Randomized phase II study of lonaprisan as second-line therapy for progesterone receptor-positive breast cancer

Annals of Oncology

Volumn 24, Issue 10, 2013, Pages 2543-2548

  Jonat, W ^a   Bachelot, T ^b   Ruhstaller, T ^c   Kuss, I ^d   Reimann, U ^d   Robertson, J F R ^e  

^a UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^b CENTRE LÉON BÉRARD   (France)

^c CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^d BAYER PHARMA AG   (Germany)

^e UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

Antiprogestin; Breast cancer; Lonaprisan; Progesterone receptor antagonist; Progesterone receptor positive

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; LONAPRISAN; PROGESTERONE RECEPTOR;

ADULT; AGED; ARTICLE; ASCITES; ASTHENIA; BONE METASTASIS; BREAST CANCER; BREAST METASTASIS; CANCER FATIGUE; CANCER STAGING; CHILL; CLINICAL EFFECTIVENESS; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECREASED APPETITE; DISEASE ASSOCIATION; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ENDOMETRIAL HYPERTROPHY; ENDOMETRIAL THICKNESS; FEMALE; HEADACHE; HEART INFARCTION; HOT FLUSH; HUMAN; HYPERTRANSAMINASEMIA; HYPERTROPHY; ILEUS; LIVER FAILURE; LIVER METASTASIS; LUNG METASTASIS; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; MORNING DOSAGE; MULTICENTER STUDY; NAUSEA; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROTEIN DETERMINATION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; VOMITING;

ANTIPROGESTIN; BREAST CANCER; LONAPRISAN; PROGESTERONE-RECEPTOR ANTAGONIST; PROGESTERONE-RECEPTOR POSITIVE;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, HORMONAL; BREAST NEOPLASMS; ESTRENES; FEMALE; HUMANS; MIDDLE AGED; RECEPTORS, PROGESTERONE; TREATMENT OUTCOME;

EID: 84884716519     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdt216     Document Type: Article

References (21)

1. Hayes E, Nicholson RI, Hiscox S. Acquired endocrine resistance in breast cancer: implications for tumour metastasis. Front Biosci 2011; 16: 838-848.
2. Cleator SJ, Ahamed E, Coombes RC et al A 2009 update on the treatment of patients with hormone receptor-positive breast cancer. Clin Breast Cancer 2009; 9 (Suppl 1): S6-S17.
3. Klijn JG, de Jong FH, Bakker GH et al Antiprogestins, a new form of endocrine therapy for human breast cancer. Cancer Res 1989; 49: 2851-2856.
4. Robertson JF, Willsher PC, Winterbottom L et al Onapristone, a progesterone receptor antagonist, as first-line therapy in primary breast cancer. Eur J Cancer 1999; 35: 214-218.
5. Perrault D, Eisenhauer EA, Pritchard KI et al Phase II study of the progesterone antagonist mifepristone in patients with untreated metastatic breast carcinoma: a National Cancer Institute of Canada Clinical Trials Group study. J Clin Oncol 1996; 14: 2709-2712.
6. Klijn JG, Setyono-Han B, Foekens JA. Progesterone antagonists and progesterone receptor modulators in the treatment of breast cancer. Steroids 2000; 65: 825-830.
7. Fuhrmann U, Hess-Stumpp H, Cleve A et al Synthesis and biological activity of a novel, highly potent progesterone receptor antagonist. J Med Chem 2000; 43: 5010-5016.
8. Busia L, Faus H, Hoffmann J et al The antiprogestin Lonaprisan inhibits breast cancer cell proliferation by inducing p21 expression. Mol Cell Endocrinol 2011; 333: 37-46.
9. Afhuppe W, Beekman JM, Otto C et al In vitro characterization of ZK 230211-a type III progesterone receptor antagonist with enhanced antiproliferative properties. J Steroid Biochem Mol Biol 2010; 119: 45-55.
10. Maibauer R, Zurth C, Schultze-Mosgau M et al First human data for ZK 230211 (ZK-PRA), a new progesterone receptor antagonist: a Phase I clinical analysis of safety and pharmacokinetics in healthy post-menopausal women. Breast Cancer Res Treat 2006; 100(Suppl 1): abstract 4074.
11. Therasse P, Arbuck SG, Eisenhauer EA et al 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 2000; 92: 205-216.
12. Guidance for industry. Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms-recommendations for clinical evaluation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071643.pdf (28 February 2013, date last accessed).
13. Buzdar A, Jonat W, Howell A et al Anastrozole, a potent and selective aromatase inhibitor, versus megestrol acetate in postmenopausal women with advanced breast cancer: results of overview analysis of two phase III trials. Arimidex Study Group. J Clin Oncol 1996; 14: 2000-2011.
14. Jonat W, Howell A, Blomqvist C et al A randomised trial comparing two doses of the new selective aromatase inhibitor anastrozole (Arimidex) with megestrol acetate in postmenopausal patients with advanced breast cancer. Eur J Cancer 1996; 32A: 404-412.
15. Robertson JF, Williams MR, Todd J et al Factors predicting the response of patients with advanced breast cancer to endocrine (Megace) therapy. Eur J Cancer Clin Oncol 1989; 25: 469-475.
16. Goldhirsch A, Colleoni M, Gelber RD. Endocrine therapy of breast cancer. Ann Oncol 2002; 13(Suppl 4): 61-68.
17. Pierson-Mullany LK, Skildum A, Faivre E et al Cross-talk between growth factor and progesterone receptor signaling pathways: implications for breast cancer cell growth. Breast Dis 2003; 18: 21-31.
18. Ng CH, Pathy NB, Taib NA et al The estrogen receptor negative-progesterone receptor positive breast carcinoma is a biological entity and not a technical artifact. Asian Pac J Cancer Prev 2012; 13: 1111-1113.
19. Yu KD, Di GH, Wu J et al Breast cancer patients with estrogen receptor-negative/progesterone receptor-positive tumors: being younger and getting less benefit from adjuvant tamoxifen treatment. J Cancer Res Clin Oncol 2008; 134: 1347-1354.
20. Cserni G, Francz M, Kalman E et al Estrogen receptor negative and progesterone receptor positive breast carcinomas-how frequent are they? Pathol Oncol Res 2011; 17: 663-668.
21. Goldhirsch A, Ingle JN, Gelber RD et al Thresholds for therapies: highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2009. Ann Oncol 2009; 20: 1319-1329.