Phase II Trial of Anastrozole Plus Goserelin in the Treatment of Hormone Receptor–Positive, Metastatic Carcinoma of the Breast in Premenopausal Women

To explore the antitumor activity of the aromatase inhibitor, anastrozole, in the treatment of premenopausal women with hormone receptor-positive, metastatic breast cancer who have been rendered functionally postmenopausal with the use of the luteinizing hormone-releasing hormone agonist, goserelin....

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Bibliographic Details
Published in:	Journal of clinical oncology Vol. 28; no. 25; pp. 3917 - 3921
Main Authors:	CARLSON, Robert W, THERIAULT, Richard, VALERO, Vicente, SCHURMAN, Christine M, RIVERA, Edgardo, CHUNG, Cathie T, PHAN, See-Chun, ARUN, Banu, DICE, Kristine, CHIV, Vivian Y, GREEN, Marjorie
Format:	Journal Article
Language:	English
Published:	Alexandria, VA American Society of Clinical Oncology 01-09-2010
Subjects:	Adult Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Breast Neoplasms - pathology Estradiol - metabolism Female Goserelin - administration & dosage Gynecology. Andrology. Obstetrics Humans Mammary gland diseases Medical sciences Middle Aged Neoplasm Metastasis Neoplasms, Hormone-Dependent - drug therapy Nitriles - administration & dosage Premenopause Triazoles - administration & dosage Tumors Antineoplastic agent Agonist Breast disease Azole derivatives Antiestrogen Gonadotropin RH Antihormone Estrogen synthase Metastasis Breast carcinoma Cancerology Phase II trial Advanced stage Hormone releasing factor Non steroid compound Human Aromatase inhibitor Premenopause Enzyme Anastrozole Enzyme inhibitor Breast cancer Malignant tumor Hypothalamic hormone Mammary gland diseases Treatment Analog Young adult Triazole derivatives Goserelin Cancer Hormonal receptor
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Summary:	To explore the antitumor activity of the aromatase inhibitor, anastrozole, in the treatment of premenopausal women with hormone receptor-positive, metastatic breast cancer who have been rendered functionally postmenopausal with the use of the luteinizing hormone-releasing hormone agonist, goserelin. Premenopausal women with estrogen and/or progesterone receptor-positive, metastatic or recurrent breast cancer were enrolled in this prospective, single-arm, multicenter phase II trial. Patients were treated with goserelin 3.6 mg subcutaneous monthly and began anastrozole 1-mg daily 21 days after the first injection of goserelin. Patients continued on treatment until disease progression or unacceptable toxicity. Thirty-five patients were enrolled of which 32 were evaluable for response and toxicity. Estradiol suppression was assessed, with mean estradiol levels of 18.7 pg/mL at 3 months and 14.8 pg/mL at 6 months. One participant (3.1%) experienced a complete response, 11 (34.4%) experienced partial response, and 11 (34.4%) experienced stable disease for 6 months or longer for a clinical benefit rate of 71.9%. Median time to progression was 8.3 months (range, 2.1 to 63+) and median survival was not been reached (range, 11.1 to 63+). The most common adverse events were fatigue (50%), arthralgias (53%), and hot flashes (59%). There were no grade 4 to 5 toxicities. The combination of goserelin plus anastrozole has substantial antitumor activity in the treatment of premenopausal women with hormone receptor-positive metastatic breast cancer.
ISSN:	0732-183X 1527-7755
DOI:	10.1200/JCO.2009.24.9565