Background The HR +HER2 subtype is the most common molecular profile in women with breast cancer and the appearance of this new group of drugs has drastically changed the prognosis of this group of patients.
Purpose To describe the safety profile of Palbociclib and Ribociclib in two third-level hospitals.
Material and methods A multicentre, retrospective, 39 month study (May 2015 to August 2018), in which we analysed all patients treated with Palbociclib or Ribociclib. The following variables were collected: age of treatment onset, metastatic disease treatment line, adverse effects, suspension and/or dose reduction. Toxicities were classified according to the Common Terminology Criteria for Adverse Events (CTCAEv5.01) (January 2018).
Results Data were collected from 26 patients, 69.2% of which (18) were treated with Palbociclib, and 30.8% (eight) with Ribociclib. Drugs were used in the first-line in 38.5% of the cases (10) and in the second-line in 61.5% (16).
The adverse reactions described for both drugs were the following: 76.9% patients (20) suffered neutropaenia, of which 7.7% were grade 1 (two), 34.6% grade 2 (nine), 42.3% grade 3 (11) and 7.7% grade 4 (two); seven joint pain (26.9%); eight asthaenia (30.7%); four nausea (15.3%); three dizziness (11.5%); four patients experienced anaemia (15.4%), grade 1 in 3 cases (11.5%) and grade 3 in the remaining case (3.8%); three headache (11.5%); three dyspnea (11.5%); two papulo-pustular rash (7.7%), two abdominal pain (7.7%), two vomiting (7.7%); two respiratory infection (7.7%); two hot flushes (7.7%); four thrombocytopaenia, three cases grade 1 (11.5%) and one case grade 3 (3.8%); and two alopecia grade 1 (7.7%); Of all of them, there were a total of seven temporary treatment suspensions (26.9%) and four dose reductions (15.3%).
Conclusion With the results of our study, we wanted to show the safety profile of these new drugs, although the reflected data do not allow comparisons with clinical trials due to the small sample size. Future studies will allow to make these comparisons, because the advantages that these drugs bring in effectiveness will lead to considerable increases in their use.
References and/or acknowledgements Hecht KA, et al. Review of cyclin-dependent kinase 4/6 inhibitors for the treatment of hormone receptor-positive advanced breast cancer. Ann Pharmacother 2018:1060028018793656.
No conflict of interest.
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