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Ibrance® (palbociclib): New Hope in Advanced Breast Cancer Treatment
Palbociclib Side Effects in the PALOMA-1
Among the side-effects Grade 3-4 neutropenia was of the most concern. In the patients treated with palbociclib plus letrozole, neutropenia occurred in 45 (54%) patients. 16 (19%) patients on the combination treatment had leucopenia. For patients treated with letrozole alone, these numbers were 1 (1%) and none respectively. Febrile neutropenia or related infections did not occur during the study.
Palbociclib Plus Fulvestrant
At the American Society of Clinical Oncology (ASCO) annual meeting 2015, Turner et al. presented the results of the Phase 3 PALOMA-3 trial. Based on this study, US FDA granted approval for the use of concurrent palbociclib and fulvestrant in advanced endocrine-resistant breast cancer.
Women with hormone receptor-positive, HER2-negative advanced breast cancer who had previously relapsed on endocrine therapy were randomised in a 2:1 ratio. 347 subject received palbociclib 125 mg/d orally at a ‘three weeks on, one week off’ schedule plus Faslodex® (fulvestrant) 500 mg per standard of care. The remainder 174 subjects received fulvestrant 500 mg per standard-of-care plus matching placebo for palbociclib. Pre- and perimenopausal patients received additional treatment with Zoladex® (goserelin). Patients who had previously received more than one line of chemotherapy for metastatic disease were excluded from the study.
The Future of CDK4/6 Inhibition
Palbociclib represents the first-in-class CDK4/6 inhibitor with promising efficacy in endocrine-resistant patients. Ongoing studies in different settings will investigate if palbociclib is useful in other selected groups of patients or diseases. Furthermore, several other drugs with similar mode of action (ribociclib & abemaciclib) are currently under investigation for breast cancer and other diseases.
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
© 2016 MediPaper Medical Communications Ltd.- Palbociclib: First in Class CDK4/6 Inhibitor