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© 2000 American Society for Clinical Oncology Prospective Observational Study of Sentinel Lymphadenectomy Without Further Axillary Dissection in Patients With Sentinel Node–Negative Breast CancerFrom the Joyce Eisenberg-Keefer Breast Center, Division of Surgical Oncology, Statistical Coordinating Unit, Department of Nuclear Medicine, and Department of Pathology, John Wayne Cancer Institute at Saint John’s Health Center, Santa Monica, CA. Address reprint requests to Armando E. Giuliano, MD, John Wayne Cancer Institute, 2200 Santa Monica Blvd, Santa Monica, CA 90404; email giulianoa{at}jwci.org
PURPOSE: Immediate complete axillary lymphadenectomy (ALND) after sentinel lymphadenectomy (SLND) has confirmed that tumor-negative sentinel nodes accurately predict tumor-free axillary nodes in breast cancer. Therefore, we hypothesized that SLND alone in patients with tumor-negative sentinel nodes would achieve axillary control, with minimal complications.
PATIENTS AND METHODS: Between October 1995 and July 1997, 133 consecutive women who had primary invasive breast tumors clinically RESULTS: Sentinel nodes were identified in 132 (99%) of 133 patients. Eight patients were excluded from further analysis. Of the 125 assessable patients, 57 had tumor-positive sentinel nodes and one had an unsuccessful mapping procedure; these patients underwent completion ALND. In the remaining 67 patients (54%), SLND was the only axillary procedure. Complications occurred in 20 patients (35%) undergoing ALND after SLND but in only two patients (3%) undergoing SLND alone (P = .001). There were no local or axillary recurrences at a median follow-up of 39 months. CONCLUSION: Complication rates are negligible after SLND alone. An absence of axillary recurrences supports SLND as an accurate staging alternative for breast cancer and suggests that routine ALND can be eliminated for patients with histopathologically negative sentinel nodes.
AXILLARY LYMPH NODE metastasis in patients with early breast cancer is the single most important prognostic factor for recurrence and survival1,2 and forms the basis for important therapeutic decisions.3 A United States National Institutes of Health consensus development conference recommended routine level I and II axillary lymphadenectomy (ALND) for staging and axillary control.4 However, ALND is associated with acute complication rates of 20% to 30% and chronic lymphedema rates of 7% to 37%.5,6 This morbidity is especially distressing because 60% to 70% of patients with clinically negative axillae do not have identifiable nodal metastases and, therefore, are unlikely to benefit from ALND.1-3,7 Sentinel lymphadenectomy (SLND) can stage early, operable breast cancer by identifying one or two lymph nodes (the sentinel nodes) for focused histopathologic examination. Many studies support the concept that the sentinel node is the first lymph node to receive lymphatic drainage from the primary breast cancer and, therefore, the node most likely to contain metastatic tumor cells.8-17 The corollary that a tumor-negative sentinel node predicts the absence of tumor in all other axillary nodes has been documented by intensive immunohistochemical staining of nonsentinel nodes.18 We hypothesized that women who had tumor-free sentinel nodes could forego ALND because their breast cancer would be accurately staged and axillary control maintained by SLND. This study was initiated to determine the complication and recurrence rates in patients undergoing SLND as the sole axillary procedure in the absence of sentinel node metastases.
Consecutive women with invasive breast carcinoma and clinically negative nodes were prospectively entered onto the study between October 17, 1995, and July 31, 1997. Patients who had primary lesions greater than 4 cm by examination or mammography, multifocal tumors, locally advanced disease, or disease diagnosed by large excisional biopsies or formal resections were excluded. The protocol methods were in accordance with the ethical standards of the joint Saint John’s Health Center and John Wayne Cancer Institute Institutional Review Board at Santa Monica, CA, and also complied with the Helsinki Declaration. Written informed consent was obtained from all study participants. Lymphatic mapping and SLND was performed using vital dye. In the last 6 months of the study, patients with medial hemisphere lesions underwent preoperative breast lymphoscintigraphy to document lymphatic drainage to the axilla. Isosulfan blue dye (1% Lymphazurin; Hirsch Industries Inc, Richmond, VA) was injected around the edge of the lesion, or through the localizing needle in the case of a nonpalpable lesion. If an excisional biopsy had been performed, dye was injected into the wall of the biopsy cavity at its periphery. After 3 to 7 minutes, depending on the distance of the tumor from the axilla, the axillary incision was made. Blue-stained afferent lymphatics were identified using blunt dissection and traced to all blue-stained sentinel nodes, which were excised and sent for frozen section. Segmental or total mastectomy was completed. Completion ALND was performed at the time of SLND if no sentinel node was identified or if a frozen section of this node contained tumor cells. ALND was performed as a second procedure after SLND if a permanent section of the sentinel node contained tumor cells revealed by hematoxylin-eosin (H&E) staining and/or immunohistochemistry (IHC). Patients whose sentinel nodes were tumor-free did not undergo ALND. Closed-suction drainage of the axilla was used for all patients undergoing ALND. Axillary drainage was not used for patients undergoing SLND alone. The histopathology of the primary tumor was determined by examination of all original biopsy and re-excision specimens by at least two pathologists. DNA flow cytometry and assays of HER2/neu, estrogen, and progesterone receptor expression were performed by Aeron Laboratories (San Leandro, CA) and by Saint John’s Health Center Pathology Department. Tumors were classified according to American Joint Committee on Cancer guidelines. Sentinel nodes were examined at two step-section levels of the paraffin block separated by 40 µm and stained at each level by H&E and by cytokeratin IHC with the monoclonal anticytokeratin antibody cocktail (Zymed Laboratories, San Francisco, CA) if the H&E stains did not reveal metastases. The decision for adjuvant radiation therapy or systemic therapy was individualized and made by the medical oncologist and the patient. External-beam radiation was recommended after segmental mastectomy. Patients received 46 to 50 Gy to the whole breast as tangential fields, with a boost to the tumor bed to a total of at least 60 Gy. No patient received dedicated radiation fields to the axilla. No patient who underwent modified radical mastectomy received chest wall radiation. Adjuvant chemotherapy consisted of four cycles of doxorubicin and cyclophosphamide or six cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF). Adjuvant hormonal therapy consisted of tamoxifen. Patients were examined at 1, 2, and 4 weeks after operation and then at 6-month intervals or more frequently as necessary. Mammography was performed biannually for the first 2 years and then annually.
Statistical analysis used Fisher’s exact test for comparison of tumor size in the two groups. For comparisons of tumor histology, differentiation and histologic markers, and surgical complications between the two groups, the
Between October 17, 1995, and July 31, 1997, 133 patients were entered onto the study. Eight patients were excluded from further analysis; three elderly patients with sentinel node micrometastases refused ALND, and five patients with tumor-free sentinel nodes underwent mastectomy for unsuspected multifocal carcinoma and had several tumor-negative nonsentinel lymph nodes removed in the axillary tail. Although excluded from analysis, these patients remain free of tumor. Characteristics of the remaining 125 patients are listed in Table 1. Mean age was 58 years. Sixty-seven patients (54%) had palpable tumors, and 58 patients (46%) had nonpalpable primary tumors detected by mammography or ultrasonography. Histopathologic diagnosis was obtained by excisional biopsy in 61 patients (49%), core needle biopsy in 35 (28%), and fine-needle aspiration cytology in 29 (23%). Primary tumors were located in the outer quadrants in 93 patients (74%), the inner quadrants in 23 (18%), and the subareolar region in nine (7%). One hundred nineteen patients (95%) chose breast conservation and underwent segmental mastectomy; six (5%) were not candidates for breast conservation or chose total mastectomy.
In general, patients had relatively small primary tumors with favorable prognostic factors (Table 2). American Joint Committee on Cancer pathologic staging criteria identified 57 stage I patients (46%), 46 stage IIa (37%), 19 stage IIb (15%), and three stage IIIa patients (2%). The three stage IIIa patients had tumors less than 4 cm by clinical and mammographic criteria but greater than 5 cm on histopathologic evaluation. Not surprisingly, primary tumors were smaller in the patients who underwent SLND without ALND, reflecting the fact that larger tumors have an increased incidence of sentinel node metastases. Also, tumors in patients who underwent SLND without ALND were more often histologically well-differentiated.
SLND was successful in 124 (99%) of 125 patients. The mean number of sentinel nodes removed was 2.1 per patient. In the one patient whose SLND was unsuccessful, ALND was performed, and one positive node was present in the specimen. The sentinel node was free of metastases in 67 patients; these patients underwent segmental mastectomy and did not undergo ALND. Sentinel nodes contained metastases in 57 patients (Table 3); 31 patients underwent ALND immediately after SLND, and 26 underwent ALND as a second procedure because frozen section failed to reveal tumor cells subsequently identified in a permanent section, usually by IHC.
Complications significantly increased when SLND was followed by ALND instead of being performed alone. The overall complication rate was higher in the SLND alone group than in the SLND plus ALND group (P = .001). Twenty (35%) of 58 patients who underwent ALND developed axillary complications, including seroma (nine patients), wound infection (three patients), hematoma (four patients), and chronic lymphedema (four patients). In contrast, only two (3%) of 67 patients who underwent SLND without ALND developed local axillary wound complications, one superficial cellulitis and one seroma. No patient undergoing SLND without ALND experienced numbness or paresthesia of skin over the intercostobrachial nerve distribution. Adjuvant systemic therapy was administered to 33 patients (49%) undergoing SLND without ALND; 23 patients (34%) received tamoxifen alone, five (8%) received CMF, four (6%) received doxorubicin and cyclophosphamide, and one (2%) received CMF plus tamoxifen. Adjuvant radiation therapy was given to 66 (98.5%) of 67 patients; one patient refused radiation. Median follow-up was 39 months, with a minimum of 24 months in survivors. Maximum follow-up was 51 months. In the 67 patients who underwent SLND without ALND, there was no evidence of local or regional recurrence. One patient in this group developed a second primary breast cancer in the contralateral breast at 33 months and then developed bone metastases at 50 months. One patient developed ovarian carcinoma at 22 months. An additional patient died at 12 months of liver failure from biopsy-proven angiosarcoma.
The purpose of ALND is three-fold: to stage the cancer, to obtain axillary control, and perhaps to improve survival. For staging purposes, a level I and II ALND accurately determines the tumor status of the axillary lymph nodes and has been recommended as the standard staging technique for patients with primary breast cancer.3,4 Before a staging procedure of lesser extent is accepted, comparable diagnostic accuracy must be demonstrated. In our prior studies, to confirm the accuracy of SLND, completion ALND was performed after SLND.9,10 In the last 107 SLND cases performed with concurrent ALND, the sentinel node was 100% predictive of axillary node status.10 To further determine the accuracy of SLND, we used multiple sections and IHC to evaluate all nonsentinel axillary nodes from patients whose sentinel nodes were free of tumor by H&E and IHC. Review of 1,087 nonsentinel nodes from 60 patients with tumor-free sentinel nodes identified only one tumor-positive nonsentinel node.18 This validated our initial hypothesis that the histopathologic status of the sentinel node accurately reflects the status of the remaining axillary nodes in women with breast cancer, and it provided the impetus for the present study. The validity of SLND for staging breast cancer has been confirmed in many other studies. Using vital dye and/or radiocolloid, investigators have identified sentinel nodes with success rates of 82% to 98% and have predicted the tumor status of axillary nodes with accuracy rates between 95% and 100%.8-17 The false-negative rate of SLND in the literature varies and cannot be attributed to any one factor. Some investigators presumed that an excisional biopsy would increase false-negative cases and, therefore, limited SLND to patients who were diagnosed by needle biopsies. However, after excluding patients who underwent excisional biopsy, two large series reported false-negative SLND rates of 5%13 and 5.6%.17 We have not found excisional biopsy to be a confounding factor.19 Location of the tumor may influence the false-negative rate. A multicenter trial of SLND using intraoperative gamma probe localization had an overall false-negative rate of 11.4%, and all were cases with tumors in the lateral half of the breast.15 This may be the major limitation of radioguided surgery. Radiocolloid at the primary injection site may mask the true sentinel nodes that are situated close to the primary site. No single technical or patient parameter seems to predict a false-negative result. The surgeon who performs SLND must document a high rate of sentinel node identification and a low rate of falsely negative sentinel nodes before abandoning ALND as a staging technique in breast cancer patients with tumor-free sentinel nodes. A high identification rate requires ascent of the initial learning curve. In a study that assessed the failure rates of five surgeons who performed a total of 700 cases of SLND, failure to identify sentinel nodes sharply diminished after about 20 cases, and success rates of 90% and 95% were reached after an average of 23 and 53 cases, respectively.20 The absolute number of cases required to achieve a low false-negative rate is less clear. A recent study reported that most false-negative cases occur in a surgeon’s first 15 cases; as more cases are performed, the false-negative rate will stabilize at about 2% to 5% but likely will never drop to zero.21 SLND without ALND in sentinel node–negative patients requires not only surgical proficiency but also contributions by colleagues from pathology and nuclear medicine. During the initial learning phase, the surgeon must validate the success of the entire team by performing ALND immediately after SLND, regardless of sentinel node pathology. The major advantage of SLND is the lower complication rate compared with ALND. Significant postoperative pain and limitation in arm motion may be present after ALND and may delay resumption of normal activities and return to work.5,6 In contrast, most patients undergoing SLND have minimal postoperative discomfort and can resume normal activities within 1 or 2 days. Chronic lymphedema, the most debilitating sequela of ALND, has not been observed after SLND alone and is unlikely to occur in such patients. ALND with its associated complications can also adversely affect quality of life.22,23 Although this issue was not directly assessed in our study, the fact that SLND is a minimally invasive procedure with fewer complications than ALND indicates that SLND should have little impact on quality of life. A second expected advantage of SLND is lower cost because SLND requires less operative time than ALND, is performed on an outpatient basis, can be undertaken with local anesthesia and intravenous sedation, and requires no axillary drainage. However, the cost of care increases for those patients who require a second operation because of sentinel node metastases not detected by frozen section. This issue was addressed by Veronesi et al,24 who used intraoperative IHC in an attempt to diminish the false-negative rate of frozen section. However, this approach is time-consuming and expensive. ALND provides excellent axillary regional control, with axillary recurrence in less than 2% of patients.25-27 However, the utility of such a procedure that is associated with potentially debilitating complications has been questioned because most patients who undergo ALND have no nodal metastases. Indeed, with the reduction of breast cancer size and nodal positivity at diagnosis in recent years, about two thirds of patients with early breast cancer have negative axillary nodes by standard pathologic techniques.7 These patients are unlikely to benefit from routine ALND. In the current study, if the sentinel nodes were examined using standard histopathologic processing with H&E alone, 89 (82%) of 124 patients would have been classified as sentinel node–negative. Ultrastaging based on cytokeratin IHC at two step-section levels of the sentinel node identified metastases in an additional 22 patients. Although the clinical significance of isolated cytokeratin-positive cells in lymph nodes remains controversial, ALND was performed on these patients per protocol. When this trial began in 1995, the results of SLND were not widely accepted, and we did not wish to understage any cancers. This decreased to 54% the proportion of women who were sentinel node–negative and who, therefore, received SLND only. Thus, 67 patients underwent SLND as the solitary axillary staging procedure and avoided ALND. Patients with small tumors and histopathologically negative sentinel nodes may choose not to receive adjuvant systemic therapy. Even if adjuvant systemic therapy is recommended because of the patient’s age, primary tumor size, or other primary tumor prognostic factors, the patient will have avoided the morbidity of ALND, but the breast cancer still will be accurately staged. At a median follow-up of 39 months in the current study, no patient with tumor-negative sentinel nodes had developed axillary recurrence. If metastatic disease remained in the nonsentinel axillary nodes after SLND, a higher axillary recurrence rate might have been expected. In the National Surgical Adjuvant Breast and Bowel Project (NSABP)-04 study, women with clinically negative axillary nodes underwent total mastectomy without radiation; low axillary nodes were removed in many of these patients. The overall axillary recurrence rate was 18% at 10 years of follow-up,28,29 and more than three quarters of these patients developed an axillary recurrence within 2 years. In the Manchester trial, 359 clinically node-negative patients with early breast cancers who underwent simple mastectomy alone had an axillary recurrence rate of 33% at 5 years and 37% at 10 years of follow-up.30 Finally, Kjaergaard et al27 evaluated axillary recurrence as a function of the number of negative nodes removed in 3,114 low-risk breast cancer patients undergoing partial axillary dissection; they concluded that the axillary recurrence rate was inversely related to the number of excised tumor-negative nodes. Although the majority of our patients had smaller tumors and their follow-up was shorter than in these three trials, it is encouraging that none of our patients have recurred in the axilla. Patients in the NSABP-04, Manchester, and Kjaergaard trials were not given adjuvant systemic therapy, whereas about half of the sentinel node–negative patients in our study received either adjuvant chemotherapy or hormonal therapy. Adjuvant systemic therapy has been shown to decrease the risk of local and regional recurrences,31-33 and therefore may in part be responsible for the lack of axillary failures in patients with tumor-negative sentinel nodes. However, to what degree adjuvant systemic therapy decreases the rate of axillary failures in patients not undergoing ALND is difficult to predict because no randomized trials of adjuvant therapy in node-negative women have been performed without ALND. In our study, the decision for or against systemic adjuvant therapy was made by the medical oncologist and was generally based on primary tumor features and patient age. In a prior study, we found that identification of tumor in the sentinel nodes of patients with T1 breast cancer and nonpalpable nodes increased the use of systemic therapy from 26% to 38%, depending on menopausal status.34 An interesting question that was not formally addressed in the current study is whether the absence of sentinel node metastases eliminated adjuvant systemic therapy from the management plan. According to recent guidelines,35 of the 67 patients in our study who did not have sentinel node metastases, 37 (55%) should have received adjuvant therapy; in fact, only 33 of these patients did receive such therapy. The recommendations for adjuvant therapy in the future may need to be re-evaluated with respect to the tumor status of the sentinel nodes. In addition to systemic therapy, although none of our patients received dedicated radiation to the axilla, usually the lower axilla receives radiation as a result of incorporation of the axillary tail of the breast into the tangential fields. Radiation also may have contributed to the excellent axillary control in the sentinel node–negative patients. Nevertheless, the point is academic because most patients treated with breast-conserving surgery, regardless of the extent of axillary dissection, usually receive adjuvant whole-breast radiation with opposing tangential fields. No patient in this study received a third radiation port to the axillary or supraclavicular nodes. Practically, SLND integrates nicely with adjuvant systemic therapy and whole breast radiotherapy. The combination provides excellent local and regional control with accurate staging and treatment planning. The last purported goal of ALND is to improve survival. However, the truly node-negative patient will not benefit from the removal of normal lymph nodes. Are the sentinel node–negative patients in our study at a survival disadvantage because they did not undergo ALND? Our answer is no because only one patient has developed metastatic breast cancer. However, this series is too small to detect slight differences in survival. Currently, there are no other survival data for patients who do not undergo ALND because they have tumor-negative sentinel nodes. Although our previous studies using IHC have demonstrated the absence of tumor in nonsentinel axillary nodes,18 we cannot exclude the possibility that these patients have subclinical nonsentinel metastases not detected by IHC that might become clinically significant in time. Large multicenter trials are required to answer these issues. Two such studies in North America are actively accruing patients. The NSABP-32 trial randomizes patients with invasive breast cancer and tumor-negative sentinel nodes to ALND or no ALND. The American College of Surgeons Oncology Group Z0010 trial is a prospective evaluation of the significance of bone marrow and sentinel node micrometastases in breast cancer patients whose sentinel nodes are negative when processed by H&E. Sentinel nodes from these patients are processed by IHC in a blinded manner, and all patients are treated with SLND only. The Z0011 trial randomizes any patients with sentinel nodes that are tumor-positive by H&E to receive either ALND or no ALND. The hope is that these trials will support our conclusions and definitively answer whether SLND can replace ALND in the management of many patients with breast cancer. Before ALND is abandoned as a routine procedure in patients with tumor-negative sentinel nodes, SLND must be validated by completion ALND to ensure a low false-negative rate. Once the surgeon has demonstrated a high success rate with SLND, we have provided evidence that suggests ALND is not required in patients with sentinel nodes which are tumor-free by both H&E and cytokeratin IHC. SLND achieves the goal of accurate staging without sacrificing axillary control and will spare patients with tumor-free sentinel nodes the morbidity of ALND.
Supported in part by funding from the Ben B. and Joyce E. Eisenberg Foundation, Los Angeles, CA, and the Fashion Footwear Association of New York, New York, NY. We thank Brent A. Blumenstein, PhD, for critical review of the manuscript.
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Krag D, Weaver D, Ashikaga T, et al: The sentinel node in breast cancer. N Engl J Med 339:941-946, 1998 16. Borgstein PJ, Pijpers R, Comans EF, et al: Sentinel lymph node biopsy in breast cancer: Guidelines and pitfalls of lymphoscintigraphy and gamma probe detection. J Am Coll Surg 186:275-283, 1998[Medline] 17. De Cicco C, Cremonesi M, Luini A, et al: Lymphoscintigraphy and radioguided biopsy of the sentinel axillary node in breast cancer. J Nucl Med 12:2080-2084, 1998 18. Turner RR, Ollila DW, Krasne DL, et al: Histopathological validation of the sentinel node hypothesis in breast cancer. Ann Surg 226:271-278, 1997[Medline] 19. Haigh PI, Hansen NM, Qi K, et al: Method of biopsy and excision volume do not affect success rate of subsequent sentinel lymph node dissection in breast cancer. Ann Surg Oncol 7:21-27, 2000[Medline] 20. Cox CE, Bass SS, Boulware D, et al: Implementation of a new surgical technology: Outcome measures for lymphatic mapping of breast carcinoma. Ann Surg Oncol 6:553-561, 1999[Medline] 21. Cody HS III, Hill ADK, Tran KN, et al: Credentialing for breast lymphatic mapping: How many cases are enough? Ann Surg 229:723-728, 1999[Medline]
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Copyright © 2000 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
4 cm in diameter and no axillary lymphadenopathy were prospectively entered onto a trial of SLND using vital blue dye. Sentinel nodes were examined by standard microscopy or immunohistochemistry. SLND was the only axillary surgery if sentinel nodes were tumor-free. Completion ALND was performed only if sentinel nodes contained metastases or if they were not identified. Excluded from subsequent analysis were patients with unsuspected multifocal carcinoma and those who refused completion ALND. The complication and axillary recurrence rates after SLND without ALND were determined. 
2 statistic was used. Statistical significance was determined by using an alpha level of 0.05 and two-sided t tests. Microsoft Access database software (Microsoft Corporation, Redmond, WA) and SAS statistical software (SAS Institute Inc, Cary, NC) were used for compilation of data and statistical analysis, respectively. 
