Literature DB >> 17918264

A phase II evaluation of goserelin and bicalutamide in patients with ovarian cancer in second or higher complete clinical disease remission.

Douglas Levine1, Kay Park, Margrit Juretzka, Julie Esch, Martee Hensley, Carol Aghajanian, Sharyn Lewin, Jason Konner, Felicia Derosa, David Spriggs, Alexia Iasonos, Paul Sabbatini.   

Abstract

BACKGROUND: The current study was conducted to determine the effect of goserelin and bicalutamide on progression-free survival (PFS) in patients with epithelial ovarian cancer who were in second or greater complete disease remission.
METHODS: Patients received bicalutamide at a dose of 50 mg orally daily and goserelin at a dose of 3.6 mg subcutaneously every 4 weeks. CA 125 was obtained monthly, with computed tomography performed every 3 months. Correlative studies included serum luteinizing hormone, follicle-stimulating hormone, vascular endothelial growth factor, free testosterone, and androstenedione and the germline polymorphisms CYP19A1 and androgen receptor.
RESULTS: Between October of 2000 and October of 2002, 35 patients were enrolled. Three patients (9%) received therapy at the time of first disease remission and were removed from the study, and 1 patient (3%) was removed for liver function test abnormalities. The most frequent toxicities were grade 1 alkaline phosphatase (54%), fatigue (57%), and hot flashes (42%) based on the National Cancer Institute common toxicity scale, version 2.0. The PFS for patients receiving protocol therapy in second disease remission (21 patients) was 11.4 months (95% confidence interval [95% CI], 10.2-12.6 months). The PFS for patients receiving protocol therapy in third or fourth disease remission (11 patients) was 11.9 months (95% CI, 10.8-14.1 months). The percentage of patients remaining in second disease remission at given times are: 100% at 3 months, 100% at 6 months, 72% at 9 months, 47% at 12 months, 28% at 15 months, 22% at 18 months, 19% at 21 months, and 13% at 24 months. There were no associations noted between androgen receptor repeat number, genotype, allelotype, or haplotypes and PFS.
CONCLUSIONS: The use of goserelin and bicalutamide did not appear to prolong PFS in patients with epithelial ovarian cancer in second or greater complete disease remission. The number of patients in disease remission at given time points may serve as a clinical trial endpoint for future studies of consolidation therapy. Copyright (c) 2007 American Cancer Society.

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Year:  2007        PMID: 17918264     DOI: 10.1002/cncr.23072

Source DB:  PubMed          Journal:  Cancer        ISSN: 0008-543X            Impact factor:   6.860


  22 in total

Review 1.  Revisiting the role of antiandrogen strategies in ovarian cancer.

Authors:  Dionysis Papadatos-Pastos; Konstantin J Dedes; Johann S de Bono; Stanley B Kaye
Journal:  Oncologist       Date:  2011-09-23

2.  Flutamide and biomarkers in women at high risk for ovarian cancer: preclinical and clinical evidence.

Authors:  Christine Gruessner; Angelika Gruessner; Katherine Glaser; Nisreen AbuShahin; Yi Zhou; Cynthia Laughren; Heather Wright; Samantha Pinkerton; Xiaofang Yi; Jha'nae Stoffer; Masoud Azodi; Wenxin Zheng; Setsuko K Chambers
Journal:  Cancer Prev Res (Phila)       Date:  2014-06-20

3.  Identifying clinical improvement in consolidation single-arm phase 2 trials in patients with ovarian cancer in second or greater clinical remission.

Authors:  Alexia Iasonos; Paul Sabbatini; David R Spriggs; Carol A Aghajanian; Roisin E O'Cearbhaill; Martee L Hensley; Howard T Thaler
Journal:  Int J Gynecol Cancer       Date:  2012-01       Impact factor: 3.437

4.  Consolidation strategies in ovarian cancer: observations for future clinical trials.

Authors:  Paul Sabbatini; David Spriggs; Carol Aghajanian; Martee Hensley; William Tew; Jason Konner; Kathryn Bell-McGuinn; Margrit Juretzka; Alexia Iasonos
Journal:  Gynecol Oncol       Date:  2010-01       Impact factor: 5.482

5.  Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO--the MIMOSA study.

Authors:  Paul Sabbatini; Philipp Harter; Giovanni Scambia; Jalid Sehouli; Werner Meier; Pauline Wimberger; Klaus H Baumann; Christian Kurzeder; Barbara Schmalfeldt; David Cibula; Mariusz Bidzinski; Antonio Casado; Andrea Martoni; Nicoletta Colombo; Robert W Holloway; Luigi Selvaggi; Andrew Li; Jose del Campo; Karel Cwiertka; Tamas Pinter; Jan B Vermorken; Eric Pujade-Lauraine; Simona Scartoni; Monica Bertolotti; Cecilia Simonelli; Angela Capriati; Carlo Alberto Maggi; Jonathan S Berek; Jacobus Pfisterer
Journal:  J Clin Oncol       Date:  2013-03-11       Impact factor: 44.544

Review 6.  Hormone response in ovarian cancer: time to reconsider as a clinical target?

Authors:  Francesmary Modugno; Robin Laskey; Ashlee L Smith; Courtney L Andersen; Paul Haluska; Steffi Oesterreich
Journal:  Endocr Relat Cancer       Date:  2012-11-09       Impact factor: 5.678

7.  Phase II trial of bicalutamide in patients with androgen receptor-positive, estrogen receptor-negative metastatic Breast Cancer.

Authors:  Ayca Gucalp; Sara Tolaney; Steven J Isakoff; James N Ingle; Minetta C Liu; Lisa A Carey; Kimberly Blackwell; Hope Rugo; Lisle Nabell; Andres Forero; Vered Stearns; Ashley S Doane; Michael Danso; Mary Ellen Moynahan; Lamia F Momen; Joseph M Gonzalez; Arooj Akhtar; Dilip D Giri; Sujata Patil; Kimberly N Feigin; Clifford A Hudis; Tiffany A Traina
Journal:  Clin Cancer Res       Date:  2013-08-21       Impact factor: 12.531

Review 8.  Luteinising hormone releasing hormone (LHRH) agonists for the treatment of relapsed epithelial ovarian cancer.

Authors:  Rekha Wuntakal; Srividya Seshadri; Ana Montes; Geoff Lane
Journal:  Cochrane Database Syst Rev       Date:  2016-06-29

9.  The role of hormonal factors and endocrine therapy in ovarian cancer.

Authors:  Krystyna Serkies; Marcin Sinacki; Jacek Jassem
Journal:  Contemp Oncol (Pozn)       Date:  2013-03-15

10.  Her-2/neu expression is a negative prognosticator in ovarian cancer cases that do not express the follicle stimulating hormone receptor (FSHR).

Authors:  Sabine Heublein; Thomas Vrekoussis; Doris Mayr; Klaus Friese; Miriam Lenhard; Udo Jeschke; Darius Dian
Journal:  J Ovarian Res       Date:  2013-01-22       Impact factor: 4.234

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