bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of fosaprepitant use on dermal and vascular adverse events in anthracycline-based regimens administered through peripheral lines.
Authors: Fujii Takeo , Nishimura Naoki , Kanai Hisako , Ishimaru Hiromasa , Kawano Junko , Takahashi Osamu , Yamauchi Hideko , Yamauchi Teruo 
Published: March 2020

9629 Background: Fosaprepitant is effective in the prevention of chemotherapy-induced nausea and vomiting. In January 2012, we started using fosaprepitant in anthracycline- and cisplatin-based regimens and observed a tendency for an increase in dermal and vascular adverse events (AEs) at local infusion sites, particularly in the anthracycline group. In this study, we tested the hypothesis that fosaprepitant use is associated with dermal and vascular AEs differentially between anthracycline- and cisplatin-based regimens. Methods: We conducted a retrospective cohort study consisting of all patients who were administered anthracycline- or cisplatin- based regimens in 2011 and 2012 at St. Luke’s International Hospital, Tokyo. Aprepitant was used in 2011 and fosaprepitant was used in 2012. All other factors including pre- and post-hydration, premedication, and injection schedule were the same. Dermal and vascular AEs was defined as any grade pain or skin changes at local infusion sites or infusion veins. Factors we considered include fosaprepitant use, chemotherapy regimen, age, number of prior regimens, and body mass index. Interaction analysis using multivariate logistic regression was used to evaluate the association between treatment regimen, fosaprepitant, and risk of AEs. Results: A total of 268 patients (aged 54.3±12.3) were included, of which 120 (44.8%) used fosaprepitant. Among fosaprepitant users, 50 patients (41.7%) developed dermal and vascular AEs, whereas only 16 patients (10.8%) experienced AEs among non-users (P< .001). When stratified by regimen, fosaprepitant was associated with a statistically significant increased risk of AEs (OR 12.10; 95% CI 5.45-26.93) in the anthracycline group. In contrast, no association was observed in the cisplatin group (OR 1.04; 95% CI 0.29-3.75). Statistically significant evidence of interaction was found (P< .001) between regimen and fosaprepitant in the risk of AEs. Conclusions: Our results support the finding that using fosaprepitant in anthracycline-based regimens increases dermal and vascular AEs. In response, we discourage the use of fosaprepitant in anthracycline-based regimens through peripheral lines.
A randomized, double-blind study of “Scrambler” therapy versus sham for painful chemotherapy-induced peripheral neuropathy (CIPN).
Authors: Campbell Toby Christopher , Nimunkar Amit J , Retseck Janet , Eickhoff Jens C. , Backonja Miroslav , Cleary James F. , Kwekkeboom Kristine L , Yen Thomas Y 
Published: March 2020

9635 Background: CIPN is a debilitating, dose-limiting toxicity. The MC5A is a non-invasive electro-analgesia device delivering “Scrambler Therapy,” which has shown benefit for painful CIPN in uncontrolled studies. No sham-controlled trials of MC5A have been performed. Methods: Eligible patients included adults with neuropathic pain (NP) for > 6 months, pain scores ≥4/10 numerical rating scale (NRS), and no history of diabetes or other peripheral neuropathies. Patients received up to 10 daily sessions of 50 minutes with either MC5A or a novel active sham device constructed to deliver a just perceptible electrical sensation. Sham output is neither a TENS nor MC5A and is designed to be nontherapeutic. Active and sham treatments were applied to the affected limbs. 14 patients were randomized with no baseline differences. Patients and evaluators were blinded to study arm. Pain was measured before, daily during, after and 3 months post-treatment (verbal NRS). The primary endpoint was change in pain. Secondary endpoints included quantitative neurosensory testing (QST), validated patient-report measures, and cytokines. Results: There were 7 patients in each arm. The table shows changes in pain scores pre- and post-treatment by day and group. There was no difference between arms and no arm x day interaction. There was no significant day or arm effect for the function sub scales. Conclusions: In a small pilot study, MC5A was not significantly different from sham therapy for the primary outcome. The sham is feasible and provides a mechanism for future controlled studies with MC5A. Secondary endpoints, e.g. QST are forthcoming. Clinical trial information: NCT01261780. [Table: see text]
Patterns of palliative radiation near the end of life: A single-institution retrospective analysis.
Authors: Alcorn Sara R. , Smith Thomas J. , McNutt Todd R. , Cheng M. Jennifer , Dy Sydney Morss , Hales Russell K. , DeWeese Theodore L. , Ellsworth Susannah G. 
Published: March 2020

9636 Background: The care of patients who receive radiation therapy (RT) at the end of life (EOL) is under scrutiny to ensure effectiveness and value, with many patients not completing RT (Gripp, 2010; Toole, 2012). This retrospective analysis seeks to describe patterns of utilization of palliative RT, including rates of completion of RT offered at the EOL and the use of single fraction RT for bone metastases. Methods: Electronic medical records were used to create a database of 3,383 RT plans for brain, bone, lung, and other metastatic sites in patients treated at Johns Hopkins Hospital from 9/1/2007-7/15/2012. RT plans without palliative intent were excluded. T-tests and logistic regression compared patient and treatment characteristics between patients who died > 1 month versus ≤ 1 month after their last RT fraction. Results: A total of 983 patients were treated to 1,524 sites, with an average of 1.7 RT sites (SD 1.3) per patient. Of these, 872 (89%) patients had complete records and were included in analysis. At the time of analysis, 85% had died. The mean age of 62.1 years (SD 3.4) did not differ statistically based on time from RT to death. Death ≤ 1 month after RT was documented in 215 (24.7%) patients. Compared to patients living > 1 month after RT, patients receiving RT within the last month of life were more likely to be lung (17% versus 9%), less likely to be brain (34% versus 44%), and equally likely to be bone (45% versus 43%) sites. Patients who died ≤ 1 month after completing RT spent on average 5 days (16.6%) of the last month of life receiving RT, with no significant difference by disease site. Conclusions: Most patients receiving palliative RT finish therapy, with 25% dying ≤ 1 month after RT. Single fraction bone RT was relatively uncommon, with no significant difference in the rates of single fraction RT based on time from RT to death. These data provide a framework to match treatment patterns with national guidelines. Additionally, they provide context to model risk of death shortly after RT, which can aid in clinical decision-making. [Table: see text]
Efficacy of rebamipide-gargle for chemotherapy-induced oral mucositis.
Authors: Nakamura Masato , Shinohara Akiyoshi , Onikubo Toshihide , Nakamura Kumi , Kamikawa Harumi , Oda Kyota , Tauchi Katsunori 
Published: March 2020

9637 Background: Chemotherapy-induced oral mucositis (CIOM) is a severe adverse event resulting from cancer chemotherapy, and causes severe pain which impacts eating, nutrition, infection and overall quality of life. CIOM can result in unplanned treatment interruptions including dose reduction or treatment delay. Toxic free radicals and several pro-inflammatory cytokines produced by anti-cancer drugs have been reported to correlate with CIOM. Rebamipid, an endogenous inducer of prostaglandins, is widely used for gastric ulcers and gastritis in Asia. It has been shown to increase gastric endogenous prostaglandin E2 and I2, to promote gastric epithelial mucin, to behave as an oxygen–free radical scavenger, and to have other anti-inflammatory actions. In this study, we made a rebamipide gargle using rebamipide and ultrahydrogel, which is added for mucosal protection and to sustain the rebamipide on oral mucosa for a long time. Methods: The objective of this study is to evaluate the efficacy of the rebamipide gargle in relieving CIOM. Each 300ml of rebamipide gargle is made by combining rebamipide 600mg, high molecular weight polyethylene oxide 3g, carrageenin 1.2g, pineapple flavor and water. Patients were instructed to use the rebamipide gargle 5-6 times a day. The severity of CIOM was assessed according to the National Cancer Institute Common TerminologyCriteria for Adverse Events (CTCAE version 4.0). Results: From November 2009 to December 2012, 175 patients with CIOM were enrolled in this study (colorectal cancer 95 patients, breast cancer 32, gastric cancer 22, lung cancer 14, and other cancers 12). The patients’ CTCAE grades (3/2/1/0) changed from (n=13/64/98/0) to (0/10/103/62) respectively after initiation of rebamipide gargle (p<.01; paired t test). A decrease in CTCAE was observed in 142 patients (81.1%) including 62 patients (35.4%) achieving grade 0. The mean duration to best response was 14 days (range: 1-49), and rebamipide gargle was continued 42 days (range: 5-970).There were no unexpected safety events. Conclusions: Rebamipide gargle was well tolerated and demonstrated significant therapeutic response for CIOM.
Oral HPV infection in HPV-positive oropharyngeal cancer cases and their spouses.
Authors: D'Souza Gypsyamber , Gross Neil D. , Pai Sara I , Haddad Robert I. , Gillison Maura L. , Posner Marshall R. 
Published: March 2020

CRA6031 The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Saturday, June, 1, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.
Serum CEA and CA 15-3 levels according to breast cancer subtypes.
Authors: Dede Isa , Utkan Gungor , Akbulut Hakan , Urun Yuksel , Mizrak Dilsa , Icli Fikri 
Published: March 2020

e11511 Background: Carcinoembryonic antigen (CEA) and carbohydrate antigen (CA) 15-3 are frequently elevated in patients with metastatic breast cancer (MBC). In this study we aimed to correlate levels according to breast cancersubtypes with MBC. Methods: From January 2008 to December 2012, ninety-eight patients with MBC who were treated at Ankara University School Of Medicine, Department of Medical Onkology were included in this study.Serum levels of CEA and CA 15-3were measured and compared according to tumor estrogen receptor (ER), progesteron receptor (PR), and human epidermal growth factor receptor 2 (HER2) status. Results: In this cohort, overall ER,PR and HER2 positivity rates were 65 %,68%,and 58%, retrospectively. Positivite ER status was associated with elevated levels of CA 15-3 and cea. Of these, CA 15-3 levels elevated in 40.5% of ER positivite and 24.1 % of ER negativite patients (p=0.027). Similarly, 46.8 % of ER positivite and 18.2% of ER negativite patients had elevated levels of CEA (P=0.022). no association between PR and HER2 status and tumor markers was observed. Conclusions: The breast cancer subtypes are correlated with serum levels of tumor markers in patients with MBC. Tumor markers elevation may be associated with biological background of breast cancer subtypes. Further validation is needed to determine the role of these markers in diffrent tumor types for monitoring patients with MBC.
Adherence to adjuvant hormone therapy (AHT) in early breast cancer (BC).
Authors: Lohmann Ana , Al Barrak Jasem , Peixoto Renata D'Alpino , Chen Leo , Cheung Winson Y. 
Published: March 2020

e11522 Background: Randomized controlled trials of early BC consistently demonstrate a survival benefit from AHT. Some studies show that adherence to AHT is suboptimal, but data are conflicting. There are concerns that poor adherence can negatively impact survival. We conducted a systematic review to evaluate adherence to AHT in early BC and clinical factors associated with non-adherence. Methods: Using search terms such as 'adherence', ‘adjuvant treatment’ and ‘breast cancer’, we identified a total of 843 articles published between 1990 and 2012 of which 43 met our eligibility criteria (7 prospective and 36 retrospective). Pooled estimates of adherence and non-adherence were derived by random effects models. Heterogeneity was assessed by the Cochran's Q and I-squared statistics. To detect for potential publication bias, Egger’s test was conducted. Results: The median rates of adherence, compliance, continuation and persistence to AHT were 77%, 79%, 69% and 81%, respectively. Compared to individuals aged <60 years, patients aged >/=60 years had a significantly higher likelihood of non-adherence (RR 1.59, 95% CI 1.27-2.00, p<0.001). Likewise, non-white patients were more likely to poorly adhere to AHT when compared to their white counterparts (RR 1.39, 95% CI 1.00-1.94, p=0.05). Additionally, prior or concurrent receipt of chemotherapy (RR 1.41, 95% CI 1.06-1.88, p=0.018) and radiation (RR 1.79, 95% CI 1.14-2.81, p=0.011) were independently associated with worse adherence. Interestingly, those with more than a moderate income level defined as >$30,000 per annum had a greater likelihood of poor adherence to AHT when compared to low income earners (RR 1.12, 95% CI 1.01-1.24, p<0.024). There was moderate to high heterogeneity across studies, but there was no evidence of publication bias. Conclusions: In this systematic review, adherence rates to AHT for early BC were suboptimal, underscoring the importance of increased vigilance and need for strategies that promote compliance with proven therapies. Poor adherence patterns were observed in specific patient subsets, but these were not limited to only marginalized populations. Prospective trials of adherence interventions that stratify by these patient subgroups are warranted.
Clinical benefit of fulvestrant in postmenopausal women with advanced breast cancer according to prior therapy.
Authors: De Angelis Carmine , Cerillo Ivana , Ruocco Raffaella , Bruzzese Dario , Forestieri Valeria , Lauria Rossella , Stanzione Brigida , Paciolla Immacolata , De Laurentiis Michelino , De Placido Sabino , Arpino Grazia 
Published: March 2020

e11528 Background: Hormone therapy (HT) is limited by the onset of resistance. Preclinical studies suggest that complete blockade of the estrogen receptor (ER) with the ER antagonist Fulvestrant (F) can overcome this resistance. The aim of this study was to evaluate the efficacy and tolerability of F in postmenopausal women with hormone-responsive (HR) metastatic breast cancer (MBC) previously treated with Tamoxifen (T) or Aromatase Inhibitors (AI). Methods: From May 2006 to July 2008 83 patients with HR MBC progressing after T or AI for adjuvant or metastatic disease receiving F 250 mg/month were identified. Median time to progression (TTP), overall survival (OS), clinical benefit rate (CBR) defined as the proportion of partial or complete responses (CR, PR) or stable disease (SD) lasting ‡6 months were analyzed. Results: Six, 32, 33 and 12 patients received F as 1st, 2nd, 3rd and 4thline of HT for MBC, respectively. Fulvestrant resulted in an overall CBR of 38.6% (32/83) with 0% CR, 9% PR, 30%SD, 56% PD. Disease was not evaluable in 4.8% of cases. Median TTP to F was 4.9 months (4 - 5.8; 95% C.I.) and OS was 20.1 months (15.8 - 24.4; 95% C.I.). Patients with visceral metastases and with more advanced lines of overall therapy had worse outcome (OR 3.13, 1.17-8.37, 95% C.I.; p 0.023 and OR 0.72, 0.54-0.96, 95% C.I.; p 0.025, respectively). However, Fulvestrant showed activity up to the fourth line of endocrine therapy regardless of number of metastatic sites and previous AI or T therapy. Overall treatment was well tolerated. Arthralgia, swelling, and myalgia were the most common adverse all were grade 1 or 2. No injection-related adverse events were reported. Conclusions: Fulvestrant is an active treatment in HR MBC previously challenged with HT. Safety profile is optimal and it may be a suitable option in extensively pre-treated patients. Further exploration of its use in this patient population is warranted.
Phase I dose escalation study of oral lapatinib in combination with docetaxel in patients with HER2-positive locally advanced or metastatic breast cancer (LAMBC): Initial safety and tolerability results.
Authors: Fumoleau Pierre , Dalenc Florence , Mailliez Audrey , Veyret Corinne , Bonneterre Jacques , Guillemet Cecile , Zanetta Sylvie , Moldovan Cristian , Guiu Séverine , Skrzypski Jeremy , Gauthier Mélanie , Coudert Bruno P. , Isambert Nicolas 
Published: March 2020

e11529 Background: Previous studies evidenced that the combination docetaxel (D) (75 mg/m²) + lapatinib (L) (1,250 mg/d) is well tolerated in heavily pretreated HER2-positive metastatic breast cancer patients (pts) in association with systematic G-CSF. This phase I study was conducted to assess safety, optimal tolerated regimen (OTR) and clinical activity of D + L in naïve treatment pts with HER-2 positive LAMBC without primary use of growth factor. Methods: Women with HER2+ LAMBC, naïve of treatment for advanced or metastatic disease, ECOG PS 0-2, were eligible for this study. Pts received once daily oral dosing of L with intravenous D on day 1 of every 3 week cycle. Initial dose was D (75 mg/m²) + L (1,250 mg/d) escalating up to D 100 mg/m² and L 1,500 mg/d until the Maximal Tolerated Dose (MTD) was reached. An expansion cohort of 6 pts was treated at the OTR level. Primary use of G-CSF was not permitted. Results: From Aug 2008 to Nov 2011, 17 pts were enrolled: median age 54.4 years [34.6-77], 59% were PS 0. All patients have metastatic disease with lung (29,4%), bone (41,2%), liver (76.5%) and lymph nodes (35.3%) metastasis. 7 pts received previously chemotherapy in adjuvant setting, 5 pts hormonotherapy and 7 pts radiotherapy. All but two pts were evaluable for dose limiting toxicities (DLT). 1 DLT/6 pts (FN) was observed at dose level (DL) 1 (D 75 mg/m² + L 1,250 mg/d) and 2 DLT/3 pts (gr 3 diarrhoea; gr4 neutropenia >7 d) at DL2 (D 75 mg/m² + L 1,500 mg/d). Only one DLT (FN) was observed in expansion cohort at OTR (D 75 mg/m² + L 1,250 mg/d; 6 pts). Over all C1, other significant toxicities (% pts) included gr4 neutropenia 53%, gr3 transaminase increase 6%, gr2 skin rash 36%, gr2 nausea/vomiting 18%, gr2 diarrhoea 12%, gr2 stomatitis 12%, gr2 hand-foot syndrome 6%; no decrease of cardiac function occurred. Conclusions: OTR for D and L was 75 mg/m² once every 3 weeks and 1,250 mg once daily respectively. This study demonstrates that this combination could be administered without systematic use of G-CSF in non pretreated pts with LAMBC. Additional safety data and preliminary evidence of activity are anticipated to be available at the time of presentation. Clinical trial information: NCT01044485.
Association of extreme age with worse survival in advanced breast cancer.
Authors: Pulido Gema , de la Haba-Rodriguez Juan , Gomez M.Auxiliadora , Jimenez Jeronimo , Cano Maria Teresa , Ortiz Maria Jose , Aranda Enrique 
Published: March 2020

e11530 Background: Age has been associated with survival in advance breast cancer. In the ALAMO Register prognostic index, older age was associated with mortality. Although recent reports suggest that age below 35 was also associated with worse prognosis. We analysed the impact of extreme ages in survival in an advance breast cancer cohort. Methods: Survival analysis of patients followed in the Advance Breast Cancer Cohort at the Reina Sofia Hospital between 1996-2006. Patients were classified in 4 groups of age: I (< 35), II (35-50), III (51-75) and IV (>75 years). Log-rank test was used to compare survivals between groups. Cases were censored after 5 years of follow-up. A uni and multivariate stepwise regression model was used to estimate factors associated with survival. Results: 212 cases of advance breast cancer were included. Patients’ main characteristics, distributed by age groups, are reported in the Table. Median (IQR) survival was shorter (p=0.01) in group I 12.4 (4.7-25.4) and group IV 10.8 (5.1-19.8) compared to groups II 23.5 (17-29.5) and group III 20.2 (15.2-23.7). Factors independently associated with survival were age groups 1-4 versus 2-3 (p=0.02), histologic grade II-II versus I-unknown (<0.01), disease free interval <24 months versus >24 months (p<0.01) and visceral versus non-visceral metastatic location (p<0.01). Conclusions: Extreme ages (<35 or >75 years) at the diagnosis of the advance breast cancer are associated with worse survival. This factor in addition with the histologic grades, the disease free interval and metastatic location were associated with survival. [Table: see text]
A gene expression profile indicative of early stage HER2 tyrosine kinase inhibitor response.
Authors: O'Neill Fiona , Madden Stephen F. , Clynes Martin , Doolan Padraig , Crown John , Aherne Sinead , O'Connor Robert 
Published: March 2020

e11536 Background: Lapatinib, afatinib and neratinib are tyrosine kinase inhibitors (TKIs) of HER2 and EGFR growth receptors. A panel of breast cancer cell lines was treated with these agents and gefintib (EGFR inhibitor) and the expression pattern of a specific panel of genes investigated as a potential marker of early drug response. Methods: RNA was extracted from breast cancer cell lines (BT474, SKBR3 and MDAMB453) with differing HER2 expression patterns and sensitivity to lapatinib before and 12hrs after treatment with 1 µM of lapatinib, 150nM of afatinib, 150nM of neratinib or 1µM of gefitinib. Gene expression changes were measured by Taqman RT-PCR and RQ values were determined using the comparative cycle threshold (Ct) method. Results: The expression of RB1CC1, ERBB3, FOXO3a, NR3C1 was directly correlated with the degree of sensitivity of the cell line to lapatinib and was observed to “switch” from up-regulated to down-regulated in the HER2 expressing lapatinib insensitive cell line (MDAMD453). The CCND1 gene (functionally linked to the other four genes) demonstrated an inversely proportional response to drug exposure; showing a trend of strong down-regulation in lapatinib-sensitive lines. A similar expression pattern was observed following the treatment with both neratinib and afatinib. In contrast, gefitinib treatment, resulted in a completely different expression pattern change. Conclusions: In these HER2-expressing cell models, lapatinib, neratinib and afatinib treatment generated a common, characteristic and specific gene expression response, proportionate to the sensitivity of the cell lines to the HER2 inhibitor. Characterisation of changes in these genes shortly after drug treatment may therefore give a valuable predictor of the likely extent and specificity of tumour HER2 inhibitor response in patients, potentially guiding more specific use of these agents.