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PARSIFAL: A randomized, multicenter, open-label, phase II trial to evaluate palbociclib in combination with fulvestrant or letrozole in endocrine-sensitive patients with estrogen receptor (ER)[+]/HER2[-] metastatic breast cancer.

ASCO: Results of PARSIFAL


Abstract No : 1007

Abstract Type : Oral Abstract Session

Indication : ER+ HER2-VE

Intervention : palbociclib in combination with fulvestrant or letrozole

Company : Pfizer

Technology : Small Molecule


Results:

By March 9th, 2020, 256 PFS events occurred. Pts characteristics were well balanced. Median age was 62 years (range: 25–90), 56.6% were ECOG 0, 40.7% had “de novo” metastatic disease, 48% had visceral disease, and 43.6% with $3 organ sites involved. At median follow-up of 32 mo, median PFS was 27.9 mo (95% confidence interval [CI], 24.2- 33.1) with PF and 32.8 mo (95% CI, 25.8-35.9) with PL (HR: 1.1; 95% CI, 0.9-1.5; P = 0.321). No differences were observed for pts with or without visceral involvement (HR: 1.3 and HR: 0.97 respectively, interaction P = 0.275), and for “de novo” or recurrent metastatic disease (HR: 1.1 and HR: 1.1 respectively, P = 0.979). The 4-year OS rate was 67.6% in PF and 67.5% in PL arm (HR: 1; 95% CI, 0.7-1.5; P = 0.986). No differences were observed in ORR or CBR between arms. Grade $3 adverse events were similar in both arms, being neutropenia and leukopenia the most frequent. No treatment-related deaths were reported.


Conclusion:

This study was not able to identify any improvement in PFS for PF over PL in patients with endocrine-sensitive ER[+]/HER2[-] MBC. As both arms demonstrated comparable 4 years-OS, PF is a reasonable alternative to PL in this setting.


Commentary:

PARSIFAL study did not show stastically superiority in PFS for fulvestrant + palbociclib over letrozole + palbociclib iin first-line metatstatic HER2-VE breast cancer. As per Delveinsight's analysis it is upto physiscian choice to pick any of the treatment for their patients.




Executive Summary

PARSIFAL study did not show stastically superiority in PFS for fulvestrant + palbociclib over letrozole + palbociclib iin first-line metatstatic HER2-VE breast cancer. As per Delveinsight's analysis it is upto physiscian choice to pick any of the treatment for their patients.

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