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Meta-Analysis
. 2012 Jul 11;2012(7):CD008926.
doi: 10.1002/14651858.CD008926.pub2.

Toremifene versus tamoxifen for advanced breast cancer

Chen Mao  1 , Zu-Yao Yang, Ben-Fu He, Shan Liu, Jun-Hua Zhou, Rong-Cheng Luo, Qing Chen, Jin Ling Tang
Affiliations
Meta-Analysis

Toremifene versus tamoxifen for advanced breast cancer

Chen Mao et al. Cochrane Database Syst Rev. .

Abstract

Background: Toremifene (TOR) and tamoxifen (TAM) can both be used as treatments for advanced breast cancer.

Objectives: To compare the efficacy and safety of TOR with TAM in patients with advanced breast cancer.

Search methods: The Cochrane Breast Cancer Group's Specialised Register was searched (1 July 2011) using the codes for "toremifene", "fareston", "tamoxifen, "nolvadex, and "breast cancer". We also searched MEDLINE (via PubMed) (from inception to 1 July 2011), EMBASE (via Ovid) (from inception to 1 July 2011), The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 7, 2011), and the WHO International Clinical Trials Registry Platform search portal (1 July 2011). In addition, we screened the reference lists of relevant trials or reviews.

Selection criteria: Randomised controlled trials (RCTs) that compared the efficacy and safety, or both of TOR with TAM in women with advanced breast cancer. Trials that provided sufficient data on one of the following items: objective response rate (ORR), time to progression (TTP), overall survival (OS), and adverse events, were considered eligible for inclusion.

Data collection and analysis: Studies were assessed for eligibility and quality. Two review authors independently extracted the following details: first author, publication year, country, years of follow-up, treatment arms, intention-to-treat (ITT) population size, menopausal status of patients, hormone receptor status, response criteria, efficacy and safety outcomes of TOR and TAM arms. Hazard ratios (HR) were derived for time-to-event outcomes, where possible, and response and adverse events were analysed as dichotomous variables. We used a fixed-effect model for meta-analysis unless there was significant between-study heterogeneity.

Main results: A total of 2061 patients from seven RCTs were included for final analysis, with 1226 patients in the TOR group and 835 patients in the TAM group. The ORR for the TOR group was 25.8% (316/1226) whereas, the ORR for the TAM group was 26.9% (225/835). The pooled risk ratio (RR) suggested that the ORRs were not statistically different between the two groups (RR 1.02, 95% confidence interval (CI) 0.88 to 1.18, P = 0.83). The median TTP was 6.1 months for the TOR group and 5.8 months for the TAM group. The median OS was 27.8 months for the TOR group and 27.6 months for the TAM group. There were no significant differences in TTP and OS between the two therapeutic groups (for TTP: HR 1.08, 95% CI 0.94 to 1.24; for OS: HR 1.02, 95% CI 0.86 to 1.20). The frequencies of most adverse events were also similar in the two groups, while headache seemed to occur less in the TOR group than in the TAM group (RR 0.14, 95% CI 0.03 to 0.74, P = 0.02). There was no significant heterogeneity between studies in most of the above meta-analyses. Sensitivity analysis did not alter the results.

Authors' conclusions: TOR and TAM are equally effective and the safety profile of the former is at least not worse than the latter in the first-line treatment of patients with advanced breast cancer. Thus, TOR may serve as a reasonable alternative to TAM when anti-oestrogens are applicable but TAM is not the preferred choice for some reason.

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Conflict of interest statement

None to declare.

Figures

1
1
Study flow diagram
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 Toremifene (TOR) vs tamoxifen (TAM), outcome: 1.5 Objective response.
4
4
Funnel plot of comparison: 1 Toremifene (TOR) vs tamoxifen (TAM), outcome: 1.5 Objective response.
5
5
Forest plot of comparison: 1 Toremifene (TOR) vs tamoxifen (TAM), outcome: 1.6 Time to progression.
6
6
Forest plot of comparison: 1 Toremifene (TOR) vs tamoxifen (TAM), outcome: 1.7 Overall survival.
1.1
1.1. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 1: Complete response
1.2
1.2. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 2: Partial response
1.3
1.3. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 3: Stable disease
1.4
1.4. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 4: Progressive disease
1.5
1.5. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 5: Objective response
1.6
1.6. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 6: Time to progression
1.7
1.7. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 7: Overall survival
1.8
1.8. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 8: Nausea
1.9
1.9. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 9: Voice changes
1.10
1.10. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 10: Vaginal discharge
1.11
1.11. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 11: Vaginal bleeding
1.12
1.12. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 12: Hot flushes
1.13
1.13. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 13: Vomiting
1.14
1.14. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 14: Headache
1.15
1.15. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 15: Thromboembolic events
1.16
1.16. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 16: Cardiac events
1.17
1.17. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 17: Vaginal dryness
1.18
1.18. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 18: Ocular disorders
1.19
1.19. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 19: Endometrial cancer
1.20
1.20. Analysis
Comparison 1: Toremifene (TOR) vs tamoxifen (TAM), Outcome 20: Sweating
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