Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy

Study Overview
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Brief Summary
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Higher rates of complications and poorer cosmetic outcomes have been reported after salvage mastectomy and implant-based versus autologous reconstruction in patients previously exposed to radiation therapy (i) on the breast as adjuvant treatment after breast conserving surgery (BCS) or (ii) on thoracic wall for Hodgkin Lymphoma (HL). Nevertheless, selected patients with favourable preoperative soft-tissue assessment may benefit from alloplastic reconstruction and fat grafting that has been suggested as an effective technique to promote the regeneration of irradiated tissues. The aims of this study are to assess: the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy) oncological safety of implant-based breast reconstruction and fat grafting.

Detailed Description
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National Comprehensive Cancer Network guidelines recommend autologous reconstruction as the preferred breast reconstruction after mastectomy in previously irradiated patients because of higher complication rates and worse aesthetic outcomes as compared to immediate breast implant reconstruction. In fact, unacceptable rates of complications (60-70%) have been reported by first experiences. Instead, autologous reconstruction showed lower complication rates as compared to implant-based breast reconstruction (25.5% vs 50.9%). However, it may not be indicated in patients with previous surgery at the donor site or in case of other contraindications, requires longer surgical time and is at risk of donor-site morbidity and loss of sensation. On the other hand, fat grafting improves softness of tissues and scars, releasing their rigidity and for these effects it has been studied for effectively promoting the regeneration of irradiated tissues, enlarging the envelope thickness for safety reasons, optimizing cosmetic outcomes and ultimately increasing patient comfort and quality of life. Therefore, a surgical technique combining implant-based breast reconstruction after mastectomy and fat grafting may favor alloplastic reconstruction in selected patients. The investigators enroll patients candidate to mastectomy and breast reconstruction who had received prior adjuvant radiation therapy after breast conserving surgery (BCS) or radiation therapy for the treatment of Hodgkin Lymphoma (HL). Aims of the study are to investigate (i) the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy); (ii) the oncological safety of implant-based breast reconstruction and fat grafting.

Official Title
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Immediate Tissue Expander and Lipofilling After Mastectomy for Breast Cancer Recurrence Following Lumpectomy and Irradiation: Retrospective Multicentric Clinical Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Immediate tissue expander and lipofilling after mastectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients candidate to mastectomy (salvage mastectomy for breast cancer recurrence or prophylactic mastectomy) who had been irradiated as adjuvant treatment after breast conserving surgery or as treatment for Hodgkin lymphoma signed informed consent to participate and to implant-based breast reconstruction absence of distant metastases or other malignancies. Exclusion Criteria: - presence of distant metastases or other malignancies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate tissue expander and fat grafting after mastectomy<br>Patients underwent simple mastectomy, skin-sparing or nipple-sparing mastectomy and implant-based, two-stage breast reconstruction: contextual mastectomy and expander positioning were performed during first stage (stage I) while substitution of the expander with definitive implant occurred during second stage (stage II). Fat grafting with regenerative intent was performed during stage I or between stage I and II. Adipose tissue was harvested from the abdomen, flanks, trochanter regions, inner thigh and medial aspect of knees. Fat was injected in the subfascial plane of the pectoralis major muscle with blunt cannula in order to avoid thrombo-embolic risks. At least six months after stage I patients underwent expander substitution with definitive implant and contralateral mammoplasty when required. In case of complications that required removal of the implant, autologous reconstruction was performed. | Procedure: Immediate tissue expander and lipofilling after mastectomy<br>* Implant-based breast reconstruction and fat grafting after salvage or prophylactic mastectomy in patients previously exposed to radiation therapy on the breast as adjuvant treatment after breast conserving surgery (BCS) or on thoracic wall for Hodgkin Lymphoma (HL).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rates after stage I and II | Identification of complication rates after stage I and II, measuring percentage of complications (pain and patient discomfort, partial necrosis of mastectomy flaps, nipple-areolar necrosis, delayed wound healing, capsular contracture, bleeding, expander or implant exposition, infection, expander rupture, re-operations, reconstruction failures) over the total number of surgical procedures of stage I and II. | 1 month, 6 months and 12 months | 
| Patient's satisfaction | Self-assessed patient reports for identification of patient's satisfaction, measuring percentage of patients that were satisfied with results overall. | 12 months | 
| Cosmetic outcomes | Clinical and photography-based assessments for cosmetic outcomes measurement graded by a plastic breast surgeon as excellent, very good, good, fair, or poor. | 1 month, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological safety of implant-based breast reconstruction and fat grafting. | Identification of rate of loco-regional and distant metastases. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Radiotherapy, Implant-based breast reconstruction, Fat grafting, Adipose tissue transplant, Lipofilling, Hodgkin lymphoma, Expander