2016
DOI: 10.1634/theoncologist.2016-0097
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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)

Abstract: Background. Palbociclib enhances endocrine therapy and improves clinical outcomes in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). Because this is a new target, it is clinically important to understand palbociclib's safety profile to effectively manage toxicity and optimize clinical benefit. Materials and Methods. Patients with endocrine-resistant, HR-positive/HER2-negative MBC (n 5 521) were randomly assigned 2:1 to receive fulvestrant … Show more

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Cited by 205 publications
(191 citation statements)
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“…The palbociclib dose-limiting toxicity 9 neutropenia is rapidly reversible and does not seem to have detrimental effect on palbociclib efficacy in MBC 10 . In the phase III, PALOMA-3 trial, there was no 11 . The effect of palbociclib on erythroid lineage might provide additional pharmacodynamic information to the effect on myeloid lineage.…”
mentioning
confidence: 97%
“…The palbociclib dose-limiting toxicity 9 neutropenia is rapidly reversible and does not seem to have detrimental effect on palbociclib efficacy in MBC 10 . In the phase III, PALOMA-3 trial, there was no 11 . The effect of palbociclib on erythroid lineage might provide additional pharmacodynamic information to the effect on myeloid lineage.…”
mentioning
confidence: 97%
“…The multicentre, double-blind, randomised phase III PALOMA-3 study (NCT01942135) (n=521) investigated the combination of fulvestrant plus palbociclib versus fulvestrant plus placebo as second-line treatment or in patients with HR-positive, HER2-negative resistant MBC. 37 Fulvestrant plus palbociclib was associated with significant and consistent improvement in PFS compared with fulvestrant plus placebo, irrespective of the degree of endocrine resistance, HR expression level, and PIK3CA mutational status. 38 Median PFS was 9.5 months (95% CI, 9.2-11.0) in the fulvestrant plus palbociclib group and 4.6 months (3.5-5.6) in the fulvestrant plus placebo group (hazard ratio, 0.46; 95% CI, 0.36-0.59; p<0.0001).…”
Section: Palbociclibmentioning
confidence: 86%
“…Second, our study included two different CDK 4/6 inhibitors (palbociclib and ribociclib) and two different hormonal backbones (letrozole and fulvestrant) and such heterogeneity may influence the outcome. Finally, this was not an individual data level analysis 26 , meaning that individual confounders were not taken into account.…”
Section: Discussionmentioning
confidence: 99%