Effect of Occult Metastases on Survival in Node-Negative Breast Cancer
The authors detected isolated tumor-cell clusters in otherwise negative nodes in 16% of women with breast cancer. The 5-year estimates of survival were 94.6% among women with occult nodal spread and 95.8% among those without occult nodal spread. A landmark 1948 article by Saph and Amromin showed tha...
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| Published in | The New England journal of medicine Vol. 364; no. 5; pp. 412 - 421 |
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| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Waltham, MA
Massachusetts Medical Society
03.02.2011
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| Subjects | |
| Online Access | Get full text |
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| Abstract | The authors detected isolated tumor-cell clusters in otherwise negative nodes in 16% of women with breast cancer. The 5-year estimates of survival were 94.6% among women with occult nodal spread and 95.8% among those without occult nodal spread.
A landmark 1948 article by Saph and Amromin showed that the routine analysis of lymph nodes in breast cancer was insufficient to detect all metastases present.
1
Although the practice of additional pathological analysis was not adopted, the concept of occult metastases (metastases that are not detected initially but are detected with further evaluation) was introduced and has been the subject of considerable research and controversy over the ensuing decades.
2
–
4
The National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-32 was designed to evaluate whether sentinel-lymph-node biopsy alone was equivalent to complete axillary dissection with respect to overall survival . . . |
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| AbstractList | Retrospective and observational analyses suggest that occult lymph-node metastases are an important prognostic factor for disease recurrence or survival among patients with breast cancer. Prospective data on clinical outcomes from randomized trials according to sentinel-node involvement have been lacking.BACKGROUNDRetrospective and observational analyses suggest that occult lymph-node metastases are an important prognostic factor for disease recurrence or survival among patients with breast cancer. Prospective data on clinical outcomes from randomized trials according to sentinel-node involvement have been lacking.We randomly assigned women with breast cancer to sentinel-lymph-node biopsy plus axillary dissection or sentinel-lymph-node biopsy alone. Paraffin-embedded tissue blocks of sentinel lymph nodes obtained from patients with pathologically negative sentinel lymph nodes were centrally evaluated for occult metastases deeper in the blocks. Both routine staining and immunohistochemical staining for cytokeratin were used at two widely spaced additional tissue levels. Treating physicians were unaware of the findings, which were not used for clinical treatment decisions. The initial evaluation at participating sites was designed to detect all macrometastases larger than 2 mm in the greatest dimension.METHODSWe randomly assigned women with breast cancer to sentinel-lymph-node biopsy plus axillary dissection or sentinel-lymph-node biopsy alone. Paraffin-embedded tissue blocks of sentinel lymph nodes obtained from patients with pathologically negative sentinel lymph nodes were centrally evaluated for occult metastases deeper in the blocks. Both routine staining and immunohistochemical staining for cytokeratin were used at two widely spaced additional tissue levels. Treating physicians were unaware of the findings, which were not used for clinical treatment decisions. The initial evaluation at participating sites was designed to detect all macrometastases larger than 2 mm in the greatest dimension.Occult metastases were detected in 15.9% (95% confidence interval [CI], 14.7 to 17.1) of 3887 patients. Log-rank tests indicated a significant difference between patients in whom occult metastases were detected and those in whom no occult metastases were detected with respect to overall survival (P=0.03), disease-free survival (P=0.02), and distant-disease-free interval (P=0.04). The corresponding adjusted hazard ratios for death, any outcome event, and distant disease were 1.40 (95% CI, 1.05 to 1.86), 1.31 (95% CI, 1.07 to 1.60), and 1.30 (95% CI, 1.02 to 1.66), respectively. Five-year Kaplan-Meier estimates of overall survival among patients in whom occult metastases were detected and those without detectable metastases were 94.6% and 95.8%, respectively.RESULTSOccult metastases were detected in 15.9% (95% confidence interval [CI], 14.7 to 17.1) of 3887 patients. Log-rank tests indicated a significant difference between patients in whom occult metastases were detected and those in whom no occult metastases were detected with respect to overall survival (P=0.03), disease-free survival (P=0.02), and distant-disease-free interval (P=0.04). The corresponding adjusted hazard ratios for death, any outcome event, and distant disease were 1.40 (95% CI, 1.05 to 1.86), 1.31 (95% CI, 1.07 to 1.60), and 1.30 (95% CI, 1.02 to 1.66), respectively. Five-year Kaplan-Meier estimates of overall survival among patients in whom occult metastases were detected and those without detectable metastases were 94.6% and 95.8%, respectively.Occult metastases were an independent prognostic variable in patients with sentinel nodes that were negative on initial examination; however, the magnitude of the difference in outcome at 5 years was small (1.2 percentage points). These data do not indicate a clinical benefit of additional evaluation, including immunohistochemical analysis, of initially negative sentinel nodes in patients with breast cancer. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00003830.).CONCLUSIONSOccult metastases were an independent prognostic variable in patients with sentinel nodes that were negative on initial examination; however, the magnitude of the difference in outcome at 5 years was small (1.2 percentage points). These data do not indicate a clinical benefit of additional evaluation, including immunohistochemical analysis, of initially negative sentinel nodes in patients with breast cancer. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00003830.). Background Retrospective and observational analyses suggest that occult lymph-node metastases are an important prognostic factor for disease recurrence or survival among patients with breast cancer. Prospective data on clinical outcomes from randomized trials according to sentinel-node involvement have been lacking. Methods We randomly assigned women with breast cancer to sentinel-lymph-node biopsy plus axillary dissection or sentinel-lymph-node biopsy alone. Paraffin-embedded tissue blocks of sentinel lymph nodes obtained from patients with pathologically negative sentinel lymph nodes were centrally evaluated for occult metastases deeper in the blocks. Both routine staining and immunohistochemical staining for cytokeratin were used at two widely spaced additional tissue levels. Treating physicians were unaware of the findings, which were not used for clinical treatment decisions. The initial evaluation at participating sites was designed to detect all macrometastases larger than 2 mm in the greatest dimension. Results Occult metastases were detected in 15.9% (95% confidence interval [CI], 14.7 to 17.1) of 3887 patients. Log-rank tests indicated a significant difference between patients in whom occult metastases were detected and those in whom no occult metastases were detected with respect to overall survival (P=0.03), disease-free survival (P=0.02), and distant-disease-free interval (P=0.04). The corresponding adjusted hazard ratios for death, any outcome event, and distant disease were 1.40 (95% CI, 1.05 to 1.86), 1.31 (95% CI, 1.07 to 1.60), and 1.30 (95% CI, 1.02 to 1.66), respectively. Five-year Kaplan-Meier estimates of overall survival among patients in whom occult metastases were detected and those without detectable metastases were 94.6% and 95.8%, respectively. Conclusions Occult metastases were an independent prognostic variable in patients with sentinel nodes that were negative on initial examination; however, the magnitude of the difference in outcome at 5 years was small (1.2 percentage points). These data do not indicate a clinical benefit of additional evaluation, including immunohistochemical analysis, of initially negative sentinel nodes in patients with breast cancer. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00003830 .) The authors detected isolated tumor-cell clusters in otherwise negative nodes in 16% of women with breast cancer. The 5-year estimates of survival were 94.6% among women with occult nodal spread and 95.8% among those without occult nodal spread. A landmark 1948 article by Saph and Amromin showed that the routine analysis of lymph nodes in breast cancer was insufficient to detect all metastases present. 1 Although the practice of additional pathological analysis was not adopted, the concept of occult metastases (metastases that are not detected initially but are detected with further evaluation) was introduced and has been the subject of considerable research and controversy over the ensuing decades. 2 – 4 The National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-32 was designed to evaluate whether sentinel-lymph-node biopsy alone was equivalent to complete axillary dissection with respect to overall survival . . . Retrospective and observational analyses suggest that occult lymph-node metastases are an important prognostic factor for disease recurrence or survival among patients with breast cancer. Prospective data on clinical outcomes from randomized trials according to sentinel-node involvement have been lacking. We randomly assigned women with breast cancer to sentinel-lymph-node biopsy plus axillary dissection or sentinel-lymph-node biopsy alone. Paraffin-embedded tissue blocks of sentinel lymph nodes obtained from patients with pathologically negative sentinel lymph nodes were centrally evaluated for occult metastases deeper in the blocks. Both routine staining and immunohistochemical staining for cytokeratin were used at two widely spaced additional tissue levels. Treating physicians were unaware of the findings, which were not used for clinical treatment decisions. The initial evaluation at participating sites was designed to detect all macrometastases larger than 2 mm in the greatest dimension. Occult metastases were detected in 15.9% (95% confidence interval [CI], 14.7 to 17.1) of 3887 patients. Log-rank tests indicated a significant difference between patients in whom occult metastases were detected and those in whom no occult metastases were detected with respect to overall survival (P=0.03), disease-free survival (P=0.02), and distant-disease-free interval (P=0.04). The corresponding adjusted hazard ratios for death, any outcome event, and distant disease were 1.40 (95% CI, 1.05 to 1.86), 1.31 (95% CI, 1.07 to 1.60), and 1.30 (95% CI, 1.02 to 1.66), respectively. Five-year Kaplan-Meier estimates of overall survival among patients in whom occult metastases were detected and those without detectable metastases were 94.6% and 95.8%, respectively. Occult metastases were an independent prognostic variable in patients with sentinel nodes that were negative on initial examination; however, the magnitude of the difference in outcome at 5 years was small (1.2 percentage points). These data do not indicate a clinical benefit of additional evaluation, including immunohistochemical analysis, of initially negative sentinel nodes in patients with breast cancer. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00003830.). |
| Author | Ashikaga, Takamaru Skelly, Joan M Harlow, Seth P Anderson, Stewart J Mamounas, Eleftherios P Krag, David N Weaver, Donald L Julian, Thomas B Wolmark, Norman |
| Author_xml | – sequence: 1 givenname: Donald L surname: Weaver fullname: Weaver, Donald L – sequence: 2 givenname: Takamaru surname: Ashikaga fullname: Ashikaga, Takamaru – sequence: 3 givenname: David N surname: Krag fullname: Krag, David N – sequence: 4 givenname: Joan M surname: Skelly fullname: Skelly, Joan M – sequence: 5 givenname: Stewart J surname: Anderson fullname: Anderson, Stewart J – sequence: 6 givenname: Seth P surname: Harlow fullname: Harlow, Seth P – sequence: 7 givenname: Thomas B surname: Julian fullname: Julian, Thomas B – sequence: 8 givenname: Eleftherios P surname: Mamounas fullname: Mamounas, Eleftherios P – sequence: 9 givenname: Norman surname: Wolmark fullname: Wolmark, Norman |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23824261$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/21247310$$D View this record in MEDLINE/PubMed |
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| CODEN | NEJMAG |
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| Cites_doi | 10.1111/j.2517-6161.1972.tb00899.x 10.1016/S1470-2045(10)70207-2 10.1002/1097-0142(19890101)63:1<181::AID-CNCR2820630129>3.0.CO;2-H 10.1097/00000478-200306000-00018 10.2307/2281868 10.1007/978-1-4757-3656-4 10.1093/jnci/djq008 10.1097/PAS.0b013e3181b274e7 10.1200/JCO.2005.08.001 10.1002/(SICI)1097-0142(20000301)88:5<1099::AID-CNCR22>3.0.CO;2-7 10.1038/modpathol.2010.36 10.1002/1097-0142(194807)1:2<238::AID-CNCR2820010208>3.0.CO;2-U 10.1245/s10434-007-9513-6 10.1200/jco.2010.28.18_suppl.cra504 10.1002/(SICI)1097-0142(19971001)80:7<1188::AID-CNCR2>3.0.CO;2-H 10.1016/S1470-2045(07)70278-4 |
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| Snippet | The authors detected isolated tumor-cell clusters in otherwise negative nodes in 16% of women with breast cancer. The 5-year estimates of survival were 94.6%... Retrospective and observational analyses suggest that occult lymph-node metastases are an important prognostic factor for disease recurrence or survival among... Background Retrospective and observational analyses suggest that occult lymph-node metastases are an important prognostic factor for disease recurrence or... |
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| Title | Effect of Occult Metastases on Survival in Node-Negative Breast Cancer |
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