早期乳腺癌內(nèi)分泌治療的一些進(jìn)展南京醫(yī)科大學(xué)第一附屬醫(yī)院乳腺內(nèi)分泌外科王水-文庫(kù)吧資料
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【正文】 Absolute reduction from baseline (95% CI) ( to ) ( to ) .0001 Kuter I, et al. SABCS 2022. Abstract 23. Early Breast Cancer: Endocrine Therapy NEWEST: Tumor Response Rates in Evaluable Patients Kuter I, et al. SABCS 2022. Abstract 23. Fulvestrant 250 mg (n = 69) Fulvestrant 500 mg (n = 69) 0 20 40 60 80 100 Response to Treatment (%) 88 ORR (CR + PR*) SD OR: () PD *PR defined as ≥ 65% reduction in tumor volume. Early Breast Cancer: Endocrine Therapy Neoadjuvant Everolimus + Letrozole in ERPositive Postmenopausal Women Everolimus 10 mg/day + Letrozole mg/day (n = 138) Placebo + Letrozole mg/day (n = 132) Postmenopausal women with ERpositive invasive breast cancer[2] (N = 270) Surgery Week 16 1. Awaada A, et al. Eur J Cancer. Nov 24。 final N will be 1000. ?Tscores at lumbar spine or femoral neck. Observation (n = 227 [112 anastrozole]) Postmenopausal women at high risk for breast cancer (N = 350*) Stratum I (Normal) Tscore ≥ 1? (n = 227) Stratum II (Osteopenic) ≤ Tscore 1? (n = 80) Stratum III (Osteoporotic) 4 Tscore ? (n = 43) Risedronate PO 35 mg weekly (n = 43 [25 anastrozole]) Placebo (n = 37 [13 anastrozole]) Risedronate PO 35 mg weekly (n = 45 [22 anastrozole]) Anastrozole 1 mg/day (n = 175) Placebo (n = 175) IBISII bone substudy Early Breast Cancer: Endocrine Therapy IBIS II Substudy: Decreased BMD With Risedronate vs Placebo at 1 Year Singh S, et al. SABCS 2022. Abstract 28. Mean Change in BMD for lumbar spine at 1 Year (%) 6 4 2 0 2 4 6 STRATUMI Normal BMD No Risedronate STRATUMII Osteopenic Risedronate or Placebo STRATUMIII Osteoporotic All Risedronate P A P P P A P R R A R R A P % % % % % % % % n = 115 112 24 13 18 25 23 22 P = .006 O O ? Results similar when hip BMD measured Early Breast Cancer: Endocrine Therapy Denosumab: Bone Resorption Inhibitor ? Adjuvant AIs more monly used than tamoxifen for postmenopausal hormone receptor–positive breast cancer – Associated with accelerated bone loss and increased fracture risk ? RANKL stimulates osteoclasts and bone resorption ? Denosumab – Novel fully human monoclonal antibody to RANKL – Does not bind TNF?, TNF?, TRAIL, or CD40L – Possible agent to reverse AIinduced bone loss Ellis G, et al. SABCS 2022. Abstract 47. RANKL RANK Bone Cancer Cells in Bone Cytokines and Growth Factors (IL6, IL8, IL1?, PGE2, TNF?, CSF1, PTHrP) Osteoclast Growth Factors (TGF?, IGFs, FGFs, PDGFs, BMPs) Osteoblast Lineage Direct effects on tumor? Bone Resorption RANKL Early Breast Cancer: Endocrine Therapy Denosumab vs Placebo in ERPositive Breast Cancer Ellis G, et al. SABCS 2022. Abstract 47. Denosumab* 60 mg SC every 6 months (n = 127) Women with hormone receptor–positive breast cancer on adjuvant AI therapy (N = 252) Placebo* SC every 6 months (n = 125) Year 2 *Both arms given calcium 1000 mg daily and vitamin D ≥ 400 IU daily. Stratified by AI use: ≤ 6 months vs 6 months ? Phase III, randomized, doubleblind, placebo controlled trial ? Primary endpoint: % change in lumbar spine BMD from baseline to Month 12 – Measured using DEXA Early Breast Cancer: Endocrine Therapy Denosumab: Effect on Lumbar Spine Bone Mineral Density ? More serious adverse events (reportedly not related to treatment) in denosumab arm (15%) vs placebo (9%) Ellis G, et al. SABCS 2022. Abstract 47. Early Breast Cancer: Endocrine Therapy Ovarian Suppression + TAM or ANA 177。365:6062. 2. Forbes JF M, et al. SABCS 2022. Abstract 41. Postmenopausal women with earlystage invasive breast cancer (N = 6241) Anastrozole (n = 3125) Tamoxifen (n = 3116) Longterm followup Year 5 ? Pr
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