bluuebunny/crossref_metadata_2025_split huggingface dataset:
Fatigue is a cause of functional dependence in older cancer survivors
Authors: Balducci L. , Luciani A. , Extermann M. , Cantor A. , Jacobsen P. 
Published: April 2020

8538 Background: The incidence and prevalence of cancer increase with age, but the impact of cancer and its treatment on the function of older cancer survivors is unknown. The aim of the study was to establish the prevalence of fatigue in older cancer patients off chemotherapy and the correlation of fatigue with Instrumental Activities of Daily Living (IADL) and Activities of Daily Living (ADL). Methods: We reviewed the cases of 214 individuals aged 70–90 with different cancers, subsequently processed through the Senior Adult Oncology Program (SAOP) over 4 months. All patients of the SAOP are evaluated for function, depression, comorbidity and fatigue, and all of them have a complete blood count. Depression is assessed with the geriatric depression scale (GDS); comorbidity with the cumulative illness rating scale for geriatrics (CIRS-G), and fatigue with the Fatigue symptom inventory (FSI). Results: We found that 82% of the patients reported some degree of fatigue and in 74% of cases fatigue interfered with their daily activities. The average fatigue severity was 5.38 ± 2.59; the FSI interference score 19.1 ± 16.1, the average number of days fatigued in a week 4.07 ± 2.6. Fatigue severity was positively correlated with CIRS_G score (p = 0.04), creatinine clearance (p = 0.02) performance status (PS) (p < 0.0001), GDS (p = 0.04); ADL (0.02); Minimental status (MMS) (p = 0.05); fatigue interference with Cr Clp = ).005); PD (p = 0.001) ADL (p = 0.02); GDS (p = 0.01), and fatigue frequency with CIRS-G (p = 0.04); Cr CL (p = 0.01), PS (p = 0.0001), ADL (p = 0.03); IADL (p = 0.03), and GDS(0.09). ADL dependence was related to intensity (0.02), interference (0.0001) and days of fatigue; IADL dependence to interference score (p = 0.0001) and days of fatigue (p = 0.017) and GDS to intensity (p = 0.004); interference score (p = 0. 006) and frequency of fatigue. Conclusions: Fatigue is common in long term older cancer survivors, and is associated with functional dependence and depression. Control of fatigue may improve the function of older cancer survivors No significant financial relationships to disclose.
Treating nonagenarians with cancer
Authors: Crane E. J. , Extermann M. 
Published: April 2020

8542 Background: In the U.S., the number of cancer patients who are greater than age 85 is expected to quadruple in the next 50 years. Barriers exist to treating this patient population because of concerns of frailty, lack of inclusion in clinical trials, and unknown outcomes when treating this patient population. This single institution retrospective evaluation provides data regarding treatment outcomes for cancer patients ages 90 or older at the time of their treatment at this cancer center. Methods: The charts of all patients registered at the Moffitt Cancer Center who were age 90 or older at during their treatment/evaluation were eligible to be reviewed. The total number of charts eligible was 643. Included patients: 1) had a diagnosis of cancer, 2) had a clear treatment plan with at least two follow-up visits over a one month time period, 3) patients with only one evaluation would be eligible if a clear treatment plan was outlined and their death occurred within 6 months of their evaluation at this cancer center. To date, 329 charts have been reviewed which has yielded 121 patients who meet the inclusion criteria. Results: Preliminary evaluation of reveals that the most common diagnoses are breast cancer (14%), malignant melanoma (11%), head and neck cancer (9%), SCC of the skin (9%), and prostate cancer (8%). Treatment plans included surgery for 45% of the patients with 36% of the patients undergoing general anesthesia. Chemotherapy was administered to 6.8% of the patients, and hospice was recommended to 7.8%. One year after evaluation at this cancer center 54% of the patients were alive, and 42% were alive at 2 years. The average number of medications that these patients used was 5.5 and greater than 95% of the patients had an ECOG performance status of 1. Conclusions: These preliminary results indicate that the nonagenarian cancer patients are probably healthy given the low number of medications taken, indicating fewer comorbid conditions. These patients do have months to years of survival after their therapies which included surgery under general anesthesia and chemotherapy. Although the nonagenarian cancer patient population found at a referral center is likely to be healthier than that found in the community, these findings indicate that nonagenarians with few comorbidities and a good performance status can be successfully treated for their cancer. No significant financial relationships to disclose.
Anticancer treatment and cognitive functions in elderly cancer patients: A prospective study
Authors: Minisini A. M. , Ermacora P. , Russo S. , Cardellino G. , Andreetta C. , Sottile R. , Piga A. , Balestrieri M. , Puglisi F. 
Published: April 2020

8543 Background: It has been reported that anticancer treatment may alterate cognitive functions in cancer patients but very few prospective studied addressed this issue. Moreover, little is known about the cognitive impact of anticancer treatment in elderly cancer patients. We aimed at investigating the effect on cognitive functions of antiblastic chemotherapy and endocrine therapy in a consecutive series of elderly cancer outpatients. Methods: We evaluated cognitive functions by means of the Cambridge Cognitive Examination (CAMCOG) test and the Mini-Mental Scale Examination (MMSE) at baseline (before anticancer systemic treatment), after 3 months and after 6 months in cancer patients aged more than 65 years. Mood disturbances such as anxiety and depression were also evaluated (Hospital Anxiety and Depression Scale); comprehensive geriatric assessment and blood tests were performed at each evaluation. Results: Sixty patients were enrolled, 15 patients received chemotherapy (group 1), 13 patients received endocrine therapy (group 2) and 32 patients had neither chemotherapy nor endocrine therapy (group 3, control). Fifty-eight (97%) patients had no evidence of disease at the time of assessment. Median age was 71.5, 73 and 71 years in group 1, 2 and 3, respectively. At baseline, median Activities of Daily Living (ADL) score, Instrumental Activity of Daily Living (IADL) score, number of comorbidities and concomitant medications were 6, 8, 5, 1 in group 1, and 6, 8, 3, 2 in group 2, and 6, 8, 4, 2 in group 3, respectively. Median hemoglobin value was 12.9, 12.8, 13.3 g/dl in group 1, 2 and 3 respectively. At baseline, no significant unbalance was evident among groups. There was a statistically significant correlation between ADL or IADL score and CAMCOG total score (Spearman test, rho=0.4, p<0.05). Higher scolarity level was associated with higher CAMCOG total score. No deterioration of CAMCOG score was evident in group 1, 2 and 3 after 3 and 6 months (paired t-test p>.05); the separate analyses for the different items in CAMCOG test did not evidence any deterioration in time in the 3 groups. No worsening was seen in MMSE. Conclusions: Our study showed that anticancer treatment is not associated with rapid cognitive deterioration in elderly cancer patients. No significant financial relationships to disclose.
Efficacy and safety of pemetrexed (P) in elderly cancer patients (pts)
Authors: Kulkarni P. M. , Chen R. , Monberg M. , Obasaju C. K. 
Published: April 2020

8544 Background: P, a novel multitargeted antifolate, has demonstrated antitumor activity in a broad range of tumor types. Approximately 60% of all new cases of cancer and 70% of all cancer-related deaths occur in the elderly population. However, few studies have specifically analyzed the utility of chemotherapy in this population. The objective of this posthoc analysis was to understand the efficacy and tolerability of pemetrexed (alone or in combination) when used in the elderly cancer population. Methods: Data from three pemetrexed registration trials conducted between April 1999 and February 2003 were pooled together. Pts in these studies were diagnosed with malignant pleural mesothelioma, NSCLC, or advanced pancreatic cancer. Pts receiving P as monotherapy or in combination with another drug (gemcitabine or cisplatin) who received at least one cycle of therapy were included in this analysis (n=764). In all studies, P 500 mg/m2 was administered every 21 days. Demographics, efficacy, and safety data from pts receiving P were stratified by age ± 65 years. Kaplan-Meier method was used to estimate survival and time to PD. Cox regression model was also used to test the survival effect of pemetrexed on age after adjusting for disease stage, performance status, gender, and type of tumors, the prognostic factors considered to influence survival. Results: * P<.05 from fisher’s exact test. The adjusted hazard ratio of elderly patients over younger patients was 1.074 with p-value 0.42. Conclusions: P produced similar treatment effects in older and younger patients and appeared to be well tolerated in the elderly population. CTC grade 3/4 Lab and Non-Lab toxicity between two age groups were similar except, as expected, the elderly group had modestly higher myelosuppression. Non-hematologic toxicities were similar between the two age groups. [Table: see text] [Table: see text]
Muscle weakness is a significant problem in older patients receiving chemotherapy
Authors: Extermann M. , Boler I. , O’Neill E. , Brown R. , Defelice J. , Levine R. , Lubiner E. , Reyes P. , Schreiber F. , Lyman G. H. , Balducci L. 
Published: April 2020

8545 Background: Accurate prediction of toxicities from chemotherapy in the elderly could lead to improved decision making and supportive care. Methods: A large prospective multicentric cohort study of older cancer patients undergoing chemotherapy is underway to document the occurrence of chemotherapy toxicity and to develop a predictive score: the CRASH score (Chemotherapy Risk Assessment Score for High Age patients). Toxicity, including muscle weakness, is assessed using the Common Toxicity Criteria v.3.0. Results: An analysis of the first 200 patients entered in the study revealed an infrequently highlighted side effect: muscle weakness. Twenty patients were not evaluable for this analysis. Muscle weakness was reported by 22 patients. This represented 12.2% of the patients, of whom 13 (7.2%) had grade 3 muscle weakness. There was no grade 4 muscle weakness. This side effect appears to be independent from fatigue: only 4/22 patients reported concomitant severe (grade 3–4) fatigue, and among the 24 patients with severe fatigue, only 4 reported any muscle weakness. Muscle weakness occurred fairly early during the treatment: median 30 days (range 6–126 days). The muscle weakness was predominantly of two types: a generalized muscle weakness, or a weakness affecting the lower extremities. It was accompanied by falls in two patients. That weakness was present across tumor types, chemotherapy types, individual physicians, and oncology centers. Like the rest of the study population, the majority of these patients had advanced disease. Other frequent severe side effects were: grade 4 neutropenia 31.7%; grade 3–4: hypokalemia 8.8%, hyperglycemia 8.3%, hyponatremia 7.2%, febrile neutropenia 7.2%, diarrhea 7.2%, infection with neutropenia 6.7%. Conclusion: Muscle weakness is a frequent and clinically significant side effect of chemotherapy in the elderly, distinguishable from fatigue. This could be targeted by a preventive physical therapy intervention to prevent muscle deconditioning. [Table: see text]
Characteristics and outcomes of cancer patients ≥80 years treated with chemotherapy at a comprehensive cancer center
Authors: Jiang P. , Choi M. , Smith D. , Heilbrun L. , Gadgeel S. M. 
Published: April 2020

8548 Background: The percentage of cancer patients ≥ 80 years old is expected to rise in the United States. However data are limited on use of chemotherapy in this group of patients. Methods: Retrospective identification of patients who received systemic chemotherapy at our cancer center between 1/1/2000 to 12/31/2004 was performed using the computer generated pharmacy data and medical records. Patients who had diagnosis of cancer and ≥ 80 years were included in the study; patients receiving only supportive care, hormonal therapy, or oral chemotherapy were excluded. The protocol for this study was approved by the Wayne State University IRB. Results: A total of 133 patients ≥ 80 years who received chemotherapy was analyzed. The median age was 83 and 31% of the patients were ≥ 85 years. There were more females (61%) than males (39%). The gender distribution was more even (47% v. 53%) after excluding gender specific tumors. The racial distribution was diverse- Whites 65 (49%); Blacks 41 (31%); Other 18 (13%); Unknown 9 (7%). 16% of the patients had hematologic malignancy and 84% had solid tumors. Gynecological cancers (32%) followed by aerodigestive cancers (26%) were the most common solid tumors. Solid tumor patients primarily had regional (48%) or distant (45%) disease. During the first regimen, 512 cycles of chemotherapy was delivered with a median of 3 cycles per patient (range 1–24 cycles); 40% of patients received only 2 cycles of chemotherapy. 64% of patients were able to receive chemotherapy without 2nd cycle delay. The distribution of single or multidrug regimens was fairly similar; Solid tumors 52% v. 48%; Hematologic cancers 43% v. 57%. Carboplatin and paclitaxel (22%) was the most common regimen among solid tumor patients. 26% of all patients received a second regimen. The 1 year survival rates among hematologic cancer and solid tumor patients were 65% and 48%, respectively. Stage of disease was the only statistically significant factor predicting survival. Conclusions: In this diverse group of cancer patients ≥ 80 years old and selected for chemotherapy, the treatment was feasible. The survival outcomes in this elderly population were comparable to those of a younger patient population suggesting that the treatment is beneficial. No significant financial relationships to disclose.
Efficacy and safety of the vasopressin antagonist conivaptan in patients with euvolemic hyponatremia evaluated in a phase III clinical trial
Authors: Verbalis J. G. , Ghali J. K. , Gross P. , Long W. A. , Smith N. 
Published: April 2020

8550 Background: Hyponatremia, often caused by the inappropriate secretion of arginine vasopressin (AVP), is a common electrolyte disorder in patients with small-cell lung cancer (15%), head and neck cancer (3%), and non-small-cell lung cancer (0.7%). Conivaptan (CNV), a novel V1A and V2 AVP antagonist, produces aquaresis–the electrolyte-sparing excretion of water. CNV was recently approved for the treatment of euvolemic hyponatremia in hospitalized patients. The efficacy of CNV 40 mg/d was compared with that of placebo (PBO) on days 2 and 4 of a 4-day study in patients with euvolemic hyponatremia. Methods: This randomized, double-blind, multicenter, PBO-controlled trial enrolled 84 patients with euvolemic or hypervolemic hyponatremia (serum [Na+] 115 to <130 mEq/L). Patients were assigned to a PBO or a CNV 20-mg IV loading dose, followed by a continuous infusion of PBO or CNV 40 or 80 mg/d for 4 days. The primary efficacy measure was the change in serum [Na+] from baseline during treatment, as measured by the area under the serum [Na+]-time curve (AUC). Secondary efficacy measures included the change from baseline in serum [Na+]; time from first dose to achieve a confirmed ≥4 mEq/L increase in serum [Na+]; and the number of patients achieving a confirmed ≥6 mEq/L increase in serum [Na+] or normal serum [Na+] (≥135 mEq/L). Of the 84 patients enrolled, 56 (66.7%) had euvolemic hyponatremia; presented here are the results from 21 given PBO and 18 given CNV 40 mg/d. Results: The baseline serum [Na+] was similar in both treatment groups (PBO: 124.3 mEq/L, CNV 40 mg/d: 123.6 mEq/L). CNV 40 mg/d improved serum [Na+] and all secondary efficacy measures significantly more than PBO (Table). CNV was well tolerated; the most common adverse events associated with CNV at the end of the 4-day treatment were infusion-site reactions, postural hypotension, and thirst. Conclusion: CNV 40 mg/d increased serum [Na+] significantly more than PBO on days 2 and 4 in patients with euvolemic hyponatremia. [Table: see text] [Table: see text]
Persistent cognitive deficits in breast cancer survivors treated with adjuvant chemotherapy: Neuropsychological and neurophysiological evidence
Authors: Schagen S. B. , Kreukels B. , Van Dam F. 
Published: April 2020

8556 Background: Cognitive deficits are reported in several studies in women with breast cancer treated with adjuvant chemotherapy. The current aim was to investigate whether breast cancer patients that had deviant cognitive performance on neuropsychological tests one year after treatment, differed from patients with intact performance on neurophysiological parameters and self-reported complaints, this time examined five years post treatment. Methods: 63 breast cancer patients treated with CMF chemotherapy underwent neuropsychological testing one year post therapy. Their performance was compared to that of healthy controls (n=60). 26 of these patients were examined neurophysiologically 4 years after the initial neuropsychological assessment. Neurophysiological assessment included quantitative EEG, auditory oddball task and a visual information processing task with concurrent EEG registration. Patients were also interviewed regarding cognitive complaints experienced in daily life. Results: At the initial neuropsychological assessment 33.3% of breast cancer patients treated with CMF chemotherapy were classified as cognitively impaired compared to 10% of healthy controls (p=.01). At the neurophysiological assessment four years later, patients that scored in the impaired range on the initial neuropsychological examination had significantly longer P3 latencies and reduced P3 amplitudes in an information processing task. The impaired patients also made more errors, had longer reaction times, and reported more cognitive complaints. Conclusion: The results of this study show converging neuropsychological and neurophysiological evidence for the persistence of cognitive problems in breast cancer patients up to five years after completion of CMF chemotherapy. [Table: see text] No significant financial relationships to disclose.
Immediate adverse reactions to chemotherapy: Experience of a large ambulatory treatment center
Authors: Escalante C. P. , Oh J. H. , Baum D. D. , Mante M. , Zalpour A. , Spivey S. , Stewart C. , Ensor J. , Grover T. , Freedman R. 
Published: April 2020

8558 Background: In recent years there has been a proliferation of Ambulatory Chemotherapy Treatment Centers (ATC). The incidence of hypersensitivity and other immediate adverse drug reactions (IADR) in these ATC units have not been well studied. We aim to describe our experience with IADR in our ATC. Methods: Retrospective chart review was conducted for all patients in the Adverse Drug Reaction Report database (Maxsys II) for the year 2004. Data was abstracted for demographics, risk factors, clinical characteristics, and outcomes of IADR. Overall frequency of different chemotherapeutic and monoclonal agents infused was obtained for the same period through the pharmacy database. Results: In 2004, 81,580 chemotherapy infusions were given and 256 IADR (0.31%) were reported. The mean age was 55 years and 45% were males. The most common drugs used were fluorouracil (12.9%), paclitaxel (9.4%), docetaxel (6.1%), carboplatin (5.9%), and gemcitabine (5.8%). The table shows the most prevalent agents that led to IADR. Common symptoms included flushing (52.3%), dyspnea (27.3%), chest discomfort (27%), pruritus (22.7%), and hypertension (18.4%). Diphenhydramine (85.5%), hydrocortisone (37.1%), and dexamethasone (17.2%) were the most common drugs used for treatment of IADR. Common risk factors included previous allergy to medications (43.4%), previous IADR (19.5%), previous reactions to iodide (7.8%), allergies to seafood (1.6%), allergic rhinitis (1.2%), urticaria (1.2%), and asthma (0.8%). Most patients had their chemotherapy resumed and completed (87.9%) on the same day. Discussion: IADR were rare. Most cases were easily treated and chemotherapy was restarted and completed in the same day. However, they still pose a significant burden to cancer patients. Prospective studies are needed to further evaluate the identified risk factors and most common offending agents in outpatient settings. This will help develop pathways for more effective prevention and treatment of these IADR. [Table: see text] No significant financial relationships to disclose.
Effectiveness and new safety profile of rasburicase (urate oxidase) in Japanese patients with malignant lymphoma and acute leukemia in phase II study (ARD5290)
Authors: Ogura M. , Ishizawa K. , Hamaguchi M. , Hotta T. , Ohnishi K. , Sasaki T. , Sakamaki H. , Tamura K. , Usui N. , Morishima Y. 
Published: April 2020

8566 Background: Rasburicase (RAS) for the prevention of tumor lysis syndrome (TLS) populations at high risk, and for the treatment of hyperuricemia (HU) has obtained approvals in most countries in the world except in Japan. Thus, we conducted licensing phase II study of RAS with primary endpoint of overall efficacy response (ER) rate. We report efficacy and the new safety profile of only RAS administration prior to chemotherapy. Methods: Fifty patients (pts) with ML and/or AL, were administered RAS for 5 days using two dose-levels (0.15 mg/kg/day or 0.20 mg/kg/day). Chemotherapies were started from 4 to 24 hours after RAS treatment. ER was defined as keeping plasma uric acid level 7.5mg/dL by 48 hr after the start of first RAS infusion and lasting until 24 hr after the start of final (Day5) RAS infusion. Results: The overall ER rate was 98%. 49 pts (98%) completed 5 days of treatment. Both doses provided equally effective reduction of uric acid under the study conditions. Seven drug-related adverse events of grade 1 or 2 by NCI-CTC occurred in 6 pts during using only RAS (before first chemotherapy). ‘Hypersensitivity’ occurred in 3 pts, and ‘rash’, ‘anorexia’, ‘application site pain’, and ‘pyrexia’ occurred in 1 patient each. No grade 3 or 4 adverse events were reported. Only five pts (10%) had anti-RAS antibodies by Day29. Conclusions: RAS has proved to be highly effective with a good safety profile including the new safety one as single agent without chemotherapy. Although both two levels were effective, level of 0.20 mg/kg seems to be an optimal dose because RAS was effective against serious cases of HU in this level. The presence of anti-RAS antibodies was very low suggesting that the possibility for retreatment maybe possible. No significant financial relationships to disclose.