Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population

Abstract

The combination of cyclin dependent kinase 4/6 inhibitors with endocrine therapy is the standard therapy in hormone receptor positive HER-2 negative metastatic breast cancer (HR+/HER2− MBC). Several randomized trials have shown the benefits of this combination, however, real world evidence in the Indian patients is warranted. The present study reports the largest real world multicentric data from Indian population on the use of Palbociclib in HR+/HER2− MBC. A multicentric study on the HR+/HER2− MBC patients who received palbociclib with hormonal agent (Aromatase inhibitors/Fulvestrant) between February 2017 and May 2020 was conducted. Clinical and demographic information and survival data was retrieved from the Hospital medical records. Among a total of 188 patients, 57% patients were premenopausal and 17% patients had bone only disease. Altogether, 115 (61%) patients received palbociclib with Aromatase inhibitors in the first line whereas 73 (39%) patients received it in the second line with Fulvestrant. The median follow up period with advanced disease was 13 months. The median progression free survival in the first line and second line was 20.2 months and 12 months, respectively (p-value < 0.0001). The objective response rate was 80% and 47.9% in first and second lines, respectively. Dose interruptions/ discontinuation were done in 14.9% and 2.7% patients in the first and second lines, respectively. In terms of toxicity, 10% patients had grade 3–4 adverse events. The present real world data of the use of palbociclib in Indian population suggests similar effectiveness to previously published real world evidences and has been adapted as the standard of care in the first and second line treatment of HR+/HER2− MBC.

Peripheral blood lymphocytes predict clinical outcomes in hormone receptor-positive HER2-negative advanced breast cancer patients treated with CDK4/6 inhibitors

“…Median PFS was 26.1 months (95% CI: 23.4–30.8) in patients receiving CDK4/6i treatment as a first-line therapy, while median PFS was 11.9 months (95% CI: 9.9–13.9) in patients receiving CDK/4/6i as subsequent lines of therapy ( Supplemental Figure 2 ). These data are consistent with results of phase III clinical trials 1 – 3 , 5 – 8 , 12 and with data from previously published real-world cohorts 24 – 27 of patients treated with ET plus CDK4/6i.…”

Real-world comparative effectiveness of palbociclib plus letrozole versus letrozole in older patients with metastatic breast cancer

“…Since the approval of palbociclib in February 2015 [ 3 ], CDK4/6 inhibitors have become a recommended treatment option for women of all ages with HR+/HER2– MBC [ 2 ], and the rapid adoption of this class of agents has facilitated collection of real-world data documenting patient experiences. Recent real-world data analyses have shown that palbociclib is effective in patients with HR+/HER2– MBC in routine US clinical practice, but detailed information about the use of CDK4/6 inhibitors specifically in older patients is limited [ [8] , [9] , [10] , [11] , [12] ]. The available real-world studies including older European patients (≥70 or ≥75 years) support the effectiveness or tolerability of palbociclib in these age groups [ 13 , 14 ].…”

Real‐world treatment patterns for palbociclib plus an aromatase inhibitor, or an aromatase inhibitor alone, for patients with metastatic breast cancer in the Flatiron Database

“…In conclusion, there is an accumulating body of real‐world evidence studies that have evaluated palbociclib in combination with an AI in patients with HR+/HER2− mBC in the 1L 16‐18,20,27‐29,31,47‐52 . The results here add to the understanding and support of the benefit of palbociclib plus an AI in the 1L for people with HR+/HER2− mBC in the real world setting.…”

“…To our knowledge, the P-REALITY X study is the In conclusion, there is an accumulating body of real-world evidence studies that have evaluated palbociclib in combination with an AI in patients with HR+/HER2À mBC in the 1L. [16][17][18]20,[27][28][29]31,[47][48][49][50][51][52] The results here add to the understanding and support of the benefit of palbociclib plus an AI in the 1L for people with HR+/HER2À mBC in the real world setting. In addition to significantly prolonged OS and rwPFS, treatment with palbociclib plus an AI in a heterogeneous population of men and postmenopausal women with HR+/HER2À mBC was associated with a longer TTC.…”