Third-Line Hormonal Treatment with Exemestane in Postmenopausal Patients with Advanced Breast Cancer Progressing on Letrozole or Anastrozole. A Phase II Trial Conducted by the Hellenic Group of Oncology (HELGO)

Gennatas, Constantine; Michalaki, Vasiliki; Carvounis, Eleni; Psychogios, J.; Poulakaki, Nikiforita; Katsiamis, George; Voros, Dionysios; Kouloulias, V.; Mouratidou, Despina; Tsavaris, Nikolaos

doi:10.1177/030089160609200103

Cited by 42 publications

(27 citation statements)

References 15 publications

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“…Therefore, further prospectively-designed analyses are required to ascertain whether fulvestrant offers any statistically significant benefits in patients with VM. However, as seen previously [9][10][11] there was also evidence for a lack of cross-resistance between exemestane and the non-steroidal AIs; it has been speculated that this may be due to the androgenic effects of exemestane [12]. These data, therefore, suggest that both fulvestrant and exemestane may be considered as suitable options for patients with VM who are eligible for further endocrine therapy, following non-steroidal AI failure.…”

Section: Discussionsupporting

confidence: 53%

“…Unfortunately, treatment options are limited when patients experience either progression or recurrence on non-steroidal AIs. There have been limited data to support the activity of both fulvestrant and exemestane in this setting, suggesting a lack of cross-resistance between these treatments and the nonsteroidal AIs [7][8][9][10][11]. Thus, there is an increasing need for alternative and effective treatments that can be used after non-steroidal AI failure, particularly in patients with VM, who are generally considered difficult to treat.…”

Section: Introductionmentioning

confidence: 99%

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Activity of fulvestrant versus exemestane in advanced breast cancer patients with or without visceral metastases: data from the EFECT trial

Mauriac

Romieu²,

Bines

2008

Breast Cancer Res Treat

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Purpose Patients with visceral metastases (VM: lung and/or liver metastases) are generally regarded as being less responsive to hormonal therapy, and chemotherapy often becomes the default treatment. This paper reports a subgroup analysis from EFECT (The Evaluation of Faslodex versus Exemestane Clinical Trial) examining the efficacy of fulvestrant and exemestane in patients with or without VM. Methods EFECT is a randomised, doubleblind, multicentre, Phase III trial in postmenopausal women with advanced breast cancer progressing or recurring after prior non-steroidal aromatase inhibitor therapy. Results Overall, approximately 57% of patients in EFECT had visceral involvement. Fulvestrant and exemestane demonstrated clinical benefit in 29.1% and 27.2% of patients with VM, respectively. Median duration of response was 13.5 vs 10.8 months and median duration of clinical benefit was 9.9 vs 8.1 months, respectively. Conclusions These results encourage the use of endocrine agents such as fulvestrant in treating patients with advanced breast cancer and VM.

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Section: Discussionsupporting

confidence: 53%

Section: Introductionmentioning

confidence: 99%

Activity of fulvestrant versus exemestane in advanced breast cancer patients with or without visceral metastases: data from the EFECT trial

Mauriac

Romieu²,

Bines

2008

Breast Cancer Res Treat

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“…Neoadjuvant endocrine therapy studies also provide an opportunity to develop insights into the biological basis for the efficacy of estrogen receptor-targeting agents. Given that there is increasing interest in sequential steroidal and non-steroidal aromatase inhibitor therapy (Table 1) [12][13][14][15][16], the rationale of this study was to compare the effects of a randomized sequence of a steroidal aromatase inhibitor (exemestane) and a non-steroidal aromatase inhibitor (anastrozole) on biological (plasma estrone sulfate and estradiol), and tumor (Ki67 expression) biomarkers when given in the neoadjuvant setting to a cohort of post-menopausal patients with locally advanced breast cancer. There are several important findings worth noting in this study.…”

Section: Discussionmentioning

confidence: 99%

A randomized trial exploring the biomarker effects of neoadjuvant sequential treatment with exemestane and anastrozole in post-menopausal women with hormone receptor-positive breast cancer

Freedman

Amir

Hanna

et al. 2009

Breast Cancer Res Treat

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Several adjuvant endocrine strategies exist for postmenopausal women with breast cancer. This study compared the effect of two sequences of aromatase inhibitor use [steroidal (exemestane) and non-steroidal (anastrozole)] on serological and pathological biomarkers when given in the neoadjuvant setting to postmenopausal women with breast cancer. Thirty women were assigned to receive exemestane 25 mg or anastrozole 1 mg each given for 8 weeks in a randomized sequence. The effect of this treatment on serum estrone sulfate and estradiol levels, as well as tumor changes in the proliferation biomarker Ki67 were evaluated at baseline, 8 weeks and 16 weeks. WHO clinical response criteria, patient preference, and quality of life were also assessed. Assessable data was available from 28 patients. There were no differences in concentration changes of serum estradiol or Ki67 between patients in the two arms. Overall clinical response rate was 68% (19/28 assessable patients) and clinical benefit was 93% (26/28 assessable patients). There was no significant difference in toxicity or quality of life scores. The majority of patients expressed a personal preference for anastrozole over exemestane. Results suggest that the order of steroidal and non-steroidal aromatase inhibitors has little effect on outcome. The majority of patients express clear preferences for drug treatments.

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“…Several clinical trials are under way to demonstrate the effectiveness of substituting tamoxifen with aromatase inhibitors [11][12][13] . Nevertheless, tamoxifen still remains a commonly used first-line endocrine therapy in postmenopausal women with advanced hormoneresponsive breast cancer [14] .…”

Section: Introductionmentioning

confidence: 99%

Surveillance for Endometrial Cancer in Women on Tamoxifen: The Role of Liquid-Based Endometrial Cytology – Cytohistological Correlation in a Population of 168 Women

Buccoliero¹,

Fambrini

Gheri³

et al. 2008

Gynecol Obstet Invest

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Aims: The aim of this study was to evaluate the utility of liquid-based cytology for endometrial surveillance in patients receiving tamoxifen. Methods: One hundred and sixty-eight women scheduled for hysteroscopy were enrolled in the study. The women sequentially underwent hysteroscopy, endometrial cytology and biopsy. Results: Endometrial biopsy only was inadequate in 112 (67%) patients, both endometrial biopsy and cytology were inadequate in 19 (11%) patients, endometrial cytology only was inadequate in 4 (2%) patients, and both endometrial biopsy and cytology were adequate in 33 (20%) patients. Overall, endometrial biopsy was inadequate in 131 (78%) patients and endometrial cytology in 23 (14%) patients. Endometrial cytology provided sufficient material for diagnosis more often than endometrial biopsy (p < 0.05). In the series of 33 patients (20%) in whom both endometrial cytology and biopsy were adequate, there was a 100% correlation between the endometrial cytology and biopsy results. Conclusions: For the first time, this study shows the diagnostic efficacy of liquid-based endometrial cytology in the follow-up of women receiving tamoxifen. It could be applied solely or in conjunction with ultrasonography.

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Third-Line Hormonal Treatment with Exemestane in Postmenopausal Patients with Advanced Breast Cancer Progressing on Letrozole or Anastrozole. A Phase II Trial Conducted by the Hellenic Group of Oncology (HELGO)

Cited by 42 publications

References 15 publications

Activity of fulvestrant versus exemestane in advanced breast cancer patients with or without visceral metastases: data from the EFECT trial

Activity of fulvestrant versus exemestane in advanced breast cancer patients with or without visceral metastases: data from the EFECT trial

A randomized trial exploring the biomarker effects of neoadjuvant sequential treatment with exemestane and anastrozole in post-menopausal women with hormone receptor-positive breast cancer

Surveillance for Endometrial Cancer in Women on Tamoxifen: The Role of Liquid-Based Endometrial Cytology – Cytohistological Correlation in a Population of 168 Women

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