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

Borges, Fátima; Costa, Filipa Alves da; Ramos, Adriana; Ramos, Catarina; Bernardo, Catarina; Brito, Cláudia; Mayer-da-Silva, A.; Furtado, Celso; Ferreira, Arlindo R.; Martins-Branco, Diogo; Miranda, Ana; Lourenço, António

doi:10.1016/j.breast.2022.02.005

Cited by 9 publications

(5 citation statements)

References 30 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In our study, the effectiveness in first-line was substantially lower compared to the PALOMA-2 trial (median PFS of 25 months, median OS of 54 months) [ 9 , 18 , 19 ], which aligns with findings from other real-world studies [ 20 , 26 – 28 ] (Table 2 ). This survival gap may partly be attributed to the strict protocol-specified definition of eligible patients for the PALOMA-2 trial, excluding individuals with poor performance status or extensive visceral disease.…”

Section: Discussionsupporting

confidence: 89%

Tolerability and effectiveness of palbociclib in older women with metastatic breast cancer

Baltussen,

Mooijaart,

Vulink

et al. 2024

Breast Cancer Res Treat

View full text Add to dashboard Cite

Purpose Palbociclib has become the standard of care for estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer, but real-world evidence in older women remains scarce. Therefore, we investigated tolerability of palbociclib in older women with metastatic breast cancer. Methods Consecutive women aged ≥ 70 with ER+/HER2- metastatic breast cancer, treated with palbociclib in any treatment line in six hospitals, were included. Primary endpoint was grade ≥ 3 palbociclib-related toxicity. Predictors of toxicity were identified using logistic regression models. Progression-free survival (PFS) and overall survival (OS) were estimated using Kaplan Meier. Results We included 144 women with a median age of 74 years. Grade 3–4 toxicity occurred in 54% of patients, of which neutropenia (37%) was most common. No neutropenic fever or grade 5 toxicity occurred. Dose reduction during treatment occurred in 50% of patients, 8% discontinued treatment due to toxicity and 3% were hospitalized due to toxicity. Polypharmacy (odds ratio (OR) 2.50; 95% confidence interval (CI) 1.12–5.58) and pretreatment low leukocytes (OR 4.81; 95% CI 1.27–18.21) were associated with grade 3–4 toxicity, while comorbidities were not. In first-line systemic therapy, median PFS was 12 months and median OS 32 months. In second-line, median PFS was 12 months and median OS 31 months. Conclusion Although grade 3–4 toxicity and dose reductions occurred frequently, most were expected and managed by dose reductions, showing that palbociclib is generally well tolerated and thus represents a valuable treatment option in the older population.

show abstract

Section: Discussionsupporting

confidence: 89%

Tolerability and effectiveness of palbociclib in older women with metastatic breast cancer

Baltussen,

Mooijaart,

Vulink

et al. 2024

Breast Cancer Res Treat

View full text Add to dashboard Cite

show abstract

“…Real-world studies of first-line CDK 4/6 inhibitors combined with endocrine therapies have demonstrated a median PFS ranging from 18.7 to 21.3 months 23 , 24 . The results of PFS in the second line are consistent with those published in the pivotal studies 25 and other real-world data studies 26 . We could conclude that all patients benefit equally regardless of the age at which they receive the treatment, since we have not observed statistically significant differences between age groups.…”

Section: Discussionsupporting

confidence: 89%

Elderly patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with CDK4/6 inhibitors in a multicentre cohort

Pla,

Felip,

Obadia

et al. 2024

Clin Transl Oncol

View full text Add to dashboard Cite

Introduction Cyclin-dependent kinases 4/6 inhibitors (CDK 4/6i) combined with endocrine therapy have become the gold standard in hormone receptor-positive (HR +) HER2-negative (HER2-) metastatic breast cancer (MBC). However, there is a significant lack of data regarding the efficacy and safety of these treatments in elderly patients. We present the results of a real-world data (RWD) cohort stratified by age at treatment initiation (≥ 70 years compared to patients < 70 years). Methods Clinico-pathological data of HR + HER2- MBC patients who were candidates for CDK4/6i therapy between January 2017 and December 2020 at the Institut Català d'Oncologia (Spain) were retrospectively collected. The primary goal was to assess Progression-Free Survival (PFS), Overall Survival (OS), and safety outcomes within this patient population. Results A total of 274 patients with MBC who received CDK4/6i treatment were included in the study. Among them, 84 patients (30.8%) were aged ≥ 70 years, with a mean age of 75, while 190 patients (69.2%) were under the age of 70, with a mean age of 55.7 years. The most frequently observed grade 3–4 toxicity was neutropenia, with similar rates in both the < 70 group (43.9%) and the ≥ 70 group (47.9%) (p = 0.728). The median Progression-Free Survival (mPFS) for the first-line CDK4/6i treatment was 22 months (95% CI, 15.4–39.8) in the < 70 group and 20.8 months (95% CI 11.2–NR) in the ≥ 70 group (p = 0.67). Similarly, the median PFS for the second-line CDK4/6i treatment was 10.4 months (95% CI, 7.4–15.1) and 7.1 months (95% CI 4.4–21.3) (p = 0.79), respectively. Median overall survival (mOS) was not reached either for the first- and second-line treatment. Conclusions Our RWD suggests that elderly patients, when compared to those under 70, experience similar survival outcomes and exhibit comparable tolerance for CDK4/6i therapy.

show abstract

“…CDK 4/6 inhibitors were introduced in 2017 for ABC; first represented by palbociclib and soon followed by ribociclib in 2018 and abemaciclib in 2020. Considering only this subgroup, the increase was 40.8 fold, supported by evidence from clinical trials and more recent real-word studies ( Cardoso Borges et al, 2022 ).…”

Section: Resultssupporting

confidence: 62%

National trends in the use of oral chemotherapy over 13 years

Moreira

Bernardo

Ramos³

et al. 2022

Front. Pharmacol.

View full text Add to dashboard Cite

Background: Systemic cancer therapy has traditionally been administered using an intravenous (IV) route, implying patients’ frequent visits to hospitals to access to their therapy. If we consider the actual pipeline in oncology, oral chemotherapy will be the main component of cancer treatment in the next few years. This shift in the administration route requires different care models in order to guarantee treatment efficacy and safety.Objective: To analyze time trends in oral chemotherapy consumption in Portugal.Method: Oral chemotherapy consumption over a 13-year period (2008–2020) was analyzed, considering dispensed units by the administration route with respective costs, resorting to the drug regulatory agency (INFARMED I.P.) database. Oral consumption patterns were further explored using common daily doses (CDD) for three conditions, including chronic myeloid leukemia (CML), non-small-cell lung cancer (NSCLC), and breast cancer (BC), to adjust for the effect of varying doses. Data were analyzed descriptively resorting to Microsoft Office Excel 2010.Results: Overall chemotherapy consumption increased +Δ54.7%, with the highest contribution in units observed in oral forms (+Δ58.8%). The total expenditure increased +Δ96.5%, and despite the increase in oral forms (+Δ221.6%), intravenous forms continued to be the major cost driver, with an important contribution from immunotherapy. Much of the increase was led by the approval of 40 new IV and 48 new oral cancer medications with higher costs introduced in the market. Using CDD as an alternative metric to units had varying impacts by indication. The observed increases seemed to focus on specific cancer sites with varying effect; in CML, there was a 2.39-fold increase, compared to 4.41 for NSCLC and 1.86 for BC. However, for BC, two distinct sub-patterns were observed for hormone therapy (increasing 1.83) and for the novel tyrosine kinase inhibitors (increasing 40.8).Conclusion: The growing use of oral chemotherapy is obvious and calls for investments in supporting patients in managing medication adherence and adverse events. The shifts in the healthcare system are complex and need to be prioritized. Our data suggest that priority could be attributed to cancer sites driving innovation, namely, advanced breast cancer.

show abstract

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

Cited by 9 publications

References 30 publications

Tolerability and effectiveness of palbociclib in older women with metastatic breast cancer

Tolerability and effectiveness of palbociclib in older women with metastatic breast cancer

Elderly patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with CDK4/6 inhibitors in a multicentre cohort

National trends in the use of oral chemotherapy over 13 years

Contact Info

Product

Resources

About