Quality of life after breast-conserving surgery.

Introduction

In early-stage breast cancer, the equivalence of mastectomy and breast-conserving surgery (BCS) with radiotherapy with respect to disease-free and overall survival is well established [1-3]. Therefore differences in quality of life (QoL) become of paramount importance in clinical decision-making [4].

Over the last two decades, a significant amount of research has been conducted in order to evaluate the impact of surgery for early-stage breast cancer on QoL, and despite initial optimism that preservation of the breast would dramatically improve outcomes for women with breast cancer [5], consistently beneficial findings have failed to materialise [6]. The reason for this is unclear. Many authors have argued that the diagnosis of a life-threatening disease overshadows other issues [5,7,8]; however, the nature and design of the studies used to evaluate these differences must also be considered [6,9-12] as they may equally explain these somewhat unexpected findings.

Here we review the literature, attempt to explain the many varied and often contradictory findings and finally suggest areas for further study, highlighting the learning points that can be drawn from existing data.

Surgery for early-stage breast cancer: a review

An abundance of studies have been conducted in an attempt to compare the effect of mastectomy, with or without reconstruction, versus BCS on QoL either as a primary or more frequently as a secondary outcome measure. A summary of the recent studies is given in Table 1. The findings are often inconsistent, and although the majority fail to demonstrate any consistent significant benefit of BCS in either the short [13-19] or long term [14], the results from most studies suggest some advantage with respect to body image [7,12,16,20-23]. BCS has long been advocated for young women on this basis and although considerable debate initially surrounded its value in the older population [14,24], BCS is now also regarded as the procedure of choice for this group [17,25,26]. Evidence regarding the influence of breast conservation on the fear of disease recurrence, however, remains equivocal [6].

On the basis of single studies alone, therefore, improved body image appears to be the only consistent advantage of breast conservation and the psychosocial significance of this finding has been questioned [5]. A meta-analysis [11] of 40 studies conducted between 1980 and 1995, however, demonstrated modest advantages for BCS over mastectomy in additional domains including improved psychological, marital-sexual and social well-being and cancer-related fears/concerns, although in keeping with the literature, there was no significant benefit in terms of global adjustment. Additional benefits of BCS have also been identified by more recent studies [26], including higher satisfaction with outcomes and reduced stress regarding appearance [10].

The lack of evidence to support the benefits of breast conservation is striking, and whereas, as many authors have proposed, it is the life-threatening diagnosis rather than its treatment that is the primary determinant of QoL, there are a number of methodological flaws in the existing research that may equally well explain these negative findings and that deserve further consideration.

Defining 'quality of life': a question of constructs

QoL is a multi-dimensional construct [27,28] with a number of divergent definitions [29-31], and no universal agreement regarding its meaning [9,30]. As QoL outcomes have become an integral part of clinical trials, however, a consensus definition of 'health-related' QoL (HRQoL) has emerged to refer to the 'physical, psychologic and social functioning of patients and the impact of the disease and treatment on their abilities and daily functioning' [32]. Global QoL, however, also potentially includes a variety of additional issues [31]. van der Steeg et al. [33] argued that 'health-related' QoL does not adequately reflect 'true' QoL, as HRQoL focuses only on individual limitations whereas 'true' QoL also ascertains how women are affected by these problems. In a review of 20 breast cancer QoL studies, it was concluded that none truly evaluated QoL and caution was urged in using the data in clinical decision-making. In addition, the majority of studies are not hypothesis driven which is of key methodological importance in QoL research [32].

QoL instruments: asking the right questions

In order to produce clinically meaningful QoL outcomes, the instrument used must be valid, reliable and sensitive to change in the population of interest [27]. The lack of a consistent definition of QoL and the lack of hypothesis-driven research characteristic of the majority of studies to date, however, has resulted in the use of QoL instruments that are potentially inappropriate for the breast cancer population and as such may have failed to detect any significant differences that indeed may exist in the BCS group.

Many studies [17,19,20,22,23] have used generic questionnaires such as short form (SF)-36 which are not cancer specific. Others have used cancer-specific questionnaires such as the European Organisation for the Research and Treatment of Cancer (EORTC) C30, Functional Assessment of Cancer Therapy--General (FACT G) or Functional Living Index--Cancer (FLIC) [10,12,13,16,21,24,26,29,34,35], which are able to detect generic cancer-related concerns, but fail to detect issues such as body image or sexual functioning which may be vitally important to the breast cancer population, and in particular may be important when assessing the potential benefits of BCS.

Many authors have identified this problem and highlighted the inadequacy of generic and general cancer-specific questionnaires in the breast cancer population [10,19,29,31,35]. To address this problem, a variety of study-specific questionnaires have been used [10,12,13,19,22,26,29,35,36] covering a range of potential areas of interest including body image, sexual issues, cosmesis and satisfaction. These have often revealed additional benefits of BCS over mastectomy [10,19,26,29]; however, such results should be interpreted with caution as these tools have often not been subject to thorough psychometric testing or validation. Potential benefits therefore may exist, but to date researchers have largely used the wrong tools and consequently asked the wrong questions to allow these to be consistently elucidated.

In addition to the above problems, there is a lack of consistency of instruments used. For example, in a review of 18 studies, Kiebert et al. [6] reported the use of 36 different QoL instruments, which severely limits the comparability of study results. This was an early review, but as Table 1 shows, the problem persists with more recent research despite the development and validation of two breast cancer-specific instruments, Functional Assessment of Cancer Therapy--Breast (FACT B) [37] and EORTC BR23 [38], with proven psychometric properties that include items addressing key breast cancer-specific concerns such as issues of body image, sexuality, adjuvant side effects and arm morbidity.

Study design

Many of the surgical studies also suffer as a result of sub-optimal study design and methodological inconsistencies. Ideally, in order to evaluate a change in QoL, a prospective longitudinal approach is required with QoL assessment at several time points including at baseline [27,33]. Several studies have used this prospective approach [10,12,14-18,20,26,34,39-41], but the majority [12,14,16-18,20,26,34] have omitted pre-operative baseline evaluation. Failure to include baseline measurements is a major flaw as it has been estimated that baseline scores may account for between 20% and 34% of variance seen in subsequent evaluation [41].

Retrospective and cross-sectional approaches have also been extensively used. The cross-sectional approach gives only a snapshot of QoL [6]. QoL measurement at one time point, however, is of little value because it is not clear how this isolated measure relates to previous or subsquent time points in the patient's journey. It is, therefore, of comparative value only. Many such studies have also included a small sample size or failed to report how patients were recruited [6,11]. Again, such a lack of consistency and methodological rigour across the studies limits the comparability and value of the results.

Patient selection

Several studies reported QoL as a secondary outcome measure in randomised controlled trials (RCTs) usually comparing the oncological benefits of BCS with mastectomy. This approach impacts the interpretation of the QoL findings on a number of levels.

Firstly, it is only ethical to include in RCTs women who express no preference regarding their surgical options. These 'undecided women' may differ intrinsically from women expressing a preference, who potentially actively participate in decision-making and may have different coping strategies and psychological profiles. Such selection bias precludes generalisation of outcomes from RCTs being applied to the population as a whole [36]. Fallowfield et al. [15], however, explored this further by investigating psychological outcome in women outside the trial setting who chose or were recommended BCS or mastectomy by their surgeon, and found the results comparable to those from RCTs [15]. A meta-analysis [11], conversely, did demonstrate some aspects of QoL that differed significantly between women who participated in an RCT and those in an observational study. Psychological adjustment was better for women undergoing BCS outside the trial setting, perhaps due to involvement in the decision-making process [8] that may have a positive impact on QoL [15,42]; however, social adjustment was superior when BCS was received as part of an RCT. This latter difference may be explained by the positive effects of the additional attention and support given to women participating in a trial, and these potential biases should be acknowledged [33].

Hence, although RCTs generally represent the most methodologically robust study design with high internal validity, the approach is flawed for QoL assessment, particularly when this is a secondary outcome measure. Observational studies incorporating patient choice, although influenced by a number of factors, most accurately reflect the 'real life' situation and thus have high external validity and produce generalisable findings [36]. Such methodological considerations should therefore be taken into account when interpreting the QoL outcomes of BCS as compared with mastectomy, particularly when QoL is a secondary outcome in an RCT.

Timing of evaluation

A further criticism of many of the QoL studies concerns the timing of QoL assessment. A large proportion of studies have considered only the acute phase of treatment, often up to a year [8,12,16-18,20,41]. It has been argued that during this time, adjustment to a cancer diagnosis and the effects of adjuvant therapy have over-riding effects on QoL [33]. Other studies, however, have looked at long-term outcomes with similar findings [14]. Timing is of particular importance in retrospective studies as 'time heals all wounds' [33] and women become more accepting of the outcomes of their surgery and the impact that this may have on their lives with time, so called 'response shift' [33]. Memory bias [6] may also occur. Timing of the QoL assessments, therefore, may additionally contribute to the negative findings seen in many studies.

Changes in surgical technique and outcomes

Much of the QoL data is also derived from what may now be regarded as an almost 'historical cohort' of women who would have received dramatically different treatment in a completely different environment from that which women experience today. In particular, women participating in early RCTs and studies may have been concerned that their procedure was experimental [14] and may have experienced poorer QoL as a result. The practice of radiotherapy has also dramatically evolved and improved over the last 20 years. Lumpectomy plus radiotherapy is now a well-established procedure with mastectomy offered much more as a last resort. The majority of women now receive lumpectomy, if oncologically possible, making it the therapeutic norm.

Surgical techniques for lumpectomy also will inevitably have improved over the last 20 years and the subsequent improvement in cosmetic outcomes may have impacted on QoL [43]. The infrastructure of breast cancer care and multi-disciplinary team-working has also evolved with better use of breast care nurses [25] and more support for women diagnosed with the disease. All these factors will invariably affect QoL outcomes and have all improved with time.

Conclusion

In summary, although the evidence suggests that BCS offers little advantage over mastectomy, the studies to date are methodologically flawed and surgical and oncological practice have both dramatically improved. As survival from breast cancer continues to increase, however, quality as well as quantity of life becomes of ever increasing importance.

QoL, however, is a highly subjective concept and if outcomes for women are to be optimised, a more holistic definition of QoL may be the key. Calman [44] defined QoL as 'the difference or gap at a particular period in time between the hopes and expectations of the person and his/her present life experiences' [28]. Individualised strategies to maximise satisfaction and outcomes for each woman with breast cancer should therefore be given careful consideration. Different aspects of QoL may be important at different life stages [35] to different women. Thus assessment of women's priorities, wishes and beliefs, active involvement in decision-making and truly informed consent in order to match experience with expectation will improve QoL outcomes and ensure that all women have the best possible result whatever their surgical approach.

References

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Shelley Potter and Zoe E Winters

Breast Reconstruction Quality of Life Group, Dept of Clinical Sciences at South Bristol, University of Bristol, Level 7, Bristol Royal Infirmary 

Correspondence to: Shelley Potter, Department of Clinical Sciences at South Bristol, Level 7, Bristol Royal Infirmary, Marlborough Street, Bristol BS2 8HW (email: [e-mail])

Table 1: Summary of studies evaluating the impact of
surgical treatment on quality of life in early-stage
breast cancer

Types of      Study design    n      Instruments      Timing of
surgery                              used             evaluation

BCS, Mx       Cross-          577    HADS, BIS,       3-203 months
and BR        sectional,             RSE Scale
              retrospective

BCS, Mx       Prospective     103    FACT-B           1 and 5
and BR                                                months after
                                                      surgery

BCS vs. Mx    Cross-          183    MHI, EORTC       6 months-5
              sectional,             C30              years
              retrospective

BCS vs. Mx    RCT             278    Study-specific   2 years
                                     10-item tool     (cross-
                                     (validity        sectional
                                     assessed)        analysis)

BCS vs. Mx    RCT             136    Study-specific   2 months and
>70 years     (Mx vs. BCS +          based on EORTC   12 months
              tamoxifen)             and HADS

BCS vs. Mx    Prospective     124    PSI              3 months,
                                                      18 months,
                                                      8 years

BCS vs. Mx    Prospective     990    EORTC C30 +      6 months after
                                     study-specific   surgery, then
                                     body image       annually for
                                     and cosmetic     5 years (no
                                     satisfaction     baseline)

BCS vs. Mx    Prospective     269    HADS, RSC,       Baseline, 2
                                     Spielberger      weeks, 3 and
                                     STAI,            12 months
                                     Interviews       after surgery

BCS vs. Mx    Prospective     563    SF-36,           3, 12 and 24
>67 years                            modified         months after
                                     CARES            surgery

BCS vs. Mx    Prospective     109    CARES, FLIC,     1, 4, 7 and
                                     KPS, POMS        13 months
                                                      after surgery

BCS vs. Mx    Prospective     691    Interviews,      3 months after
>65 years                            SF-36,           surgery and
                                     CARES-SF         two additional
                                                      occasions
                                                      within the
                                                      following year

BCS vs. Mx    Cross-          274    EORTC C30,       Mean interval
              sectional,             body image,      4.2 years
              retrospective          satisfaction
                                     with
                                     treatment,
                                     cosmesis fear
                                     of recurrence
                                     (validity
                                     assessed)

BCS vs. Mx    Matched         152    EORTC C30,       Median
              pairs, cross-          study-specific   interval
              sectional              questionnaire    46 months

BCS, Mx       Cross-          1357   EORTC C30 and    Mean
and BR        sectional,             BR23             interval
              retrospective                           2.5-2.8
                                                      years

BCS vs. Mx    Cross-          291    EORTC C30,       11-16 months
              sectional,             HADS,            (median
              retrospective          study-specific   12.2 months)
                                     questionnaire

BCS vs. Mx    Prospective     291    EORTC C30,       3 months
                                     HADS,            and 1 year
                                     study+specific
                                     questionnaire

BCS, Mx RCT   Prospective     93     POMS             3 days after
vs. patient                                           surgery, 3
choice                                                months after
                                                      surgery

BCS, Mx       Cross-          257    DAS-59, SF-36,   NS
and BR        sectional,             HADS, study-
              retrospective          specific items

BCS, Mx       Prospective     198    MUIS, POMS,      Baseline,
and BR                               FACT             1, 3, 6, 12,
                                                      18 and 24
                                                      months after
                                                      surgery

BCS vs. Mx    RCT             184    LASA, STAI,      Mean assessment
              Retrospective          semi-            time 31 months
              evaluation of          structured       (range 15-65
              QoL                    interview        months)

BCS vs. Mx    Prospective     63     POMS, study-     Baseline, 10
                                     specific         days, 3, 6
                                     questionnaire    and 12 months
                                     (modified        after surgery
                                     tools)

BCS, Mx, BR   Cross-          1957   SF-36, CES-D,    Approx 3 years
              sectional,             WSFQ, CARES
              retrospective

BCS vs. Mx    Prospective     161    EORTC C30,       Diagnosis, 3
                                     CAWAC            months and 12
                                                      months after
                                                      surgery

BCS vs. Mx    Prospective     227    CARES, KPS       1, 4, 7 and
                                                      13 months
                                                      after surgery

BCS vs. Mx    Cross-          78     SF-36            At least 12
              sectional,             Study-specific   months post
              retrospective          questionnaire    diagnosis

Types of      Design                                   Reference
surgery

BCS, Mx       BCS superior to BR superior to Mx in        [25]
and BR        terms of anxiety, depression, body
              image, sexuality and self-esteem

BCS, Mx       Similar QoL scores at 6 months.             [34]
and BR        Mx--worse body image, functional
              and physical well-being; BCS--worse
              emotional well-being and concern
              about effects of stress on illness

BCS vs. Mx    Women undergoing BCS experienced            [24]
              significantly greater psychological
              distress and marginally worse QoL
              than those undergoing Mx after
              40 months

BCS vs. Mx    BCS produces better body image and          [36]
              satisfaction with treatment. No
              differences in fear of recurrence

BCS vs. Mx    No significant differences, but better      [13]
>70 years     arm function in BCS group

BCS vs. Mx    Global QoL equivalent, distress             [14]
              dependent on age (younger patients
              much more distressed than older
              women)

BCS vs. Mx    Mx patients had significantly lower         [26]
              body image, role and sexual
              functioning and lifestyle disruption
              scores than BCS. Body image and life
              style scores in >70 year group still
              better after BCS. BCS better for all
              age groups

BCS vs. Mx    No significant differences.                 [15]
              Participation in RCT has no obviously
              detrimental effects

BCS vs. Mx    Better body image after BCS. Shared         [20]
>67 years     decision-making important for older
              women

BCS vs. Mx    No significant difference in QoL,           [16]
              mood disturbance or global
              adjustment. BCS resulted in better
              body image and fewer problems with
              clothing

BCS vs. Mx    Surgical modality has no impact after       [17]
>65 years     controlling for other factors

BCS vs. Mx    BCS resulted in better body image,          [29]
              more satisfaction with treatment,
              better cosmetic outcome. Increased
              fear of recurrence with BCS. Current
              QoL tools inadequate

BCS vs. Mx    No differences in EORTC C30, but            [10]
              BCS patients more satisfied with
              cosmetic appearance, change in
              appearance and have less stress
              regarding their appearance. Standard
              QoL instruments not adequate to
              detect differences

BCS, Mx       No differences with the exception of        [21]
and BR        body image

BCS vs. Mx    BCS patients report better body             [35]
              image but worse physical function.
              Negative impact worse for young
              women regardless of treatment

BCS vs. Mx    BCS patients better body image than         [12]
              Mx. Complex interaction between
              surgery, age and marital status

BCS, Mx RCT   Choice led to worse psychological           [39]
vs. patient   outcomes at 3 months
choice

BCS, Mx       No psychological advantages                 [22]
and BR        between treatment groups. Body
              image better after BR

BCS, Mx       Body image better following BCS and         [40]
and BR        BR than Mx. Greater mood
              disturbance following BCS than Mx
              (only significant at 12 months)

BCS vs. Mx    No benefit for BCS. Body image less         [7]
              impaired following BCS than Mx

BCS vs. Mx    No difference except better sexual          [8]
              adjustment in BCS group

BCS, Mx, BR   Body image and feelings of                  [23]
              attractiveness most positive after
              BCS. After 1 year, QoL more likely to
              be influenced by age and adjuvant
              therapy than surgery

BCS vs. Mx    BCS predictive of better physical           [41]
              functioning and body image 1 year
              after surgery

BCS vs. Mx    No differences between type of              [18]
              surgery and QoL

BCS vs. Mx    No significant differences except           [19]
              better vitality with BCS using SF-36.
              BCS had less impact on the way
              women dress, comfort with nudity
              and sex drive compared with Mx

BCS, breast-conserving surgery; BIS, body image scale;
BR, breast reconstruction; CARES, cancer rehabilitation
evaluation system; CAWAC, caring about women and cancer;
CES-D, Centre for Epidemiological Studies Depression
Scale; DAS-59, Derriford Appearance Scale; EORTC,
European Organisation of Research and Treatment of
Cancer; FACT, Functional Assessment of Cancer Therapy;
FACT-B, Functional Assessment of Cancer Therapy-Breast;
FLIC, Functional Living Index-Cancer; HADS, Hospital
Anxiety and Depression Scale; KPS, Karnofsky Performance
Status; LASA. Linear Analogue Self-assessment scale;
MHI, Mental Health Inventory; MUIS, Mischel Uncertainty
in Illness Scale; Mx, mastectomy; NS, not stated; POMS,
Profile of Mood State; PSI, Psychiatric Symptom Index;
QoL, quality of life; RCT, randomised controlled trial;
RSC, Rotterdam Symptom Checklist; RSE, Rosenberg Self-
Esteem Scale; STAI, State-trait Anxiety Index; SF,
short form; vs., versus; WSFQ, Watts Sexual Function
Questionnaire.