来曲唑与氨鲁米特对照治疗绝经后晚期乳腺癌113例

目的 对比来曲唑和氨鲁米特治疗妇女绝经后晚期乳腺癌患者的有效性和耐受性。 方法 采用开放、随机、多中心对照研究。患者随机分组接受口服来曲唑2．5mg．d-1或氨鲁米特1g．d-1的对照治疗。 结果 来曲唑组(n=59)有效率23．73％(CR 2例，PR 12例，ITT有效率21．88％)，SD 20．31％(13例)。氨鲁米特组(n=54)有效 率11．11％(CR 1例，PR 5例，ITT有效率10．17％)，SD 20．34％(12例)，2组疗效无统计学差异(P>0．05)。来曲唑组和氨鲁米特 组不良反应发生率分别为18．64％和42．11％，与治疗相关的不良反应发生率分别为13．56％和33．33％。比较2组总的和与治疗 相关的不良反应发生率均以来曲唑组明显较低，P值均为0．002。 结论 来曲唑对绝经后、ER／PR阳性或不明的晚期乳腺癌患者有效率为23．73％，与氨鲁米特比较无统计学差异。但来曲唑不良 反应较氨鲁米特明显低，可以代替氨鲁米特用于晚期绝经后受体阳性或不明乳癌患者的治疗。     

来曲唑治疗绝经后晚期乳腺癌临床观察

目的观察来曲唑治疗绝经后晚期乳腺癌的疗效和不良反应。方法42例雌激素或孕激素受体阳性或不明的绝经后晚期乳腺癌患者口服来曲唑每日一次,每次2.5mg,28天一周期,至少2周期。结果42例患者中,可评价疗效者42例。完全缓解(CR)0例;部分缓解(PR)5例,占11.9%;稳定(SD)23例,占54.8%,其中SD≥6个月14例,占33.3%;临床获益CBR(CR PR SD≥6个月)19例,占45.2%;进展14例,占33.3%。肿瘤进展时间2月~58月,中位进展时间(TTP)10月。未出现严重不良反应。结论来曲唑治疗绝经后晚期乳腺癌疗效确切,不良反应轻微,耐受性好。     

弗隆和氨鲁米特治疗绝经后妇女晚期乳腺癌临床观察

目的观察弗隆和氨鲁米特治疗绝经后晚期乳腺癌的疗效和不良反应。方法50例绝经后晚期乳腺癌患者随机进入弗隆组26例和氨鲁米特组24例。弗隆2.5mg口服,每天1次。氨鲁米特,第1周125mg口服,每日2次;第2周,250mg,每日2次;第3周250mg,每日3次;从第4周开始,250mg,每日4次。治疗30天为1周期。结果弗隆组有效患者(CR PR)7例(26.9%),高于氨鲁米特组3例(12.5%),但差异无显著性(P=0.294)。两组病情稳定(SD)患者分别有14例(53.8%)和12例(50.0%);病情进展(PD)患者分别有5例(19.2%)和9例(37.5%)。两药疗效在不同受体状态、无病间期、病变部位和治疗阶段的分层比较,差异均无显著性(P值均>0.05)。弗隆组主要的不良反应有乏力(15.4%)、食欲下降(11.5%)、头晕、恶心、头痛、嗜睡发生率均<8%,且程度较轻;氨鲁米特组恶心(25.0%)、呕吐(16.7%)发生明显高于弗隆组,差异有显著性(P值分别为0.045和0.046),头晕(25.0%)、乏力(20.8%)、食欲下降(16.7%)、嗜睡(12.5%)、皮肤瘙痒(12.5%)的发生也均高于弗隆组,但差异无显著性(P值均>0.05),另外有1例患者出现过敏性皮疹。结论弗隆治疗绝经后晚期乳腺癌有一定疗效,部分不良反应比氨鲁米特轻,患者耐受性强。     

弗隆和氨鲁米特治疗绝经后妇女晚期乳腺癌临床观察

目的:观察弗隆和氨鲁米特治疗绝经后晚期乳腺癌的疗效和不良反应.方法:50例绝经后晚期乳腺癌患者随机进入弗隆组26例和氨鲁米特组24例.弗隆2.5mg口服,每天1次.氨鲁米特,第1周125mg口服,每日2次;第2周,250mg,每日2次;第3周250mg,每日3次;从第4周开始,250mg,每日4次.治疗30天为1周期.结果:弗隆组有效患者(CR PR)7例(26.9%),高于氨鲁米特组3例(12.5%),但差异无显著性(P=0.294).两组病情稳定(SD)患者分别有14例(53.8%)和12例(50.0%);病情进展(PD)患者分别有5例(19.2%)和9倒(37.5%).两药疗效在不同受体状态、无病间期、病变部位和治疗阶段的分层比较,差异均无显著性(P值均＞0.05).弗隆组主要的不良反应有乏力(15.4%)、食欲下降(11.5%),头晕、恶心、头痛、嗜睡发生率均＜8%,且程度较轻;氨鲁米特组恶心(25.0%)、呕吐(1 6 7%)发生明显高于弗隆组,差异有显著性(P值分别为0.045和0.046);头晕(25.0%)、乏力(20.8%)、食欲下降(16.7%)、嗜睡(12.5%)、皮肤瘙痒(12.5%)的发生也均高于弗隆组,但差异无显著性(P值均＞0.05),另外有1例患者出现过敏性皮疹.结论:弗隆治疗绝经后晚期乳腺癌有一定疗效,部分不良反应比氨鲁米特轻,患者耐受性强.     

弗隆和氨鲁米特治疗绝经后妇女晚期乳腺癌临床观察(英文)

目的观察弗隆和氨鲁米特治疗绝经后晚期乳腺癌的疗效和不良反应。方法 50例绝经后晚期乳腺癌患者随机进入弗隆组26例和氨鲁米特组24例。弗隆2.5mg 口服,每天1次。氨鲁米特,第1周125mg 口服,每日2次;第2周,250mg,每日2次;第3周250mg,每日3次;从第4周开始,250mg,每日4次。治疗30天为1周期。结果弗隆组有效患者(CR+PR)7例(26.9%),高于氨鲁米特组3例(12.5%),但差异无显著性(P=0.294)。两组病情稳定(SD)患者分别有14例(53.8%)和12例(50.0%);病情进展(PD)患者分别有5例(19.2%)和9例(37.5%)。两药疗效在不同受体状态、无病间期、病变部位和治疗阶段的分层比较,差异均无显著性(P 值均>0.05)。弗隆组主要的不良反应有乏力(15.4%),食欲下降(11.5%)、头晕、恶心、头痛、嗜睡发生率均<8%,且程度较轻;氦鲁米特组恶心(25.0%)、呕吐(16.7%)发生明显高于弗隆组,差异有显著性(P 值分别为0.045和0.046),头晕(25.0%)、乏力(20.8%)、食欲下降(16.7%)、嗜睡(12.5%)、皮肤瘙痒(12.5%)的发生也均高于弗隆组,但差异无显著性(P 值均>0.05),另外有1例患者出现过敏性皮疹。结论弗隆治疗绝经后晚期乳腺癌有一定疗效,部分不良反应比氨鲁米特轻,患者耐受性强。     

来曲唑治疗绝经后乳腺癌骨转移

目的 研究来曲唑解救治疗绝经后乳腺癌骨转移的疗效和副作用。方法：36例绝经后乳腺癌骨转移患者给予来曲唑2．5mg，每日1次，口服至少2月。结果：36例可评价疗效和毒副作用患者中，完全缓解(CR)2例，部分缓解(PR)8例，总有效率占27．7％。稳定(SD)20例占55．5％，其中病情稳定≥6月者ll例，临床获益患者(CR PR SD)≥6月21例占58．3％，病情进展6例占16．6％。治疗中无严重不良反应。结论：来曲唑治疗绝经后乳腺癌骨转移有一定疗效，药物不良反应轻，患者容易耐受。     

来曲唑治疗晚期乳腺癌的临床观察

目的:观察来曲唑(Letrozole)治疗晚期乳腺癌的疗效及不良反应。方法:63例晚期乳腺癌患者给予来曲唑(进口或国产)2.5 mg口服,每日1次。结果:63例患者中,可评价疗效者62例,可评价不良反应者63例。完全缓解(CR)0例;部分缓解(PR)9例,占14.5 %;稳定(SD)30例,占48.4 %,其中SD≥6个月10例,占16.1 %;临床获益(CR PR SD≥6个月)19例,占30.6 %;病情进展(PD)23例,占37.1 %。一线治疗9例,有效率44.4 %,临床获益率66.7 %。二线治疗19例,有效率10.5 %,临床获益率36.8 %。三线及以上治疗34例,有效率8.8 %,临床获益率26.5 %。骨、软组织和内脏转移有效率依次为13.3 %、12.8 %和11.9 %。治疗中1例因变态反应停药,其余无严重不良反应。结论:来曲唑治疗晚期乳腺癌有一定疗效,药物不良反应轻,患者易于耐受。     

来曲唑及去势联合来曲唑综合治疗晚期乳腺癌46例分析

目的观察来曲唑组及去势联合来曲唑治疗组间治疗晚期乳腺癌的疗效及不良反应。方法来曲唑组36例绝经后晚期乳腺癌患者接受来曲唑2.5mg口服,每日1次;去势联合来曲唑治疗组10例绝经前晚期乳腺癌接受去势治疗和来曲唑治疗,部分患者加用局部放疗。结果来曲唑组及去势联合来曲唑组治疗晚期乳腺癌均有较好效果。但来曲唑组较去势联合来曲唑组在平均生存时间(37.1个月对26.1个月)以及两年生存率(94.0%对60.0%)均有优势。结论来曲唑治疗晚期乳腺癌效果较好,药物不良反应轻。绝经前女性通过去势联合来曲唑也可以取得满意效果。     

来曲唑与TP-来曲唑序贯方案治疗绝经后晚期乳腺癌

[目的]比较来曲唑与TP-来曲唑序贯联用两种方案治疗绝经后晚期乳腺癌的疗效和不良反应。[方法]47例晚期绝经后乳腺癌随机分为两组,A组23例接受来曲唑2.5mg,口服,每天1次,30天为1个周期;B组24例先接受TP方案(多西紫杉醇、顺铂)化疗2个疗程,继服来曲唑,方法同A组。[结果]两组有效率分别为39.1%和41.7%,临床获益率分别为69.6%和70.8%(P>0.05),在不同的受体状态、绝经情况、治疗阶段,两组疗效无差异(P>0.05),B组对内脏转移疗效高于A组(P<0.01);两组中位疾病进展时间(TTP)及中位缓解期分别为6.5个月vs.7.5个月和9.6个月vs.11.6个月(P>0.05)。两组主要不良反应为Ⅰ～Ⅱ级的消化道反应、骨髓抑制和乏力。[结论]单服来曲唑和TP-来曲唑序贯方案治疗绝经后晚期乳腺癌安全、疗效肯定,可作为一线方案。对伴内脏转移患者,首选TP-来曲唑序贯方案。     

尿多酸肽联合化疗治疗晚期肿瘤Ⅲ期临床研究

[目的]研究尿多酸肽联合化疗治疗晚期肿瘤的疗效及毒副作用.[方法]尿多酸肽注射液300ml深静脉置管给药,联合不同的化疗方案治疗非小细胞肺癌、乳腺癌、原发性肝癌,观察疗效及毒副反应,评价生活质量及临床受益反应.[结果]尿多酸肽联合化疗治疗病人45例,可评价疗效38例,CR 1例,PR 17例,MR 3例,SD 15例,PD 2例,总缓解率(CR PR)47.4%(ITT40.0%),总好转率(CR PR MR)55.3%(ITT46.7%);对照组8例,可评价疗效5例,PR 1例,SD3例,PD 1例,总缓解率(CR PR)20.0%(ITT12.5%),总好转率20.0%(ITT12.5%);两组均无严重毒副反应.[结论]尿多酸肽对晚期肿瘤有一定的抗癌作用,且不加重化疗的毒副作用,并可明显提高患者的生活质量.     

Double-blind randomised trial comparing the non-steroidal aromatase inhibitors letrozole and fadrozole in postmenopausal women with advanced breast cancer.

BACKGROUND: To compare the efficacy, safety and tolerability of letrozole, an advanced non-steroidal aromatase inhibitor, and fadrozole hydrochloride, an older-generation drug in this class, we conducted a randomised double-blind trial in postmenopausal women with advanced breast cancer. PATIENTS AND METHODS: One hundred and fifty-seven postmenopausal women with advanced breast cancer were enrolled and randomly assigned to receive letrozole or fadrozole in a multicentre, randomised double-blind trial in Japan. One hundred and fifty-four eligible patients were treated with either letrozole 1.0 mg once daily (n = 77) or fadrozole 1.0 mg twice daily (n = 77), for a minimum of 8 weeks. RESULTS: Letrozole showed a significantly higher overall objective response rate [complete response (CR) + partial response (PR)] than fadrozole (31.2% and 13.0%, respectively; P = 0.011, Fisher's exact test). Clinical benefits defined as CR, PR and stable disease (no change in status for more than 24 weeks) were also higher in patients treated with letrozole (50.6%) than fadrozole (35.1%). Letrozole was significantly superior to fadrozole in terms of the dominant lesion in soft tissue, bone and viscera (P = 0.011, stratified Mantel-Haenszel test). Median time to progression was 211 days in the letrozole group and 113 days in the fadrozole group with no significant difference (P = 0.175, log-rank test). Letrozole markedly reduced the estradiol, estrone and estrone sulfate levels in peripheral blood within 4 weeks. The suppressive effect of fadrozole on these hormone levels was insufficient. Adverse drug reactions were observed in 35.9% of the patients treated with letrozole and in 39.5% of those treated with fadrozole with no significant difference between the two groups (P = 0.74, Fisher's exact test). Most of the adverse drug reactions were rated as grade 1 or 2. CONCLUSIONS: The results show letrozole at a dose of 1.0 mg once daily to be more effective in treating postmenopausal women with advanced breast cancer than fadrozole at 1.0 mg twice daily, with similar safety and tolerability profiles.     

Letrozole, a new oral aromatase inhibitor: Randomised trial comparing 2.5 mg daily, 0.5 mg daily and aminoglutethimide in postmenopausal women with advanced breast cancer

Background: The study compares letrozole and aminoglutethimide (AG), astandard therapy for postmenopausal women with advanced breast cancer,previously treated with anti-oestrogens.Patients and methods: 555 women were randomly assigned letrozole 2.5 mgonce daily (n = 185), letrozole 0.5 mg once daily (n = 192) oraminoglutethimide 250 mg twice daily with corticosteroid support (n = 178)in an open-label, multicentre trial. The primary endpoint was objectiveresponse rate (ORR), with time events as secondary. ORR was analysed ninemonths after enrolment of the last patient, while survival was analysed 15months after the last patient was enrolled. We report the results of theseanalyses plus an extended period of observation (covering a total durationof approximately 45 months) to determine the duration of response andclinical benefit.Results: Overall objective response rates (complete + partial) of19.5%, 16.7% and 12.4% were seen for letrozole 2.5 mg,0.5 mg and AG respectively. Median duration of response and stable diseasewas longest for letrozole 2.5 mg (21 months) compared with letrozole 0.5 mg(18 months) and AG (14 months). Letrozole 2.5 mg was superior to AG in timeto progression, time to treatment failure and overall survival.Treatment-related adverse events occurred in fewer patients on letrozole(33%) than on AG (46%). Transient nausea was the most frequentevent with letrozole (7% on 0.5 mg, 10% on 2.5 mg, 10%on AG), rash with AG (11%, 1% on 0.5 mg, 3% on 2.5 mgletrozole).Conclusions: Letrozole 2.5 mg offers longer disease control thanaminoglutethimide and letrozole 0.5 mg in the treatment of postmenopausalwomen with advanced breast cancer, previously treated with anti-oestrogens.     

Letrozole (Femara), a new aromatase inhibitor for advanced breast cancer]

The study compares letrozole (Femara and aminoglutethimide (AG), a standard therapy for postmenopausal women with advanced breast cancer, previously treated with anti-estrogens. 555 women were randomly assigned letrozole 2.5 mg once daily (n = 185), letrozole 0.5 mg once daily (n = 192) or aminoglutethimide 250 mg twice daily with corticosteroid support (n = 178) in an open-label, multicenter trial. The primary end-point was objective response rate (ORR), with time events as secondary. ORR was analysed nine months after enrollment of the last patient, while survival was analysed 15 months after the last patients was enrolled. We report the results of these analyses plus an extended period of observation (covering a total duration of approximately 45 months) to determine the duration of response and clinical benefit. Overall objective response rates (complete + partial) of 19.5%, 16.7% and 12.4% were seen for letrozole 2.5 mg, 0.5 mg and AG respectively. Median duration of response and stable disease was longest for letrozole 2.5 mg (21 months) compared with letrozole 0.5 mg (18 months) and AG (14 months). Letrozole 2.5 mg was superior to AG in time to progression, time to treatment failure and overall survival. Treatment-related adverse events occurred in fewer patients on letrozole (33%) than on AG (46%). Letrozole 2.5 mg offers longer disease control than aminoglutethimide and letrozole 0.5 mg in the treatment of postmenopausal women with advanced breast cancer, previously treated with anti-estrogens.     

Efficacy of first-line letrozole versus tamoxifen as a function of age in postmenopausal women with advanced breast cancer

PURPOSE: To compare the efficacy, in regard to time to progression (TTP) and objective response rate (ORR), of letrozole (Femara; Novartis Pharma AG; Basel Switzerland), an oral aromatase inhibitor, with that of tamoxifen (Tamofen; Leiras OY; Turku, Finland) as first-line therapy in younger (<70 years) and older (>/=70 years) postmenopausal women with advanced breast cancer. MATERIALS AND METHODS: Nine hundred seven patients with advanced breast cancer were randomly assigned to receive 2.5 mg letrozole (n = 453) or 20 mg tamoxifen (n = 454) once daily in a double-blind, multicenter, international trial. Among the prospectively planned analyses were analyses of TTP and ORR by age (<70 and >/=70 years). The results of these prospectively planned analyses are reported here. RESULTS: Letrozole was as effective in older postmenopausal women (>/=70 years of age) as it was in younger postmenopausal women (<70 years of age). The overall ORR in the older subgroup was significantly higher in patients treated with letrozole (38%) than in patients treated with tamoxifen (18%). In the younger subgroup of postmenopausal patients, the ORRs were not significantly different (letrozole, 26%; tamoxifen, 22%). TTP was significantly longer for letrozole than for tamoxifen in both age groups (younger: letrozole median TTP, 8.8 months; tamoxifen, 6.0 months; older: letrozole median TTP, 12.2 months; tamoxifen, 5.8 months). Although age was independently prognostic of TTP, there was no significant effect of age on ORR in the presence of other factors. CONCLUSION: The data show that letrozole, 2.5 mg once daily, is as effective in older, postmenopausal women as it is in younger postmenopausal women with advanced breast cancer. In addition, letrozole was more effective than tamoxifen in both younger and older patients.     

Low-dose aminoglutethimide with and without hydrocortisone replacement as a first-line endocrine treatment in advanced breast cancer: a prospective randomized trial of the Italian Oncology Group for Clinical Research.

PURPOSE: A randomized study comparing low-dose aminoglutethimide (AG) with and without hydrocortisone (HC) was performed to investigate whether corticosteroid replacement contributes to the therapeutic effects of the drug administered as a front-line endocrine therapy in postmenopausal advanced breast cancer. PATIENTS AND METHODS: Postmenopausal patients who had not had prior endocrine therapy for advanced disease and with estrogen receptor (ER) or progesterone receptor (PgR) status positive or unknown were eligible. AG was administered at a dose of 250 mg twice a day orally (125 mg twice a day during the first month) with or without HC (20 mg twice a day orally). Seventy-nine and 74 patients were assessable for response on the AG plus HC arm and on the AG arm, respectively. The two treatment groups were well balanced and patients were largely untreated. Approximately 60% had not received any adjuvant treatment, and approximately 75% had not received any medical treatment after relapse. RESULTS: The overall responses (complete response [CR] plus partial response [PR]) were 44% and 41% for the AG plus HC and the AG arm, respectively, showing no significant difference. Time to progression (median, 8.1 and 6.3 months), duration of response (median, 15.8 and 13.7 months), and duration of survival (median, 34.2 and 36.3 months) were not significantly different between the two treatment arms. Side effects were infrequent and mild in both arms, with no significant differences. CONCLUSION: We conclude that half of the conventional daily dose of AG has optimal therapeutic activity as a front-line endocrine treatment of postmenopausal advanced breast cancer and that HC does not significantly contribute to the therapeutic effects.     

Superiority of letrozole to tamoxifen in the first-line treatment of advanced breast cancer: evidence from metastatic subgroups and a test of functional ability

PURPOSE: The letrozole study 025 is a large (n = 907), international, double-blind, randomized, phase III trial in postmenopausal women with advanced breast cancer. This subanalysis compares the efficacies of letrozole and tamoxifen as first-line therapy in postmenopausual women with advanced breast cancer according to site of metastatic lesions and Karnofsky Performance Status (KPS). MATERIALS AND METHODS: Nine hundred seven patients with advanced breast cancer were randomly assigned to once-daily oral letrozole (2.5 mg; Femara; Novartis Pharma AG; Basel, Switzerland) or tamoxifen (20 mg; Tamofen; Leiras OY; Turku, Finland). Time to progression (TTP) was estimated using the Kaplan-Meier product-limit method. Treatments were compared by Cox proportional hazards regression models. RESULTS: Letrozole treatment significantly prolonged TTP in all subsets of patients: those with nonvisceral metastases, those with visceral metastases without liver involvement, and those with liver metastases. The reduction in risk of progression ranged from 25%, for patients with nonvisceral metastases, to 36%, for patients with liver metastases. The distributions of baseline KPS scores for both treatment groups were similar (57% had KPS scores >/=90). Time to worsening of 20 points or more in KPS score was significantly longer with letrozole than with tamoxifen, but modest numbers of patients experienced such deterioration (letrozole, 20%, tamoxifen, 22%, in patients without visceral metastases; 23%-24% in patients with liver metastases; and letrozole, 14%, tamoxifen, 30%, in patients with visceral metastases without liver involvement). CONCLUSION: These data demonstrate the consistent superiority of letrozole over tamoxifen and support the use of letrozole as a new standard of endocrine therapy in postmenopausal women with advanced breast cancer.     

Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group.

PURPOSE: The efficacy and tolerability of anastrozole (Arimidex; AstraZeneca, Wilmington, DE, and Macclesfield, United Kingdom) and tamoxifen were compared as first-line therapy for advanced breast cancer in 353 postmenopausal women. PATIENTS AND METHODS: The randomized, double-blind, multicenter study was designed to evaluate anastrozole 1 mg once daily relative to tamoxifen 20 mg once daily in patients with hormone receptor-positive tumors or tumors of unknown receptor status who were eligible for endocrine therapy. Primary end points were objective response (OR), defined as complete (CR) or partial (PR) response, time to progression (TTP), and tolerability. RESULTS: Anastrozole was as effective as tamoxifen in terms of OR (21% v 17% of patients, respectively), with clinical benefit (CR + PR + stabilization > or = 24 weeks) observed in 59% of patients on anastrozole and 46% on tamoxifen (two-sided P =.0098, retrospective analysis). Anastrozole had a significant advantage over tamoxifen in terms of TTP (median TTP of 11.1 and 5.6 months for anastrozole and tamoxifen, respectively; two-sided P =.005). The tamoxifen:anastrozole hazards ratio was 1.44 (lower one-sided 95% confidence limit, 1.16). Both treatments were well tolerated. However, thromboembolic events and vaginal bleeding were reported in fewer patients who received anastrozole compared with those who received tamoxifen (4.1% v 8.2% [thromboembolic events] and 1.2% v 3.8% [vaginal bleeding], respectively). CONCLUSION: Anastrozole satisfied the predefined criteria for equivalence to tamoxifen. Furthermore, we observed both a significant increase in TTP and a lower incidence of thromboembolic events and vaginal bleeding with anastrozole. These findings indicate that anastrozole should be considered as first-line therapy for postmenopausal women with advanced breast cancer.     

Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment.

PURPOSE: To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) and anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. PATIENTS AND METHODS: Patients (n = 451) with advanced breast cancer were randomized to receive fulvestrant 250 mg as a once-monthly (one x 5 mL) intramuscular injection or an oral dose of anastrozole 1 mg in this open, parallel-group, multicenter trial. The primary end point was time to progression (TTP). Secondary end points included objective response (OR) rates, defined as complete response (CR) or partial response (PR), duration of response (DOR), and tolerability. RESULTS: Patients were followed for a median period of 14.4 months. In terms of TTP, fulvestrant was as effective as anastrozole (hazard ratio, 0.98; confidence interval [CI], 0.80 to 1.21; P =.84). Median TTP was 5.5 months for fulvestrant and 5.1 months for anastrozole. OR rates showed a numerical advantage for fulvestrant (20.7%) over anastrozole (15.7%) (odds ratio, 1.38; CI, 0.84 to 2.29; P =.20). Clinical benefit rates (CR + PR + stable disease > or = 24 weeks) were 44.6% for fulvestrant and 45.0% for anastrozole. Median DOR was 14.3 months for fulvestrant and 14.0 months for anastrozole. Both treatments were well tolerated, with 3.2% and 1.3% of fulvestrant- and anastrozole-treated patients, respectively, withdrawn from treatment because of an adverse event. CONCLUSION: Fulvestrant was as effective as anastrozole. These data confirm that fulvestrant is an additional, effective, and well-tolerated treatment for advanced breast cancer in postmenopausal women whose disease progressed on prior endocrine therapy.     

A randomised study of CGS 16949A (fadrozole) versus tamoxifen in previously untreated postmenopausal patients with metastatic breast cancer

BACKGROUND:: Fadrozole, a potent, highly specific inhibitor of aromataseactivity, has only been used as second-line therapy in treatmentof post-menopausal women with advanced breast cancer. A prospectivelyrandomised study was therefore undertaken to compare relativeclinical efficacy of fadrozole as first-line treatment to thatof tarnoxifen. PATIENTS AND METHODS:: Eighty postmenopausal women who had not received prior treatmentfor advanced/metastatic breast cancer were randomised to receiveeither fadrozole, 1 mg twice daily, or tamoxifen, 20 mg daily. RESULTS:: Toxicity was not statistically different on the two treatmentarms. Only mild to moderate toxicity was documented: hot flashesin 37%, headaches in 6.5%, mild fatigue in 2.6%. There werealso no statistically significant differences in objective responserates, survival or time to treatment failure (TTF). Objectiveresponse rate on fadrozole was 50% (complete response (CR) 8.3%and partial response (PR) 42%). On tamoxifen objective responsewas 44.7% (CR 21% and PR 24%). Median TTF was 4.9 months onfadrozole and 5 months on tamoxifen. Median survival was 22.7months on fadrozole and 27.5 months on tamoxifen. CONCLUSION:: While response rates, survival and TTF were not statisticallysignificantly different, there were more complete responseson tamoxifen and duration of objective response (CR + PR) wassignificantly longer in the patients treated with tamoxifen. breast cancer, fadrozole, postmenopausal, tamoxifen