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Annals of Oncology Advance Access published online on January 10, 2008
Annals of Oncology, doi:10.1093/annonc/mdm573
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© 2008 European Society for Medical Oncology. For Permissions, please email: journals.permissions@oxfordjournals.org

review

Breast conservation therapy for stage I or stage II breast cancer: a meta-analysis of randomized controlled trials

S. H. Yang1,3, K. H. Yang1,*, Y. P. Li2, Y. C. Zhang3, X. D. He3, A. L. Song3, J. H. Tian1, L. Jiang1, Z. G. Bai1, L. F. He1, Y. L. Liu1 and B. Ma1

1 Evidence Based Medicine Center of Lanzhou University, Lanzhou City, Gansu Province
2 Chinese Cochrane Center, Chengdu, Sichuan
3 Department of General Surgery, Lanzhou University Second Hospital, Lanzhou City, Gansu Province, China

* Correspondence to: Prof. K. H. Yang, Evidence Based Medicine Center of Lanzhou University, Donggang West Road No. 199, Chengguan District, Lanzhou City 730030, Gansu Province, China. Tel: +86-931-8915076; Fax: +86-931-8915076; E-mail: kehuyangebm2006{at}126.com


   Abstract
Top
 Abstract
introduction
 methods
 results
 discussion
 Acknowledgements
 References
 
Background: We carried out a meta-analysis to determine the effectiveness of breast conservation therapy (BCT) or mastectomy (MT) for stage I or stage II breast cancer.

Methods: A fully recursive literature search was conducted in the Cochrane Controlled Trials Register Databases, Medline, EMBASE and Chinese Biomedical Literature Database in any language. Randomized controlled trials (RCTs) were considered for inclusion. Analyses were carried out using RevMan software.

Results: In all, 18 RCTs including a total of 9388 patients were included. The meta-analysis showed that the overall survival in 3, 5, 10, 15 and 20 years and the locoregional recurrence rate in 3, 5, 15 and 20 years were not statistically significantly different between group BCT and group MT, but 10-year locoregional recurrence rate increased in group BCT. The sensitivity analysis indicated that both overall survival and locoregional recurrence rate were not statistically significant difference between group BCT and group MT. In the subgroup analysis, there was no significant difference in OS and locoregional recurrence rate between group BCT and group MT, but 20-year locoregional recurrence rate was statistically significantly higher in group BCT than group MT for women with tumors 2 cm or smaller.

Conclusion: BCT was better choice than MT for women with stage I or stage II breast cancer.

breast conservation therapy, breast neoplasms, mastectomy, meta-analysis, randomized controlled trials


   introduction
Top
 Abstract
 introduction
methods
 results
 discussion
 Acknowledgements
 References
 
Although breast cancer continues to be the most common malignant tumor among women, it is a highly treatable disease [1]. Mastectomy (MT) (radical MT or modified radical MT) was the treatment of choice for breast cancer of any size or type, regardless of the patient's age, for 80 years [2]. Scientific efforts, however, have been focused on the improvement of quality of life of these women. At present, it is well accepted that breast conservation therapy (BCT) (localized surgery with or without radiation) is equivalent to MT in terms of survival for early-stage breast cancer. Some randomized controlled trials (RCTs) have been published comparing these two treatment modalities [3–9]. In most trials, no significant differences were found in overall survival (OS) and disease-free survival between the two treatment options.

A meta-analysis, which was published in 1995, found no differences in OS at 10 years. But there existed some limitations, such as some new large sample trials were not included and the overview was based largely on patients with tumors 2 cm or smaller. So the evidence for the efficacy of BCT in patients with larger tumors after long-term follow-up remained limited [10].

Local or regional recurrence represents the main disadvantage of BCT. Some RCTs reported that BCT was associated with higher rates of positive margins and the incidence of local failure than MT [5, 8, 11–14].

Therefore, it is necessary to carry out a meta-analysis of the evidence on outcomes for MT or BCT for stage I or stage II breast cancer from randomized sources. In this study, we reviewed the published literatures and carried out a meta-analysis aimed to help surgeons in choosing a better approach for the management of individual women with stage I or stage II breast cancer.


   methods
Top
 Abstract
 introduction
 methods
results
 discussion
 Acknowledgements
 References
 
literature search
A fully recursive literature search to January 2007 was conducted in the Cochrane Controlled Trials Register Databases, Medline, EMBASE and Chinese Biomedical Literature Database for relevant articles published in any language. We used the following Medical Subject Heading terms and/or text words: ‘breast neoplasm’,‘breast cancer’, ‘breast carcinoma’, ‘mastectomy’, ‘modified radical mastectomy’, ‘radical mastectomy’, ‘breast conserving therapy’, ‘breast-conserving surgery’, ‘breast conservation’, ‘breast-sparing surgery’ combined with ‘randomized controlled trials’, ‘randomized controlled trial’ and ‘random allocation’. In addition, colleagues in the field of oncology were contacted and asked to provide details of clinical trials. Meeting abstracts were searched in the Information Sciences Institute Proceedings database (1990–2007). Two investigators (SHY and JHT) conducted the search independently and they also evaluated study quality using Cochrane recommendations [15]. Disagreement was solved by discussion with others.

inclusion and exclusion criteria
We considered RCTs. Studies with MT versus BCT were considered for inclusion if they reported survival or recurrence rate. Studies without raw data available for retrieval and a clearly defined type of dissection were excluded. Women with early (stage I or II) breast cancer undergoing MT or BCT who did not have history of prior cancer and evidence of metastatic disease were included.

data analysis and statistical methods
Meta-analyses were carried out by using Review Manager software (RevMan, version 4.2.10) provided by the Cochrane Collaboration [16]. There was no statistically significant heterogeneity in this analysis, so fixed effect model was used. If the results of trials had heterogeneity, random effects model was used for meta-analysis. Statistical heterogeneity between studies was evaluated with the chi-square test and the I2 statistic [17]. Potential causes of heterogeneity were explored by carrying out sensitivity and subgroup analyses. The odds ratio (OR) was calculated for dichotomous data with 95% confidence intervals (CIs) for all analyses [15, 18]. P values that were <0.05 were considered statistically significant.


   results
Top
 Abstract
 introduction
 methods
 results
discussion
 Acknowledgements
 References
 
study description
In all, 18 RCTs including a total of 9388 patients, of whom 5359 were allocated to BCT (group BCT) and 4038 for MT (group MT) were included. The characteristics of the 18 included studies are summarized in the Table 1 and Table 2.


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  		Table 1. Characteristics of included RCTs

 

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  		Table 2. Methodological quality of included RCTs

 
primary analysis
1. Three-year OS (nine studies) [5, 19, 21, 22, 24, 25, 30, 31, 33]: 92.8% (1975 of 2129 patients in group BCT) compared with 94.4% (1419 of 1503 patients in group MT); OR (fixed effect model) 0.84, 95% CI (0.63–1.12), P = 0.24, there was no statistically significant difference between group BCT and group MT (Table 3).
2. Five-year OS (12 studies) [4, 5, 8, 19, 21, 24, 25, 28–30, 33, 35]: 82.6% (2726 of 3300 patients in group BCT) compared with 83.5% (2492 of 2985 patients in group MT); OR (fixed effect model) 0.97, 95% CI (0.84–1.11), P = 0.64, there was no statistically significant difference between group BCT and group MT (Table 3).
3. Ten-year OS (eight studies) [5, 8, 12, 19, 21, 27, 34, 35]: 69.7% (2085 of 2992 patients in group BCT) compared with 69.3% (2014 of 2906 patients in group MT); OR (fixed effect model) 1.09, 95% CI (0.97–1.23), P = 0.16, there was no statistically significant difference between group BCT and group MT (Table 3).
4 Fifteen-year OS (six studies) [6, 5, 8, 12, 21, 26]: 56.2% (1447 of 2576 patients in group BCT) compared with 58.6% (1107 of 1888 patients in Group MT); OR (random effects model) 0.90, 95% CI (0.80–1.02), P = 0.10, there was no statistically significant difference between group BCT and group MT (Table 3).
5. Twenty-year OS (five studies) [5, 6, 12, 21, 26]: 44.1% (938 of 2128 patients in group BCT) compared with 45.0% (661 of 1468 patients in group MT); OR (random effects model) 1.09, 95% CI (0.95–1.25), P = 0.23, there was no statistically significant difference between group BCT and group MT (Table 3).
6. Three-year locoregional recurrence rate (five studies) [21, 22, 24, 31, 32]: 3.2% (59 of 1860 patients in group BCT) compared with 1.9% (12 of 631 patients in group MT); OR (random effects model) 1.52, 95% CI (0.40–5.69), P = 0.54, there was no statistically significant difference between group BCT and group MT (Table 3).
7. Five-year survival locoregional recurrence rate (10 studies) [4, 5, 8, 20, 21, 24, 28–30, 33]: 7.4% (305 of 4111 patients in group BCT) compared with 7.1% (151 of 2137 patients in group MT); OR (random effects model) 1.19, 95% CI (0.77–1.85), P = 0.44, there was no statistically significant difference between group BCT and group MT (Table 3).
8. Ten-year locoregional recurrence rate (eight studies) [5, 8, 12, 19, 21, 25, 26, 35]: 10.4% (385 of 3691 patients in group BCT) compared with 8.0% (218 of 2736 patients in group MT); OR (random effects model) 1.55, 95% CI (1.05–2.30), P = 0.03, there was statistically significant difference between group BCT and group MT (Table 3).
9. Fifteen-year locoregional recurrence rate (two studies) [12, 21]: 7.1% (78 of 1094 patients in group BCT) compared with 3.6% (16 of 440 patients in group MT); OR (random effects model) 1.59, 95% CI (0.84–2.98), P = 0.15, there was no statistically significant difference between group BCT and group MT (Table 3).
10. Twenty-year locoregional recurrence rate (four studies) [5, 6, 12, 21]: 11.6% (288 of 2477 patients in group BCT) compared with 10.1% (115 of 1144 patients in group MT); OR (random effects model) 1.89, 95% CI (0.48–7.50), P = 0.37, there was no statistically significant difference between group BCT and group MT (Table 3).


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  		Table 3. Primary analysis

 
sensitivity analyses
The sensitivity analysis showed that the overall survival in 3, 5, 10, 15 and 20 years and the locoregional recurrence rate in 3, 5, 10, 15 and 20 years were not statistically significantly different between group BCT and group MT after we excluded two trials [26, 29] in which the patients did not accept radiation therapy in group BCT (Table 4).


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  		Table 4. Sensitivity analyses

 
subgroup analyses
The subgroup analysis showed that the overall survival in 3, 5, 10, 15 and 20 years and the locoregional recurrence rate in 3, 5, 10 and 20 years were not statistically significantly different between group BCT and group MT for patients with tumors up to 5 cm in diameter (Table 5). Also the overall survival in 3, 5, 10, 15 and 20 years and the locoregional recurrence rate in 3, 5, 10 and 20 years were not statistically significantly different between group BCT and group MT for patients with tumors 2 cm or smaller. But 20-year locoregional recurrence rate was statistically significantly higher in group BCT than group MT (Table 6).


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  		Table 5. Subgroup analyses for patients with tumors up to 5 cm in diameter

 

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  		Table 6. Subgroup analyses for patients with tumors up to 2 cm in diameter

 

   discussion
Top
 Abstract
 introduction
 methods
 results
 discussion
Acknowledgements
 References
 
Effective breast-conserving surgical techniques for early-stage disease were developed to improve breast cancer women's quality of life. BCT may offer an advantage over MT in terms of body image, psychological and social adjustment [36], but BCT may be associated with higher rates of positive margins than MT and the incidence of local failure [11–14].

The meta-analysis showed that the overall survival in 3, 5, 10, 15 and 20 years and the locoregional recurrence rate in 3, 5, 15 and 20 years were not statistically significantly different between group BCT and group MT, but 10-year locoregional recurrence rate increased in group BCT than group MT. When we excluded two studies in which the patients in group BCT did not accept radiation therapy in a sensitivity analysis, group BCT was equivalent to group MT in terms of OS and locoregional recurrence rate. In the subgroup analysis, 20-year locoregional recurrence rate was statistically significantly higher in group BCT than group MT for women with tumors 2 cm or smaller. It may be influenced by some factors such as radiation-induced second malignant solid cancers [37, 38]. Thus, the results of the sensitivity analysis and subgroup analysis supported the conclusions of the primary analysis.

Our analysis showed that both group BCT and group MT 15-year locoregional recurrence rate was lower than 10-year locoregional recurrence rate because the included studies on the basis of patients with tumors 2 cm or smaller for identifying 15-year locoregional recurrence rate.

These conclusions from this meta-analysis of RCTs may have several limitations as follows:

1. Computerized searching is essential for identifying clinical trials. It is, however, possible that not all the relevant studies be identified from computerized searching. Communication with the authors of clinical trials was not very productive, as the responses were not only small in number but also in uncertainties.
2. Survival data at 15 and 20 years of follow-up were lacking in several trials, which may lead to a biased estimate in favor of BCT.
3. Among articles cited in the present study, some authors referred to adopted BCT as quadrantectomy plus axillary dissection, while others adopted tumourectomy plus axillary dissection, which may slightly sway the reliable conclusion.
4. The methodological quality of several included RCTs was only moderate or poor (Table 2).
5. There may be a publication bias in favor of new surgical techniques.
6. The small sample size of some included RCTs may not allow for a reliable conclusion.

Some studies recommend that post-MT radiation therapy was considered as part of standard care for all women at high risk. Adjuvant radiation therapy was statistically significantly associated with improved survival for up to 10 years [39–41] and reduced locoregional recurrence [41] among women with operable breast cancer. Thus, it is necessary that localized surgery was followed by radiation therapy for stage I or stage II breast cancer. Our meta-analysis also showed that 10-year locoregional recurrence rate, in patients without radiation therapy, was increased in group BCT.

In conclusion, the results of this meta-analysis revealed that BCT was equivalent to MT in terms of OS for women with stage I or stage II breast cancer and localized surgery followed by radiation therapy did not increase the risk of locoregional recurrence rate. It, however, needs to be interpreted with caution because the outcome of these meta-analyses on the basis of summary data derived from the literature may be influenced by a series of bias.


   Acknowledgements
Top
 Abstract
 introduction
 methods
 results
 discussion
 Acknowledgements
References
 
We thank Jianjun Wu (Gansu Traditional Chinese Medicine College, Lanzhou, Gansu) for secretarial support. We also thank Jiye Peng (Library of Lanzhou University) for entering database. In particular, we thank Tanxiang Wu (Chinese Cochrane Center) for the conduct of the Methodology.

Received for publication August 23, 2007. Revision received November 18, 2007. Accepted for publication November 27, 2007.


   References
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 Abstract
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 References
 
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