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

Nishimura,Reiki; Anan,Keisei; Yamamoto,Yutaka; Higaki,Kenji; Tanaka,Maki; Shibuta,Kenji; Sagara,Yasuaki; Ohno,Shinji; Tsuyuki,Shigeru; Mase,Takahiro; Teramukai,Satoshi

doi:10.3892/or.2013.2312

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

Authors:
- Reiki Nishimura
- Keisei Anan
- Yutaka Yamamoto
- Kenji Higaki
- Maki Tanaka
- Kenji Shibuta
- Yasuaki Sagara
- Shinji Ohno
- Shigeru Tsuyuki
- Takahiro Mase
- Satoshi Teramukai
View Affiliations

Affiliations: Department of Breast and Endocrine Surgery, Kumamoto City Hospital, Kumamoto 862-8505, Japan, Department of Surgery, Kitakyushu Municipal Medical Center, Kitakyushu 802-0077, Japan, Department of Breast and Endocrine Surgery, Kumamoto University Hospital, Kumamoto 860-8556, Japan, Department of Breast Surgery, Hiroshima City Hospital, Hiroshima 730-8518, Japan, Department of Surgery, Social Insurance Kurume Daiichi Hospital, Kurume 830‑0013, Japan, Department of Breast Surgery, Ueo Breast Surgical Hospital, Oita 870-0854, Japan, Department of Breast/Thyroid Gland, Hakuaikai Medical Corporation, Sagara Hospital, Kagoshima 892-0833, Japan, Division of Breast Oncology, National Kyushu Cancer Center, Fukuoka 811-1395, Japan, Department of Breast and General Surgery, Osaka Red-Cross Hospital, Osaka 543-8555, Japan, Department of Breast and Endocrine surgery, Ichinomiya Municipal Hospital, Ichinomiya 491-8558, Japan, Department of Clinical Trial Design and Management Translational Research Center, Kyoto University Hospital, Kyoto 606-8507, Japan
Published online on: February 27, 2013 https://doi.org/10.3892/or.2013.2312
Pages: 1707-1713
Copyright: © Nishimura et al. This is an open access article distributed under the terms of Creative Commons Attribution License [CC BY_NC 3.0].

Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )

Metrics: Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )

Cited By (CrossRef): 0 citations Loading Articles...

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.

View Figures

View References

1	Jonat W, Kaufmann M, Sauerbrei W, Blamey R, Cuzick J, Namer M, Fogelman I, de Haes JC, de Matteis A, Stewart A, Eiermann W, Szakolczai I, Palmer M, Schumacher M, Geberth M and Lisboa B; Zoladex Early Breast Cancer Research Association Study. Goserelin versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy in premenopausal patients with node-positive breast cancer: the ‘Zoladex’ Early Breast Cancer Research Association study. J Clin Oncol. 20:4628–4635. 2002.
2	Kaufmann M, Jonat W, Blamey R, Cuzick J, Namer M, Fogelman I, de Haes JC, Schumacher M and Sauerbrei W; Zoladex Early Breast Cancer Research Association (ZEBRA) Trialists' Group. Survival analyses from the ZEBRA study: goserelin (Zoladex) versus CMF in premenopausal women with node-positive breast cancer. Eur J Cancer. 39:1711–1717. 2003. View Article : Google Scholar : PubMed/NCBI
3	Ackerman GE, Smith ME, Mendelson CR, MacDonald PC and Simpson ER: Aromatization of androstenedione by human adipose tissue stromal cells in monolayer culture. J Clin Endocrinol Metab. 53:412–417. 1981. View Article : Google Scholar : PubMed/NCBI
4	Jonat W, Kaufmann M, Blamey RW, Howell A, Collins JP, Coates A, Eiermann W, Jänicke F, Njordenskold B and Forbes JF: A randomized study to compare the effect of the luteinising hormone releasing hormone (LH-RH) analogue goserelin with or without tamoxifen in pre- and perimenopausal patients with advanced breast cancer. Eur J Cancer. 31A:137–142. 1995. View Article : Google Scholar
5	Forward DP, Cheung KL, Jackson L and Robertson JF: Clinical and endocrine data for goserelin plus anastrozole as second-line endocrine therapy for premenopausal advanced breast cancer. Br J Cancer. 90:590–594. 2004. View Article : Google Scholar : PubMed/NCBI
6	Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC and Gwyther SG: New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 92:205–216. 2000. View Article : Google Scholar : PubMed/NCBI
7	Japan Breast Cancer Society. General Rules for Clinical and Pathological Recording of Breast Cancer. 14th edition. Kanehara Publications; Tokyo: 2000, (In Japanese).
8	National Cancer Institute. Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). http://ctep.cancer.gov.
9	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 and Pujade-Lauraine E: 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. 2012. View Article : Google Scholar
10	Smith IE and Dowsett M: Aromatase inhibitors in breast cancer. N Engl J Med. 348:2431–2442. 2003. View Article : Google Scholar : PubMed/NCBI
11	Smith IE, Dowsett M, Yap YS, Walsh G, Lønning PE, Santen RJ and Hayes D: Adjuvant aromatase inhibitors for early breast cancer after chemotherapy-induced amenorrhoea: caution and suggested guidelines. J Clin Oncol. 24:2444–2447. 2006. View Article : Google Scholar
12	Carlson RW, Theriault R, Schurman CM, Rivera E, Chung CT, Phan SC, Arun B, Dice K, Chiv VY, Green M and Valero V: Phase II trial of anastrozole plus goserelin in the treatment of hormone receptor-positive, metastatic carcinoma of the breast in premenopausal women. J Clin Oncol. 28:3917–3921. 2010. View Article : Google Scholar : PubMed/NCBI
13	Michaud JB, Jones KL and Buzdar AU: Combination endocrine therapy in the management of breast cancer. Oncologist. 6:538–546. 2001. View Article : Google Scholar : PubMed/NCBI
14	Nabholtz JM, Buzdar A, Pollak M, Harwin W, Burton G, Mangalik A, Steinberg M, Webster A and von Euler M: Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. J Clin Oncol. 18:3758–3767. 2000.PubMed/NCBI
15	Paridaens RJ, Dirix LY, Beex LV, Nooij M, Cameron DA, Cufer T, Piccart MJ, Bogaerts J and Therasse P: Phase III study comparing exemestane with tamoxifen as first-line hormonal treatment of metastatic breast cancer in postmenopausal women: the European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group. J Clin Oncol. 26:4883–4890. 2008. View Article : Google Scholar
16	Mouridsen H, Gershanovich M, Sun Y, Pérez-Carrión R, Boni C, Monnier A, Apffelstaedt J, Smith R, Sleeboom HP, Jänicke F, Pluzanska A, Dank M, Becquart D, Bapsy PP, Salminen E, Snyder R, Lassus M, Verbeek JA, Staffler B, Chaudri-Ross HA and Dugan M: Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International Letrozole Breast Cancer Group. J Clin Oncol. 19:2596–2606. 2001.
17	Osborne CK, Pippen J, Jones SE, Parker LM, Ellis M, Come S, Gertler SZ, May JT, Burton G, Dimery I, Webster A, Morris C, Elledge R and Buzdar A: Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J Clin Oncol. 20:3386–3395. 2002. View Article : Google Scholar
18	Kaufmann M, Bajetta E, Dirix LY, Fein LE, Jones SE, Zilembo N, Dugardyn JL, Nasurdi C, Mennel RG, Cervek J, Fowst C, Polli A, di Salle E, Arkhipov A, Piscitelli G, Miller LL and Massimini G: Exemestane is superior to megestrol acetate after tamoxifen failure in postmenopausal women with advanced breast cancer: results of a phase III randomized double-blind trial. J Clin Oncol. 18:1399–1411. 2000.
19	Yao S, Xu B, Li Q, Zhang P, Yuan P, Wang J, Ma F and Fan Y: Goserelin plus letrozole as first- or second-line hormonal treatment in premenopausal patients with advanced breast cancer. Endocr J. 58:509–516. 2011. View Article : Google Scholar : PubMed/NCBI
20	Gnant M, Mlineritsch B, Schippinger W, Luschin-Ebengreuth G, Pöstlberger S, Menzel C, Jakesz R, Seifert M, Hubalek M, Bjelic-Radisic V, Samonigg H, Tausch C, Eidtmann H, Steger G, Kwasny W, Dubsky P, Fridrik M, Fitzal F, Stierer M, Rücklinger E and Greil R; ABCSG-12 Trial Investigators and Marth C. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N Engl J Med. 360:679–691. 2009. View Article : Google Scholar : PubMed/NCBI
21	Torrisi R, Bagnardi V, Rotmensz N, Scarano E, Iorfida M, Veronesi P, Luini A, Viale G, Santoro A, Colleoni M and Goldhirsch A: Letrozole plus GnRH analogue as preoperative and adjuvant therapy in premenopausal women with ER positive locally advanced breast cancer. Breast Cancer Res Treat. 126:431–441. 2011. View Article : Google Scholar : PubMed/NCBI
22	Masuda N, Sagara Y, Kinoshita T, Iwata H, Nakamura S, Yanagita Y, Nishimura R, Iwase H, Kamigaki S, Takei H and Noguchi S: Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial. Lancet Oncol. 13:345–352. 2012. View Article : Google Scholar