bluuebunny/crossref_metadata_2025_split huggingface dataset:
Breast cancer characteristics in yielders and nonyielders of nipple aspiration fluid.
Authors: Brutus V. , McGathey C. , Kmiecik T. , Bethke K. P. , Jeruss J. S. , Hansen N. M. , Khan S. A. 
Published: February 2017

71 Background: Nipple aspirate fluid (NAF) is an attractive biosample for the investigation of breast cancer risk factors. The reported NAF yield rate varies from 30% to 90% in various studies, raising questions about its value as a risk assessment and about the generalizability of data generated in NAF-yielders to non-yielders. To date, there is no data regarding the characteristics of breast cancers that arise in NAF-yielders and non-yielders. Methods: We examined breast cancer characteristics in NAF yielders and the non NAF yielders in an on-going case control study assessing the hormone concentrations of NAF in breast cancer cases and healthy screening controls. 299 women with recently diagnosed breast cancer were recruited from the Lynn Sage Breast Center. NAF collection was performed from the non cancer breast in the clinic, either before surgery or more than one week post-operatively. NAF yielders produced at least 2 ul of NAF. Each patient completed a detailed study questionnaire. Breast cancer characteristics were recorded on each participant. Results: Among 299 recruited patients 130 (40%) were non NAF yielders (group A) and 169 (60%) were NAF yielders (group B). The association of breast cancer risk factors was compared between them. There were no significant differences in the tumor characteristics. The tumor size, grade, number of positive lymph nodes, and fraction of hormone receptor positive, HER2 positive, and triple negative tumors was similar in NAF-yielders and non-yielders (smallest p value 0.295, for histology, ductal versus lobular). Among the major breast cancer risk factors, the only significant differences were that NAF yielders were younger than non-yielders (50.8 vs. 53.6 years, p < 0.0001) and were more likely to have a history of post-menopausal hormone use (27% among NAF yielders and 7% among non-yielders, p < 0.0001). Conclusions: Tumor characteristics of NAF-yielders and non-yielders are similar, suggesting that there is no qualitative difference between these two groups. The risk predictors developed in yielders can apply to non-yielders.
Nomograms for predicting the risk of arm lymphedema after axillary dissection in breast cancer.
Authors: Bevilacqua J. L. B. , Kattan M. W. , Yu C. , Koifman S. , Mattos I. E. , Koifman R. J. , Bergmann A. 
Published: February 2017

8 Background: Lymphedema (LE) after axillary dissection (AD) is a multifactorial, chronic, and disabling condition that currently affects an estimated 4 million people worldwide. Although several risk factors have been described, it is difficult to estimate the risk in individual patients. We therefore developed nomograms based on a large data set. Methods: Clinicopathological features were collected from a prospective cohort study of 1,054 women with unilateral breast cancer undergoing AD as part of their surgical treatment from 8/2001 to 11/2002. LE was defined as a volume difference of at least 200 mL between arms at 6 months or more after surgery. The cumulative incidence of LE was ascertained by the Kaplan-Meier method, and Cox proportional hazards models were used to predict the risk of developing LE based on the available data at each timepoint: (I) preoperatively; (II) within 6 months from surgery; and (III) 6 months or later after surgery. Results: The 5-year cumulative incidence of LE was 30.3%. Independent risk factors for LE were age, body mass index, ipsilateral arm chemotherapy infusions, level of AD, location of radiotherapy field, development of postoperative seroma, infection, and early edema. When applied to the validation set, the concordance indexes were 0.706, 0.729, and 0.736 for models I, II, and III, respectively. Conclusions: The proposed nomograms can help physicians and patients to predict the 5-year probability of LE after AD for breast cancer. Free online versions of the nomograms will be available.
Effect of axillary dissection for occult detected sentinel nodes metastases on survival: NSABP B-32.
Authors: Julian T. B. , Anderson S. J. , Mamounas E. P. , Krag D. N. , Weaver D. , Ashikaga T. , Harlow S. P. , Wolmark N. 
Published: February 2017

80 Background: In NSABP B-32 trial 5,611 women with invasive breast cancer were randomly assigned to sentinel lymph node biopsy (SLNB) plus axillary dissection (Group [Grp] 1) or SLNB alone (Grp 2). There was no significant difference in OS or DFS reported between the two groups. Initial permanent pathologic assessment of the SLNs at participating sites was designed to identify all macrometastases >2 mm and consisted of slicing the SLNs at approximately 2.0 mm intervals, embedding all slices in paraffin tissue blocks, and examining one hematoxylin and eosin stained slide from each block. Routine use of IHC or sectioning of deeper levels was prohibited. SLN paraffin tissue blocks from cases with pathologically negative SLNs were later evaluated centrally for occult metastases deeper in the blocks. This study evaluates group outcomes related to occult metastases. Methods: Routine and cytokeratin IHC stains were used at two widely spaced additional levels. Using this technique, occult metastases were detected in 15.9% of the patients (pts) with initially negative SLNs (616 / 3884 cases). Of the 616 cases, 431 (69.8%) had isolated tumor-cell clusters, 171 (27.9%) had micrometastases, and 14 (2.3%) had macrometastases (Weaver D, et al: N Engl J Med, 2011). Results: 316 (16.4%) of 1924 pts had occult metastases in Grp 1 and 300 (15.3%) of 1960 in Grp 2. Non-sentinel node status was available in 312/316 pts in Grp 1; 23 (7.4%) had positive non-sentinel nodes. In pts with occult metastases, there were no significant differences in OS or DFS between groups (Grp 2 vs. Grp 1 OS HR: 0.89, p=0.62; DFS HR: 0.79, p=0.16). There were no significant differences in OS or DFS between the groups in pts who were negative for occult metastases (Grp 2 vs. 1 OS HR:1.25, p=0.07; DFS HR: 1.11, p=0.22). Conclusions: A more detailed assessment of the SLNs with deeper sectioning and IHC staining detected a significant level of occult metastases in clinically node negative pts. However, no benefit was seen by the addition of axillary dissection in pts with occult SLN metastases. Supported by NCI: U10-CA-12027, U10-CA-37377, U10-CA-69974, U10-CA-69651, and ARRA ROI CA 74137
Outcomes by breast cancer subtype in patients treated with accelerated partial breast irradiation.
Authors: Wilkinson J. B. , Shah C. , Amin M. , Shaitelman S. F. , Nadeau L. , Chen P. , Wallace M. , Mitchell C. , Grills I. S. , Martinez A. A. , Vicini F. A. 
Published: February 2017

83 Background: To determine clinical outcomes for patients treated with accelerated partial breast irradiation (APBI) based on breast cancer subtype. Methods: We evaluated 516 consecutive patients who received APBI with a minimum follow-up of 6 months. Methods of APBI delivery included interstitial brachytherapy (n=221), balloon-based brachytherapy (n=201), and 3D-CRT (n=106). Women were assigned a breast cancer subtype (BCST) based on results of testing for estrogen (ER), progesterone (PR), and human epidermal growth factor (HER2/neu) receptors. Those without test results for all three receptors were excluded. 278 patients were eligible and submitted for analysis. Receptor subtypes were approximated as follows: ER+, PR+/–, and HER-2 negative [luminal A (LA), 164 pts.]; ER+, PR+/–, and HER-2 positive [luminal B (LB), 81 pts.]; ER/PR–, HER-2+ [HER-2 (H2), 5 pts.], and ER/PR/HER-2 negative [basal (B), 28 pts.]. An analysis was then performed to estimate IBTR, RNF, DM, DFS, CSS, and OS. Results: Mean age was 66 years, median follow-up was 4.9 yrs. Basal and H2 subtype patients had higher histologic grades (Gr. 3 = 75% vs. 10% LA/LB, p<0.001), larger tumors (13.0mm vs. 10.7mm LA/LB, p=0.05), and were more likely to receive chemotherapy (68% vs. 15% LA/LB, p<0.001). Basal subtype patients were also more likely to be African American (18% vs. 4% LA/LB, p=0.002). Margin and nodal status were similar between all BCSTs. At five years, IBTR rates were 2.9%, 3.2%, 0%, and 4.8% for LA, LB, H2, and B subtypes, respectively (p=0.75). The IBTR within the B subtype group was due to a single elsewhere failure, the rate of which was not statistically different than that for the LA subtype (2.9%, p=0.30). DM was only seen in LA (2.5%) and LB (1.4%) (p=0.87). Disease-free survival (95-100%), CSS (97%-100%), and OS (80-100%) (Table) were also not statistically different (p=0.98, 0.85, 0.24, respectively) between BCST categories. Conclusions: Five-year local control rates after treatment with APBI are excellent for luminal, HER2, and triple-negative phenotypes of early-stage breast cancer. Further study of BCST is important and may be useful when counseling patients on adjuvant treatment options following breast-conserving surgery.
The DOC combination in advanced gastric cancer: Preliminary data of a phase II study.
Authors: Pancotti A. , Santomaggio A. , Cianci G. , Scipioni T. , Martella F. , Foglia R. , Marchetti P. 
Published: February 2017

104 Background: We describe activity of first line chemotherapy in advanced gastric carcinoma with docetaxel (DTX), oxaliplatin (OHP) and capecitabine (CAP). Methods: Patients (pts) were enrolled in the phase II study, if they had the main subsequent criteria: histologically confirmed diagnosis of advanced gastric cancer (AGC) (local advanced or metastatic disease); normal renal and hepatic function; no myocardial infarction or angina pectoris; no uncontrolled severe diseases or active infections. Treatment schedule: DTX at fixed dose of 65 mg/m2 on day 1, OHP at fixed dose of 110 mg/m2 on day 1, CAP at fixed dose of 1,600 mg/ m2 with crhonomodulation in trhee daily administration from day 1 to day 14, every 3 weeks. Dose-limiting toxicity (DLT): G3 non-haematological or G4 haematological. Study design: Simon two-stage phase II optimal design with power (1- b) 80%, error a 5%, error b 20%, P0 40%, P1 60%. Planned sample size: I stage 7/16, II stage 23/46. Primary endpoint was response rate (RR). Secondary endpoints were time to progression (TTP), overall survival (OS), toxicity and quality of life. Results: 38 pts were enrolled: 24 men and 14 women, median age of 58 years (range 50-67). Median number of cycles per pts was 4,5 (range 3-6). Total cycles administered: 41. Cumulative G3-4 toxicities were: neutropenia 21%, anemia 14%, asthenia 9%. G1-2 toxicities were: diarrhea 22%, neurotoxicity 18%. Median received-DI of DTX: 20 mg/mq/week (93% of recommended-DI), OHP 35 mg/mq/week (95%), CAP 7,000 mg/mq/week (94%) per patient, respectively. Overall pts were assessable (according to intent-to-treat analysis) with 58% (a0.05, CI + 29) of objective responses (OR): 7 partial responses, 4 stable disease and 1 progression. The disease control rate (DCR) was 91%. TTP and OS not done because median follow-up was of 8 months (2-15) only. Conclusions: The combination DOC is tolerable without G3-4 toxicity and preliminary data show very high activity. No significant financial relationships to disclose.
Radiation oncologist density and esophageal cancer mortality.
Authors: Aneja S. , Yu J. B. 
Published: February 2017

116 Background: Although the use of radiation therapy to treat esophageal cancer is increasing, there exists a geographic variation among the distribution of radiation oncologists. The impact of this variation on esophageal cancer (EC) outcomes remains unexplored. The goal of this study was to determine the effect of radiation oncologist density on EC mortality. Methods: Using county- level data from the 2008 Area Resource File, National Program for Cancer Registries, and U.S. Centers for Disease Control, a multivariate regression model was constructed for EC mortality, controlling for county-level categorized radiation oncologists density, demographics, socioeconomic status, and existing hospital facilities. Results: There was a statistically significant reduction in esophageal cancer mortality (reduction ranging from 22% to 79% p < 0.001) associated with counties that possessed at least one radiation oncologist. However, increasing the county density to greater than two radiation oncologists per 100,000 people had no statistically significant reduction in EC mortality. Conclusions: The presence of a radiation oncologist is associated with lowered mortality for EC within that county, but increasing radiation oncologist density does not yield further improvements. Therefore, as the use of radiation therapy to treat EC increases, a detailed understanding of distribution of the radiation oncologists is essential for providing the greatest improvement in EC mortality outcomes. [Table: see text] No significant financial relationships to disclose.
Phase II trial of S-1 combined with oxaliplatin (SOX) as neoadjuvant chemotherapy for locally advanced gastric cancer.
Authors: Chen L. 
Published: February 2017

122 Background: Previous phase II trial with combination therapy of S-1 plus oxaliplatin (SOX) demonstrated high response rate and well tolerability in patients with untreated advanced gastric cancer. The aim of this phase II trial was to evaluate the efficacy and safety of SOX as neoadjuvant chemotherapy for locally advanced gastric cancer (AGC). Methods: Eligibility criteria included a histologically proven AGC with stage IIIb, IIIc (AJCC 7th edition), at least 1 measurable lesion, no prior chemotherapy, ECOG 0∼2, adequate hepatic, renal, and bone marrow function. Enrolled patients were staged by EUS and CT. The neoadjuvant chemotherapy consisted of 3-4 cycles of oxaliplatin (130 mg/m2) on day 1 and S-1 (80 mg/m2/day) for 14 days with 7 days rest. After chemotherapy, the patients underwent surgery. Results: From Dec 2009 to Sep 2010, 35 patients (IIIb; 19pts, IIIc; 16pts) were enrolled. The median age of the patients was 54.6 years (range; 20-72 y). All patients were available for evaluating the clinical responese and adverse events. The overall response rate was 68.5% (1CR, 23 PR, 9 SD, 2 PD). 32 patients underwent surgical resection. Of them, 27 patients underwent standard D2 surgery and 5 patients had palliative surgery. 25 patients had R0 resection. Postoperative pathological examination showed that most of the surgical patients were in T4a stage. According to Lauren classification, 71.9% patiens (23/32pts) were diffuse type, SOX showed higher respons rate (1CR, 20 PR, 2 SD, RR: 91.3%) among these patients. Major grade 3/4 hematological toxicities were anemia (5.7%), neutropenia (5.7%) and liver dysfunction (8.6%) and non-hematological toxicities were anorexia (5.7%) and vomiting (11.4%). But most of the adverse events were managable. Conclusions: Neoadjuvant chemotherapy with S-1 plus oxaliplatin (SOX) showed high response rate and and R0 resection rate for locally advanced GC, especially for diffuse type patients. All the patients did not have severe toxicity during the process of chemotherapy. This is the preliminary results, and the survival benefit in locally advanced GC patients that respond to SOX neoadjuvant chemotherapy needs to be addressed by a randomized-controlled trial. No significant financial relationships to disclose.
Phase I dose-finding study of epirubicin, oxaliplatin, and S-1 (EOS) in patients with previously untreated advanced gastric cancer (AGC).
Authors: Sym S. , Hong J. , Park J. , Cho E. , Lee W. , Chung M. , Park Y. , Lee J. , Shin D. 
Published: February 2017

123 Background: To determine the recommended dose (RD) and dose-limiting toxicity (DLT) of EOS combination in patients with previously untreated AGC. Methods: Previously untreated patients with histologically proven metastatic or recurrent AGC and ECOG performance status 0-2 were enrolled. Fixed dose of epirubicin (50 mg/m2) and oxaliplatin (130 mg/m2) was administered i.v. on day 1. The dose of S-1 was escalated as following schedule: Level I: 30 mg/m2, Level II: 40 mg/m2, Level III: 45 mg/m2, Level IV: 50 mg/m2. S-1 was administered orally twice a day on days 1-14. Each cycle was repeated every 21 days. DLTs were evaluated during the first two cycles of treatment. Results: Nineteen patients were enrolled: 13 patients in dose-escalation phase and 6 patients in the extension at the RD. Median age was 53 years (range, 40-71 years). At dose level II, 1 DLT (grade 4 neutropenia lasting more than 5 days) was found among 6 patients while at dose level III, 2 DLTs (grade 3 diarrhea and nausea) were observed among 4 patients. Therefore, the dose level II was determined as RD. Cumulative (all cycles) grade 3/4 toxicity included neuropenia (58%), leucopenia (32%), thrombocytopenia (11%), diarrhea (11%), and nausea (5%). Of 13 patients with measurable lesions, 8 achieved partial response and 3 showed stable diseases, and the objective response rate was 62% (95% CI, 36-88%). The median progression-free survival was 6.5 months (95% CI, 4.7-8.2 months). Conclusions: The RD of the EOS regimen in patients with previously untreated AGC was epirubicin 50 mg/m2 and oxaliplatin 130 mg/m2 on day 1 and S-1 40 mg/m2 twice a day on days 1-14 of every 21-day cycle. This regimen seems to have promising preliminary activity. No significant financial relationships to disclose.
Population-based analysis of multimodality treatment of gastric cancer.
Authors: Cen P. , Xing Y. , Wray C. J. , Fallon M. B. , Machicao V. I. , Dougherty D. , Amato R. J. 
Published: February 2017

124 Background: Limited data is available for the role of multimodality management for gastric adenocarcinoma and its outcome in the community. Methods: We retrospectively reviewed the outcomes for 341 patients (pts) who were diagnosed with gastric cancer in a community-based health-care system, including 9 hospitals, from 2000 to 2009. Results: 148/341 pts had undergone surgery and were included in the analysis. Median age at diagnosis was 68 year (range: 32-96), 56% were male, 55% were Caucasian and 25% were black. The stage distribution was as follows: 27% (40 pts) localized, 61% (90 pts) locally advanced and 12% (18 pts) with distant metastasis. 98 pts (66%) received surgery alone, 22 pts (15%) received perioperative chemotherapy, and 28 pts (19%) received perioperative chemo-radiation. After a median follow-up time of 5.2 yrs, the median OS for the entire group was 1.9 years, and 88 deaths had occurred at the last follow up. By stage, the median OS was 7 yrs, 2.3 yrs, and 0.3 yrs for localized stage, regional stage, and metastatic disease, respectively. The 5-yr survival was significantly better in pts who received perioperative chemo-radiation (68%), compared to those who received with surgery alone (33%) or perioperative chemotherapy (0%) (p=0.002). The 5-yr survivals by stage and treatment are shown in the table. Conclusions: Perioperative chemo-radiation was associated with a significantly better OS compared to surgery alone. Trimodality therapy for gastric cancer appears to be underutilized in the community setting described here. The survival advantage of surgery plus chemoradiation compared to surgery plus chemotherapy remains controversial and should be investigated in clinical trials. [Table: see text] No significant financial relationships to disclose.
Palonosetron versus other 5-HT3–receptor antagonists for chemotherapy-induced nausea and vomiting prevention in patients with noncolon gastrointestinal cancers.
Authors: Balu S. , Craver C. , Gayle J. , Buchner D. 
Published: February 2017

129 Background: This study analyzed the risk of chemotherapy induced nausea and vomiting (N&V) [CINV] associated with palonosetron versus other 5-HT3 receptor antagonists (5-HT3-RAs) initiation among patients with non-colon gastrointestinal cancers receiving chemotherapy (CT) in a hospital outpatient setting. Methods: Patients diagnosed with any non-colon gastrointestinal cancer initiating any CT and antiemetic prophylaxis with palonosetron (Group 1) or other 5-HT3-RAs (Group 2) for the first time (index date) between 4/1/2007-3/31/2009 were identified from the Premier Perspective database. Patients included were aged ≥ 18 years, with no evidence of N&V, CT, and antiemetic medication in the 6 month pre-index date period, and with at least 36 consecutive months of data. A negative binomial GLM regression analysis was done estimating the number of CINV events (identified through either ICD-9-CM codes for N&V and/or volume depletion or CINV-related rescue medications 1 day after CT administration) in the follow-up period (first of 8 CT cycles or 6 months post index date) between the 2 groups (after matching on CT and specific CT cycle). Results: Of 658 identified patients, 215 initiated on palonosetron (Group 1; 32.7%). Group 1 patients were significantly younger [61.7 (SD: 11.3) vs. 62.2 (12.1) years; p = 0.0073], a higher percent received highly emetogenic chemotherapy (27.4% vs. 19.4%; p < 0.0001), and comprised of less African Americans (7.0% vs. 13.3%). In the follow-up period, the unadjusted number of CINV events per patient per CT cycle for Group 1 patients was lower versus Group 2 patients, though statistically non-significant (4.7 vs. 5.2; p = 0.1714). However, after controlling for differences in demographic and clinical variables, the regression model predicted a statistically significant reduction (30.9%) in the total CINV events per patient per CT cycle in favor of Group 1 patients; p = 0.0086. Conclusions: In this analysis, patients with non-colon gastrointestinal cancers initiated on palonosetron were more likely to experience a significantly lower rate of CINV events per patient per CT cycle versus those initiated on other 5-HT3-RAs. [Table: see text]
The use of small-caliber, covered, self-expandable metal stents for palliation of severe malignant dysphagia.
Authors: Kucera S. , Harris C. L. , Vignesh S. , Klapman J. , Barthel J. S. 
Published: February 2017

134 Background: Self-expandable covered metal stents are an important component of palliative care for malignant dysphagia; however significant complication rates have been associated with large diameter stents. We hypothesized that small-caliber, fully covered, self-expandable metal stents (sccSEMS) would prove adequate palliation of dysphagia in the absence of major complications. Methods: Prospective observational study of 17 patients presenting with severe malignant dysphagia between 12/1/08 and 7/30/10. 31 sccSEMS with internal diameters ranging from 8 mm to 16 mm were placed in 17 patients with pre-stent luminal diameters of < 8 mm (n = 13) or 8-10 mm (n = 4). 7 tracheobronchial stents (internal diameter 14–16 mm), 2 biliary stents (internal diameter 8–10 mm), and 22 specially constructed esophageal stents (internal diameter 12–16 mm) were placed. All stents were placed under direct endoscopic vision without fluoroscopic support. Dysphagia scores, migration rates, and complications were identified through review of endoscopy reports, outpatient clinical encounters, and 24-hour post-procedure phone surveys. Anticipated stent migration was defined as events which occurred during chemoradiation. Unanticipated stent migration was defined as events which occurred in the absence of treatment. Results: The post-stent median dysphagia score improved (decreased) from 3 to 2 (p = 0.0003). The overall median duration of first stent placement was 64 days, IQR 32 – 110 days. The overall migration rate was 35.5% (11/31). The anticipated migration rate was 60% (9/15); the unanticipated migration rate was 18.2% (2/11) (p = 0.051). All 11 of the migrated stents were retrieved endoscopically without complication. 9.7% (3/31) of patients reported self-limited sore throat or chest pain within 24-hours of stent placement. All 3 patients were managed conservatively without need for narcotic analgesics, hospitalization, or repeat endoscopy. No other complications occurred. Conclusions: The direct endoscopic placement of sccSEMS in patients presenting with severe malignant dysphagia significantly improved dysphagia scores, provided excellent durability, and resulted in no major complications. No significant financial relationships to disclose.