Largest study of breast reconstruction outcomes seeks pedicle TRAMs
Many women facing mastectomy after a breast cancer diagnosis choose breast reconstruction to alleviate some of the adverse psychosocial effects of their disease and treatment. To actively participate in the reconstruction decision-making process, however, breast cancer survivors need objective, up-to-date information on breast reconstruction outcomes - information that surgeons often struggle to provide, leaving both the patient and her doctor at a loss.
With 11 high-volume breast reconstruction centers (see list at bottom) participating in the Mastectomy Reconstruction Outcomes Consortium (MROC) study, plastic surgeons will soon be able to provide definitive answers for patients preparing to undergo any of the eight common breast reconstruction procedures. Fueled by a $5.1 million grant from the National Cancer Institute (NCI) and with more than 350 breast reconstruction patients already enrolled, the MROC study is poised to become the largest and most comprehensive patient outcomes study of its kind.
Led by Ed Wilkins, MD, professor of plastic surgery at the University of Michigan, Ann Arbor, and Andrea Pusic, MD, associate attending surgeon at Memorial Sloan-Kettering Cancer Center in New York, the MROC study is designed to evaluate breast reconstruction from the patient's point of view, tracking postoperative pain, psychosocial well-being, physical functioning, fatigue and patient satisfaction. Complications and costs will also be evaluated. The procedures being compared include:
- Deep inferior epigastric perforator (DIEP) flaps
- Free TRAM flaps
- Inferior gluteal artery perforator (IGAP) techniques
- Latissimus dorsi flaps with implant
- Pedicle transverse rectus abdominis musculocutaneous (TRAM) flaps
- Superficial inferior epigastric artery (SIEA) flaps
- Superior gluteal artery perforator (SGAP) flaps
"This will be the largest study of its kind, and if it works, everybody benefits - most importantly, the patients that we serve," says Dr. Wilkins. "Plastic surgeons have never really attempted something like this on this scale. We have shown in the past that breast reconstruction contributes significantly to patients' quality of life, but previous studies were not as advanced as the MROC, and they were mainly conducted in single centers with much smaller numbers of patients. The MROC study involves thousands of patients from 11 leading centers in the United States and Canada – it has the opportunity to demonstrate the quality-of-life benefits in this patient population."
Patient surveys are administered at several intervals beginning with a preoperative assessment to establish a baseline and then one week, three months, one year and two years post-op.
"Many of these outcomes continue to evolve for years after these operations," says Dr. Wilkins. "One of the challenging parts of this type of research is that you need to stick around for a long time to see how people are doing before you really know what you've achieved or, in some cases, haven't achieved."
The MROC study will track patients through 2016 with a goal of comparing outcomes for roughly 5,000 breast reconstruction patients. To complete their surveys, the study allows patients to log-on from work or home with a password, which has streamlined the data-gathering process and is expected to improve patient participation over the two-year evaluation period. MROC will also evaluate the effects of race and ethnicity on reconstruction outcomes. Both immediate and delayed breast reconstruction patients are eligible to participate in the study.
"Over the past 10 years, the development of a number of condition-specific, patient-reported outcome measures such as Dr. Pusic's BREAST-Q® and the European Organisation for Research and Treatment of Cancer's Quality of Life Survey, have enabled us to do this," says Dr. Wilkins. "Most surgeons have never undergone breast reconstruction, so when patients ask us specific questions, we can often speak only in generalities and anecdotes."
With the ability to precisely measure factors such as fatigue, satisfaction and pain on a large scale, the goal of the MROC study is to provide patients and physicians with useable, relevant, up-to-date information on the relative pros and cons of various breast reconstruction operations.
"As surgeons, we are involved in a shared decision-making process, so the information will be there to help in choosing the right operation for the right patient," Dr. Wilkins says. "Ultimately, the patients are the best judges of what works best, and that's the approach we wanted to take with this study."
Pedicle TRAMs needed
Plastic surgery practices that perform high volumes of breast reconstruction that would be interested in volunteering to participate in the MROC are encouraged to contact The PSF via email at firstname.lastname@example.org or call (847) 228-3355.
Drs. Wilkins and Pusic are particularly interested in enrolling more patients who have undergone pedicle TRAM flap procedures before the patient recruitment process ends in the summer of 2014.
"Although pedicle TRAMs are still the most common natural tissue reconstruction for post-mastectomy patients, most of the academic medical centers have evolved more into doing microsurgical flaps for breast reconstruction," Dr. Wilkins explains. "It's important for this type of study to evaluate operations and care as they are actually being performed in the real world. We have plenty of implant-based technique centers, but we would like to have more pedicle TRAM centers - so if you are a high-volume site that does pedicle TRAMs, we would be delighted to speak with you."
The MROC findings could impact a wide range of stakeholders - beyond patients and physicians - in the healthcare arena. Data from the study is expected to offer policymakers and insurance providers insight on the effectiveness and relative costs of surgical options for breast reconstruction, thereby promoting a more evidence-based approach to treatment and policy decision-making. Study findings may also assist healthcare organizations in designing systems of care tailored to the specific needs and preferences of diverse patient populations.
"Information like this is important for payers and policymakers to figure out what works best and where scarce healthcare funds should be invested," Dr. Wilkins says, noting that low reimbursement keeps many plastic surgeons from performing natural tissue and microsurgical breast reconstruction.
"The Women's Health and Cancer Rights Act of 1998 mandated coverage of breast reconstruction, but it didn't mandate levels of reimbursement," he says. "So the payers tend to promote the smaller operations like expanders and implants at the expense of larger flap operations. I go where the data lead me, so I don't know what we're going to find, but what if the MROC study shows significant benefits of the flap operations over the implant procedures? Would that encourage payers to incentivize plastic surgeons through better reimbursement to do more flap operations? It could, and it should if, indeed, flap operations are shown to yield better outcomes from the patient's point of view. These kinds of results can help us take the case to payers and policymakers - there are a number of potential benefits to being empowered with this kind of information."
A great investment
While the information to be gleaned from the MROC study could be priceless, Dr. Wilkins credits ASPS membership for making it possible, noting that planning and development for the MROC study began in 2007, with a pilot study funded by the National Endowment for Plastic Surgery (NEPS) through The PSF.
"The PSF also provided funding for development of the BREAST-Q, which is a key outcome measure in the MROC study," Dr. Pusic notes. "Without a reliable and valid breast reconstruction-specific patient-reported outcome instrument, we could not achieve the kind of precise, clinically meaningful outcome measurement that we are aiming for in MROC."
A second pilot, underwritten by the Michigan Institute for Clinical and Healthcare Research, further refined the study's methodology, and a proposal for a full-scale, five-year version of the project was initially submitted to the NCI in 2009 and again in 2010 when it ranked in the sixth percentile and was awarded a $5.1 million grant on Aug. 1, 2011 - a result that Dr. Wilkins likens to a minor miracle.
"For a bunch of plastic surgeons, it's pretty remarkable to score in the sixth percentile because most of these NIH grants are submitted by people who do nothing but research - they don't have day jobs where they take care of patients," says Dr. Wilkins. "And it began with a $50,000 NEPS grant that turned into a $5 million NCI grant to look at breast reconstruction outcomes - this is what ASPS members' contributions to The PSF go toward. And that's a pretty good return on investment."
"Over the past five years, The PSF leadership has made a number of wise research investments toward a compelling vision of high-quality, multicenter prospective studies," says Dr. Pusic. "We are now seeing the results of these investments. As The PSF Clinical Trials Network continues to expand and grow, I have no doubt that we'll be seeing more and more studies like MROC in plastic surgery."
"Dr. Pusic and I are very grateful to The PSF and everyone who contributes to the NEPS - because of them, this is happening," Dr. Wilkins adds. "The money from The PSF is what got us started."
MROC participating centers
Dartmouth Medical School
MD Anderson Cancer Center
Memorial Sloan Kettering Cancer Center
St. Joseph's/Mercy Health Care System
The Ohio State University
University of California - Los Angeles
University of Manitoba
University of Michigan