Clinical investigation: breast
Complications and patient satisfaction following expander/implant breast reconstruction with and without radiotherapy

Presented in part at the 41st Annual Meeting of the American Society for Therapeutic Radiology and Oncology, San Antonio, TX (USA), October 31–November 4, 1999.
https://doi.org/10.1016/S0360-3016(00)01402-4Get rights and content

Abstract

Purpose: To compare the rates of complications and patient satisfaction among breast cancer patients treated with mastectomy and tissue expander/implant reconstruction with and without radiotherapy.

Methods and Materials: As part of the Michigan Breast Reconstruction Outcome Study (MBROS), breast cancer patients undergoing mastectomy with reconstruction were prospectively evaluated with respect to complications, general patient satisfaction with reconstruction, and esthetic satisfaction. Included in this study was a cohort of women who underwent breast reconstruction using an expander/implant (E/I). A subset of these patients also received radiotherapy (RT). At 1 and 2 years postoperatively, a survey was administered which included 7 items assessing both general satisfaction with their reconstruction and esthetic satisfaction. Complication data were also obtained at the same time points using hospital chart review. Radiotherapy patients identified in the University of Michigan Radiation Oncology database that underwent expander/implant reconstruction but not enrolled in the MBROS study were also added to the analysis.

Results: Eighty-one patients underwent mastectomy and E/I reconstruction. Nineteen patients received RT and 62 underwent reconstruction without RT. The median dose delivered to the reconstructed breast/chest wall, including boost, was 60.4 Gy (range, 50.0–66.0 Gy) in 1.8- to 2.0-Gy fractions. With a median follow-up of 31 months from the date of surgery, complications occurred in 68% (13/19) of the RT patients compared to 31% (19/62) in the no RT group (p = 0.006). Twelve of 81 patients (15%) had a breast reconstruction failure. Reconstruction failure was significantly associated with experiencing a complication (p = 0.0001) and the use of radiotherapy (p = 0.005). The observed reconstruction failure rates were 37% (7/19) and 8% (5/62) for patients treated with and without radiotherapy, respectively. Tamoxifen was associated with a borderline risk of complications (p = 0.07) and a significant risk of reconstruction failure (p = 0.01). Sixty-six patients of the study group completed the satisfaction survey; 15 patients did not. To offset potential bias for patients not completing the survey, we analyzed satisfaction data assuming “dissatisfaction” scores for surveys not completed. In the analysis of patients with unilateral E/I placement, reconstruction failure was significantly associated with a lower general satisfaction (p = 0.03). Ten percent of patients experiencing a reconstruction failure were generally satisfied compared to 23% who completed E/I reconstruction. In addition, tamoxifen use was associated with a significantly decreased esthetic satisfaction (p = 0.03). Radiotherapy was not associated with significantly decreased general or esthetic satisfaction.

Conclusion: Irradiated patients had a higher rate of expander/implant reconstruction failure and complications than nonirradiated patients. Despite these differences, our pilot data suggest that both general satisfaction and patient esthetic satisfaction were not significantly different following radiotherapy compared to patients who did not receive RT. Although statistical power was limited in the present study and larger patient numbers are needed to validate these results, this study suggests comparable patient assessment of cosmetic outcome with or without radiotherapy in women who successfully complete expander/implant reconstruction.

Introduction

Breast conservation therapy is the preferred local management in Stages I and II breast cancer, but there are contraindications to its use1, 2. These include two or more gross tumors in separate quadrants of the breast, diffuse indeterminate or malignant-appearing microcalcifications, pregnancy, active collagen vascular disease, and history of prior irradiation to the breast. Mastectomy is the recommended treatment in these cases. Until recently, postmastectomy radiotherapy was generally reserved for patients with four or more positive lymph nodes, positive margins, and T3 tumors. However, with the publication of three trials now demonstrating a survival advantage in favor of postmastectomy radiotherapy in all node positive Stage II disease, more women are being referred for therapy in the postmastectomy setting 3, 4, 5.

Many patients will desire breast reconstruction after mastectomy. The primary options for reconstruction are autologous tissue reconstruction and tissue expansion with subsequent prosthetic expander/implant (E/I). Most autologous tissue reconstructions consist of a transverse rectus abdominus musculocutaneous (TRAM) flap or a latissimus dorsi muscle flap with an implant. Autologous reconstruction in patients requiring radiotherapy has resulted in acceptable rates of reconstruction failure and complications 6, 7, 8, 9. A two-staged expander/implant procedure is an alternative option for breast reconstruction for patients who are not candidates for autologous reconstruction or who prefer an implant reconstruction. Little data exist, however, comparing E/I reconstruction in irradiated and nonirradiated patients. Prior reports of limited numbers of patients have suggested increased rates of complications and adverse cosmetic results in women with implants treated with locoregional radiotherapy 10, 11, 12, 13, 14. There are even fewer studies that analyze patient satisfaction in the E/I reconstruction setting 11, 14, 15, 16. Therefore, our goals were to compare complications and rates of breast reconstruction failure in patients undergoing E/I reconstruction treated with and without radiation, and to analyze patient satisfaction by cohort.

Section snippets

Patients

The Michigan Breast Reconstruction Outcomes Study (MBROS) was initiated in 1994 to evaluate the outcomes of first time mastectomy reconstructions. Patients were enrolled if they were acceptable candidates for either autologous tissue or implant reconstruction. Twelve hospitals across the United States and Canada participated in the study. Patients were prospectively followed for complications and patient satisfaction. Our study included a cohort who underwent E/I reconstruction. A subset of

Results

Twenty-four patients (30%) had bilateral reconstructions, and 57 (70%) had unilateral reconstructions. In the no RT group, 19 (31%) had bilateral, and 43 (69%) had unilateral reconstructions. Forty-four of the no RT group had immediate reconstruction, and 14 had delayed reconstruction. Four of the no RT group had bilateral surgeries consisting of an immediate reconstruction on one side and delayed on the other. In the RT group, 5 (26%) had bilateral, and 14 (74%) had unilateral reconstruction.

Discussion

In our study of E/I reconstruction with or without radiotherapy, we report a higher rate of complications and implant failure in women who received radiotherapy compared to the nonirradiated cohort. This has also been shown by others in retrospective reports 10, 13, 15, 16. A comparison of irradiated and nonirradiated patients was evaluated in implant only reconstructions (excluding expanders) at M.D. Anderson (12). In their 20-year experience, complication rates of 43% (6 of 14) and 12% (33 of

Conclusion

Patients requiring radiotherapy had a higher rate of E/I reconstruction failure and complications compared to patients who did not receive RT. Despite these findings, our pilot data suggest that both general and esthetic satisfaction, as assessed by the patient, were not significantly different following radiotherapy compared to rates of satisfaction in patients who did not receive RT. For patients who are not candidates for TRAM but are motivated to pursue reconstruction, E/I may be an

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