Breast Cancer
Conditions
Keywords
Breast cancer, Radiotherapy, Implant-based breast reconstruction, Fat grafting, Adipose tissue transplant, Lipofilling, Hodgkin lymphoma, Expander
Brief summary
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: 1. the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy) 2. oncological safety of implant-based breast reconstruction and fat grafting.
Detailed description
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.
Interventions
PROCEDUREImmediate tissue expander and lipofilling after mastectomy
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).
Sponsors
Morgagni Pierantoni Hospital
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication rates after stage I and II | 1 month, 6 months and 12 months | 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. |
| Patient's satisfaction | 12 months | Self-assessed patient reports for identification of patient's satisfaction, measuring percentage of patients that were satisfied with results overall. |
| Cosmetic outcomes | 1 month, 6 months and 12 months | Clinical and photography-based assessments for cosmetic outcomes measurement graded by a plastic breast surgeon as excellent, very good, good, fair, or poor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oncological safety of implant-based breast reconstruction and fat grafting. | 5 years | Identification of rate of loco-regional and distant metastases. |
Countries
Italy
Outcome results
None listed