Phase II study of fulvestrant in recurrent/metastatic endometrial carcinoma: A Gynecologic Oncology Group Study

Gynecologic Oncology

Volumn 120, Issue 2, 2011, Pages 185-188

  Covens, Allan L ^a   Filiaci, Virginia ^b   Gersell, Deborah ^a   Lutman, Christopher V ^c   Bonebrake, Albert ^d   Lee, Yi Chun ^e  

^a UNIVERSITY OF TORONTO   (Canada)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

^c RIVERSIDE METHODIST HOSPITAL   (United States)

^d Cancer Research for the Ozarks   (United States)

^e SUNY DOWNSTATE MEDICAL CENTER   (United States)

Author keywords

Hormonal therapy; Metastatic endometrial cancer; Recurrent endometrial cancer

Indexed keywords

ESTROGEN RECEPTOR; FULVESTRANT; PROGESTERONE RECEPTOR;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLEEDING; CANCER LOCALIZATION; CANCER THERAPY; CONTROLLED STUDY; COUGHING; CYTOLOGY; DEPRESSION; DIARRHEA; DISEASE COURSE; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; ENDOMETRIUM CARCINOMA; FATIGUE; FEMALE; HEMATOLOGIC DISEASE; HISTOLOGY; HOT FLUSH; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; INFECTION; INJECTION SITE REACTION; LEUKOPENIA; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; METASTASIS; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROLOGIC DISEASE; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RECURRENT CANCER; SKIN DISEASE; THROMBOSIS; TREATMENT DURATION; TREATMENT RESPONSE; VISUAL DISORDER; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, HORMONAL; DISEASE-FREE SURVIVAL; ENDOMETRIAL NEOPLASMS; ESTRADIOL; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM RECURRENCE, LOCAL; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE;

EID: 79251593149     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2010.10.015     Document Type: Article

References (23)

1. J.T. Thigpen, M.F. Brady, H.D. Homesley, J. Malfetano, B. DuBeshter, and R.A. Burger Phase III trial of doxorubicin with or without cisplatin in advanced endometrial carcinoma: a Gynecologic Oncology Group Study J Clin Oncol 22 2004 3902 3908
2. P.J. Hoskins, K.D. Swenerton, J.A. Pike, F. Wong, P. Lim, and C. Acquino-Parsons Paclitaxel and carboplatin, alone or with radiation, in advanced or recurrent endometrial cancer: a phase II study J Clin Oncol 19 2001 4048 4053
3. A.A. Garcia, J.A. Blessing, S. Nolte, and R.S. Mannel A phase II evaluation of weekly docetaxel (NSC #628503) in the treatment of recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group Study Gynecol Oncol 111 2008 22 26
4. G.F. Fleming, V.L. Filiaci, R.C. Bentley, T. Herzog, J. Sorosky, and L. Vaccarello Phase III randomized trial of doxorubicin + cisplatin versus doxorubicin + 24-hour paclitaxel + filgrastim in endometrial carcinoma: a Gynecologic Oncology Group Study Ann Oncol 15 2004 1173 1178
5. H.G. Ball, J.A. Blessing, S.S. Lentz, and D.G. Mutch A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: a Gynecologic Oncology Group Study Gynecol Oncol 62 1996 278 281
6. J.T. Thigpen, M.F. Brady, R.D. Alvarez, M.D. Adelson, H.D. Homesly, and A. Manetta Oral medroxyprogesterone acetate in the treatment of advanced or recurrent endometrial carcinoma: a dose-response study by the Gynecologic Oncology Group J Clin Oncol 17 1999 1736 1744
7. L.P. Pertschuk, S. Masood, J. Simone, J.G. Feldman, R.G. Fruchter, and C.A. Axiotis Estrogen receptor immunocytochemistry in endometrial carcinoma: a prognostic marker for survival Gynecol Oncol 63 1996 28 33
8. Z.G. Zhang, M.H. Xu, and M.Q. Wang Immunohistochemical study on estrogen receptors in conventional formalin-fixed, paraffin-embedded tissues of endometrial carcinoma Zhonghua Fu Chan Ke Za Zhi 29 667-9 1994 699 700
9. P.G. Rose, V.L. Brunetto, L. VanLe, J. Bell, J.L. Walker, and R.B. Lee A phase II trial of anastrozole in advanced, recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study Gynecol Oncol 78 2000 212 216
10. T. Thigpen, M.F. Brady, H.D. Homesley, J.T. Soper, and J. Bell Tamoxifen in the treatment of advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group study J Clin Oncol 19 2001 364 367
11. L.E. Rutqvist Stockholm Breast Cancer Study Group. Long-term follow-up of the randomized Stockholm trial on adjuvant tamoxifen among postmenopausal patients with early stage breast cancer Acta Oncol 46 2007 133 145
12. A.E. Wakeling, M. Dukes, and J. Bowler A potent specific pure antiestrogen with clinical potential Cancer Res 51 1991 3867 3873
13. S. Addo, R.A. Yates, and A. Laight A phase I trial to assess the pharmacology of the new estrogen receptor antagonist fulvestrant on the endometrium in healthy postmenopausal volunteers Br J Cancer 87 2002 1354 1359
14. L. Morales, P. Neven, D. Timmerman, H. Wildiers, M.L. Konstantinovic, and M.R. Christiaens Prospective assessment of the endometrium in postmenopausal breast cancer patients treated with fulvestrant Breast Cancer Res Treat 117 2009 77 81
15. E. Kaplan, and P. Meier Nonparametric estimation from incomplete observations J Am Stat Assoc 53 1958 457 481
16. A. Agresti A Survey of Exact Inference for Contingency Tables Statist Sci 7 1992 131 153
17. T.T. Chen, and T. Ng Optimal flexible designs in phase II clinical trials Stat Med 17 1998 2301 2312
18. Sill MW: Adapting rejection boundaries when the targeted accrual is not attained in 2-stage phase II clinical trials, Technical Report 04-01, Department of Biostatistics, The University at Buffalo. http://www.gog.org/sdcstaff/ MikeSill/Research/Tech0401/Tech0401Info.htm
19. M.A. Hoffman, and A. Khan Durable response of metastatic endometrial carcinoma to treatment with fulvestrant (Faslodex) after prior progestin and anastrozole therapy Gynecol Oncol 100 2006 439 441
20. M.P. Lux, E.M. Wenkel, K. Beckmann, M.W. Beckmann, and F. Thiel Fulvestrant: a further treatment option for patients with metastatic uterine cancer? Onkologie 29 2006 577 580
21. A. Howell, J. Pippen, R. Elledge, L. Mauriac, I. Vergote, and S. Jones Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma: a prospectively planned combined survival analysis of two multicenter trials Cancer 104 2005 236 239
22. C. Whitney, V. Brunetto, R. Zaino, S. Lentz, J. Sorosky, and D. Armstrong Phase II study of medroxyprogesterone acetate plus tamoxifen in advanced endometrial carcinoma: a gynecologic oncology group study Gynecol Oncol 92 2004 4 9
23. J. Fiorica, V. Brunetto, P. Hanjani, S. Lentz, R. Mannel, and W. Andersen Phase II trial of alternating courses of megestrol acetate and tamoxifen in advanced endometrial carcinoma: a gynecologic oncology group study Gynecol Oncol 92 2004 10 14