EARLY real-world treatment and dosing patterns of ribociclib for metastatic breast cancer (mBC): A retrospective observational study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13059-e13059
Author(s):  
Sanjeev Balu ◽  
Joyce O'Shaughnessy ◽  
Mary Lisha Paul ◽  
Bismark Baidoo ◽  
Lavanya Sudharshan
Keyword(s):  
Endocrine Therapy ◽  
Real World ◽  
Menopausal Status ◽  
Eastern Cooperative Oncology Group ◽  
Metastatic Breast ◽  
Treatment Information ◽  
The Us ◽  
Line Setting ◽  
Metastatic Sites ◽  
Dosing Patterns

e13059 Background: Ribociclib and abemaciclib in combination with endocrine therapy have demonstrated survival benefit in women with HR-positive/HER2-negative mBC. This study assessed early real-world treatment and dosing patterns of ribociclib for mBC in a US community oncology setting. Methods: This was a retrospective, observational, descriptive study of female mBC patients initiating treatment with ribociclib between March 1, 2017 and September 30, 2018 within the US Oncology Network (USON) and followed through December 31, 2018. USON’s iKnowMed (iKM) EHR database was used to identify patients and medical chart data review was conducted to abstract treatment information. Descriptive analyses were performed to assess patient and treatment characteristics. Results: A total of 161 patients were selected for chart review, of which 116 patients who received ribociclib were confirmed as eligible. The mean age of patients at initiation of treatment was 66 (SD 14) years. Among patients with documented menopausal status, 90% were post-menopausal, and 10% were pre-menopausal. Among patients with documented receptor status, 99% were ER+/HER2-. Patients most commonly initiated ribociclib in the first-line setting (1L n = 52, 2L n = 30, 3L n = 9, 4L+ n = 25) and in combination with letrozole (n = 33, 28.4%). Eastern Cooperative Oncology Group (ECOG) performance score at time of ribociclib initiation was 0-1 in 60.4% of patients. Documented metastatic sites were present in bone (35.3%), lung (8.6%), and liver (6%). The most common comorbidities documented within 6 months of treatment initiation were cardiovascular disease (53.4%), diabetes (19%), and depression (18.1%). Overall, 46.6% (n = 54) of patients received prior neoadjuvant or adjuvant chemotherapy and 32.8% patients (n = 38) received prior neoadjuvant or adjuvant endocrine therapy. 95% of patients started at the full dose of 600mg. One-fourth of patients (n = 29) had a dose-hold and 27.6% (n = 32) patients experienced a dose reduction with ribociclib therapy. Conclusions: This study represents early ribociclib uptake in a real-world setting in the US. Early utilization demonstrates patients receiving ribociclib are older and sicker than those in pivotal clinical trials. Substantial heterogeneity in ribociclib initiation by LOT was observed.

scholarly journals Patterns of treatment and outcome of palbociclib plus endocrine therapy in hormone receptor-positive/HER2 receptor-negative metastatic breast cancer: a real-world multicentre Italian study

2021 ◽  
Vol 13 ◽  
pp. 175883592098765
Author(s):  
Raffaella Palumbo ◽  
Rosalba Torrisi ◽  
Federico Sottotetti ◽  
Daniele Presti ◽  
Anna Rita Gambaro ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Real World ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Her2 Receptor ◽  
Treatment Line ◽  
Hormone Receptor Positive

Background: The CDK4/6 inhibitor palbociclib combined with endocrine therapy (ET) has proven to prolong progression-free survival (PFS) in women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (MBC). Few data are available regarding the efficacy of such a regimen outside the clinical trials. Patients and methods: This is a multicentre prospective real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary aim was the clinical benefit rate (CBR); secondary aims were the median PFS, overall survival (OS) and safety. Patients received palbociclib plus letrozole 2.5 mg (cohort A) or fulvestrant 500 mg (cohort B). Results: In total, 191 patients (92 in cohort A, 99 in cohort B) were enrolled and treated, and 182 were evaluable for the analysis. Median age was 62 years (range 47–79); 54% had visceral involvement; 28% of patients had previously performed one treatment line (including chemotherapy and ET), 22.6% two lines and 15.9% three. An overall response rate of 34.6% was observed with 11 (6.0%) complete responses and 52 (28.6%) partial responses. Stable disease was achieved by 78 patients (42.9%) with an overall CBR of 59.8%. At a median follow-up of 24 months (range 6–32), median PFS was 13 months without significant differences between the cohorts. When analysed according to treatment line, PFS values were significantly prolonged when palbociclib-based therapy was administered as first-line treatment (14.0 months), to decrease progressively in second and subsequent lines (11.7 and 6.7 months, respectively). Median OS was 25 months, ranging from 28.0 months in 1st line to 18.0 and 13.0 months in 2nd and subsequent lines, respectively. Conclusions: Our data indicate that palbociclib plus ET is active and safe in HR+/HER2− MBC, also suggesting a better performance of the combinations in earlier treatment lines.

Real-world Indian scenario of CDK4/6 inhibitors (palbociclib and ribociclib) with endocrine therapy in upfront hormone positive metastatic breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13028-e13028
Author(s):  
Ajay Gogia ◽  
Shalabh Arora ◽  
Priyanshu Choudhary ◽  
Rakesh Kumar ◽  
Sanjay Thulkar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Real World ◽  
De Novo ◽  
Metastatic Breast ◽  
Common Side Effect ◽  
Drug Discontinuation ◽  
Grade 3 ◽  
Visceral Disease

e13028 Background: CDK4/6 inhibitors (CDKi), in combination with endocrine therapy (ET), has become the standard of care in the treatment of hormone positive (HR+)/ HER2 neu negative metastatic breast cancer (MBC) patients. We evaluated clinical outcomes and toxicity in MBC patients, who have received ET with two CDKi, namely palbociclib and ribociclib. Methods: This is an ambispective, single institutional analysis of de-novo HR+ MBC patients treated with CDKi (palbociclib 125 mg and ribociclib 600 mg once a day for 21 days /28 days cycle) from November 2016- October 2020 at AIIMS, New Delhi, India. The primary endpoint was progression-free survival (PFS) and the secondary endpoint was response rate and toxicity. A total of 157 female patients were recruited in this study however the response and toxicity data were available in 120 cases. All premenopausal women received ovarian suppression or ovarian ablation. Results: A total of 120 patients were included in this study with a median age of 57 years (35-75) and 93 (77.5%) cases were postmenopausal. Twenty-three (19.1%) patients had a bone-only disease, 49 (40.9%) had bone and visceral disease and 48 (40%) had only visceral disease. In this study 91 (75.9%) patients received palbociclib and 29 (24.2%) received ribociclib. The median PFS was 18 months (4-36). Twenty four (20%) patients achieved a complete response, 69 (57.5%) patients attained partial response, 18(15%) patients had stable disease and 9 (7.5%) had disease progression. Grade 3–4 neutropenia, thrombocytopenia, and anaemia were observed in 18(15%), 8 (6.7%), and 4 (3.3%) cases respectively. None of the patients developed febrile neutropenia. Cutaneous, renal, hepatic, and gastrointestinal toxicity was observed in 1,1,3,4 cases respectively. Prolonged QTc was observed in one case. Grade 3 fatigue was observed in 7 cases. Dose interruption/delay (mean dose delay of 7 days), dose modification, and drug discontinuation were observed in 24 (20%), 12 (10%), and 10 (8.3%) of cases respectively. Conclusions: This is one of the largest real-world Indian data on CDK4/6 inhibitors on upfront HR+ MBC. Side effects are less than published literature with similar efficacy. Neutropenia was the most common side effect which was managed by brief dose interruption.

Utilization and patient characteristics for the trastuzumab originator, biosimilars, and other HER2 inhibitors in the United States.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 308-308
Author(s):  
Young Hee Nam ◽  
Aaron Mendelsohn ◽  
James Marshall ◽  
Nancy Lin ◽  
Jeffrey Brown ◽  
...  
Keyword(s):  
Endocrine Therapy ◽  
Metastatic Breast ◽  
Patient Characteristics ◽  
The United States ◽  
Baseline Period ◽  
Research Network ◽  
Health Plans ◽  
Clinical Practices ◽  
Full Data ◽  
The Us

308 Background: Biosimilars for trastuzumab, a HER2 inhibitor (HER2I), have been available for use in the US since in 2019, yet information on their utilization and patient characteristics is limited. We assessed utilization and patient characteristics for the trastuzumab originator, biosimilars, and other HER2Is in the US. Methods: We analyzed healthcare claims for 10/1/2016-up to 2/29/2020 (end date varied across health plans) from the Biologics and Biosimilars Collective Intelligence Consortium’s Distributed Research Network ( > 95 million persons) using the FDA’s Sentinel distributed analysis tools. We conducted descriptive analyses on the number of incident users and patients’ characteristics for each HER2I. Adults continuously enrolled in their health plan with medical and drug coverage ≥365 days (baseline period) prior to their incident HER2I use were eligible for analysis. Results: Of the incident users (incident to any HER2Is), we identified 6,631 originator trastuzumab users, 122 trastuzumab-anns, 116 ado-trastuzumab emtansine, 54 neratinib, and 54 lapatinib users. Trastuzumab-dkst and trastuzumab/hyaluronidase-oysk had < 11 users each. Mean age was the highest for trastuzumab/hyaluronidase-oysk (73.7 years; SD, 18.6) and similar between the trastuzumab originator and biosimilars (52.5-59.0). The number of incident users/100,000 person-years decreased for the trastuzumab originator from 13.5 in 2016 to 9.4 in 2020 and increased for trastuzumab-anns from 0.4 in 2019 to 4.9 in 2020. Of the baseline clinical characteristics examined, Charlson/Elixhauser comorbidity score was the highest for lapatinib (2.0), lowest for trastuzumab-dkst and neratinib (0.5), and similar between the trastuzumab originator (1.1) and trastuzumab-anns (1.3). The proportion of patients who received any chemotherapy during the baseline period was 38.9% for lapatinib, 18.5% for the trastuzumab originator, and 14.8% for trastuzumab-anns. The proportion of endocrine therapy users was the highest for neratinib (63.0%) and similar between the trastuzumab originator (11.1%) and trastuzumab-anns (10.7%). Among incident users with metastatic breast cancer, endocrine therapy receivers during the baseline period accounted for 19.3% for the trastuzumab originator and 69.6% for lapatinib. Conclusions: Though full data were not available for 2019-2020 for all health plans, these preliminary findings suggest that utilization of biosimilar trastuzumab-anns increased whereas the trastuzumab originator use decreased over time and that there is a variation in patient characteristics between HER2Is and by metastatic status while the characteristics were generally similar between the trastuzumab originator and trastuzumab-anns. We plan to conduct ongoing assessment of HER2I utilization as more data become available to help inform clinical practices and health policies.

Real-world starting dose and outcomes of palbociclib plus an aromatase inhibitor for metastatic breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13021-e13021
Author(s):  
Debra A. Patt ◽  
Xianchen Liu ◽  
Benjamin Li ◽  
Lynn McRoy ◽  
Rachel M. Layman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Aromatase Inhibitor ◽  
Real World ◽  
Metastatic Breast ◽  
Routine Practice ◽  
First Line ◽  
Starting Dose ◽  
The Us

e13021 Background: Palbociclib (PA) has been approved for HR+/HER2–advanced/metastatic breast cancer (mBC) in combination with an aromatase inhibitor (AI) or fulvestrant for more than 6 years. Regardless of the labeled recommended starting dose of 125mg/day, some patients initiate palbociclib at lower doses in routine practice. This study described real-world starting dose, patient characteristics, and effectiveness outcomes of first line PA+ AI for mBC in the US clinical setting. Methods: We conducted a retrospective analysis of Flatiron Health’s nationwide longitudinal electronic health records, which came from over 280 cancer clinics representing more than 2.2 million actively treated cancer patients in the US. Between February 2015 and September 2018, 813 HR+/HER2– mBC women initiated PA+AI as first-line therapy and had ≥ 3 months of potential follow-up. Patients were followed from start of PA+AI to December 2018, death, or last visit, whichever came first. Real-world progression-free survival (rwPFS) was defined as the time from the start of PA+AI to death or disease progression. Real-world tumor response (rwTR) was assessed based on the treating clinician’s assessment of radiologic evidence for change in burden of disease over the course of treatment. Multivariate analyses were performed to adjust for demographic and clinical characteristics. Results: Of 813 eligible patients, 68.3% were white, median age was 65.0 years, and 42.9% had visceral disease (lung and/or liver). Median duration of follow-up was 21.0 months. 805 patients had records of PA starting dose, with 125mg and 75/100mg/day being 86.5% and 13.5%, respectively. Patients who started at 75/100mg/day were more likely to be ≥75 years than those who started at 125mg/day (38.5% vs 17.1%). Other baseline and disease characteristics were generally evenly distributed. Patients who started at 125mg/day had longer median rwPFS (27.8 vs 18.6 months, adjusted HR=0.74, 95%CI=0.52-1.05) and higher rwTR (54.0% vs. 40.4%) than those patients who started 100/75mg/day (adjusted OR=1.76, 95%CI=1.13-2.74). Table presents results in detail. Conclusions: Most patients in this study initiated palbociclib at 125mg/day and dose adjustment was similar regardless of starting dose. These real-world findings may support initiation of palbociclib at a dose of 125mg/day in combination with AI for the first-line treatment of HR+/HER2- mBC. [Table: see text]

Real-world clinical outcomes and toxicity in metastatic breast cancer patients treated with palbociclib and endocrine therapy

2019 ◽  
Vol 176 (2) ◽  
pp. 429-434 ◽  
Author(s):  
Leticia Varella ◽  
Akaolisa Samuel Eziokwu ◽  
Xuefei Jia ◽  
Megan Kruse ◽  
Halle C. F. Moore ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Endocrine Therapy ◽  
Clinical Outcomes ◽  
Real World ◽  
Metastatic Breast ◽  
Breast Cancer Patients

scholarly journals Outcome in patients of hormone receptor (HR) positive (Her 2) negative metastatic breast cancer treated with palbociclib – A real-world experience

2022 ◽  
Vol 0 ◽  
pp. 1-5
Author(s):  
Ajay Bapna ◽  
A. Samar ◽  
Pulkit Nag ◽  
Sanjeev Patni ◽  
Nidhi Patni
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Real World ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
Visceral Metastasis ◽  
First Line ◽  
Real World Data ◽  
Best Response ◽  
Line Setting

Objectives: We present real-world outcome with the use of palbociclib in patients with HR-positive Her2-negative breast cancer treated at single center in India. Material and Methods: We conducted a medical audit of consecutive patients with HR-positive Her2-negative metastatic breast cancer, who were treated with palbociclib at our center between November 2016 and May 2020. Palbociclib was commenced at a dose of 125 mg orally once daily and a schedule of 21 days on therapy followed by 7 days off therapy was followed. Survival analysis included the Kaplan–Meier method using Statistical Package for the Social Sciences software (Version 26). HRs were calculated using Cox proportional hazard regression models and 95% confidence intervals (CIs) for the incidence estimates. Results: A total of 67 female patients were commenced on treatment with palbociclib between November 2016 and May 2020. The median age was 55 years (range 29–78 years). A total of 51 (76%) of these patients were postmenopausal and the remaining 16 were premenopausal. Baseline metastatic disease involved one organ/site in 23 (34%), two organs/sites in 32 (48%), three or more in 12 (18%). Bony metastasis alone was seen in 17 (25%) patients, visceral alone in 30 (45%), and the remaining 20 had both bony and visceral metastases. For these 67 patients, palbociclib was commenced as 1st line systemic therapy in 24 (36%) cases. Amongst the remaining 43 cases, it was 2nd line in 21 (31%); 3rd line and beyond in 22 (33%). Median PFS was 16.1 months (95% CI: 9.6–22.8) and median OS was 20.7 months (95% CI: 14.1–27.3). Median PFS for palbociclib use in first line was 18.7 months (95% CI: 4.6–32.9) while in subsequent lines, it was 13.8 months (95% CI: 9.8–17.9; log-rank P = 0.228). Median OS in patients who received palbociclib in first line was 23.2 months (95 % CI 20.1–26.3) and for those why received it in subsequent lines was 16.3 months (95 % CI: 12.5–20.1; P = 0.069). In total population, best response on imaging was CR in 11 (16%) cases (06 in 1st line setting and 05 in subsequent line setting); PR in 33 (49%); SD in 03; and progressive disease in 20. Median PFS with bone only metastasis: 20.9 months (95 % CI: 5.9–36.0), while with visceral metastasis 16.1 months (95% CI: 9.8–22.5; P = 0.537). Median OS with bone only metastasis: 22.7 months (95% CI: 17.8–27.5), while with visceral metastasis, it was 18.5 months (95% CI: 13.6–23.4; P = 0.314). Conclusion: Palbociclib is a useful addition in the management of HR +ve Her2 –ve breast cancer patients. Its benefit is confirmed in our real-world setting, both in the first and subsequent lines of therapy and the data are on similar lines as the global real-world data on palbociclib effectiveness.

Sign in / Sign up

Export Citation Format

Share Document