Quality of life of breast cancer patients with lymphedema

Quality of life of breast cancer patients with lymphedema

SCIENTIFIC PAPERS Quality of Life of Breast Cancer Patients with Lymphedema Vic Velanovich, MD, Wanda Szymanski, RN, BSN, Detroit, Michigan BACKGROU...

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SCIENTIFIC PAPERS

Quality of Life of Breast Cancer Patients with Lymphedema Vic Velanovich, MD, Wanda Szymanski, RN, BSN, Detroit, Michigan

BACKGROUND: Quality of life has increasingly become an important issue in breast cancer treatment. One of the impetuses for sentinel lymph node biopsy or selective axillary lymph node dissection (ALND) is the assumed decreased incidence of lymphedema compared with standard ALND. This is based on the assumption that ALND is associated with a clinically significant incidence of lymphedema and that this lymphedema decreases the quality of life of these patients. However, few data exist on this issue. This study attempts to define the incidence and effect on quality of life of postoperative lymphedema in breast cancer patients. METHODS: To determine the incidence of postoperative lymphedema, the Breast Cancer Registry at Henry Ford Hospital was accessed to obtain information on all patients who underwent ALND in the management of breast cancer over a 7-year period. The registry is a prospectively gathered data base to include the development of various complications, such as lymphedema. To determine the effects of lymphedema on quality of life, 101 consecutive, unselected patients who underwent breast surgery were asked to complete the SF-36, a generic quality of life instrument. The SF-36 measures eight domains of quality of life. Patients were then divided into three groups: (1) breast surgery without ALND (-ALND), (2) breast surgery with ALND but no lymphedema (-LE), and (3) breast surgery with ALND and lymphedema (1LE). RESULTS: In all, 827 patients with ALND were identified in the registry. Of these, 8.3% developed clinically apparent lymphedema. Patients in -ALND and -LE groups had similar scores in all domains of the SF-36. However, patients in the 1LE group had significantly lower scores in the domains of role-emotional and bodily pain. A significantly higher percentage of patients in the 1LE group had scores below one standard devi-

From the Division of General Surgery, Department of Surgery, Henry Ford Hospital, Detroit, Michigan. Presented in part at the Surgical Forum of the 83rd Annual Clinical Congress of the American College of Surgeons, Chicago, Illinois, October 15, 1997. Requests for reprints should be addressed to Vic Velanovich, MD, Division of General Surgery, K-8, Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, Michigan 48202-2689. Manuscript submitted August 10, 1998, and accepted in revised form November 25, 1998.

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ation compared with national norms in the domains of bodily pain (P 5 0.005), mental health (P 5 0.01), and general health (P 5 0.04). CONCLUSIONS: Although postoperative lymphedema occurs in a minority of patients, when it does occur it can produce demonstrable diminutions in quality of life. Therefore, efforts to reduce the incidence of lymphedema, such as sentinel lymph node biopsy or selective ALND, would benefit breast cancer patients. Am J Surg. 1999;177:184 –188. © 1999 by Excerpta Medica, Inc.

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he quality of life of breast cancer patients has been an area of increasingly active research. Topics of study have included the emotional, social, psychological, and sexual effects of breast cancer treatment.1– 4 For example, patients treated with breast conservation retain a better body image than those treated with mastectomy.5 Of the patients treated with mastectomy, those who undergo immediate reconstruction seem also to retain a better body image.6 It also has been shown that breast cancer treatments themselves can alter quality of life.7 The standard surgical therapy for breast cancer includes axillary lymph node dissection (ALND). However, recently a debate has started on the routine use of ALND in all women treated for breast cancer.8 This is because ALND is not a benign procedure. Complication rates of 2% to 40% have been reported.9 One of the most grievous of these complications is arm lymphedema. In fact, it is in order to avoid these complications that sentinel lymph node biopsy10 or selective ALND11,12 have been advocated. The argument to eliminate standard ALND rests on the assertion that lymphedema, among other reasons, is a frequent and debilitating problem. However, few objective, patient-derived data exist on the subject. The purpose of this study was to determine the frequency of clinically apparent lymphedema, and its effects on the quality of life of breast cancer patients.

METHODS AND MATERIALS Determining the Frequency of Lymphedema The Department of Surgery at Henry Ford Hospital maintains a Breast Cancer Registry of all patients diagnosed with breast cancer. All data are prospectively entered into the Registry upon first consultation and then at each follow-up. Data collected include demographic data, pertinent family and medical history, all surgical procedures, pathology, all treatments, and early postoperative and late complications. Shoulder dysfunction, arm lymphedema, and arm, shoulder, and chest wall pain are all tracked. These complications are included in the Registry when 0002-9610/99/$–see front matter PII S0002-9610(99)00008-2

QUALITY OF LIFE OF BREAST CANCER PATIENTS WITH LYMPHEDEMA/VELANOVICH AND SZYMANSKI

they become clinically apparent; that is, when the patient complains of these problems or the surgeon notes them on the physical examination. The Registry was accessed to obtain information on all patient treated with ALND over the 7-year period from 1990 to 1996, inclusive. Data obtained included the total number of patients undergoing ALND and the number of these patients who had lymphedema documented. Comparing Quality of Life of with and without Lymphedema Patients with breast disease who had undergone some type of breast surgery followed up by one of the authors (VV) were evaluated for the effects of breast surgery with and without lymphedema on quality of life. All patients are consecutive patients seen in the first author’s practice without selection bias. These breast operations included excisional biopsies/lumpectomies, simple mastectomies, modified radical mastectomies, or lumpectomy with ALND. All patients were at least 6 months from the time of their operation, with a range of evaluation from 6 months to 4 years following surgery. No patients were undergoing any other type of breast cancer therapy. Patients were divided into three groups: (1) patients who underwent breast surgery (ie, biopsy, lumpectomy or mastectomy) without ALND (-ALND); (2) patients who underwent ALND but had no clinical evidence of lymphedema (-LE); and (3) patients who underwent ALND and had clinically apparent lymphedema (1LE). Patients were considered to have lymphedema if either the mid-humerus or mid-radius circumference of the operated side was at least 1 cm larger than the uninvolved side. All measurements were done by the primary author. In addition, information was obtained on the patient’s age, type of procedure, number of lymph nodes harvested, differences in mid-humerus and mid-radius circumference between the affected and unaffected arms, and pathology. Quality of life was determined using the SF-36, a welltested, generic health status instrument developed by the Medical Outcomes Trust and in wide use in a variety of fields. Moreover, the SF-36 has been chosen by the National Adjuvant Surgical Breast and Bowel Project (NSABP) as the quality of life instrument in their breast cancer prevention trial.13 The SF-36 measures eight domains of quality of life: physical functioning (PF), rolephysical (RP), role-emotional (RE), bodily pain (BP), vitality (VT), mental health (MH), social functioning (SF), and general health (GH). All scores are standardized so that the worst possible score is 0 and the best possible score is 100 (ie, the optimal level of health in that domain). Each domain is scored separately. There is no “grand total” quality of life score. The Medical Outcomes Trust has published national norms with percentiles and standard deviations for each domain of the SF-36.14 Each patient was asked to complete the SF-36 while in the clinic. Therefore, there was 100% compliance with the questionnaire. Patients were not influenced by any of the clinic personnel with regard to their answers. The questionnaire was scored by one of the authors (VV). Statistical Analysis Statistical analysis was done using the True Epistat15 statistical computer program. Data were initially analyzed to determine if they followed a normal distribution using

the Wilk-Shapiro test. These data were found not to follow a normal distribution; therefore, they were further analyzed nonparametrically using the Mann-Whitney U test, the Kruskal-Wallis analysis of variance, and the NewmanKuell test for multiple medians. Data for the quality of life scores are presented as medians with ranges. Data for the frequency of quality of life scores below one standard deviation from the national norms were analyzed using the chi-square test with Yates’s continuity correction. Linear regression analysis was done to correlate the number of lymph nodes excised to the extent of lymphedema and to quality of life scores. A P value of 0.05 was considered statistically significant.

RESULTS Frequency of Post-ALND Lymphedema A total of 827 patients with breast cancer were identified as undergoing ALND as part of their treatment. In all of these patients, the ALND was done either simultaneously with lumpectomy or mastectomy, or subsequently after biopsy. In 68 patients (8.3%), clinically apparent lymphedema developed sometime during the course of their followup. Demographics of Quality of Life Study Group A total of 101 patients were studied. The -ALND group consisted of 45 patients, with an average age of 55.2 6 13.8 years. The -LE group consisted of 45 patients, with an average age of 62.8 6 12.7 years. The 1LE group consisted of 11 patients, with an average age of 59.1 6 11.7 years. There was no statistically significant difference in the average age among these groups. The average number of lymph nodes harvested in the -LE group was 16 6 8, compared with 22 6 8 in the 1LE group (no statistically significant difference). Of the patients with lymphedema, linear regression analysis determined that the slope of the regression was not statistically significant. In addition, the correlations between the number of lymph nodes removed and the difference in mid-humerus or mid-radius circumference was weak (r ,0.2). Quality of Life Comparisons among -ALND, -LE, and 1LE Groups Figure 1 presents the median scores of all domains of the SF-36 for each group of patients. There was a statistically significant difference among all medians for the role-emotional domain, and statistical significance was approached (P 5 0.08) in the bodily pain domain. More importantly, when comparing difference between medians using the Newman-Kuell test, the scores in the role-emotional and bodily pain domain for patients with LE were statistically significantly lower than for the other two groups; that is, there was impaired quality of life in these domains for the 1LE group. However, in all groups the ranges of scores were wide; therefore, in order to better assess the frequency of patients with significant impairments, we analyzed the number of patients below one standard deviation of the national norm for each domain, as published by the Medical Outcomes Trust14 (Figure 2). This reflects the percentage of patients with severe impairments of quality of life scores. There were statistically significantly higher percentages of patients below one standard deviation of the national norms

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Figure 1. A. Median scores of the SF-36 comparing -ALND, -LE, and 1LE groups for physical functioning (PF), role-physical (RP), role-emotional (RE), and bodily pain (BP).*Over the 1LE median for the RE and BP domain identified that these medians are statistically significantly lower than the medians for the -ALND and -LE groups by the Newman-Kuell test. B. Median scores of the SF-36 comparing -ALND, -LE, and 1LE groups for vitality (VT), mental health (MH), social functioning (SF), and general health (GH). The P value under each domain is the result of the Kruskal-Wallis analysis of variance comparing all medians.

Figure 2. A. The percentage of patients below one standard deviation of national norms in each domain for -ALND, -LE, and 1LE groups for physical functioning (PF), role-physical (RP), role-emotional (RE), and bodily pain (BP). B. The percentage of patients below one standard deviation of national norms in each domain for -ALND, -LE, and 1LE groups for vitality (VT), mental health (MH), social functioning (SF), and general health (GH). The P value under each domain is the result of the chi-square test with Yate’s correction.

in the domains of bodily pain (P 5 0.005), mental health (P 5 0.01), and general health (P 5 0.04) in the 1LE group. Although the percentage was also higher in this sample in the role-emotional domain, this did not reach statistical significance. Linear regression analysis also determined that there were no correlations between the number of lymph nodes removed in the ALND and any of the SF-36 domains.

COMMENTS In the modern treatment of breast cancer, the quality of life of survivors is as almost an important an issue as survival. Recently, a plethora of studies has been published on this subject. Many have identified significant impairments in emotional, psychological, social, sexual, and physical well being. For example, Ganz et al4 identified frequent problems associated with physical and recreational activities, body image, sexual interest, sexual function, and problems with dating for those who are single. Longman et al16 found that depression in breast cancer patients plays a negative role in overall quality of life. Clearly these are issues that, although not affecting survival, profoundly affect how survivors live. Quality of life outcomes have also served as endpoints in studies of treatments. For example, Wapnir et al17 demon186

strated superior quality of life in patients undergoing breast conservation versus those treated with mastectomy. Poulsen et al5 also showed that body image was less impaired with breast conservation. Hann et al18 report, using the SF-36, that breast cancer patients undergoing bone marrow transplantation had significantly impaired physical functioning, physical role functioning, general health, vitality, social functioning, and role-emotional functioning. Another recent study demonstrated that high-dose chemotherapy produces more severe cognitive impairment than standard dose chemotherapy.19 On the other hand, Dow et al20 have shown that in long-term breast cancer survivors, that although significant impairments in quality of life existed, many patients reported positive outcomes in the areas of hopefulness, having a life purpose, and having a positive change after treatment. What these studies clearly demonstrate is that breast cancer treatments have an important impact on quality of life and this impact cannot be ignored. One of the ways breast cancer treatment affects quality of life is postlymphadenectomy lymphedema. In fact, the impetus to use selective ALND12 or to assessed lymph node involvement using sentinel lymph node biopsy21 instead of complete ALND is to avoid lymphedema, among its other

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side effects. Fortunately, the incidence of lymphedema has decreased as operations have become less radical. Of patients undergoing radical mastectomy, 40% suffered from lymphedema, compared with 15% of patients undergoing modified radical mastectomy and 3% of patients treated with lumpectomy and ALND.9 In this report, the overall incidence for both modified radical mastectomy and lumpectomy with ALND is 8.3%. Even though it is generally accepted that more extensive dissection leads to an increased incidence of lymphedema, we did not find a significant difference in the number of lymph nodes removed in patients who developed lymphedema and those who did not (22 versus 16, P 5 not significant). This lack of difference could have been due to too few patients studied, that is, a beta-error. Therefore, depending on the mix of procedures performed, the incidence of lymphedema will be between 5% and 15% for the typical breast cancer practice. Nevertheless, this study demonstrates that when lymphedema occurs, it can be a debilitating problem. When compared with patients who did not undergo ALND, patients whose treatment include ALND but did not develop lymphedema had similar quality of life scores in all domains (Figure 1); in addition, these groups had similar frequencies of patients below 1 standard deviation of the national norms (Figure 2). This implies that ALND by itself does not significantly impair quality of life. On the other hand, patients who developed lymphedema had statistically significant lower median scores (ie, more quality of life impairments) in the domains of bodily pain and role-emotional. Even though many patients with lymphedema appeared to function well, a statistically higher percentage had quality of life scores below 1 standard deviation of the national norm in the domains of bodily pain, mental health, and general health (Figure 2). This suggests that for a significant proportion of patients, lymphedema can be physically and emotionally disabling. Only two other studies of lymphedema were identified in the literature. Carter22 found that most women with lymphedema were able to continue living normal lives; however, some women experienced depression, anxiety, and impairments related to their intimate, work, and social relationships. Mirolo et al23 found lymphedema-related quality of life was improvement with an intensive physical therapy and selfmanagement regimen. These studies support our conclusions. Therefore, lymphedema can produce significant impairments in the quality of life in breast cancer patients. In conclusion, lymphedema is an uncommon, but potentially significant problem in breast cancer patients treated with ALND. These data support the argument to avoid ALND in patients with a very low probability of lymph node metastases or in whom knowledge of the lymph node status would not alter additional therapies. Although data with respect to complications of sentinel lymph node biopsy are lacking, it is generally assumed that the incidence of complications, especially lymphedema, would be negligible when compared with standard ALND. Therefore, further studies and refinements of this technique appear warranted.

REFERENCES 1. Lee CO. Quality of life and breast cancer survivors. Psychosocial and treatment issues. Cancer Pract. 1997;5:309 –316.

2. Moyer A. Psychosocial outcomes of breast-conserving surgery versus mastectomy: a meta-analytic review. Health Psychol. 1997; 16:284 –298. 3. Ganz PA. Sexual functioning after breast cancer: a conceptual framework for future studies. Ann Oncol. 1997;8:105–107. 4. Ganz PA, Coscarelli A, Fred C, et al. Breast cancer survivors: psychosocial concerns and quality of life. Breast Cancer Treat Res. 1996;38:183–199. 5. Poulsen B, Graversen HP, Beckmann J, Blichert-Toft M. A comparative study of post-operative psychosocial function in women with primary operable breast cancer randomized to breast conservation therapy or mastectomy. Eur J Surg Oncol. 1997;23: 327–334. 6. Wilkins EG, Lowery JC, Kuzon WM, Perkins MS. Functional outcomes in postmastectomy breast reconstruction: preliminary results of the Michigan Breast Reconstruction Outcomes Study. Surg Forum. 1997;48:609 – 612. 7. Ganz PA. Long-range effect of clinical trial interventions on quality of life. Cancer. 1994;74(suppl 9):2620 –2624. 8. Cady B. The need to reexamine axillary lymph node dissection in invasive breast cancer. Cancer. 1994;73:505–508. 9. Horsley JS, Styblo T. Lymphedema in the postmastectomy patient. In: Bland KI, Copeland EM III, eds. The Breast. Philadelphia:WB Saunders; 1991:701–706. 10. Giuliano AE, Dale PS, Turner RR, et al. Improved axillary staging of breast cancer with sentinel lymphadenectomy. Ann Surg. 1995;222:394 –399. 11. Silverstein MJ, Geirson ED, Waisman JR, et al. Axillary lymph node dissection for T1a breast carcinoma: is it indicated? Cancer. 1994;73:664 – 667. 12. Velanovich V. Axillary lymph node dissection for breast cancer: a decision analysis of T1 lesions. Ann Surg Oncol. 1998;5: 131–139. 13. Ganz PA, Day R, Ware JE Jr, et al. Baseline quality of life assessment in the National Surgical Adjuvant Breast and Bowel Breast Cancer Prevention Trial. J Natl Cancer Inst. 1995;87:1372– 1382. 14. McHorney CA, Kosinski M, Ware JE Jr. Comparisons of the costs and quality of norms for the SF-36 Health Survey collected by mail versus telephone interview: results from a national survey. Med Care. 1994;32:551–567. 15. Gustafson TL. True Epistat. 4th ed. Richardson, Tex: Epistat Services; 1991. 16. Longman AJ, Braden CJ, Mishel MH. Side effects burden in women with breast cancer. Cancer Pract. 1996;4:274 –280. 17. Wapnir IL, Cody RP, Greco RS. Superior quality of life following lumpectomy-axillary dissection in patients with stage I and stage II breast cancer. Surg Forum. 1996;47:635– 637. 18. Hann DM, Jacobson PB, Martin SC, et al. Quality of life following bone marrow transplantation for breast cancer: a comparative study. Bone Marrow Transplant. 1997;19:257–264. 19. van Dam FSAM, Schagen SB, Muller MJ, et al. Impairment of cognitive function in women receiving adjuvant treatment for high-risk breast cancer: high-dose versus standard-dose chemotherapy. J Natl Cancer Inst. 1998;90:210 –218. 20. Dow KH, Ferrell BR, Leigh S, et al. An evaluation of the quality of life among long-term survivors of breast cancer. Breast Cancer Treat Res. 1996;39:261–273. 21. Albertini JJ, Lyman GH, Cox C, et al. Lymphatic mapping and sentinel node biopsy in the patient with breast cancer. JAMA. 1996;276:1818 –1822. 22. Carter BJ. Women’s experience of lymphedema. Oncol Nurs Forum. 1997;24:875– 882. 23. Mirolo BR, Bunce IH, Chapman M, et al. Psychosocial benefits of postmastectomy lymphedema therapy. Cancer Nurs. 1995;18: 197–205.

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EDITORIAL COMMENT Velanovich and Szymanski properly document the significant concerns of patients who develop lymphedema following the surgical therapy of breast carcinoma. The frequency reported by the authors (8.3%) of clinically apparent lymphedema is similar to that found in other large series and bears on the importance of its avoidance to enhance quality of life (QOL). Patients developing lymphedema in the series had significantly lower scores in the domains of role-emotional and body pain. Moreover, lymphedema patients were observed to have significantly lower scores when compared with the national norms in the domains of bodily pain, mental health, and general health. Although this complication is infrequent, its appearance diminishes considerably the QOL of these patients; medical management should involve a multidisciplinary approach in the long-term care of patients to avoid these complications. The Halstedian radical mastectomy of the past has been replaced by the more conservative modified radical mastectomy. Since its description in 1948 by Patey and Dyson, decreasing rates of lymphedema have been reported, with the development of an equivalent procedure that confines the axillary dissection to level 1 and 2 nodal groups. The newer techniques, of lymph node mapping and sentinel lymph node biopsy, do promise to provide full nodal staging information with a simple lymph node biopsy. Potentially, lymphedema would thereafter become nonexistent, if lymph node dissection could be avoided in patients with pathologically negative axillae. Unequivocally, attention to detail and proper surgical techniques, including sharp anatomical dissection, proper hemostasis, closed-suction drainage, and tissue approximation without tension, are the cardinal features to avoid this untoward complication. Efforts to diminish wound sepsis, including perioperative antibiotics, are prime considerations in management. The evolution of radiobiological principles also indicates that radiation therapy to the axilla should be avoided following

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lumpectomy, with the exception of pathological evidence of extracapsular nodal extension or fixation of large volumes of tumor to soft tissues. The completion of a comprehensive axillary dissection (Patey) with axillary radiation increases the frequency of lymphedema 8- to 10-fold. As indicated by the authors, the importance of QOL issues throughout the treatment of breast cancer patients with lymphedema is evident. QOL variables are being continually evaluated for various organ systems to safeguard the patients’ sense of well-being and self-esteem. This is important to preserve organ, endocrine, hormonal, and exocrine function while fostering the best possible QOL for the patient in either the palliative or curative setting.1 The next millennium will undoubtedly usher into practice targeted and more aggressive therapies that combine multimodal approaches that utilize surgery, radiotherapy, pharmacologic, genetic, and biological agents. Indeed, the future holds great promise for enhanced tumor responsiveness, especially with novel biological and genetic agents that will emerge following phase I–III studies. Following the determination of proper sequencing, administration, and toxicity of these agents, breast cancer patients will experience decreased morbidity, increased survival, and improved QOL parameters. It is our responsibility as surgeons and physicians—the principal health care providers for breast cancer patients—to be aware of the patients’ personal concerns on a multitude of issues that enhance QOL preservation. Perhaps nowhere in our teachings and experience is the dictum “primum non nocere” (“First, do no harm”), as espoused by Hippocrates, more important than in the planning of therapeutic strategies to achieve the optimal state of QOL issues. Kirby I. Bland Providence, Rhode Island 1. Bland KI. Quality-of-life management for cancer patients. CA Cancer J Clin. 1997;47:194 –197.

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