Results of Breast Reconstruction Trial Announced
(ChemotherapyAdvisor) – Breast reconstruction surgery, post-mastectomy, might be getting something of a makeover after Cytori Therapeutics announced on March 19 that it has published results of the RESTORE-2 trial in the peer-reviewed European Journal of Surgical Oncology. The study, entitled “Prospective trial of Adipose-Derived Regenerative Cell (ADRC)-enriched grafting for partial mastectomy defects: the RESTORE-2 trial”, appeared online on March 15.
“Women undergoing breast conservation therapy (BCT) for breast cancer are often left with contour defects and few acceptable reconstructive options. RESTORE-2 is the first prospective clinical trial using autologous adipose-derived regenerative cell (ADRC)-enriched fat grafting for reconstruction of such defects. This single-arm, prospective, multi-center clinical trial enrolled 71 patients post-BCT with defects ≤150mL,” the authors wrote. In this trial, the majority of patients underwent radiation prior to the procedure, creating an unfavorable ischemic environment for which breast reconstruction with ADRC-enriched fat grafting appears to be ideally suited.
Data from self-reported assessment metrics include high rates of investigator (85%) and patient (75%) satisfaction with the overall treatment results at 12 months. There were also high rates of investigator (87%) and patient (67%) satisfaction with overall breast deformity (based on functional and cosmetic outcomes) at 12 months as well as improved breast contour at both 6 and 12 months. In terms of safety, there were no local cancer recurrences or serious adverse events related to the ADRC-enriched fat grafting procedure.
"Following cancer treatment, the patient's breast tissue can suffer from radiation injury, scarring and tight skin," said Consultant Plastic and Reconstructive Surgeon Mrs. Eva Weiler-Mithoff, co-principal investigator for RESTORE-2 at the NHS Glasgow Royal Infirmary Hospital. "This new technique is exciting because it may offer the opportunity to resolve some of the most difficult to treat conditions where other approaches, including fat alone, do not achieve satisfactory results."