bluuebunny/crossref_metadata_2025_split huggingface dataset:
Mammography use in women age 80 and older with breast cancer
Authors: Giordano S. H. , Badgwell B. , Duan Z. , Bedrosian I. , Hortobagyi G. , Babiera G. 
Published: March 2020

9039 Background: The guidelines for screening mammography use in patients age 80 years and older are not clear. The purpose of this study was to determine the effect of mammography use on stage and tumor size at breast cancer diagnosis. Methods: The study is a retrospective cohort using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database. We evaluated 14,976 women aged 80 and older diagnosed with breast cancer between 1996–2002. Patients were divided into three cohorts based on screening mammography use in the 60 months prior to diagnosis: nonusers, non-regular users (1–2 mammograms), and regular users (3+). The effects of screening on tumor stage (0-I vs. II-IV) and size were determined by logistic regression and multivariate analysis of variance. Results: Regular mammography use for the age groups 80–84, 85–89, and >= 90 was 29%, 19%, and 9%, respectively. Among regular users of mammography, 26% presented with stage II or greater cancer while 64% of non-users presented with stage II or greater disease. On multivariate analysis, non-users were 4.7 (95% CI 4.26–5.14) times more likely to present with high-stage cancer. Non-users, non-regular users, and regular users had an adjusted mean tumor size of 5.08 (4.44–5.72), 3.26 (2.57–3.95), and 2.77 (2.02–3.51), respectively. Conclusions: Regular screening mammography among women aged 80 years and older is associated with earlier stage at presentation and smaller tumor size compared to mammography nonusers. Health care providers should consider discussing potential benefits of screening mammography with their older patients particularly for those without significant comorbidity. No significant financial relationships to disclose.
Fosfomycin prevents cisplatin-induced ototoxicity: Results of a randomized, double blind, placebo controlled trial
Authors: Green D. , Chavez-Mac Gregor M. , Sosa-Sanchez R. , Andraca R. , Enriquez L. , Leon E. , Ponce de Leon S. 
Published: March 2020

9041 Background: Cisplatin is one of the most frequently used chemotherapy agents. The main dose-limiting toxicity for its use is hearing-loss, present in 40–100% of patients. To date, no treatment has proven efficacy in preventing or reducing cisplatin acoustic damage. Fosfomycin, acting as a free-radical scavanger, has shown to reduce cisplatin-induced ototoxicity and nephrotoxicity in animal models, without affecting its antineoplastic activity. This trial evaluated the effect of fosfomycin in cisplatin-induced ototoxicity. Methods: 22 chemotherapy naive patients with normal audition, scheduled to receive cisplatin-based chemotherapy (cumulative dose =200mg/m2) were randomized to receive placebo (n=11) or 1g of IV fosfomycin concurrent with each cisplatin administration (2–4 cycles). Primary outcome was ototoxicity when comparing audiometric studies (low and high frequencies and otoaccustic emissions) at baseline and at completion of chemotherapy. With β=0.8 and a=0.05 the study was powered to detect differences =20 dB at any given frequency. Fisher's test, Wilcoxon and Mann-Whitney test were used. Results: Groups were balanced for baseline characteristics, cisplatin dose and response rates. No differences were found when comparing ototoxicity at low frequency ranges. When analyzing high frequencies and otoaccustic emissions, 9 patients (82%) in the placebo group developed ototoxicity vs 4 (36%) in the fosfomycin group (p=0.04). The degree of hearing-loss, evaluated by comparing percentage of change in each evaluated frequency, was significantly lower in patients receiving fosfomycin (p=0.04). Other chemotherapy toxicities were similar in both groups. Conclusions: In patients with audiometric integrity, the concurrent administration of fosfomycin with cisplatin significantly reduces ototoxicity. The degree of hearing-loss is lower in patients receiving fosfomycin than in those receiving placebo. The use of fosfomycin in combination with cisplatin is safe and does not interfere with its antineoplastic activity. To our knowledge this is the first clinical-trial that demonstrates prevention and reduction of cisplatin-induced hearing-loss. No significant financial relationships to disclose.
Assessing adherence to the American College of Chest Physicians’ (ACCP) recommendations for thromboprophylaxis in hospitalized cancer patients
Authors: Amin A. N. , Stemkowski S. A. , Lin J. , Yang G. 
Published: March 2020

9047 Background: This study evaluates whether clinicians are providing appropriate VTE prophylaxis to at-risk surgical and non- surgical cancer patients in accordance with ACCP guidelines. Methods: Premier's inpatient administrative data were used to assess VTE prophylaxis rates in fourteen cancer types. Patients age 40 or older, with a minimum length of stay of six days, and no contraindications for anti-coagulation were included in the study. Two rates were determined; the rate of discharges receiving any level of anticoagulation and the rate of patients receiving appropriate prophylaxis by comparing daily use of anti-coagulants and compression devices, dosage, and prophylaxis duration with ACCP recommendations. The 6th guidelines were used due to their release prior to the study period. Rates based on the 7th guidelines were calculated for the same patient cohort to assess how the revised guidelines affect our findings. Trends were assessed by comparing prophylaxis rates by quarter. Results: 72,391 discharges from 225 hospitals between January 2002 and September 2005 met the inclusion criteria. 29% of all at-risk cancer discharges received the recommended prophylaxis regimen. Rates varied by cancer type ranging from 18.7% in prostate to 36.3% in colorectal cancer discharges. 55% did not receive any anti-coagulation prophylaxis, 9.5% received insufficient dosage and 5.8% did not receive prophylaxis for the appropriate duration. The appropriate VTE prophylaxis rate is higher for surgical cancer than for non-surgical cancer discharges (32.3% vs. 27.7%). Trends suggest a slight increase in appropriate prophylaxis rates for all types of cancer discharges. Appropriate prophylaxis rates based on 7th guidelines are lower than rates based on the 6th guidelines due to the more specific recommendation in the 7th guidelines. Conclusions: Cancer patients are known to have significant risk for VTE, yet VTE prophylaxis for at-risk non-surgical cancer patients in hospitals is not optimal. Rates for surgical cancer patients were only slightly higher. Using the 7th recommendations results in lower prophylaxis rates. More effort is required to increase awareness of the ACCP recommendations for thromboprophylaxis in cancer patients. No significant financial relationships to disclose.
Treatment of liver toxicity in women undergoing adjuvant chemotherapy for breast cancer: A phase III, monocentric, prospective, randomised trial of ursodeoxycolic acid (UDCA) vs no treatment
Authors: Cannizzaro R. , Crivellari D. , Lombardi D. , Magri M. , Fornasarig M. , Cadelli L. , Bidoli E. , Talamini R. , Veronesi A. 
Published: March 2020

9060 Background: Liver toxicity during adjuvant chemotherapy (CT) represents one of the causes of treatment delay and dose reduction, with impairment of dose intensity and of final results. UDCA, a hydrophilic bile acid, has been reported to be effective in cholestasis. Aim: to evaluate the efficacy of UDCA (12 mg/kg/die) plus CT discontinuation vs CT discontinuation alone in the treatment of liver toxicity. Methods: The study provided two arms of randomization: discontinuation of CT and administration of UDCA at the dosage of 12 mg/kg/day or discontinuation of CT. CT was resumed at normalization of liver tests. Pts with liver metastases, acute or chronic hepatopathy, heart or kidney failure, or PS<70 were excluded. During a 3 year period, 118/305 pts developed CT-induced hepatotoxicity and were enrolled into the study. Logistic multiple models and Fisher test or χ2 test and the Mann-Whitney test were used. Results: Out the 118 pts, 66% were treated with CMF, 29% with Anthracyclines alone or in sequence with CMF and 5% with Anthracyclines and Taxanes. Liver toxicity occurred respectively in 37 pts after the 1st cycle, in 35 after the 2nd, in 15 after the 3rd, in 19 after the 4th, in 9 after the 5th and in 3 after the 6th. CT was definitely stopped in 8% of pts. CT was delayed of 1 week in 53%, of 2 wks in 31% and of 3 or more in 16%. 95% of pts had a hepatocytolitic damage and nobody purely cholestatic. G1 toxicity was observed in 34%, G2 in 57%, G3 in 9%. Pts were randomized in two groups of 59 pts each. UDCA group: 3 pts (5%) stopped CT and 11 (19%) had dose reduction. Control group: 6 pts (10%) stopped CT and 7 (12%) had dose reduction. No statistically significant difference between UDCA group and control group was noted both for dose reduction (p = 0.31) and for CT stop (p = 0.30), even if twice as many pts of the control group had to stop CT (6/59). No correlation between alcohol use and liver damage was noted. Conclusions: Most cases of liver toxicity are of low or intermediate grade. No statistically significant difference was found between UDCA and control, even if there was a positive trend in reducing liver toxicity, that can have a positive impact on the final results of adjuvant CT. No significant financial relationships to disclose.
A double-blind, randomized cross-over trial of venlafaxine versus clonidine to treat hot flashes in breast cancer patients
Authors: Mom C. , Buijs C. , Willemse P. H. , Boezen H. , Maurer J. , Wymenga A. , Nieboer P. , de Jong R. S. , de Vries E. G. , Mourits M. J. 
Published: March 2020

9083 Background: Breast cancer patients who become postmenopausal due to their treatment can experience more frequent and severe hot flashes than healthy postmenopausal women. Estrogens are considered to be contra-indicated. Venlafaxine and clonidine are both used to alleviate hot flashes, with different side effects. This study compared side effects, efficacy and patient preference. Methods: In a double-blind, cross-over study women <60 years, with a history of breast cancer, and experiencing at least 14 hot flashes/week were randomized to receive venlafaxine 75 mg od (and placebo bid) for 8 weeks, followed by a 2 week wash-out period, and 8 weeks of clonidine 0.025 mg bid (and placebo od) or vice versa. Hot flash frequency and hot flash score (frequency × severity) were recorded in a diary and side effects were scored using a questionnaire during the 2nd and 8th week of both treatment periods, and these were compared to a baseline week. Results: Sixty patients were randomized to start with venlafaxine (n=30) and clonidine (n=30), 40 completed both treatment periods. Premature treatment discontinuation occurred in 15/59 patients during venlafaxine and in 5/53 during clonidine due to side effects (p<0.05). The main side effects of venlafaxine were nausea and headache, and of clonidine dry mouth. In the 8th week of treatment women reported more loss of appetite (24% vs 4%; p=0.03) and improved sleeping (55% vs 75%; p=0.03) with venlafaxine. A =50% reduction in hot flash score was found in 21 (49%) and 26 (55%) of the patients with venlafaxine and clonidine respectively (ns). The decrease in hot flash score was most marked in the first treatment period. At study completion 20 (33%) of the patients chose to continue clonidine, and 17 (29%) preferred venlafaxine (ns), whereas 23 (38%) declined further treatment. Conclusions: Venlafaxine and clonidine are both moderately and equally effective in the reduction of hot flashes. Side effects are the main reason for discontinuation, occurring more often during treatment with venlafaxine. No significant financial relationships to disclose.
Urinary incontinence in women with gynecologic malignancies before and after primary therapy
Authors: Downs L. S. , Li Z. , Wyman J. F. 
Published: March 2020

9087 Background: There is limited data on the impact of treatment for gynecologic cancer on future urinary incontinence. Our objective is to determine degree of urinary incontinence in women previously treated for gynecologic cancer and women not yet treated. Methods: With IRB approval gynecologic cancer patients that had completed therapy over 1 year prior and those not yet receiving therapy were asked to participate. Consenting subjects completed the Incontinence Impact Questionnaire (IIQ) and Urogenital Distress Inventory (UDI). Both are scored from 0–100 with higher scores representing more incontinence. We also assessed general health. Mean scores were calculated and compared with adjustments for covariates. In established patients Kruskal-Wallis was used to test overall equality of IIQ and UDI across various diagnoses and treatments. Results: Ninety new patients and 104 established patients were enrolled. Age, parity, tobacco use and use of incontinence medications were similar between the groups. General health status was worse in the new patients (p<0.0001). Mean (± S.E.) IIQ scores were similar between new (6.87 ± 1.4) and established patients (4.76 ± 0.96), p=0.56. Mean UDI scores were also similar for new (17.2 ± 9.0) and established (13.2 ± 9.8) patients, p=0.20. After adjusting for health status, parity, age, tobacco use, prior use of incontinence medications there was no significant difference in either score. There was a significant positive association between age and incontinence as assessed by IIQ (p=0.02). We compared scores for established patients diagnosed with cervical, ovarian, uterine and vulvar cancer and found no significant difference in either IIQ (p=0.55) or UDI (p=0.76). Similarly there was no significant difference in scores for patients receiving hysterectomy, radical hysterectomy, BSO, vulvectomy, tumor debulking, chemotherapy or radiation therapy. Although not significant there was a trend toward more incontinence in patients having received radical hysterectomy. Conclusions: Urinary incontinence as measured by IIQ and UDI dose not appear to be different at the time of diagnosis of gynecologic cancer and a year from the completion of therapy. There is no apparent difference in urinary incontinence across diagnoses. No significant financial relationships to disclose.
Prevalence of insomnia and associated symptoms in patients with cancer
Authors: Stepanski E. J. , Schwartzberg L. S. , Blakely L. J. , Fu D. , Fortner B. V. 
Published: March 2020

9098 Background: High rates of insomnia have been reported in patients undergoing treatment for cancer. The etiology of insomnia in these patients is unknown, but may be related to psychological factors (anxiety or depression), pain, treatment-related toxicity, or other co-morbid medical conditions. Insomnia has been linked with increased rates of depression, decreased quality of life, and increased fatigue in other patient populations, and is therefore important to understand in the context of cancer. Methods: The Patient Care Monitor (PCM; Supportive Oncology Services, Memphis, TN) is a validated software package assessing oncology-related patient symptoms using a 11- point Likert scale. This instrument is administered routinely to patients at each office visit at most community oncology clinics within the Accelerated Community Oncology Research Network (ACORN). Cross-sectional patient-reported data from 11,445 consecutive patients evaluated at ACORN sites are presented here. Results: The mean age of the sample was 61.5 (±14.2; range 18–95), and 74.3% was female. 25% had received chemotherapy within the prior month. The sample size by tumor site was as follows: breast- 3,316; GU- 2,966; GI- 1,634; hematologic- 1,373; lung- 1,224; head and neck- 501; skin- 321. 55% of the pts reported trouble sleeping, with 26% describing this trouble as moderate or severe. Mean values from patient reported symptoms on the PCM are reported below. 21.9% of patients without insomnia had recent chemotherapy, compared with 27.5% of patients with insomnia who had recent therapy (p<.001). Conclusions: Insomnia occurs commonly in patients with cancer, and is associated with significantly increased fatigue, pain, and depressed mood. Additional research will explore changes in insomnia over the course of treatment, and relate these to possible etiological factors. [Table: see text] No significant financial relationships to disclose.
Radiation-induced esophagitis: A double-blind randomized clinical trial of aluminum hydroxide plus magnesium hydroxide plus oxetacaine suspension versus aluminum hydroxide plus magnesium hydroxide suspension
Authors: Bruns F. , Riesenbeck D. , Muecke R. , Klasser M. , Willich N. 
Published: March 2020

9100 Background: To assess whether oral administered oxetacaine-containing suspension is effective in treating acute radiation- induced esophagitis in cancer patients. Methods: A double-blind, prospective-randomized clinical trial was conducted across 20 radiotherapy institutions in Germany. Patients [pts.] with head and neck or thoracic cancer without dysphagia/odynophagia received definitive or postoperative radiotherapy [RT] with or without chemotherapy including at least 5 cm of the esophagus in the high dose volume. Pts. were randomized to receive oral aluminum hydroxide plus magnesium hydroxide plus oxetacaine (Tepilta [T]) suspension or aluminum hydroxide plus magnesium hydroxide suspension without oxetacaine (Magaldrat [M]) as first-line treatment for acute radiation-induced esophagitis. Primary endpoint was the interval between begin of RT and failure of first-line treatment of esophagitis defined as need for additional systemic analgesics. Data on pts.’ symptoms were collected during and for at least 2 weeks after treatment. Results: A total of 158 pts. were randomized, of whom 103 had take at least one dose of the study medication for acute esophagitis = grade 2 (CTC). Of the 105 pts., 51 were randomized to receive T and 52 M. The cumulative incidence of acute esophagitis = grade 2 (CTC) was 25% for the T and 22% for the M arm. Kaplan-Meier analysis showed a statistically significant difference between the two groups regarding the need for systemic analgesics under consideration of the intake time in favor of T (p = 0.032). No statistically significant difference was found between the two groups regarding the secondary endpoints need respective delay of additional parenteral nutrition (p = 0.28 respective p = 0.12), and pts.`s and investigator`s estimation of global effectivity of the study medication (0.08 and 0.12). Conclusions: This trial demonstrated a statistically significant delay of the intake time for systemic analgesics in pts. randomized to receive oral aluminum hydroxide plus magnesium hydroxide plus oxetacaine suspension. No significant financial relationships to disclose.
Prophylactic oral glutamine for docetaxel or paclitaxel associated taste alterations in cancer patients: A randomised, parallel, placebo-controlled, double-blind study
Authors: Strasser F. , Demmer R. , Boehme C. , Schmitz S. , Thuerlimann B. , Cerny T. , Gillessen S. 
Published: March 2020

9104 Background: Taste alterations (TA) can occur as side-effects of taxane-based chemotherapy (T-Ch) and studies suggest that glutamin can reduce neurotoxicity. We compared in patients (pts) with a first time T-Ch oral glutamin (G) with placebo (P) for occurrence and severity of TA. Methods: Pts were randomised for 30g per day G or P (maltodextrin) (Baxter, Switzerland) from the first day of T-Ch. Subjective TA (dysgeusia) was measured daily by VAS, at baseline 3 times. On each cycle of T-Ch, objective (sour, sweet, salty, bitter) and subjective (4-categorical scale of 4 tastes) TA, and toxicity (NCI CTC V.3) were assessed. Stomatitis and zinc deficiency were screened for and treated. Of 47 pts receiving at least one day G or P, three (2 G, 1 P) died to tumor progression and three (2 G, 1 P) withdraw consent in the first cycle of T-Ch. For primary outcomes, repeated dysgeusia scores were analyzed by linear mixed model and repeated binary values of each objective taste item by generalized estimating equation using logit link function. Results: G (n=21) and P (n=20) pts groups were comparable for demographics (f:m 5:16, median age 67 [49,83], 9 prostate, 3 lung, 3 breast, 6 other cancer; 8:12, 63 [40,73], 2, 6, 6, 6), and T-Ch drug (docetaxel 11/paclitaxel 10; 7/13), schedule (weekly 18/3-weekly 3; 14/6), or goal (adjuvant 1/palliative 20; 5/15). At baseline, average median dysgeusia was 11 in both groups (0,90; SD 23. 0,99; 22), 4 tastes were recognized by 12, 16, 13, and 15 pts in G (n=16) and 16, 19, 17, 19 in P (n=20). Study duration was 73 days for G (median; 4, 385) and 74 for P (7, 187). 19 of 39 pts (11 G, 8 P) developed peripheral neuropathy G1 or G2, none G3. Maximal (mean) dysgeusia was 31 (1, 100) in G and 33 (4, 74) in P; increase from baseline was 20 (1, 100) and 22 (1, 63). No effect of G or P on dysgeusia was detected (p=ns), linear time effect was p=0.46. Baseline dysgeusia effect was significant (p<0.0001), two group analysis (dysgeusia =11) did not alter results. Objective taste tests (no baseline effect) or subjective TA were not different, as were adverse events. Conclusions: Oral glutamin at the dose given did not decrease subjective taste disturbances or altered taste perception associated with T-Ch compared to placebo. No significant financial relationships to disclose.
Prospective study of specialist oncology community nursing resulting in improvements in key patient supportive care outcomes
Authors: Sussman J. , Howell D. , Whelan T. , Brazil K. , Pyette N. , Bainbridge D. 
Published: March 2020

9107 Background: Cancer patients report ongoing significant gaps in supportive care. To date few interventions have been shown to improve supportive care outcomes in cancer. Research in other areas suggests that specialist nursing interventions in the community may address gaps in unmet need, continuity of care and quality of life. This study prospectively studied a community based nursing intervention for cancer patients. Methods: Patients were followed using a longitudinal cohort design, with assessments at baseline (T1), four (T2) and eight (T3) weeks, upon enrollment in a specialist nursing program. The nursing intervention included a comprehensive supportive care assessment and subsequent care delivery or linkage to appropriate services in the community. Validated patient assessment outcomes included: Supportive Cancer Needs Survey Short Form 34, Quality of Life (EORTC QLC-30(v3)), Continuity and Coordination of Care (CCCQ), and a service utilization instrument. Results: 72 of 109 enrolled patients completed all study measures. The majority had advanced stage disease. Median age was 59 years. Disease categories for participants included: breast (33%), gastrointestinal. (18.1%), lung (13.9%), ovarian (9.7%), and head and neck (8.3%). All participants received a baseline comprehensive assessment and had a mean of 1.7 home visits with a mean of 3.9 telephone contacts. We observed significant reductions in most supportive care need domains ( Table ). There were trends to improvement in domains of quality of life and continuity of care. We also observed reductions in acute care services use and increased community agency use. Conclusions: This is one of the first prospective studies in cancer patients that demonstrates improvements in a number of supportive care outcomes through a community based specialist nursing intervention. A randomized study to confirm these findings is currently underway. [Table: see text] No significant financial relationships to disclose.