Comparative efficacy of everolimus plus exemestane versus fulvestrant for hormone-receptor-positive advanced breast cancer following progression/ recurrence after endocrine therapy: A network meta-analysis

Breast Cancer Research and Treatment

Volumn 143, Issue 1, 2014, Pages 125-133

  Bachelot, Thomas ^a   McCool, Rachael ^b   Duffy, Steven ^b   Glanville, Julie ^b   Varley, Danielle ^b   Fleetwood, Kelly ^c   Zhang, Jie ^d   Jerusalem, Guy ^e  

^a CENTRE LÉON BÉRARD   (France)

^b UNIVERSITY OF YORK   (United Kingdom)

^c Logan Building   (United Kingdom)

^d NOVARTIS PHARMA AG   (Switzerland)

^e UNIVERSITY OF LIÈGE   (Belgium)

Author keywords

Advanced breast cancer; Everolimus; Exemestane; Fulvestrant; Meta analysis; Progression free survival

Indexed keywords

AROMATASE INHIBITOR; EVEROLIMUS; EXEMESTANE; FULVESTRANT;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER RECURRENCE; CANCER SURVIVAL; DRUG CHOICE; DRUG EFFICACY; DRUG RESPONSE; HORMONAL THERAPY; HUMAN; META ANALYSIS; POSTMENOPAUSE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SURVIVAL RATE;

ANDROSTADIENES; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AROMATASE INHIBITORS; BREAST NEOPLASMS; CLINICAL TRIALS AS TOPIC; DISEASE PROGRESSION; ESTRADIOL; FEMALE; HUMANS; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PROPORTIONAL HAZARDS MODELS; RECEPTOR, ERBB-2; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE; SIROLIMUS; TREATMENT OUTCOME;

EID: 84892824037     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-013-2778-5     Document Type: Article

References (23)

1. Cardoso F, Costa A, Norton L, Cameron D, Cufer T, Fallowfield L, Francis P, Gligorov J, Kyriakides S, Lin N, Pagani O, Senkus E, Thomssen C, Aapro M, Bergh J, Di Leo A, El Saghir N, Ganz PA, Gelmon K, Goldhirsch A, Harbeck N, Houssami N, Hudis C, Kaufman B, Leadbeater M, Mayer M, Rodger A, Rugo H, Sacchini V, Sledge G, van't Veer L, Viale G, Krop I, Winer E (2012) 1st International consensus guidelines for advanced breast cancer (ABC 1). Breast 21(3):242-252. doi: 10.1016/j.breast.2012.03.003
2. Cardoso F, Harbeck N, Fallowfield L, Kyriakides S, Senkus E (2012) Locally recurrent or metastatic breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 23(suppl 7):vii11-vii19. doi: 10.1093/annonc/mds232
3. National Comprehensive Cancer Network (2012) NCCN clinical practice guidelines in oncology: breast cancer. Version 3.2012. http://www.nccn.org/ professionals/physician-gls/pdf/breast.pdf. Accessed 25 Oct 2013
4. Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN (2012) Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 366(6):520-529. doi: 10.1056/NEJMoa1109653
5. Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM, SoFEA investigators (2013) Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol 14(10):989-998. doi: 10.1016/S1470-2045(13)70322-X
6. Gennatas C, Michalaki V, Carvounis E, Psychogios J, Poulakaki N, Katsiamis G, Voros D, Kouloulias V, Mouratidou D, Tsavaris N (2006) Third-line hormonal treatment with exemestane in postmenopausal patients with advanced breast cancer progressing on letrozole or anastrozole. A phase II trial conducted by the Hellenic Group of Oncology (HELGO). Tumori 92(1):13-17
7. Piccart M, Baselga J, Noguchi S, Burris HA, Gnant M, Hortobagyi GN, Mukhopadhyay P, Taran T, Sahmoud T, Rugo H (2012) Final progression-free survival analysis of BOLERO-2: a phase III trial of everolimus for postmenopausal women with advanced breast cancer. Presented at CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, TX, 4-8 December 2012. Poster P6-04-02
8. Chia S, Gradishar W, Mauriac L, Bines J, Amant F, Federico M, Fein L, Romieu G, Buzdar A, Robertson JF, Brufsky A, Possinger K, Rennie P, Sapunar F, Lowe E, Piccart M (2008) Double-blind, randomized placebo controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive, advanced breast cancer: results from EFECT. J Clin Oncol 26(10):1664-1670. doi: 10.1200/JCO.2007.13.5822
9. Di Leo A, Jerusalem G, Petruzelka L, Torres R, Bondarenko IN, Khasanov R, Verhoeven D, Pedrini JL, Smirnova I, Lichinitser MR, Pendergrass K, Garnett S, Lindemann JP, Sapunar F, Martin M (2010) Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 28(30):4594-4600. doi: 10.1200/JCO.2010.28.8415
10. Mickisch GH, Schwander B, Escudier B, Bellmunt J, Maroto JP, Porta C, Walzer S, Siebert U (2011) Indirect treatment comparison of bevacizumab+interferon-alpha-2a vs tyrosine kinase inhibitors in first-line metastatic renal cell carcinoma therapy. Clinicoecon Outcomes Res 3:19-27. doi: 10.2147/CEOR.S16118
11. Hoaglin DC, Hawkins N, Jansen JP, Scott DA, Itzler R, Cappelleri JC, Boersma C, Thompson D, Larholt KM, Diaz M, Barrett A (2011) Conducting indirect-treatment-comparison and network-meta-analysis studies: report of the ISPOR Task Force on indirect treatment comparisons good research practices: part 2. Value Health 14(4):429-437. doi: 10.1016/j.jval.2011.01.011
12. Jansen JP, Fleurence R, Devine B, Itzler R, Barrett A, Hawkins N, Lee K, Boersma C, Annemans L, Cappelleri JC (2011) Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on indirect treatment comparisons good research practices: part 1. Value Health 14(4):417-428. doi: 10.1016/j.jval.2011.04.002
13. National Institute for Health and Care Excellence (2013) A generalised linear modelling framework for pairwise and network meta-analysis of randomised controlled trials (TSD2). http://www.nicedsu.org.uk/Evidence-Synthesis-TSD- series(2391675).htm. Accessed 25 Oct 2013
14. Howell A, Robertson JF, Abram P, Lichinitser MR, Elledge R, Bajetta E, Watanabe T, Morris C, Webster A, Dimery I, Osborne CK (2004) Comparison of fulvestrant versus tamoxifen for the treatment of advanced breast cancer in postmenopausal women previously untreated with endocrine therapy: a multinational, double-blind, randomized trial. J Clin Oncol 22(9):1605-1613. doi: 10.1200/JCO.2004.02.112
15. Paridaens RJ, Dirix LY, Beex LV, Nooij M, Cameron DA, Cufer T, Piccart MJ, Bogaerts J, Therasse P (2008) Phase III study comparing exemestane with tamoxifen as first-line hormonal treatment of metastatic breast cancer in postmenopausal women: the European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group. J Clin Oncol 26(30):4883-4890. doi: 10.1200/JCO.2007.14.4659
16. Regan MM, Neven P, Giobbie-Hurder A, Goldhirsch A, Ejlertsen B, Mauriac L, Forbes JF, Smith I, Lang I, Wardley A, Rabaglio M, Price KN, Gelber RD, Coates AS, Thurlimann B, BIG Collaborative Group, International Breast Cancer Study Group (2011) Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 8.1 years median follow-up. Lancet Oncol 12(12):1101-1108. doi: 10.1016/S1470-2045(11)70270-4
17. Welton NJ, Sutton AJ, Cooper NJ, Abrams KR, Ades AE (2012) Evidence synthesis for decision making in healthcare. Wiley, Chichester. doi: 10.1002/9781119942986.ch1
18. Fulvestrant with or without anastrozole or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer (2013). http://www.clinicaltrials.gov/ct2/show/NCT00253422?term=sofea&rank=1. Accessed 25 Oct 2013
19. Bachelot T, Bourgier C, Cropet C, Ray-Coquard I, Ferrero JM, Freyer G, Abadie-Lacourtoisie S, Eymard JC, Debled M, Spaeth D, Legouffe E, Allouache D, El Kouri C, Pujade-Lauraine E (2012) Randomized phase II trial of everolimus in combination with tamoxifen in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer with prior exposure to aromatase inhibitors: a GINECO study. J Clin Oncol 30(22):2718-2724. doi: 10.1200/JCO.2011.39.0708
20. Johnston S, Kilburn LS, Ellis P, Cameron D, Dodwell D, Howell A, Im YH, Coombes G, Dowsett M, Bliss JM (2012) Fulvestrant alone or with concomitant anastrozole vs exemestane following progression on non-steroidal aromatase inhibitor - first results of the SoFEa trial (CRUKE/03/021 & CRUK/09/007) (ISRCTN44195747). Eur J Cancer 48(suppl 3):S2 Abstract 2LBA
21. Cope S, Ouwens MJ, Jansen JP, Schmid P (2013) Progression-free survival with fulvestrant 500 mg and alternative endocrine therapies as second-line treatment for advanced breast cancer: a network meta-analysis with parametric survival models. Value Health 16(2):403-417. doi: 10.1016/j.jval.2012.10.019
22. Bergh J, Jonsson PE, Lidbrink EK, Trudeau M, Eiermann W, Brattstrom D, Lindemann JP, Wiklund F, Henriksson R (2012) FACT: an open-label randomized phase III study of fulvestrant and anastrozole in combination compared with anastrozole alone as first-line therapy for patients with receptor-positive postmenopausal breast cancer. J Clin Oncol 30(16):1919-1925. doi: 10.1200/JCO.2011.38.1095
23. Dias S, Sutton AJ, Welton NJ, Ades AE (2011) NICE DSU Technical Support Document 3: heterogeneity: subgroups, meta-regression, bias and bias-adjustment. Last updated April 2012. http://www.nicedsu.org.uk. Accessed 25 Oct 2013