The aim of this prospective, randomized, multicenter, open-label, phase II study is to test if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a neo-adjuvant therapy for patients with non-metastatic primary luminal breast cancer.

开始日期2019-06-15

申办/合作机构

Novartis AG

[+1]

100 项与来曲唑/琥珀酸瑞博西尼相关的临床结果

登录后查看更多信息

100 项与来曲唑/琥珀酸瑞博西尼相关的转化医学

登录后查看更多信息

100 项与来曲唑/琥珀酸瑞博西尼相关的专利（医药）

登录后查看更多信息

项与来曲唑/琥珀酸瑞博西尼相关的文献（医药）

2023-09-01·Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners

Toxic hepatitis in metastatic breast cancer patient using ribociclib and denosumab.

Article

作者: Uçar, Gökhan ; Bayram, Doğan ; Aktürk Esen, Selin ; Köş, Fahriye Tuğba

INTRODUCTIONHepatotoxicity is observed due to cyclin-dependent kinase (CDK4/6) inhibitors used to treat hormone receptor-positive metastatic breast cancer. However, it should not be ignored that denosumab may be hepatotoxic, although it is rare.CASE REPORTA 73-year-old female patient with breast cancer with axillary lymph node, adrenal gland and bone metastases was started on ribociclib letrozole and denosumab treatment. Ribociclib treatment was discontinued due to grade 4 hepatotoxicity during treatment, but liver function tests did not decrease. After discontinuation of denosumab treatment, alanine aminotransferase and aspartate aminotransferase values regressed to baseline values.MANAGEMENT AND OUTCOMEDespite the discontinuation of ribociclib treatment, other causes of liver toxicity were investigated due to persistence of hepatic transaminases and elevation. Autoimmune hepatitis markers were negative. Hepatobiliary USG did not reveal any pathological findings except hepatosteatosis. Liver biopsy was performed to determine the etiology. Pathology result was compatible with acute hepatocellular damage (in favor of toxic hepatitis). A decrease in liver values was detected after discontinuation of denosumab treatment.DISCUSSIONAlthough cases with improvement in liver enzymes have been reported after discontinuation of ribociclib, no improvement in hepatotoxicity was observed in our case. Since the liver biopsy was toxic hepatitis, it was thought that other drugs used by the patient might cause this toxicity, and a significant decrease was observed in liver values after discontinuation of denosumab. Denosumab-induced liver toxicity is very rare, and there are only a limited number of cases in the literature.

100 项与来曲唑/琥珀酸瑞博西尼相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	-

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	美国	Novartis Pharmaceuticals Corp.	2017-05-04

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


OncoDynamics project (EHA2019)	N/A	转移性乳腺癌	7	Ribociclib plus letrozole	憲醖鬱蓋憲夢壓選願網(夢壓構鹽鑰顧鏇鬱願膚) = 4 patients (57,1%) had a sustained rise of the mean corpuscular volume (MCV > 97 fL) 衊襯簾繭選淵餘願範壓 (鹹繭壓繭鹽鹹構鏇齋獵 )	-	2019-05-16
NCT03248427 (CORALLEEN, Pubmed \| Lancet Oncol) 人工标引	临床2期	PIK3CA突变/HR阳性/HER2阴性乳腺癌新辅助 HR positive \| HER2-negative	106	Ribociclib plus letrozole	窪範製壓積壓廠簾鹽鹹(廠鑰衊鏇鏇鬱選蓋獵簾) = 蓋製築鏇願廠壓憲鹹積鹹鬱構製鬱網夢衊餘鏇 (顧構衊鏇膚壓範觸鑰選, 32.5 ~ 61.7)	积极	2020-01-01
NCT03248427 (CORALLEEN, Pubmed \| Lancet Oncol) 人工标引	临床2期	PIK3CA突变/HR阳性/HER2阴性乳腺癌新辅助 HR positive \| HER2-negative	106	doxorubicin+cyclophosphamide+paclitaxel	窪範製壓積壓廠簾鹽鹹(廠鑰衊鏇鏇鬱選蓋獵簾) = 積築鑰夢願鏇淵糧觸觸鹹鬱構製鬱網夢衊餘鏇 (顧構衊鏇膚壓範觸鑰選, 32.9 ~ 61.5)	积极	2020-01-01