Patterns of treatment and outcomes in real world elderly patients with metastatic oestrogen receptor positive (ER+) breast cancer receiving the CDK4/6 inhibitor Palbociclib and endocrine therapy

Skrobo, Darko; Prior, Lisa; Walshe, Janice; Gullo, Giuseppe; Crown, J.

doi:10.1016/s0959-8049(20)30810-8

Cited by 4 publications

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“…Three retrospective studies using data from the Flatiron Health longitudinal database had different study time frames and populations (in terms of patient age); however, there remains a possibility of patient overlap across studies [ 35 , 37 , 52 ]. Older patients were defined as ≥ 60 years of age in one study [ 40 ], ≥ 65 years in 21 studies [ 30 , 32 , 34 , 36 – 39 , 42 , 43 , 45 , 46 , 49 , 50 , 52 , 53 , 56 – 58 , 64 , 65 , 68 ], ≥ 70 years in 11 studies [ 31 , 44 , 47 , 48 , 54 , 55 , 59 – 63 , 66 , 67 ], and ≥ 75 years in four studies [ 33 , 35 , 41 , 51 ]. Three studies evaluated CDK 4/6 inhibitors as a class; however, ≥ 80% of the patients received palbociclib as the CDK 4/6 inhibitor [ 43 , 58 , 67 ].…”

Section: Resultsmentioning

confidence: 99%

“…Of the 26 RWE studies (nine in first-line setting; 15 regardless of line of therapy; line of therapy not specified in two studies) that reported PFS data, 20 studies compared results between older and younger patients (Table 1 ). In 16 studies, there was no significant difference in real-world progression-free survival (rwPFS) between younger and older patients who received treatment with palbociclib [ 34 , 38 , 39 , 46 – 49 , 51 – 53 , 55 , 56 , 58 , 59 , 65 , 67 , 68 ]. In three studies, rwPFS benefit was comparable between younger and older patients; however, no test for significance was conducted [ 45 , 50 , 66 ].…”

Section: Resultsmentioning

confidence: 99%

“…Dose reduction data for older patients who received palbociclib were reported in 13 RWE studies. Of these studies, seven compared data between older and younger patients [ 32 , 34 , 39 , 40 , 44 , 50 , 67 ]. In five studies, older patients in comparison with younger patients had a higher rate of dose reductions with no detrimental effect on survival outcomes [ 32 , 39 , 44 , 50 , 67 ].…”

Section: Resultsmentioning

confidence: 99%

“…In a study assessing clinical outcomes in patients receiving palbociclib plus ET, 15% of older patients (> 65 years) and 10% of younger patients (≤ 65 years) had dose reductions; the effectiveness (objective response rate [ORR], rwPFS, and OS) of palbociclib plus ET did not depend on age [ 50 ]. In a study examining treatment patterns and outcomes in older patients receiving palbociclib plus ET, palbociclib dose reductions occurred in 40% of the patients, with neutropenia as the most common reason, similar for both age groups (< 65 and ≥ 65 years); there was no statistically significant difference in rwPFS and OS between the two groups [ 34 ]. In a study assessing tolerability of palbociclib in older and younger patients with advanced breast cancer, there were no significant differences in dose reductions (≥ 60 years, 51% vs < 60 years, 46%; P = 0.61) [ 40 ].…”

Section: Resultsmentioning

confidence: 99%

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Palbociclib in Older Patients with Advanced/Metastatic Breast Cancer: A Systematic Review

Brain,

Chen,

Simon

et al. 2024

Targ Oncol

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Background Palbociclib in combination with endocrine therapy is approved for treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer. In addition to clinical trials, several real-world studies have evaluated the effectiveness of palbociclib. With increased life expectancy in the general population, breast cancer in older women is also expected to increase. Objective The aim was to systematically review evidence from both clinical trials and real-world studies for palbociclib treatment outcomes in older patients with HR+/HER2− advanced/metastatic breast cancer (a/mBC). Older patients are often underrepresented in clinical trials, and real-world evidence (RWE) will enrich the analysis of palbociclib outcomes in this subgroup of patients. Design A systematic literature search in PubMed, EMBASE, and Cochrane Library through May 4, 2023, yielded 2355 unique articles. A total of 52 articles (13 and 39 articles reporting results from seven randomized controlled trials [RCTs] and 37 RWE studies, respectively) were included based on study eligibility criteria. Results All RCTs used age cutoffs of ≥ 65 years to define older population ( n = 722; 437 received palbociclib); all RWE studies, except one with an age cutoff of > 60 years, had age cutoffs of ≥ 65 years or higher to define older population ( n = 9840; 7408 received palbociclib). Overall, in studies that compared efficacy (progression-free survival [seven RCTs, 20 RWE studies], overall survival [four RCTs, 11 RWE studies], tumor response [three RWE studies], and clinical benefit rate [one RCT, two RWE studies]) and safety outcomes (three RCTs, three RWE studies) between older and younger patients, palbociclib showed similar benefits, regardless of age. Results from two RCTs and two RWE studies showed that global quality of life (QoL) was maintained in older patients receiving palbociclib. Overall, palbociclib dose modifications (two RWE studies), dose reductions (one RCT, seven RWE studies), and treatment discontinuation rates (three RCTs, three RWE studies) were higher in older patients compared with younger patients; however, these differences did not appear to adversely impact efficacy outcomes. Conclusions In this systematic review, data from RCTs showed that palbociclib was effective, well tolerated, and maintained QoL in older patients with HR+/HER2− a/mBC. Palbociclib treatment in older patients in real-world settings was associated with similar clinical benefit as in RCTs. PROSPERO Registration CRD42023444195. Supplementary Information The online version contains supplementary material available at 10.1007/s11523-024-01046-z.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Palbociclib in Older Patients with Advanced/Metastatic Breast Cancer: A Systematic Review

Brain,

Chen,

Simon

et al. 2024

Targ Oncol

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“…In addition to the comparative studies described above, several prior single-arm, real-world studies have evaluated rwPFS and OS in elderly patients with advanced or mBC receiving palbociclib ( 31 – 35 ). In a national United Kingdom retrospective study of patients aged ≥ 75 years with ER+/HER2− advanced breast cancer receiving 1L palbociclib plus AI (N = 276), 12- and 24-month rwPFS rates were 75.9% and 64.9%, respectively, and OS rates were 85.1% and 74.0%, respectively ( 31 ).…”

Section: Discussionmentioning

confidence: 99%

Real-world treatment patterns and effectiveness of palbociclib plus an aromatase inhibitor in patients with metastatic breast cancer aged 75 years or older

Brufsky,

Liu,

et al. 2023

Front. Oncol.

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BackgroundElderly patients are generally underrepresented in oncology clinical trials; therefore, real-world data are needed to inform clinical management of elderly patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2−) metastatic breast cancer (mBC). This subanalysis of the P-REALITY X study (NCT05361655) evaluated palbociclib treatment patterns and comparative effectiveness of palbociclib plus an aromatase inhibitor (AI) versus an AI alone among patients with HR+/HER2− mBC aged ≥ 75 years treated in routine clinical practice in the United States.MethodsThis retrospective observational cohort study used electronic health records from the Flatiron Health Analytic Database. Palbociclib treatment patterns, overall survival (OS), real-world progression-free survival (rwPFS), and time to chemotherapy (TTC) were evaluated. Three methods were used for comparative analyses: (1) an unadjusted analysis, (2) stabilized inverse probability treatment weighting (sIPTW; primary analysis), and (3) propensity score matching (PSM; sensitivity analysis).ResultsA total of 961 patients aged ≥ 75 years with HR+/HER2− mBC were identified who started palbociclib plus an AI (n = 313) or an AI alone (n = 648) as first-line (1L) therapy between February 2015 and March 2020 (data cut-off: September 30, 2020). Among patients in the palbociclib plus an AI group with a documented palbociclib starting dose (n = 306), approximately 75% started palbociclib at 125 mg/day, and approximately 40% experienced dose adjustment. After sIPTW, patients treated with palbociclib plus an AI versus an AI alone had significantly improved OS (median of 43.0 vs. 32.4 months; hazard ratio [HR], 0.66 [95% confidence interval (CI), 0.51–0.84]; P = 0.0007), rwPFS (median of 20.0 vs. 15.0 months; HR, 0.72 (0.59–0.89); P = 0.0021), and TTC (median of 40.2 vs. 27.4 months; HR, 0.69 [0.55–0.87]; P = 0.0014). These significant improvements in OS, rwPFS, and TTC remained consistent in the unadjusted analysis and after PSM.ConclusionThis real-world comparative analysis demonstrated that 1L palbociclib plus an AI is associated with improved effectiveness compared with an AI alone among patients with HR+/HER2− mBC aged ≥ 75 years. These findings support palbociclib plus an AI as a standard-of-care 1L treatment for elderly patients with HR+/HER2− mBC.

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Optimizing CDK4/6 inhibitors in advanced HR+/HER2- breast cancer: A personalized approach

Fontanella

Giorgi

Russo³

et al. 2022

Critical Reviews in Oncology/Hematology

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Patterns of treatment and outcomes in real world elderly patients with metastatic oestrogen receptor positive (ER+) breast cancer receiving the CDK4/6 inhibitor Palbociclib and endocrine therapy

Cited by 4 publications

References 0 publications

Palbociclib in Older Patients with Advanced/Metastatic Breast Cancer: A Systematic Review

Palbociclib in Older Patients with Advanced/Metastatic Breast Cancer: A Systematic Review

Real-world treatment patterns and effectiveness of palbociclib plus an aromatase inhibitor in patients with metastatic breast cancer aged 75 years or older

Optimizing CDK4/6 inhibitors in advanced HR+/HER2- breast cancer: A personalized approach

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