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-資料下載頁
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【正文】 Therapy Preoperative Hormonal Therapy ? Preoperative hormonal therapy a relatively nontoxic alternative to chemotherapy – Reduces tumor burden – Reduces chemotherapyprohibiting orbidities – Allows for determination of tumor’s susceptibility to surgery – Makes breast conservation surgery feasible ? Optimal regimens unknown Early Breast Cancer: Endocrine Therapy NEWEST: HighDose vs LowDose Fulvestrant for ER+ Breast Cancer Postmenopausal women with locally advanced (T2,3,4b, N0, M0), ERpositive breast cancer (N = 211) HighDose Fulvestrant 500 mg/month + 500 mg on Day 14 of Month 1 (n = 109) Week 4 Week 16 (surgery) StandardDose Fulvestrant 250 mg/month (n = 102) Kuter I, et al. SABCS 2022. Abstract 23. ? Phase II, randomized neoadjuvant trial ? Dosedependent downregulation of ER and Ki67 biomarkers with fulvestrant noted in 2 presurgical studies – No data on clinical/biological activity of fulvestrant at doses 250 mg Early Breast Cancer: Endocrine Therapy NEWEST: Impact of High and LowDose Fulvestrant on Ki67 Labeling ? Greater reduction in Ki67 labeling index with highdose fulvestrant corresponds with significantly greater reduction in ER expression at 4 weeks (P .0003) ? At Week 16, reductions in Ki67 labeling index (P .0001), ER expression, and PgR expression greater with highdose fulvestrant pared with standarddose fulvestrant Reduction in Ki67 Labeling Index at 4 Weeks HighDose Fulvestrant (n = 60) StandardDose Fulvestrant (n = 63) P Value Mean % reduction from baseline, % (95% CI) ( to ) ( to ) .0001 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。[Epub ahead of print]. 2. Baselga J, et al. SABCS 2022. Abstract 2066. ? Everolimus: kinase inhibitor of mTOR – Targets the mTORphosphoinositide 3 kinaseAkt axis, which is activated in breast cancer oncogenesis – Suppresses cell growth and proliferation ? Combination therapy with letrozole and everolimus has additive effects in vitro and has shown antitumor effects and no drugdrug interactions in a phase Ib study[1] Early Breast Cancer: Endocrine Therapy Unavailable Everolimus + Letrozole: Overall Clinical Response Baselga J, et al. SABCS 2022. Abstract 2066. Everolimus (n = 138) Placebo (n = 69) 0 20 40 60 80 100 Response to Treatment (%) 13 88 CR PR No Change PD ORR 9 55 50 25 30 4 10 3 2 68 59 Early Breast Cancer: Endocrine Therapy Everolimus + Letrozole: Safety Profile Baselga J, et al. SABCS 2022. Abstract 2066. Most Common Adverse Events, n (%) Everolimus Arm (n = 137) Placebo Arm (n = 132) Stomatitis 50 () 8 () Rash 28 () 10 () Thrombocytopenia 25 () 1 () Asthenia 24 () 13 () Hypercholesterolemia 22 () 8 () Hyperglycemia 18 () 4 () Pruritus 18 () 0 Fatigue 17 () 6 () Anorexia 17 () 5 () ALT increase 16 () 5 () ? Grade 3 adverse events in everolimus arms: hyperglycemia (%), stomatitis (%), infections (%), interstitial lung disease (%), fatigue (%), thrombocytopenia (%), hypokalemia (%), ALT increase (%) ? 1 grade 4 infection in everolimus arm Early Breast Cancer: Endocrine Therap
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