Palbociclib in highly pretreated metastatic ER-positive HER2-negative breast cancer

Hoste, Griet; Punie, Kevin; Wildiers, Hans; Beuselinck, Benoît; Lefever, I.; Nieuwenhuysen, Els Van; Han, Sileny; Berteloot, Patrick; Concin, Nicole; Salihi, Rawand; Vergote, Ignace; Neven, Patrick

doi:10.1007/s10549-018-4827-6

Cited by 13 publications

(12 citation statements)

References 29 publications

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“…None of the investigated clinical variables could predict CBR. Safety data are consistent with the previous reported data with treatment delays or interruptions in 43.9% of patients 25…”

Section: Real-life Studiessupporting

confidence: 91%

Palbociclib in metastatic breast cancer: current evidence and real-life data

Serra

Lapidari

Quaquarini

et al. 2019

DIC

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The purpose of this review is to summarize the background and latest evidence for the use of palbociclib, an oral, first-in-class, highly selective cyclin-dependent kinase 4/6 inhibitor, in advanced breast cancer, with a focus on some of the unanswered questions about the performance of this agent in clinical practice. The available clinical data from both controlled clinical trials and real-life experiences concerning palbociclib-based combinations in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic disease, including patient-reported outcomes and subgroup analyses, have been reviewed and discussed. Palbociclib significantly improved progression-free survival and clinical benefit rates when added to letrozole in postmenopausal women as initial endocrine-based therapy, and it prolonged progression-free survival and overall survival when added to fulvestrant in women who progressed on previous endocrine therapy in randomized clinical trials. Tolerability profile was manageable, with neutropenia occurring most commonly, without detrimental impact on quality of life. Available data from real-life experiences confirm the good performance of palbociclib in unselected, heavily pretreated populations. Palbociclib in combination with endocrine therapy is a valuable emerging option for patients with HR+/HER2− advanced or metastatic breast cancer. Further investigation is needed to provide solutions for palbociclib resistance and to identify the best sequence to use for the best patient benefit with a minimal toxicity.

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“…None of the investigated clinical variables could predict CBR. Safety data are consistent with the previous reported data with treatment delays or interruptions in 43.9% of patients 25…”

Section: Real-life Studiessupporting

confidence: 91%

Palbociclib in metastatic breast cancer: current evidence and real-life data

Serra

Lapidari

Quaquarini

et al. 2019

DIC

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“…Limited available data in heavily pretreated patients indicate lower efficacy of CDK4/6i [9,10]. Here we demonstrate that prior receipt of at least three chemotherapy lines was an independent predictor of worse outcomes, thus supporting the use of CDK4/6i earlier in the disease trajectory.…”

Section: Discussionsupporting

confidence: 66%

“…In the first-and second-line CDK4/6i trials, the majority of patients were treatment naïve or had progressed after at most one chemotherapy line, while the majority of patients allocated to the control groups never received CDK4/6i at a later therapy line. On the other hand, available data from real-world settings demonstrate decreased efficacy of CDK4/6i among heavily pretreated patients compared with outcomes reported in prospective trials [9,10], which implies that patient selection may be a major driver behind reported outcomes from clinical trials. In addition, adherence to dose modification guidelines within clinical trials is presumably higher compared to the use of novel agents in routine practice, with the prognostic implications being largely unexplored.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of cyclin dependent kinases 4/6 inhibitors in the treatment of metastatic breast cancer: a real-world experience

et al. 2020

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Background: Randomized trials have shown survival gains for patients with metastatic breast cancer (BC) treated with CDK4/6 inhibitors (CDK4/6i) in combination with endocrine agents. It is not unlikely that there may be discrepancies between the generally fit clinical study population and the real-world setting that could affect adherence to treatment guidelines, tolerance to treatment and outcome. Material and methods: Consecutive patients with metastatic or locally advanced and unresectable BC that were treated between

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“…A small trial from a single USA cancer center reports 26.5% of ORR in 22 patients treated with palbociclib and ET, with a median treatment duration of 5 months, an estimated PFS at 18 months of 50%, and G3/4 neutropenia in 45% of the patients, with half of the patients requiring dose reductions (Malik et al, 2017). In a recent (Hoste et al, 2018).…”

Section: Discussionmentioning

confidence: 99%

“…The median PFS was 3.17 months, with 34 patients not progressing within 6 months, resulting in an overall CB of 41.5%. The safety profile was favorable (Hoste et al, ).…”

Section: Discussionmentioning

confidence: 99%

Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor‐positive, advanced breast cancer: A real‐world experience

Pizzuti

Giordano

Michelotti

et al. 2018

Journal Cellular Physiology

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Data from 423 human epidermal growth factor receptor 2‐negative (HER2−), hormone receptor‐positive (HR+) advanced breast cancer (aBC) patients treated with palbociclib and endocrine therapy (ET) were provided by 35 Italian cancer centers and analyzed for treatment outcomes. Overall, 158 patients were treated in first line and 265 in second/later lines. We observed 19 complete responses and 112 partial responses. The overall response rate (ORR) was 31% (95% confidence interval [CI], 26.6–35.4) and clinical benefit was 52.7% (95% CI, 48–57.5). ORR was negatively affected by prior exposure to everolimus/exemestane ( p = 0.002) and favorably influenced by early line‐treatment ( p < 0.0001). At 6 months, median progression‐free survival was 12 months (95% CI, 8–16) and median overall survival was 24 months (95% CI, 17–30). More favorable outcomes were associated with palbociclib in early lines, no visceral metastases and no prior everolimus/exemestane. The main toxicity reported was neutropenia. Our results provide further support to the use of palbociclib with ET in HER2−, HR+ aBC. Differences in outcomes across patients subsets remain largely unexplained.

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Palbociclib in highly pretreated metastatic ER-positive HER2-negative breast cancer

Abstract: Palbociclib in combination with endocrine therapy shows an unexpectedly high CBR and favorable safety profile in heavily pretreated endocrine-resistant estrogen receptor-positive, HER2-negative MBC patients.

Cited by 13 publications

References 29 publications

Palbociclib in metastatic breast cancer: current evidence and real-life data

Palbociclib in metastatic breast cancer: current evidence and real-life data

Efficacy and safety of cyclin dependent kinases 4/6 inhibitors in the treatment of metastatic breast cancer: a real-world experience

Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor‐positive, advanced breast cancer: A real‐world experience

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