A randomized trial of combination anastrozole plus gefitinib and of combination fulvestrant plus gefitinib in the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer

Breast Cancer Research and Treatment

Volumn 133, Issue 3, 2012, Pages 1049-1056

  Carlson, Robert W ^a   O'Neill, Anne ^a,b   Vidaurre, Tatiana ^a,c   Gomez, Henry L ^c   Badve, Sunil S ^d   Sledge, George W ^e  

^a Eastern Cooperative Oncology Group   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c INSTITUTO NACIONAL DE ENFERMEDADES NEOPLÁSICAS   (Peru)

^d INDIANA UNIVERSITY   (United States)

^e INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Anastrozole; Fulvestrant; Gefitinib; Metastatic breast cancer; Randomized phase II

Indexed keywords

ANASTROZOLE; ANTINEOPLASTIC AGENT; ESTROGEN RECEPTOR; FULVESTRANT; GEFITINIB; PROGESTERONE RECEPTOR;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BREAST METASTASIS; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; FATIGUE; FEMALE; HAND FOOT SYNDROME; HUMAN; HYPOXIA; INFECTION; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; POSTMENOPAUSE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; SIDE EFFECT; SURVIVAL TIME; UNSPECIFIED SIDE EFFECT; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; ESTRADIOL; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; NITRILES; QUINAZOLINES; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE; SURVIVAL ANALYSIS; TREATMENT OUTCOME; TRIAZOLES;

EID: 84863717166     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-012-1997-5     Document Type: Article

References (25)

1. Nicholson RI, McClelland RA, Gee JM, Manning DL, Cannon P, Robertson JF, Ellis IO, Blamey RW(1994) Epidermal growth factor receptor expression in breast cancer: association with response to endocrine therapy. Breast Cancer Res Treat 29(1):117-125
2. Hiscox S, Morgan L, Barrow D, Dutkowskil C, Wakeling A, Nicholson RI (2004) Tamoxifen resistance in breast cancer cells is accompanied by an enhanced motile and invasive phenotype: inhibition by gefitinib ('Iressa', ZD1839). Clin Exp Metastasis 21(3):201-212. doi:10.1023%2FB%3ACLIN.0000037697.76011.1d
3. Kurebayashi J (2005) Resistance to endocrine therapy in breast cancer. Cancer Chemother Pharmacol 56(Suppl 1):39-46. doi: 10.1007/s00280-005-0099-z
4. Arpino G, Green SJ, Allred DC, Lew D, Martino S, Osborne CK, Elledge RM (2004) HER-2 amplification, HER-1 expression, and tamoxifen response in estrogen receptor-positive metastatic breast cancer: a southwest oncology group study. Clin Cancer Res 10(17):5670-5676. doi:10.1158/1078-0432.CCR-04-0110
5. Massarweh S, Osborne CK, Creighton CJ, Qin L, Tsimelzon A, Huang S, Weiss H, Rimawi M, Schiff R (2008) Tamoxifen resistance in breast tumors is driven by growth factor receptor signaling with repression of classic estrogen receptor genomic function. Cancer Res 68(3):826-833. doi:10.1158/0008-5472. CAN-07-2707
6. Frogne T, Benjaminsen RV, Sonne-Hansen K, Sorensen BS, Nexo E, Laenkholm AV, Rasmussen LM, Riese DJ 2nd, de Cremoux P, Stenvang J, Lykkesfeldt AE (2009) Activation of ErbB3, EGFR and Erk is essential for growth of human breast cancer cell lines with acquired resistance to fulvestrant. Breast Cancer Res Treat 114(2):263-275. doi:10.1007/s10549-008-00 11-8
7. Klijn JG, Berns PM, Schmitz PI, Foekens JA (1992) The clinical significance of epidermal growth factor receptor (EGF-R) in human breast cancer: a review on 5232 patients. Endocr Rev 13(1):3-17. doi:10.1210/er.13.1.3
8. Gutteridge E, Agrawal A, Nicholson R, Leung Cheung K, Robertson J, Gee J (2010) The effects of gefitinib in tamoxifen-resistant and hormone-insensitive breast cancer: a phase II study. Int J Cancer 126(8):1806-1816
9. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92(3):205-216. doi:10.1093/jnci/92.3.205
10. National Cancer Institute: Common terminology criteria for adverse events v2.0 (CTCAE) (2010) http://ctep.cancer.gov/protocolDevelopment/electronic- applications/ctc.htm. Accessed 17 March 2010
11. Howell A, Mackintosh J, Jones M, Redford J, Wagstaff J, Sell-wood RA (1988) The definition of the 'no change' category in patients treated with endocrine therapy and chemotherapy for advanced carcinoma of the breast. Eur J Cancer Clin Oncol 24(10):1567-1572. doi:10.1016/0277-5379(88)90046-6
12. Robertson JF, Howell A, Buzdar A, von Euler M, Lee D (1999) Static disease on anastrozole provides similar benefit as objective response in patients with advanced breast cancer. Breast Cancer Res Treat 58(2):157-162. doi:10.1023/A:1006391902868
13. Robertson JF, Willsher PC, Cheung KL, Blamey RW (1997) The clinical relevance of static disease (no change) category for 6 months on endocrine therapy in patients with breast cancer. Eur J Cancer 33(11):1774-1779. doi:10.1016/S0959-8049(97)00178-0
14. Kaplan EL, Meier P (1958) Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481. doi: 10.2307/2281868
15. Brookmeyer R, Crowley J (1982) A confidence interval for the median survival time. Biometrics 38:29-41. doi:10.2307/2530286
16. Robertson JF, Osborne CK, Howell A, Jones SE, Mauriac L, Ellis M, Kleeberg UR, Come SE, Vergote I, Gertler S, Buzdar A, Webster A, Morris C (2003) Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women: a prospective combined analysis of two multicenter trials. Cancer 98(2):229-238. doi:10.1002/cncr.11468
17. 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
18. Smith IE, Walsh G, Skene A, Llombart A, Mayordomo JI, Detre S, Salter J, Clark E, Magill P, Dowsett M (2007) A phase II placebo-controlled trial of neoadjuvant anastrozole alone or with gefitinib in early breast cancer. J Clin Oncol 25(25):3816-3822. doi:10.1200/JCO.2006.09.6578
19. Cristofanilli M, Valero V, Mangalik A, Royce M, Rabinowitz I, Arena FP, Kroener JF, Curcio E, Watkins C, Bacus S, Cora EM, Anderson E, Magill PJ (2010) Phase II, randomized trial to compare anastrozole combined with gefitinib or placebo in postmenopausal women with hormone receptor-positive meta-static breast cancer. Clin Cancer Res 16(6):1904-1914. doi: 10.1158/1078-0432.CCR-09- 2282
20. Carlson RW, Henderson IC (2003) Sequential hormonal therapy for metastatic breast cancer after adjuvant tamoxifen or anas-trozole. Breast Cancer Res Treat 80(Suppl 1):S19-26 doi: 10.1023/A:1025459232293 (discussion S27-18)
21. Houston SJ, Plunkett TA, Barnes DM, Smith P, Rubens RD, Miles DW (1999) Overexpression of c-erbB2 is an independent marker of resistance to endocrine therapy in advanced breast cancer. Br J Cancer 79(7-8):1220-1226. doi:10.1038/sj.bjc. 6690196
22. Nicholson RI, Hutcheson IR, Harper ME, Knowlden JM, Barrow D, McClelland RA, Jones HE, Wakeling AE, Gee JM (2002) Modulation of epidermal growth factor receptor in endocrine-resistant, estrogen-receptor-positive breast cancer. Ann N Y Acad Sci 963:104-115. doi:10.1111/j.1749-6632.2002.tb04101.x
23. Kurebayashi J, Okubo S, Yamamoto Y, Sonoo H (2004) Inhibition of HER1 signaling pathway enhances antitumor effect of endocrine therapy in breast cancer. Breast Cancer 11(1):38-41. doi:10.1007/BF02968000
24. Massarweh S, Osborne CK, Jiang S, Wakeling AE, Rimawi M, Mohsin SK, Hilsenbeck S, Schiff R (2006) Mechanisms of tumor regression and resistance to estrogen deprivation and fulvestrant in a model of estrogen receptor-positive, HER-2/neu-positive breast cancer. Cancer Res 66(16):8266-8273. doi:10.1158/0008-5472.CAN-05-4045
25. Creighton CJ, Massarweh S, Huang S, Tsimelzon A, Hilsenbeck SG, Osborne CK, Shou J, Malorni L, Schiff R (2008) Development of resistance to targeted therapies transforms the clinically associated molecular profile subtype of breast tumor xenografts. Cancer Res 68(18):7493-7501. doi:10.1158/0008-5472.CAN- 08-1404