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خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
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Phase III trials of fulvestrant plus cyclin dependent kinase 4/6 inhibitors or placebo for advanced hormone receptor-positive, HER2-negative breast cancer

Phase III trials of fulvestrant plus cyclin dependent kinase 4/6 inhibitors or placebo for advanced hormone receptor-positive, HER2-negative breast cancer
Treatment Trial name Enrollment Median progression-free survival (months) Median overall survival (months)
Fulvestrant plus palbociclib or placebo PALOMA-3[1,2] 521 patients with progressive disease 9.5 versus 4.6* 40 versus 30*
Fulvestrant plus ribociclib or placebo MONALEESA-3[3] 726 postmenopausal patients:
  • Half of whom were receiving first-line therapy for metastatic disease or treatment for advanced disease
  • Half of whom were receiving second-line therapy or had early relapse
  • Overall group: 21 versus 13*
  • First-line therapy group: 34 versus 19*
  • Second-line therapy or early relapse group: 15 versus 9.1*
  • Overall group: 54 versus 42*
  • First-line therapy group: Not reached versus 52*
  • Second-line therapy or early relapse group: 40 versus 34
Fulvestrant plus abemaciclib or placebo MONARCH2[4] 669 postmenopausal patients with progressive disease 16.4 versus 9.3* 47 versus 37*

HER2: human epidermal growth factor 2.

* Statistically significant.

¶ Within 12 months after completion of adjuvant or neoadjuvant endocrine therapy.
References:
  1. Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): Final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol 2016; 17:425.
  2. Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med 2018; 379:1926.
  3. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382:514.
  4. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy-MONARCH 2: A randomized clinical trial. JAMA Oncol 2020; 6:116.
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