Celecoxib and exemestane versus placebo and exemestane in postmenopausal metastatic breast cancer patients: A double-blind phase III GINECO study

Breast Cancer Research and Treatment

Volumn 116, Issue 3, 2009, Pages 501-508

  Falandry, C ^a,b   Debled, M ^c   Bachelot, T ^d   Delozier, T ^e   Cretin J ^f,g   Romestaing, P ^b   Mille, D ^h   You, B ^b   Mauriac, L ^c   Pujade Lauraine, E ⁱ   Freyer, G ^a,b  

^a UNIVERSITÉ DE LYON   (France)

^b CENTRE HOSPITALIER LYON SUD   (France)

^c INSTITUT BERGONIÉ   (France)

^d CENTRE LÉON BÉRARD   (France)

^e CENTRE FRANÇOIS BACLESSE   (France)

^f Clinique de Valdegour   (France)

^g Clinique Bonnefon   (France)

^h Institut de Cancerologie de la Loire   (France)

ⁱ HÔTEL DIEU   (France)

Author keywords

Aromatase; Breast cancer; Celecoxib; Clinical trial; Cyclooxygenase 2; Exemestane

Indexed keywords

CELECOXIB; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ESTROGEN RECEPTOR; EXEMESTANE; PLACEBO; PROGESTERONE RECEPTOR; TAMOXIFEN; ANDROSTANE DERIVATIVE; AROMATASE INHIBITOR; NONSTEROID ANTIINFLAMMATORY AGENT; PYRAZOLE DERIVATIVE; SULFONAMIDE;

ADULT; AGED; ALOPECIA; ANOREXIA; ARTHRALGIA; ARTICLE; ASTHENIA; BONE METASTASIS; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER RESISTANCE; CANCER SURVIVAL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG WITHDRAWAL; DYSESTHESIA; DYSPNEA; EDEMA; FEMALE; GASTROINTESTINAL SYMPTOM; HEART ARRHYTHMIA; HEPATIC CYTOLYSIS; HUMAN; INSOMNIA; LIVER DISEASE; LIVER METASTASIS; LUNG METASTASIS; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; METASTASIS; MUCOSA INFLAMMATION; MULTICENTER STUDY; PAIN; PHASE 3 CLINICAL TRIAL; PLEURA METASTASIS; POSTMENOPAUSE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PURPURA; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOFT TISSUE METASTASIS; TREMOR; VISUAL DISORDER; WEIGHT GAIN; WEIGHT REDUCTION; ADJUVANT CHEMOTHERAPY; BREAST TUMOR; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG COMBINATION; DRUG EFFECT; LIVER TUMOR; LUNG TUMOR; LYMPH NODE; MIDDLE AGED; NEOPLASM; PATHOLOGY; PROGNOSIS; SOFT TISSUE TUMOR; SURVIVAL RATE; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; ANDROSTADIENES; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; AROMATASE INHIBITORS; BREAST NEOPLASMS; CARDIOVASCULAR DISEASES; CHEMOTHERAPY, ADJUVANT; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; LIVER NEOPLASMS; LUNG NEOPLASMS; LYMPH NODES; LYMPHATIC METASTASIS; MIDDLE AGED; NEOPLASMS, HORMONE-DEPENDENT; PLACEBOS; POSTMENOPAUSE; PROGNOSIS; PYRAZOLES; SOFT TISSUE NEOPLASMS; SULFONAMIDES; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 70349567230     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-008-0229-5     Document Type: Article

References (45)

1. American CancerSociety (2006) Cancer facts and figures 2006. American Cancer Society, Atlanta
2. Parkin DM, Bray F, Ferlay J, Pisani P (2005) Global cancer statistics, 2002. CA Cancer J Clin 55:74-108
3. Crown J, Dieras V, Kaufmann M et al (2002) Chemotherapy for metastatic breast cancer-report of a European expert panel. Lancet Oncol 3:719-727. doi:10.1016/S1470-2045(02)00927-0
4. von Minckwitz G (2006) Evidence-based treatment of metastatic breast cancer-2006 recommendations by the AGO Breast Commission. Eur J Cancer 42:2897-2908. doi:10.1016/j.ejca. 2006.06.033
5. Wilcken N, Hornbuckle J, Ghersi D (2003) Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. Cochrane Database Syst Rev CD002747
6. Beslija S, Bonneterre J, Burstein H et al (2007) Second consensus on medical treatment of metastatic breast cancer. Ann Oncol 18:215-225. doi:10.1093/annonc/mdl155
7. Bonneterre J, Buzdar A, Nabholtz JM et al (2001) Anastrozole is superior to tamoxifen as first-line therapy in hormone receptor positive advanced breast carcinoma. Cancer 92:2247-2258. doi:10.1002/1097-0142(20011101)92:9\2247::AID- CNCR1570[3.0.CO;2-Y
8. Mouridsen H, Gershanovich M, Sun Y et al (2003) Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group. J Clin Oncol 21:2101-2109. doi:10.1200/JCO.2003.04.194
9. Nabholtz JM, Buzdar A, Pollak M et al (2000) Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial Arimidex Study Group. J Clin Oncol 18:3758-3767
10. Paridaens RJ, Dirix LY, Beex LV et al (2008) Results of a randomized clinical trial comparing exemestane with tamoxifen as first-line hormonal treatment of metastatic breast cancer in postmenopausal women: a phase III study conducted by the EORTC Breast Cancer Cooperative Group. Breast Cancer Res Treat (in press)
11. Schrey MP, Patel KV (1995) Prostaglandin E2 production and metabolism in human breast cancer cells and breast fibroblasts. Regulation by inflammatory mediators. Br J Cancer 72: 1412-1419
12. Huang M, Stolina M, Sharma S et al (1998) Non-small cell lung cancer cyclooxygenase-2-dependent regulation of cytokine balance in lymphocytes and macrophages: up-regulation of interleukin 10 and down-regulation of interleukin 12 production. Cancer Res 58:1208-1216
13. Chang S-H, Liu CH, Conway R et al (2004) Role of prostaglandin E2-dependent angiogenic switch in cyclooxygenase 2-induced breast cancer progression. Proc Natl Acad Sci USA 101:591-596. doi:10.1073/pnas.2535911100
14. Tsujii M, DuBois RN (1995) Alterations in cellular adhesion and apoptosis in epithelial cells overexpressing prostaglandin endoperoxide synthase 2. Cell 83:493-501. doi:10.1016/0092-8674(95)90127-2
15. Tsujii M, Kawano S, Tsuji S et al (1998) Cyclooxygenase regulates angiogenesis induced by colon cancer cells. Cell 93:705- 716. doi:110.1016/S0092-8674(00)81433-6
16. O'Neill GP, Ford-Hutchinson AW (1993) Expression of mRNA forcyclooxygenase-1 and cyclooxygenase-2 in human tissues. FEBS Lett 330:156-160. doi:10.1016/0014-5793(93)80263-T
17. Eberhart CE, Coffey RJ, Radhika A et al (1994) Up-regulation of cyclooxygenase 2 gene expression in human colorectal adenomas and adenocarcinomas. Gastroenterology 107:1183-1188
18. Parrett M, Harris R, Joarder F, Clausen K, Robertson F (1997) Cyclooxygenase-2 gene expression in human breast cancer. Int J Oncol 10:503-507
19. Liu CH, Chang S-H, Narko K et al (2001) Overexpression of cyclooxygenase-2 is sufficient to induce tumorigenesis in transgenic mice. J Biol Chem 276:18563-18569. doi:10.1074/jbc.M010787200
20. Howe LR, Chang S-H, Tolle KC et al (2005) HER2/neu-induced mammary tumorigenesis and angiogenesis are reduced in cyclooxygenase- 2 knockout mice. Cancer Res 65:10113-10119. doi: 10.1158/0008-5472.CAN-05-1524
21. Harris RE, Namboodiri KK, Farrar WB (1996) Nonsteroidal antiinflammatory drugs and breast cancer. Epidemiology 7:203-205. doi:10.1097/00001648-199603000- 00017
22. Kucab JE, Lee C, Chen CS et al (2005) Celecoxib analogues disrupt Akt signaling, which is commonly activated in primary breast tumours. Breast Cancer Res 7:R796-R807. doi:10.1186/bcr1294
23. Basu GD, Pathangey LB, Tinder TL et al (2004) Cyclooxygenase- 2 inhibitor induces apoptosis in breast cancer cells in an in vivo model of spontaneous metastatic breast cancer. Mol Cancer Res 2:632-642
24. Alshafie GA, Abou-Issa HM, Seibert K, Harris RE (2000) Chemotherapeutic evaluation of celecoxib, a cyclooxygenase-2 inhibitor, in a rat mammary tumor model. Oncol Rep 7:1377-1381
25. Howe LR, Subbaramaiah K, Patel J et al (2002) Celecoxib, a selective cyclooxygenase 2 inhibitor, protects against human epidermal growth factor receptor 2 (HER-2)/neu-induced breast cancer. Cancer Res 62:5405-5407
26. Lanza-Jacoby S, Miller S, Flynn J et al (2003) The cyclooxygenase- 2 inhibitor, celecoxib, prevents the development of mammary tumors in HER-2/neu mice. Cancer Epidemiol Biomarkers Prev 12:1486-1491
27. Higuchi T, Iwama T, Yoshinaga K et al (2003) A randomized, double-blind, placebo-controlled trial of the effects of rofecoxib, a selective cyclooxygenase-2 inhibitor, on rectal polyps in familial adenomatous polyposis patients. Clin Cancer Res 9:4756-4760
28. Steinbach G, Lynch PM, Phillips RKS et al (2000) The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis. N Engl J Med 342:1946-1952. doi:10.1056/NEJM200006293422603
29. Muller-Decker K, Berger I, Ackermann K et al (2005) Cystic duct dilatations and proliferative epithelial lesions in mouse mammary glands upon keratin 5 promoter-driven overexpression of cyclooxygenase- 2. Am J Pathol 166:575-584
30. Pesenti E, Masferrer J, di Salle E (2001) Effect of exemestane and celecoxib alone or in combination on DBMA-induced mammary carcinoma in rats. Breast Cancer Res 69:288 abstract
31. Canney PA, Machin MA, Curto J (2006) A feasibility study of the efficacy and tolerability of the combination of exemestane with the COX-2 inhibitor celecoxib in post-menopausal patients with advanced breast cancer. Eur J Cancer 42:2751-2756. doi: 10.1016/j.ejca.2006.08.014
32. Chow LW, Wong JL, Toi M (2003) Celecoxib anti-aromatase neoadjuvant (CAAN) trial for locally advanced breast cancer: preliminary report. J Steroid Biochem Mol Biol 86:443-447. doi: 10.1016/S0960-0760(03)00355-8
33. Dirix LY, Ignacio J, Nag S et al (2008) Treatment of advanced hormone-sensitive breast cancer in postmenopausal women with exemestane alone or in combination with celecoxib. J Clin Oncol 26:1253-1259. doi:10.1200/JCO.2007. 13.3744
34. Solomon SD, McMurray JJ, Pfeffer MA et al (2005) Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 352:1071-1080. doi:10.1056/NEJMoa050405
35. Harris R, Beebe-Donk J, Alshafie G (2006) Reduction in the risk of human breast cancer by selective cyclooxygenase-2 (COX-2) inhibitors. BMC Cancer 6:27. doi:10.1186/1471-2407-6-27
36. Rahme E, Ghosn J, Dasgupta K, Rajan R, Hudson M (2005) Association between frequent use of nonsteroidal anti-inflammatory drugs and breast cancer. BMC Cancer 5:159. doi:10.1186/1471-2407-5-159
37. Zhao Y, Agarwal VR, Mendelson CR, Simpson ER (1996) Estrogen biosynthesis proximal to a breast tumor is stimulated by PGE2 via cyclic AMP, leading to activation of promoter II of the CYP19 (aromatase) gene. Endocrinology 137:5739-5742. doi: 10.1210/en.137.12.5739
38. Chow LWC, Toi M (2005) Celecoxib anti-aromatase neoadjuvant (CAAN) trial for locally advanced breast cancer. Paper presented at 28th annual San Antonio breast cancer symposium, San Antonio, 8-11 December 2005
39. Dang CT, Dannenberg AJ, Subbaramaiah K et al (2004) Phase II study of celecoxib and trastuzumab in metastatic breast cancer patients who have progressed after prior trastuzumab-based treatments. Clin Cancer Res 10:4062-4067. doi:10.1158/1078- 0432.CCR-03-0463
40. US Food and Drug Administration (2004) FDA statement on the halting of a clinical trial of the Cox-2 inhibitor celebrex. US Food and Drug Administration. Available via http://www.fda.gov/bbs/topics/news/2004/NEW01144.html. Cited 24 June 2008
41. US Food and Drug Administration (2004) Public Health Advisory: non-steroidal anti-inflammatory drug products (NSAIDs). US Food and Drug Administration. Available via http://www. fda.gov/cder/drug/advisory/nsaids.htm. Cited 24 June 2008
42. US Food and Drug Administration (2005) Analysis and recommendations for Agency action regarding non-steroidal antiinflammatory drugs and cardiovascular risk. US Food and Drug Administration. Available via http://www.fda.gov/cder/ drug/infopage/COX2/NSAIDdecisionMemo.pdf. Cited 24 June 2008
43. Bouchard MF, Taniguchi H, Viger RS (2005) Protein kinase Adependent synergism between GATA factors and the nuclear receptor, liver receptor homolog-1, regulates human aromatase (CYP19) PII promoter activity in breast cancer cells. Endocrinology 146:4905-4916. doi:10.1210/en.2005-0187
44. Zhou J, Suzuki T, Kovacic A et al (2005) Interactions between prostaglandin E(2), liver receptor homologue-1, and aromatase in breast cancer. Cancer Res 65:657-663
45. Bulun SE, Sebastian S, Takayama K et al (2003) The human CYP19 (aromatase P450) gene: update on physiologic roles and genomic organization of promoters. J Steroid Biochem Mol Biol 86:219-224. doi:10.1016/S0960-0760(03)00359-5