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

Phase III trials of aromatase inhibitors 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) Most frequent grade ≥3 toxicities
Letrozole plus palbociclib or placebo PALOMA-2[1,2] 666 postmenopausal patients, no prior treatment for metastatic disease 25 versus 15* 54 versus 51
  • Neutropenia (66 versus 1.4%)
  • Leukopenia (25 versus 0%)
  • Anemia (5.4 versus 1.8%)
  • Fatigue (1.8 versus 0.5%)
Letrozole plus ribociclib or placebo MONALEESA-2[3,4] 668 postmenopausal patients, no prior treatment for metastatic disease 25 versus 16* 64 versus 51*
  • Neutropenia (62 versus 0.2%)
  • Leukopenia (21 versus <1%)
  • Increased liver function tests (0.2 versus 2.4%)
Goserelin with either an aromatase inhibitor or tamoxifen plus ribociclib or placebo MONALEESA-7[5,6] 672 pre or perimenopausal patients, no prior endocrine treatment for metastatic disease; one line of chemotherapy for advanced disease was permitted 24 versus 13* 59 versus 48*
  • Neutropenia (61 versus 4%)
  • Leukopenia (14 versus 1%)
  • Increased alanine aminotransferase (5 versus 1%)
Aromatase inhibitor plus abemaciclib or placebo MONARCH3[7] 493 postmenopausal patients, no prior treatment for metastatic disease 28 versus 15* 67 versus 55
  • Diarrhea (9.5 versus 1.2%)
  • Neutropenia (21 versus 1.2%)
  • Fatigue (2 versus 0%)

HER2: human epidermal growth factor 2.

* Statistically significant.
References:
  1. Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med 2016; 375:1925.
  2. Finn RS, Rugo HS, Dieras VC, et al. Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ER+/HER2- ABC): Analyses from PALOMA-2. J Clin Oncol 2022; 40:LBA1003.
  3. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med 2022; 386:942.
  4. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol 2018; 29:1541.
  5. Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): A randomised phase 3 trial. Lancet Oncol 2018; 19:904.
  6. Lu Y-S, Im S-A, Colleoni M, et al. Updated overall survival of ribociclib plus endocrine therapy versus endocrine therapy alone in pre- and perimenopausal patients with HR+/HER2- advanced breast cancer in MONALEESA-7: A phase III randomized clinical trial. Clin Cancer Res 2022; 1:851.
  7. Goetz MP, Toi M, Huober J, et al. MONARCH 3: Interim overall survival (OS) results of abemaciclib plus a nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+, HER2- advanced breast cancer (ABC). Ann Oncol 2022; 33:S1384.
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