title: Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: results of the JMTO BC08-01 phase II trial.
abstract: The aim of the present study was to assess the efficacy and tolerability of a luteinizing hormone-releasing hormone (LH-RH) analogue plus an aromatase inhibitor following failure to respond to standard LH-RH analogue plus tamoxifen (TAM) in premenopausal patients. Premenopausal women with estrogen receptor (ER)-positive and/or progesterone-receptor positive, advanced or recurrent breast cancer refractory to an LH-RH analogue plus TAM received goserelin (GOS) in conjunction with anastrozole (ANA). The primary endpoint was the objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR) and safety. Between September 2008 and November 2010, 37 patients were enrolled. Thirty-five patients (94.6%) had ER-positive tumors, and 36 (97.3%) had human epidermal growth factor receptor (HER) 2-negative tumors. Thirty-six (97.3%) had measurable lesions and 1 (2.7%) had only bone metastasis. The ORR was 18.9% [95% confidence interval (CI), 8.0-35.2%], the CBR was 62.2% (95% CI, 44.8-77.5%) and the median PFS was 7.3 months. Eight patients had adverse drug reactions but none resulted in discontinuation of treatment. GOS plus ANA is a safe effective treatment for premenopausal women with hormone receptor-positive, recurrent or advanced breast cancer. The treatment may become viable treatment in the future, particularly when TAM is ineffective or contraindicated. Further studies and discussion are warranted.
authors: Department of Breast and Endocrine Surgery, Kumamoto City Hospital, Kumamoto 862-8505, Japan. nishimura.reiki@cityhosp-kumamoto.jp
authors: Reiki
authors: R
authors: Nishimura
authors: Keisei
authors: K
authors: Anan
authors: Yutaka
authors: Y
authors: Yamamoto
authors: Kenji
authors: K
authors: Higaki
authors: Maki
authors: M
authors: Tanaka
authors: Kenji
authors: K
authors: Shibuta
authors: Yasuaki
authors: Y
authors: Sagara
authors: Shinji
authors: S
authors: Ohno
authors: Shigeru
authors: S
authors: Tsuyuki
authors: Takahiro
authors: T
authors: Mase
authors: Satoshi
authors: S
authors: Teramukai
mesh_terms: D000328:Adult; D000077384:Anastrozole; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000235:genetics / Q000378:metabolism; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000031:analogs & derivatives; D017273:Goserelin / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism; D009570:Nitriles / Q000008:administration & dosage / Q000009:adverse effects; D017697:Premenopause; D011960:Receptors, Estrogen / Q000235:genetics / Q000378:metabolism; D011980:Receptors, Progesterone / Q000235:genetics / Q000378:metabolism; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects; D014230:Triazoles / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D047072:Aromatase Inhibitors; D009570:Nitriles; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D014230:Triazoles; D013629:Tamoxifen; D017273:Goserelin; D000077384:Anastrozole; D007987:Gonadotropin-Releasing Hormone; D066246:ErbB Receptors