Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2-advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial

被引:5
作者
Salvador Bofill, Javier [1 ]
Moreno Anton, Fernando [2 ]
Rodriguez Sanchez, Cesar Augusto [3 ]
Galve Calvo, Elena [4 ]
Hernando Melia, Cristina [5 ,6 ]
Ciruelos Gil, Eva Maria [7 ]
Vidal, Maria [8 ,9 ,10 ]
Jimenez-Rodriguez, Begona [11 ]
De la Cruz Merino, Luis [12 ]
Martinez Janez, Noelia [13 ]
Villanueva Vazquez, Rafael [14 ]
de Toro Salas, Ruben [15 ]
Anton Torres, Antonio [16 ]
Alvarez Lopez, Isabel Manuela [17 ]
Gavila Gregori, Joaquin [18 ]
Quiroga Garcia, Vanesa [19 ]
Vicente Rubio, Elena [20 ]
de la Haba-Rodriguez, Juan [21 ]
Gonzalez-Santiago, Santiago [22 ]
Diaz Fernandez, Nieves [23 ]
Barnadas Molins, Agusti [24 ,25 ]
Sanchez de Ibarguen, Blanca Cantos [26 ]
Delgado Mingorance, Juan Ignacio [27 ]
Bellet Ezquerra, Meritxell [28 ,29 ]
de Casa, Sonia [30 ]
Gimeno, Asuncion [30 ]
Martin, Miguel [31 ]
机构
[1] Hosp Univ Virgen Rocio, Inst Biomed Sevilla IBIS, Seville, Spain
[2] Hosp Clin San Carlos, Madrid, Spain
[3] Hosp Univ Salamanca IBSAL, Dept Oncol Med, Salamanca, Spain
[4] Hosp Univ Basurto, Bilbao, Spain
[5] Hosp Clin Univ Valencia, Serv Oncol, Valencia, Spain
[6] Inst Invest Sanitaria INCLIVA, Valencia, Spain
[7] Hosp Univ 12 Octubre, Madrid, Spain
[8] Hosp Clin Barcelona, Dept Med Oncol, Barcelona, Spain
[9] IDIBAPS, Translat Genom & Targeted Therapies Solid Tumors, Barcelona, Spain
[10] Univ Barcelona, Dept Med, Barcelona, Spain
[11] UGCI Oncol Med Hosp Reg & Virgen Victoria, Malaga, Spain
[12] Hosp Univ Virgen Macarena, Seville, Spain
[13] Hosp Univ Ramon Y Cajal, Madrid, Spain
[14] Hosp Duran & Reynals, Inst Catala Oncol, Barcelona, Spain
[15] Hosp Univ Jerez, Jerez de la Frontera, Spain
[16] Hosp Univ Miguel Servet, Zaragoza, Spain
[17] Hosp Univ Donostia BioDonostia, Donostia San Sebastian, Spain
[18] Fdn Inst Valenciano Oncol, Valencia, Spain
[19] Inst Catala Oncol, Dept Oncol, Badalona Appl Res Grp Oncol B ARGO Grp, Badalona, Spain
[20] Hosp Univ Insular Gran Canaria, Gran Canaria, Spain
[21] Univ Cordoba, Hosp Reina Sofia, Inst Maimonides Invest Biomed IMIBIC, Cordoba, Spain
[22] Hosp Univ San Pedro Alcantara, Caceres, Spain
[23] Hosp Univ San Juan Alicante, Alicante, Spain
[24] Univ Autonoma Barcelona, Dept Med, Hosp Univ Santa Creu & St Pau, Barcelona, Spain
[25] Univ Autonoma Barcelona, Dept Med, CIBERONC Breast Canc Programme, Barcelona, Spain
[26] Hosp Puerta Hierro Majadahonda, Madrid, Spain
[27] Hosp Univ Infanta Cristina, Badajoz, Spain
[28] Hosp Univ Vall dHebron, Barcelona, Spain
[29] Inst Oncol Vall dHebron VHIO, Barcelona, Spain
[30] Novartis Pharmaceut Spain, Barcelona, Spain
[31] Hosp Univ Gregorio Maranon, Madrid, Spain
关键词
Advanced breast cancer; Ribociclib; CDK4; 6; inhibitor; Postmenopausal; Premenopausal; THERAPY;
D O I
10.1016/j.breast.2022.09.006
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: Breast cancer is the most common malignancy and the second leading cause of cancer-related mortality in Spanish women. Ribociclib in combination with endocrine therapy (ET) has shown superiority in prolonging survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) vs. ET alone.Methods: CompLEEment-1 is a single-arm, open-label phase 3b trial evaluating ribociclib plus letrozole in a broad population of patients with HR+, HER2- ABC. The primary endpoints were safety and tolerability. Here we report data for Spanish patients enrolled in CompLEEment-1.Results: A total of 526 patients were evaluated (median follow-up: 26.97 months). Baseline characteristics showed a diverse population with a median age of 54 years. At study entry, 56.5% of patients had visceral metastases and 8.7% had received prior chemotherapy for advanced disease. Rates of all-grade and Grade >= 3 adverse events (AEs) were 99.0% and 76.2%, respectively; 21.3% of patients experienced a serious AE, and 15.8% of AEs led to treatment discontinuation. AEs of special interest of neutropenia, increased alanine aminotransferase, increased aspartate aminotransferase and QTcF prolongation occurred in 77.8%, 14.8%, 11.4% and 4.0% of patients, respectively. Patients aged >70 years experienced increased rates of all-grade and Grade >= 3 neutropenia and anemia. Efficacy results were consistent with the global study.Conclusions: Results from Spanish patients enrolled in CompLEEment-1 are consistent with global data showing efficacy and a manageable safety profile for ribociclib plus letrozole treatment in patients with HR+, HER2-ABC, including populations of interest (NCT02941926).Trial registration: ClinicalTrials.gov NCT02941926
引用
收藏
页码:77 / 84
页数:8
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