Sequential Tamoxifen and Aminoglutethimide Versus Tamoxifen Alone in the Adjuvant Treatment of Postmenopausal Breast Cancer Patients: Results of an Italian Cooperative Study

Boccardo, Francesco; Rubagotti, Alessandra; Amoroso, Domenico; Mesiti, M.; Romeo, D; Caroti, C.; Farris, A.; Cruciani, Giorgio; Villa, E.; Schieppati, G.; Mustacchi, Giorgio

doi:10.1200/jco.2001.19.22.4209

Cited by 82 publications

(41 citation statements)

References 22 publications

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“…12 In the latest Italian study, cardiac toxicity was reported as cardiovascular disease; whereas, in the previous Italian trial, it was reported as cardiovascular events. 5,25 In the Intergroup Exemestane Study trial, events were defined as cardiovascular events (ie, ischemic cardiac; such as myocardial infarction and angina) plus other cardiac events, whereas only myocardial infarction was reported in the pooled analysis of ABCSG8 and ARNO. 10,13,26 Because of these and other differences across RCTs, any conclusion should be interpreted with caution.…”

Section: Discussionmentioning

confidence: 99%

“…8,9,11,12,26 Two trials were designed with the up-front strategy (11,108 patients), 8,9 and 5 trials were designed with the early switch strategy (8974 patients). 5,6,10,11,13,25,26 The median follow-up ranged from 28 months to 68 months. Trial characteristics are listed in Table 1.…”

Section: Selected Trialsmentioning

confidence: 99%

“…Seven trials (19,818 patients) were identified that were eligible for inclusion in this analysis 5,6,8,[10][11][12][13]15,25 ( Fig. 1).…”

Section: Selected Trialsmentioning

confidence: 99%

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Do adjuvant aromatase inhibitors increase the cardiovascular risk in postmenopausal women with early breast cancer

Cuppone

Bria

Verma

et al. 2007

Cancer

114

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BACKGROUND.Despite the advantages from using aromatase inhibitors (AIs) compared with tamoxifen for early breast cancer, an unexpectedly greater number of grade 3 and 4 cardiovascular events (CVAE) (as defined by National Cancer Institute of Canada‐Common Toxicity Criteria [version 2.0] was demonstrated.METHODS.Phase 3 randomized clinical trials (RCTs) comparing AI with tamoxifen in early breast cancer were considered eligible for this review. The event‐based risk ratios (RRs) with 95% confidence intervals (95% CIs) were derived, and a test of heterogeneity was applied. Finally, absolute differences (ADs) in event rates and the number of patients needed to harm 1 patient (NNH) were determined.RESULTS.Seven eligible RCTs (19,818 patients) reported CVAE results. When considering all RCTs, the AD of the primary endpoint (CVAE) between the 2 arms (0.52%), tamoxifen versus AI, was statistically significant (RR, 1.31; 95% CI, 1.07–1.60; P = .007). This translated into an NNH value of 189 patients; when only third‐generation AIs were considered, the difference (0.57%) remained significant (RR, 1.34; 95% CI, 1.09–1.63; P = .0038). Thromboembolic events were significantly more frequent in the tamoxifen arm, regardless of the strategy adopted (RR, 0.53; 95% CI, 0.42–0.65; P < .0001), without significant heterogeneity (P = .21). An AD of 1.17% and an NNH value of 85 patients were observed.CONCLUSIONS.According to the results from this meta‐analysis, the risk of grade 3 and 4 CVAEs in patients who were receiving AIs was higher compared with the risk in patients who were receiving tamoxifen, and the difference reached statistical significance. However, the AD was relatively low, and from 160 to 180 patients had to be treated to produce 1 event. Cancer 2008. © 2007 American Cancer Society.

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Section: Discussionmentioning

confidence: 99%

Section: Selected Trialsmentioning

confidence: 99%

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Do adjuvant aromatase inhibitors increase the cardiovascular risk in postmenopausal women with early breast cancer

Cuppone

Bria

Verma

et al. 2007

Cancer

114

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“…El estudio GROCTA 4B 23 , consistente en cirugía±RT±QT, seguido de tamoxifen 2-3 años, randomizado a tamoxifen 2-3 años frente a anastrozol 2-3 años. El número de pacientes incluidos ha sido de 448, con un seguimiento medio de 36 meses, recaída locorregional 13% en brazo tamoxifen frente a 2% en anastrozol, metástasis a distancia 19% frente a 10% y aparición de segundo primario, 10% frente a 5%.…”

Section: Ensayo Ibcsg VIIIunclassified

Tratamiento hormonal del cáncer de mama

Herruzo¹

2004

Oncología (Barc.)

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“…The benefit in mortality, favoring the switching strategy, was demonstrated by the first mature analysis of the former of the 2 studies performed by us in this framework. 14 The latter trial adopted the same design with anastrozole (ANA), a more potent aromatase inhibitor, in place of aminoglutethimide (AG). The preliminary analysis of this study showed a significant difference between groups in relation to both event-free and recurrence-free survival in favor of the women who switched to ANA.…”

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confidence: 99%

Switching to an aromatase inhibitor provides mortality benefit in early breast carcinoma

Boccardo¹,

Rubagotti²,

Aldrighetti

et al. 2007

Cancer

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BACKGROUNDThe superiority of new generation aromatase inhibitors over tamoxifen in the adjuvant treatment of early breast carcinoma has emerged from several randomized trials. However, until now not all previous studies have shown a mortality benefit.METHODSA pooled analysis of 2 prospective multicentric trials, sharing the same study design and nearly identical inclusion criteria, was performed. In both trials, women treated previously with tamoxifen for 2 or 3 years were randomly assigned to either continuing tamoxifen for an additional 2 or 3 years or to having their treatment switched to aminoglutethimide or anastrozole for a comparable time period. Mortality was analyzed according to allocated treatment and other patient and tumor variables.RESULTSIn all, 828 postmenopausal women, mostly with estrogen receptor (ER)‐positive and node‐positive tumors who had been monitored for a median time of 78 months (range, 6–141 months) were analyzed. Of these women, 415 were randomly selected to continue tamoxifen and 413 switched to aminoglutethimide or anastrozole. All‐cause mortality and breast cancer‐specific mortality were significantly improved by the switch: all‐cause mortality: hazard ratio (HR) = 0.61 (0.42–0.88) P = .007; breast cancer‐specific mortality: HR = 0.61 (0.39–0.94) P = .025. No increase was recorded in breast cancer‐unrelated mortality in women after switching. Multivariate analysis showed that patient age, tumor size, allocated treatment, and nodal status, in that order, were independent mortality predictors.CONCLUSIONSSwitching to an aromatase inhibitor after 2 or 3 years of tamoxifen therapy significantly improves survival compared with continuing 2 or 3 years of additional tamoxifen treatment. Cancer 2007. © 2007 American Cancer Society.

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Sequential Tamoxifen and Aminoglutethimide Versus Tamoxifen Alone in the Adjuvant Treatment of Postmenopausal Breast Cancer Patients: Results of an Italian Cooperative Study

Cited by 82 publications

References 22 publications

Do adjuvant aromatase inhibitors increase the cardiovascular risk in postmenopausal women with early breast cancer

Do adjuvant aromatase inhibitors increase the cardiovascular risk in postmenopausal women with early breast cancer

Tratamiento hormonal del cáncer de mama

Switching to an aromatase inhibitor provides mortality benefit in early breast carcinoma

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