bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract P1-01-03: Comparison of sentinel lymph node biopsy guided by the multi-modal method of indocyanine green fluorescence, radioisotope and blue dye versus the radioisotope in breast cancer; A randomized phase II trial
Authors: Jung S-Y , Kim S-K , Kim SW , Lee S , Lee J , Shin I-s , Kwon Y , Lee E 
Published: August 2014

Abstract
Background: Sentinel lymph node (SLN) biopsy is a standard surgery for axillary staging of early breast cancer. This study aimed to evaluate the identification rate and surgery time of SLN biopsy with the multi-modal method using the mixture of indocyanine green (ICG) fluorescence, RI and blue dye as a new method, in comparison with the RI, in clinically node negative breast cancer patients.
Materials and methods: In this phase-II randomized study, 86 patients with clinically node negative breast cancer were randomized to receive periareolar injection of the mixture including ICG fluorescence, RI and blue dye or the only RI for SLN biopsy. We compared the identification rate, the number of SLN, and detections time of SLN biopsy between these two groups.
Results: The mean age of the multimodal group and the only RI group was 48.2 years and 51.0 years (p = 0.12), respectively. There were no differences of histopathologic factors including tumor size, node positivity, hormone receptor positivity and HER2 positivity between two groups. Sentinel lymph nodes were identified in all patients of both groups (100% in the multimodal group vs 100% in the RI group). The average number of SLN in the mixture group was more than that of the RI group (3.4 ±1.37 vs 2.3 ± 1.04; p &lt; 0.001). The time to excise the first SLN was similar in each group (6.5 ± 5.16 min vs 8.0 ± 4.35 min; p = 0.13). In multimodal group, percutaneous lymphatic drainage was visualized by fluorescent imaging in 90.7% (39 of 43 patients) and all of the first SLN were detected by both ICG fluorescent and RI. After operation, there was no complication including skin staining or necrosis.
Conclusions: This study is the first randomize trial which compared the multimodal method using the mixture of ICG fluorescence, RI and blue dye and the conventional RI method for SLN biopsy. The multimodal method is an available method for SLN biopsy, which allows percutaneous visualization of lymphatic vessels and intraoperative lymph node detection.
Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-01-03.
Abstract P1-01-06: Evaluation of the stage IB designation of the 7th edition of the AJCC staging system: Biologic factors are more important
Authors: Mittendorf EA , Ballman KV , McCall LM , Hansen N , Lucci A , Gabram S , Urist M , Crow J , Hurd T , Hunt KK , Giuliano AE 
Published: August 2014

Abstract
Purpose: The stage IB designation was added to the AJCC 7th edition staging system to denote micrometastasis in patients with T1 tumors. We have previously examined this group and found that receptor status and nuclear grade were better survival discriminates than the presence of micrometastases. The current study was undertaken to validate this finding in a larger cohort from the American College of Surgeons Oncology Group (ACOSOG) Z0010 study.
Methods: Clinicopathologic and outcomes data from patients enrolled on ACOSOG Z0010 were recorded. All patients underwent breast conserving surgery, sentinel lymph node biopsy and whole breast radiation for clinical T1-2, N0 breast cancer. Sentinel lymph nodes were evaluated by H&E locally and if negative, by immunohistochemistry (IHC) at a central laboratory. Patients were staged according to the 7th edition AJCC system and recurrence-free (RFS), disease-specific (DSS) and overall survival (OS) were determined using the Kaplan-Meier method and compared using the log-rank test.
Results: There were 5210 eligible and evaluable patients enrolled on ACOSOG Z0010. AJCC stage distribution was known in 4590 and included: 2849 (62.0%) stage IA, 376 (8.2%) stage IB, 878 (19.1%) stage IIA, 322 (7.0%) stage IIB, and 170 (3.7%) stage III. Median follow-up for the cohort was 9.0 years (range 0–12.6). Five and 10-year RFS, DSS and OS rates for patients with stage IA versus IB disease are shown in table 1.

There were no significant differences between groups. When all stage I patients (stage IA and IB) were evaluated by ER status (positive vs negative) or grade (grade 1 vs 2 vs 3), these biologic factors were able to significantly discriminate patients with respect to RFS, DSS and OS (table 2).

Conclusion: Differentiating patients with micrometastases (stage IB) from node negative patients (stage IA) does not stratify patients well with respect to survival. Biologic factors including ER status and grade are better discriminants of survival than the presence of small volume nodal metastases in patients with early stage breast cancer. Breast cancer staging should include biologic factors from the primary tumor.
Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-01-06.
Abstract P1-01-09: Which nomograms may be the best for predicting nonsentinel lymph node metastasis in breast cancer patients: a meta-analysis.
Authors: Chen K , Jin L , Zhu L , Shan Q , Su F 
Published: August 2014

Abstract
Background: Axillary lymph node dissection (ALND) is the standard treatment for breast cancer patients with positive sentinel lymph nodes (SLNs). Several nomograms were developed to identify SLN-positive patients with low risk of nonsentinel lymph nodes (NSLNs) metastasis. These nomograms were validated in different populations and it is still unknown which is the best. This study is to present a systemic review and perform a meta-analysis to obtained the pooled AUC (Area Under the receiver-operator Curve) value of each models.
Methods: This review focused on six models: Cambridge, MSKCC, Mayo, MDA, Tenon and Stanford models. A “Pubmed” search and “Web of science” search were conducted and 35 literatures were ultimately included. AUC and the number of patients with positive NSLNs were extracted. Publication bias and heterogeneity were analyzed. AUCs were converted to odds ratios (ORs) for combination. The combined ORs were converted back to AUCs to represent the integrated discriminative capabilities of each models.
Findings: In total, the Cambridge, Mayo, MDA, MSKCC, Stanford and Tenon models were validated in 8, 6, 4, 39, 14 and 15 studies, with 2156, 2431, 843, 8143, 3700 and 3648 patients included, respectively. There were no publication bias or heterogeneity observed in the Cambridge, Mayo, MDA and Tenon models (Table 1). The combined ORs and the corresponding AUCs of each models were listed as follow: Cambridge (OR = 3.86, AUC = 0.71), Mayo (OR = 3.71, AUC = 0.71), MSKCC (OR = 3.47, AUC = 0.70), MDA(OR = 3.44, AUC = 0.70), Tenon (OR = 3.46, AUC = 0.70) and Stanford (OR = 2.92, AUC = 0.67). For each of the predictive models, both fixed and random effect models were used to calculate the combined OR. The presence of larger difference between the fixed and random effect analysis suggests small study effects, rendering the meta-analysis relatively less reliable. The combined ORs were identical when fixed and random effect models were used in the Cambridge and MDA models, suggesting that there was no small study effects in these two models.

Conclusions: All of the included models are all better than random chance but not provide excellent discriminative capabilities. The Cambridge and Stanford models were relatively superior and inferior when compared with the other models, respectively.
Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-01-09.
Abstract P1-01-10: Comparison of sentinel lymph node positivity rates pre and post introduction of OSNA molecular analysis
Authors: Rusby J , Agabiti E , Waheed S , Barry P , Roche N , Allum W , Gui G , MacNeill F , Christaki G , Osin P , Nerurkar A 
Published: August 2014

Abstract
Introduction: Intra-operative assessment (IOA) of the axillary sentinel lymph node (SLN) allows immediate completion axillary lymph node dissection (cALND) for a positive SLN. One-step nucleic acid amplification assay (OSNA, (Sysmex)), a molecular technique, is very sensitive and may upstage the axilla compared with other forms of intra-operative assessment and with formal, paraffin-embedded haematoxylin and eosin (H&E) histopathology. This would result in an increased cALND rate at a time when efforts are being made to reduce unnecessary axillary surgery in line with the Z0011 trial (Giuliano et al. 2011).
This study compares node positive rates before and after two changes in practice: the introduction of OSNA and the unit policy to perform cALND for macrometastatic SLN disease only.
Methods: All patients in our unit undergo pre-operative axillary ultrasound with fine needle aspiration cytology of any suspicious nodes. Those with malignant cytology proceed directly to ALND. Radiologically and cytologically node negative patients undergo SLNB. Consecutive electronic records were examined for all SLNB procedures in two groups: Pre-OSNA from June 2006 to December 2010 and OSNA from August 2011 to March 2012. Pre-OSNA, patients were offered cALND for micro-or macroscopic SLN disease identified by H&E histology. Following Z0011, patients in the OSNA group proceeded to cALND for SLN macrometastases but not for micrometastases. The chi-squared test was used to compare results between the two groups.
Results: The groups were similar in terms of age, tumour size, grade and receptor status. Sentinel node and cALND results are shown in table 1.

In summary, testing by OSNA resulted in a higher node positive rate and a greater proportion reported with micrometastases (40% compared with 23% pre-OSNA). The OSNA macrometastasis rate was equal to the pre-OSNA overall node positive rate (22%). Among patients proceeding to cALND (all node-positive pre-OSNA patients and OSNA patients with macrometastases) there was no significant difference in the proportion with additional positive nodes in the cALND or the proportion with a total of four or more positive nodes.
Conclusion: The introduction of OSNA has increased the proportion of patients identified as node positive, and has increased the proportion reported to have macrometastasis. Simultaneously, the decision not to perform cALND for patients with micrometastasis was intended to limit the additional surgery performed in the SLNB group as a whole. However, since this decision was based on data from studies using H&E assessment, we should look for ways to raise the threshold for cALND such that it includes only the patients at the highest risk of axillary recurrence.
Reference
Giuliano AE et al. JAMA 2011; 305(6): 569–75.
Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-01-10.
Abstract P1-01-12: The Performance of the One Step Nucleic acid Amplification (OSNA) Assay in Breast Cancer Patients with Receiving Preoperative Systemic Therapy
Authors: Yagata H , Yamauchi H , Horii R , Osako T , Iwase T , Akiyama F , Kinoshita T , Tsuda H , Tsugawa K , Nakamura S 
Published: August 2014

Abstract
Background: The OSNA (One Step Nucleic acid Amplification) assay is a semi-automated lymph node examination method using molecular biological technique. The OSNA assay has been validated for breast cancer patients without receiving preoperative systemic therapy (PST) by several clinical studies and has currently become more popular as sentinel lymph node (SLN) examination method with the following two main advantages; 1) to allow examination of the whole portion of a node, 2) to allow intraoperative judgment of metastasis positive or negative. However, the feasibility of the OSNA assay in breast cancer patients treated by PST has never been confirmed. In this multi-central clinical study, we compared the judgments of the OSNA assay and of pathological examination on lymph nodes dissected after receiving PST to evaluate the performance of the OSNA assay.
Material & Methods: Three hundred two nodes dissected from the 80 breast cancer patients who received PST were examined. Each lymph node was divided at 2mm intervals and the slices were alternately applied to the OSNA assay and pathological examination with H&E staining and CK19 immunohistochemical staining of permanent-section. In pathological examination, judgments of metastasis positive or negative were determined by one central-review pathologist according to the criteria of AJCC 7th edition (“positive” if &gt;0.2mm metastases were detected).
Result: The overall concordance rate between the OSNA assay and pathological examination was 91.1% (275/302) with sensitivity of 88.3% (53/60) and specificity of 91.7% (222/242) (Table). These results are very similar to those of the Japanese clinical validation study in breast cancer patients without receiving PST which was conducted by the almost same protocol (Tamaki Y, et al. Clin Cancer Res, 2009, 15: 2879–2884).
Conclusion & Discussion: These results indicate the OSNA assay can be applicable for breast cancer patients after receiving PST as well as breast cancer patients without receiving PST. The OSNA assay will enable to examine the whole portion of nodes, leading to more detection of metastases (especially micrometastases) and more exact nodal staging for breast cancer patients treated by PST. Also, for the patients who receive sentinel lymph node biopsy after PST, the OSNA assay will be useful as intraoperative examination method of SLNs because it is expected to provide more correct judgments than current intraoperative methods such as frozen-section or touch-print cytology.

Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-01-12.
Abstract P1-01-14: Effects of axillary lymph node dissection on survival of patients with sentinel lymph node metastasis of breast cancer in the Surveillance, Epidemiology and End Results (SEER) database using a propensity score matching analysis
Authors: Bendifallah S , Chereau E , Bezu C , Coutant C , Rouzier R 
Published: August 2014

Abstract
Background: In two randomized trials, axillary lymph node dissection (ALND) did not significantly affect overall or disease-free survival of patients with a positive sentinel lymph node (SLN). These two trials closed early without the targeted enrollment questioning a lack of sufficient power. In retrospective observational studies, patients receive treatment according to tumor and patient (age, health status) factors and thus biasing the comparisons. Propensity score matching (PSM) analysis has been proposed as an alternative method to adjust for confounding factors with a statistical advantage over the standard methods of confounder adjustment. The method involves generation of a propensity score for each subject which is an estimate of the conditional probability of receiving a treatment given a set of known covariates. Propensity scores are used to reduce selection bias by equating groups based on these covariates.
Objective: To evaluate whether patients with SLN metastasis of breast cancer who underwent complete ALND demonstrate improved survival in the Surveillance, Epidemiology and End Results database using a propensity score matching.
Methods: The study population comprised 21073 patients. The 5-year cause-specific survival was tested, in order to examine the survival impact of complete lymphadenectomy by using propensity score matching analysis. The propensity scores to determine the conditional probability of receiving ALND were generated using logistic regression model. Patients were then matched using the propensity score by an optimal matching algorithm.
Results: The PSM was based on age, race, region of diagnosis, tumor type and grade, tumor size, nodal status (micrometastasis vs macrometastasis) and hormone receptor status. It generated a balanced, matched cohort (3229 patients in each group) in which baseline characteristics were not significantly different. Five-year overall survival was 96.9% (95% CI 96.1–97.6%) in the ALND group and 94.0 (95% CI 92.6–95.4%) in the SLN biopsy alone group. The benefit of complete lymphadenectomy was significant: p = 0.028.
Conclusion: Using PSM analysis, our results show evidence of benefit for ALND in case of metastatic sentinel lymph node. The results of randomized trials demonstrating no benefit for ALND may not been generalizable.
Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-01-14.
Abstract P1-01-16: Intraoperatively-palpable “non-sentinel” nodes: should they be removed?
Authors: Crivello ML , Ruth K , Sigurdson ER , Egleston BL , Boraas M , Bleicher RJ 
Published: August 2014

Abstract
Background: Sentinel lymphadenectomy is the standard of care for evaluation of the axilla in breast cancer. Not infrequently, despite a clinically negative axilla, axillary nodes are found and removed that are only palpable intraoperatively at the time of sentinel lymph node biopsy. There is limited data suggesting that their resection is beneficial, and there is some controversy over whether these non-hot, non-blue nodes should also be called “sentinel nodes” (SNs).
Methods: A retrospective chart review was conducted of breast cancer patients who underwent sentinel lymph node biopsy from 2007 to 2011 at a single institution. Patients were only included if they had SNs removed (defined as blue and/or radioactive nodes), as well as additional non-sentinel nodes that were only palpable intraoperatively (pNSNs) and not part of an axillary dissection (ALND). Pathology of both SNs and pNSNs were reviewed. Histologic nodal evaluation was performed by H&E alone.
Results: From 2007 to 2011, a total of 59 patients had both SNs and pNSNs removed. Fifty-five patients (93.2%) were female and the average age was 55 years old. Fifty-two patients (88.1%) had invasive ductal carcinoma while 7 had lobular carcinoma (11.9%). Average tumor size was 2.0 cm. Among the 59 patients, a total of 109 SNs (mean 1.8, median 1, range 1–6) and 202 pNSNs (mean 3.4, median 2, range 1–30) were removed at the same surgery. Twenty patients (33.9%) had metastases in either the SNs and/or pNSNs with 16 (80.0%) of these having metastases in the SNs alone. Sixteen patients proceeded to an ALND. There were 4 patients (6.8%, 95% CI 1.9–16.5%) who had SNs negative for tumor but pNSNs positive for tumor, and 4 (6.8%, 95% CI 1.9–16.5%) separate patients who had extracapsular extension (ECE) in their pNSNs but no ECE in the SNs. The pNSNs thus provided information altering operative treatment by American College of Surgeons Oncology Group (ACOSOG) Z0011 trial criteria in 8 patients (13.6%). Two patients (3.4%, 95% CI 0.4–11.7%) had ECE present in ALND nodes, but not present in either their SNs or pNSNs.
Conclusion: pNSNs provide information that changes the surgical plan by ACOSOG Z0011 criteria in 14% of cases. Whether their removal changes patient outcomes remains unclear, especially as SNs and pNSNs may, together, be falsely-negative for ECE present within the axilla. While we recommend their removal at this time based upon the added information they provide, further study is required to determine whether the changes resulting from pNSN dissection (i.e. need for ALND) provide any outcome benefit in this era of effective systemic therapy.
Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-01-16.
Abstract P1-02-02: Receptor discordance in breast cancer recurrence: Is re-biopsy a necessity?
Authors: Fujita T , Sawaki M , Hattori M , Kondo N , Horio A , Ushio A , Gondo N , Hiroji I 
Published: August 2014

Abstract
Background: Decision making on systematic treatment of patients with metastatic breast cancer is based on features like estrogen receptor (ER), progesterone receptor (PgR), and HER2 status assessed on the primary tumor. Recent prospective studies have investigated discordance in receptor status between the primary and metastatic tumor. We evaluated the discordance of receptor status between the primary and metastatic tumor and assessed the impact of re-biopsy on patient management.
Methods: In breast cancer patients who underwent surgical resection of primary tumor and re-biopsy of metastatic tumor at Aichi Cancer Center hospital, we examined the discordance of ER status, PgR status, and HER2 status between the primary and metastatic tumor. For sampling of metastases, core needle biopsy (CNB), trans-bronchial lung biopsy (TBLB), or surgical resection was performed. And fine-needle aspiration biopsy was not used.
The ER and PgR status were assessed using Allreds scoring system by IHC. These statuses were categorized as positive when the total score was more than two. HER2 expression status was tested by IHC and FISH. HER2 3+ by IHC, or 2+ and FISH positive were judged as HER2 positive.
Results: 48 patients underwent re-biopsy from 2003 to 2012. Twenty-eight were loco-regional (local: 25, Supraclavicular: 2, Axilla: 1) and 21 were distant (Lung: 14, Liver: 6, Bone: 1). Discordance in ER, PgR, or HER2 between the primary and metastatic tumor were 6.2% (3/48), 16.7% (8/48), and 4.2% (2/48), respectively. One patient had discordance on re-biopsy with initial triple negative primary tumor (1/5, 20%). 11/48 patients (22.9%) changed the molecular subtype (Group A), and 37/48 patients (77.1%) did not change (Group B). Time to recurrence (TTR) was significantly longer in Group A than Group B (82.3 months vs 51.2 months, p = 0.04). No significant difference in re-biopsy techniques (CNB and TBLB vs surgical resection), metastatic lesions (loco-regional vs distant), and adjuvant therapy were observed between Group A and Group B.
Conclusions: Our results show the low level of discordance for ER and HER2 between the primary and metastatic tumor. But re-biopsy should be considered in the patients with long TTR, since it is likely to impact treatment choice. Further study is needed to determine the value of re-biopsy.
Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-02-02.