The efficacy of palbociclib and ribociclib in the first-line treatment of metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer in male patients: a Turkish oncology group (TOG) study

被引:3
作者
Yildirim, Hasan Cagri [1 ]
Kutlu, Yasin [2 ]
Mutlu, Emel [3 ]
Aykan, Musa Baris [4 ]
Korkmaz, Mustafa [5 ]
Yalcin, Selim [6 ]
Sakalar, Teoman [7 ]
Celayir, Ozde Melisa [8 ]
Kayikcioglu, Erkan [9 ]
Aslan, Ferit [10 ]
Hafizoglu, Emre [11 ]
Altintas, Yunus Emre [12 ]
Keskinkilic, Merve [13 ]
Chalabiyev, Elvin [1 ]
Celebi, Abdussamet [14 ]
Dursun, Bengu [15 ]
Kapar, Caner [16 ]
Ozen, Mirac [17 ]
Acar, Oemer [18 ]
Dulgar, Ozgecan [19 ]
Kut, Engin [20 ]
Biter, Sedat [21 ]
Kus, Fatih [1 ]
Almuradova, Elvina [22 ]
Erdogan, Atike Pinar [18 ]
Saray, Seray [23 ]
Guven, Deniz Can [1 ]
Simsek, Eda Tanrikulu [24 ]
Uskent, Necdet [24 ]
Kemal, Yasemin [25 ]
Cakar, Burcu [26 ]
Acikgoz, Ozgur [2 ]
Kilickap, Saadettin [27 ]
Aksoy, Sercan [1 ]
机构
[1] Hacettepe Univ, Fac Med, Dept Med Oncol, Ankara, Turkiye
[2] Istanbul Medipol Univ, Med Fac, Dept Med Oncol, Istanbul, Turkiye
[3] Erciyes Univ, Fac Med, Dept Med Oncol, Kayseri, Turkiye
[4] Gulhane Training & Res Hosp, Dept Med Oncol, Ankara, Turkiye
[5] Tokat State Hosp, Dept Med Oncol, Tokat, Turkiye
[6] Kirikkale Univ, Dept Med Oncol, Fac Med, Kirikkale, Turkiye
[7] Kahramanmaras Necip Fazil City Hosp, Dept Med Oncol, Kahramanmaras, Turkiye
[8] MAA Acibadem Univ, Dept Med Oncol, Istanbul, Turkiye
[9] Suleyman Demirel Univ, Dept Med Oncol, Isparta, Turkiye
[10] Med Pk Ankara Batikent Hosp, Dept Med Oncol, Ankara, Turkiye
[11] Ankara City Hosp, Dept Med Oncol, Ankara, Turkiye
[12] Koc Univ, Med Fac, Dept Med Oncol, Istanbul, Turkiye
[13] Eylul Univ, Dept Med Oncol, Fac Med, Izmir, Turkiye
[14] Marmara Univ, Fac Med, Dept Med Oncol, Istanbul, Turkiye
[15] Ankara Univ, Fac Med, Dept Med Oncol, Ankara, Turkiye
[16] Bakirkoy Dr Sadi Konuk Educ & Res Hosp, Dept Med Oncol, Istanbul, Turkiye
[17] Sakarya Univ, Fac Med, Dept Med Oncol, Sakarya, Turkiye
[18] Manisa Celal Bayar Univ, Dept Med Oncol, Fac Med, Manisa, Turkiye
[19] Umraniye Training & Res Hosp, Dept Med Oncol, Istanbul, Turkiye
[20] Manisa State Hosp, Dept Med Oncol, Manisa, Turkiye
[21] Cukurova Univ, Fac Med, Dept Med Oncol, Adana, Turkiye
[22] Tinaztepe Galen Hosp, Dept Med Oncol, Izmir, Turkiye
[23] Balikesir State Hosp, Dept Med Oncol, Balikesir, Turkiye
[24] Anadolu Med Ctr, Dept Med Oncol, Kocaeli, Turkiye
[25] Samsun Med Pk Hosp, Dept Med Oncol, Samsun, Turkiye
[26] Ege Univ, Fac Med, Dept Med Oncol, Izmir, Turkiye
[27] Istinye Univ, Liv Hosp, Dept Med Oncol, Ankara, Turkiye
关键词
Male breast cancer; CDK4/6; inhibitors; Palbociclib; Ribociclib; SURVIVAL; ABEMACICLIB; LETROZOLE; THERAPY; TRENDS; PLUS;
D O I
10.1007/s10147-023-02460-5
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
IntroductionMale breast cancer, comprising approximately 1% of all breast cancer cases, often leads to the exclusion of male patients as a criterion in clinical trials. While the efficacy of Cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitors has been established in metastatic hormone receptor-positive (HR +) and human epidermal growth factor receptor 2-negative (HER2 -) breast cancer in women, limited data exist on their effectiveness in male patients.We aimed to evaluate the efficacy and safety of palbociclib or ribociclib in male patients with breast cancer.IntroductionMale breast cancer, comprising approximately 1% of all breast cancer cases, often leads to the exclusion of male patients as a criterion in clinical trials. While the efficacy of Cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitors has been established in metastatic hormone receptor-positive (HR +) and human epidermal growth factor receptor 2-negative (HER2 -) breast cancer in women, limited data exist on their effectiveness in male patients.We aimed to evaluate the efficacy and safety of palbociclib or ribociclib in male patients with breast cancer.MethodsThis study is a multicenter, retrospective study. We included male patients with HR + and HER2-metastatic breast cancer who received palbociclib or ribociclib as first-line treatment. Our primary endpoints were progression-free survival (PFS), overall response rates (ORR), and drug-related adverse effects.ResultsA total of 46 male patients from 27 institutions were enrolled. The median age at initiation of CDK 4/6 inhibitors was 63.64 +/- 13.69 years, with a median follow-up of 21.33 (95% CI 14.92-27.74) months. The ORR were 84% for palbociclib and 76.2% for ribociclib. The mPFS for the entire cohort was 28.06 months (95% CI 18.70-37.42). No significant difference in PFS was observed between palbociclib and ribociclib (mPFS: 24.46 months (95% CI 11.51-37.42) vs 28.33 months (95% CI 14.77-41.88), respectively, p = 0.211). No new adverse events were reported.DiscussionThis study demonstrates that palbociclib and ribociclib are effective and safe options for first-line treatment in male patients with HR + /HER2 - metastatic breast cancer. However, further prospective studies are warranted to establish their efficacy in this population.
引用
收藏
页码:258 / 265
页数:8
相关论文
共 24 条
[1]   Trends in 5-year survival rates among breast cancer patients by hormone receptor status and stage [J].
Chen, Lu ;
Linden, Hannah M. ;
Anderson, Benjamin O. ;
Li, Christopher I. .
BREAST CANCER RESEARCH AND TREATMENT, 2014, 147 (03) :609-616
[2]   Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2-Advanced Breast Cancer [J].
Dieras, Veronique ;
Rugo, Hope S. ;
Schnell, Patrick ;
Gelmon, Karen ;
Cristofanilli, Massimo ;
Loi, Sherene ;
Colleoni, Marco ;
Lu, Dongrui R. ;
Mori, Ave ;
Gauthier, Eric ;
Huang Bartlett, Cynthia ;
Slamon, Dennis J. ;
Turner, Nicholas C. ;
Finn, Richard S. .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2019, 111 (04) :419-430
[3]   The Epidemiology of Male Breast Cancer [J].
Ferzoco, Raina M. ;
Ruddy, Kathryn J. .
CURRENT ONCOLOGY REPORTS, 2016, 18 (01) :1-6
[4]  
Finn RS, 2022, J CLIN ONCOL, V40
[5]   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
[6]   Breast carcinoma in men - A population-based study [J].
Giordano, SH ;
Cohen, DS ;
Buzdar, AU ;
Perkins, G ;
Hortobagyi, GN .
CANCER, 2004, 101 (01) :51-57
[7]   MONARCH 3: Interim overall survival (OS) results of abemaciclib plus a nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+, HER2-advanced breast cancer (ABC) [J].
Goetz, M. P. ;
Toi, M. ;
Huober, J. ;
Sohn, J. ;
Tredan, O. ;
Park, I. H. ;
Campone, M. ;
Chen, S. C. ;
Sanchez, L. M. Manso ;
Paluch-Shimon, S. ;
van Hal, G. ;
Shahir, A. ;
Iwata, H. ;
Johnston, S. .
ANNALS OF ONCOLOGY, 2022, 33 (07) :S1384-S1384
[8]   Male patient with metastatic stage IV breast cancer achieves complete remission on second line Abemaciclib, Fulvestrant and Leuprolide: A case report [J].
Hansra, Damien ;
Jackson, Shirelle ;
Sequeira, Judy ;
Vazirani, Rajendra ;
Alvarez, Ricardo .
MOLECULAR AND CLINICAL ONCOLOGY, 2020, 12 (02) :120-125
[9]   Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer [J].
Hortobagyi, G. N. ;
Stemmer, S. M. ;
Burris, H. A. ;
Yap, Y. -S. ;
Sonke, G. S. ;
Paluch-Shimon, S. ;
Campone, M. ;
Blackwell, K. L. ;
Andre, F. ;
Winer, E. P. ;
Janni, W. ;
Verma, S. ;
Conte, P. ;
Arteaga, C. L. ;
Cameron, D. A. ;
Petrakova, K. ;
Hart, L. L. ;
Villanueva, C. ;
Chan, A. ;
Jakobsen, E. ;
Nusch, A. ;
Burdaeva, O. ;
Grischke, E. -M. ;
Alba, E. ;
Wist, E. ;
Marschner, N. ;
Favret, A. M. ;
Yardley, D. ;
Bachelot, T. ;
Tseng, L. -M. ;
Blau, S. ;
Xuan, F. ;
Souami, F. ;
Miller, M. ;
Germa, C. ;
Hirawat, S. ;
O'Shaughnessy, J. .
NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (18) :1738-1748
[10]   Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer [J].
Hortobagyi, Gabriel N. ;
Stemmer, Salomon M. ;
Burris, Howard A. ;
Yap, Yoon-Sim ;
Sonke, Gabe S. ;
Hart, Lowell ;
Campone, Mario ;
Petrakova, Katarina ;
Winer, Eric P. ;
Janni, Wolfgang ;
Conte, Pierfranco ;
Cameron, David A. ;
Andre, Fabrice ;
Arteaga, Carlos L. ;
Zarate, Juan P. ;
Chakravartty, Arunava ;
Taran, Tetiana ;
Le Gac, Fabienne ;
Serra, Paolo ;
O'Shaughnessy, Joyce .
NEW ENGLAND JOURNAL OF MEDICINE, 2022, 386 (10) :942-950