April 13, 2011 — Sentinel lymph node (SNL) biopsy alone can accurately diagnose lymph node involvement in patients with early-stage endometrial cancer, according to the results of a prospective multicenter trial published online April 12 in the Lancet Oncology.
The less invasive procedure could be a favorable alternative to either systematic lymphadenectomy, with its inherent complications, or no dissection at all in patients with endometrial cancer of low or intermediate risk, the authors, led by Marcos Ballester, MD, from Tenon University Hospital, Paris, France, write.
"Moreover, our study suggests that SLN biopsy could provide important data to tailor adjuvant therapy," they add.
An expert not involved in the study, Henry C. Kitchener, MD, from the University of Manchester, in the United Kingdom, suggests that SLN biopsy can now be considered standard care in early-stage endometrial cancer and possibly in another gynecologic cancer.
"A full lymphadenectomy can necessitate extensive dissection, which might be time consuming and involve morbidity," Dr. Kitchener writes in an accompanying comment. "SLN detection and biopsy is established practice for melanoma and breast cancer, and will probably become standard of care for vulval cancer within a few years."
Staging of endometrial cancer is important in the planning of effective treatment. Histologic type and grade, as well as the depth of myometrial invasion, are prognostic factors in early-stage disease, but the prognostic relevance of assessing lymph node status using lymphadenectomy is debatable, according to the authors.
Lymphadenectomy, which involves the removal of all the pelvic lymph nodes, has not been shown to have any effect on overall or recurrence-free survival in early-stage disease and has been associated with a higher incidence of early and late complications, including lymphocysts and lymphedema.
Prospective Multicenter Study Is a First
Several studies have shown that SLN identification in endometrial cancer is feasible, but they have been retrospective single-center trials.
SENTI-ENDO was a prospective multicenter study designed to investigate the utility of SLN biopsy in predicting lymph node status in patients with early-stage endometrial cancer.
Between July 2007 and August 2009, 133 patients with early-stage endometrial cancer from 9 centers in France underwent SLN biopsy followed by complete lymphadenectomy, either with laparoscopy or an open approach.
At least 1 SLN was detected in 111 patients of the 125 who were analyzed, the investigators report. Of these 111 patients, 19 (17%) had pelvic lymph-node metastases and 5 (5%) had an associated SLN in the paraaortic area.
The SLN detection rate in the right hemipelvis was 77% (95% confidence interval [CI], 69 to 83), and in the left hemipelvis was 76% (95% CI, 68 to 83); the detection rate per patient was 89% (range, 82% to 93%).
There were no false negatives in any of the cases when the hemipelvis was considered as the unit of analysis, for a negative predictive value of 100% (95% CI, 95 to 100) and a sensitivity of 100% (95% CI, 63 to 100). When the patient was considered as the unit of analysis, 3 patients had false-negative results (2 had metastatic nodes in the contralateral pelvic area and 1 had metastatic nodes in the paraaortic area), for a negative predictive value of 97% (95% CI, 91 to 99) and a sensitivity of 84% (95% CI, 62 to 95). All 3 of these patients had type 2 endometrial cancer.
The study also found that SLN biopsy upstaged 10% of patients with low-risk and 15% of those with intermediate-risk endometrial cancer.
The authors conclude: "Further studies are needed to evaluate the cost-effectiveness of systemic lymphadenectomy compared with lymphoscintigraphy and the SLN procedure, and the effect of the SLN procedure on adjuvant therapies and quality of life."
In his comment, Dr. Kitchener suggests that SNL biopsy, incorporating ultrastaging with immunohistochemistry, might be a "win–win" scenario — a more conservative procedure and a more sensitive means of identifying women at high risk and selecting them for adjuvant therapy."
He added: "The procedure seems feasible (almost 90% of women had detectable SLNs), and it seems reliable in terms of negative predictive value and sensitivity when ultrastaging of SLNs is implemented."
Dr. Ballester and Dr. Kitchener have disclosed no relevant financial relationships.
Lancet Oncol. Published online April 12, 2011. Ballester abstract, Kitchener abstract
The less invasive procedure could be a favorable alternative to either systematic lymphadenectomy, with its inherent complications, or no dissection at all in patients with endometrial cancer of low or intermediate risk, the authors, led by Marcos Ballester, MD, from Tenon University Hospital, Paris, France, write.
"Moreover, our study suggests that SLN biopsy could provide important data to tailor adjuvant therapy," they add.
An expert not involved in the study, Henry C. Kitchener, MD, from the University of Manchester, in the United Kingdom, suggests that SLN biopsy can now be considered standard care in early-stage endometrial cancer and possibly in another gynecologic cancer.
"A full lymphadenectomy can necessitate extensive dissection, which might be time consuming and involve morbidity," Dr. Kitchener writes in an accompanying comment. "SLN detection and biopsy is established practice for melanoma and breast cancer, and will probably become standard of care for vulval cancer within a few years."
Staging of endometrial cancer is important in the planning of effective treatment. Histologic type and grade, as well as the depth of myometrial invasion, are prognostic factors in early-stage disease, but the prognostic relevance of assessing lymph node status using lymphadenectomy is debatable, according to the authors.
Lymphadenectomy, which involves the removal of all the pelvic lymph nodes, has not been shown to have any effect on overall or recurrence-free survival in early-stage disease and has been associated with a higher incidence of early and late complications, including lymphocysts and lymphedema.
Prospective Multicenter Study Is a First
Several studies have shown that SLN identification in endometrial cancer is feasible, but they have been retrospective single-center trials.
SENTI-ENDO was a prospective multicenter study designed to investigate the utility of SLN biopsy in predicting lymph node status in patients with early-stage endometrial cancer.
Between July 2007 and August 2009, 133 patients with early-stage endometrial cancer from 9 centers in France underwent SLN biopsy followed by complete lymphadenectomy, either with laparoscopy or an open approach.
At least 1 SLN was detected in 111 patients of the 125 who were analyzed, the investigators report. Of these 111 patients, 19 (17%) had pelvic lymph-node metastases and 5 (5%) had an associated SLN in the paraaortic area.
The SLN detection rate in the right hemipelvis was 77% (95% confidence interval [CI], 69 to 83), and in the left hemipelvis was 76% (95% CI, 68 to 83); the detection rate per patient was 89% (range, 82% to 93%).
There were no false negatives in any of the cases when the hemipelvis was considered as the unit of analysis, for a negative predictive value of 100% (95% CI, 95 to 100) and a sensitivity of 100% (95% CI, 63 to 100). When the patient was considered as the unit of analysis, 3 patients had false-negative results (2 had metastatic nodes in the contralateral pelvic area and 1 had metastatic nodes in the paraaortic area), for a negative predictive value of 97% (95% CI, 91 to 99) and a sensitivity of 84% (95% CI, 62 to 95). All 3 of these patients had type 2 endometrial cancer.
The study also found that SLN biopsy upstaged 10% of patients with low-risk and 15% of those with intermediate-risk endometrial cancer.
The authors conclude: "Further studies are needed to evaluate the cost-effectiveness of systemic lymphadenectomy compared with lymphoscintigraphy and the SLN procedure, and the effect of the SLN procedure on adjuvant therapies and quality of life."
In his comment, Dr. Kitchener suggests that SNL biopsy, incorporating ultrastaging with immunohistochemistry, might be a "win–win" scenario — a more conservative procedure and a more sensitive means of identifying women at high risk and selecting them for adjuvant therapy."
He added: "The procedure seems feasible (almost 90% of women had detectable SLNs), and it seems reliable in terms of negative predictive value and sensitivity when ultrastaging of SLNs is implemented."
Dr. Ballester and Dr. Kitchener have disclosed no relevant financial relationships.
Lancet Oncol. Published online April 12, 2011. Ballester abstract, Kitchener abstract
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