Mark D. Ebert

Learning curves for breast cancer sentinel lymph node mapping based on surgical volume analysis

BACKGROUND Implementation of new procedures, including lymphatic mapping for breast cancer, must be done and overseen by the medical community in a responsible way to ensure that the procedures are performed correctly. This study addresses the issues of adequacy of training and certification of surgeons performing lymphatic mapping. Ensuring quality in surgical care requires outcomes measures that are described in this study. STUDY DESIGN Sixteen surgeons performed lymphatic mapping in 2,255 patients with breast cancer using a combination blue dye and Tc99m-labeled sulfur colloid to identify the sentinel lymph nodes (SLNs). All participants were trained in a 2-day CME-accredited course. The Cox learning curve model (total number of mapping failures/total number of mapping cases) for a consecutive series of lymphatic mapping cases is described. The relationship of the Surgical Volume Index, the cases performed in a 30-day period, to the failure rate for each surgeon was modeled as a logistic regression curve (y = e(a+bx)/[1 + e(a+bx)]). RESULTS Surgeons performing less than three SLN biopsies per month had an average success rate of 86.23% +/- 8.30%. Surgeons performing three to six SLN biopsies per month had a success rate of 88.73% +/- 6.36%. Surgeons performing more than six SLN biopsies per month had a success rate of 97.81% +/- 0.44%. CONCLUSIONS This experience defines a learning curve for lymphatic mapping in breast cancer patients. Data suggest that increased volumes lead to decreased failure rates. These data provide surgeons performing SLN biopsy with a new paradigm for assessing their skill and adequacy of training and describes the relationship between volume of cases performed and success rate of SLN detection.

Age and Body Mass Index May Increase the Chance of Failure in Sentinel Lymph Node Biopsy for Women with Breast Cancer

Age and body mass index (BMI) have been shown to correlate with an increased incidence of failure in identifying a sentinel lymph node (SLN). Mapping senior, overweight adults is common; therefore, the relationship of patient age and BMI on SLN biopsy success is essential. This study examines the mapping failures as they relate to age and BMI. From April 1994 to May 1999, patients underwent an injection of radiocolloid (450 mci) and blue dye (5 cc) prior to SLN biopsy. SLN biopsy failure was defined as lymph nodes being unidentifiable by blue dye or having an in vivo node radiocolloid count of less than 3:1 over background count. BMI was measured as (weight in pounds)(703)/(height in inches) 2; 1,356 patients were attempted for SLN mapping, and 54 failed (3.98%). The radioactive node count was inversely proportional to age ( p < 0.0001). The radioactive node count decreased by a mean of 34 counts per node with each additional year ( p < 0.001). The estimated odds ratios for success were 0.945 for age and 0.946 for BMI. Therefore, every increase of 1 year of age or one unit of BMI decreased the odds of success by approximately 5%. The mean BMI was 29.54 in failed patients and was 26.42 in successful mapping patients ( p = 0.042). Surgeons should be aware that node counts will decrease with increasing age and that increased age and BMI are potential risk factors for SLN mapping failure. However, increased age and/or BMI alone do not appear to be contraindications for SLN biopsy in older or overweight patients.

Benign mechanical transport of breast epithelial cells to sentinel lymph nodes

The evaluation of sentinel lymph nodes (SLNs) for the presence of malignant epithelial cells is essential to the staging of breast cancer patients. Recently, increased attention has focused on the possibility that epithelial cells may reach SLNs by benign mechanical means, rather than by metastasis. The purpose of this study was to test the hypothesis that pre-SLN biopsy breast massage, which we currently use to facilitate the localization of SLNs, might represent a mode of benign mechanical transport. We studied 56 patients with invasive and/or in situ ductal carcinoma and axillary SLNs with only epithelial cells and/or cell clusters (≤0.2 mm in diameter and not associated with features of established metastases) detected predominantly in subcapsular sinuses of SLNs on hematoxylin and eosin- and/or anti-cytokeratin-stained sections. No patient had an SLN involved by either micro- or macro-metastatic carcinoma. Epithelial cells and cell clusters, ≤0.2 mm in size and without features of established metastases, occurred more frequently in the SLNs of patients who underwent pre-SLN biopsy breast massage (P < 0.001, χ2 test). The latter finding supports the hypothesis that pre-SLN biopsy breast massage is a mode of benign mechanical transport of epithelial cells to SLNs.

Radioactive seed localization breast biopsy and lumpectomy: can specimen radiographs be eliminated?

AbstractBackground: Wire localization (WL) is the current standard for surgical diagnosis of nonpalpable breast lesions. Many disadvantages inherent to WL are solved with radioactive seed localization (RSL). This trial investigated the ability of RSL to reduce the need for specimen radiographs and operating room delays associated with WL. Methods: A total of 134 women were entered onto an institutional review board–approved study. RSL was performed by placing a titanium seed containing .29 to 20 mCi of iodine-125 to within 1 cm of the suggestive breast lesion. The surgeon used a handheld gamma detector to locate and excise the iodine-125 seed and the lesion. Results: Specimen radiographs were eliminated in 98 (79%) of 124 patients. Surgical seed retrieval was 100% in 124 patients. No seed migration occurred after correct radiographical placement. A total of 26 (21%) of 124 patients required a specimen radiograph; 22 (85%) of these 26 were performed for microcalcifications. Conclusions: After surgical removal, RSL can eliminate specimen radiographs when the radiologist accurately places the seed and the pathologist grossly identifies the lesion. If small microcalcifications are noted before surgery, then specimen radiographs may be necessary. RSL reduced requirements for specimen radiographs, decreased OR time, improved incision placement, and improved resections to clear margins.

Completion axillary lymph node dissection minimizes the likelihood of false negatives for patients with invasive breast carcinoma and cytokeratin positive only sentinel lymph nodes

OBJECTIVE To document the incidence of metastatic disease in complete axillary lymph node dissections (CALND) of patients with invasive carcinoma after a sentinel lymph node (SLN) biopsy, positive only by immunohistochemical staining for cytokeratin (CK-IHC). METHODS Sections of all SLNs, negative by routine histology, were immunostained and examined for cytokeratin positive cells. Sections of lymph nodes from CALND specimens were interpreted using routine hematoxylin and eosin (H&E) staining. RESULTS A total of 409 patients (29.6%) had metastatic disease in at least one sentinel lymph node on H&E examination. Of 971 H&E negative patients, 78 (8.0%) were positive only by CK-IHC. Sixty-two of the CK-IHC positive only patients underwent CALND. Nine of these 62 patients (14.5%) had metastases identified in the CALND specimen. CONCLUSIONS Because 14.5% of patients with invasive breast cancer and SLNs positive only by CK-IHC were found to have H&E positive lymph nodes on CALND, we conclude first, that CK-IHC should be used to evaluate SLNs, and second, that CALND should be considered when SLNs are positive by CK-IHC only. This approach will result in an absolute reduction of the false negative rate (absolute false negative rate reduced by 2.6% in our series).

Breast cancer in patients with prior augmentation: Presentation, stage, and lymphatic mapping

The purpose of this study was to determine whether breast cancer patients who had prior breast augmentation presented at a more advanced stage than nonaugmented breast cancer patients, and to determine the mode of presentation and effectiveness of lymphatic mapping and sentinel lymph node biopsy in this same group of patients. A total of 4186 breast cancer patients from 1987 to 2002 were reviewed. Patients who had augmentation before their diagnosis of breast cancer were compared with a control group of nonaugmented breast cancer patients. The Wilcoxon rank sum test was used to compare tumor size, node positivity, and stage. The patient’s age at presentation was also compared by the two-sided pooled t test. Seventy-six patients who previously underwent augmentation were identified with 78 breast cancers. Seventy percent (48 of 69) were initially detected by palpation, whereas 30 percent (21 of 69) were initially identified mammographically. Fifty-three percent (n = 41) underwent mastectomy and 47 percent (n = 37) underwent a lumpectomy. This compares with a 63.6 percent (2615 of 4110) breast conservation rate in the nonaugmented population during the same time period. The two groups did not differ regarding (tumor) size (p = 0.77), nodal positivity (p = 0.32), or stage (p = 0.34). The mean time between implant placement and a diagnosis of breast cancer was 14 years. The average age of the patients who had previously undergone augmentation at breast cancer diagnosis was 49.5 years (SD, 9.0 years) versus 57.1 years (SD, 13.5 years) for the nonaugmented patients (p < 0.0001). Forty-nine of the patients underwent lymphatic mapping, with a 100 percent success rate in identifying the sentinel lymph node. There have been no clinically detected axillary recurrences in the patients who had a negative sentinel lymph node biopsy. Breast cancer patients who have undergone previous augmentation are more likely to present with a palpable mass. This initial mode of detection does not appear to translate into a larger tumor size or worse prognosis. Breast conservation and lymphatic mapping can be performed successfully in previously augmented patients.

Utility of Internal Mammary Lymph Node Removal When Noted by Intraoperative Gamma Probe Detection

Background: Lymphatic mapping LM for breast cancer has made internal mammary node IMN detection practical and dependable. This study demonstrates the necessity of IMN removal when suggested by intraoperative radioguided surgery detection.Methods: From April 1998 to July 2000, 1273 patients underwent LM for breast cancer. LM was performed using the combined dye and radiocolloid technique. Patients were scanned operatively with a gamma probe over the IMN area, and most underwent preoperative lymphoscintigraphy. Nodes were removed from patients in whom radioactivity was detected in the internal mammary area.Results: Thirty of the 1273 2.4% patients mapped had at least one IMN removed. Twenty-two of 30 73.3% had inner quadrant lesions. Five of 30 16.7% patients had IMNs that were positive for metastatic disease. Three of these five had no metastatic spread to the axillary sentinel lymph node SLN. One of thirty 3.3% patients with IMN localization had neither hot nor blue nodes detected in an SLN procedure.Conclusions: Radioguided SLN detection should be attempted in the IMN basin with all tumors. If an IMN is identified, it should be removed. IMN biopsy is a feasible, low-risk procedure when directed by radioguided LM and provides a guide for radiotherapy for patients with positive IMNs.

The effect of sentinel node selective axillary lymphadenectomy on the incidence of postmastectomy pain syndrome.

BACKGROUND Postmastectomy pain syndrome (PMPS) has been reported following procedures involving complete lymph node dissection (CLND). Since the triggering event is probably related to nerve injury, sentinel lymph node dissection (SLND) should decrease the incidence of PMPS. The purpose of this report is to determine the impact of SLND on the number of patients referred to the pain clinic for PMPS treatment. METHODS The records of all breast surgical patients with a diagnosis of PMPS referred to the Moffitt Cancer Center pain clinic were reviewed. The criterion for diagnosis of PMPS was a history of postoperative pain in the upper anterior chest wall, upper extremity, axilla, and/or shoulder in the absence of recurrent disease. RESULTS A total of 55 patients with a diagnosis of PMPS were seen in the pain clinic since 1991. Treatments included local anesthetics/corticosteroid injection, stellate ganglion block, and tricyclic antidepressants. A decrease from 15 patients in 1991 to 3 in 1998 was observed. All but one of the 55 patients with PMPS had CLND, and none referred to the pain clinic had undergone SLND. CONCLUSIONS PMPS is a complication of CLND. The increased use of SLND in our center has reduced the number of referrals to the pain clinic for treatment of PMPS. This benefit of SLND reduces suffering in the postoperative breast patient.

Novel techniques in sentinel lymph node mapping and localization of nonpalpable breast lesions: the Moffitt experience.

The concept of lymphatic mapping has helped to redefine the clinical significance of lymph nodes with respect to breast cancer. The combination technique using both blue dye and radiocolloid is the most effective method of lymphatic mapping. The data in the literature support the concept that all patients undergoing lympectomy or especially mastectomy should undergo lymphatic mapping if a diagnosis of invasive cancer is remotely possible. The low morbidity, high sensitivity, and specificity of mapping indicate its use for increasing number of patients thought initially not to be candidates for the procedure.

Effect of Lymphatic Mapping on Diagnosis and Treatment of Patients with T1a, T1b Favorable Breast Cancer

ObjectiveTo investigate the incidence of nodal metastasis in a consecutive series of patients treated at the authors’ institution with highly selective criteria, and to determine the impact that lymphatic mapping and sentinel node biopsy have on the detection of nodal metastases in this carefully selected patient population. MethodsStudy patients were selected from the 7,750 breast cancer patients entered into the authors’ database from April 1989 to August 2001, based on the following criteria: nonpalpable, T1a and T1b, non-high nuclear grade tumors, without lymphovascular invasion. ResultsOf the 7,750 patients in the database 1,327 (17%) were found to have T1a and T1b lesions. Three hundred eighty-nine patients were confirmed to meet all four selection criteria. This represents 5% (389/7,750) of the authors’ breast cancer patients and 29.3% (389/1,327) of the authors’ T1a/T1b tumors. One hundred sixty patients were diagnosed before routine use of lymphatic mapping, and only one patient had a positive axillary lymph node. Two hundred twenty-nine patients underwent lymphatic mapping and sentinel lymph node biopsy, and 10 had a positive axillary lymph node. The difference in proportions of nodal positivity between the mapped and unmapped patients was significant. ConclusionsThis study clearly demonstrates the ability of lymphatic mapping and a more detailed examination of the sentinel node to increase the accuracy of axillary staging. It has been argued that this highly selected group of breast cancer patients possessing retrospectively identified “favorable” characteristics does not require axillary staging. This select population represents only 5% of breast cancer patients in this series, and the authors do not believe they can be accurately identified preoperatively. Therefore, the authors strongly argue for evaluation of the axillary nodal status by lymphatic mapping.