bluuebunny/crossref_metadata_2025_split huggingface dataset:
Persistance of residual vein thrombosis after an episode of deep vein thrombosis of the lower limbs and the risk of new cancer and cardiovascular disease
Authors: Fulfaro F. , Siragusa S. , Anastasio R. , Malato A. , Casuccio A. , Arcara C. , Badalamenti G. , Valerio M. , Abbene I. , Gebbia N. 
Published: April 2020

8531 Background: In patients with a first episode of idiopathic or provoked Deep Vein Thrombosis (DVT), the presence of Residual Vein Thrombosis (RVT), detected by UltraSonography (US) at the 3rd month from the index DVT, is an independent risk factor for developing recurrent Venous Thromboembolism (VTE) in the subsequent 2 years. Its absence can safely permit to stop Oral Anticoagulants (OA). At the present, it is unknown whether RVT may also identify patients at increased risk for developing cancer and/or cardiovascular disease (CD). In patients with previous DVT of the lower limbs, we conducted a prospective study for evaluating the correlation between RVT findings and the risk of new cancer and/or CD. Methods: Three hundred-forty-five patients, with a previous episode of idiopathic or provoked DVT, were evaluated; presence/absence of RVT was detected at the 3rd month of OA and patients managed consequently. In the present study, the incidence of VTE recurrence, cancer and new CD was evaluated in the subsequent 3 years after the index DVT. The Kaplan-Meyer curve and the Breslow test has been used for the statistical comparison among groups. Results: The results among the 3 groups are listed in the Table. Patients without RVT had a significant reduction in recurrent VTE and new cancer in comparison to patients with RVT; they also showed a not significant trend in the reduction of CD; these data are applicable in patients with idiopathic or provoked index DVT. In patients with RVT, the advantage of prolonging anticoagulation over 12 months (Group A1) is lost at the end of the treatment. Conclusions: US-detected RVT, at 3rd month from the index DVT, is an independent risk factor for recurrent VTE and cancer; this risk remains over a period of 3 years, independently whether index DVT was idiopathic or provoked. In these patients, the advantage of indefinite anticoagulation should be assessed in properly designed study. [Table: see text] No significant financial relationships to disclose.
Continuous low-dose intravenous lidocaine is effective for visceral pain secondary to peritoneal carcinomatosis in terminal cancer patients
Authors: Tanaka T. , Okano S. , Tsukui R. , Tomaru M. , Ueno M. , Tsuchiya M. , Obokata K. , Saigo S. , Ogawa T. , Abe T. , Ikeya T. 
Published: April 2020

8533 Background: Lidocaine, a local anesthetic, is often used as an anti-arrhythmic and as an analgesic of best support care (BSC) for patients with neuropathic pain. However, little is known about the effect of low-dose lidocaine on the abdominal pain of terminally-ill patients with peritoneal carcinomatosis. Aim: To evaluate whether visceral pain is controlled and activities of daily life (ADL) are improved during continuous lidocaine infusion. Methods: 28 terminally ill patients with peritoneal carcinomatosis due to the gastrointestinal (26) and gynecologic (2) cancers were studied. Despite aggressive pain management with opiates, non-steroidal anti-inflammatory drugs and other adjuvants, debilitating pain persisted. After a test dose of 2mg/kg intravenously, lidocaine was administered at low-doses (0.4 and/or 0.8mg/kg-h) through a vein and continued for more than 24 hours. Pain was quantitated on a faces rating scale from the level 0 (no pain) to 5 (severe pain); doses of opiates, amounts of oral intake, side effects, and ADL were measured before and after lidocaine. Results: Age (mean±SE) was 62±2, and percentage of males was 54%. Patients were not hypercalcemia but were slightly malnutrished (albumin 2.9±0.1g/dl) and anemic (hemoglobin 10.3±0.4g/dl). The duration of lidocaine administration in hospital was 18±3days. Abdominal symptoms improved within 1.2±0.1days after beginning lidocaine, and pain scale decreased from 2.7±0.2 to 0.6±0.2; p<0.001. In 68% of patients, the pain level became zero. Blood concentration of lidocaine at 0.8mg/kg-h was 3.0±0.4μg/ml 1 week later. 68% of patients needed no increase in opiate dosage during lidocaine administration. Waist size did not decrease, however, oral intake increased (p=0.002) during lidocaine administration. No obvious side effects, such as perioral numbness, were seen except for emotional lability noted in 4 patients. 43% patients were able to be discharged for continued end-of-life comfort care with home parenteral nutrition and continuation of lidocaine administration. Conclusions: We suggest that continuous, low-dose intravenous lidocaine is BSC and is a very effective approach for analgesia and improvement of ADL in patients with peritoneal carcinomatosis. No significant financial relationships to disclose.
SNPs associated with the genetic predisposition to develop therapy-related acute myelogenous leukemia after chemotherapy for breast cancer
Authors: Guillem V. , Mata M. , Lluch A. , Gonzalez M. , Esteve J. , Nomdedeu J. , Calasanz M. , Cervantes A. , Chirivella I. , Tormo M. 
Published: April 2020

8536 Background: t-AML is a syndrome occurring after exposure to chemo or radiotherapy. Since for similar treatments only some patients ends developing a secondary leukemia, it has been proposed a genetic predisposition associated to this syndrome. Methods: To analyse single nucleotide polymorphisms (SNPs) on genes that could be involved on risk of developing t-AML by means of RFLP and SNP genome screening using high density microarrays .Two groups of individuals were genotyped: Group A, composed by patients that develop t-AML after chemotherapy for breast cancer (BC) and Group B (control), formed by chemotherapy treated BC patients that after a period of more than 10 years have not developed t-AML. We have studied 12 polymorphisms on genes from drug detoxification pathways (NOQ1, GSTP1), DNA repair (XPC[3 ], XRCC1[2 ], NBS1, ERCC5 and XRCC3) and DNA synthesis (MTHFR[2 ]), in which the nucleotide change implies a change in the protein sequence (nA=16, nB=18) . Alternatively, for each patient, more than 10.000 SNPs were genotyped by means of of high density microarrays (Affymetrix) (nA=12, nB=18). The alele frequencies for each SNP between two groups were compared. Results: In RFLP study, we observe two SNPs on MTHFR gene displaying remarkably different allele frequencies between BC patients (Table). In microarray study, we found 12 SNPs with differences of allele frequency higher that 45% between A and B groups, located 6 on chromosome 8. Conclusions: The results suggest that the MHFTR gene is a candidate for being studied by its possible relation with the genetic predisposition to develop t-AML after BC treatment although its functional implication with the disease must still be elucidated. Moreover, data from SNP arrays suggest that the genome regions marked by those 12 SNPs, specially those on chromosome 8, are candidate for being studied by its possible relation with the genetic predisposition to develop t-AML after BC treatment. Financed by FIS G03/008. [Table: see text] No significant financial relationships to disclose.
A pilot study of the Vulnerable Elders Survey-13 (VES-13) as compared to Comprehensive Geriatric Assessment (CGA) to examine geriatric domains in older prostate cancer patients at risk for decline
Authors: Mohile S. G. , Bylow K. , Stadler W. M. , Rodin M. 
Published: April 2020

8539 Background: Impairments in geriatric domains (e.g. function and cognition) adversely affect health outcomes of the elderly. CGA is a key component of the treatment approach for older cancer pts, but is time-consuming. We evaluated the reliability and validity of a brief functionally-based screening tool, the VES-13, in identifying those older prostate cancer (PCa) pts at risk for impairment in the oncology clinic setting. Methods: PCa pts aged ≥ 70 yrs treated with androgen ablation followed within the oncology clinics at the University of Chicago were eligible. Pts self-completed VES-13 and CGA at baseline with VES-13 repeated 1 mth later. Physical performance and cognitive assessments were administered by a research assistant. Pts with impairment were offered follow-up in a “standard of care” frail geriatric elders program. Results: Of 36 participating pts, 50% were impaired by VES-13 (score ≥ 3). 62% of pts scored as impaired on ≥ 2 tests within the CGA exhibiting deficits in multiple geriatric domains. The reliability of the VES-13 (comparing baseline to 1 mth scores) was 0.92 (pearsons correlation coefficient). The cut-off point of 3 on the VES-13 had 72.7% sensitivity and 85.7% specificity and was highly predictive in identifying impairment (ROC AUC 0.8977) when compared to the CGA. Pts with a mean score of VES-13 ≥ 3 performed significantly worse on evaluations of Instrumental Activities of Daily Living (measures ability to live independently) (p=.006), physical performance (p=.024), comorbidity (p<.001), numbers of medications (p=.022), and cognition (p=.018). In multivariate analysis, low education remained significant for VES-13 impairment after adjustment for age (p=.039). 50% of pts accepted referral to an off-site multidisciplinary geriatrics clinic. Reasons for refusal included perceived lack of need by the pt and transportation difficulties. Conclusions: Older PCa pts receiving androgen ablation have significant geriatric impairment. The VES-13 screening measure was predictive in identifying impairment when compared to the CGA and demonstrates feasibility for use in the oncology clinic setting. No significant financial relationships to disclose.
Management and survival of frail elderly cancer patients within a Geriatric Oncology Program
Authors: Basso U. , Vamvakas L. , Falci C. , Lamberti E. , Pasetto L. M. , Brunello A. , Tonti S. , Lonardi S. , Vigorelli S. , Monfardini S. 
Published: April 2020

8547 Background: Abstention from administration of either chemo- or endocrine therapy to elderly cancer patients deemed frail at the Multidimensional Geriatric Assessment is still controversial, and few data are available concerning the actual survival of such patients. Methods: To evaluate the management and survival of all consecutive frail cancer patients older than 70 years, seen from October 2004 to December 2005 within our Geriatric Oncology Program. Frailty was defined by one or more of the following: age ≥ 85 years, dependence in one or more Activity of Daily Living (ADL), presence of at least three comorbidity of grade 3 or one of grade 4 according to CIRS-G, one or more geriatric syndromes [Balducci L, Cancer Control 2001]. Results: A total of 364 elderly patients were divided into three categories: fit (26.4%), vulnerable (49.5%) and frail patients (24.2%). These 88 frail patients had a median age of 79 years (range, 70–93), 43.2% males. Motives for being considered frail were age alone (13.6% of patients), ADL dependence (25%), comorbidity (14.8%), geriatric syndromes (6.8%) or, more frequently, the co-existence of two or more of these factors (39.8%). Thirty patients (34.1%) underwent chemotherapy: 8 for gastro-intestinal tumors, 7 lung, 7 hematological and 8 other sites. Patients received standard regimens at standard doses (27.6%) or with ≥ 25% dose reduction (24.1%), age-adapted regimens at standard doses (44.8%) or with reduced doses (6.9%). Six patients (20%) derived some clinical benefit but only two (6.7%) showed radiological response. Twenty-two patients interrupted chemotherapy prematurely due to toxicity/death (23.3%) or refusal/drop out (26.7%). All twenty-eight women with estrogen receptor positive breast cancer (31.9% of all frail patients) were prescribed endocrine therapy either adjuvantly, neo-adjuvantly or for metastatic disease, with a predominance of aromatase inhibitors (82.1%) compared to tamoxifen. Thirty out of 88 patients have died, with a 2-year overall survival of 35%. Conclusions: Frailty was observed in one fourth of all our elderly patients, but it did not prevent treatment of tumor with either chemo- or endocrine therapy in 66% of cases. Overall survival of frail elderly patients with cancer appears worse than in geriatric series. No significant financial relationships to disclose.
Impact on the cosmetic outcome of concurrent administration of adjuvant chemotherapy and radiotherapy after breast-conservative surgery: Differences between patient’s and doctor’s views
Authors: Toledano A. , Garaud P. , Serin D. , Fourquet A. , Bosset J. , Breteau N. , Body G. , Azria D. , Suzanne I. , Calais G. 
Published: April 2020

8554 Purpose: A multicenter randomized study comparing after breast-conservative surgery, sequential versus concurrent adjuvant chemotherapy (CT) with radiation therapy (RT) was initiated (ARCOSEI). After a median follow-up of 6.7 (4.3–9) years, we assessed prospectively late effects and cosmesis satisfaction of these two strategies. Methods and material: After breast-conserving surgery, patients were treated either with sequential treatment with CT first followed by RT (arm A) or CT administered concurrently with the same normofractinnated breast RT (arm B).With structured questions, 214 patients (107 in each arm) rated their satisfaction considering cosmesis, the difference in overall appearance, and specific changes of the breast. Late toxicity (LENT/SOMA scale) and cosmesis were blinded to treatment and assessed by a radiation oncologist by a qualitative scale and another semi-qualitative and semi-quantitative evaluation. Results: Subcutaneous fibrosis (SF), telangectasia (T), skin pigmentation (SP), and breast atrophy (BA) were significantly increased in arm B. Patient’s cosmesis satisfaction was not statistically different between the two arms with 92.6% of good results in arm A and 86% in arm B (p=0.72); although patients have found more important differences in the treated breast in arm B than in arm A, with 28.8% vs 14.3% of bad results, respectively. Physician’s prospective assessment found less favorable cosmesis results with concomitant treatment than with sequential one, with 40% and 15% of unsatisfaction, respectively (p=0.0014) using a semi-quantitative and qualitative scale; The use of a subjective 5-point scale found also a worse physician’s cosmesis satisfaction in arm B than in arm A (p=0.0013) Conclusion: The concurrent use of CT with RT is significantly associated with an increase incidence of grade 2 or greater late side effects. Rating of cosmesis is also subjective. Patients’ satisfaction with cosmesis is greater than the doctors’ for concomitant radiochemotherapy in breast cancer, and is not only determined by radiation late effects. With two methods, physician found a worse cosmesis outcome for concomitant radiochemotherapeutic arm. No significant financial relationships to disclose.
Longitudinal evaluation of fine motor deficits in children with leukemia
Authors: Hockenberry M. J. , Krull K. , Moore I. M. , Pasvogel A. , Gregurich M. , Kaemingk K. 
Published: April 2020

8559 Background: Fine motor assessments are important tools to use in screening children undergoing treatment for acute lymphoblastic leukemia (ALL) that may provide decisive data that can reveal subtle changes in neurodevelopment over time. Methods: Fine motor and visual-motor skills were assessed longitudinally in a group of 83 children receiving treatment for ALL. Children in this study had the first fine motor assessment at an average of 8 weeks into treatment and had already received several doses of Vincristine. Fine motor and visual-motor skills assessments were repeated at years 1 and 2 into therapy. The mean age at time of first assessment was 7.2 years and 58% were female. Results: Fine motor speed deficits were evident at the first assessment, and for many, continued to be problematic at Years 1 and 2. In addition to fine motor speed deficits, a significant decline in visual motor integration skills was noted from the baseline level (p = 0.019). Visual motor integration skills observed at Years 1 and 2 were predicted by the baseline performance on the Purdue Pegboard test. Our results indicate that the factors underlying these declines in higher-level skills begin within six months of the onset of chemotherapy. Conclusions: Early reductions in fine motor speed, possibly due to Vincristine, steroids and/or acute Methotrexate toxicity, may lead to reduced visual motor integration and construction abilities. The reduced fine motor skills, which predict eventual declines in visual motor integration, may be part of the underlying process for reduced perceptual abilities and nonverbal intellect often reported in long-term follow-up studies. For children with ALL, motor and sensory-perceptual examinations during treatment may identify those most at risk for significant long-term effects interfering with integration of visual spatial construction. These basic processing skills are necessary elements to the development of higher-level cognitive abilities, including nonverbal intelligence and academic achievement, particularly in arithmetic and written language. Early identification of reduced processing skills can provide an opportunity to identify at risk patients and intervene prior to reduction in these higher-level skills. Supported by NIH/NICHD RO-1 Funding: Grant number HD 37816 No significant financial relationships to disclose.
What is a clinically significant improvement in the intensity of fatigue among cancer patients?
Authors: Reddy S. G. , Pace E. , Zhang T. , Bruera E. 
Published: April 2020

8560 Background: Fatigue is the most common symptom in cancer patients. The FACIT-F fatigue subscale and the ESAS Fatigue 0–10 are the most commonly used scales for research and clinical care, respectively. However, clinically significant improvement has not been well established. Methods: We reviewed the data from 3 RCTs of fatigue in 194 patients. In all cases patients completed the FACIT-F and ESAS at baseline and Day 8. All patients also provided a global benefit score [1=not beneficial, 7=greatly important] during Day 8 reflecting their global perception of fatigue improvement. All patients who reported their global perception as ≥ 4 [moderate improvement, consistent benefit] were considered to have a clinically significant improvement. We determined the median [25–75% quartiles] change in ESAS and FACIT-F as well as their screening performance when using the clinically significant difference to define responder status. Results: Mean age was 56 ± 12 years. 72 patients [37%] were female. Median baseline FACIT-F and ESAS scores were 18 ± 8 and 7.5 ± 1.7, respectively. Patients who reported a clinically significant improvement had a median [quartiles] change of 4 [3–6 ] in ESAS and 17 [9–25 ] in FACIT-F sub score resulting in a specificity of 72% for ESAS and 93% for FACIT-F, respectively. The sensitivity, positive predictive value and negative predictive value for ESAS were 66%, 56%, and 78%, and for FACIT-F were 52%, 81%, 76%, respectively. The correlation between global benefit score and change in ESAS was 0.57 [p<0.001], global benefit score and change in FACIT-F was 0.61 [p=0.001], and change in FACIT-F and change in ESAS was 0.62 [p≤0.001]. Conclusions: A difference in ≥ 4 in the ESAS and ≥ to 17 in the FACIT-F can be considered clinically significant in patients with cancer fatigue. The FACIT-F score showed higher specificity. Improvements in the FACIT-F score reported in clinical trials of fatigue are frequently not clinically significant. More research is needed to better characterize responder status in cancer fatigue. No significant financial relationships to disclose.
A randomized trial of denosumab (AMG 162) versus intravenous (IV) bisphosphonates (BP) in cancer patients (pts) with bone metastases (BM) on established IV BP and evidence of elevated bone resorption
Authors: Suarez T. , Fizazi K. , Rahim Y. , Wilson J. , Fan M. , Jun S. , Lipton A. 
Published: April 2020

8562 Background: Pts on established (≥ 8 weeks) IV BP who have elevated bone resorption markers, especially urinary N-telopeptide (uNTx), are at increased risk for skeletal related events (Coleman, J Clin Oncol 2005). Denosumab, a fully human monoclonal antibody, inhibits osteoclastic bone resorption by binding and neutralizing RANK ligand, a key mediator of osteoclast differentiation and function. Denosumab efficacy and safety were evaluated in a phase 2, randomized, open label, active-controlled study in advanced cancer pts with BM and elevated levels of uNTX despite established IV BP therapy. We report preliminary results from an interim analysis of 49 pts at week 13. Methods: Eligible pts (≥18 yrs old with solid tumor [except lung] or multiple myeloma [MM]; confirmed BM; screening uNTx > 50 nM BCE/mM creatinine [Cr]; on IV BP for ≥ 8 weeks before randomization) are stratified by baseline uNTx (50–100, >100) and tumor type. Pts are randomized to 1 of 3 arms: IV BP every 4 weeks (Q4W) or 180 mg denosumab given subcutaneously Q4W or Q12W. The primary endpoint is the proportion (%) of pts with uNTx < 50 nM BCE/mM Cr at week 13. Enrollment is ongoing (planned N = 135). Results: The mean (range) age of all pts in the analysis (33 denosumab; 16 BP) was 62.5 (39, 81) yrs; 96% had > 2 BM. The median time on prior IV BP (mostly zoledronic acid) was 5.1 months. Tumors included prostate (n = 24), breast (n = 20), other/MM (n = 5). The % of pts with uNTx < 50 nM BCE/mM Cr at week 13 was greater with denosumab (pooled arms) than IV BP: 76% (95% CI: 60.3, 91.2) vs 38% (95% CI: 18.5, 61.4; P = .015 Cochran-Mantel-Haenzel), respectively. No treatment-related serious adverse events (SAEs) were reported. Commonly reported AEs in the denosumab arms included nausea, peripheral edema, anemia, bone pain, and constipation. At data cutoff, 10 deaths (6/33 denosumab, 4/16 BP) had occurred on-study. Conclusions: These interim data suggest that denosumab normalizes uNTx more frequently than IV BP in pts with elevated uNTx despite 8 weeks of IV BP, across all tumor types. The AE profile of denosumab appeared similar to that of cancer pts undergoing treatment. [Table: see text]
Long-term tolerability of fentanyl effervescent buccal tablets: Interim analysis in patients with cancer-related breakthrough pain
Authors: Slatkin N. , Charu V. , Niebler G. , Rauck R. 
Published: April 2020

8567 Background: Fentanyl effervescent buccal tablets (FEBT) are designed to enhance the rate and efficiency of fentanyl absorption through the buccal mucosa. Results reported here represent a pre-specified interim analysis of an open-label safety and efficacy study of FEBT in opioid-tolerant patients with cancer-related breakthrough pain (BTP). Methods: Patients with cancer-related BTP receiving around-the-clock and supplemental opioids were eligible to enroll. Patients who had participated in a previous dose-titration study of FEBT enrolled directly into the 1-year phase; new patients entered a titration phase to determine an effective FEBT dose before entering the 1-year phase. An effective FEBT dose was defined as the dose needed to provide adequate analgesia for BTP. By October 3, 2005, 170 patients (aged 24 to 95 years) received FEBT (100–800 μg) and had documented safety data. Results: Of the 112 new patients, 70.5% identified an effective FEBT dose and were eligible for enrollment. In the long-term phase, patients received FEBT for a mean of 109.8 days; 8% at 100 μg, 15% at 200 μg, 23% at 400 μg, 25% at 600 μg, and 29% at 800 μg. The FEBT dose remained reasonably stable during the long-term phase, but 43 patients had a dose increase and 6 had a dose decrease at the discretion of the investigator. Only 2 patients required a change in the FEBT dose because of tolerability. The most common adverse events (AEs) are given in the table. The incidence of AEs did not correlate with the effective FEBT dose. The 42 patient deaths that occurred were all attributed to cancer-related pathology or the progression of cancer. Conclusions: Overall, FEBT was well tolerated in opioid-tolerant patients with cancer-related BTP. [Table: see text] [Table: see text]