Clinical and demographic characteristics of patients with hormone-sensitive HER2-negative advanced breast cancer receiving ribociclib in combination with endocrine therapy or combination chemotherapy in routine clinical practice in the Russian Federation: interim results of the ValerEE study

In this article, we report the interim results of a prospective non-interventional ValerEE study analyzing the efficacy and safety of ribociclib therapy in combination with endocrine therapy compared to other combination chemotherapy regimens in the first-line treatment of patients with hormone-sensitive HER2-negative advanced breast cancer in routine clinical practice in Russia. We analyzed the data of 188 patients, of whom 146 patients received ribociclib in combination with endocrine therapy, while 27 patients received other combination chemotherapy. Fifteen patients were excluded from the analysis as they did not meet the inclusion criteria (received monochemotherapy). The majority of participants were women (99.4 %) with a mean age of 59.1 years; most of them (76.9 %) reached menopause. Mastectomy with lymphadenectomy were the most common surgeries (47.4 % of cases). Ductal cancer was diagnosed in 83.2 % of patients. Expression of estrogen and progesterone receptors was detected in 100 % and 89.6 % of participants, respectively. Metastases were primarily located in the bones (60.7 %), lungs (53.8 %) and liver (50.3 %). Anastrozole was the most common endocrine agent used in combination with ribociclib (65.8 %); paclitaxel plus carboplatin were the most common (33.3 %) combination chemotherapy. The ratio of therapeutic options observed in this study reflects current clinical recommendations and routine clinical practice in the Russian Federation. Patient groups were well balanced with no significant differences between them, which will ensure accurate assessment of the effectiveness of different therapeutic regimens later.

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