Sentinel Lymph Node Identification Rate Research Articles

Abstract P1-01-17: Sentinel node biopsy for breast cancer: Intraoperative injection of radiocolloid

Abstract INTRODUCTION. Preoperative injection of radiocolloid for axillary sentinel node biopsy for breast cancer is visibly uncomfortable for many patients. We sought to determine whether injection of the radiocolloid once the patient has been anesthetized would be reliable for sentinel lymph node identification when compared to preoperative injection. METHODS. A cohort of patients with breast cancer who underwent intraoperative injection of radiocolloid was compared to those who received their injection preoperatively. All injections employed 1mCi 0.5 ml of filtered (0.22 micron) Tc-99m sulfur colloid. All operative surgeons directed injections into the retroareolar tissue; some also intradermally directly over the tumor. RESULTS. 904 sentinel node biopsy procedures were performed in the six years study period. 759 sentinel node biopsies were analyzed, 664 with preoperative injection of radiocolloid for localization and ninety-five with intraoperative injection. The average age of the patients was 56.8 years: 57.3 years in the preoperative injection group and 53.8 years in the intraoperative injection group. 753 of the 759 patients were women. Sentinel Node Identification. The overall sentinel lymph node identification rate was similar for the two groups: 94.1% for the preoperative injection group and 93.5% for the intraoperative injection group (P = NS). The identification rate remained equivalent for both groups when analyzed by T stage of the tumor. Similarly, the average number of lymph nodes removed did not differ between preoperative vs. intraoperative injection: 2.66 nodes and 2.55 nodes, respectively. Sentinel Node Positivity. The overall rate of positive sentinel nodes was also similar for the two groups, 24.7% for the preoperative injection group and 26.4% for the intraoperative injection group (P = NS). When analyzed by T stage, the positivity rate remained similar and not statistically significant. T1 tumors were 21.6% positive in the preoperative group versus 23.9% in the intraoperative group, and T2 tumors were 40.1% vs. 37.0%, respectively. DISCUSSIONS. Our sentinel lymph node identification rate of 93.5% for the intraoperative injection group appears similar to that of the published literature (96-100%). Our study also showed no statistical difference in positive sentinel node biopsy between preoperative injection (24.7%) and intraoperative injection (26.2%) and is comparable to that of others When analyzed by T stage, our study had 23.9% positive sentinel node biopsies for T1, and 37% for T2 with intraoperative injection. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P1-01-17.

Abstract CS01-2: The role of radiation in the treatment of the axilla in the setting of neoadjuvant chemotherapy

Abstract There is considerable controversy regarding the appropriate surgical procedure and its timing for evaluating the status of the axillary nodes in the neoadjuvant setting. Sentinel lymph node (SLN) surgery following initial chemotherapy avoids an axillary dissection and its associated morbidity in clinical N0 patients who have pathologic negative SLN. SLN identification and false negative rates (FNR) have been acceptable in these women and axillary recurrence rates without radiation directed to the axilla are £1%. For clinical N1 disease, 2 recent studies (SENTINA, ACOSOG 1071) reported SLN identification rates of 80% and 91%, FNR of 12.8 and 14% and ypN0 rates of 52% and 40% respectively. The SLN was the only positive node(s) in 58% and 40% of the ypN1 patients. Several studies have evaluated the role of regional node (RN) irradiation in clinical N1 patients who are ypN0 following neoadjuvant chemotherapy and have found no improvement in local-regional disease free survival. RN failure rates are low as reported by the NSABP B18 and 27 trials in the absence of post mastectomy radiation or with breast only radiation. The question of RN radiation is being addressed by an NRG (NSABP-RTOG) randomized trial. For women with clinical N1 disease who remain ypN1, axillary radiation may substitute for axillary dissection. Axillary radiation has been shown in randomized trials to be equivalent to axillary dissection in the adjuvant setting for clinical N0 women (NSABP B04) including those with positive SLN (Dutch Mirror, IBCSG 23-01, AMAROS). The Alliance trial will address this question. The potential advantage of neoadjuvant chemotherapy is the ability to adjust surgical and radiation treatment based on pathologic response and thereby minimize the morbidity of combined therapy. Various clinical scenarios will be presented with treatment options. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr CS01-2.

Abstract P1-01-27: SentiMAG multicentre trial*: Comparison of sentinel node biopsy identification rates using a magnetic tracer vs. standard technique. * UKCRN ID 12178 (UK); NTR 3283 (Netherlands)

Abstract Background: The SentiMAG Multicentre Trial, an international phase II paired equivalence trial, evaluated a new magnetic technique for sentinel node biopsy (SLNB) against the standard (radioisotope and patent blue dye; or radioisotope alone). The magnetic technique does not utilize radiation and provides both a colour change (brown dye) and a hand-held probe for node localization. The primary end-point of this trial was defined as the proportion of sentinel nodes detected with each technique (identification rate) and was found to be non-inferior with the magnetic when compared to the standard technique, in the primary analysis on 160 patients (95% vs 94%, 0.62% difference; 95% upper confidence limit 4.4%). The trial was extended to 350 patients in order to evaluate identification rates further with each technique and at each trial site. Methods: Women with breast cancer scheduled for SLNB, who were clinically and radiologically node negative, were recruited from 7 centres in the UK and the Netherlands. Sentinel node biopsy was undertaken after administration of both the magnetic and standard tracers (radioisotope +/- blue dye). To determine local identification rate with both techniques, a minimum of 30 cases were recruited at each site. Results: A total of 364 patients were recruited and 17 were excluded due to a breech of protocol (e.g: no radioisotope or magnetic dye given). SLNB procedures were undertaken on 347 patients. The overall identification rate was 96.3% (334/347) with the standard technique and 91.9% (319/347) with the magnetic technique (4.3% difference; 95% upper confidence limit 7.2%; 9.5% discordance). The identification rate was 93.4% (324/347) with the radioisotope alone (compared with magnetic technique 1.4% difference; 95% upper confidence limit 4.5%; 11.2% discordance). Identification rates with the standard technique at each site, ranged between 87% - 100% and with the magnetic technique between 84% - 100%. Of the 21% (72/347) of patients with lymph node involvement, 15% (51/347) had at least 1 macrometastasis and 6% (21/347), a micrometastasis only. Another 2% (8/347) had isolated tumour cells. Of 825 lymph nodes removed, 625 (76%) were true sentinel nodes identified with the standard technique. The lymph node retrieval rate was 2.38 nodes per patient overall, 1.80 nodes per patient with the standard technique and 1.83 nodes per patient with the magnetic technique. Conclusion: The magnetic technique is a feasible technique for SLNB, with an identification rate non-inferior to the radioisotope technique but inferior to the standard technique, within the non-inferiority margins setout for this trial. Variation exists in sentinel node identification rates between sites with both techniques. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P1-01-27.

Abstract P1-01-18: Sentinel lymph node identifcation in breast cancer using methylene blue and patent blue: A randomized controlled trial

Abstract Background: Sentinel lymph node biopsy (SLNB) is the standard of care for management of axilla in West. However, In India few centres have established SLN program for breast cancer. The main reason is non- availability & high cost of commercial blue dye & gamma probe. Methylene blue (MB) is not recommended for SLNB in West. The biochemical reason attributed for MB not being useful for SLNB has been its inability to bind to plasma proteins. However, Sutton has demonstrated the ability of MB in reducing the glutathione sulphhydryl group by nucleophilic additive mechanism that may explain the success of MB in identifying SLN I in few case series from third world .However, there is no RCT comparing SLN identification using MB and patent blue violet (PBV) till date. Aim:To compare the sentinel node (SN) identification rate using patent blue violet (PBV) in combination with radiotracer versus methylene blue (MB) in combination with radiotracer in breast cancer. Sample size: Assuming that MB identified SN in 75% of cases and PBV in 85% of cases, a two group continuity corrected X2 test with 0.05 two sided test will have 80% power to detect the difference when the sample size is 107. Materials and Methods: Clinically axillary lymph node negative (N0) patients with breast cancer with tumor (T) stage T1, T2; T3 and T4b were included in the study. T3 and T4b patients received NACT. Patients with palpable hard axillary lymph node, cytologically positive lymph node, stage IV diseae and thoses with previous history of surgery, radiation therapy to axila were excluded from the study. SLNB was performed using combination technique. TC99 sufur colloid was injected at periareolar site intradermally in all patients. Technique of blue dye injection was as follows- 4 ml of 1% PBV: 1 ml intradermal over the tumor, 0.5 ml at 12, 3, 6 and 9 o clock position intraparenchymal around the tumor and 1 ml subareolar. In the MB group, 4 ml of 1% MB was injected at same sites as above.The site of intradermal injection was included in the skin incision. The excised SLN were sent for frozen section and imprint cytology. If SLN was negative for metastasis, only SLNB was performed as surgical treatment of axilla. Results: Between Jan 2010- Jan 2013, 227 of 232 eligible patients (115 in MB arm & 112 in PBV arm) with primary breast cancer with clinically negative axilla consenting to take part in the study were enrolled. T status: T1: 48; T2:126; LABC: 37, Tx: 6. SLN was identified in 215/227 pts (95%). SLN was negative in 133 (62%). All SLN +ve patients (82; (38%) underwent ALND. Among those with positive SLN, SLN was the only positive node in 24 (29%) patients and rest had non sentinel nodes involvement (58; 71%). SLN identification rate using MB (107/112) in combination with Tc99 S Colloid was similar to that with PBV in combination with Tc99S colloid (108/115). Number of nodes harvested nodes (299 v/s 302), blue nodes (260v/s 261) and positive nodes (60 v/s 63) were similar in both groups. Conclusion: MB can be used for SLB in breast cancer with similar identification & false negative rates as PBV in institutions where commercial blue dye and facilities for radiotracer guided technique are not available. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P1-01-18.

Intraoperative Injection of Radiocolloid for Sentinel Node Biopsy in Breast Cancer

Preoperative injection of radiocolloid for axillary sentinel node biopsy in breast cancer is uncomfortable for patients. This study evaluated the reliability of radiocolloid injection as determined by sentinel node identification rate and positive sentinel node biopsy rate, after the patient has been anesthetized in the operating room as compared with preoperative injection. After institutional review board approval, a retrospective cohort of patients with breast cancer who underwent sentinel node biopsy from January 2005 through December 2010 was evaluated for analysis. Patients who received intraoperative injection of radiocolloid were compared with those who received their injection preoperatively. Patients with incomplete pathologic staging or having received neoadjuvant chemotherapy were excluded. All patients received radiocolloid injections into the retroareolar tissue; some also received intradermal injection directly over the tumor. All injections contained 37 MBq (1 mCi) in 0.5 mL of filtered (0.22-μm) (99m)Tc-sulfur colloid. Over the 6-y study period there were 904 sentinel node biopsy procedures, and 165 patients were excluded from analysis. Of the 739 sentinel node biopsies that were analyzed, 647 had preoperative injection of radiocolloid and 92 had intraoperative injection. The overall sentinel lymph node identification rates were similar for the 2 groups: 93.5% for the preoperative injection group and 94.6% for the intraoperative injection group (not statistically significant). The identification rates remained comparable for both groups when analyzed by T stage of the tumor. The average number of sentinel lymph nodes removed was similar between preoperative and intraoperative injection: 2.60 and 2.70 nodes, respectively. The overall rates of positive sentinel nodes were comparable for the 2 groups: 25.6% for the preoperative injection group and 26.4% for the intraoperative injection group (not statistically significant). When analyzed by T stage, the positive sentinel node rates remained similar between the 2 groups. The sentinel lymph node identification rate of 94.6% for the intraoperative injection group was similar to other published sentinel lymph node identification rates (96%-100%). The positive sentinel lymph node rate was also comparable to that of published series. Intraoperative injection of radiocolloid for axillary sentinel node biopsy appears equivalent to preoperative injection and is a less painful experience for breast cancer patients.

Evaluación de la eficacia en la detección del ganglio centinela en el cáncer de mama: evolución cronológica e influencia de la incorporación de una gammacámara portátil intraoperatoria

To define the sentinel node identification rate in breast cancer, the chronological evolution of this parameter and the influence of the introduction of a portable gamma camera.A retrospective study was conducted using a prospective database of 754 patients who had undergone a sentinel lymph node biopsy between January 2003 and December 2011. The technique was mixed in the starting period and subsequently was performed with radiotracer intra-peritumorally administered the day before of the surgery. Until October 2009, excision of the sentinel node was guided by a probe. After that date, a portable gamma camera was introduced for intrasurgical detection.The SN was biopsied in 725 out of the 754 patients studied. The resulting technique global effectiveness was 96.2%. In accordance with the year of the surgical intervention, the identification percentage was 93.5% in 2003, 88.7% in 2004, 94.3% in 2005, 95.7% in 2006, 93.3% in 2007, 98.8% in 2008, 97.1% in 2009 and 99.1% in 2010 and 2011. There was a significant difference in the proportion of identification before and after the incorporation of the portable gamma camera of 4.6% (95% CI of the difference 2-7.2%, P = 0.0037).The percentage of global identification exceeds the recommended level following the current guidelines. Chronologically, the improvement for this parameter during the study period has been observed. These data suggest that the incorporation of a portable gamma camera had an important role.

Evaluation of the efficacy of sentinel node detection in breast cancer: chronological course and influence of the incorporation of an intra-operative portable gamma camera

AimTo define the sentinel node identification rate in breast cancer, the chronological evolution of this parameter and the influence of the introduction of a portable gamma camera. Material and methodsA retrospective study was conducted using a prospective database of 754 patients who had undergone a sentinel lymph node biopsy between January 2003 and December 2011. The technique was mixed in the starting period and subsequently was performed with radiotracer intra-peritumorally administered the day before of the surgery. Until October 2009, excision of the sentinel node was guided by a probe. After that date, a portable gamma camera was introduced for intrasurgical detection. ResultsThe SN was biopsied in 725 out of the 754 patients studied. The resulting technique global effectiveness was 96.2%. In accordance with the year of the surgical intervention, the identification percentage was 93.5% in 2003, 88.7% in 2004, 94.3% in 2005, 95.7% in 2006, 93.3% in 2007, 98.8% in 2008, 97.1% in 2009 and 99.1% in 2010 and 2011. There was a significant difference in the proportion of identification before and after the incorporation of the portable gamma camera of 4.6% (95% CI of the difference 2–7.2%, P=0.0037). ConclusionsThe percentage of global identification exceeds the recommended level following the current guidelines. Chronologically, the improvement for this parameter during the study period has been observed. These data suggest that the incorporation of a portable gamma camera had an important role.

Sentinel Lymph Node Biopsy Technique in Colon Cancer. Experience in 125 Cases

IntroductionThe level of lymph node involvement is the most important factor in staging colorectal cancer without metastasis. Sentinel lymph node mapping identifies the node(s) that most accurately reflect the lymph node status of patients, and intensive techniques that improve staging can be focused on these nodes. The aim of this study was to assess the efficacy of ex vivo sentinel lymph node mapping in the staging of colon cancer. Materials and methodsA prospective study was conducted on 125 patients from the Álava-Txagorritxu University Hospital Health Region (Álava), who were diagnosed prior to surgery with colon cancer without distant metastasis from September 2009 to December 2011. Ex vivo sentinel lymph node mapping with methylene blue was use in these patients to study the sentinel nodes with multiple slices using immunohistochemical techniques and haematoxylin–eosin staining. A comparative study was also performed based on a control group of 170 patients staged with conventional techniques, and involving a single slice and haematoxylin–eosin staining. ResultsThe sentinel lymph node identification rate was 98%, with 5.6% false negatives. Upstaging occurred in 14.2% of cases compared to the group studied using conventional techniques (P=.006). ConclusionsEx vivo sentinel lymph node mapping with methylene blue accurately reflects the lymph node status of patients with colon cancer. This approach upstages patients classified as stages i and ii by conventional techniques to stage iii, indicating chemotherapy that may improve their prognosis.

Sentinel Lymph Node Biopsy in Malignant Eyelid Tumor: Hybrid Single Photon Emission Computed Tomography/Computed Tomography and Dual Dye Technique

To study the utility of hybrid single photon emission computed tomography / computed tomography (SPECT/CT) scan and dual-dye technique in identification of the sentinel lymph node (SLN) in patients with an advanced malignant eyelid tumor. Nonrandomized prospective interventional study. setting: A tertiary eye care center. study population: Patients with an advanced malignant eyelid tumor without clinically involved regional lymph nodes. intervention: SLN biopsy was performed using dual-dye technique (a combination of radiotracer and vital blue dye) following localization by SPECT/CT. main outcome measures: Localization of SLN in the regional node basin by hybrid SPECT/CT scan; SLN identification rate using dual-dye technique; SLN positivity rate; false-negative rate; and complications, if any, of SLN biopsy. Sixteen patients of biopsy-proven eyelid malignancy (7 squamous cell carcinomas [43.75%], 5 sebaceous cell carcinomas [31.25%], and 4 malignant melanomas [25%]) were included in the study. Preoperative localization of SLN was performed using SPECT/CTin 12 patients. SLN biopsy using dual-dye technique was performed in 16 patients. SPECT/CT accurately localized SLN in 11 out of 12 patients. The preauricular region was the most common site of SLN. SLN identification rates for dual-dye, radiotracer, and blue dye techniques were 100% (16/16 patients), 100% (16/16 patients), and 87.5% (14/16 patients), respectively. SLN showed metastasis in 2 patients (12.5%). On follow-up, 1 patient developed cervical lymph node metastasis, thus giving a false-negative rate of 7.14%. There were no complications associated with SLN biopsy. Accurate preoperative localization of SLN in relation to adjacent anatomic structures using SPECT/CT aids in intraoperative identification of SLN. SLN biopsy should be considered in patients with eyelid tumors at significant risk for metastasis who have clinically negative nodal basins. Dual-dye technique is safe and feasible in advanced eyelid tumors. Blue dye technique can be used for SLN biopsy in settings where nuclear medicine facilities are not available, albeit with a lower SLN identification rate. Detection of metastasis in SLNs in ∼12% of cases emphasizes the utility of SLN biopsy in accurate staging and treatment of eyelid malignancies.

Sentinel lymph node mapping in early stage non-small cell lung carcinoma

Background: This study aims to assess the accuracy and feasibility of intraoperative sentinel lymph node (SLN) mapping in patients with clinical early stage (stage I-II) non-small cell lung carcinoma (NSCLC). Methods: A total of 22 patients with pathologically proven clinically early stage NSCLC (2 females, 20 males; mean age 57.62 years; range 45 to 76 years) were included. During thoracotomy, tumor and nodal stations were surveyed with a hand-held gamma counter. Serial-section histological examination and immunohistochemistry were performed to confirm the presence of metastatic disease. Results: According to preoperative results of fluorine-18- deoxyglucose (FDG) positron emission tomography (PET)/ computed tomography (CT) scan and mediastinoscopy, all of the 22 patients were clinical stage 1A (n=7), stage 1B (n=7), stage 2A (n=7) and stage 2B (n=1). A total of 422 lymph nodes were harvested in 22 patients undergoing thoracotomy and histological examination was performed (mean 19.2±1.8, range 6 to 37 lymph nodes). Metastatic involvement was detected in three of 22 SLNs (13.63%) in 22 patients. The identification rate of SLN was 81.81% and accuracy and sensitivity rate were 100%, while false negativity ratio was 0%. Conclusion: Intraoperative SLN mapping can be performed in patients with NSCLC with a high accuracy and sensitivity rate. The knowledge of tumor lymphatic drainage by intraoperative SLN mapping in NSCLC may help the surgeon to perform a better lymphadenectomy and encourage the use of more sensitive pathological and molecular techniques to discover occult or micrometastatic disease.

Comparison of the sentinel node procedure between patients with multifocal and unifocal breast cancer in the EORTC 10981-22023 AMAROS Trial: Identification rate and nodal outcome

IntroductionMultifocal breast cancer is associated with a higher risk of nodal involvement compared to unifocal breast cancer and the drainage pattern from multifocal localisations may be different. For this reason, the value of the sentinel node biopsy (SNB) procedure for this indication is debated. The aim of the current analysis was to evaluate the sentinel node identification rate and nodal involvement in patients with a multifocal tumour in the EORTC 10981-22023 AMAROS trial. Patients and MethodsFrom the first 4000 registered patients, 342 were identified with a multifocal tumour on histological examination and compared to a randomly selected control group of 684 patients with a unifocal tumour. The outcome of the SNB was assessed. ResultsThe sentinel node was identified in 96% of the patients with a multifocal tumour and in 98% of those with unifocal disease. In the multifocal group, 51% had a metastasis in the sentinel node compared to 28% in the unifocal group; and further nodal involvement after a positive sentinel node was found in 40% (38/95) and 39% (39/101) respectively. ConclusionIn this prospective international multicentre study, the 96% detection rate indicates that the SNB procedure can be highly effective in patients with a multifocal tumour. Though the tumour-positive rate of the sentinel node was twice as high in the multifocal group compared to the unifocal group, further nodal involvement after a positive sentinel node was similar in both groups. This suggests that the SNB procedure is safe in patients with multifocal breast cancer.

Technical Effects of Adding 1 % Lidocaine to Technetium Sulfur Colloid for Sentinel Lymphatic Mapping in Early Breast Cancer: Analysis of Data from a Double-blind Randomized Controlled Trial

A practice standard in sentinel lymph node (SLN) mapping in breast cancer is intradermal injection of technetium-99m sulfur colloid (Tc-99m), resulting in significant patient discomfort and pain. A previous randomized controlled trial showed that adding lidocaine to Tc-99m significantly reduced radioisotope injection-related pain. We tested whether 1% lidocaine admixed with Tc-99m affects feasibility of SLN mapping. Between January 2006 and April 2009, 140 patients with early breast cancer were randomly assigned (1:1:1:1) to receive standard topical 4% lidocaine cream and intradermal Tc-99m (control) or to one of three other study groups: topical placebo cream and injection of Tc-99m containing sodium bicarbonate (NaHCO3), 1% lidocaine, or both. All SLN data were collected prospectively. Study groups were comparable for clinicopathological parameters. As previously reported, the addition of 1% lidocaine to the radioisotope solution significantly improved patient comfort. Overall SLN identification rate in the trial was 93%. Technical aspects of SLN biopsy were similar for all groups, including time from injection to operation, first SLN (SLN 1) gamma probe counts, ex vivo counts for SLN 1 and SLN 2, and axillary bed counts. SLN identification rates were comparable statistically: control (96%), lidocaine (90%), sodium bicarbonate (97%), and sodium bicarbonate-lidocaine (90%). The control group had a significantly higher SLN 2/SLN 1 ex vivo count ratio, and the number of SLNs detected was significantly reduced in the lidocaine versus no-lidocaine groups (p<0.05). Addition of 1% lidocaine to standard radioisotope solution for SLN mapping in breast cancer is associated with fewer SLNs detected, but it does not appear to compromise SLN identification.

Técnica del ganglio centinela en el cáncer de colon. Experiencia en 125 casos

IntroductionThe level of lymph node involvement is the most important factor in staging colorectal cancer without metastasis. Sentinel lymph node mapping identifies the node(s) that most accurately reflect the lymph node status of patients, and intensive techniques that improve staging can be focused on these nodes. The aim of this study was to assess the efficacy of ex vivo sentinel lymph node mapping in the staging of colon cancer. Materials and methodsA prospective study was conducted on 125 patients from the Alava-Txagorritxu University Hospital Health Region (Alava), who were diagnosed prior to surgery with colon cancer without distant metastasis from September 2009 to December 2011. Ex vivo sentinel lymph node mapping with methylene blue was use in these patients to study the sentinel nodes with multiple slices using immunohistochemical techniques and haematoxylin-eosin staining. A comparative study was also performed based on a control group of 170 patients staged with conventional techniques, and involving a single slice and haematoxylin-eosin staining. ResultsThe sentinel lymph node identification rate was 98%, with 5.6% false negatives. Upstaging occurred in 14.2% of cases compared to the group studied using conventional techniques (P=.006). ConclusionsEx vivo sentinel lymph node mapping with methylene blue accurately reflects the lymph node status of patients with colon cancer. This approach upstages patients classified as stages i and ii by conventional techniques to stage iii, indicating chemotherapy that may improve their prognosis.

Factors Influencing the Success of In Vivo Sentinel Lymph Node Procedure in Colon Cancer Patients

The sentinel lymph node (SLN) procedure has the potential to provide relevant improvement in nodal staging in colon cancer patients. However, there remains room for improvement for SLN identification and sensitivity. Therefore, the objective of the present investigation was to analyze factors influencing the success of the SLN procedure in colon cancer patients. One hundred seventy-four consecutive colon cancer patients were prospectively enrolled in this multicenter study and underwent in vivo SLN procedure with isosulfan blue 1 % followed by open standard oncologic colon resection. Several patient-, tumor-, and procedure-related factors possibly influencing the SLN identification and sensitivity were analyzed. Sentinel lymph node identification rate and accuracy were 89.1 and 83.9 %, respectively. Successful identification of SLN was significantly associated with the intraoperative visualization of blue lymphatic vessels (p < 0.001) and with female gender (p = 0.024). True positive SLN results were significantly associated with higher numbers of SLN (p = 0.026) and with pN2 stage (p = 0.004). There was a trend toward better sensitivity in patients with lower body mass index (BMI) (p = 0.050). The success of the SLN procedure in colon cancer patients depends on both procedure-related factors (intraoperative visualization of blue lymphatic vessels, high number of SLN identified) and patient factors (gender, BMI). While patient factors can not be influenced, intraoperative visualization of blue lymphatics and identification of high numbers of SLN are key for a successful SLN procedure.

Role of fluorine-18-labeled 2-fluoro-2-deoxy-D-glucose positron emission tomography-computed tomography in the evaluation of axillary lymph node involvement in operable breast cancer in comparison with sentinel lymph node biopsy

Purpose:Role of (18 [F] fluorine-18-labeled 2-fluoro-2-deoxy-D-glucose [FDG] positron emission tomography-computed tomography [PET-CT]) in the evaluation of axillary lymph node involvement in T1T2N0 breast cancer and compare results with sentinel lymph node biopsy (SLNB).Methods:A total of 37 patients of proven T1T2N0 breast cancer were included in the study. Patients with past history of breast surgery, T3T4 disease, uncontrolled diabetes mellitus and pregnant patients were excluded from the study. Pre-operative FDG PET-CT was performed followed by sentinel lymph node (SLN) biopsy with blue dye or combined technique.Results:SLN was identified in 32 of 37 patients with an identification rate of 86.48% (32/37). With combined technique SLN identification rate was 100% (6/6) while with blue dye alone; it was 83.8% (26/31). Among 37 patients, 16 had axillary metastases of which 12 had macrometastases and four had micrometastases detected by immunohistochemistry (IHC). Of 12 patients with axillary macrometastases, skip metastases were present in two patients in whom SLN was negative and in two patients SLN was not identified, but axillary dissection showed metastases. PET-CT had shown sensitivity, specificity, negative predictive value and positive predictive value of 56%, 90%, 73%, and 81.8%, respectively. IHC of SLN detected four patients with micrometastases upstaging the disease by 11% (4/37).Conclusion:Because FDG PET-CT has a high specificity in the evaluation of axillary lymph node involvement in T1T2N0 breast cancer patients according to the results of this study if FDG PET-CT is positive in axillary lymph nodes, axillary lymph node dissection may be considered instead of SLNB.

An Experimental Study to Evaluate the Fluobeam 800 Imaging System for Fluorescence-Guided Lymphatic Imaging and Sentinel Node Biopsy

Visualization of the lymphatic system is challenging. Lymphatic imaging is a crucial diagnostic tool for benign and malignant lymphatic pathologies. Fluorescence-guided imaging allows selective lymphatic mapping and sentinel lymph node (SLN) identification. There are a few fluorescence systems, but some drawbacks remain due to technical and ergonomic aspects. The aim of this study was to evaluate the feasibility of the new Fluobeam 800 imaging system. After approval by the ethics committee, the system was evaluated for lymphography and SLN biopsy in an animal model. Five pigs each with 4 lymph node (LN) stations (n = 20 LN stations) were subjected to lymphatic imaging using indocyanine green (ICG). Additionally, the use of ICG was compared with ICG adsorbed to human serum albumin (ICG-HSA). Lymphatic vessels and SLN identification rates were measured. After injection, a clear fluorescence signal of the lymphatic vessels was visualized leading to the LN station. Overall, ICG fluorescence imaging identified a mean of 2.0 lymphatic vessels and 1.1 (range = 1-2) SLN in 20 of 20 LN stations. Reverse lymphography was feasible. A clinical difference in resolution was not detected between use of ICG-HSA and ICG. This is the first study analyzing the feasibility of the Fluobeam 800 imaging system allowing transcutaneous real-time imaging. It enables detection of the SLN by fluorescence retention with increased detection depth and resolution. After fixation to the ceiling, the ergonomics advanced for simultaneous field navigation and dissection. The new system can be applied for lymphatic imaging for lympatico-reconstructive surgery and SLN biopsy.

Abstract S2-1: The role of sentinel lymph node surgery in patients presenting with node positive breast cancer (T0-T4, N1-2) who receive neoadjuvant chemotherapy – results from the ACOSOG Z1071 trial

Abstract Background: The utility of sentinel lymph node (SLN) surgery after neoadjuvant chemotherapy (NAC) in patients presenting with node-positive breast cancer has not been determined. The American College of Surgeons Oncology Group (ACOSOG) Z0171 trial was designed to evaluate SLN surgery after NAC in women presenting with node positive disease. Methods: ACOSOG Z1071 enrolled women with clinical T0-4, N1-2, M0 breast cancer receiving NAC. At the time of surgery, all patients were to undergo SLN surgery followed by axillary lymph node dissection (ALND). The primary endpoint was false negative rate (FNR) in women with cN1 disease with 2 or more SLNs reviewed. Positive SLNs were defined as metastases &amp;gt;0.2mm on H&amp;E. The protocol encouraged dual tracer technique. A Bayesian study design with a non-informative prior was chosen to assess whether the probability that the SLN surgery FNR is greater than 10%. Results: From July 2009 to July 2011, 756 patients were enrolled from 136 institutions. Fifteen women were ineligible and 33 withdrew. Of 708 evaluable pts (668 cN1, 40 cN2), 643 had a SLN identified and an ALND (607 cN1, with indeterminate SLN results in 2); 52 pts (48 cN1) had no SLN identified and had ALND; 11 underwent ALND only (all cN1), and 2 pts had SLN only (both cN1). In patients with SLN and ALND, the SLN identification rate was 92.5% (92.7% in cN1, 90% in cN2). SLN correctly identified nodal status in 84% of the 695 pts [258 of pathologically node negative and 327 of pathologically node positive; cN1: 83.8% (549/655), cN2: 90.0% (36/40)]. Of the 643 pts with a SLN identified there was a complete pathologic response in 40.3% (40.3 % for cN1 and 50% for cN2). Of the pts with a positive SLN, the SLN was the only site of disease in 40%. For pts with cN1 disease with 2+ SLNs identified with residual nodal disease, the SLN FNR was 12.8%. In pts with dual tracer technique the FNR was 11.1%. There were no FN results among pts with cN2 disease with 2+ SLNs reviewed. Of the 40 pts with a false negative SLN of the 528 cN1 patients with 2+ SLNs examined, the number of positive nodes at ALND was 1 (50.0%); 2 (25%); 3 (10.0%) and 4–9 (15.0%). Conclusions: NAC resulted in eradication of lymph node disease in 40% of node positive breast cancer patients. SLN surgery after NAC in node positive breast cancer pts correctly identified nodal status in 84% of all patients and was associated with a FNR of 12.8%. The FNR of SLN is higher than the prespecified study endpoint of 10%. Further analysis of factors associated with FNR such as clinical response, histological findings and axillary ultrasound findings is warranted prior to widespread use of SLN in these patients. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr S2-1.

Abstract P1-01-25: Sentinel lymph node biopsy in breast cancer: The approach in day surgery under local anaesthesia for quality-of-life and significant cost reduction

Abstract Background: Sentinel lymph node biospy (SLNB) is widely used in the management of breast cancer patients without axillary metastases or inflammatory breast cancer (IBC). Methods: From Jan. 1st 2006 through Dic. 31st 2011 we performed 302 SLNB at St. M. Goretti Hospital. Mammary carcinoma was diagnosed as malignant by aspiration citology and/or biospy. In all cases with positive citology or biospy, we performed quadrantectomy and SLNB at the same time. All patients underwent pre-operative lymphoscintigraphy with intradermal pericicatritial and/or periareola injection of 12–15 MBq 99Tc colloidal albumin particles 50–80 nm size range, in 0,2 ml saline solution. We never used vital blue dye. All patients underwent surgical treatment 3–12 h. later. We performed SLNB and quadrantectomy in day surgery (DS) and local anaesthesia (LA) with 2% of Carbocaine. Axillary incision was 3–4 cm. This study was approved by an ethics committee, was discussed with all patients and informed consent was obtained. Purpose of the study is to investigate the approach in DS under LA for quality of life and significant cost reduction. Results: Six patients underwent pre-operative lymphoscintigraphy the radiotracer did not show any sentinel lymph node (SLN), in five cases we performed axillary dissection (AD). In one case of young patient who had previously been treated with chemotherapy for non-Hodgkin's lymphoma, negative positron emission tomography (PET), we performed quadrantectomy without AD. In three cases the axilla was positive. In four cases of multifocal (MF) and two of multicentric (MC) invasive breast cancer, the SLN was identified in axilla and SLNB was perfomed. SLNB in MF and MC tumors was similar to unifocal cancers. Only one case of MC cancer the SLN was positive. Six patients classified T4b according to AJCC, were treated with neoadjuvant chemotherapy (NC). The axilla was negative to ultrasound (US), PET and citology. After completion of NC, lymphatic mapping was able to identify SLN and we performed SLNB. In these patients SLN was negative. In two cases of male cancer the axilla was negative to clinical examination, in both cases SLN was positive for macrometastases. Six cases showed axillary isolated tumor cells (ITC). Eighteen micrometastases. Thirty-two macrometastases. In two case of negative SLN there was a positive second palpable lymph node. One case showed a double SLN in the axilla and internal mammary chain, only the internal mammary lymph node was positive. The SLN identification rate was 99%. After surgery we distributed a questionnaire to the patients about the acceptability of this approach. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-01-25.

Sentinel lymph node biopsy in patients with locally advanced breast cancer after neoadjuvant chemotherapy

To check the rate of sentinel lymph node (SLN) identification in patients with locally advanced breast cancer who underwent neoadjuvant chemotherapy comparing intraoperative contact cytology (imprint) and embedded in paraffin and validation of methods. A cross-sectional validation of diagnostic test involving 34 patients from the outpatient clinic of the Maternity School Assis Chateaubriand. The patients had locally advanced breast cancer and were treated with neoadjuvant chemotherapy. Those with clinically negative axilla underwent SLN biopsy, studied by imprint and histopathology in paraffin. All patients underwent axillary dissection and its histopathological study. The SLN identification rate was 85.3% (29/34). The sensitivity of imprint associated with paraffin on detection of metastasis compared to histopathology of the axillary content was 84.62% and specificity of 100% with false-negative rate of 12.01% and an accuracy of 92.77%. The search for metastases in the SLN by imprint and histopathological analysis in paraffin compared to the gold standard (axillary dissection) had a low sensitivity with high rate of false negatives in our sample.

Preclinical Study of Near-Infrared–Guided Sentinel Lymph Node Mapping of the Porcine Lung

The presence of lymph node metastasis is the most important prognostic factor in early non-small cell lung cancer. Our objective was to develop a rapid, simple, and reliable method for thoracic sentinel lymph node (SLN) identification using near-infrared fluorescence imaging and clinically available contrast agents. Indocyanine green (ICG) reconstituted in saline, human serum albumin, human fresh frozen plasma, and autologous porcine plasma was evaluated for optimal formulation and dosing for SLN within porcine lungs. Animals were imaged using the fluorescence-assisted resection and exploration for surgery imaging system. The SLN identification rate, time to identification and fluorescence intensity of the SLN, bronchus, and background were measured. The SLN identification rates varied widely, ranging from 33% to 100% as a function of the carrier used for ICG reconstitution. No significant difference was noted in SLN fluorescence intensity; however, bronchial intensity was significantly higher with ICG: albumin, which resulted in the lowest rate of SLN identification. Subsequent evaluation with 125 μM and 250 μM ICG:porcine plasma resulted in identification of strongly fluorescent SLNs, with identification rates of 93% and 100% and median signal-to-background ratios of 8.5 and 12.15, respectively, in less than 2 minutes in situ. Near-infrared fluorescence imaging with ICG is a reliable method for SLN mapping in the lung with high sensitivity. Mixing of ICG with plasma resulted in strong SLN fluorescence signal with reliable identification rates.