Real-World Clinical Data of Palbociclib in Asian Metastatic Breast Cancer Patients: Experiences from Eight Institutions

Lee, Jieun; Park, Hyung Soon; Won, Hye Sung; Yang, Ji Hyun; Lee, Hee Yeon; Woo, In Sook; Shin, Kabsoo; Hong, Ji Hyung; Yang, Young Joon; Chun, Sang Hoon; Byun, Jae Ho

doi:10.4143/crt.2020.451

Cited by 13 publications

(19 citation statements)

References 33 publications

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“…While the recommended starting dose is 125mg, a more careful approach is given to more fragile patients and/or with relevant comorbidities. With respect to dose reduction, 43.24% of patients in our study had the initial dose reduced, in line with previous real-world studies (ranging from 31% to 50%), which could suggest that this is the prevalence of palbociclib dose reduction in real-life context in this indication [10,22,25,26].…”

Section: Discussionsupporting

confidence: 90%

“…Although some real-world studies about the effectiveness of palbociclib plus fulvestrant exist, the majority found in the literature has some limitations, particularly being single-centre studies, having limited sample sizes and/or short follow-up times [ 21 , 22 , 25 , 26 , [28] , [29] , [30] ]. Furthermore, other works privileged analyses per line of treatment irrespective of concomitant medicine (AI, fulvestrant or other), which may be a challenge for indirect comparisons and understanding the real benefit of this association [ [31] , [32] , [33] ].…”

Section: Discussionmentioning

confidence: 99%

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Real-world effectiveness of palbociclib plus fulvestrant in advanced breast cancer: Results from a population-based cohort study

Borges¹,

Costa

Ramos³

et al. 2022

The Breast

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Real-world effectiveness of palbociclib plus fulvestrant in advanced breast cancer: Results from a population-based cohort study

Borges¹,

Costa

Ramos³

et al. 2022

The Breast

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“…Liver metastasis was already suggested to associate with poor prognosis following CDK4/6 treatment in previous studies (30,31). Our study also suggested that liver metastasis was associated with poor response to palbociclib with letrozole.…”

Section: Discussionsupporting

confidence: 78%

Which Clinicopathologic Parameters Suggest Primary Resistance to Palbociclib in Combination With Letrozole as the First-Line Treatment for Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer?

Kim

Park

et al. 2021

Front. Oncol.

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In this study, we evaluated clinical parameters to predict the primary resistance of palbociclib in combination with endocrine therapy as the first-line treatment in patients with hormone receptor (HR)+, human epidermal growth factor receptor 2 (HER2)- metastatic breast cancer (MBC). We performed a data analysis of patients diagnosed with HR+, HER2-MBC who received palbociclib plus letrozole as the first-line treatment in the metastatic setting from the clinical data warehouse in Samsung Medical Center. In this study, 305 patients were included in the final data analysis. The median follow-up duration was 31 months, and we observed 123 cases of disease progression. The median progression-free survival (PFS) was 28.7 months, and 38 patients (12.5%) had less than a 6-month PFS. The multivariate analysis suggested that primary resistance to adjuvant endocrine therapy (ET) (hazard ratio: 1.91), presence of liver metastasis (hazard ratio: 2.17), initial elevation of serum CA-15-3 (hazard ratio: 1.99), weak positivity of estrogen receptor (ER) (hazard ratio: 2.28), Ki-67 3+ or 4+ (hazard ratios: 2.58 and 10.28), and presence of mutation (hazard ratio: 9.59) were associated with a short PFS duration. A further prediction model was developed with data from 256 patients and 33 cases of disease progression in 6 months. This model included five factors—primary resistance to adjuvant ET (odds ratio, OR: 1.14), liver metastasis (OR: 1.56), initial CA-15-3 elevation (OR: 1.51), weak ER expression (OR: 2.22), and BRCA2 mutation (OR: 2.85)—and the area under the receiver operating characteristic curve was 0.842 (95% CI: 0.775, 0.909; p < 0.001). Finally, we divided them into four risk groups according to the prediction model with the five risk factors. These four groups had different PFS (p < 0.001) and primary resistance of palbociclib with letrozole [OR of group 2 vs. group 1 (ref): 2.18 (p = 0.002), OR of group 3: 3.91 (p < 0.001), and OR of group 4: 4.25 (p < 0.001)]. We developed a prediction model of primary resistance to palbociclib with letrozole as the first-line treatment for HR+, HER2-MBC. Our prediction model might be helpful for considering the first-line treatment strategies. Further well-designed clinical trials would be warranted to validate our prediction model.

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“…Overall, our results with both letrozole and fulvestrant suggest a substantial benefit of palbociclib on PFS in women with HR-positive, HER2−negative metastatic breast cancer in a Canadian context, as observed in the existing literature [17][18][19][20][21][22][23][24][25][26][27].…”

Section: Study Results In the Context Of Existing Literaturesupporting

confidence: 73%

“…In real-world settings, oncologists have deviated from conventional monograph dosing recommendations and varied their prescribing strategies in attempts to mitigate neutropenic effects, hoping to maintain palbociclib tolerability and extend overall treatment duration. Recent studies have reported real-world outcomes and described dosing modifications trends [17][18][19][20][21][22][23][24][25][26][27]. However, to the best of our knowledge, this is the first real-world study assessing the direct impact of palbociclib off-monograph dosing modifications on PFS.…”

Section: Introductionmentioning

confidence: 99%

The Impact of Real-World Alternative Dosing Strategies of Palbociclib on Progression-Free Survival in Patients with Metastatic Breast Cancer

Kano

et al. 2022

Current Oncology

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Background: Palbociclib, a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor, in combination with letrozole or fulvestrant has been demonstrated to prolong the progression-free survival (PFS) in patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) metastatic breast cancer. In efforts to mitigate neutropenic toxicities, oncologists in real-world practice have prescribed alternative dosing strategies with palbociclib, yet the implication on PFS is unknown. Methods: We conducted a retrospective, observational chart review of all female patients at our clinics with HR+, HER2- metastatic breast cancer receiving palbociclib in combination with either letrozole or fulvestrant with a first dose initiated between June 2016 and December 2018 and followed their disease course until 30 April 2020. Results: The median PFS for all clinic patients receiving palbociclib and letrozole (n = 63) was 40.8 months (95% confidence interval (CI) 25.6–not estimable) and 16.97 months (95% CI 8.57–not estimable) for patients receiving palbociclib and fulvestrant (n = 11). We identified seven alternative dosing strategies prescribed by oncologists, the most prevalent being prescribing palbociclib for three weeks on and two weeks off (n = 8). The Kaplan–Meier curves for PFS in patients receiving letrozole and palbociclib prescribed alternative dosing strategies appear to diverge from monograph dosing early in the treatment. Many patients prescribed palbociclib using alternative dosing strategies continued to be observed even by the 18-month timepoint. The prevalence of grade 4 neutropenia was lower for patients on palbociclib with letrozole, suggesting a possible mitigation of severe neutropenia with alternative dosing strategies. Conclusion: We conclude that alternative dosing strategies used by oncologists such as prescribing palbociclib for three weeks on, two weeks off may achieve comparable disease control while mitigating neutropenic toxicities when compared to standard monograph dosing recommendations, prolonging treatment tolerability and adherence. Further large-scale studies are needed to confirm these results for future clinical adoption.

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Real-World Clinical Data of Palbociclib in Asian Metastatic Breast Cancer Patients: Experiences from Eight Institutions

Cited by 13 publications

References 33 publications

Real-world effectiveness of palbociclib plus fulvestrant in advanced breast cancer: Results from a population-based cohort study

Real-world effectiveness of palbociclib plus fulvestrant in advanced breast cancer: Results from a population-based cohort study

Which Clinicopathologic Parameters Suggest Primary Resistance to Palbociclib in Combination With Letrozole as the First-Line Treatment for Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer?

The Impact of Real-World Alternative Dosing Strategies of Palbociclib on Progression-Free Survival in Patients with Metastatic Breast Cancer

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