Patient satisfaction and quality of life after MammoSite breast brachytherapy

The American Journal of Surgery (2008) 196, 545–548

The American Society of Breast Surgeons

Patient satisfaction and quality of life after MammoSite breast brachytherapy Anthony E. Dragun, M.D.a,*, Jennifer L. Harper, M.D.b, Carla E. Taylorb, Joseph M. Jenrette, M.D.b a

Radiation Oncology, Roy Richards Sr. Cancer Center, 165 Clinic Ave, Carrollton, GA 30117, USA; bDepartment of Radiation Oncology, Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA KEYWORDS: Breast cancer; Brachytherapy; Quality of life; MammoSite; Patient satisfaction

Abstract PURPOSE: To perform a satisfaction/quality-of-life (QOL) survey of patients undergoing MammoSite brachytherapy (MBT; Hologic, Inc, Marlborough, MA). METHODS: We asked patients 15 questions regarding treatment decision-making, and experience on-therapy/post-treatment. RESULTS: A total of 52 patients responded (median follow-up 30 months). Regarding decisionmaking, 5.8% viewed the avoidance of mastectomy as “not important.” If MBT were not available, 55.8% would opt for whole-breast radiotherapy (WBRT) without difficulty, 28.8% would have significant travel/financial difficulty, and 15.4% would refuse radiotherapy/opt for mastectomy. Regarding choice factors, patients selected “focused therapy” (44.2%), “convenience” (36.5%), and “cutting edge” (17.3%). A total of 61.5% patients were not concerned about a second surgical procedure; 90.4% were not/somewhat concerned about infection. During treatment, 73.1% reported no pain/discomfort with catheter, 73.1% no wound difficulty, 51.0% no pain during removal, and 71.2% no pain post-treatment. A total of 98.1% of patients rated the experience good/excellent, 90.4% reported no/minor side effects, 92.3% rated cosmesis good/excellent, 98.1% were very/extremely likely to choose MBT again, and 100% would recommend MBT. CONCLUSIONS: QOL is high during/after MBT. More data are needed from ongoing trials to compare with WBRT. © 2008 Elsevier Inc. All rights reserved.

Over the last 25 years, there has developed a steady trend of decreasing toxicity and improving quality of life (QOL) in the treatment of early-stage breast cancer, specifically in the paradigm shift from radical mastectomy to breast conservation therapy (BCT). It is now well accepted that patients choosing lumpectomy, followed by postoperative Post-acceptance of this manuscript, A.E.D. accepted an invitation to the speakers’ bureau of Hologic, Inc, manufacturer of the MammoSite device. * Corresponding author: Tel.: ⫹1-770-836-9824; fax: ⫹1-770-8329850. E-mail address: [email protected] Manuscript received April 7, 2008; revised manuscript May 19, 2008

0002-9610/$ - see front matter © 2008 Elsevier Inc. All rights reserved. doi:10.1016/j.amjsurg.2008.06.014

whole-breast radiotherapy (WBRT), have equivalent cure rates compared to those receiving a mastectomy. Contemporary analysis of several studies suggest that the majority of recurrences occur in the immediate region of the lumpectomy site after BCT, and this has led many investigators to propose that irradiation of only the tumor bed would yield similar local control results as WBRT.1–3 Accelerated partial-breast irradiation (APBI), the delivery of large fractions of radiation to the lumpectomy cavity area in a shorter overall treatment time, has been proposed as an alternative to WBRT in an effort to limit excess radiation to normal breast tissue.

546

The American Journal of Surgery, Vol 196, No 4, October 2008

Table 1

Patient demographics

Total patients Age (y) Median Range Tumor stage DCIS T1a T1b T1c T2 Node stage N0 N1 Follow-up (mo) Median Range Patient status Disease-free In-breast failure Distant failure

No.

%

52

100%

64 44-85 10 4 20 15 3

19% 8% 38% 29% 6%

49 3

94% 6%

30 9-47 50 1 1

96% 2% 2%

DCIS ⫽ ductal carcinoma in situ.

With continued accumulation of data from large patient registries and single- and multiple-institution studies, the evidence supporting the safety and efficacy of APBI continues to grow, and its availability has become more widespread since the introduction of the MammoSite brachytherapy (MBT) system (Hologic, Inc, Marlborough, MA).4 – 6 MBT has been used in the treatment of thousands of patients nationally and is currently a subject of a major phase III Intergroup trial (National Surgical Adjuvant Breast Project [NSABP] B-39/Radiation Therapy Oncology Group [RTOG] 0413). MBT is thought to be a popular choice of adjuvant treatment among patients with early-stage breast cancer, mainly because it offers the advantage of completing radiotherapy in 5 days rather than 6 weeks. Potential disadvantages compared to WBRT, however, include the need for a second invasive procedure (the placement of the MammoSite balloon catheter), the inherent risk of infection, and the theoretical higher risk of long-term side effects due to the higher radiation dose-per-fraction that is delivered in APBI. Although numerous reports of initial experience with MBT regarding efficacy, toxicity, and cosmesis have been published in the surgical and oncology literature, less is known regarding the factors that contribute to patients’ choice of MBT, their QOL during and after treatment, and their overall satisfaction with their therapy experience. The Medical University of South Carolina (MUSC) was one of the first institutions in the country to offer MBT after its approval by the US Food and Drug Administration (FDA) and currently maintains one of the largest singleinstitution databases with some of the longest follow-up of MBT patients. In this cross-sectional study, we report pa-

tient responses to a satisfaction and QOL survey completed by MBT patients. A 15-item questionnaire was developed by investigators in the Department of Radiation Oncology at MUSC. The questionnaire was specifically designed to target the concerns and qualify the experience of patients who choose MBT as adjuvant therapy for early-stage breast cancer. The questionnaire was intended to be easily comprehended by English-speaking patients and was divided into 3 sections (treatment decision-making, on-treatment experience, posttreatment experience), each containing 5 questions. Women who received MBT at MUSC between May 2002 and May 2007 were the target population for this study, which was conducted by mailing the 15-item questionnaire to 117 patients who were alive and had up-to-date demographic contact information at the time of the study. The first survey section, entitled “Treatment DecisionMaking,” posed 5 questions to delineate factors motivating patients to choose MBT over traditional WBRT. The second and third sections were entitled “On-Treatment Experience” and “Post-Treatment Experience,” respectively. The 10 questions in these 2 sections were designed for patients to rate their symptoms and QOL during therapy, and their overall level of satisfaction with their chosen treatment. Questionnaires were coded to ensure anonymity and patients were requested to complete and return their survey in a postage-paid envelope. Returned surveys were then matched to coded clinical data that had been previously collected in a prospective database. Fully completed surveys were returned by 52 patients (44.4%) who were a median age of 64 years and at a median time from completion of treatment of 30 months. Other demographics of the surveyed cohort are shown in Table 1. Of note, the majority of patients reflected current American Society of Breast Surgeons (ASBS) or American Brachytherapy Society (ABS) MammoSite eligibility recommendations.5,6 Patient responses to 3 of 5 questions regarding treatment decision-making are shown in Figure 1. Only a small minority of women (5.8%) viewed the avoidance of mastectomy as “not important.” Most patients (61.5%) were not concerned that MBT involved a second surgical procedure and the majority (90.4%) was not or only somewhat concerned about the risk of infection. The final 2 questions of the treatment decision-making section asked about alterna-

Figure 1

Pretreatment decision-making and concerns.

A.E. Dragun et al.

Figure 2

Patient satisfaction after MammoSite therapy

On-treatment and post-treatment experience.

tives to MBT and the most important factor in choosing MBT. If MBT were not available, 55.8% of women said they would opt for traditional WBRT with no difficulty, 28.8% would have significant travel or financial difficulty, 7.7% would refuse radiotherapy, and 7.7% would opt for mastectomy. The most important factor for most patients (44.2%) was that MBT was “focused therapy”; others cited convenience of 5-day therapy (36.5%), that it was “cutting edge” (17.3%), or that they had personally read or heard positive feedback about MBT (1.9%). Patient ratings of pain, discomfort, and difficulty during their on-treatment and post-treatment experience are consolidated in Figure 2. The majority of patients had very little or no breast pain with the balloon catheter in place, upon its removal, and in the days and months after treatment. Additionally, nearly all patients (98.1%) rated their overall on-treatment experience as good/excellent versus fair (1.9%) or poor (0%). Fifty of 52 patients (96.2%) noted that they were in remission at the time of their completion of the survey, while 1 patient reported having had an in-breast recurrence and 1 had developed metastatic disease. Concerning self-reported cosmetic outcome, 48 of 52 patients (92.3%) rated their cosmesis as good/excellent, while 4 women reported fair (5.8%) or poor (1.9%) results. With regard to other questions designed to assess posttherapy satisfaction, most women indicated that they would be very/extremely likely to choose MBT again (98.1%) versus somewhat likely (1.9%) or not likely (0%). All 52 women (100%) reported that they would recommend MBT to a friend or family member who was diagnosed with breast cancer. MBT is a relatively new form of APBI and, since its approval by the FDA in 2002, an explosion of interest in its utility and effectiveness has come from patients and physicians alike. Currently, MBT and 2 other forms of APBI (multi-catheter interstitial brachytherapy and hypofractionated 3-dimensional conformal radiotherapy) are undergoing evaluation in NSABP-B39/RTOG 0413; however, early endpoints from this trial are unlikely to be available for several years. Therefore, most available information regarding experience with MBT currently comes from 3 main sources: analyses of single- or multi-institution series, collaborative registry data, and extrapolation of data generated from the use of the other forms of APBI.

547

There have been numerous efforts to collect data regarding MBT with regard to disease control and physician-rated toxicity and cosmesis, but relatively little information exists regarding patient satisfaction and QOL, outside the anecdotal setting. Studies that have focused on similar endpoints in the analysis of patients undergoing BCT versus mastectomy have shown that women treated by mastectomy report worse body image than those treated by breast conservation.7 However, women who undergo traditional radiation therapy as adjuvant treatment for BCT have been shown to report increased post-treatment breast pain, fibrosis, and lymphedema of the arm.8,9 Furthermore, some patients, especially older women, are often concerned about their ability to manage the self-care issues during adjuvant treatment, and, if given a choice, may prefer a therapy that does not require additional procedures after initial treatment.10 Our questionnaire was designed specifically to target the concerns of MBT patients by providing a comprehensive survey of their entire treatment experience: from treatmentdecision-making through post-therapy recovery. Patients chose MBT largely for its targeted nature and convenience. Only slightly more than half of our patients would have been able to undergo traditional WBRT with little difficulty if MBT were unavailable. Patients had relatively little in the way of side effects and toxicity, and their self-rated cosmetic outcome was largely good-to-excellent, consistent with physician-assessed reports.1,5 In general, our patients tended to be very satisfied with their choice of MBT and their overall experience, as exemplified by their willingness (100%) to recommend the same therapy to a friend or family member with breast cancer. Although our results are largely positive, our study is limited by the potential for biases that are inherent in any retrospective analysis involving patient-reported subjective endpoints. When MBT was offered to our patients, a significant amount of additional time was taken to explain the options, risks, and benefits of its use compared to WBRT. While this is expected with any novel therapy or investigational protocol, the amount of treatment information and physician-initiated communication has been shown to influence satisfaction with care.10 Additionally, patients who have a positive on-treatment experience may be more likely to share that information with others in the setting of a QOL study.8 –10 It is clear that the traditionally more “reliable” studies involving objective assessments—such as physical examination or physician/nursing questionnaires—are necessary for evidence-based treatment recommendations. However, in clinical counseling and decision-making, patients also benefit from information on subjective complications, because the same grade complications may be perceived differently by individual patients.9 Over the coming decades, the population of women most appropriate for MBT (older women with early-stage disease) is projected to constitute a larger percentage of newly diagnosed breast cancer patients.10 With the concurrent rapid advancements of tech-

548 nology, more choices will be available with regard to breast cancer therapy and thus, QOL data will play a more important clinical role in the counseling of patients on their therapeutic options. At a median follow-up time approaching 3 years, patient satisfaction and QOL both during and after MBT therapy has been extremely high. We encourage further efforts to collect data comparing MBT with traditional WBRT. Specifically, evidence generated from ongoing randomized trials regarding the relationship between treatment-decision making factors and post-treatment QOL and satisfaction will be of great clinical utility in the counseling of patients with early-stage breast cancer.

References 1. Keisch M, Vicini F, Kuske R, et al. Initial clinical experience with the MammoSite breast brachytherapy applicator in women with earlystage breast cancer treated with breast-conserving therapy. Int J Radiat Oncol Biol Phys 2003;55:289 –93. 2. Polgar C, Major T, Somogyi A, et al. Sole brachytherapy of the tumor bed after breast conserving surgery: a new radiotherapeutic strategy for patients at low risk of local relapse. Neoplasma 1999;46:182–9.

The American Journal of Surgery, Vol 196, No 4, October 2008 3. Baglan KL, Martinez A, Frazier R, et al. The use of high-dose-rate brachytherapy alone after lumpectomy in patients with early-stage breast cancer treated with breast-conserving therapy. Int J Radiat Oncol Biol Phys 2001;50:1003–11. 4. Harper JL, Jenrette J, Vanek K, et al. Acute complications of MammoSite brachytherapy: a single institution’s initial clinical experience. Int J Radiat Oncol Biol Phys 2005;61:169 –74. 5. Vicini FA, Beitsch P, Quiet C, et al. First analysis of patient demographics, technical reproducibility, cosmesis, and early toxicity: results of the American Society of Breast Surgeons MammoSite breast brachytherapy trial. Cancer 2005;104:1138 – 48. 6. Arthur D, Vicini F, Kuske R, et al. Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. Brachytherapy 2002;1:184 –90. 7. Kenny P, King L, Shiell A, et al. Early stage breast cancer: costs and quality of life one year after treatment by mastectomy or conservative surgery and radiation therapy. Breast 2000;9:37– 44. 8. Marchal F, Dravet F, Classe J, et al. Postoperative care in patient’s satisfaction after ambulatory surgery for breast cancer patients. J Cancer Surg 2005;31:495–99. 9. Ishiyama H, Niino K, Hosoya T, et al. Result of a questionnaire survey for symptom of late complications caused by radiotherapy in breast conserving therapy. Breast Cancer 2006;13:197–201. 10. Liang W, Burnett C, Rowland J, et al. Communication between physicians in older women with localized breast cancer: implications for treatment and patient’s satisfaction. J Clin Oncol 2002; 20:1008 –16.