bluuebunny/crossref_metadata_2025_split huggingface dataset:
P3-07-35: Validation of Online Calculators To Predict Non-Sentinel Lymph Node Status in Sentinel Lymph Node-Positive Breast Cancer Patients.
Authors: Tanaka S , Sato N , Fujioka H , Takahashi Y , Kimura K , Iwamoto M 
Published: June 2012

Abstract
Purpose: Axillary lymph node dissection (ALND) is recommended for breast cancer patients with sentinel lymph node (SLN) metastasis, but further nodal disease is not always present. Several models exist for predicting non-sentinel lymph node (non-SLN) metastasis in SLN metastasis. This study evaluated and compared the predictive values of the Memorial Sloan-Kettering Cancer Center (MSKCC) nomogram and the Stanford nomogram, which were conveniently available online, and clarified their usefulness for the micrometastasis or isolated tumor cell (ITC) subgroup.
Methods: Data from 89 patients with positive SLN biopsy who underwent ALND were used, including 59 patients with macrometastasis and 30 with micrometastasis/ITC. The predicted probability of non-SLN metastasis was calculated using a computerized model from the websites for each nomogram. Results were compared using area under the curve (AUC) of the receiver operating characteristics curve for each model. False-negative and false-positive rates were also calculated.
Results: AUC for the entire population was 0.701 with the MSKCC nomogram and 0.756 with the Stanford nomogram. AUCs of macrometastasis and micrometastasis/ITC were 0.680 and 0.469 with the MSKCC nomogram and 0.676 and 0.574 with the Stanford nomogram, respectively.

Conclusions: This independent comparison found no significant difference between the two nomograms. In our results, these nomograms could not reliably predict positive non-SLN in cases with SLN micrometastasis/ITC. Further validation in other patient populations is needed.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-07-35.
P3-07-40: Impact of the Sentinel Lymph Node Procedure on the Detection of Positive Lymph Nodes in Breast Cancer.
Authors: Smeets A , Yoshihara E , Laenen A , Wildiers H , Reynders A , Soens J , Paridaens R , Van Ongeval C , Floris G , Moerman P , Neven P , Christiaens M-R 
Published: June 2012

Abstract
Introduction: The objective of the sentinel lymph node (SLN) procedure in breast cancer is to perform an accurate axillary staging and provide good local control, while sparing the patients the morbidity of an axillary lymph node dissection (ALND). Since its routine clinical use, questions have been raised concerning the upstaging of a subgroup of node-negative patients and an increase in the overall percentage of node-positive patients.
The goal of our study was to investigate the impact of the SLN procedure on the detection of positive lymph nodes.
Patients and methods: We included 1119 consecutive breast cancer patients from one center (2007-2009) who underwent primary surgery for a breast cancer smaller than 5 cm diameter without clinical involvement of axillary lymph nodes. 31 patients had a bilateral breast cancer.
Logistic regression models were used to analyze the effect of various predictors on the presence of positive lymph nodes.
First, we fitted univariable models for a number of predictors of which the relationship with lymph node involvement was to be expected. (multifocality, tumor location in the breast, tumor size, LVI, ER, PR, Her-2, tumor grade, age and histologic subtype).
In a second stage, we fitted a multivariable model including the procedure (SLN biopsy or ALND) and the predictors that have been shown to be related to lymph node involvement in univariable analysis or for which this relationship has been suggested in the literature. The probability of finding positive lymph nodes was thus calculated in both groups correcting for relevant predictors of lymph node involvement.
Results: The SLN biopsy group includes 830 patients, the ALND group 320. Tumors in the ALND group are larger (mean 26.65 mm versus 18.43mm) and more frequently multifocal (24.44% versus 8.19%). 33% of patients in the ALND group were lymph node positive, 28% in the SLN procedure group. Univariable and multivariable analyses revealed that LVI, tumor size and multifocality are the most significant predictors of lymph node involvement (table 1). The AUC for the multivariate model is 0.754.
By comparing ALND en SLN biopsy an odds ratio (OR) of 0.7635 (95% confidence interval: 0.5334−1.0930) is observed, suggesting a higher probability of finding positive lymph nodes with SLN procedure. However, the difference between the procedures is not significant (p= 0.1404).
Conclusion: For comparable tumors, the chance of detecting positive lymph nodes is not lower when applying SLN procedure compared to ALND. The results even point in the direction of a higher detection rate with SLN.
However, care should be taken in making this conclusion given a non-significant result.

Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-07-40.
P3-07-48: Axillary Imaging with Dynamic MRI Following Subcutaneous Injection of Superparamagnetic Iron Oxide Nanoparticles.
Authors: Douek M , Johnson L , Parikh J , Charles-Eduards G , Hall-Craggs M 
Published: June 2012

Abstract
Background: Surgical axillary staging with sentinel node biopsy in clinically node negative patients is standard of care in the management of breast cancer. However sentinel node biopsy is associated with morbidity including a 5% risk of lymphoedema. Superparamagnetic iron oxide (SPIO) enhanced axillary MRI is a promising novel imaging modality that could be used to characterize sentinel nodes non-invasively. We evaluated subcutaneous SPIO enhanced axillary MRI for pre-operative axillary imaging.
Material and methods: Patients scheduled for sentinel node biopsy as part of surgical management of early breast cancer were invited to undergo pre-operative axillary MRI. All images were acquired on a 1.5T scanner using a surface coil. The initial 7 scans were acquired on a Siemens Avanto and the later scans on a Achieva MRI scanner (Philips Best, Netherlands). Following a T2-weighted morphological scan, patients were injected with 2ml of SPIO (4ml in the final 3 patients) subcutaneously into the circumareolar margin in the upper outer quadrant of the affected breast. Post injection, a slightly T2*-weighted dynamic scan was performed (gradient echo, TE = 1.53ms, TR=2.9ms, flip angle 7 degrees, 3mm slice thickness). In addition to the dynamic scan, in 16 patients, a T2 mapping sequence was performed at 10minutes and 120 minutes post injection (turbo spin echo, 8 equi-spaced TEs from 10 to 80ms, TR=2136ms, 3mm slices with an in plane resolution of 1.4×1.4mm). Image analysis was undertaken using Osirix (v3.8, 64-bit). Two consultant radiologists experienced at reading breast and axillary MRI reported all scans. Results: A total of 23 patients underwent axillary MRI with subcutaneous SPIO. Of these in 18 patients (78%), uptake of SPIO was seen in sentinel nodes and lymphatic tracts. At least 1 sentinel node was identified in 17 patients (74%). A total of 106 nodes were identified (4.6 ± 1.7 nodes per patient) and of these 40 demonstrated a significant drop in signal intensity following SPIO injection (1.7 ± 1.3 nodes per patient). All 3 involved nodes were seen to contain a metastatic deposit on MRI.
Discussion: Axillary MRI with subcutaneous SPIO injection is a robust method for imaging sentinel nodes. The normal node count of the axillary basin is lower than expected on histology, suggesting that only the larger nodes and those that take up SPIO are visualized on MRI.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-07-48.
P3-11-04: A Randomized Phase II Biomarker Study of Atorvastatin in Premenopausal Women at Increased Risk for Breast Cancer.
Authors: Wood ME , Kingsley F , Ellerton JA , Atkins JN , Grubs SS , Muss HB , Garber JE 
Published: June 2012

Abstract
Statins have been shown in epidemiological and laboratory studies to have breast cancer risk reduction properties. We evaluated the effect of atorvastatin on breast mammographic density (MD) and other breast cancer biomarkers in a small randomized placebo controlled trial.
Methods: Premenopausal women at increased risk for breast cancer (due to family history, BRCA positivity, prior biopsy history or history of chemoradiotherapy for Hodgkins disease) enrolled after signing informed consent and received either 40 mg of atorvastatin or placebo daily for 1 year. Biomarker assessment was performed prior to initiation and prior to completion of study medication. MD was determined using both Breast Imaging Reporting and Data System (BI-RADS) and the Visual Analogue Scale (VAS).
Results: 63 women were enrolled between 7/05 - 8/10 in this multi-institutional trial. 44 have completed study medication and 3 remain on study. 25% have withdrawn; 17% of them for toxicity/side effects. Of those completing the study; mean age was 47 (range 35–50), 96% Caucasian, mean BMI 26.8. 66% had a strong family history (2% were BRCA+), 27.7% had ADH/LCIS. We present analysis of MD in the first 37 women completing study drug. The two treatment groups were well balance for age, BMI, risk factors and baseline density. Mean density by VAS was 31.6% at study entry and 32.4% at end of treatment. There was no different in change in density over time between atorvastatin and placebo using either BIRAD or VAS; controlling for BMI did not change results. Futility analysis demonstrates low probability of a significant difference between treatment groups and the study was closed.
Conclusions: In this multi-institutional randomized prospective clinical trial of premenopausal women at increased risk for breast cancer we have failed to demonstrate a significant effect of atorvastatin on mammographic density. There are several possible reasons for this relating to: the study population, method of density determination and/or biomarker analyzed. While the primary aim of this study (MD) was not met we have shown that biomarker studies can be done in a multi-institutional setting. Further biomarker evaluation may prove informative.
Funding: This study is sponsored by grants from Breast Cancer Research Foundation and Cancer and Leukemia Group B to M. Wood.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-11-04.
P3-11-05: An Efficient Resource To Accelerate Research into the Cause and Prevention of Breast Cancer: The Love/Avon Army of Women.
Authors: Love SM 
Published: June 2012

Abstract
Background
It is well established that more research into the cause and prevention of breast cancer is needed. While many studies are done in cell lines and laboratory animals, translation of findings to women often falters due to perceived difficulty in recruiting women for research. The Dr. Susan Love Research Foundation received a grant from the Avon Foundation to form the Love/Avon Army of Women (AOW); an on-line recruitment resource launched in 2008, designed to partner one million women with the research community in an effort to accelerate breast cancer research.
Methods: Researchers submit a proposal to the AOW Scientific Advisory Committee. If a study is accepted, a mass e-mail describing the study procedures and inclusion/exclusion criteria is sent to the entire AOW database. Women sign up at www.armyofwomen.org to join and receive AOW e-mails about breast cancer research studies. Women self select based on interest and study criteria, and undergo a secondary on-line screening before contact information is passed on to the researcher for the enrollment process.
Results: Over 356,000 women have signed up, including survivors and healthy women, ranging from ages 18 to 100, representing all 50 US states and 49 countries. To date, the AOW has recruited for 48 studies, both regional and national, that vary from biomarker and circadian rhythm research to psycho-social and quality of life studies. With over 54,000 AOW members having participated in the research process, this method of recruitment has been found to be effective and efficient. The diversity of the AOW members has proved beneficial for many studies, such as those needing to enroll racial/ethnic minorities, women of varying sexual orientations, or young survivors.
Nine studies were closed to enrollment within the first 48 hours after accruing all subjects while others were very quickly over-enrolled by 5–10%. A urine biomarker study in search of healthy women and breast cancer survivors closed within eight hours, after 2,076 women signed up, representing a 58% over-enrollment. This overwhelming response has led many researchers to seek additional funding to increase their statistical significance and accommodate all eligible subjects.
Conclusions: The AOW has proved to be a successful resource for scientists to accelerate accrual, expand the number and diversity of their subject population and to obtain exactly the type of specimens they need when they need it. This partnership between women and scientists has revolutionized research and accelerated efforts to eradicate breast cancer.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-11-05.
P3-13-01: Boost Radiation Therapy Not of Value in Reducing IBTR of Invasive or Noninvasive Breast Cancers for Patients with DCIS: Results from the NSABP B-24 Trial.
Authors: Julian TB , Vicini FA , Costantino JP , Arthur DW , Kidwell KM , Land SR , Mamounas EP , Wolmark N 
Published: June 2012

Abstract
Background: Whole breast irradiation therapy following lumpectomy for invasive breast cancer (IBC) or noninvasive breast cancer (DCIS) significantly reduces the risk of local recurrence. Boost radiation therapy to the tumor bed has been proven to additionally lower the risk of recurrence for IBC. The benefit of boost therapy in patients with DCIS is less certain. We carried out a review of the NSABP B-24 trial to assess the benefit of boost therapy.
Methods: After lumpectomy and radiation therapy, 1804 women with DCIS were randomly assigned to placebo (902) or tamoxifen (902). Whole breast irradiation therapy (50 Gy) was mandatory. Boost radiation therapy was optional, and boost status was known for 1,569 patients. Of these, 1392 patients (86.97%) were identified as having all data sufficient for multivariate analysis. Of these, 613 received boost therapy ranging from 1 Gy −20 Gy, with 81.5% receiving 10 Gy. Mean time of follow-up was 161 months.
Results: Patients who received boost radiation therapy were more likely to be younger (p=0.04), have positive margins (p=0.007), and be more likely to have comedo necrosis (p=0.03). Multivariate analysis identified only treatment (tamoxifen vs placebo) (HR=0.74, 95% CI=0.57−0.98, p=0.034), age (≥ 50 verses &lt; 50) (HR=0.47, 95% CI=0.36−0.61, p&lt;0.0001), and margin status (positive vs negative) (HR: 1.79, 95% CI= 1.31−2.43, p&lt;0.001) as significant predictors for ipsilateral breast tumor recurrence (IBTR). Boost had no significant effect on IBTR (HR=0.87, 95% CI=0.66−1.15, p=0.33). The lack of boost effect applied to both invasive (HR=0.86, 95% CI=0.58−1.27, p=0.44) and noninvasive IBTR (HR=0.89, 95% CI=0.60−1.33, p=0.56).
No interaction was seen between boost and treatment, age, margin status, or comedo necrosis.
Conclusion: In NSABP B-24, the addition of boost radiation therapy was not found to be of value in reducing IBTR of invasive or noninvasive breast cancers for patients with DCIS.
Supported by PHS grants NCI-U10-CA-69651, NCI-U10-CA-12027, and NCI P30-CA-14599 from the US NCI and AstraZeneca.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-13-01.
P3-13-04: Functional and Cosmetic Outcomes Following Post-Mastectomy Irradiation with Tissue Expander/Implant Reconstruction.
Authors: Baschnagel A , Shah C , Wilkinson JB , Dekhne N , Margolis J , Arthur DW , Vicini F 
Published: June 2012

Abstract
Purpose: To examine the rate of breast reconstruction failure and cosmetic outcomes following post-mastectomy radiation therapy (PMRT) with temporary tissue expander or implant in place.
Methods and Materials: Ninety-four patients with 95 primary breast malignancies underwent mastectomy and immediate tissue expander reconstruction followed by PMRT. Ninety tissue expanders and five implants were irradiated. All patients received a dose of 5,400 cGy given in 180 cGy fractions. Twenty-one patients (22%) received tangents alone and seventy-four patients (78%) were treated with tangents and a supraclavicular field via a mono-isocentric technique. Bolus was used in 91 patients (96%). Eighty-eight patients (93%) received chemotherapy and 78 patients (82%) received endocrine therapy.
Results: With a median follow up of 22.4 months, nineteen patients (20%) developed a reconstruction failure. Ten patients lost their tissue expanders with a median time to reconstruction failure of 7 months (range 3–9 months) while ten patients lost their permanent implant with a median time to loss of 19 months (range 9–31 months) following PMRT. The one and two-year actuarial rate of reconstruction failure was 11.2% and 24.9%, respectively. The most common cause of failure was infection (37%), followed by skin break down (21%), extrusion of expander or implant (16%), fibrosis/eschar (11%), trauma (11%) and pain (5%). Out of the 19 failures, eight patients were salvaged with an autologous flap reconstruction. Univariate analysis was performed to examine the association between age, chemotherapy, hormonal therapy, smoking status, hypertension, diabetes, menopause status, weight and the use of a third supraclavicular RT field on reconstruction failure. However no risk factors were found to be associated with reconstruction failure. In patients who did not have reconstruction failure, good/excellent cosmesis was observed in 79% of patients and fair/poor cosmesis was observed in 21% of patients.
Conclusions: In our series of women with a high risk of recurrence, PMRT with a tissue expander in place followed by a prosthetic implant provides good cosmesis in the majority of women with an acceptable risk of expander or implant loss.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-13-04.
P3-13-09: Impact of Estrogen Receptor Negativity on Clinical Outcomes Following Accelerated Partial Breast Irradiation.
Authors: Wilkinson JB , Baschnagel A , Shah C , Amin M , Nadeau L , Mitchell CK , Wallace MF , Chen PY , Grills IS , Martinez AA , Vicini FA 
Published: June 2012

Abstract
Purpose: To determine the impact of estrogen receptor (ER) negativity on clinical outcomes for patients treated with Accelerated Partial Breast Irradiation (APBI).
Materials/Methods(s): We evaluated 506 consecutive patients treated with interstitial brachytherapy (n= 199), balloon-based brachytherapy (n=203), and 3D-CRT (n=104). ER negative (ERN) status was assigned using the traditional definition of an ER nuclear IHC stain &lt; 10%, which corresponds to an Allred/NSABP staining score of &lt; 2. 63 patients (12.5%) were ER negative and 443 (87.5%) were ER positive (ERP). Patient demographics and clinical outcomes (IBTR, RNF, DM, DFS, CSS, OS) were analyzed for each group.
Results: The two groups had similar patient characteristics. Tumor sizes were slightly larger for the ERN group at 11.9mm vs. 10.7mm, although this was not statistically significant (p=0.14). No differences were seen in median age (63 vs. 64 years, p=0.36), rate of HER-2/neu overexpression (83% vs. 91%, p=0.11), or lymph node positivity (6% vs. 9%, p=0.55) between the ERN vs. ERP groups, respectively. There were an equal distribution of invasive ductal carcinoma (ERN n=55, 87%; ERP n=387, 87%) and DCIS (ERN n=8, 13%; ERP n=56, 13%) patients within each group. The use of chemotherapy (55% vs. 15%, p&lt;0.001) and nuclear grade (71% vs. 12%, p&lt;0.001) were higher in the ERN vs. ERP cohort. With a mean follow up of 6.1 years, the 5-year actuarial rates of ipsilateral breast tumor recurrence (IBTR), regional nodal failure (RNF), and distant metastasis (DM) for the entire cohort were 1.8%, 0.6%, and 3.2%. Although this was not statistically significant, ERN patients appear to have an increased rate of local failure than patients with ERP histology (4.0% vs. 1.5%, p=0.13). Rates of RNF and DM were, however, significantly higher for the ERN group (RNF: 4.9% ERN vs. 0% ERP, p&lt;0.001; DM: 12.1% ERN vs. 2.0% ERP, p&lt;0.001). Although there was no difference in overall survival at six years (86% vs. 90%, p=0.67), we observed a shorter disease-free survival (86.4% vs. 96.5%, p= 0.01) and cause-specific survival (90% vs. 98%, p=0.01) for the ERN vs. ERP groups.
Conclusion: The ER negative phenotype of early-stage breast cancer may have a decreased rate of locoregional control. We observed a higher rate of DM with reduced disease-free and cause-specific survival in ER negative cases, emphasizing the importance of systemic therapy and careful, long-term follow up for these patients. Prospective study of this histologic subtype with a larger cohort of patients is needed to substantiate these findings.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-13-09.
P3-14-07: Relative Risk of Recurrence (RR) over Time in ER Positive and Negative T4 Breast Cancer Patients Achieving Less Than pCR (&lt;pCR) after Primary Chemotherapy: A Reversal Trend of Recurrence beyond 60 Months after Diagnosis.
Authors: Ionta MT , Atzori F , Pusceddu V , Notari F , Valle E , Guerzoni D , Chiappe A , Marongiu M , Minerba L , Massidda B 
Published: June 2012

Abstract
Background
It is widely assumed that patients (pts) who achieve a pCR have a good prognosis and better outcomes compared with pts with &lt;pCR, regardless of hormone receptor status. Emerging data suggest that achieving &lt;pCR identifies a heterogeneous group with different risks of recurrence and death, being ER negative the subgroup with the worst prognosis.
Aim of our study was to evaluate the relative risk of recurrence (RR) over time in ER-positive (ER+) and ER-negative (ER-) &lt;pCR patients.
Material and Methods: We analyzed 139 consecutive &lt;pCR T4 pts, of whom 85 were ER+ (cut-off 10%) and 54 were ER-. Median age was 53 y ( range 29–73). Median follow up was 137 months (range 8–233). All pts received primary anthra-based chemotherapy with or without taxanes followed by endocrine therapy for 5 years, if hormone receptor positive. We examined the RR of recurrence at 0–24, 25–60, 61–120 and beyond 120 months (m) interval after diagnosis.
Results: For all 139 pts, the total number of pts with recurrence was 95 (68%), 54 (63%) in ER+ and 41 (76%) in ER-.tumors. For the entire group and both in ER+ and in ER-, the RR of recurrence was greatest for the interval between 0–24 months, then decreased rapidly in ER- and slowly in ER+ through the 25–120 m interval. For the 0–24 m and 25–60 m intervals the RR of recurrence was higher for ER-pts and after 60 m it crossed and beyond 60 m the RR of recurrence was higher in ER+ than in ER- pts. Notably, beyond 120 months we observed a little second peak of recurrence, higher in ER+ (7) than in ER- (3) pts. Nine of these 10 relapses occurred between 120 to 180 m interval, 7 in ER+ (13%) and 2 in ER- (5%) subgroup. In the first 24 m ER- pts were 86% more likely to relapse compared with ER+, vice versa between 61–120 and beyond 120 m intervals, ER- pts were 19% and 18% less likely to relapse, respectively, compared with ER+ pts.
Conclusions: The present study confirmed the previous reports which showed unfavorable prognosis of the &lt;pCR patients with negative ER status, due to their significantly higher relative risk of recurrence between 0 to 60 months interval. The ER+ recurrences occurred more frequently in late follow-up. A reversal of recurrence between ER positive and negative patients beyond 60 months after diagnosis was detected. The fact might indicate the importance of long term adjuvant hormone therapy for T4 ER positive breast cancer patients with &lt;pCR after primary chemotherapy.

Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-14-07.