A phase II study of fulvestrant in the treatment of multiply-recurrent epithelial ovarian cancer

Gynecologic Oncology

Volumn 113, Issue 2, 2009, Pages 205-209

  Argenta, Peter A ^a   Thomas, Sajeena G ^a   Judson, Patricia L ^a   Downs Jr , Levi S ^a   Geller, Melissa A ^a   Carson, Linda F ^a   Jonson, Amy L ^a   Ghebre, Rahel ^a  

^a UNIVERSITY OF MINNESOTA   (United States)

Author keywords

Estrogen; Estrogen receptor; Faslodex; Fulvestrant; Ovarian cancer; Phase II

Indexed keywords

CA 125 ANTIGEN; ESTROGEN RECEPTOR; FULVESTRANT; IBUPROFEN; PARACETAMOL;

ARTICLE; BONE MINERAL; BROMIDROSIS; CANCER CHEMOTHERAPY; CANCER CONTROL; CANCER GROWTH; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HUMAN; LOADING DRUG DOSE; MAINTENANCE DRUG DOSE; MAJOR CLINICAL STUDY; MULTIPLE CANCER; MULTIPLE CYCLE TREATMENT; OVARY CANCER; PERITONEUM CANCER; PHASE 2 CLINICAL TRIAL; PHYSICAL EXAMINATION; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RECURRENT CANCER; SWEAT GLAND DISEASE;

ALKALINE PHOSPHATASE; ANTINEOPLASTIC AGENTS, HORMONAL; BONE AND BONES; COLLAGEN TYPE I; ESTRADIOL; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; OVARIAN NEOPLASMS; PEPTIDES;

EID: 64149110213     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2009.01.012     Document Type: Article

References (36)

1. Armstrong D.K., Bundy B., Wenzel L., Huang H.Q., Baergen R., Lele S., et al., Gyncologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N. Engl. J. Med. 354 1 (2006) 34-43
2. McGuire W.P., Hoskins W.J., Brady M.F., Kucera P.R., Partridge E.E., Look K.Y., et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N. Engl. J. Med. 334 1 (1996) 1-6
3. Piccart M.J., Bertelsen K., James K., Cassidy J., Mangioni C., Simonsen E., et al. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J. Natl. Cancer Inst. 92 9 (2000) 699-708
4. Fisher B., Redmond C., Brown A., Fisher E.R., Wolmark N., Bowman D., et al. Adjuvant chemotherapy with and without tamoxifen in the treatment of primary breast cancer: 5-year results from the National Surgical Adjuvant Breast and Bowel Project trial. J. Clin. Oncol. 4 4 (1986) 459-471
5. Untch M., Gelber R.D., Jackisch C., Procter M., Baselga J., Bell R., et al., HERA Study Team. Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial. Ann. Oncol. 19 6 (2008) 1090-1096
6. Geyer C.E., Forster J., Lindquist D., Chan S., Romieu C.G., Pienkowski T., et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N. Engl. J. Med. 355 26 (2006) 2733-2743
7. Fiorica J.V., Brunetto V.L., Hanjani P., Lentz S.S., Mannel R., Andersen W., and Gynecologic Oncology Group study. Phase II trial of alternating courses of megestrol acetate and tamoxifen in advanced endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol. Oncol. 92 1 (2004) 10-14
8. Demetri G.D., von Mehren M., Blanke C.D., Van den Abbeele A.D., Eisenberg B., Roberts P.J., et al. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N. Engl. J. Med. 347 7 (2002) 472-480
9. Markman M., Iseminger K.A., Hatch K.D., Creasman W.T., Barnes W., and Dubeshter B. Tamoxifen in platinum-refractory ovarian cancer: a Gynecologic Oncology Group ancillary report. Gynecol. Oncol. 62 1 (1996) 4-6
10. Bookman M.A., Darcy K.M., Clarke-Pearson D., Boothby R.A., and Horowitz I.R. Evaluation of monoclonal humanized anti-HER2 antibody, trastuzumab, in patients with recurrent or refractory ovarian or primary peritoneal carcinoma with overexpression of HER2: a phase II trial of the Gynecologic Oncology Group. J. Clin. Oncol. 21 2 (2003) 283-290
11. Alberts D.S., Liu P.Y., Wilczynski S.P., Jang A., Moon J., Ward J.H., et al. Phase II trial of imatinib mesylate in recurrent, biomarker positive, ovarian cancer (Southwest Oncology Group Protocol S0211). Int. J. Gynecol. Cancer 17 4 (2007) 784-788
12. Burger R.A., Sill M.W., Monk B.J., Greer B.E., and Sorosky J.I. Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: a Gynecologic Oncology Group study. J. Clin. Oncol. 25 33 (2007) 5165-5171
13. Smyth J.F., Gourley C., Walker G., MacKean M.J., Stevenson A., Williams A.R., et al. Antiestrogen therapy is active in selected ovarian cancer cases: the use of letrozole in estrogen receptor-positive patients. Clin. Cancer Res. 13 12 (2007) 3617-3622
14. Walker G., MacLeod K., Williams A.R., Cameron D.A., Smyth J.F., and Langdon S.P. Estrogen-regulated gene expression predicts response to endocrine therapy in patients with ovarian cancer. Gynecol. Oncol. 106 3 (2007) 461-468
15. O'Donnell A.J., Macleod K.G., Burns D.J., Smyth J.F., and Langdon S.P. Estrogen receptor-alpha mediates gene expression changes and growth response in ovarian cancer cells exposed to estrogen. Endocr. Relat. Cancer 12 4 (2005) 851-866
16. Zhou B., Sun Q., Cong R., Gu H., Tang N., Yang L., et al. Hormone replacement therapy and ovarian cancer risk: a meta-analysis. Gynecol. Oncol. 108 3 (2008) 641-651
17. Silva E.G., Tornos C., Deavers M., Kaisman K., Gray K., and Gershenson D. Induction of epithelial neoplasms in the ovaries of guinea pigs by estrogenic stimulation. Gynecol. Oncol. 71 2 (1998) 240-246
18. Breast International Group (BIG) 1-98 Collaborative Group, Thürlimann B., Keshaviah A., Coates A.S., Mouridsen H., Mauriac L., Forbes J.F., et al. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N. Engl. J. Med. 353 26 (2005) 2747-2757
19. Stanway S.J., Purohit A., Woo L.W., Sufi S., Vigushin D., Ward R., et al. Phase I study of STX 64 (667 Coumate) in breast cancer patients: the first study of a steroid sulfatase inhibitor. Clin. Cancer Res. 12 5 (2006) 1585-1592
20. Chia S., Gradishar W., Mauriac L., Bines J., Amant F., Federico M., et al. 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 (2008) 1664-1670
21. Neven P., Paridaens R., Pelgrims G., Martens M., Bols A., Goeminne J.C., et al. Fulvestrant (Faslodextrade mark) in advanced breast cancer: clinical experience from a Belgian cooperative study. Breast Cancer Res. Treat. 109 1 (2008) 59-65
22. Wakeling A.E., Dukes M., and Bowler J. A potent pure antiestrogen with clinical potential. Cancer Res. 51 (1991) 3867-3873
23. Robertson J.F., and Harrison M.P. Equivalent single-dose pharmacokinetics of two different dosing methods of prolonged-release fulvestrant ('Faslodex') in postmenopausal women with advanced breast cancer. Cancer Chemother. Pharmacol. 52 4 (2003) 346-348
24. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., and Rubinstein L. 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 (2000) 205-216
25. Guppy A.E., and Rustin G.J.S. CA125 response: can it replace the traditional response criteria in ovarian cancer?. The Oncologist 7 (2002) 437-443
26. Simon R. Optimal two-stage designs for phase II clinical trials. Control. Clin. Trials 10 (1989) 1-10
27. Mlineritsch B., Psenak O., Mayer P., Moik M., Namberger K., and Hauser-Kronberger C. Fulvestrant ('Faslodex') in heavily pretreated postmenopausal patients with advanced breast cancer: single centre clinical experience from the compassionate use programme. Breast Cancer Res. Treat. 106 1 (2007) 105-112
28. Sasano H., Suzuki T., Miki Y., and Moriya T. Intracrinology of estrogens and androgens in breast carcinoma. J. Steroid Biochem. Mol. Biol. 108 3-5 (2008) 181-185
29. du B.A., Meier W., Lück H.J., Emon G., Moebus V., and Schroeder W. Chemotherapy versus hormonal treatment in platinum- and paclitaxel-refractory ovarian cancer: a randomised trial of the German Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) Study Group Ovarian Cancer. Ann. Oncol. 13 2 (2002) 251-257
30. Duffaud F., van der Burg M.E., Namer M., Vergote I., Willemse P.H.B., and ten Bokkel Huinink W. D-TRP-6-LHRH (Triptorelin) is not effective in ovarian carcinoma: an EORTC Gynaecological Cancer Co-operative Group study. Anticancer Drugs 12 2 (2001) 159-162
31. Chura, JC, Ryu, HS, Simard, M, Poirrer, D, Tremblay, Y, Brooker, DC, Blomquist, CH, Argenta PA Steroid-converting enzymes in human ovarian cancers. Mol Cell Endocrinol. In press.
32. Chura, JC, Blomquist, CH, Ryu, HS, Argenta PA. estrone sulfatase activity in patients with advanced ovarian cancer. Gynecol Oncol 2009;112(1)(Jan):205-9.
33. García-Velasco A., Mendiola C., Sánchez-Muñoz A., Ballestín C., Colomer R., and Cortés-Funes H. Prognostic value of hormonal receptors, p53, ki67 and HER2/neu expression in epithelial ovarian carcinoma. Clin. Transl. Oncol. 10 6 (2008) 367-371
34. Høgdall E.V., Christensen L., Høgdall C.K., Blaakaer J., Gayther S., and Jacobs I.J. Prognostic value of estrogen receptor and progesterone receptor tumor expression in Danish ovarian cancer patients: from the 'MALOVA' ovarian cancer study. Oncol. Rep. 18 5 (2007) 1051-1059
35. Neven P., Paridaens R., Pelgrims G., Martens M., Bols A., et al. Fulvestrant (Faslodex) in advanced breast cancer: clinical experience from a Belgian cooperative study. Breast Cancer Res. Treat. 109 (2008) 59-65
36. Osborne C.K., Pippen J., Jones S.E., Parker M., Ellis S., et al. Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J. Clin. Oncol. 20 (2002) 3386-3395