bluuebunny/crossref_metadata_2025_split huggingface dataset:
Survivorship care plans: Recommended vs delivered care.
Authors: Smith Karen L. , Sobel Talia , McGurk Kathy , Magnant Colette , Croog Victoria , Vaclavik Ida , Stearns Vered , Wolff Antonio C. , Wright Jean 
Published: September 2018

10076 Background: The Committee on Cancer set a benchmark for the provision of survivorship care plans (SCP) to ≥50% of early cancer patients by the end of 2017 despite limited data indicating benefit. One hypothesis is that SCP will reduce overuse of medical care in survivors. Methods: We performed a retrospective review of all patients with early breast cancer (BC) who were seen by a single nurse practitioner (NP) for provision of SCP after completion of primary therapy (surgery, radiation +/- chemotherapy). We evaluated adherence to recommendations for follow-up (FU) care and testing in accordance with established guidelines. Results: Between August 2013 and December 2014, 152 patients received SCP after completion of primary therapy (median 2 months, range 0-27). 98% of SCP were given to patients, but only 38% were sent to primary care providers (PCP). Median FU was 23 months. Among 130 patients who did not undergo bilateral mastectomy for whom surveillance breast imaging (SBI) was recommended, 10 (8%) had 1st SBI ≥3 months earlier than time recommended (TR), 102 (78%) within 2 months of TR, 12 (9%) ≥3 months after TR, and 6 (5%) lacked confirmation of 1st SBI. Among 113 in whom 2nd SBI dates were specified, 25 (23%) had SBI ≥3 months earlier than TR, 62 (55%) within 2 months of TR, 7 (6%) ≥3 months after TR, and 18 (16%) lacked confirmation of 2nd SBI. Among 71 patients for whom first medical oncology (MO) FU visit dates are known, 64 (90%) occurred within 3 months of TR and among 81 patients for whom first radiation oncology (RO) FU visit dates are known, 67 (83%) occurred within 3 months of TR. However, among 47 patients for whom first FU visit dates with at least 2 types of providers (MO, RO and/or surgery) are known, 15 (32%) visited 2 providers within 2 months of one other. During the 1styear after completion of primary therapy, 22% underwent body imaging (CT, PET-CT, or bone scan) and 21% had liver function tests. Conclusions: Despite provision of a SCP to patients, PCP were often not notified and healthcare utilization exceeded recommendations. Nearly a third of patients had redundant visits, a fourth had SBI earlier than recommended, and a fifth had body imaging and lab testing. Ongoing efforts are needed to coordinate care and minimize unnecessary testing in BC survivors.
Association of nutritional parameters and survival in parenteral nutrition-supported (PN) gastrointestinal cancer patients.
Authors: Liu Wenli , Qdaisat Aiham , Lee Eric , Yeung Jason , Vu Khanh , Lin Junzhong , Canada Todd , Song Juhee , Cohen Lorenzo , Bruera Eduardo , Yeung Sai-ching J. 
Published: September 2018

10078 Background: PN is a major tool in managing nutritional challenges in cancer patients. However, a clear set of clinical and biochemical indices to determine PN application in cancer patients has not been developed. We assessed the association between PN related nutritional parameters and survival in a large group of gastrointestinal (GI) cancer patients. Methods: 1197 consecutive GI cancer patients who received PN support between 08/01/08 – 08/01/13 were reviewed. Height, weight, plasma glucose (baseline and within 48 hours after PN initiation), surgical history, and pharmacy data including PN contents (dextrose, amino acids, and fat) and non-PN dextrose or fat in drug administration were recorded. Body mass index (BMI), Ideal body weight (IBW), PN and non-PN Calorie, and nitrogen were calculated for analysis. Data were entered into a multivariate analysis controlling for age, gender, cancer site, and medical comorbidities. Results: Median BMI was 25.4. 70% of the patients had unsteady weight ( > 2.5% change) before PN initiation. The magnitude of weight change was inversely related to survival (HR 1.02), P < 0.001). Patients with BMI > 25 and < 7.5% weight change prior to PN initiation had the most favorable survival. Glycemic instability (maximum plasma glucose variation > 100mg/dL) was independently related to shorter survival (HR 1.53, P < 0.001). Total calorie by IBW (kcal/kg/day) (HR 0.97, P < 0.001), non-PN calorie % (HR 1.04, P < 0.001), and calorie to nitrogen ratio (kcal:g) (HR 1.02, P < 0.001) were all independently associated with overall survival. Conclusions: Lower BMI, weight instability, and glycemic instability were adversely associated with survival. Higher total PN calorie and amino acid support were associated with better survival. Higher non-PN calorie % was adversely related to survival. Future studies must focus on developing a set of indices incorporating independent prognostic clinical and biochemical factors in determining PN application and monitoring in cancer patients. Optimum calorie and amino acids in PN support for cancer patients also require further investigation.
Secondary solid tumors in patients younger than 55 with chronic lymphocytic leukemia (CLL).
Authors: Carter Jordan Spencer , Lee William May , Nathan Rachel , Rivas Doris Maria , Liang Ya Yu , Jain Maneesh Rajiv , Ward Kristine Marie , Styler Michael 
Published: September 2018

10083 Background: Patients with CLL are at an increased risk of secondary solid tumors. Few studies have looked at this risk in patients < 55, despite research suggesting that this is a distinct cohort with a longer overall survival. What data does exist has yielded variable results in limited populations. In light of this, our study utilized the SEER registry to look at secondary solid tumors in patients < 55 with CLL. Methods: 4559 patients 15-54 years old with CLL were identified in the SEER registry between 1973 and 2013. Cancer risk was assessed using standardized incidence ratios (SIR) of observed (O) and expected (E) cancers. 95% confidence intervals (CI) were calculated assuming a Poisson distribution. Results where the CI = 1 were excluded. Results: 498 patients (O/E = 1.4) developed a secondary solid tumor after CLL with a mean age at diagnosis of 48.8 and 59.9 years for CLL and a second tumor, respectively. Higher than expected risk was seen in lip (O/E = 7.5), non-epithelial skin (O/E = 5.4), salivary (O/E = 4.8), mesothelioma (O/E = 4.4), melanoma (O/E = 3.1), lung (O/E = 2.4), and kidney (O/E = 1.7) cancers. Uterine cancer had a lower risk (O/E = 0.4). Stratifying the cohort by gender and race found that lip cancer in whites (O/E = 7.6) and men (O/E = 7.3), descending colon cancer (O/E = 13.3) in blacks and ureter cancer (O/E = 19.8) in women posed the highest risks. Lung cancer was the most prevalent among all groups. Secondary tumor risk was elevated in the < 1, 1-5, 5-10, and 10-15 years after diagnosis with CLL (O/E = 2.3, 1.4, 1.5, and 1.4, respectively). The cancers with the highest SIR in each period were thyroid ( < 1 year, O/E = 9.2), lung (1-5 years, O/E = 3.1), nose/ear (5-10 years, O/E = 11.8), and lip (10-15 years, O/E = 15.6). In 4459 patients > 55 (O/E = 1.1), Kaposi sarcoma (O/E = 4.9), non-epithelial skin (O/E = 3.6), salivary (O/E = 2.8), melanoma (O/E = 2.1), nose/ear (O/E = 2.0), lip (O/E = 1.7), soft tissue (O/E = 1.6), lung (O/E = 1.4), kidney (O/E = 1.3), and colon cancers (O/E = 1.2) were significant. Conclusions: Patients < 55 have a unique tumor profile and greater risk of secondary solid tumors compared to patients > 55. This risk differs on the basis of gender, race, and survival time. Further research may help influence screening guidelines.
Chemotherapy-induced neutropenia risk models to guide the use of myeloid stimulating factors in intermediate risk chemotherapy: A cost and practicality analysis.
Authors: Jeurkar Chetan , Pompa Tiffany , Yeung Ho-man , Crilley Pamela A. , Topolsky David Lane , Styler Michael 
Published: September 2018

10086 Background: The National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) have published guidelines for use of prophylactic colony stimulating factors (CSF) for patients at risk for chemotherapy induced neutropenia (CIN). Both recommend CSF if the chemotherapy regimen has a >20% febrile neutropenia (FN) risk. If the regimen is of intermediate CIN risk, the guidelines are less definitive. In this study, we looked at lung cancer patients receiving intermediate CIN risk chemotherapy and applied two risk models developed by Hosmer et al and Bozcuk et al to see if they have adjunct value to the NCCN and ASCO guidelines to more accurately predict CIN. Methods: This was a retrospective study of 43 patients with a diagnosis of lung cancer who were treated with chemotherapy at Drexel University from 2005-2016. Risk models developed by Hosmer et al and Bozcuk et al along with the NCCN and ASCO guidelines were applied to the cohort of patients. Results: The Hosmer calculator recommended giving CSF to 26 patients, the Bozuk calculator for 22 patients, the NCCN guidelines for 25 patients and the ASCO guidelines for 38 patients. Sensitivities, specificities, and pricing information for one course of filgrastim are listed for each risk model in the Table. Conclusions: In lung cancer patients receiving intermediate CIN risk chemotherapy, the Hosmer calculator had the best combination of sensitivity, specificity, and ease of use. The Bozcuk calculator, while accurate, was more difficult to use. The NCCN guidelines missed more patients with severe CIN while the ASCO guidelines gave CSF to the greatest number of patients. The cost for using CSF would have been highest using the ASCO guidelines. Therefore, we recommend the Hosmer calculator for lung cancer patients receiving intermediate risk CIN chemotherapy as it lends to accurate but judicious use of CSF. [Table: see text]
Factors influencing the analgesic response over time of the oxycodone-naloxone association in painful cancer patients: GREAT study.
Authors: Corli Oscar , Legramandi Lorenzo , Marabese Mirko , Roberto Anna 
Published: September 2018

10089 Background: The prolonged use of opioids is usually associated with the appearance of adverse events as drowsiness, constipation, nausea/vomiting, and dizziness. Some effects are self-limiting over time for the onset of tolerance while others, as constipation, persist. Clinical studies demonstrated that the association oxycodone-naloxone (OXN), reduced the constipation in the presence of unchanged analgesic efficacy. Though, the variability of the analgesic response to OXN is not explained yet. The aim of this study was to evaluate the association between the clinical and genetics factors and analgesics response at OXN. Methods: In this study the cancer patients with moderate to severe pain received OXN and followed for 28 days. At each visit pain intensity modifications of therapy and adverse drug reactions (ADRs) were recorded. The primary efficacy endpoint was the proportion of responders, defined as patients with a decrease of the average pain intensity from baseline to last visit ≥30% and a final average pain score≤4, measured on 0-10 numerical rating scale. Genetic tests to identify SNPs related to opioid response were performed in each patient. Results: 14 centers participated in the study and recruited 206 patients. Among 176 patients analyzed for a primary endpoint the mean age was 68 (SD 10); 56% were male. Average and worst pain intensity decreased from baseline to last visit from 6.2 to 2.9 and from 8.3 to 4.6 respectively. 81% of patients were responders. Digestive system tumors (p = 0.05), concomitant thyroid endocrinopathy (p = 0.023), psychological irritability (p = 0.0029) and breakthrough pain at baseline were found to decrease the risk of positive response. None of the investigated polymorphisms influenced the analgesic response. Moderate to severe intensity ADRs were mainly constipation (26%), drowsiness (19%) and dry mouth (12%). Conclusions: In patients with moderate to severe cancer pain, OXN showed a strong analgesic effect (about 50% pain reduction). In comparison with other studies the induced constipation appears substantially lower. Some clinical factors influence the analgesic response while none genetic polymorphisms modulate the response. Clinical trial information: NCT02293785.
LOTUS (NCT02162719): A double-blind placebo (PBO)-controlled randomized phase II trial of first-line ipatasertib (IPAT) + paclitaxel (P) for metastatic triple-negative breast cancer (TNBC).
Authors: Dent Rebecca Alexandra , Kim Sung-Bae , Im Seock-Ah , Espie Marc , Blau Sibel , Tan Antoinette R. , Isakoff Steven , Oliveira Mafalda , Saura Cristina , Wongchenko Matthew , Kapp Amy V. , Chan Wai Y. , Singel Stina M. , Maslyar Daniel J. , Baselga Jose 
Published: September 2018

1009 Background: The oral Akt inhibitor IPAT is being evaluated in cancers with a high prevalence of PI3K/Akt pathway activation, including TNBC. Methods: Eligible patients (pts) had measurable inoperable locally advanced/metastatic TNBC previously untreated with systemic therapy. Pts were stratified by prior (neo)adjuvant therapy, chemotherapy-free interval and tumor PTEN status, and randomized 1:1 to P 80 mg/m2 (d1, 8 & 15) with either IPAT 400 mg or PBO (d1–21) q28d until progression or unacceptable toxicity. Co-primary endpoints were progression-free survival (PFS) in the ITT population and pts with PTEN-low tumors by IHC. Secondary endpoints included objective response rate (ORR), duration of response (DoR) and overall survival in the ITT and IHC PTEN-low populations, efficacy in pts with PIK3CA/AKT1/PTEN-altered tumors by next-generation sequencing (NGS), and safety. Results: Baseline characteristics were generally balanced between arms. Efficacy is shown below. The most common grade ≥3 AEs (grouped terms) were diarrhea (23% IPAT+P vs 0% PBO+P; no grade 4 or colitis in either arm), neutropenia (18% vs 8%), asthenia (5% vs 6%), peripheral neuropathy (5% vs 5%) and pneumonia (5% vs 0%). More pts receiving IPAT+P than PBO+P had an AE leading to dose reduction of IPAT/PBO (21% vs 6%) or P (38% vs 11%) but median cumulative dose intensity was similar (IPAT/PBO: 99% vs 100%; P: 100% vs 100%). AEs led to IPAT/PBO discontinuation in 13% vs 11% of pts, respectively; 2 pts (3%) discontinued IPAT for grade 3 diarrhea. Conclusions: Adding IPAT to P for TNBC modestly improved PFS in the ITT pts. The effect was more pronounced in the prespecified subgroup with PIK3CA/AKT1/PTEN alterations, warranting further evaluation of IPAT in these pts. AEs were manageable. Clinical trial information: NCT02162719. [Table: see text]
Two-year trends of taxane-induced neuropathy in women enrolled in a randomized trial of acetyl-l-carnitine (SWOG S0715).
Authors: Hershman Dawn L. , Unger Joseph M. , Crew Katherine D. , Ebnesajjad Cyrus , Greenlee Heather , Fehrenbacher Louis , Moinpour Carol , Minasian Lori M. , Lew Danika L , Wong Siu-Fun , Wade James Lloyd , Fisch Michael , Albain Kathy S. , Henry Norah Lynn 
Published: September 2018

10093 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and disabling side effect of taxanes that leads to suboptimal treatment and adversely affects quality of life. Acetyl-L-Carnitine (ALC) was unexpectedly found to increase CIPN in a randomized trial. We investigated the long-term patterns of CIPN among patients enrolled in this trial. Methods: S0715 was a randomized, double-blind, multi-center trial comparing ALC (1000 mg TID) versus placebo for 24 weeks in women with stage I-III breast cancer undergoing taxane-based chemotherapy. The primary objective was to determine if ALC prevents CIPN as measured by the 11-item neurotoxicity (NTX) component of the FACT-Taxane scale at 12 weeks. Additional assessments were conducted at weeks 24, 36, 52 and 104. We examined the reduction of NTX score over 2 years using linear mixed models for longitudinal data, adjusting for stratification factors and the baseline NTX score. Individual assessment time-points were examined using linear regression. Results: SWOG S0715 registered 437 patients, of whom 409 were eligible and evaluable, including 208 assigned to receive ALC and 201 to placebo. Patterns of evaluability were similar over time by arm. The results for the primary outcome of interest, NTX, show a statistically significant (p = 0.01) average difference of -1.39 (95% CI: -2.47 to -0.31) between treatment groups, with the ALC group having lower scores (worse CIPN) on average than the placebo group. These differences were particularly evident at Weeks 24 (p = 0.02), 36 (p = 0.04), and 52 (p = 0.02). A clinically meaningful (≥5 points) reduction in NTX score over baseline was observed more frequently for the ALC vs. control arm (week 24, 41% vs. 34%; week 36, 41% vs. 28%; 1 year, 41% vs. 32%; 2 years, 40% vs. 34%). For both treatment groups 2 year NTX scores were significantly different compared to baseline (p < 0.001). Conclusions: For both groups NTX scores were reduced with taxane-therapy and remained persistently low 2-years following treatment. Twenty-four weeks of ALC therapy resulted in significantly worse CIPN at weeks 24 36 and 52. Understanding the mechanism of this persistent effect may inform prevention and treatment strategies. Clinical trial information: NCT00775645.
RCT of brief behavioral therapy (BBT-CI) for cancer-related insomnia and circadian rhythm during chemotherapy in a community oncology setting (NCORP).
Authors: Palesh Oxana , Scheiber Caroline , Tong Bingjie , Packer Melissa , Kesler Shelli , Janelsins Michelle Christine , Guido Joseph John , Heckler Charles E. , Schmidt Karen , Mustian Karen Michelle 
Published: September 2018

10094 Background: Insomnia is experienced by up to 80% of cancer patients, and it frequently co-occurs with circadian rhythm disruption. The relationship is reciprocal in that disruption in circadian rhythm can cause or result from insomnia and vice versa. There are no effective brief behavioral interventions that can be delivered directly in infusion centers. We aimed to evaluate the efficacy of a novel intervention, BBT-CI, for improving sleep and circadian rhythm disruption in BC patients undergoing chemotherapy. Methods: In our phase II, two-arm, randomized clinical trial, 71 BC patients (mean age = 52.5) who reported moderate insomnia were randomized to: 1) BBT-CI or 2) a healthy eating behavioral control (HEAL). BBT-CI and HEAL were delivered over 6 weeks (2 face-to-face sessions + 4 phone calls) at 5 NCI-funded NCORP clinics by trained assistants. Sleep disruption was measured with the Insomnia Severity Index (ISI) and circadian rhythm with the Actiwatch-64 (Mesor, Amplitude, and Acrophase for 12- and 24-hour cycles). Participants completed the ISI at baseline and post-intervention and wore the Actiwatch for 7 days prior to each visit. Results: The study showed excellent feasibility and acceptability of BBT-CI as reflected by a recruitment rate of over 75% and an intervention adherence of 74%, with 75% of intervention components successfully delivered by trained community staff. ANCOVA results indicate that patients who received BBT-CI exhibited improvements in insomnia compared to HEAL at post-intervention (p = .049) and at 1-month follow-up (p = .002). Furthermore, results reveal a significant treatment effect in circadian rhythm at post-intervention for 24-hour amplitude (p = .009) and 12-hour Acrophase (p = .012) as well as a trend for Mesor in favor of BBT-CI (p = .10). Conclusions: BBT-CI demonstrated greater improvements in insomnia and circadian rhythm than HEAL. In addition, this novel intervention has shown efficacy in community oncology clinics. BBT-CI has the potential of changing clinical practice as it reduces patients’ psychophysiological symptoms and burden due to its behavioral design and capacity to be delivered directly in infusion centers. Clinical trial information: NCT02002533.
A genome-wide association study (GWAS) meta-analysis of chemotherapy-associated cognitive impairment (CACI) in Asian early-stage breast cancer patients (ESBC).
Authors: NG Terence , Yeo Hui Ling Angie , Shwe Maung , Gan Yan Xiang , Foo Koon Mian , Loh Wei-Jen Kiley , Koo Si-Lin , Chay Wen Yee , Tan Tira Jing Ying , Beh Sok Yuen , Lim Hsuen Elaine , Lee Guek Eng , Dent Rebecca Alexandra , Yap Yoon Sim , Ng Raymond C.H. , Chu Pak Yan Pat , Khor Chiea Chuen , Ho Han Kiat , Chan Alexandre 
Published: September 2018

10096 Background: Genetic variations among genes regulating neuronal function, neurotransmission and plasticity may contribute to varying risk of CACI. In order to fully elucidate the complex genetic structure underlying CACI, a GWAS meta-analysis was performed to identify genetic variants associated with CACI among ESBC patients. Methods: A GWAS meta-analysis of two independent cohorts totaling 266 chemotherapy-receiving ESBC patients (mean age: 51.0 ± 9.2 years; 80.8% Chinese) was performed. Patients’ self-perceived cognitive function was assessed using the validated FACT-Cog (v.3). Genome-wide genotyping was performed using the Illumina HumanOmniExpress-24 version 1.1 BeadChips kits. Each beadchip contains over 700,000 genetic markers. Covariates included in the meta-analysis were the first two dimensions of the multi-dimensional scaling. Results: After applying stringent quality control measures and removing four population outliers, data from 546,399 SNPs were available for 84 cases and 170 controls. In the meta-analysis, two SNPs (rs6443264 and rs4686371) exceeded the suggestive threshold of P < 1×10-5 (Table). Following adjustment for the first two MDS dimensions in the meta-analysis, both SNPs remained as top two SNPs with P < 1×10-4. Both rs6443264 and rs4686371 are located in chromosome 3p25 and lie in the intronic regions encoding OGG1 and ARPC4 genes, respectively. Alteration of the OGG1 gene could compromise the functions of downstream neuronal genes, and modification of the ARPC4 gene could affect the formation of the actin-related protein 2/3 complex and impair memory formation. Conclusions: To the best of our knowledge, this is the first GWAS meta-analysis to identify two loci, namely rs6443264 and rs4686371 that are suggestive of genome-wide association with CACI among Asian ESBC patients. [Table: see text]