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Monitoring
Summary of Prescibing Information
PALBACE® has a well-characterised and consistent safety profile.1-6
PALOMA Trials
Dose reductions or modifications and discontinuation rates across the PALOMA trials are as follows1,5:
Neutropenia
Limited or no correlation between neutropenia and viral infections
In a long-term pooled analysis, overlapping of viral infections (all grades) and Grade ≥3 neutropenia occurred in 10.5% of patients treated with PALBACE®, with 99.8% of viral infections being Grade 1 or 2. Overlapping of Grade ≥3 viral infections occurred in only 0.2% of patients with Grade ≥3 neutropenia.5,*
Febrile neutropenia
Febrile neutropenia has been reported in about 2% of patients exposed to PALBACE® in a pooled analysis of the PALOMA trials.1
Discontinuation rates due to neutropenia
In a pooled analysis of the PALOMA trials up to 5 years5, 1.7% of patients permanently discontinued treatment due to neutropenia.
Neutropenia can be managed by dose delay or modification without an apparent effect on efficacy
In 2 exploratory analyses from PALOMA-2 and -3, dose reductions did not appear to have an effect on efficacy.4,5
*Patients who have additional risk factors that make them susceptible to infection (e.g. elderly or patients with weakened immune systems) should be carefully monitored for the signs of infection.⁵ As per the PALBACE® LPD, patients should be monitored for the signs and symptoms of infection and treated as medically appropriate.¹
AR, adverse reaction; ALT, alanine aminotransferase; AST, aspartate aminotransferase; LPD, local product document; PALOMA, PALbociclib: Ongoing trials in the Management of breast cAncer.
References:
Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.
Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial [published correction appears in Lancet Oncol. 2016;17(4):e136] [published correction appears in Lancet Oncol. 2016;17(7):e270]. Lancet Oncol. 2016;17(4):425-439.
Verma S, Bartlett CH, Schnell P, et al. Palbociclib in combination with fulvestrant in women with hormone receptor-positive/HER2-negative advanced metastatic breast cancer: detailed safety analysis from a multicenter, randomized, placebo-controlled, phase III study (PALOMA-3). Oncologist. 2016;21(10):1165-1175.
Finn RS, Rugo HS, Gelmon KA, et al. Long-term pooled safety analysis of palbociclib in combination with endocrine therapy for hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: updated analysis with up to 5 years of follow-up. Oncologist. 2021;26(5):e749-e755.
Diéras V, Harbeck N, Joy AA, et al. Palbociclib with letrozole in postmenopausal women with ER+/HER2- advanced breast cancer: hematologic safety analysis of the randomized PALOMA-2 trial. Oncologist. 2019;24(12):1514-1525.
Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
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PP-IBR-IND-0626 September 2023
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Recommended dosing schedule and dose modifications for AEs
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