CONTEXT:  Peer reviewed publication of a large scale retrospective study in metastatic breast cancer, published in “Breast Cancer Research” journal.  Outcomes from th study underline the value of RWE in complementing traditional RCTs to better understand a therapy’s overall effectiveness.

IMPACT:  High

READ TIME:  5 mins

Quality Level Mean [1 – 10]:  9

1. “First large-scale comparative effectiveness analysis of a CDK 4/6 inhibitor plus letrozole evaluating progression-free and overall survival versus letrozole alone. Pfizer Inc. (NYSE:PFE) today announced the peer-reviewed publication of real-world evidence (RWE) demonstrating that first-line therapy with IBRANCE® (palbociclib) in combination with letrozole was associated with improved real-world progression-free survival (rwPFS) and overall survival (OS) in women with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) metastatic breast cancer (mBC) compared with letrozole alone.” 

2. “”With more than six years of patient experience, a positive benefit-risk profile, strong clinical data and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.”” 

3. “The data from this real-world analysis is consistent with available data from the Phase 3 PALOMA-2 trial, which studied IBRANCE plus letrozole versus placebo plus letrozole as initial endocrine-based therapy in post-menopausal women with estrogen-receptor positive (ER+), HER2- mBC.” 

4. “About IBRANCE® (palbociclib) 125 mg tablets and capsules. IBRANCE is an oral inhibitor of CDKs 4 and 6,1 which are key regulators of the cell cycle that trigger cellular progression.2,3 In the U.S., IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy.” 

5. “The most common adverse reactions (≥10%) of any grade reported in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).” 

Source URL: https://finance.yahoo.com/news/real-world-evidence-supports-effectiveness-104500305.html