scholarly journals Real-world treatment of patients with palbociclib for HR+/HER2-advanced/metastatic breast cancer: the Europe IRIS study

2021 ◽  
Author(s):  
Katie Mycock ◽  
Lin Zhan ◽  
Kieran Hart ◽  
Gavin Taylor-Stokes ◽  
Gary Milligan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Real World ◽  
Clinical Characteristics ◽  
Low Dose ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Survival Rates ◽  
Metastatic Breast ◽  
Kaplan Meier

Aim: To report the Europe Ibrance Real World Insights study findings. Methods: Physicians abstracted demographic/clinical characteristics, treatment and outcomes data for women with HR+/HER2- locally advanced breast cancer (ABC) or metastatic  breast cancer (MBC) receiving palbociclib + aromatase inhibitor (AI) or palbociclib + fulvestrant. Kaplan–Meier analysis estimated progression-free rates (PFRs) and survival rates (SRs). Results: 238 physicians abstracted data for 1723 patients. For patients (>90%) initiating at 125 mg/day, dose was reduced in 18.9% of palbociclib + AI and 12.3% of palbociclib + fulvestrant patients. At 12 months, PFR for palbociclib + AI was 88.1%, and SR was 97.3%; PFR for palbociclib + fulvestrant was 79.8%, and SR was 97.5%. Conclusion: Low dose-reduction rates and favorable PFRs and SRs suggest that palbociclib + AI/fulvestrant is well tolerated and effective for HR+/HER2– ABC/MBC in real-world clinical practice.

scholarly journals Real-World Palbociclib Use in HR+/HER2− Advanced Breast Cancer in Canada: The IRIS Study

2021 ◽  
Vol 28 (1) ◽  
pp. 678-688
Author(s):  
Katie Mycock ◽  
Lin Zhan ◽  
Gavin Taylor-Stokes ◽  
Gary Milligan ◽  
Debanjali Mitra
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Medical Records ◽  
Survival Rates ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Retrospective Chart Review ◽  
Hormone Receptor Positive ◽  
Kaplan Meier ◽  
Epidermal Growth

Background: Palbociclib is a selective cyclin-dependent kinase (CDK) 4/6 inhibitor used in combination with aromatase inhibitors or fulvestrant for patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2)-negative advanced/metastatic breast cancer (ABC/MBC). Palbociclib was the first CDK 4/6 inhibitor approved for HR+/HER2− ABC/MBC treatment in Canada in combination with letrozole (P+L) as an initial endocrine-based therapy (approved March 2016), or with fulvestrant (P+F) following disease progression after prior endocrine therapy (approved May 2017). The Ibrance Real World Insights (IRIS) study (NCT03159195) collected real-world outcomes data for palbociclib-treated patients in several countries, including Canada. Methods: This retrospective chart review included women with HR+/HER2− ABC/MBC receiving P+L or P+F in Canada. Physicians reviewed medical records for up to 14 patients, abstracting demographic and clinical characteristics, treatment patterns, and clinical outcomes. Progression-free rates (PFRs) and survival rates (SRs) at 6, 12, 18, and 24 months were estimated via Kaplan–Meier analysis. Results: Thirty-three physicians examined medical records for 247 patients (P+L, n = 214; P+F, n = 33). Median follow-up was 8.8 months for P+L and 7.0 months for P+F. Most patients were initiated on palbociclib 125 mg/d (P+L, 90.2%; P+F, 84.8%). Doses were reduced in 16.6% of P+L and 14.3% of P+F patients initiating palbociclib at 125 mg/d. The PFR for P+L was 90.3% at 12 months and 78.2% at 18 months; corresponding SRs were 95.6% and 93.0%. For P+F, 6-month PFR was 91.0%; 12-month SR was 100.0%. Conclusions: Dose reduction rates were low and PFR and SR were high in this Canadian real-world assessment of P+L and P+F treatments, suggesting that palbociclib combinations are well tolerated and effective.

Ixabepilone efficacy and tolerability in metastatic breast cancer (MBC) patients in a real-world setting.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13067-e13067
Author(s):  
Tara Hyder ◽  
Margaret Q. Rosenzweig ◽  
Adam Brufsky
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Real World ◽  
Triple Negative ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Sensory Neuropathy ◽  
Progression Free Survival ◽  
Real World Setting

e13067 Background: Ixabepilone is a microtubule stabilizing agent that was approved as monotherapy and in combination with capecitabine for the treatment of refractory metastatic or locally advanced breast cancer. With limited options for refractory MBC, especially in triple negative breast cancer (TNBC), ixabepilone has demonstrated an increase in progression free survival (PFS) in randomized control trials. We assess the effectiveness and safety of the drug in a real-world setting. Methods: A large, ongoing clinical database of over 1800 women (1999 to present) was used to identify 91 patients who had received ixabepilone during their treatment course. Clinical outcomes were retrospectively analyzed utilizing descriptive and comparative statistics. Results: Treatment was late in the disease course; median line of treatment was 5.3. At the time of receiving ixabepilone, the patients PFS was 3.5 months with n = 4 patients attaining a PFS > 12 months. Overall survival (OS) was 11.3 months. A subset of patients that had triple negative breast cancer (N = 37) had similar PFS, 3.6 months, and OS, 10.2 months, as the total population. Most common adverse events of any grade were fatigue (37%), nausea (32%), and peripheral sensory neuropathy (28%). Grade 3 or higher anemia was present in 10% of the patients. Conclusions: Ixabepilone has demonstrated efficacy in the treatment of patients with MBC, including the challenging population of TNBC patients in this real-world example. It is also well tolerated. These findings make ixabepilone a reasonable chemotherapeutic agent for refractory MBC and TNBC patients. [Table: see text]

scholarly journals Real-World Treatment Patterns and Clinical Outcomes in Patients Receiving Palbociclib for Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast Cancer in Argentina: The IRIS Study

2019 ◽  
pp. JGO.18.00239 ◽  
Author(s):  
John Waller ◽  
Debanjali Mitra ◽  
Katie Mycock ◽  
Gavin Taylor-Stokes ◽  
Gary Milligan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Epidermal Growth Factor Receptor ◽  
Metastatic Breast Cancer ◽  
Real World ◽  
Survival Rates ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Epidermal Growth ◽  
Overall Survival Rates

PURPOSE The selective cyclin-dependent kinase 4/6 inhibitor palbociclib was approved in Argentina in 2015 for postmenopausal women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer (ABC) or metastatic breast cancer (MBC) based on phase III study results. The Ibrance Real World Insights (IRIS) study aims to evaluate palbociclib in patients with HR-positive/HER2-negative ABC or MBC in the real-world setting in multiple countries globally. Here we report results from patients enrolled in the IRIS study in Argentina. PATIENTS AND METHODS This retrospective medical chart review study included postmenopausal women with confirmed HR-positive/HER2-negative ABC or MBC who were treated with palbociclib plus letrozole as first-line endocrine-based therapy or with palbociclib plus fulvestrant in women with disease progression after endocrine therapy. Participating physicians reviewed medical records of up to six patients each, collecting demographic and clinical data. Outcomes included progression-free and overall survival rates. RESULTS Records were extracted for 162 patients in Argentina (palbociclib plus letrozole, n = 105 [65%]; palbociclib plus fulvestrant, n = 57 [35%]). The 6-month progression-free survival rate was 94% for patients treated with palbociclib plus letrozole and 95% for patients treated with palbociclib plus fulvestrant; 85% and 80% of patients treated with palbociclib plus letrozole were progression free at 12 and 18 months, respectively. Six-month survival rates were 98% for palbociclib plus letrozole and 98% for palbociclib plus fulvestrant; 93% and 89% of patients treated with palbociclib plus letrozole were alive at 12 and 18 months, respectively. CONCLUSION Results from this first real-world evaluation of clinical outcomes in Argentina suggest that palbociclib plus letrozole or fulvestrant delivers favorable effectiveness, as measured by progression-free and overall survival rates.

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