Cell-enriched breast reconstruction procedure improves breast deformity in lumpectomy patients

Dec 14 2009

Interim results from a European clinical trial, RESTORE 2, demonstrate that cell-enriched breast reconstruction achieved a high rate of patient and physician satisfaction and improvements in overall breast deformity in lumpectomy patients. These results are based on six-month follow up from the first 32 women enrolled and treated. The results were presented at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium (Poster #4123) by Dr. Eva Weiler-Mithoff, M.D., co-principal investigator for the Restore 2 Trial at the Glasgow Royal Infirmary.

The highlights from the interim data of Cytori Therapeutics’ (NASDAQ: CYTX) RESTORE 2 clinical trial include:

• A high rate of patient satisfaction (73%) and physician satisfaction (82%) with the overall outcome after a single treatment was reported in difficult to treat breast cancer patients
• Mean patient and physician satisfaction scores dramatically improved for breast symmetry, scarring and deformity from baseline to six month follow-up
• Qualitative analyses of imaging data confirmed clinical improvement in both breast defect and overall breast shape

Breast conserving therapy (BCT) or partial mastectomy for breast cancer is a surgical technique that preserves as much native tissue as possible, focusing tissue removal on the target area affected by cancer plus some surrounding tissue for margin. The majority of patients treated with breast cancer today receive BCT. Although the goal is to protect as much of the patient’s own tissue as possible, the procedure can create a deformity that can be extremely difficult to repair. In patients with severe deformities, a tissue flap may be taken from the back and used to reconstruct the defect, but requires at least one additional surgery, creates another defect and scar at the donor site and can be a long and expensive procedure. For most patients however, there are no good reconstructive options.

Cell-enriched breast reconstruction is a new procedure which addresses this unmet need created by BCT. In this approach, a woman’s own fat tissue is combined with her own naturally available adipose-derived regenerative cells (ADRCs). The ‘cell-enriched’ fat graft is then injected into and around the defect area. In RESTORE 2, the ADRCs were extracted from the patient’s own fat tissue using Cytori’s Celution® 800/CRS System. The Celution® 800/CRS System was CE Marked in 2007 and is commercially available in Europe and certain other markets. More information on cell-enriched breast reconstruction and other reconstructive surgery options for breast cancer may be found at www.cellreconstruction.eu.

"These patients really suffer from these deformities because they interfere with their choice of clothing, lifestyle, confidence, and body image,” commented Dr. Weiler-Mithoff. “We now have a way of treating these patients without major surgery and major additional scarring. Half my patients are at the 12 month stage and I have found a continued improvement of the skin, the tissues, how the breast feels, how it moves on the chest wall and in particular in the pain the patients often describe pre-operatively over the second six months. We are expecting even more improvement to happen in the latter part of the observation period. Considering that defects after breast conservation and radio-therapy are very difficult to correct and quite often only 50% can be improved with secondary treatment, the RESTORE 2 study outcome is a very good result."

RESTORE 2 is a post-marketing study primarily intended to measure patient and physician satisfaction in reconstructing the breast utilizing the Celution® 800/CRS System. The goal is to support hospital and physician reimbursement and adoption of the Celution® 800/CRS System throughout Europe. The outcomes of the study will be assessed at 12 months, per study design. The co-principal investigators for RESTORE 2 are Dr. Weiler-Mithoff, Consultant Plastic Surgeon at the Canniesburn Plastic Surgery Unit at the Glasgow Royal Infirmary and Dr. Rosa Pérez Cano, Chief of Plastic Surgery Services at Hospital Universitario Gregorio Marañón in Madrid, Spain.

“Breast cancer treatment is not complete until after reconstruction,” said Marc Hedrick, M.D., president of Cytori. “Going into this study, we knew the technology both worked and made patients look and feel better. Now we have strong supporting data such as MRI and photographic evidence and formal physician questionnaires to complete the reimbursement dossier on our products. Our goal is to make the Celution®-based procedure the gold standard treatment for reconstruction of defects following breast conserving therapy.”

Clinical Results: The study reported a high degree of patient (73%) and physician (82%) satisfaction at the interim six-month observation period with the overall outcome after a single treatment in difficult to treat breast reconstruction patients. On a scale of zero to five (five is extremely satisfied and zero is extremely dissatisfied), mean patient satisfaction scores improved from 2.8 at baseline to 3.9 at six-month follow up. Mean physician satisfaction scores improved from 3.1 to 4.1. For the 32 patients, there was a mean age of 52 years and a mean defect volume estimated by the investigators of 106 milliliters in 33 treated breasts (one patient had both breasts treated).

General anesthesia was used in most patients (32 out of 33 during liposuction and 20 of 33 for re-injection). In 24 patients, a single donor site was used, in eight patients two sites, and in one patient, three sites were used for liposuction. The abdomen was the preferred site for harvest of the graft (28 of the total 43 harvest sites). One operative complication was reported. A patient on anticoagulation therapy had a postoperative hematoma that resolved without continuing harm to the patient. Patient and physician satisfaction scores are based on pre-operative versus post operative assessment of symmetry, scarring, pigmentation, and overall breast deformity.

Imaging Results: All MRIs were evaluated by an independent blinded core lab to avoid assessment bias. Qualitative assessments of MRI for changes in breast shape and defect shape were included in the abstract. Of the 31 patients with imaging data reviewed at the time of publication, 19 had defects assessable by MRI. The remaining 12 patients either had defects not assessable by MRI, such as in the extreme upper lateral quadrant, or presented mostly with breast asymmetry. One of 31 patients developed an asymptomatic lipid cyst that was observed on MRI; no treatment was required.

The shape of the breast improved (58%), significantly improved (13%), or remained stable (29%) in all of the 31 cases assessed (100%). None of the patients had negative changes in the overall shape of their breasts. The shape of the defect improved (47%), significantly improved (11%), or remained stable (31%) in 17 of the 19 cases (89%).

Breast Cancer and BCT: More than one million women worldwide are diagnosed with breast cancer annually. The reported number of new cases is about equally spread geographically between the Americas, Europe and Asia. The U.S. has the highest incidence rate of any country in the world where breast cancer will be diagnosed in approximately 1 in 8 women during their lifetime. According to the American Cancer Society, the U.S. also reports the greatest number of cases with an estimated 190,000 new diagnoses per year. The increased emphasis on early detection means that a growing percentage of women are discovering the cancer earlier in the disease progression, receiving earlier and better care with corresponding improvement in survival. Earlier detection means more patients are eligible for BCT versus a full mastectomy, with the majority of breast cancer patients now eligible for BCT.

Source: Glasgow Royal Infirmary