Everolimus as treatment for breast cancer patients with bone metastases only: Results of the phase II RADAR study

Journal of Cancer Research and Clinical Oncology

Volumn 139, Issue 12, 2013, Pages 2047-2056

  Maass, Nicolai ^a   Harbeck, Nadia ^b   Mundhenke, Christoph ^c   Lerchenmüller, Christian ^d   Barinoff, Jana ^e   Lück, Hans Joachim ^f   Ettl, Johannes ^g   Aktas, Bahriye ^h   Kümmel, Sherko ⁱ   Rösel, Siegfried ^j   Wagner, Steffen ^k   Müller, Lothar ^l   Bischoff, Joachim ^m   Lübbe, Kristina ⁿ   Schwedler, Kathrin ^o   Schmidt, Marcus ^p   Bauerschlag, Dirk ^a   Nekljudova, Valentina ^q   Von Minckwitz, Gunter ^q   Loibl, Sibylle ^q  

^a UNIVERSITY HOSPITAL RWTH AACHEN   (Germany)

^b UNIVERSITY OF MUNICH   (Germany)

^c UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^d Gemeinschaftspraxis Dres Wehmeyer   (Germany)

^e DR HORST SCHMIDT KLINIKEN   (Germany)

^f Gynkologisch onkologische Praxis Hannover   (Germany)

^g TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^h UNIVERSITY HOSPITAL ESSEN   (Germany)

ⁱ KLINIKEN ESSEN MITTE   (Germany)

^j Onkodok GmbH   (Germany)

^k Pneumologische Gemeinschaftspraxis Saarbrücken   (Germany)

^l Onkologische Praxis Leer ^*  (Germany)

^m UNIVERSITY HOSPITAL MAGDEBURG   (Germany)

ⁿ Frauenklinik   (Germany)

^o UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^p UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^q GERMAN BREAST GROUP   (Germany)

more..

Author keywords

Bone metastases; Everolimus; Metastatic breast cancer

Indexed keywords

CA 15-3 ANTIGEN; CALCIUM; EVEROLIMUS; GLUCOSE; HORMONE RECEPTOR; PLACEBO; VITAMIN D; ZOLEDRONIC ACID;

ANEMIA; ARTICLE; BODY WEIGHT DISORDER; BONE METASTASIS; BREAST CANCER; CANCER PATIENT; COHORT ANALYSIS; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG RESPONSE; DRUG SAFETY; DYSPNEA; FEMALE; GLUCOSE BLOOD LEVEL; HEADACHE; HEART DISEASE; HORMONAL THERAPY; HUMAN; HYPERGLYCEMIA; HYPERTRIGLYCERIDEMIA; LEUKOPENIA; LONG TERM CARE; LUNG ALVEOLITIS; MAJOR CLINICAL STUDY; MENTAL DISEASE; METABOLIC DISORDER; MULTICENTER STUDY; MUSCULOSKELETAL PAIN; NAUSEA; NEUTROPENIA; OSTEOCLAST; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SENSORY NEUROPATHY; SKIN DISEASE; STOMATITIS; TASTE DISORDER; THROMBOCYTOPENIA; VERTIGO; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS; BONE NEOPLASMS; BREAST NEOPLASMS; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; MIDDLE AGED; PLACEBOS; SIROLIMUS;

EID: 84888395367     PISSN: 01715216     EISSN: 14321335     Source Type: Journal    
DOI: 10.1007/s00432-013-1518-x     Document Type: Article

References (16)

1. Andre F, Campone M, O'Regan R, Manlius C, Massacesi C, Sahmoud T, Mukhopadhyay P, Soria JC, Naughton M, Hurvitz SA (2010) Phase I study of everolimus plus weekly paclitaxel and trastuzumab in patients with metastatic breast cancer pretreated with trastuzumab. J Clin Oncol 28:5110-5115
2. Bachelot T, Bourgier C, Cropet C, Ray-Coquard I, Ferrero JM, Freyer G, Abadie-Lacourtoisie S, Eymard JC, Debled M, Spaëth D, Legouffe E, Allouache D, El Kouri C, Pujade-Lauraine E (2012) Randomized phase II trial of everolimus in combination with tamoxifen in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer with prior exposure to aromatase inhibitors: a GINECO study. J Clin Oncol 30:2718-2724
3. Baselga J, Semiglazov V, van Dam P, Manikhas A, Bellet M, Mayordomo J, Campone M, Kubista E, Greil R, Bianchi G, Steinseifer J, Molloy B, Tokaji E, Gardner H, Phillips P, Stumm M, Lane HA, Dixon JM, Jonat W, Rugo HS (2009) Phase II randomized study of neoadjuvant everolimus plus letrozole compared with placebo plus letrozole in patients with estrogen receptor-positive breast cancer. J Clin Oncol 27:2630-2637
4. Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN (2012) Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 366:520-529
5. Busaidy NL, Farooki A, Dowlati A, Perentesis JP, Dancey JE, Doyle LA, Brell JM, Siu LL (2012) Management of metabolic effects associated with anticancer agents targeting the PI3K-Akt-mTOR pathway. J Clin Oncol 30:2919-2928
6. Campone M, Noguchi S, Pritchard K, Rugo H, Hortobagyi GN, Baselga J, Panneerselvam A, Taran T, Sahmoud T, Piccart M (2012) Efficacy and safety of everolimus in postmenopausal women with advanced breast cancer (BOLERO-2): effect of visceral metastases and prior endocrine therapy. Ann Oncol 23(suppl 9):ix116-ix143
7. Costelloe CM, Rohren EM, Madewell JE, Hamaoka T, Theriault RL, Yu TK, Lewis VO, Ma J, Stafford RJ, Tari AM, Hortobagyi GN, Ueno NT (2009) Imaging bone metastases in breast cancer: techniques and recommendations for diagnosis. Lancet Oncol 10:606-614
8. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J (2009) New response evaluation criteria in solid tumours: revided RECIST guideline (version 1.1). Eur J Cancer 45:228-247
9. Ellard SL, Clemons M, Gelmon KA, Norris B, Kennecke H, Chia S, Pritchard K, Eisen A, Vandenberg T, Taylor M, Sauerbrei E, Mishaeli M, Huntsman D, Walsh W, Olivo M, McIntosh L, Seymour L (2009) Randomized phase II study comparing two schedules of everolimus in patients with recurrent/metastatic breast cancer: NCIC Clinical Trials Group IND.163. J Clin Oncol 27:4536-4541
10. Gnant M, Balic M, Petru E, Raunik W, Singer CF, Steger GG, Watzke IM, Brodowicz T (2012) Treatment of bone metastases in patients with advanced breast cancer. Breast Care (Basel) 7:92-98
11. Hayashi N, Costelloe CM, Hamaoka T, Wei C, Niikura N, Theriault RL, Hortobagyi GN, Madewell JE, Ueno NT (2013) A prospective study of bone tumor response assessment in metastatic breast cancer. Clin Breast Cancer 13(1):24-30
12. Kneissel M, Luong-Nguyen NH, Baptist M, Cortesi R, Zumstein-Mecker S, Kossida S, O'Reilly T, Lane H, Susa M (2004) Everolimus suppresses cancellous bone loss, bone resorption, and cathepsin K expression by osteoclasts. Bone 35:1144-1156
13. Lipton A, Theriault RL, Hortobagyi GN, Simeone J, Knight RD, Mellars K, Reitsma DJ, Heffernan M, Seaman JJ (2000) Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo-controlled trials. Cancer 88:1082-1090
14. Meric-Bernstam F, Gonzalez-Angulo AM (2009) Targeting the mTOR signaling network for cancer therapy. J Clin Oncol 27:2278-2287
15. Rustin GJ, Timmers P, Nelstrop A, Shreeves G, Bentzen SM, Baron B, Piccart MJ, Bertelsen K, Stuart G, Cassidy J, Eisenhauer E (2006) Comparison of CA-125 and standard definitions of progression of ovarian cancer in the intergroup trial of cisplatin and paclitaxel versus cisplatin and cyclophosphamide. J Clin Oncol 24:45-51
16. Theriault RL, Lipton A, Hortobagyi GN, Leff R, Glück S, Stewart JF, Costello S, Kennedy I, Simeone J, Seaman JJ, Knight RD, Mellars K, Heffernan M, Reitsma DJ (1999) Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: a randomized, placebo-controlled trial. J Clin Oncol 17:846-854