| [1] |
National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: breast cancer[EB/OL]. [2022-12-20]．
URL
|
| [2] |
中国女医师协会临床肿瘤学专业委员会，中国抗癌协会乳腺癌专业委员会．中国进展期乳腺癌诊疗共识指南(CABC 2015)[J]. 癌症进展，2015，13(3)：223-245.
|
| [3] |
Partridge AH, Rumble RB, Carey LA, et al. Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative(or unknown)advanced breast cancer: American Society of Clinical Oneology Clinical Practice Guideline [J]. Clin Oncol, 2014，32(29)：3307-3329.
|
| [4] |
Dixon AR, Jackson L, Chan S, et al. A randomised trial of second-line hormone vs single agent chemotherapy in tamoxifen resistant advanced breast cancer [J]. Br J Cancer, 1992, 66: 402-404.
|
| [5] |
Jerusalem G, De Boer RH, Hurvitz S, et al. Everolimus plus exemestane vs everolimus or capecitabine monotherapy for estrogen receptor-positive, HER-2-negative advanced breast cancer [J]. JAMA Oncol, 2018, 4(10): E1-E8.
|
| [6] |
Park YH, Kim TY, Kim GM, et al. Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER-2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial [J]. Lancet Oncol, 2019, 20(12): 1750-1759.
|
| [7] |
Martin M, Zielinski C, Ruiz-Borrego M, et al. Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomized controlled trial-PEARL [J]. Ann Oncol, 2021, 32(4): 488-99.
|
| [8] |
Giuliano M, Schettini F, Rognoni C, et al. Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER-2-negative, metastatic breast cancer: a systematic review and network meta-analysis [J]. Lancet Oncol, 2019, 20(10): 1360-1369.
|
| [9] |
Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer [J]. N Engl J Med, 2016, 375(20): 1925-1936.
|
| [10] |
Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer [J]. N Engl J Med, 2017, 35(32): 3638-3646.
|
| [11] |
Johnston S, Martin M, Di Leo A, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer [J]. NPJ Breast Cancer, 2019, 5(5): 1-8.
|
| [12] |
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, HER-2-negative advanced breast cancer [J]. J Clin Oncol, 2017, 35(15): 1038-1038.
|
| [13] |
Ellis MJ, Llombart-Cussac A, Feltl D, et al. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: overall survival analysis from the phase II FIRST study [J]. J Clin Oncol, 2015, 33(32): 3781-3787.
|
| [14] |
Robertson JFR, Bondarenko IM, Trishkina E, et al. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial [J]. Lancet, 2016, 388(10063): 2997-3005.
|
| [15] |
Guo Q, Lin X, YE L, et al. Comparative efficacy of CDK4/6 inhibitors plus aromatase inhibitors versus fulvestrant for the first-line treatment of hormone receptor-positive advanced breast cancer: a network meta-analysis [J]. Target Oncol, 2019, 14(2): 139-148.
|
| [16] |
Slamon DJ, Neven P, Chia S, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3 [J]. Clin Oncol, 2018, 36(25)：2465-2472.
|
| [17] |
Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer [J]. N Engl J Med, 2020, 382(6): 514-524.
|
| [18] |
Albanell J, Martinez MT, Ramos M, et al. Randomized phase II study of fulvestrant plus palbociclib or placebo in endocrine-sensitive, hormone receptor-positive/HER2-advanced breast cancer: GEICAM/2014-12 (FLIPPER) [J]. Eur J Cancer, 2022, 161: 26-37.
|
| [19] |
Llombart-Cussac A, Pérez-García JM, Bellet M, et al. Fulvestrant-palbociclib vs letrozole-palbociclib as initial therapy for endocrine-sensitive, hormone receptor-positive, ERBB2-negative advanced breast cancer: a randomized clinical trial [J]. JAMA Oncol, 2021，7(12)：1791-1799.
|
| [20] |
Fasching PA, Delea T, LU YS, et al. 330P comparative effectiveness of ribociclib plus fulvestrant (RIB＋FUL) versus palbociclib plus letrozole (PAL＋LET) as first-line (1L) treatment (Tx) of HR＋/HER-2－ advanced breast cancer (ABC) assessed by matching-adjusted indirect comparison (MAIC) [J]. Ann Oncol, 2020, 31: S377-S378.
|
| [21] |
Chandarlapaty S, Chen D, HE W, et al. Prevalence of ESR1 mutations in cell-free DNA and outcomes in metastatic breast cancer: a secondary analysis of the BOLERO-2 clinical trial [J]. JAMA Oncol, 2016, 2(10): 1310-1315.
|
| [22] |
Berger F, Marce M, Delaloge S, et al. Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1[J]. BMJ Open, 2022，12: e055821.
|
| [23] |
Bidard FC, Hardy-Bessard AC, Dalenc F, et al. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial [J]. Lancet Oncol, 2022, 23(11)1367-1377.
|
| [24] |
André F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer [J]. N Engl J Med, 2019, 380(20): 1929-1940.
|
| [25] |
Rugo HS, Lerebours F, Ciruelos E, et al. Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study [J]. Lancet Oncol, 2021, 22(4): 489-498.
|
| [26] |
Spring LM, Gupta A, Reynolds KL, et al. Neoadjuvant endocrine therapy for estrogen receptor-positive breast cancer: a systematic review and meta-analysis [J]. JAMA Oncol, 2016, 2(11): 1477-1486.
|
| [27] |
Eiermann W, Paepke S, Appfelstaedt J, et al. Preoperative treatment of postmenopausal breast cancer patients with letrozole: a randomized double-blind multicenter study [J]. Ann Oncol, 2001, 12(11): 1527-1532.
|
| [28] |
Sheri A, Smith IE, Johnston SR, et al. Residual proliferative cancer burden to predict long-term outcome following neoadjuvant chemotherapy [J]. Ann Oncol, 2015, 26(1): 75-80.
|
| [29] |
Ellis MJ, Suman VJ, Hoog J, et al. Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline pam50-based intrinsic subtype-ACOSOG Z1031 [J]. J Clin Oncol, 2011, 29(17): 2342-2349.
|
| [30] |
Khan QJ, O’Dea A, Bardia A, et al. Letrozole ＋ ribociclib versus letrozole ＋ placebo as neoadjuvant therapy for ER＋ breast cancer (FELINE trial) [J]. Clin Oncol, 2020, 38(15): 505.
|
| [31] |
Prat A, Saura C, Pascual T, et al. Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER-2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial [J]. Lancet Oncol, 2020, 21(1): 33-43.
|
| [32] |
Cottu P, D’Hondt V, Dureau S, et al. Letrozole and palbociclib versus chemotherapy as neoadjuvant therapy of high-risk luminal breast cancer [J]. Ann Oncol, 2018, 29(12): 2334-2340.
|
| [33] |
Delaloge S, Dureau S, D’Hondt V, et al. Survival outcomes after neoadjuvant letrozole and palbociclib versus third generation chemotherapy for patients with high-risk oestrogen receptor-positive HER2-negative breast cancer [J]. Eur J Cancer, 2022, 166：300-308.
|
| [34] |
O’Shaughnessy J, Johnston SRD, Harbeck N, et al. Primary outcome analysis of invasive disease-free survival for monarch E: abemaciclib combined with adjuvant endocrine therapy for high-risk early breast cancer[EB/OL]. [2023-05-10]．
URL
|
| [35] |
Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR＋，HER2－，node-positive, high risk, early breast cancer (monarch E) [J]. Ann Oncol, 2020, 31(4): S1143.
|
| [36] |
Johnston SRD, Toi M, O’Shaughnessy J, et al. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarch E): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial [J]. Lancet Oncol, 2023, 24(1): 77-90.
|
| [37] |
Mayer EL, Demichele AM, Pfeiler G, et al. PALLAS: a randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR＋/HER2－ early breast cancer [J]. Ann Oncol, 2020, 31：S1145.
|
| [38] |
Loibl S, Marmé F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER-2-negative early breast cancer-the Penelope-B trial [J]. Clin Oncol, 2021, 39(14): 1518-1530.
|
| [39] |
Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR(＋)/HER-2(－) metastatic breast cancer [J]. Clin Cancer Res, 2017, 23(17): 5218-5224.
|
| [40] |
Spring LM, Zangardi ML, Moy B, et al. Clinical management of potential toxicities and drug interactions related to cyclin-dependent kinase 4/6 inhibitors in breast cancer: practical considerations and recommendations [J]. Oncologist, 2017, 22(9): 1039-1048.
|
| [41] |
Desnoyers A, Nadler MB, Kumar V, et al. Comparison of treatment-related adverse events of different cyclin-dependent kinase 4/6 inhibitors in metastatic breast cancer: a network meta-analysis [J]. Cancer Treat Rev, 2020, 90(1)：102 086.
|