bluuebunny/crossref_metadata_2025_split huggingface dataset:
Work situation and work-related difficulties in stomach cancer survivors compared with the general population
Authors: Lee K. , Lee M. , Bae J. , Kim S. , Kim Y. , Ryn K. , Lee J. , Noh J. , Sohn T. , Hong S. , Yun Y. 
Published: March 2020

9084 Background: We aimed to investigate the work situation and work-related difficulties among stomach cancer survivors compared with the general population. Methods: We enrolled 426 stomach cancer survivors diagnosed 2001 to 2003 from two hospitals and 994 members without a history of cancer selected randomly from a representative sample of Korea adults. We identified work situation and work-related difficulties in two groups using multivariate logistic regression. Results: An employment rate of stomach cancer survivors decreased from 66.2% to 53.1% at average 28 months after their diagnosis and it was lower than that of general population (63.5%). The primary reason for not-working in survivors were that they were easily fatigued (31.2%) and had limitations in physical functioning (13.0%). Examining work-related difficulties, 50.6% of survivors who were working at the time of survey reported that they were easily fatigued and 37.5% of survivors reported that their capacity of work decreased whereas only 22.4%, 10.6% of general population reported. Survivors had housework- related difficulties because they were easily fatigued (74.4%) and emotionally distressful (12.2%) whereas 58.0% and 4.0% of general population reported. Older age (adjusted odds ratio [aOR]=18.12; 95% confidence interval [CI]=6.59 to 49.81), female (aOR=5.30; 95% CI=7.37 to 31.31), low income (aOR=1.87; 95% CI=1.04 to 3.33), poor physical functioning (aOR=0.97; 95% CI=0.95 to 0.98) and total gastrectomy (aOR=2.40; 95% CI=1.26 to 4.60) were more likely to increase the likelihood of not working in stomach cancer survivors. Conclusions: Stomach cancer and its treatment had a negative impact on employment rate as previous studies with other type of cancer. Our study found that stomach cancer survivors had an experience not only work-related but also housework-related difficulties. This information on stomach survivors’ might be help to make a better plan for the intervention of stomach cancer survivors’ return to work. No significant financial relationships to disclose.
Automated home-based symptom monitoring coupled with centralized telecare management in a statewide trial involving rural and urban community-based oncology practices
Authors: Theobald D. E. , Kroenke K. , Iseminger K. A. , Sanders R. , Norton K. , McCalley S. , Harvey P. , Butler D. , Dugan W. M. , Bechar N. 
Published: March 2020

9089 Background: Pain and depression are two of the most prevalent and treatable cancer-related symptoms, each present in at least 20–30% of oncology patients. Therefore, we are conducting the NCI-funded Indiana Cancer Pain and Depression (INCPAD) study, a randomized clinical trial conducted in a statewide network of 13 community-based cancer clinics located in both rural and urban oncology practices. Methods: Patients are screened at the local clinics followed by telephone-based enrollment and informed consent, depression and pain care management, and serial research outcome assessments over a 12-month period. Patients randomized to the intervention complete automated home-based symptom monitoring by interactive voice-recorded phone calls or by internet on a tapering schedule (twice a week tapering to monthly), allowing a single nurse care manager to centrally monitor treatment of patients asynchronously and efficiently. Results: Of the first 1,612 patients screened for the trial, 820 (51%) screened positive for depression and/or pain. Of these screen-positive patients, 760 (93%) were successfully contacted by telephone, of whom 203 were ineligible (most often because of symptoms that did not reach severity thresholds), 299 refused, and 163 were enrolled. Reasons that patients refused included lack of interest in trial participation (n=176), the belief their symptoms were not cancer-related (n=35), too sick (n = 30), too busy (n = 21), or other reasons (n = 36). Conclusions: INCPAD demonstrates the feasibility of enrolling cancer patients from multiple geographically-dispersed practices and providing centralized symptom care management. The fact that two-thirds of eligible patients still refuse to participate in a relatively “low burden” trial focused on alleviating bothersome symptoms and conducted almost exclusively by telephone highlights the need for additional strategies to facilitate enrollment in cancer trials. In particular, specific approaches to overcome low enthusiasm for trial participation need to be developed. No significant financial relationships to disclose.
Inpatient chemotherapy and risk for venous thromboembolism
Authors: Sousou T. , Khorana A. 
Published: March 2020

9092 Background: Chemotherapy is a known risk factor for venous thromboembolism (VTE) but contemporary rates and risk factors for chemotherapy-associated VTE are not well described. Furthermore, it is linked to increased hospital length of stay and has negative impact on patient quality of life (QOL). Methods: We used discharge codes to identify all patients admitted to the University of Rochester Medical Center in Rochester, NY from January, 2000 through December, 2005 for chemotherapy and conducted a retrospective chart review to identify those that developed VTE. Inclusion criteria consisted of patients with a malignancy, age greater than eighteen years and no prior history of VTE. VTE was defined as any deep venous thrombosis (DVT) or pulmonary embolism (PE) occurring within 4 weeks of receiving inpatient chemotherapy. Results: A total of 659 patients were admitted for inpatient chemotherapy during the study period. Fifty-four patients developed a DVT and 14 patients developed a PE for a total VTE rate of 9.6%. Median time to developing VTE was 12 days (range, 1 to 28 days). Common sites of cancer among patients who developed VTE included lymphoma (36%) followed by leukemia (28%), multiple myeloma (13%) and gastrointestinal malignancies (8%) among others. Fifteen patients (23%) had stage IV disease. Twelve patients (18%) had a pre-chemotherapy platelet count greater than 350,000/mm3, a known risk factor for chemotherapy-associated VTE. Conclusions: VTE is common in patients receiving chemotherapy, including those with hematologic malignancies and can have significant impacts on patient QOL. The risk for VTE extends beyond the period of inpatient hospitalization. Increased efforts to improve compliance with thromboprophylaxis are warranted to reduce the burden of VTE among cancer patients receiving inpatient chemotherapy. No significant financial relationships to disclose.
Vitamin E in the neuroprotection of cisplatin induced peripheral neurotoxicity and ototoxicity
Authors: Pace A. , Carpano S. , Galiè E. , Savarese A. , Della Giulia M. , Aschelter A. , Silvani A. , Di Lauro L. , Jandolo B. , Cognetti F. 
Published: March 2020

9114 Background: Peripheral neurotoxicity is a well recognized effect of cisplatin chemotherapy that can result in severe disability and represents a major dose-limiting factor. Several phase II studies have recently investigated the role of vitamin E as neuroprotectant in the prevention of cisplatin induced peripheral neurotoxicity and ototoxicity. Methods: An Italian randomized, placebo controlled, double blind multicentric study is ongoing to confirm the role of vitamin E supplementation in the prevention of neurotoxicity and ototoxicity induced by cisplatin Patients candidates to cisplatin chemotherapy were randomised to either vitamin E supplementation (a-tocopherol 400 mg/day) or to placebo. Patients were evaluated with neurological and neurophysiological examination before and after treatment. Neurotoxicity was measured using the comprehensive clinical and neurophysiological Total Neuropathy Score (TNS). Ototoxicity was evaluated with audiometric test and acoustic evoked potential before and after treatment. Results: 81 patients have been enrolled in 3 italian oncologic centers. An interim analysis on the first 50 patients was carried out. 25 patients (11 in the vit E group and 14 in the placebo group) received a cumulative dose higher than 300 mg/mq and were evaluable for neurotoxicity. Statistical analysis showed a significant difference (p < 0.05) in median neurotoxicity score observed in vit E group (TNS=1) respect to the placebo group (TNS=5). Conclusions: This is the first randomised, placebo controlled, double blind trial exploring the efficacy of vitamin E in the neuroprotection of cisplatin neurotoxicity. The results of this study confirm the neuroprotective effect of vitamin E supplementation against cisplatin-induced neurotoxicity. No significant financial relationships to disclose.
Effect of chemotherapy on exercise capacity in patients with advanced non-small cell lung cancer (NSCLC)
Authors: Kasymjanova G. , Kreisman H. , Pepe C. , Lajeunesse L. , Gagne S. , Dajczman E. , Pierre D. St. , Agulnik J. , Small D. 
Published: March 2020

9115 Background: The 6 minute walking distance (6MW) is commonly used to evaluate cardiopulmonary exercise capacity in a variety of patient (pt) populations. Although the 6MW test improved in advanced breast cancer pts who responded to 2 cycles of chemotherapy, (Nieman et al 1995), little is known about exercise capacity of pts with inoperable lung cancer. We prospectively evaluated 6MW in advanced NSCLC pts at diagnosis and following 2 cycles of chemotherapy (CT). Methods: 6MW was performed twice pre (one practice test) and once post 2 cycles of CT. Intent to treat (ITT) analysis was performed in pts who did not complete the last walk. A score of 0 was assigned to those who died and the last observation was carried forward for those with missing data. Results: 59 pts were enrolled though 6 pts withdrew following the practice test due to clinical deterioration (2 pts), pulmonary embolism (1pt), leg pain following the practice walk (1 pt) and withdrawal of consent (2 pts). The mean age of the remaining 53 pts was 61 ±11, PS was 0–1 in 46 (87%) and 2 in 7 (13%) of pts. 8 pts (15%) were stage 3A/3B and 45 (85%) were stage 3B /4 NSCLC. 45 (85%) pts received platinum-based doublets, whereas 8 (15%) had monotherapy. 39 pts completed the study and 14 pts did not complete the second evaluation (4 died, 8 withdrew due to worsening symptoms and 2 were lost for follow-up). The practice 6MW of the 20 pts who dropped out was 361±99 m compared to 448± 93m for the 39 who completed the study (p=0.002). The 6MW decreased from 461±108 m (range 247–748) to 431±98 (range 431–630) in the 39 pts who completed the study (p=0.02) and from 444±106 to 395±107 in the 53 pts using the ITT analysis (p<0.003). There was a clinically significant (>54 m) decrease in 6MW in 11 pts (28%), an increase in 6MW in 2 pts (5%), and no change in 26 (67%) others. The 6MW was higher in men and in pts in stages 3A/B (p<0.05). Conclusions: Exercise capacity, measured by 6MW, declines significantly after two cycles of chemotherapy. This decline may have been underestimated as pts with lower 6MW were more likely to drop out of the study. No significant financial relationships to disclose.
Phase I/II study of percutaneous vertebroplasty (PVP) for painful malignant vertebral compression fracture(PMVCF): JIVROSG- 0202
Authors: Arai Y. ,   Japan Interventional Radiology in Oncology Study Group (JIVROSG), Kobayashi K. , Takeuchi Y. , Nakajima Y. , Shioyama Y. , Sone M. , Tanigawa N. , Matsui O. , Kadoya M. , Inaba Y. 
Published: March 2020

9118 Backgrounds: This multi-center prospective study was conducted to evaluate the safety and efficacy of PVP, a new treatment modality for PMVCF, using techniques of interventional radiology. Methods: Enrolled patients (pts) had PMVCF by primary or metastatic tumor; restricted activities by PMVCF; tumor not exposed into spinal canal; adequate hematologic, hepatic, renal and cardiac functions; 0–3 ECOG performance status (PS); estimated prognosis over 4 weeks; and written consent. In phase I, 9 pts were enrolled; in phase II, 24 pts. Safety and efficacy were evaluated by NCI-CTC Ver. 2 and Visual Analogue Scale (VAS) at week 1 after PVP, respectively. By VAS score decreases, efficacy was classified into significantly effective (SE: =5 or reached 0–2), moderately effective (ME: 2–4), or not effective (NE: <2 or increase). Response rate was the ratio of pts with SE or ME in total pts. PVP was performed by insertion of 14–16 G bone biopsy needle into fractured vertebral body (FVB) using fluoroscopy or CT guidance, injection of bone cement (BC) under real time imaging observation, and discontinuation of BC injection at its distribution to adequate area of FVB or into extra bone space. Results: Procedures were completed in all 33 patients with 42 PMVCF. PS of pts was 0 in 1, 1 in 7, 2 in 12 and 3 in 13. In 30 days after PVP, 2 patients died of primary disease progression, but no major adverse reaction (>Grade 2) was observed. Response rate was 73% (56–85% in 95% CI) (61% (n=20) with SE; 12% (n=4) with ME; 27% (n=9) with NE), and increased to 83% at week 4. Median to PVP effect was 1 day (mean: 2.4). Median pain controlled survival was 73 days. Conclusion: For PMVCF, PVP is a safe and effective treatment modality with immediate responses. A phase III trial comparing PVP and standard radiation therapy is planned to evaluate PVP as the front line treatment. No significant financial relationships to disclose.
Ostarine increases lean body mass and improves physical performance in healthy elderly subjects: Implications for cancer cachexia patients
Authors: Evans W. , Smith M. R. , Morley J. E. , Barnette K. G. , Rodriguez D. , Steiner M. S. , Dalton J. T. 
Published: March 2020

9119 Background: Cancer cachexia results in selective loss of skeletal muscle resulting in weakness, reduced physical activity and a lower quality of life. Cancer cachexia also diminishes response to chemotherapy and survival. Anabolic steroids appear to increase weight and muscle mass in cancer patients, but have the potential for masculinization in women and prostate stimulation in men. A new class of non-steroidal selective androgen receptor modulators (SARMs) is being developed for use in cancer cachexia. SARMs are designed to have predominately anabolic activity in muscle and bone with minimal androgenic effects in most other tissues. We conducted a randomized phase II proof of concept study of ostarine, the first-in-class SARM, in healthy postmenopausal women and elderly men prior to intitiating a phase II study in cancer patients. Methods: Sixty elderly men (mean age 66 years) and 60 postmenopausal women (mean age 63 years) were randomly assigned to ostarine 0.1, 0.3, 1 mg, 3 mg or placebo for three months. The primary end point was change from baseline to three months in total lean body mass (LBM) measured by dual energy x-ray absorptiometry (DXA). The key secondary end point was a stair climb functional performance test that measured speed and power exerted. Evaluations included laboratory safety assessments and additional assessments of androgenic activity including PSA, sebum production and luteinizing hormone. Results: Ostarine treatment resulted in a dose dependent increase in total LBM, with an increase of 1.4 kg compared to placebo (p<0.001) at the 3 mg dose. Increased LBM translated to an improvement in the stair climb test in both speed (+15.5% ± 12.9 faster time, p=0.006) and power (+25.5% ± 20.3 watts, p=0.005). There were no serious adverse events reported. There were no significant changes in PSA, sebum production or luteinizing hormone. Conclusions: Ostarine improves LBM and physical performance in healthy older men and women. Ostarine had no unwanted androgenic side effects. A phase II study is planned to evaluate the safety and efficacy of ostarine in patients with cancer cachexia. No significant financial relationships to disclose.
Predictors of febrile neutropenia among Medicare patients with breast, lung and colorectal cancer
Authors: Hosmer W. D. , Wong M. D. , Malin J. L. 
Published: March 2020

9120 Background: Neutropenia and associated impaired immunity is the major dose limiting toxicity for systemic chemotherapy administration. Current guidelines recommend the prophylactic use of G-CSF when the risk of febrile neutropenia (FN) is approximately 20% because it decreases the duration and risk of FN. Advanced age has been identified as a risk factor for FN; however, little is known about the impact of other factors on the incidence of FN in the elderly. Methods: We analyzed SEER-Medicare data on patients diagnosed between 1995 and 2000 with breast, colorectal, and lung cancer, who received chemotherapy within 11 months of diagnosis. We examined a number of factors that might potentially be associated with FN in the first cycle of chemotherapy, including patient demographics, cancer stage at diagnosis, number of myelosupressive chemotherapeutics, frequency of chemotherapy administration, and comorbid conditions, including previous history of anemia and other blood disorders. Outcome was defined as admission to hospital within 30 days of initial chemotherapy administration with neutropenia (ICD9 288.0) coded as an admission diagnosis. Results: Of 18,637 patients who met inclusion criteria 751 (4.0%) had an episode of FN within 30 days of initial chemotherapy administration. In multivariate logistic regression analysis, independent predictors of FN included cancer type (lung cancer, OR 3.77, CI: 1.02–13.9, as compared to breast cancer) and history of blood disorder (OR 1.49, CI: 1.10–2.0), with a trend towards history of COPD (OR 1.19, CI: 0.98–1.44) and three or more myelosupressive agents (OR 4.01, CI: 0.76–21.2, as compared to non-myelosupressive chemotherapy). Initiating chemotherapy less than 1 month after cancer diagnosis was also associated with a higher odds of developing FN (OR 1.88, CI:1.42–2.49 compared to 3 months or more after diagnosis). Discussion: By utilizing the SEER-Medicare dataset we were able to examine predictors of febrile neutropenia in a large population of elderly patients with common malignancies. Knowledge of predisposing factors for neutropenia will allow more tailored prophylactic use of G-CSF in this at-risk population. No significant financial relationships to disclose.
Secondary vs. primary cachexia in patients with advanced cancer
Authors: Del Fabbro E. , Dalal S. , Delgado M. , Freer G. , Bruera E. 
Published: March 2020

9128 Background: Cachexia results in decreased survival and adherence to chemotherapy, and increased treatment toxicity. Primary Cachexia (PC) is characterized by weight loss, anorexia and fatigue and it is the result of tumor-host interactions producing neurohormonal dysfunction and an aberrant pro-inflammatory response. The clinical effects of PC may be exacerbated by complications capable of decreasing energy intake (Secondary Cachexia) such as dysgeusia, anxiety, depression, pain, early satiety, nausea and constipation. The objective of this study was to determine the causes and the frequency of secondary cachexia (SC) in a cohort of patients with PC. Methods: We reviewed the charts of 50 consecutive advanced cancer patients who underwent a structured assessment in a specialized cachexia clinic at a comprehensive cancer center. Results: All patients gathered criteria for cachexia, including a weight loss of >5% within the preceding 6 months. The most frequent causes of SC were early satiety in 40 patients(80%), constipation in 37(74%), depression or anxiety in 30(60%), uncontrolled pain in 31(62%), chronic nausea in 21(42%), dysgeusia in 14(28%),dental problems in 4(8%), dysphagia in 3(6%)chronic aspiration in 2 (4%) and oral candidiasis in 1 (2%).All 50 patients presented with at least 2 secondary causes of cachexia, and 44(88%) presented with = 3. The median number of causes of secondary cachexia was 4 (range 2–5). 211 interventions were used in these patients to treat secondary causes of cachexia. 14(28%) of the patients referred were already on a medication for appetite stimulation (megestrol acetate, dronabinol, corticosteroids). Conclusions: SC should be ruled out in all patients who have PC since the vast majority of patients referred to a cachexia clinic have 2 or more causes of SC. All cancer patients with involuntary weight loss in our series had “mixed cachexia”. Inexpensive effective treatments are available for most of the causes of SC, but they are frequently underused. No significant financial relationships to disclose.
Hearing loss in children with osteosarcoma
Authors: Lewis M. , DuBois S. , Fligor B. , Goorin A. , Grier H. 
Published: March 2020

9517 Background: Cisplatin is one of the most effective agents against osteosarcoma. Cisplatin is usually administered as a short IV infusion in most contemporary North American osteosarcoma treatment protocols. Ototoxicity from such protocols has not been well defined. The aim of this study was to determine the incidence and the risk factors for hearing loss in children with osteosarcoma. Methods: Eligible patients (pts) in this retrospective cohort study had osteosarcoma diagnosed and treated at our center from 1/1/1995 to 12/31/2004, were 3–18 years of age at diagnosis, and had a normal audiogram prior to the start of chemotherapy. All pts received cisplatin according to either standard practice or current open protocol. Most regimens prescribed a cumulative dose of 480 mg/m2 over 4 cycles. Pts with hearing loss at lower doses had cisplatin held on an individualized basis. Hearing was evaluated using pure-tone audiometry prior to the start of therapy, before each cycle of cisplatin administration, and off-therapy. The primary endpoint was any hearing loss as defined as > 20 dB decrease in hearing above 4,000 Hz. Fisher's exact test and logistic regression methods were used to identify univariate and independent predictors of hearing loss, respectively. Results: The incidence of hearing loss was 16/40 (40%). Six pts discontinued cisplatin early due to hearing loss. Seven of 9 pts (77.8%) who received cisplatin 120 mg/m2 as a short IV infusion on 1 day developed hearing loss compared to 9 of 31 (29.0%) pts who received this same dose as two daily infusions (p=0.018). On univariate analyses, age and cumulative cisplatin dose were not predictive of hearing loss. Logistic regression controlling for age, sex, race, and cumulative dose showed that administration of cisplatin 120 mg/m2 on 1 day compared to 2 days was an independent predictor of hearing loss (odds ratio of 11.6, 95% confidence interval = 1.62–82.87). Conclusions: Cisplatin given as 120 mg/m2/dose on 1 day was associated with greater risk of hearing loss than 60 mg/m2/dose on 2 days. Cumulative dose and age were not found to be predictors of hearing loss in this relatively small cohort. No significant financial relationships to disclose.