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Annals of Surgical Oncology 8:542-548 (2001)
© 2001 Society of Surgical Oncology

ORIGINAL ARTICLES

Quality of Life Influenced by Primary Surgical Treatment for Stage I-III Breast Cancer—Long-Term Follow-Up of a Matched-Pair Analysis

W. Janni, MD, D. Rjosk, MD, Th. Dimpfl, MD, K. Haertl, PhD, B. Strobl, MD, F. Hepp, MD, A. Hanke, F. Bergauer, MD and H. Sommer, MD, PhD

From the Department of Gynecology and Obstetrics, Women’s Clinic at Ludwig-Maximilians-University, Munich, Germany.

Correspondence: Address correspondence and reprint requests to: Wolfgang Janni, MD, Department of Gynecology and Obstetrics, Klinikum der Ludwig-Maximilians-Universitaet Muenchen, Maistrasse 11, 80337 Munich, Germany; Fax: 49-821-2090260; E-mail: janni{at}fk-i.med.uni-muenchen.de


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Background: Breast-conserving therapy has been demonstrated to be just as safe and a less disruptive experience compared with mastectomy for surgically manageable breast cancer. There is, however, no agreement in the literature about the impact of these procedures on several important aspects of quality of life (QOL). The purpose of the present study is to compare the long-term impact of these two surgical approaches on QOL in patients with identical tumor stages and to suggest possible shortcomings of the standard QOL questionnaires.

Method: Between August 1999 and May 2000, QOL questionnaires were answered by 152 pair-matched patients at the I. Frauenklinik, Ludwig-Maximilians University Munich, as part of routine follow-up examinations. The pairs of patients, each consisting of one patient after mastectomy and one after breast conservation, were selected according to the highest degree of equivalence in tumor stage. All patients had been initially treated for stage I-III breast cancer without evidence of distant metastases. The QOL was evaluated by using the QLQ-C30 questionnaire version 2.0 of the EORTC Study Group on Quality of Life. We formulated seven additional questions about the patients’ satisfaction with the primary surgical treatment modality as viewed from their current perspective. The QOL questionnaires were answered after a median interval of 46 months following primary treatment.

Results: Tumor stage, prognostic factors, and adjuvant systemic treatment were well balanced between the two groups. No differences between the two groups were observed in terms of all QOL items measured by the QLQ-C30. Our additional questions, however, revealed that patients in the mastectomy group were less satisfied with the cosmetic result of their primary operation (P < .0001), were more likely to feel basic changes in their appearance (P < .0001), and were more likely to be emotionally stressed by these facts (P < .0001). From their perspective at the time of completing the questionnaires, 11 patients in the mastectomy group (15%) would decide differently about the surgical treatment modality, compared with only 3 patients (4%) in the breast conservation group (P = .025).

Conclusion: While the primary surgical treatment modality seems to have no long-term impact on general QOL, certain body-image-related problems may be caused by mastectomy. Standard measuring instruments for QOL may fail to detect differences in satisfaction and adaptation with the primary surgical treatment modality.

Key Words: Breast neoplasm • Quality of life (QOL) • Mastectomy • Breast conservation


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Breast-conserving treatment (BCT) has been established as standard treatment for most cases with surgically manageable breast cancer. Several prospective, randomized controlled trials have uniformly reported similar rates of distant disease-free survival and overall survival after long-term follow-up.7,16,20,33,37,39 The risk for local recurrence, once the major concern in BCT, is now well controlled by breast irradiation.15 Therefore, breast conservation is widely favored because, based on the emotional attachment to this organ,5 it is seen as less mutilating than mastectomy.23

Viewpoints about the impact of the primary surgical treatment modality (i.e., breast conservation versus mastectomy) on the quality of life (QOL) are divergent. While some studies emphasize that breast conservation helps to maintain the patients’ body image9–11 and sexual functioning,21,30others fail to demonstrate a difference in QOL in general.17,30 Furthermore, patients are more likely to fear recurrence and to experience postoperative chronic pain after breast conservation.13,25,36 Most data indicate that the procedures do not lead to differences in overall emotional adjustment.4,32,35

The purpose of the present study was to evaluate the impact of the primary surgical treatment modality on long-term QOL. The EORTC QLQ-C30 questionnaire, as well as seven additional items, were used to question the patients’ current adaptation to surgical treatment. We examined 152 matched-paired patients with primary breast cancer in identical tumor stages at a median interval of 46 months after primary treatment.


   PATIENTS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
Patients
Between August 1999 and May 2000, QOL questionnaires were answered by 152 pair-matched patients at the I. Frauenklinik, Ludwig-Maximilians University Munich, as part of routine follow-up examinations. The 76 pairs of patients, each pair consisting of one patient after mastectomy and one after breast conservation, were selected according to the highest degree of equivalence in the following hierarchical, sequential order: surgical therapy, number of lymph node metastases, tumor size at time of primary diagnosis, and age. The time difference between dates of primary therapy of both patients in a pair had to be <5 years. Each parameter was required to have a P value > .10 to achieve intergroup homogeneity.

Eligible patients were required to have previously undergone primary surgical therapy at our hospital at the time of primary diagnosis of stage I-III breast cancer. The patients were also required to be without any evidence for recurrence of the disease at the time of follow-up examination. The tumor stage at primary diagnosis was classified according to the UICC TNM (tumor, node, metastasis) classification.34

Primary Treatment
The primary surgical treatment consisted of either breast conservation (n = 76) or modified radical mastectomy (n = 76), leading to R0 resection in all reported cases. Routine axillary dissection included lymph nodes of levels I and II, while those of level III were excised only in cases with macroscopic metastatic involvement of the lower levels. For the diagnosis of lymph node metastasis, single embedded lymph nodes were screened at up to three levels. Breast reconstruction was not available at the study site and was not offered to the patients. Telecobalt radiotherapy was administered to all 76 patients treated with breast conservation. Chest wall irradiation following mastectomy was performed in 20 patients (26%) with large tumors of extensive lymphangiosis carcinomatosa. According to local policies, all premenopausal patients with axillary lymph node metastases received adjuvant chemotherapy (n = 46). Postmenopausal patients with positive hormone receptor status (n = 32) received adjuvant endocrine therapy with tamoxifen (20 mg/d). In the 25 patients with 1 to 3 involved axillary lymph nodes, cytotoxic therapy consisted of 6 cycles of CMF – cyclophosphamide (600 mg/m2 body-surface area), methotrexate (40 mg/m2), and 5-fluoruracil (600 mg/m2) – every 21 days. In 21 cases with >=4 regional lymph nodes, 4 sequential courses of EC – epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) – followed by 3 courses of CMF, were given in some cases, while other patients received 6 courses of DE – epirubicin (90 mg/m2) and docetaxel (75 mg/m2). No systemic adjuvant therapy was given to 76 node-negative patients.

QOL Questionnaire
The QOL was evaluated by using the QLQ-C30 questionnaire Version 2.0 of the EORTC Study Group on Quality of Life.2 The questionnaire is composed of scales that evaluate physical function, role function, emotional function, cognitive function, and social function, as well as physical health status, global QOL, and general health/QOL. Higher mean scores on these scales represent better functioning and QOL. Three symptom scales measure nausea and vomiting, pain, and fatigue. Six single items assess financial impact and physical symptoms of dyspnea, sleep disturbance, appetite, diarrhea, and constipation. Higher mean values on the symptom scales and single items mean more symptomatology.

In addition to the EORTC QLQ-C30 questionnaire, seven supplementary items were appended to examine specific aspects concerning the impact of the primary surgical treatment. Patients were asked: (1) to rate the cosmetic result of the operation from 1 (dreadful) to 7 (excellent); (2) whether a substantial change of the physical appearance was caused by the surgery (answered on a 4-point scale); (3) whether the physical appearance caused any emotional stress; (4) whether everyday life was still impaired by the primary treatment; (5) whether the patient regretted her choice of surgical treatment; (6) to what extent the patient was in fear of recurrent disease; and (7) whether a different choice of surgical treatment option would have been made in hindsight (answered yes or no).

Statistical Analysis
In accordance with The EORTC QLQ-C30 Scoring Manual,14 questionnaire items were encapsulated in scales of the categories: Global Health Status, Functional Scales, and Symptom Scales. Those questionnaire items that were appended to examine additional aspects concerning the primary surgical treatment were evaluated statistically by analogy to the symptom scales. The raw score (RS) was calculated as the mean of the component items according to the formula: RS = (Item1 [I1] + I2 + ... + In)/n. For the functional scales, the linear transformation score (TS) was calculated by applying the formula: S = {1-[(RS - 1)/range]} x 100. The range was the difference between the maximum and the minimum possible value of TS. For the symptom scales, global health status, and appended questionnaire items, the following formula was used: TS = {(RS - 1)/range} x 100.

Data quality was controlled by re-examining original data files. To compare categorical variables, we used the {chi}2 test or Fisher’s exact test as appropriate according to the number of cases. The two-tailed t-test and the Whitney U test were used to calculate the differences of the mean of the linear transformed scales. P values < .05 were considered significant. As suggested by Cella et al.,8,12,18 the clinical relevance of potential differences in QOL was additionally examined by calculating the effect size (ES) using the following formula: ES = {(mean value of test score in the breast conservation group) - (mean value of test score of the mastectomy group)}/(standard deviation of the mastectomy group). The Statistical Package for the Social Sciences® 10.0 software package (SPSS Inc., Chicago, IL) was used for all calculations.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Patients’ Characteristics
Seventy-six pairs, each pair consisting of one patient after breast-conserving surgery and one patient after mastectomy, were created by matched-pair analysis to make the major prognostic factors comparable in both groups. The QOL questionnaires were answered at a median interval of 46 months (3.8 years) after primary treatment. Table 1 depicts no statistically significant difference between the two groups in terms of age (P = .14, {chi}2 test), tumor size (P = 1.0), or lymph node status (P = 1.0). No statistical correlation was observed between the primary surgical treatment and the presence of positive estrogen receptor status (P = .10), menopausal status (P = .62), or histopathological tumor grading (P = .91). However, nuclear grading was not determined in 65 patients. Therefore, this parameter could not be evaluated with sufficient validity and was not used for survival analyses. All women in the breast conservation group received radiotherapy compared with 26% (P < .001, {chi}2 test) in the mastectomy group. No difference relating to adjuvant endocrine therapy (P = .43) or chemotherapy (P = .46) was detected between the two groups.


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  		TABLE 1. Clinical characteristics of the patients at time of primary diagnosis
 
QOL as Measured by EORTC Quality of Life QLQ-C30
Table 2 compares the linearly transformed mean values with Student’s t-test. It shows no statistically significant differences in QOL as measured by the QLQ-C30. The global health status (P = .74) and QOL in general (P = .92) were identical in both groups. All P values in the functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning) and in the symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) were above .10 and, therefore, showed no clear trend between the groups. The symptom scale with the lowest P value was the dyspnea scale, which showed close to a trend for less dyspnea (QOL score, 27.2) in patients after mastectomy compared with patients after BCT (QOL score, 18.9; P = .11).


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  		TABLE 2. Quality of life according to EORTC quality of life QLQ-C30: Comparison of mean values by BCT and mastectomy
 
To increase the validity of the evaluation, all items were reexamined with the nonparametrical Mann-Whitney U test. The results in Fig. 1 again show no statistically significant difference for any item between the two groups. The symptom scale yielding the lowest P value was again the dyspnea scale (P = .081), while the social functioning scale showed a trend toward increased social functioning for patients in the BCT group (P = .072). The effect score (ES), calculated to estimate the clinical significance of potential differences between the two groups, correlated well with the Pvalues of Student’s t test and Mann-Whitney U test. No clinically significant differences (>=.30) were detected between the two groups in any of the QLQ-C30 items.



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  		FIG. 1. Quality of Life according to EORTC Quality of Life QLQ-C30: Comparison of Mann-Whitney’s Average Rank by BCT and Mastectomy.

 
Additional Aspects of QOL
The items that were added to the QLQ-C30 to evaluate certain surgery-related aspects revealed both similarities and differences between the two groups. Table 3 and Figure 2 summarize these additional aspects of QOL. They show that patients reported with equal frequency an impairment of everyday life caused by the primary treatment (P = .10, Student’s t-test; P = .08, Mann-Whitney U test; respectively). Fear of recurrence was also equally frequent in both groups (P = .18 in both tests). There was no statistical difference on whether or not the patient regretted her choice of primary surgical treatment (BCT vs. mastectomy) according to Student’s t-test (P = .12). However, the ES (.23) showed a higher degree of resentment among patients in the mastectomy group according to the Mann-Whitney U test (P = .027). All tests demonstrated a highly statistically significant difference between the groups for the four remaining additional aspects items. Patients in the mastectomy group were significantly less satisfied with the cosmetic result of their operation (P < .0001; ES, .30). They were twice as likely to feel that their physical appearance had critically changed (P < .0001; ES, .63). Furthermore, patients in the mastectomy group were twice as likely to feel emotional stress, thought to be caused by the surgical treatment modality, in personal interactions (P < .0001, ES, .54). From their perspective at the time of completing the questionnaire, 11 patients in the mastectomy group (15%) would have decided differently about the surgical treatment modality, while only 3 patients (4%) in the breast conservation group (P = .025; ES, .30) would have decided differently.


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  		TABLE 3. Additional aspects of quality of life: Comparison of mean values by BCT and mastectomy
 


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  		FIG. 2. Additional aspects of Quality of Life: Comparison of Mann-Whitney’s Average Rank by BCT and Mastectomy.

 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
In line with previous publications,17,30 the standardized QOL questionnaire used in this study (EORTC QLQ-C30) failed to demonstrate a difference in the global long-term QOL between patients free of recurrence after receiving BCT or mastectomy. However, our data also suggest that more than 3 years after presentation with breast cancer, the primary surgical treatment modality still strongly influences the patients’ lives. This is demonstrated by a greater dissatisfaction with body image and a higher degree of emotional stress caused by the physical appearance of patients who were treated by mastectomy. It is particularly noteworthy that more than three times as many patients would decide differently about their surgical treatment modality in the mastectomy group than would patients in the breast conservation group, if told that the treatments were equivalent.

Patient characteristics, including primary tumor stage and adjuvant systemic treatment, were well balanced between the two groups. Therefore, a similar baseline QOL may be assumed and the patient groups may be regarded to be qualified for comparison. Patients in the mastectomy group were slightly, but not significantly, older. This might be thought to cause a bias toward an age-related decrease in QOL in this group.19 Younger patients, by contrast, usually manifest greater QOL disruptions by cancer treatment than older patients.40 Compared with QLQ-C30 measures in a sample of the general population without cancer disease,19 the patients in our study had similar global QOL values. This might be explained by the relatively long disease-free interval of our patients. The patients in our study, however, were noteworthy for clearly lower scores in the emotional functioning scale than the general population, and they were more likely to report symptoms of fatigue and insomnia. This contrast with noncancer patients is true for both groups in our study and does not, therefore, seem to be associated with the primary surgical treatment.

This is the first study that used the EORTC QLQ-C30 questionnaire to directly compare QOL between patients after breast conservation or mastectomy. The validity of this questionnaire has previously been well established,31 and it is widely used to assess the impact of various treatments on the QOL of cancer patients. Because of the role the breast plays in women’s body image, we particularly expected differences between the two groups in the scales for emotional functioning, role functioning, and social functioning. However, in line with previous studies,4,13,21,27,32 no such differences were detected. To date, no meta analysis of published data on this issue has been performed, but it has been consistently reported that, with conventional QOL scales, no major differences can be expected. Our data suggest that this also holds true for the EORTC QLQ-C30 questionnaire.

There has been much disagreement about the impact of primary surgical treatment on long-term QOL in cancer patients. No study has yet demonstrated significant differences in global QOL or performance status between patients treated with mastectomy or BCT.17,22,30 However, a series of studies reported a higher degree of impairment of body image in patients after mastectomy.9–11,17,21,29 Quality of sex life has been reported to be increased among patients after breast conservation in some studies,21,30 while this was negated in another large longitudinal study.28 Some studies indicate that patients after breast conservation are more likely to experience fear of recurrence,13,25 while others found no difference in this respect.9 One study even found patients in the mastectomy group to be more apprehensive about this fear.21

This conflicting picture of results may be explained by two major methodological differences used in the studies. First, the measuring instruments and scoring systems used in the studies differ widely. While the EORTC QLQ-C30 questionnaire1 and the FACIT questionnaire24 are the two most widely used measurement systems for QOL in clinical studies at present, they were not used in the quoted studies. Instead, a variety of less standardized and less validated tools, such as the Visual Analogue Scale,36 the Meyerowitz framework,10,11 the Functional Living Index-Cancer,17 the Profile of Mood Status,30 and many others, as well as many self-constructed questionnaires, were used. The variety of measurement instruments makes it difficult to compare the studies and predisposes for methodology-related discrepancies that might be clinically irrelevant. Second, QOL is a multidimensional concept which includes several components, such as symptom status, physical and emotional role, and cognitive, sexual, and social functioning.26 Different measurement instruments include different components and, therefore, may or may not detect differences in certain aspects of QOL. Sexual functioning, for example, is not included as a scale in the QLQ-C30 questionnaire. A difference between the groups in this respect will, therefore, necessarily be missed. The same holds true about the patients’ body image and its impact on daily life.

The results of our study confirm that there are some undeniable advantages in BCT for patients, even several years after the primary diagnosis. Our patients’ satisfaction with the surgical treatment was higher, and the stress associated with physical appearance was lower, with the conservative surgical approach. This result was not, however, detected by the standard questionnaire QLQ-C30. The result was detected by the additional items that we added to the survey. This is a remarkable discrepancy between the two instruments. The results generated by the additional aspects items should be interpreted with great caution, since there is no broad validation for them, and it is possible that these results will not be reproduced by further studies. Yet these results, consistent with the results of previous studies that also conflict with the results obtained by the standard questionnaires, support the hypothesis that current standard QOL questionnaires do not cover all pertinent aspects of QOL. This seems particularly likely with respect to surgical treatment choices. We, therefore, conclude that the lack of statistical detection of differences between two cancer treatment modalities by standard questionnaires does not necessarily rule out clinically relevant differences. Because QOL becomes increasingly important as a secondary end point for cancer treatment besides survival,3,6,38 current measurement instruments should be reevaluated critically on a regular basis. To derive clinically relevant conclusions from comparative studies, it appears imperative for these instruments to cover all therapy-related aspects of QOL. While the results of this study might be difficult to apply in clinical practice, they should, however, alert breast surgeons to the necessity of a clear dialogue with the patient and the family, who have to decide between breast conservation and mastectomy.


   Acknowledgments
 
The authors thank David and Sally Gray for their helpful editorial support. This study was supported by a grant from the Friedrich-Baur Stiftung, Muenchen, Germany.

Received for publication December 7, 2000. Accepted for publication February 16, 2001.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 

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K. Hartl, W. Janni, R. Kastner, H. Sommer, B. Strobl, B. Rack, and M. Stauber
Impact of medical and demographic factors on long-term quality of life and body image of breast cancer patients
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The Collaborative Ocular Melanoma Study-Quality of
Development and Validation of Disease-Specific Measures for Choroidal Melanoma: COMS-QOLS Report No. 2
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