Abstract PS10-16: Real-world efficacy of ribociclib + aromatase inhibitor/fulvestrant, or endocrine monotherapy, or chemotherapy as first-line treatment in women with HR-positive, HER2-negative locally advanced or metastatic breast cancer: Third interim analysis from the RIBANNA study

2021 ◽  
Author(s):  
Achim Wöckel ◽  
Cosima Brucker ◽  
Thomas Decker ◽  
Jörg Falbrede ◽  
Helmut Forstbauer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Aromatase Inhibitor ◽  
Real World ◽  
Interim Analysis ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Australian real-world outcomes of ribociclib and aromatase inhibitor in hormone receptor (HR) positive, HER2 negative metastatic breast cancer (MBC): Results from Kisqali Access Registry for Metastatic breast cancer in Australia (KARMA) collected alongside a medicine access program.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13018-e13018
Author(s):  
Vanessa Wong ◽  
Richard de Boer ◽  
Sally E. Baron-Hay ◽  
Robert helmut Blum ◽  
Benjamin Carl Forster ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Aromatase Inhibitor ◽  
Real World ◽  
Metastatic Breast ◽  
Line Treatment ◽  
First Line ◽  
Access Program ◽  
Dose Reductions ◽  
First Line Treatment

e13018 Background: International guidelines recommend a combination of CDK4/6 inhibitor and endocrine therapy (ET) as first line treatment for HR+, HER2- MBC. Results from MONALEESA-2 demonstrate improved progression free survival (PFS) with ribociclib (CDK4/6 inhibitor) and ET as compared to ET alone. Prior to Australia’s Pharmaceutical Benefits Scheme funding, ̃800 patients participated in the ribociclib Medicine Access Program (MAP) from May 2017 to June 2018. Methods: KARMA is a secondary data use, non-interventional study of Australian patients who received first line treatment with ribociclib and aromatase inhibitor (AI), obtained via a MAP, for HR+, HER2- MBC. The aim was to capture comprehensive patient and treatment data to reflect real world practice and outcomes. Direct comparisons were made with the ribociclib/letrozole cohort in MONALEESA-2 given that the eligibility criteria were similar for both studies. Results: Data from 160 patients at 17 sites was analysed with a median follow up of 36.5 months. Baseline characteristics are shown in the table. 63 of 160 (39%) patients remain on ribociclib/AI at time of analysis. 58% of patients had at least 1 dose reduction, with the majority (77%) requiring only a single dose reduction. The most common reasons for dose reductions were neutropenia (68%) and abnormal liver enzymes (17%). 16 of 160 (10%) discontinued treatment due to toxicity, including 1 patient with QTc prolongation > 600ms. There were no deaths due to toxicity. Median duration of treatment and PFS were 24.5 (95% CI 17.8-33.3) and 36.3 months (95% CI 29.9- NR) respectively, compared to 20.2 and 25.3 months in MONALEESA-2. Landmark PFS was 76% at 12 months, 67% at 18 months and 64% at 24 months. Conclusions: This is the first real world study of ribociclib and AI developed alongside a MAP. The combination treatment was well tolerated with similar rates of dose reductions (58% in both) and treatment discontinuation due to toxicity (10% vs 8%) when compared to MONALEESA-2. This real-world cohort achieved a superior PFS, potentially explained in part by a younger population with more favourable baseline disease characteristics, including fewer disease sites and higher rates of bone only metastases. It is encouraging to see drug tolerability and efficacy replicated in real world patients.[Table: see text]

Efficacy of pertuzumab in combination with trastuzumab and a taxane in first-line treatment for metastatic breast cancer (MBC): A multicenter, retrospective, observational study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12504-e12504 ◽  
Author(s):  
Teresa Gamucci ◽  
Lucia Mentuccia ◽  
Isabella Sperduti ◽  
Alain Gelibter ◽  
Loretta D'Onofrio ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Observational Study ◽  
Real World ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Rank Test ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

e12504 Background: Pertuzumab (P) , Trastuzumab (T) and Docetaxel (D) is standard first-line treatment in patients (pts) with HER2 + metastatic breast cancer (MBC). This multicenter retrospetive observational study was performed to evaluate the activity of P and T in combination with D or Paclitaxel (Tx) in real world HER2 + MBC pts. Methods: We identified HER2 + MBC pts treated with P, T and D or Ptx optionally followed by P, T and endocrine therapy (ET) maintenance in hormone positive (HR+) BC, in 17 Italian cancer centres between 09/2012 and 08/2016. Overall Survival (OS) and Progression Free Survival (PFS) were calculated by the Kaplan-Meier product-limit method. Log-rank test was used to assess differences between subgroups. Results: 191 pts were included in our analysis. Pts characteristics: median age 54 years (range 29-80); PS 0 in 127 (67%) pts and PS 1 in 54 (28%); 107 (56%) had visceral metastases (mts), 23 (12%) only bone mts and 28 (15%) brain mts, 130 (68%) were ER/PgR +. 76 pts (40%) were metastatic at diagnosis; 148 (78) were treated with D while 43 (22%) with Tx. The ORR was 78% (CI 95% 72-84), RC 18% and RP 60%, only 10 (5%) had PD. To date, of the 54 pts treated with ET maintenance, 26% had a further improvement of response (7 pts had RC). At median follow-up of 17 months (mo) (range 6- 52), median PFS was 20 mo (95% CI 14-26) and median OS at 2 years was 80%. No differences in PFS were found for age (p = 0.92), PS (p = 0.18), receptor status (p = 0.57), visceral mts (p = 0.54) and chemotherapy (cht) type (p = 0.47), whereas number of mts site (1 vs > 1) affected PFS (28 vs 16 mo, p = 0.002). Moreover median PFS in naïve pts and in pts pretreated with only cht was 28 mo (95% CI, 20-36) and 27 mo (95% CI, 16-38) respectively, whereas in pts pretreated with T it was 12 mo (95% CI 16-38 p 0.002). In HR+ pts ET maintenance together with P and T had an impact on PFS (28 vs 15 mo, p = 0.01). Conclusions: Our analysis confirms, in real world HER2 MBC pts, the efficacy of P, T and a taxane combination in first line treatment; in this population PFS was shorter in pts pretreated with T. ET maintenance in association with P and T in HR+ pts improved PFS. Data collection is ongoing and update results will be presented.

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

2020 ◽  
Author(s):  
Hongnan Mo ◽  
Fei Ma ◽  
Qing Li ◽  
Pin Zhang ◽  
Peng Yuan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Propensity Score ◽  
Real World ◽  
Metastatic Breast ◽  
Treatment Patterns ◽  
Line Treatment ◽  
First Line ◽  
Han Population ◽  
First Line Treatment

Abstract 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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