Clinical outcome and toxicity data in patients with advanced breast cancer treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors combined with endocrine therapy in a real-world clinical setting

Fountzilas, Elena; Koliou, Georgia-Angeliki; Rapti, Vasiliki; Nikolakopoulos, Achilleas; Christopoulou, Athina; Moirogiorgou, Evangelia; Binas, Ioannis; Aravantinos, G.; Kostadima, Lida; Nikolaidi, Adamantia; Karteri, Sofia; Zagouri, Flora; Saridaki, Zenia; Molfeta, A.; Oikonomopoulou, P.; Res, Eleni; Tryfonopoulos, Dimitrios; Koumakis, Georgios; Fountzilas, George; Razis, E.

doi:10.1093/annonc/mdz242.029

Cited by 3 publications

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“…We found that palbociclib-based therapy as rst-line systemic treatment resulted in a DCR of 93.7% and a median PFS of 14.0 months in Han patients with ER+HER2-metastatic breast cancer. The e cacy pro le of palbociclib-based treatment in the Han population was similar to the real-world clinical outcomes in patients from the United States (6,8,14). These results are also comparable to the clinical bene t rate (CBR) and PFS data from the PALOMA-2 (palbociclib plus letrozole, CBR 84.3%, median PFS 24.8 months) and PALOMA-3 (palbociclib plus fulvestrant, CBR 67%, median PFS 9.5 months) studies (4,5,15).…”

Section: Discussionsupporting

confidence: 53%

“…In the settings of clinical trials, palbociclib in combination with fulvestrant or letrozole as rst-line treatment has signi cantly prolonged progressionfree survival (PFS) in ER+ metastatic breast cancer patients from 6.6 to 10.3 months with tolerable side effects (4,5). Real-world data from the United States, mainly of White people, have supported the bene ts of the addition of CDK4/6 inhibitors as rst-line treatment for improving long-term outcomes (6)(7)(8). Data from other races may further support the value of CDK4/6 inhibitors in patients with ER+ metastatic breast cancer.…”

Section: Introductionmentioning

confidence: 99%

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Treatment patterns and clinical outcomes in patients with metastatic breast cancer treated with palbociclib-based therapies: Real-world data in the Han population

et al. 2020

Preprint

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Background: Palbociclib combined with endocrine therapy has become the standard treatment for estrogen receptor-positive (ER+) metastatic breast cancer. However, little is known about the effectiveness of diverse palbociclib-based regimens other than letrozole and fulvestrant in the real-world clinical setting. This study aimed to reveal the treatment patterns and clinical outcomes in Han patients in routine clinical practice.Methods: The clinical data of patients with ER+ metastatic breast cancer treated with palbociclib were collected from the China National Cancer Center database. The efficacy profile of palbociclib in this Han population was evaluated, especially in patients younger than 40 years, in those with bone-only metastasis, for various regimen combinations, and as different treatment lines. Propensity score matching was employed to match patients with or without previous everolimus treatment. Results: A total of 186 patients from 89 cities in 18 provinces in China were enrolled. The median progression-free survival (PFS) was similar among different palbociclib-combined groups (P=0.566): 10.0 months (95% confidence interval [CI] 3.8–16.1) in the exemestane plus palbociclib group, 9.7 months (95% CI 6.3–13.1) in the letrozole plus palbociclib group, 7.8 months (95% CI 5.5–10.2) in the fulvestrant plus palbociclib group, 7.2 months (95% CI 3.2–11.3) in the toremifene plus palbociclib group, and 6.1 months (95% CI 1.2–11.0) in the anastrozole plus palbociclib group. Kaplan-Meier analysis revealed that patients with bone-only metastasis (median PFS: 8.8 vs. 7.8 months; P=0.023) and those who received palbociclib as first-line treatment (median PFS: 14.0 months, 95% CI 11.4–16.6; P<0.001) had prolonged PFS compared with other patients. Patients pretreated with everolimus had significantly worse PFS (3.4 months, 95% CI 0.7–6.1) than those in the everolimus-naïve group (8.8 months, 95% CI 6.6–11.0, P=0.001) in the whole population. After propensity score matching, patients pretreated with everolimus had inferior PFS (4.4 months, 95% CI 0.5–8.2) compared with everolimus-naïve patients (6.1 months, 95% CI 4.7–7.5, P=0.439). Conclusions: Various palbociclib-based regimens have promising efficacy in real-world settings, even in patients with bone-only metastasis. Palbociclib resistance is more common in patients pretreated with everolimus, and in the settings of subsequent treatment compared with first-line treatment.

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Section: Discussionsupporting

confidence: 53%

Section: Introductionmentioning

confidence: 99%

Treatment patterns and clinical outcomes in patients with metastatic breast cancer treated with palbociclib-based therapies: Real-world data in the Han population

et al. 2020

Preprint

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“…We found that palbociclib-based therapy as first-line systemic treatment resulted in a DCR of 93.7% and a median PFS of 14.0 months in Han patients with ER + HER2-metastatic breast cancer. The efficacy profile of palbociclib-based treatment in the Han population was similar to the real-world clinical outcomes in patients from the United States (6,8,14). These results also compare favorably with the clinical benefit rate (CBR) and PFS data from the phase 3 trials, the PALOMA-2 (palbociclib plus letrozole, CBR 84.3%, median PFS 24.8 months) and PALOMA-3 (palbociclib plus fulvestrant, CBR 67%, median PFS 9.5 months) studies (4,5).…”

Section: Discussionmentioning

confidence: 60%

“…In the settings of clinical trials, palbociclib in combination with fulvestrant or letrozole as first-line treatment has significantly prolonged progression-free survival (PFS) in ER + metastatic breast cancer patients from 6.6 to 10.3 months with tolerable side effects (4,5). Real-world data from the United States, mainly of White people, have supported the benefits of the addition of CDK4/6 inhibitors as first-line treatment for improving long-term outcomes (6)(7)(8). Data from other races may further support the value of CDK4/6 inhibitors in patients with ER + metastatic breast cancer.…”

Section: Introductionmentioning

confidence: 99%

Treatment Patterns and Clinical Outcomes in Patients with Metastatic Breast Cancer Treated with Palbociclib-Based Therapies: Real-World Data in the Han Population

Ma²,

et al. 2020

Preprint

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Background: Palbociclib combined with endocrine therapy has become the standard treatment for estrogen receptor-positive (ER+) metastatic breast cancer. However, little is known about the effectiveness of diverse palbociclib-based regimens other than letrozole and fulvestrant in the real-world clinical setting. This study aimed to reveal the treatment patterns and clinical outcomes in Han patients in routine clinical practice. Methods: The clinical data of patients with ER+ metastatic breast cancer treated with palbociclib were collected from the China National Cancer Center database. The efficacy profile of palbociclib in this Han population was evaluated, especially in patients younger than 40 years, in those with bone-only metastasis, for various regimen combinations, and as subsequent systemic therapy. Propensity score matching was employed to match patients with or without previous everolimus treatment. Results: A total of 186 patients from 89 cities in 18 provinces in China were enrolled. Patients older than 40 years (P=0.189), those with metastasis other than bone metastasis (P=0.023), and those who received palbociclib as first-line treatment (P<0.001) had prolonged progression-free survival (PFS) compared with other patients. Median PFS was similar among different palbociclib-combined groups (P=0.566): 10.0 months (95% confidence interval [CI] 3.8–16.1) in the exemestane plus palbociclib group, 9.7 months (95% CI 6.3–13.1) in the letrozole plus palbociclib group, 7.8 months (95% CI 5.5–10.2) in the fulvestrant plus palbociclib group, 7.2 months (95% CI 3.2–11.3) in the toremifene plus palbociclib group, and 6.1 months (95% CI 1.2–11.0) in the anastrozole plus palbociclib group. Patients pretreated with everolimus had significantly worse PFS (3.4 months, 95% CI 0.7–6.1) than those in the everolimus-naïve group (8.8 months, 95% CI 6.6–11.0, P=0.001) in the whole population. After propensity score matching, patients pretreated with everolimus had inferior PFS (4.4 months, 95% CI 0.5–8.2) compared with everolimus-naïve patients (6.1 months, 95% CI 4.7–7.5, P=0.439). Conclusions: Various palbociclib-based regimens have promising efficacy in real-world settings, even in patients with bone-only metastasis. Palbociclib resistance is more common in patients younger than 40 years, in those pretreated with everolimus, and in the settings of subsequent treatment compared with first-line treatment.

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“…Real-world data from the United States, mainly from White people, have supported the benefits of the addition of CDK4/6 inhibitors as first-line treatment for improving long-term outcomes. [ 9 – 11 ] Real-world data from other races may further support the value of CDK4/6 inhibitors in patients with ER+ metastatic breast cancer.…”

Section: Introductionmentioning

confidence: 99%

Treatment patterns and clinical outcomes in patients with metastatic breast cancer treated with palbociclib-based therapies: real-world data in the Han population

et al. 2022

Chinese Medical Journal

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Background: This study aimed to reveal the treatment patterns and clinical outcomes of diverse palbociclib-based regimens in Han patients with estrogen receptor-positive (ER+) metastatic breast cancer in routine clinical practice. Methods: The clinical data of patients with ER+ metastatic breast cancer treated with palbociclib were collected from the National Cancer Center database. The efficacy profile of palbociclib in this Han population was evaluated, especially for various combination regimens. The efficacy of palbociclib-based therapy in patients with prior everolimus treatment was also assessed. Results: A total of 186 patients from 89 cities in 18 provinces in China were enrolled. The median progression-free survival (PFS) was similar among different palbociclib-combined groups ( P = 0.566): 10.0 months (95% confidence interval [CI] 3.8–16.1) in the +exemestane group, 9.7 months (95% CI 6.3–13.1) in the +letrozole group, 7.8 months (95% CI 5.5–10.2) in the +fulvestrant group, 7.2 months (95% CI 3.2–11.3) in the +toremifene group, and 6.1 months (95% CI 1.2–11.0) in the +anastrozole group. Thirty-four patients (18.3%) had received everolimus for their metastatic disease before the prescription of palbociclib. The disease control rate was significantly lower in patients who had received previous everolimus than in the everolimus-naïve group (50.0% vs . 82.2%, P < 0.001). Patients pre-treated with everolimus had significantly worse PFS than those in the everolimus-naïve group (3.4 months vs . 8.8 months, P = 0.001). After propensity score matching, patients pre-treated with everolimus had similar PFS (4.4 months, 95% CI 0.5–8.2) compared with everolimus-naïve patients (6.1 months, 95% CI 4.7–7.5, P = 0.439). Conclusions: Various palbociclib-based regimens have promising efficacy in ER+ metastatic breast cancer in real-world settings, even in patients who had been pre-treated with everolimus.

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Clinical outcome and toxicity data in patients with advanced breast cancer treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors combined with endocrine therapy in a real-world clinical setting

Cited by 3 publications

References 0 publications

Treatment patterns and clinical outcomes in patients with metastatic breast cancer treated with palbociclib-based therapies: Real-world data in the Han population

Treatment patterns and clinical outcomes in patients with metastatic breast cancer treated with palbociclib-based therapies: Real-world data in the Han population

Treatment Patterns and Clinical Outcomes in Patients with Metastatic Breast Cancer Treated with Palbociclib-Based Therapies: Real-World Data in the Han Population

Treatment patterns and clinical outcomes in patients with metastatic breast cancer treated with palbociclib-based therapies: real-world data in the Han population

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