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

Targeted Oncology, Год журнала: 2024, Номер 19(3), С. 303 - 320

Опубликована: Март 28, 2024

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 palbociclib. With increased life expectancy general population, cancer older women also expected increase. The aim was systematically review evidence from both trials and palbociclib outcomes patients HR+/HER2− advanced/metastatic (a/mBC). Older are often underrepresented (RWE) will enrich analysis this subgroup patients. A systematic literature search PubMed, EMBASE, Cochrane Library through May 4, 2023, yielded 2355 unique articles. total 52 articles (13 39 reporting results seven randomized controlled [RCTs] 37 RWE studies, respectively) were included based on study eligibility criteria. All RCTs used age cutoffs ≥ 65 years define population (n = 722; 437 received palbociclib); all except one an cutoff > 60 years, had or higher 9840; 7408 palbociclib). Overall, that compared efficacy (progression-free survival [seven RCTs, 20 studies], overall [four 11 tumor response [three benefit rate [one RCT, two studies]) safety (three three studies) between younger patients, showed similar benefits, regardless age. Results global quality (QoL) maintained receiving dose modifications (two studies), reductions (one discontinuation rates patients; however, these differences did not appear adversely impact outcomes. review, data effective, well tolerated, QoL a/mBC. settings associated as RCTs. CRD42023444195.

Язык: Английский

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Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2− advanced/metastatic breast cancer: updated systematic review

Frontiers in Oncology, Год журнала: 2025, Номер 15

Опубликована: Март 10, 2025

Aim Since 2021, additional real-world evidence (RWE) has emerged on the effectiveness of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) as first-line treatment HR-positive/HER2-negative (HR+/HER2−) advanced/metastatic breast cancer (A/MBC), necessitating this updated review. Methods MEDLINE ® , Embase and Cochrane Databases (07/06/2019–01/09/2024), key congresses (2020–2024) were searched. Studies reporting CDK4/6i use, over 100 participants, progression-free survival (PFS) and/or overall (OS) data included. Results This update included 82 unique studies, 42.7% for palbociclib, 7.3% ribociclib, 3.7% abemaciclib; 46.3% assessed multiple CDK4/6i. In studies including CDK4/6is, median PFS was 23.4–31.0 months 19.8–44.0 14.0–39.5 abemaciclib. When reached, OS 38.0–58.0 months, 40.4–52.0 34.4 respectively. These results within range single-arm versus endocrine therapy (ET) where demonstrated greater benefits than ET alone. Conclusion First-line RWE demonstrates significant clinical in HR+/HER2− A/MBC. are important to guide decision-making, they include patients who not adequately represented trials. with longer follow-up needed assess long-term all three therapies

Язык: Английский

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Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2− Metastatic Breast Cancer

Cancer Medicine, Год журнала: 2025, Номер 14(7)

Опубликована: Март 27, 2025

ABSTRACT Introduction Cyclin‐dependent kinase 4/6 inhibitors (CDK4/6is) in combination with endocrine therapy are the current standard of care for first‐line (1L) treatment hormone receptor–positive and human epidermal growth factor receptor 2–negative (HR+/HER2–) metastatic breast cancer (mBC). To investigate effectiveness palbociclib, first‐in‐class CDK4/6i, plus an aromatase inhibitor (AI) older patients, we compared overall survival (OS) a Medicare population treated 1L palbociclib + AI versus alone. Methods Patients aged ≥ 65 years who were diagnosed de novo HR+/HER2– mBC from 2015 to 2019 identified Surveillance, Epidemiology, End Results (SEER)–linked database eligible if they initiated or The primary endpoint was OS. Stabilized inverse probability weighting (sIPTW) used balance baseline patient characteristics. Of 779 296 received 483 alone as treatment. After sIPTW, median follow‐up 23.1 months 18.2 Adjusted OS longer (sIPTW: 37.6 vs. 25.5 months, HR = 0.73 [95% CI, 0.59–0.91]). In multivariable Cox proportional hazards regression, patients had 39% lower risk death (HR 0.61 0.48–0.77]). Conclusion routine US clinical practice, associated significantly prolonged mBC, adding growing body evidence on benefit this population. Trial Registration ClinicalTrials.gov identifier: NCT06086340

Язык: Английский

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Real-world experience with CDK4-6 inhibition in the old and oldest old with a diagnosis of breast cancer

Seminars in Oncology, Год журнала: 2024, Номер 51(3-4), С. 95 - 105

Опубликована: Фев. 22, 2024

Язык: Английский

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Palbociclib: Randomized Studies and Real-world Evidence as the Basis for Therapeutic Planning in Metastatic Breast Cancer

Geburtshilfe und Frauenheilkunde, Год журнала: 2024, Номер 84(09), С. 813 - 836

Опубликована: Сен. 1, 2024

Abstract Endocrine-based combination therapy with an inhibitor of the cyclin-dependent kinases 4 and 6 (CDK4/6 inhibitors) is currently first-line choice for patients hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2−), locally advanced or metastatic breast cancer (mBC). The efficacy safety treatment palbociclib, first CDK4/6 approved this indication, have been confirmed in large randomized controlled clinical trials (RCTs) strictly defined patient cohorts. Since then, many relevant questions about inhibition palbociclib mBC investigated RCTs real-world studies. Based on evidence, widely used practice since years because its good tolerability. aim review to summarize findings from RWE considering clinically aspects such as safety, tolerability, quality life a focus specific characteristics. A critical discussion overall evidence endocrine-based can contribute support decisions daily practice.

Язык: Английский

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First- vs second-line CDK 4/6 inhibitor use for patients with hormone receptor positive, human epidermal growth-factor receptor-2 negative, metastatic breast cancer in the real world setting

Breast Cancer Research and Treatment, Год журнала: 2024, Номер 208(2), С. 263 - 273

Опубликована: Июнь 26, 2024

To compare CDK4/6 inhibitor (CDK4/6i) with endocrine therapy (ET) in the first- versus second-line setting for treatment of hormone receptor positive (HR+), HER2 negative, metastatic breast cancer (MBC) using real-world evidence.

Язык: Английский

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Efficacy and Safety of Cyclin-Dependent Kinase 4/6 Inhibitors in Patients with Breast Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials and Real-World Studies

Targeted Oncology, Год журнала: 2024, Номер unknown

Опубликована: Дек. 10, 2024

Язык: Английский

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Real-world effectiveness of CDK4/6 inhibitors on patients with HR+/HER2– advanced breast cancer in South Korea, focusing on underrepresented patients

Current Medical Research and Opinion, Год журнала: 2024, Номер 40(6), С. 967 - 975

Опубликована: Май 8, 2024

Objective We assessed the real-world effectiveness of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors as first-line treatments in postmenopausal patients with HR+/HER2- advanced breast cancer, focusing on younger (<45 years) older (>78 populations not considered clinical trials.

Язык: Английский

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

Clinical & Translational Oncology, Год журнала: 2024, Номер unknown

Опубликована: Июнь 3, 2024

Abstract 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 CDK4/6i in practice Autonomous Community Andalusia (Spain) between November 2017 April 2020. In addition, will be described an exploratory analysis. Methods Physicians from 12 centers participated selecting characteristics, treatment, outcome women HR /HER2- MBC treated without addition hormonal setting, 3:1 proportion. Kaplan–Meier analysis estimated progression-free rates (PFRs) survival (SRs). Results A total 212 were included, whom 175 (82.5%) group 37 (17.5%) non-CDK4/6i (control group). Patients CDK 4/6i younger (p = 0.0011), biopsies site at moment relapse most commonly performed 0.0454), had multiple sites 0.0025). The benefit rate (CBR) was 82.3% 67.8% control group. Median time progression event death (PFS) 20.4 months (95%CI 15.6–28) 12.1 7.9–not reached) Conclusions Younger patients, disease more frequently our daily practice.

Язык: Английский

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The treatment pattern of advanced HR-positive and HER2-negative breast cancer in central southern China: a hospital-based cross-sectional study

BMC Cancer, Год журнала: 2024, Номер 24(1)

Опубликована: Июль 30, 2024

Abstract Aims This investigation aims to elucidate the treatment status of advanced HR+/HER2- breast cancer patients in Hunan Province Central Southern China from November 2021 December 2022. Methods Data 301 with were collected project under guidance Chinese Society Clinical Oncolfogy (CSCO). The data included clinical characteristics and first-line second-line rescue treatment. Results First-line chemotherapy endocrine therapy for mBC accounted 40% (121/301) 60% (180/301) treatments, respectively. AI (21%), plus CDK4/6 inhibitor (28%), fulvestrant (24%) or (18%) most common therapies. Taxane-based was (59%). Second-line 43% (72/166) 57% (94/166) Fulvestrant (23%) (29%) prevalences decreased 19% 11%, T (taxane)-based still regimen (46%). Third-line more prevalent than (57% vs. 41%). (33%). AI, inhibitor, 21%, 12% 18% third-line therapies, Conclusions Compared chemotherapy, a favorable choice Province.

Язык: Английский

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