黑色素瘤病患接受建议之切片者仍不到半数


  April 14, 2009 — 虽然自从1998年以来,临床实务指引即已建议第IB或第II期黑色素瘤病患接受前哨淋巴腺切片检查,但这些病患实际做这项检查者不到半数。
  
  一篇新研究确认了这个已知的发现,也提供此一检查利用率低的观点。
  
  根据登载于3月9日临床肿瘤期刊的研究,使用切片与多种临床因素有关,也与健康体系的因素有关。
  
  资深作者、Julie Lange医师向Medscape Oncology表示,我们发现,使用前哨淋巴腺切片与非临床因素有强烈关联,例如保险有无给付、医院类型、地区;Lange医师是约翰霍普金斯医学院皮肤肿瘤外科副教授。
  
  她解释,投保Medicaid或Medicare(以及非私人保险)或者住在东北、南方、西部病患,比较不会接受前述检查。此外,第IB和第II期病患如果是在国家综合癌症网络(NCCN)或者国家癌症研究中心(NCI)之指定医院接受治疗者,比较会接受前述检查。
  
  主要作者、Karl Bilimoria医师在声明中表示,显然包括一线照护医师、皮肤科医师以及外科医师都需要相关的教育,前哨淋巴腺切片不只是可接受的方法,对于第IB或第II期黑色素瘤病患的分期和临床决策都有好处。在研究当时,Bilimoria医师是西北大学Feinberg医学院的美国外科学院研究员。
  
  作者指出,前哨淋巴腺切片与改善局部疾病控制和改善无病存活有关。
  
  不过,Lange医师指出,此方法尚未被证实可以改善整体存活。
  
  研究者也发现,75岁以上的第IB或第II期黑色素瘤病患、以及TIb肿瘤病患、没有肿瘤溃疡或者头/颈/躯干溃疡者,比较不会使用前哨淋巴腺切片。
  
  【对指引的接受度不同?】
  为了发现与使用前哨淋巴腺切片有关的因素,研究者使用国家癌症资料库检视8,525名于2004至2005年间治疗第IB/II期黑色素瘤的病患,他们也检视8,073名第IA期病患,以了解NCCN指引建议之外的切片比率。
  
  对于第IB或第II期黑色素瘤,只有48.7%病患接受建议的前哨淋巴腺切片,至于第IA期病患,有13.3%病患进行切片。
  
  研究者表示,第IB或第II期黑色素瘤病患切片使用率低的原因,包括Medicaid/Medicare保险情况、区域考量、医院类型,这些都不令人意外;他们写道,与社会经济和地理因素有关的癌症治疗变异,以前在乳癌、大肠癌、前列腺癌以及其它常见恶性病出现。不过,在目前的研究之前,有关黑色素瘤使用或未使用切片之相关因素的了解相当有限。
  
  作者写道,前哨淋巴腺切片在收治较多黑色素瘤的中心被广为接受。实际上,在新研究中,若病患是在NCCN或NCI指定医院治疗,有60%的第IB或第II期黑色素瘤病患接受前哨淋巴腺切片,在退伍军人医院有25%、社区医院则有43%进行切片。
  
  尽管发现了适用病患使用前哨淋巴腺切片比率偏低的相关因素,作者们仍寻找有关临床实务运用不佳的其它因素。
  
  他们写道,某些医院的前哨淋巴腺切片使用率偏低的原因仍不清楚。可能是如同本研究发现的,反映出参与照护的皮肤科医师、一般外科医师、肿瘤外科、整形外科、耳鼻喉科医师、肿瘤内科、放射肿瘤科医师等对于指引的不同接受度。
  
  作者认为,或许是因为对此检查的目的不清楚,他们写道,即使此检查的主要目的是提供预后与分期信息,在缺乏对整体存活改善的明确证据下,有些仍会质疑是否常规使用前哨淋巴腺切片。
  
  Lange医师不认为此一切片检查的伤害/利益比率可以用来解释利用率偏低的原因。
  
  她表示,前哨淋巴腺切片是一种低风险手术,但也不是全无风险。有时候加入外科手术中(与单纯广泛切除相较),感染与淋巴囊肿风险较低。再者,前哨淋巴腺切片的四肢水肿风险也低,趋近于零。根据病患的病史与考量,有些案例决定不进行前哨淋巴腺切片是相当合理的。
  
  美国外科医师学院临床奖学金住院医师计画以及西北大学Feinberg医学院外科支持本研究。
  

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.

    
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