postmenopausal at the beginning of treatment with palbociclib. Patients had received a median of 3 previous lines of endocrine therapy (ET) for advanced disease. Real-world tumor response (rwTR) and clinical benefit rate were 5.9% (n = 13) and 46.2% (n = 101), respectively. The median real world progression-free survival (rwPFS) was 6.0 months (95% CI 5.7-7.0) and the median overall survival was 19.0 months (95% CI 16.4-21.7). Subgroup analysis revealed a significant difference in median rwPFS in patients treated with palbociclib plus fulvestrant depending on the duration of prior treatment with fulvestrant monotherapy (>6 versus <= 6 months; HR 1.93, 95% CI 1.37-2.73, p < 0.001). The most frequently reported toxicities were neutropenia, asthenia, thrombopenia and anemia. Conclusions: Palbociclib can be an effective and safe treatment option in patients with heavily pretreated endocrine-sensitive mBC, especially in those with longer PFS to previous ET. (C) 2020 The Author(s). Published by Elsevier Ltd.

引用

页码：286 / 292

页数：7

共 29 条

[1]

[Anonymous], 2017, IBRANCE R PFIZER INC

[2] Efficacy and safety of palbociclib in heavily pretreated patients with HR+/HER2-metastatic breast cancer [J].

Ban, Marija ;

Mise, Branka Petric ;

Majic, Ana ;

Drazic, Ivanka ;

Vrdoljak, Eduard .

FUTURE ONCOLOGY, 2018, 14 (06) :537-544

[3] Palbociclib and endocrine therapy in heavily pretreated hormone receptor-positive HER2-negative advanced breast cancer: the UK Compassionate Access Programme experience [J].

Battisti, Nicolo Matteo Luca ;

Kingston, Belinda ;

King, Judy ;

Denton, Arshi ;

Waters, Simon ;

Sita-Lumsden, Ailsa ;

Rehman, Farah ;

Stavraka, Chara ;

Kristeleit, Hartmut ;

Sawyer, Elinor ;

Houghton, David ;

Davidson, Neville ;

Howell, Sacha ;

Choy, Julia ;

Harper, Peter ;

Roylance, Rebecca ;

Fharat, Raja ;

Mohammed, Kabir ;

Ring, Alistair ;

Johnston, Stephen .

BREAST CANCER RESEARCH AND TREATMENT, 2019, 174 (03) :731-740

[4] 3rd ESO-ESMO international consensus guidelines for Advanced Breast Cancer (ABC 3) [J].

Cardoso, F. ;

Costa, A. ;

Senkus, E. ;

Aapro, M. ;

Andre, F. ;

Barrios, C. H. ;

Bergh, J. ;

Bhattacharyya, G. ;

Biganzoli, L. ;

Cardoso, M. J. ;

Carey, L. ;

Corneliussen-James, D. ;

Curigliano, G. ;

Dieras, V. ;

El Saghir, N. ;

Eniu, A. ;

Fallowfield, L. ;

Fenech, D. ;

Francis, P. ;

Gelmon, K. ;

Gennari, A. ;

Harbeck, N. ;

Hudis, C. ;

Kaufman, B. ;

Krop, I. ;

Mayer, M. ;

Meijer, H. ;

Mertz, S. ;

Ohno, S. ;

Pagani, O. ;

Papadopoulos, E. ;

Peccatori, F. ;

Pernault-Llorca, F. ;

Piccart, M. J. ;

Pierga, J. Y. ;

Rugo, H. ;

Shockney, L. ;

Sledge, G. ;

Swain, S. ;

Thomssen, C. ;

Tutt, A. ;

Vorobiof, D. ;

Xu, B. ;

Norton, L. ;

Winer, E. .

BREAST, 2017, 31 :244-259

[5] 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 [J].

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 .

LANCET ONCOLOGY, 2016, 17 (04) :425-439

[6] CDK 4/6 Inhibitor Palbociclib (PD0332991) in Rb+ Advanced Breast Cancer: Phase II Activity, Safety, and Predictive Biomarker Assessment [J].

DeMichele, Angela ;

Clark, Amy S. ;

Tan, Kay See ;

Heitjan, Daniel F. ;

Gramlich, Kristi ;

Gallagher, Maryann ;

Lal, Priti ;

Feldman, Michael ;

Zhang, Paul ;

Colameco, Christopher ;

Lewis, David ;

Langer, Melissa ;

Goodman, Noah ;

Domchek, Susan ;

Gogineni, Keerthi ;

Rosen, Mark ;

Fox, Kevin ;

O'Dwyer, Peter .

CLINICAL CANCER RESEARCH, 2015, 21 (05) :995-1001

[7] Efficacy of Palbociclib and Endocrine Treatment in Heavily Pretreated Hormone Receptor-positive/HER2-negative Advanced Breast Cancer: Retrospective Multicenter Trial [J].

Demir, Atakan ;

Mandel, Nil Molinas ;

Paydas, Semra ;

Demir, Gokhan ;

Er, Ozlem ;

Turhal, Nazim Serdal ;

Bavbek, Sevil ;

Eralp, Yesim ;

Saip, Pinar Mualla ;

Guler, Emine Nilufer ;

Aydiner, Adnan ;

Uluc, Basak Oyan ;

Kilickap, Sadettin ;

Uskent, Necdet ;

Karadurmus, Nuri ;

Kaplan, Mehmet Ali ;

Yanmaz, Mustafa Teoman ;

Demir, Hacer ;

Alan, Ozkan ;

Korkmaz, Taner ;

Olgun, Polat ;

Uysal, Ozlem Sonmez ;

Altundag, Kadri ;

Gunduz, Seyda ;

Gunaldi, Meral ;

Sari, Murat ;

Beypinar, Ismail ;

Basaran, Gul .

BALKAN MEDICAL JOURNAL, 2020, 37 (02) :104-107

[8] Efficacy of Palbociclib Combinations in Hormone Receptor-Positive Metastatic Breast Cancer Patients After Prior Everolimus Treatment [J].

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 .

CLINICAL BREAST CANCER, 2018, 18 (06) :E1401-E1405

[9] Efficacy of palbociclib plus fulvestrant after everolimus in hormone receptor-positive metastatic breast cancer [J].

du Rusquec, Pauline ;

Palpacuer, Clement ;

Campion, Loic ;

Patsouris, Anne ;

Augereau, Paule ;

Gourmelon, Carole ;

Robert, Marie ;

Dumas, Laurence ;

Caroline, Folliard ;

Campone, Mario ;

Frenel, Jean-Sebastien .

BREAST CANCER RESEARCH AND TREATMENT, 2018, 168 (02) :559-566

[10] Palbociclib and Letrozole in Advanced Breast Cancer [J].

Finn, Richard S. ;

Martin, Miguel ;

Rugo, Hope S. ;

Jones, Stephen ;

Im, Seock-Ah ;

Gelmon, Karen ;

Harbeck, Nadia ;

Lipatov, Oleg N. ;

Walshe, Janice M. ;

Moulder, Stacy ;

Gauthier, Eric ;

Lu, Dongrui R. ;

Randolph, Sophia ;

Dieras, Veronique ;

Slamon, Dennis J. .

NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (20) :1925-1936

← 1 2 3 →