Cell-Enhanced Reconstruction after Breast Conservation Therapy: A Proven Technique.

Abstract

Abstract Background: While breast conservation therapy (BCT) is safe (Lancet 2000, 355, 1757-1770) and widely accepted, it remains underutilized (J Clin Oncol 2001; 19:2254) as primary treatment for Stage I and II breast cancer due to limited reconstructive options post-BCT. Common sequelae of BCT are tissue defects and asymmetry. Commercially available implants do not adequately address post–BCT defects while other surgical options are traumatic and require prolonged hospitalization. Transplantation of autologous fat tissue (AFT) has been tried with unpredictable clinical outcomes due to variable rates of fat transplant retention over time. The Celution® System's novel technology, commercially available in Europe, enriches AFT with adipose-derived stem and regenerative cells (ADRCs) to improve graft survival and resulting clinical outcomes including patient and physician satisfaction.Materials and Methods: The RESTORE-2 study is a prospective, single-arm, multi-center clinical study evaluating the transplantation of AFT enriched with ADRCs in patients with breast deformities post-BCT. The study will enroll up to 70 patients at up to 12 clinical centers in the EU. Ethical committees at each enrolling center approved the study. Forty patients have been treated to date. Standard tumescent liposuction was performed under general anesthesia. Half of the AFT harvested was processed with the Celution® System yielding a 5 mL suspension of concentrated ADRCs. The remaining AFT was washed to remove blood and waste, enriched with the concentrated ADRCs, and injected into and around the post-BCT defect under local or general anesthesia during the same surgical procedure.Results: To date 15 of the 40 treated patients reached the 6-month follow up. The procedure was safe and well tolerated in all patients. The only treatment-emergent adverse event (TEAE) reported was a post-operative bleed at the liposuction site which was attributed to excessive anticoagulation therapy given to the patient and resolved without sequelae. No other TEAEs have been reported. In review of 6-mo data of the first 15 patients, mean age was 52 years, and mean radiation dose for 14 of 15 patients was 53.6 Gy. Mean transplant volume was 119 mL. Satisfaction scores are protocol-defined endpoints based on assessment of deformity, symmetry, scarring, and pigmentation. On a 1-6 scale patient satisfaction scores improved from 2.7 at baseline to 4.0 and physician satisfaction improved from 2.9 to 4.5.Conclusions: Early outcomes of RESTORE-2 indicate that the use of ADRC-enhanced autologous fat grafts in breast reconstruction is safe and results in a high level of patient and physician satisfaction. The Celution® System is a valuable tool for the enhancement of AFT grafts with ADRCs to improve clinical outcomes in patients post-BCT. An interim analysis of 6-mo imaging and clinical data from the first 30 sequentially treated patients will be presented at the San Antonio Breast Cancer Symposium in December 2009. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 4123.