Unchanging: Less Than Half of Melanoma Patients Receive Recommended Biopsy
By Nick Mulcahy
Medscape Medical News
April 14, 2009 — Less than half of melanoma patients with stage?IB or II disease receive a sentinel lymph node biopsy, even though the procedure has been recommended in these patients by clinical practice guidelines since 1998.
This previously established finding has been confirmed by a new study, which also provides insight into the underuse of the procedure.
The use of the biopsy was associated with a variety of clinical factors, but was also associated with health-system factors, according to the authors of the study, which was published online March 9 in the Journal of Clinical Oncology.
"We found that the use of sentinel node biopsy is strongly associated with nonclinical factors, such as insurance coverage, type of hospital, and geographic region," senior author Julie Lange, MD, ScM, told Medscape Oncology. Dr. Lange is an associate professor of surgery, oncology and dermatology at Johns Hopkins Medicine, in Baltimore, Maryland.
She explained that patients who are either covered by Medicaid and Medicare (and not private insurance) or who live in the Northeast, the South, or the West were less likely to undergo the procedure. Also, stage?IB and II patients were significantly more likely to undergo the procedure if they were treated at National Comprehensive Cancer Network (NCCN)- or National Cancer Institute (NCI)-designated hospitals.
"There obviously needs to be education of providers at multiple levels — the primary-care physician, the dermatologist, and even the surgeon — that sentinel lymph node biopsy is not only acceptable but is beneficial in staging and clinical decision-making for patients with stage?IB or II melanomas," said lead author Karl Bilimoria, MD, in a statement. At the time of the study, Dr. Bilimoria was an American College of Surgeons Research Fellow at the Feinberg School of Medicine of Northwestern University, in Chicago, Illinois.
Sentinel lymph node biopsy is associated with improved regional disease control and improved disease-free survival, note the authors.
However, Dr. Lange noted that the procedure has not been proven to improve overall survival.
The researchers also found that the use of sentinel lymph node biopsy was less likely to be used in stage?IB or II patients who were older than 75 years, had TIb tumors, and had no tumor ulcerations or head/neck/truncal ulcerations.
Differing Acceptance of Guidelines?
To uncover factors associated with sentinel lymph node biopsy use, the researchers used the National Cancer Data Base to identify 8525 patients treated for stage?IB/II melanoma in 2004 and 2005. They also identified 8073 patients with stage?IA disease to see what proportion were biopsied outside of the recommended NCCN guidelines.
For clinical stage?IB or II melanoma, recommended sentinel lymph node biopsy use was reported in only 48.7% of patients. For clinical stage?IA melanoma, 13.3% of patients had a biopsy.
The reasons behind the underuse of the biopsy in stage?IB and II melanoma patients — which include Medicaid/Medicare status, regional preferences, and type of hospital — are not totally surprising, suggest the authors.
"Variance in cancer management related to socioeconomic and geographic factors has been shown in breast, colon, and prostate cancer, as well as other common malignancies," they write. However, before the current study, the factors associated with use and nonuse of the biopsy in melanoma were "poorly understood."
Sentinel lymph node biopsy is "widely accepted" in most high-volume melanoma centers, write the authors. Indeed, in the new study, 60% of patients with stage?IB or II melanoma underwent sentinel lymph node biopsy if they were treated at NCCN- or NCI-designated centers, compared with 25% at Veterans Affairs centers and 43% at community hospitals.
Despite their findings about the factors associated with the less likely use of sentinel lymph node biopsy in appropriate patients, the authors searched for additional answers about the poor uptake of clinical guidelines on the matter.
"Reasons for the persistent underuse of [sentinel lymph node biopsy] in certain subsets is unclear," they write. "It is possible that the variances found in this study reflect a different level of acceptance of the stated guidelines among the different specialties," they add, noting that professionals involved in the care of these patients include dermatologists, general surgeons, surgical oncologists, plastic surgeons, otolaryngologists, medical oncologists, and radiation oncologists.
The purpose of the procedure might not be well understood, suggest the authors. "Some still question whether [sentinel lymph node biopsy] should be used routinely in the absence of clear documentation of an improvement in overall survival, even though the primary purpose of the procedure is to provide prognostic and staging information," they write.
Dr. Lange does not believe that underuse of the biopsy can be explained by the harm/benefit ratio of the procedure.
"Sentinel node biopsy is a low-risk procedure, but not a no-risk procedure. It adds some time to the surgical procedure (compared with wide excision alone) and there are minor risks of infection and lymphocoele," she said. Furthermore, the risk for limb edema from a sentinel node biopsy is low, she said, adding that it was not, however, 0. "There are some cases in which, based on a patient's own medical history and concerns, a decision not to do a sentinel node biopsy is perfectly rational," she observed.
The study was supported by the American College of Surgeons Clinical Scholars in Residence program and the Department of Surgery at the Feinberg School of Medicine of Northwestern University, in Chicago, Illinois.
J Clin Oncol. 2009;27:1857-1863.
