Goserelin (Zoladex) in premenopausal advanced breast cancer: duration of response and survival

Dixon, A. R.; Robertson, J. F. R.; Jackson, L.; Nicholson, Robert Ian; Walker, K. J.; Blamey, R. W.

doi:10.1038/bjc.1990.397

Cited by 24 publications

(7 citation statements)

References 14 publications

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“…In order to render premenopausal breast cancer patients in a postmenopausal state, medicinal ovarian function suppression using GnRH-analogs like goserelin has been developed leading to ORRs and duration of remission comparable to those seen following oophorectomy. 23 In our study, the ORR was 38.6% and higher than previously reported rates of 30% 24 and 33% 25 in patients only treated with GnRH-analogs. Our CBR was 65.9% and also higher than 48% with only goserelin medication in premenopausal advanced breast cancer patients, 25 which indicates that the clinical efficacy of goserelin combined with exemestane therapy in premenopausal women with local advanced or MBC is superior than goserelin medication alone.…”

Section: Discussioncontrasting

confidence: 48%

“…23 In our study, the ORR was 38.6% and higher than previously reported rates of 30% 24 and 33% 25 in patients only treated with GnRH-analogs. Our CBR was 65.9% and also higher than 48% with only goserelin medication in premenopausal advanced breast cancer patients, 25 which indicates that the clinical efficacy of goserelin combined with exemestane therapy in premenopausal women with local advanced or MBC is superior than goserelin medication alone. In addition, no grade-4 toxicities were observed, and those that did occur were consistent with the use of a single-agent AI treatment in postmenopausal women with breast cancer.…”

Section: Discussioncontrasting

confidence: 48%

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Phase II trial of goserelin and exemestane combination therapy in premenopausal women with locally advanced or metastatic breast cancer.

Wang

Yuan

et al. 2015

JCO

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A promising option as the treatment of choice for premenopausal patients with locally advanced or metastatic breast cancer (MBC) could be the combination of a luteinizing hormone-releasing hormone analog and an aromatase inhibitor. However, no prospective studies on the efficacy of goserelin with exemestane in locally advanced or MBC premenopausal breast cancer patients have been reported. We present the phase II trial of goserelin plus exemestane in a total of 44 premenopausal women with locally advanced or MBC. All patients received a subcutaneous injection of 3.6 mg goserelin every 4 weeks along with 25 mg exemestane daily. The primary end point was progression-free survival (PFS). The second end point included overall survival (OS), objective response rate (ORR), duration of response (DOR), and clinical benefit rate (CBR) based on complete response (CR), partial response (PR), or stable disease (SD) for !6 months. The median PFS was 13 months (range: 2-42 months). The median DOR was 8 months (range: 2-40 months). Two patients achieved CR (4.5%), and 15 patients experienced PR (34.1%). Fifteen patients (34.1%) had SD !6 months. The ORR was 38.6%, and the CBR was 65.9%. Primary progressive disease occurred in 15 patients (34.1%). Five patients (11.4%) died during the study period. Because a few patients have died, the median OS has not been reached. Drug therapy was well tolerated. The most frequent grade-3 adverse events were arthralgia (18.2%), skin rash (6.8%), and myalgia (4.5%). No participants withdrew from the study due to drug toxicity. This study suggested that goserelin and exemestane might be highly effective and well-tolerated regimens in premenopausal women with hormone-responsive, locally advanced or MBC.

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Section: Discussioncontrasting

confidence: 48%

Section: Discussioncontrasting

confidence: 48%

Phase II trial of goserelin and exemestane combination therapy in premenopausal women with locally advanced or metastatic breast cancer.

Wang

Yuan

et al. 2015

JCO

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“…Although our clinical results in terms of remission rate and response duration are similar to those reported for goserelin alone (response rates ranging from 33% to 45% and median response durations ranging from 8 to 15 months; Dixon et al, 1990;Kaufinann et al, 1991;Blamey et al, 1992;Bajetta et al, 1994b), it remains an open question whether tamoxifen may offer any advantage for patients treated with medical castration by the analogue. No prospective study aesing the efficacy of the combination has yet been published although, in a retrospective study of 50 patients receiving the combination, an overall response rate of only 18% was reported; a further 30% of patients showed stable disease, but no significant survival difference between these two response groups was observed (Dixon et al, 1991).…”

Section: Analysis Of Resultsmentioning

confidence: 45%

Combination goserelin and tamoxifen therapy in premenopausal advanced breast cancer: a multicentre study by the ITMO group

et al. 1995

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S_ary It has been suggested that tamoxifen may improve the efficacy of medical castration with luteinising hormone-releasing hormone analogues, but very few data have so far been published concerning the clinical and endocrinological activity of this therapeutic modality. In this phase II During the 1980s, a novel endocrine tool was developed after the introduction of luteinising hormone-releasing hormone (LH-RH) analogues, which provided a means for decreasing circulating oestrogen levels without the need for irreversible surgical oophorectomy (Santen et al., 1986).In patients with premenopausal advanced breast cancer, the clinical efficacy of a number of LH-RH analogues has been reported (Klijn and de Jong, 1982;Harvey et al., 1985) and, although the response rates for surgical and medical forms of castration are similar, the use of these analogues leads to a lower rate of morbidity. Goserelin is a potent LH-RH analogue which can be easily administered by means of the monthly injection of a depot formulation (Matta et al., 1988).Experience with tamoxifen therapy in young patients is more limited than that acquired in post-menopausal women, but the response to this agent has been reported to be similar to that of oophorectomy (Buchanan et al., 1986) blocking ovarian steroid production with the analogue and, at the same time, using the antioestrogen to counteract any residual oestrogen action on cancer cells in an attempt to obtain an increase in the rate and/or duration of response.Given the potential benefits and the very few published data concerning this therapeutic approach, the present phase II trial was undertaken by our group with the aim of acquiring further information on the efficacy and toxicity of combined goserelin and tamoxifen treatment in patients with previously untreated premenopausal advanced breast cancer. An attempt was also made to determine the effects of the therapy on the patients' hormonal environment.

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“…Leuprolide, an LHRH agonist in premenopausal patients with a major effect via ovarian suppression (Nicholson et al, 1985, Dixon et al, 1990) and formestane (4-hydroxyandrostenedione), an aromatase inhibitor in oestrogen synthesis in postmenopausal women (Stein et al, 1990) were used in preference to tamoxifen in an attempt to facilitate assessment at 3 months, as tamoxifen, in our experience, can cause tumour flare and also takes longer to achieve a response (Gazet et al, 1994).…”

Section: Patients Materials and Methodsmentioning

confidence: 99%

“…Thirteen (27.6%) had a complete regression. Others (Bonadonna et al, 1990) In premenopausal women with advanced breast cancer LHRH agonists will reduce serum oestradiol levels to the equivalent of the menopause or surgical oophorectomy (Dixon et al, 1990). These agents have an indirect action by reducing peripheral hormones rather than acting directly on LHRH receptors on the tumour (Harris et al, 1989).…”

Section: Patients Materials and Methodsmentioning

confidence: 99%

Assessment of the effect of pretreatment with neoadjuvant therapy on primary breast cancer

Gazet

Coombes²,

Ford³

et al. 1996

Br J Cancer

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Goserelin (Zoladex) in premenopausal advanced breast cancer: duration of response and survival

Cited by 24 publications

References 14 publications

Phase II trial of goserelin and exemestane combination therapy in premenopausal women with locally advanced or metastatic breast cancer.

Phase II trial of goserelin and exemestane combination therapy in premenopausal women with locally advanced or metastatic breast cancer.

Combination goserelin and tamoxifen therapy in premenopausal advanced breast cancer: a multicentre study by the ITMO group

Assessment of the effect of pretreatment with neoadjuvant therapy on primary breast cancer

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