Efficacy and safety of palbociclib in patients with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2

Gelmon, Karen A.; Walshe, Janice; Mahtani, Reshma; Joy, Anil A.; Karuturi, Meghan Sri; Neven, Patrick; Lu, Dongrui R.; Kim, Sindy; Schnell, Patrick; Bananis, Eustratios; Schwartzberg, Lee S.

doi:10.1016/j.breast.2021.07.017

Cited by 23 publications

(8 citation statements)

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“…While not all patients started palbociclib at the recommended dose of 125 mg/day and 37.9% had their dose reduced, studies have shown that dose reduction does not adversely affect PFS. Clifton et al 32 reported more dose reductions in older adults (aged >65.0 years); however, they found rwPFS to be longer (but not significantly so after adjustment) for patients who experienced dose reductions; 32 while patients with pre‐existing conditions often experienced dose reductions, they still obtained a PFS benefit 33 . In a real‐world study of patients receiving palbociclib with fulvestrant in the 2L or greater treatment setting, median rwPFS did not differ among patients with neutropenia‐related dose reductions and interruptions and those without dose modifications 34 .…”

Section: Discussionmentioning

confidence: 99%

“…Clifton et al 32 reported more dose reductions in older adults (aged >65.0 years); however, they found rwPFS to be longer (but not significantly so after adjustment) for patients who experienced dose reductions; 32 while patients with pre-existing conditions often experienced dose reductions, they still obtained a PFS benefit. 33 In a real-world study of patients receiving palbociclib with fulvestrant in the 2L or greater treatment setting, median rwPFS did not differ among patients with neutropenia-related dose reductions and interruptions and those without dose modifications. 34 While these studies report no adverse effect of lower doses, at least one study observed that patients starting palbociclib at the recommended dose had a higher rwPFS and real-world best tumor responses than the small proportion of patients who started at lower doses.…”

Section: Probability (%)mentioning

confidence: 91%

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Real‐world treatment patterns for palbociclib plus an aromatase inhibitor, or an aromatase inhibitor alone, for patients with metastatic breast cancer in the Flatiron Database

Rugo,

Liu,

et al. 2023

Intl Journal of Cancer

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There are limited real‐world comparative effectiveness data for palbociclib plus an aromatase inhibitor (AI) as a first‐line (1L) treatment examining endpoints that require long term follow‐up and post 1L progression. The Flatiron Health Analytic Database was used to characterize treatment and dosing patterns in patients with hormone receptor‐positive/human epidermal growth factor 2‐negative (HR+/HER2−) metastatic breast cancer (mBC) receiving palbociclib plus an AI vs an AI alone in routine US clinical practice. In addition, time to chemotherapy (TTC) and real‐world progression‐free survival (rwPFS) when combining 1L and second‐line of therapy (rwPFS2) were assessed. Of 1324 patients who received palbociclib plus an AI between February 3, 2015 and March 31, 2020, 1110 (83.8%) started palbociclib at the recommended 125 mg/day dose. After stabilized inverse probability treatment‐weighting (sIPTW), median TTC in patients treated with palbociclib plus an AI and AI alone was 37.4 months (95% confidence interval [CI], 33.7‐40.7) and 29.2 months (95% CI, 26.8‐33.5), respectively (hazard ratio [HR] = 0.77 [95% CI, 0.69‐0.86], P < .0001); median rwPFS2 was 32.6 months (95% CI, 29.4‐35.2) and 20.7 months (95% CI, 18.9‐22.6), respectively (HR = 0.62 [95% CI, 0.54‐0.70], P < .0001). Sensitivity analyses with propensity score matching showed similar results to sIPTW analyses. Results from this large real‐world study examining additional effectiveness outcomes beyond 1L rwPFS and overall survival support the use of palbociclib plus an AI as a 1L treatment for patients with HR+/HER2− mBC.

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Section: Discussionmentioning

confidence: 99%

Section: Probability (%)mentioning

confidence: 91%

Real‐world treatment patterns for palbociclib plus an aromatase inhibitor, or an aromatase inhibitor alone, for patients with metastatic breast cancer in the Flatiron Database

Rugo,

Liu,

et al. 2023

Intl Journal of Cancer

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“…In a pooled analysis of the PALOMA 1,2 and 3 studies, median progression-free survival was signi cantly improved in patients aged 65-74 years (hazard ratio [HR], 0.66; 95% con dence interval [CI], 0.45-0.97; P = 0.016) and ≥ 75 years (HR, 0.31; 95% CI, 0.16-0.61; P < 0.001) receiving palbociclib plus letrozole and in patients aged 65-74 years (HR, 0.27; 95% CI, 0.16-0.48; P < 0.001) receiving palbociclib plus fulvestrant (24). A consistent bene t of CDK4/6i in combination with AI was observed across all subgroups examined in the P-REALITY and P-REALITY-X studies (older patient groups and among patients with and without visceral metastases or bone-only disease) (14,28) and also that patients with different comorbidities continue to bene t from palbociclib (29).…”

Section: Discussionmentioning

confidence: 90%

Retrospective registry of patients with locally advanced/metastatic HR+/HER2− breast cancer treated in clinical practice in Andalusia.

Piudo,

López-Barajas,

Flores

et al. 2024

Preprint

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Background Limited data are available regarding the real-world effectiveness and safety of Cyclin Dependent Kinase 4/6 inhibitor (CDK4/6i) (palbociclib/ribociclib) just as a first-line treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2‒) metastatic breast cancer (MBC). Objective To assess whether clinical or demographic characteristics limit access to first line CDK4/6i treatment in clinical practice in the Autonomous Community of Andalusia (Spain) between November 2017, and April 2020. In addition, effectiveness will be described in an exploratory analysis. Methods Physicians from 12 centers abstracted demographic and clinical characteristics, treatment and outcome data for women with HR+/HER2- MBC receiving and not receiving CDK4/6i in addition to hormonal treatment in the first-line setting a 3:1 proportion. Kaplan–Meier analysis estimated progression-free rates (PFRs) and survival rates (SRs). Results A total of 212 patients were included, of whom 175 (82.5%) were in the CDK4/6i treatment group and 37 (17.5%) were in the non-CDK4/6i treatment group (control group). CDK 4/6i treated patients were younger (p = 0.0011), and biopsies of the metastatic disease were done more frequently (p = 0.0454), with multiple metastases, and with differences in relation to the time of diagnosis of metastatic disease (p = 0.0304). The clinical benefit rate (CBR) was 82.3% in the CDK4/6i group and 67.8% in the control group. Median time to a progression event or death (PFS) was 20.4 months (95%CI 15.6–28) in the CDK4/6i group and 12.1 months (95%CI 7.9-not reached) in the control group. Conclusions Younger patients, biopsies of metastatic disease and with multiple metastases were more frequently treated with CDK4/6i.

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“…Therefore, the level of HER2 expression may also have an impact on the outcome of individuals with HR + breast cancer. Prior studies [ 27 – 29 ] have also evinced that HER2 non-expression or low-expression has a specific influence on the survival of HR + breast cancer, although not statistically significant. This phenomenon deserves further investigation in the future and may be incorporated into predictive models to more accurately assess the survival prognosis of HR + /HER2- MBC.…”

Section: Discussionmentioning

confidence: 99%

Efficacy, safety, and predictive model of Palbociclib in the treatment of HR-positive and HER2-negative metastatic breast cancer

Wang,

Lei,

Fang

et al. 2024

BMC Cancer

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Purpose This research designeded to: 1. Analyze the efficacy and safety of Palbociclib treatment in HR-positive and HER2-negative (HR + /HER2-) metastatic breast cancer(MBC) patients. 2. Establish and validate a nomogram model for predicting the progression-free survival (PFS) rates of 6 months, 12 months, and 18 months in HR + /HER2- MBC patients after receiving Palbociclib plus endocrine therapy (ET). Patients and methods 1. This research retrospectively analyzed the efficacy and safety of Palbociclib combined with ET in 214 patients with HR + /HER2- MBC. 2. A nomogram was designed and constructed with the retrospective clinical data of 214 patients with HR + /HER2- MBC who received Palbociclib plus ET at Zhejiang Cancer Hospital in China from August 2018 to August 2022. Among these patients, 161 were randomly assigned to the training cohort, while 53 to the validation cohort. The predictive accuracy of the nomogram was assessed through the analysis the area under the receiver operating characteristic(ROC) curve, calibration curve, and decision curve analysis(DCA). Results 1. Median PFS was 7.17 months (95% CI: 7.61—10.05 months), with an objective response rate (ORR) of 2.80% and a disease control rate (DCR) of 34.58%. The most prevalent grade 3–4 adverse event was neutropenia (38.79%). 2. Multiple variable analysis of the training set revealed that age < 60 years old, PR < 20%, Ki-67 ≥ 20%, luminal B molecular subtype, primary resistance to ET, receipt of late-stage chemotherapy, and presence of liver metastasis or ≥ 2 visceral metastases were independent prognostic factors associated with poor PFS (P < 0.05). Then, the predictive model underwent development and validation utilizing the aforementioned parameters. On the one hand, the area under the ROC curve (AUC) values of the training set at 6 months, 12 months, and 18 months were 0.771, 0.783, and 0.790, respectively, indicating a strong predictive ability of the developed model. On the other hand, the AUC of the validation set at 6 months, 12 months, and 18 months were 0.720, 0.766, and 0.754, respectively, suggesting the favorable discriminatory ability of the model. The calibration curves also exhibited a good fit with the ideal curves, and the DCA demonstrated the clinical applicability of the model. The nomogram's different scores could distinguish PFS. Conclusion This retrospective study demonstrates the efficacy of Palbociclib in Chinese breast cancer patients. Moreover, the clinical parameters showed a significant association with the prognosis of HR + /HER2- MBC, and the prognostic models constructed based on these variables also displayed robust predictive power, which could offer more intuitive and convenient references for clinical doctors to formulate follow-up treatment plans.

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Efficacy and safety of palbociclib in patients with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2

Cited by 23 publications

References 12 publications

Real‐world treatment patterns for palbociclib plus an aromatase inhibitor, or an aromatase inhibitor alone, for patients with metastatic breast cancer in the Flatiron Database

Real‐world treatment patterns for palbociclib plus an aromatase inhibitor, or an aromatase inhibitor alone, for patients with metastatic breast cancer in the Flatiron Database

Retrospective registry of patients with locally advanced/metastatic HR+/HER2− breast cancer treated in clinical practice in Andalusia.

Efficacy, safety, and predictive model of Palbociclib in the treatment of HR-positive and HER2-negative metastatic breast cancer

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