bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract P5-13-02: Impact of Adjuvant Trastuzumab on Local Regional Recurrence: Data from the NCCTG N9831 Study
Authors: Halyard MY , Dueck AC , Pisansky TM , McLaughlin SA , Pierce LJ , Marks LB , Solin LJ , Pockaj BA , Perez EA. 
Published: April 2011

Abstract
Background: Trastuzumab (H) improves disease-free survival (DFS) in patients (pts) with HER2 positive breast cancer (BR Ca) when used with adjuvant chemotherapy. We herein compare the rates of local regional recurrence (LRR) in pts randomized to adjuvant chemotherapy with or without adjuvant H.
Methods: The phase 3 randomized trial NCCTG N9831 enrolled 3505 pts with high risk HER2 positive Br Ca to evaluate the effect of adjuvant H on DFS. Pts were randomized to either doxorubicin (A) and cyclophosphamide (C) followed by paclitaxel (T); or AC→TH→H. RT was given concurrently with H after ACT chemotherapy. Pts analyzed underwent lumpectomy (L) + radiotherapy (RT), mastectomy (M) alone, or M+RT. All pts underwent sentinel lymph node biopsy alone and/or axillary dissection. 2816 pts were eligible for competing risk analysis of LRR as a first event (competing risks were distant recurrence, contralateral Br Ca, second primary cancer, or death). Median follow-up is 5.3 years.
Results: Primary breast therapy included L+RT 1062 (38%), M 711 (25%), and M+RT 1043 (37%). Axillary dissection was performed in 90% of pts but less frequently with L+RT (83%) compared to M (88%) or M+RT (98%), chi-sq P&lt;0.001. Stage at presentation was I 41%, II 51%, and III 8% with a significant greater proportion of higher stage pts undergoing M+RT, chi-sq P&lt;0.001. Overall the 5-year LRR rate was 4.1% (95% CI 3.5-4.9%) and similar among the treatment groups: L+RT 4.7% (95% CI 3.6-6.1%), M 3.5% (95% CI 2.4-5.1%), and M+RT 2.3% (95% CI 1.6-3.4%). Among pts with a LRR, 66% were local recurrence only, 11% were local-regional, and 23% were regional only. In the L+RT patients with a LRR, the corresponding rates were 74%, 7%, and 19%, respectively. In the M patients with a LRR, the corresponding rates were 40%, 23%, and 37%, respectively. In the M+RT patients with LRR, the rates were 79%, 4%, and 17%, respectively. H is associated with a non-statistically significant reduction in the risk of LRR for pts who receive L+RT or M+RT (Table 1). No such trend was seen in the M alone group but the number of events was low.
Table 1. LRR According to Local and Adjuvant Treatment Groups
Conclusion: The LRR as the first reported site of failure was low with a median 5. 3 year follow-up. Adjuvant H was associated with a trend of lower LRR in the pts treated with L + RT or M+RT. This observation suggests an additive effect of RT and H on LRR that warrants further investigation. The small number of local-regional events in this one randomized trial supports further investigation of LRR across other adjuvant trastuzumab trials.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-13-02.
Abstract P5-13-04: Use of Bisphosphonates in the Adjuvant Setting for Breast Cancer — A More Than 10 Years Single Centre Experience
Authors: Jakob A , Groh U , Schwoerer D , Schattenberg A , Siebers JW. 
Published: April 2011

Abstract
Background: Adjuvant therapies for early breast cancer are associated with substantial decrease in bone mineral density. Bisphosphonates are antiresorptive agents that have an established role in preventing skeletal morbitity in patients with bone metastases and in the treatment of osteoporosis. It has also been shown that these agents are active in preventing cancer treatment induced bone loss in women with early stage breast cancer. Recently, several trials have demonstrated that bisphosphonates may exert anticancer effects in the adjuvant setting. Patients and methods: Since 1997 we treated an increasing number of unselected patients with early breast cancer with bisphosphonates (up to 2009: 1144 out of 1876 patients). There was no significant difference in the two patient groups concerning tumour size, nodal status, hormone receptor (HR) expression, HER-2 expression and adjuvant treatment modalities. In most cases we used zoledronic acid, but also clodronate ibandronate or alendronate.
Results: Disease-free survival (DFS) was significant better in patients treated with bisphosphonates (p = 0.009). This was also true in the subgroup of patients with hormone receptor positive disease (p=0.0011) and even more striking in patients with N+ disease (p=0.00003). There was no significant difference in DFS in patients with hormone receptor negative disease. In our analyses especially patients with N+ and ER/PR+ disease showed a significant advantage from treatment with bisphosphonates. Conclusion: This large single centre experience demonstrates a significant improvement of disease-free survival in patients with breast cancer treated with bisphosphonates in the adjuvant setting. The benefit was more pronounced in the subgroup of nodal positive and hormone receptor positive disease.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-13-04.
Abstract P5-13-06: Survival Benefit of Bisphophonates in Early Breast Cancer: A Meta-Analysis
Authors: Lin Y , Ying X , Wang F , He P. 
Published: April 2011

Abstract
Objectives: Bone is one of the most common metastatic sites of breast cancer. Recent date from randomized clinical studies suggested that the use of bisphophonates affect bone metastasis and survival in early breast cancer patients. Results from some of these trials are encouraging but somewhat contradictory. We conducted a meta analyses to assess the effect of bisphosphonates on bone metastasis and survival in primary breast cancer patients.
Methods: Trials were retrieved by searching the PubMed database, Cochrane Library and major cancer scientific conferences up to January 2010. All tirals randomized patients to receive any bisphosphonate versus non-use or placebo. Hazard ratios (HR) and its 95% CIs for bone metastasis free survival and overall survival were estimated.
Results: 8 eligible trials including 6132 patients entered the analysis. 3049 patients were treated with bisphosphonates and 3083 received either placebo or no treatment. Compared with no use, bisphophonates in the adjuvant setting improved the overall survival (HR=0.808; 95%CI 0.708-0.923; P = 0.022). However, the reduction of bone metastasis was failure to be seen (HR = 1.011; 95% CI 0.996-1.027; P = 0.667). Conclusion: Our meta-analysis provides additional evidence that adjuvant breast cancer treastment with bisphosphonates brought a survival benefit. However, the result should be carefully interpreted for that the statistical significance was not consistent in the bone benefit. Results of new clinical trials were awaited.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-13-06.
Abstract P5-13-07: Hormone Levels in the OPTION Trial Show No Ovarian Protection by Goserelin in Adjuvant Chemotherapy for Early Breast Cancer — An Anglo-Celtic Collaborative Group and NCRN Trial
Authors: Leonard R , Adamson D , Anderson R , Ballinger R , Bertelli G , Coleman R , Fallowfield L , Keerie C , McLinden M , Mansi J , Thomas G , Yellowlees A. 
Published: April 2011

Abstract
Non-randomised data suggest a protective benefit on ovarian function for using GnRH analogues to suppress menses during chemotherapy. However there have been no published randomised clinical trials to date that confirm this protection indicated by recovery of menstrual function.
Observational data suggest that patient age and cumulative dose of alkylating agent or selection and intensity of dose other agents such as anthracyclines or taxanes are also important variables that determine the risk of chemotherapy-induced premature ovarian failure (POF). This trial in premenopausal women has tested the effect of goserelin (G) given randomly before and during adjuvant chemotherapy in premenopausal women with breast cancer. Any standard regimen was allowed but women were randomised in 2 strata, under 40 yrs and over 40 yrs at diagnosis. 227 patients were recruited by end December 2009, and 173 met the criteria for 1 year follow-up for this analysis; 140 patients of these 173 patients had provided adequate data on menstrual bleeding; 87 patients were aged under 40 and 53 patients were aged over 40 at the time of chemotherapy. Cessation of menstruation during chemotherapy was defined as at least two consecutive cycles with no menstrual bleeding since the previous cycle. Additionally, prior to the final cycle of chemotherapy, there had to be no return of menstrual bleeding. Of those patients who had ceased periods during chemotherapy, those with no further menstrual bleeding at 12 months follow up were deemed to have reached menopause. Patients were randomised to receive G or no G at start of chemotherapy. Primary endpoint was recovery of menses at 12 months from start of chemotherapy. Secondary endpoints included quality of life, oestrogen/LH/FSH levels at start and completion and at 12 months along with anti-mullerian hormone (AMH, as an indicator of impending ovarian failure). Endocrine data over time showed a close correlation with menses in that both measures indicated no protective effect in the treatment group. There was no significant difference with respect to POF when all patients were considered. However there was a trend to poorer recovery of menstrual function at 12 months in the under-40 yrs group who had G with 34.7% having POF in the G treated group and 15.8% in the chemotherapy only treated group (P ≥0.05). This is mirrored by the oestrogen data which show an incomplete recovery at 12 months of oestrogen in the G group compared with controls although a complete recovery at 24 months. LH and FSH levels showed appropriate suppression by G and thereafter similar levels to controls. Early follow up data on the hormone levels shows no difference between the treatment groups.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-13-07.
Abstract P5-13-11: Medico-Economic Assessment of the Genomic Grade Index on Adjuvant Treatment Strategy in Elston-Ellis Grade 2, Estrogen Receptor Positive, HER2 Negative, Node Negative, Small Size Breast Carcinomas
Authors: Reyal F , Bollet M , Caly M , Hajage D , Carpentier S , Peyro-Saint-Paul H , Pierga J-Y , Sigal-Zafrani B , Vincent-Salomon A , Sastre X. 
Published: April 2011

Abstract
Background: Elston-Ellis grading (EE) is one of the key criteria for adjuvant therapy decision in ER+/HER2-/pN0/pT1 -2 tumors. The genomic grade index (GGI) is a 97-gene micro-array assay able to identify tumors of high or low genomic grade. GGI has been developed in order to improve the prognosis determination, especially in EE2 tumors which represent a significant proportion of breast carcinomas and where the inter-assessor variability is the highest. The aim of the present study was to model the influence of the GGI on adjuvant treatment decision in EE2 patients, using a cohort of ER+/HER2-/pN0/pT1-2 tumors.
Methods: A randomly selected series of pT1-2, pN0 breast cancers from the Institut Curie 1995-1996 cohort was profiled using Affymetrix HGU133 Plus 2.0 gene chips. The GGI was calculated using Ipsogen Mapßuant Dx®. Treatment decisions were made for EE2 cases based on the Institut Curie adjuvant treatment guidelines (www.curie.fr). The treatment decision algorithm was firstly run using the grade as defined by Elston Ellis, and secondly using the GGI (undetermined cases were classified as grade2).
Results: Out of 72 EE2 tumors, 35 were classified as GGI-1 (49%) and 13 (18%) as GGI-3. Based on EE, 7% of patients would have received adjuvant chemotherapy (ACT) alone (all were ER-/PR-), 50% adjuvant hormonal therapy (AHT) alone, and 43% both. Using the GGI, 7% (n=5) of patients would have been spared AHT and 10% (n=7) ACT. In the ER+/HER2- subgroup of 62 pts, 58% of patients would have received AHT alone and 42% AHT+ACT based on EE; GGI would have lead to a 14% reduction in AHT prescription and to a 26% reduction in ACT prescription. Conclusion: Applying the Genomic Grade Index instead of the Elston Ellis Grade to determine the adjuvant treatment strategy in a series of EE2/ER+/HER2-/pN0/pT1-2 breast carcinomas would lead to a 14% and 27% reduction in the administration of, respectively, adjuvant hormone-therapy and chemotherapy.
Adjuvant treatment decision: models based on Elston-Ellis or Genomic Grading

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-13-11.
Abstract P5-14-01: The Influence on Upper Limb Function after Sentinel Lymph Node Biopsy or Axillary Lymph Node Dissection
Authors: Miyajima S , Utsumi T , Kobayashi N , Hikichi M. 
Published: April 2011

Abstract
Background
Sentinel lymph node biopsy (SLNB) is accepted as a method in patients with clinically negative axillary lymph nodes because it was assumed to be associated with improvement of upper limb morbidity. The purpose of this study was to investigate that SLNB reduces upper limb morbidity of patients with breast cancer compared with axillary lymph node dissection (ALND). Methods
The study comprised 362 patients with breast cancer who underwent measuring the upper limb mobility before and after surgery (at discharge, 1 month and 3 months after surgery). 241 patients underwent SLNB, 121 patients underwent ALND. In the SLNB group, 148 patients (48.1%) underwent breast conserving surgery (BCS), 67 patients (18.5%) underwent mastectomy. In the ALND group, 68 patients (18.8%) underwent BCS, 53 patients (14.6%) underwent mastectomy. Upper limb mobility was measured by the difference of the angle of the flexion and the angle of abduction between before and after surgery. The recovery defined that the difference of the angle between before and after surgery, is within 10 degree. The recovery rate was investigated by Kaplan-Meier method, and comparisons were evaluated using the log-rank test. Results
The recovery rate of patients in the SLNB group was 85% in measuring flexion, 90% in measuring abduction 3 month after surgery. The recovery rate of patients in the ALND group was 52% in measuring flexion, 58% in measuring abduction. The recovery rate of upper limb function increase by SLNB than by ALND (P&lt;0.001).’
Conclusions
SLNB reduces upper limb morbidity of patients with breast cancer compared with ALND. SLNB can improve activity of daily life (ADL) by improving of the upper limb function.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-14-01.
Abstract P5-14-02: Immediate Breast Reconstruction: The Effect of Radiation
Authors: Hwang ESS , Sasaki T , Itakura K , Foster R , Fowble B , Tanaka J , Ewing CA , Alvarado MD , Esserman LJ. 
Published: April 2011

Abstract
Background:
Prior history of breast irradiation or anticipated need for postmastectomy radiation have been considered relative contraindications for immediate breast reconstruction. We evaluated the surgical outcomes between three groups of patients: patients without radiation exposure, those with radiation prior to immediate reconstruction, and those with radiation following immediate reconstruction to determine the differences in risk of post-surgical complications among groups. Methods:
All patients undergoing mastectomy and immediate reconstruction with either a tissue expander or implant between January 1, 2005 and June 30, 2009 were entered into an IRB-approved prospective database. Routine institutional protocol consisted of immediate reconstruction with tissue expander, expansion during the1-2 months following surgery, radiation if indicated, followed by implant exchange at 3-6 months after completion of radiation. All complications were collected and recorded within a week of the event, and all patients had a minimum follow-up period of 6 months after implant exchange to allow for sufficient monitoring of complications. Major complications included infection requiring IV antibiotics, unplanned return to surgery, and tissue expander/implant loss. Results:
A total of 446 mastectomies were identified. Of these, 341 had no radiation history, 33 had prior ipsilateral breast radiation, and 72 had post-mastectomy radiation. Overall, there were 160 major complications (36%), including 50 (11%) expander/implant losses. Patient age, BMI, diabetes, and history of tobacco use were not associated with increased risk of major complications in this cohort. However, both prior and postoperative radiation was associated with higher risk of both major complications and implant loss.
Conclusion:
Immediate reconstruction with implant or tissue expander is associated with a 36% risk of major postoperative complications, with the greatest number seen in those patients with history of previous chest wall irradiation. However, most implants were salvaged even in the setting of complications, and the overall implant loss rate was only 8% in unirradiated patients and 22% in those patients with postoperative RT. Although radiation history is not a contraindication to immediate breast reconstruction, patients undergoing this procedure must be well informed of their substantial risk of postoperative complications.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-14-02.
Abstract P5-14-05: Improved Survival of Patients with Primary Distant Metastatic Breast Cancer in the Period of 1995 — 2007
Authors: Ruiterkamp J , Ernst MF , de Munck L , van der Heiden-van der Loo M , Bastiaannet E , van de Poll-Franse LV , Bosscha K , Tjan-Heijnen VCG , Voogd AC. 
Published: April 2011

Abstract
Introduction
During the last fifteen years, important changes have taken place concerning the sy stemic treatment for patients with metastasized breast cancer. It would be interesting to know whether these improvements have also taken place patients with primary distant metastatic breast cancer. Additionally, several retrospective studies have shown an improvement in overall survival in patients who have received breast surgery. Therefore, we also analyzed the role of surgical resection of the primary breast tumor. Methods
According to the database of the Dutch Cancer Registry 7,358 (5.0%) patients were diagnosed with primary distant metastases between 1997 and 2007. To establish whether improvement of prognosis had taken place, patients were divided into three periods of diagnosis, based on the year of diagnosis of their disease; 1995-1999, 2000-2003 and 2004-2007. The follow-up of these patients was completed until January 1, 2009. Results
The median survival was 1.42 years for patients diagnosed in the period 1995-1999, 1.56 years in the period 2000-2003 and 2.0 years in the period 2004-2007. Only the difference between the periods 2000-2003 and 2004-2007 was statistically significant (P&lt;0.0001). When analyzed according to age group, the improvement of the median survival was most pronounced for patients of 50 years or younger, with an increase of 2.18 to 3.01 years (P&lt;0.0002). The median survival of the patients undergoing surgery was 2.5 years, compared to 1.3 years for the patients without surgical treatment of the primary tumor. Nevertheless, the proportion of patients who underwent a resection of the breast tumor decreased from 31% in the period 1995-1999 to 24% in the last period. In the multivariable analysis, the hazard ratio's (HRs) for mortality in the second and third period as compared to the first period were 0.95 (P=0.13) and 0.86 (P&lt;0.0001), respectively. Older age and larger tumor size were associated with a higher mortality risk. Patients receiving systemic treatment (HR 0.36), locoregional radiotherapy (HR 0.79) or breast surgery (HR 0.65) had a significantly lower risk of death compared to the patients not receiving these treatments. Conclusion
An improvement of six months is seen in the median survival of patients with primary distant metastatic breast cancer, resulting in a median survival of two years in 2007. Maybe, if surgery was more performed in the most recent time period, the improvement of the median survival was even better. However, it seems reasonable to argue that this improvement is due to new developments in systemic treatment.
Figures available in online version.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-14-05.
Abstract P5-14-10: Risk Factors Associated with Surgical Site Infection after Breast Operations
Authors: Scow JS , Throckmorton AD , Hoskin TL , Boughey JC , Boostrom SY , Holifield AC , Baddour LM , Degnim AC. 
Published: April 2011

Abstract
INTRODUCTION: Surgical site infection (SSI) is a problematic cause of morbidity following breast/axillary surgery. The breast/axilla has a higher rate of SSI than expected for clean wounds. We evaluated risk factors associated with SSI after breast/axillary operations.
Methods: A retrospective review of breast/axillary procedures from July 2004 to July 2006 was performed. SSI was defined using Centers for Disease Control and Prevention criteria, including cases with cellulitis as the only criterion of infection. Data collected included patient demographics, BMI, surgical procedure, ASA class, antibiotic use, drains, and prior radiation (RT).
RESULTS: We identified 389 patients who underwent 678 procedures. Thirty-seven SSI (5.5% of procedures) were identified, of which 24 (65%) had only cellulitis. Median time from surgery to SSI diagnosis was 9 days (range 2-112), with 81% occurring in the first 30 days. Univariate analysis identified prior RT, BMI, type of procedure, operative time, use of drain, and postoperative seroma to be associated with SSI (all P&lt;0.05). With multivariate analysis, procedure type remained significant overall (p=0.04). Specifically, mastectomy with sentinel lymph node biopsy (SLNB) and modified radical mastectomy remained significantly associated with higher risk of SSI, with hazard ratios (HR) of 6.3 and 13.5 fold respectively compared to SLNB alone. Seroma (HR 9.0, 95% CI 2.7-29.3), prior RT (HR 3.4, 1.2-9.9), and BMI &gt;=30 (HR 3.1, 1.6-6.2) also remained significantly associated with SSI.
CONCLUSION(S): SSI are more frequent after breast/axillary operations than other clean wounds and are associated with prior RT, obesity, more extensive and longer procedures, and postoperative seroma.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-14-10.