Evaluating the current evidence to support therapeutic mammoplasty or breast-conserving surgery as an alternative to mastectomy in the treatment of multifocal and multicentric breast cancers.

The oncological safety of treating multiple ipsilateral breast cancers (MIBCs) with types of breast conserving surgery (BCS) compared to mastectomy remains uncertain. This is predicated on the absence of any randomised controlled trials or high-quality protocol defined prospective cohort studies. A single recently published systematic review by the first author, reports its summarised results in this review. Fundamentally the important question is the evaluation of clinical safety following BCS compared to mastectomy for treating MIBC, which is reported in only six studies. Consequently, current evidence doesn't support the latest St Gallen consensus suggesting the possibility of using BCS to treat all MIBC. There is minimal comparative outcomes data on multicentric (MC) cancers compared to multifocal (MF) cancers comparing BCS or mastectomy. There is also poor evidence of clinical outcomes following therapeutic mammoplasty (TM) for MIBC compared to mastectomy. The potential recommendation of two potential radiotherapy boosts to separate lumpectomy sites following BCS for MC cancers remains a novel treatment concept whose feasibility will be evaluated in the forthcoming NIHR funded randomised feasibility trial called MIAMI. This is a world first attempt to assess the feasibility of a randomised trial design alongside the on-going Alliance registry study (ACOSOG, American College of Surgeons Oncology Group Z11102) in the USA, in which there is no comparative evaluation of mastectomy outcomes. The MIAMI trial aims to assess the clinical safety of multiple lumpectomies combined with TM compared to the standard of mastectomy in MIBC stratified by MF or MC cancers. There is limited evidence on the impacts of inter-tumoral heterogeneity relating to breast cancer subtypes in relation to individualised treatments and recommendations for types of breast surgery. Recent studies have highlighted the potential contributions of stromal epigenetic changes that are currently poorly understood regarding their contributions to either clinical unifocal or MF cancers.

A systematic review of the clinical evidence to guide treatment recommendations in breast reconstruction based on patient- reported outcome measures and health-related quality of life.

BACKGROUND: Advances in breast cancer diagnosis and management have produced significant improvements in disease-free and breast cancer related survival. Consequently, there is increasing focus on the quality of long-term cancer survivorship. Of the 44,000 women diagnosed annually in the United Kingdom, 30% to 40% are required to undergo mastectomy. During the past 30 years, significant technical advances in breast reconstruction have increased performance of this surgical practice as a means to potentially improve health-related quality of life (HRQoL) for breast cancer survivors. Breast reconstruction studies increasingly aim to assess more discriminating outcomes based on the patients' own perception of the surgical result and its effect on HRQoL. This incremental output in HRQoL evaluation is being fuelled by both healthcare providers and official bodies such as the Food and Drug Administration, together with demands for more comprehensive comparative effectiveness data to permit fully informed consent by patients. METHODS: In this systematic review, the authors apply inclusion and exclusion criteria to effectively screen 1012 abstracts identified in the field of HRQoL in breast reconstruction between 1978 and 2009. Each study was evaluated with respect to its design and statistical methodology. Each was reviewed with a recommended standard checklist of methodological requirements as described by Efficace et al (J Clin Oncol. 2003;21:3502-3511). RESULTS: A total of 34 papers that included HRQL outcomes in breast reconstruction were identified and reviewed in detail. The majority of studies were retrospective in nature with significant inherent limitations. Specifically, they were compromised by potentially biased patient recall. Most of these studies lacked both an a priori outcome of interest and statistical rigor jeopardizing estimations of potential effect size. In addition, more than 90% of the studies failed to report or describe missing data. Thirteen studies provided level I (n = 2) and II (n = 11) evidence. While these studies benefited from more robust design, the majority used generic instruments such as 36-item short form (SF-36), which may not be sufficiently sensitive to measure changes consequent to breast reconstruction (ie, effect on body image or psychosocial well-being). Furthermore, these studies were generally underpowered to detect meaningful clinical difference or to permit subgroup analyses. Further limitations included reliance on single center design that may negatively impact generalizability and deficiencies in reporting the number and types of surgical complications, which potentially has an effect on HRQoL outcomes. CONCLUSIONS: This systematic review reveals tendency for sound scientific methodology in HRQoL to be undermined by poorly designed and underpowered studies. In the current healthcare environment, patients and providers increasingly seek meaningful data to guide clinical decisions; policy makers are similarly in need of a rigorous patient-centered, comparative effectiveness data to inform national level decision-making. In light of this and the limitations of the existing published data, there is a pressing need for further Level I and II evidence in the form of randomized controlled trials as well as well-designed, multicenter prospective longitudinal studies in breast reconstruction. Such studies should incorporate sensitive and condition-specific patient-report outcome measures, provide adequate sample sizes, and respect established guidelines for rigorous HRQoL methodology.

A prospective longitudinal study of cosmetic outcome in immediate latissimus dorsi breast reconstruction and the influence of radiotherapy.

BACKGROUND: Immediate breast reconstruction may result in superior cosmetic outcomes as a result of the preservation of the skin envelope. The impact of implant use and radiotherapy (RT) on the cosmetic outcome of latissimus dorsi (LD) breast reconstruction, however, has never been prospectively evaluated with adequate long-term follow-up. METHODS: Women undergoing immediate LD breast reconstruction from January 2000 to February 2007 underwent photographic assessment and clinical evaluation for breast retraction analysis (BRA) at 3, 6 and 12 months postoperatively and on the anniversary of their surgery. The resulting photographs were subject to panel cosmetic assessment. A patient-reported cosmetic outcome questionnaire and the body image scale (BIS) were administered to each woman at a single time point to coincide with the anniversary of their surgery. Multilevel linear regression modelling was used to analyse the results. RESULTS: Seventy-three women underwent 53 implant-assisted LD breast reconstructions and 20 autologous procedures with a mean follow-up of 2.71 years. The incidence of radiotherapy in this cohort was 43%. RT over time adversely influenced overall cosmetic outcome as assessed by the panel (P = 0.0002), and BRA (P = 0.033), both of which were significantly worse in the implant-assisted group (P = 0.020). Patient reporting of overall cosmetic outcome and BIS, however, did not differ significantly between the LD groups or following RT. CONCLUSION: Radiotherapy may adversely affect the cosmetic outcome of latissimus dorsi breast reconstruction, particularly if an implant is used, but this is not universal. Patient assessment of their cosmetic outcome may, however, differ significantly from the clinician's view.