bluuebunny/crossref_metadata_2025 huggingface dataset:
The efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: A phase III randomized, double blind, placebo-controlled NCCTG trial, N01C3
Authors: Renno S. I. , Rao R. D. , Sloan J. , Wong G. , Johnson D. , Howard G. M. , Novotny P. , Patrick F. J. , Loprinzi C. L.
Published: April 2020

8530

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose limiting complication of chemotherapy. Lamotrigine (an anti-convulsant drug) appears to have some benefit when used to treat pain from neuropathy due to various etiologies. Based on these data, we conducted a phase III randomized placebo controlled study to determine the efficacy of lamotrigine in treating symptoms from CIPN. Methods: Patients with CIPN for 1 month or more were randomly assigned to lamotrigine (target dose 300 mg/day, increased by 50 mg/2 weeks) or placebo for 10 weeks. The co-primary endpoints were differences in average CIPN symptoms assessed by pro-rated area under the curve (AUC) of a numerical pain rating scale (NRS) and the Eastern Cooperative Oncology Group sensory neuropathy (ESN) scale. Accrual of 60 patients per group provided t-tests with 80% power to detect a difference of 0.57 standard deviation for each co-primary endpoint (moderate effect size) with a type I error of 0.025. Results: 131patients were enrolled, with complete data available for analysis in 93 (72%). Analyses were limited to this cohort but will be updated. Chemotherapy drugs considered to be causative of the CIPN were vinca alkaloids (30%), taxanes (25%), platinum-agents (7%), combinations (34%), and others (3%). Patients were equally matched with regards to baseline characteristics. Patients who enrolled had severe symptoms, with a baseline median ESN at enrollment of 3 (out of 3) in both groups. Toxicities were similar in both groups, however, more patients discontinued lamotrigine due to toxicities/refusals than those on placebo (32% vs 13% resp; p=0.04) and were therefore less likely to complete the 10 weeks therapy (60% vs. 78% resp, p=0.08). Average AUC of NRS score for patients on lamotrigine and placebo was 30.5 and 33.7 resp (p=0.48). The corresponding average AUC of the ESN scores were 12.4 and 14.5 (p=0.23). The proportions of patients with a 10 point (of 100) improvement in worst pain score (39% vs 36%) and a 1 point change in ESN (25% vs 27%) were similar between the lamotrigine and placebo arms, resp. Conclusions: These results suggest that lamotrigine is not effective for managing pain and symptoms due to CIPN.

No significant financial relationships to disclose.
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.
Evaluating end of life care: The Quality Oncology Practice Initiative (QOPI) experience
Authors: Neuss M. N. , Jacobson J. O. , Earle C. , Desch C. E. , McNiff K. , Thacker L. , Simone J. V.
Published: April 2020

8573

Background: Little is known about the quality of end-of-life (EOL) care provided to cancer patients, with data largely available only from administrative databases. QOPI is a practice-based system of quality self-assessment now available to any ASCO physician wishing to participate. QOPI methodology allows comparison of EOL care among practices and provides a basis for self-improvement. Methods: In Summer 2005, during the pilot phase of QOPI, several EOL questions were included in the survey instrument. Practices were requested to review the records of at least 15 patients who had died. Practice members performed standardized chart abstractions and data were entered directly on to a secure web-based application. A total of 455 charts were abstracted from 22 practices. Results: See table. Conclusion : QOPI provides an effective mechanism for collecting practice-specific EOL data. Aggregate data from the 22 QOPI pilot practices demonstrate a high level of performance compared with results reported from population-based studies. Significant variation among practices is present, representing an opportunity to improve the EOL care of cancer patients.

[Table: see text]

No significant financial relationships to disclose.
The use of palliative sedation for intractable symptoms in a palliative care unit (PCU) in a comprehensive cancer center
Authors: Elsayem A. , Curry E. , Boohene J. , Ibrahim H. , Pace E. , Hung S. , Bruera E.
Published: April 2020

8577

Background: There is wide variation in the frequency of reported use of palliative sedation (PS) to control intractable and refractory symptoms. Institutions have established policies for midazolam infusion in cases of PS. The indications and outcomes of this procedure have not been well characterized Methods: Our midazolam policy for PS requires 1:1 nursing for the first 24 hours and documentation of discussions regarding sedation. We reviewed our PCU database for all admissions for the first 11 months of 2005. We used pharmacy records for all patients who received medications used for sedation (chlorpromazine, lorazepam, midazolam). We reviewed all charts of pts who received any of these drugs to establish if the indication had been PS. Results: 148/484 admissions died in the PCU [31%]. 65/484 admissions (13%), and 47/ 148 patients who died (32%) received PS. Median age of patients (pts) was 58, 42 pts were male [65%], and the most frequent primaries observed were lung 24 [37%], hematologic 12 [18%], head and neck 7 [11%], and gastrointestinal 7 [11%]. Results are indicated in the table. * 2 patients had more than one indication for sedation The main causes for PS in our patients were delirium 57 [88%], dyspnea 6 [9%], and bleeding 4 [6%]. 18/65 patients who received PS [35%] were discharged alive, versus 318/419 [76%] who did not receive PS [p< 0.001]. Midazolam was used in 11/65 episodes [17%]. 4/6 pts with PS for dyspnea received midazolam [66%], versus 8/57 with PS for delirium or bleeding [14%], p=0.01]. 18/54 pts who received PS using other drug were discharged alive [33%], versus 0/11 pts who received midazolam [p=0.02]. Conclusions: Palliative sedation was required in 32% of pts who died in the hospital. Reporting midazolam utilization rates for monitoring overall PS outcomes, results in significant under reporting. Midazolam was used more frequently in cases of progressive dyspnea and poor prognosis. Less restrictive policies in the use of midazolam may result in more use for PS. Data accrual continues.

[Table: see text]

No significant financial relationships to disclose.
Symptom assessment tools used in a hospital-based pain and symptom care program at the University of North Carolina–A novel proxy rating system
Authors: Bernard S. A. , Lee C. B. , Usher B. , Qaqish B. , Schwartz R. , Hanson L. C.
Published: April 2020

8579

Background: Level of consciousness (LOC) often varies in the palliative care patient population. Tools are needed to reliably rate symptoms. The purpose of our analysis was to describe the patient demographics and rating distributions elicited by two distinct measurement tools, one for those able to self-rate (SR) and one for proxy-rated (PR) patients. Methods: Data obtained prospectively over the time period 1/2002–12/2004 was reviewed. A symptom distress scale using 11 items on a 5 point Likert-type scale (5=most severe) was adapted from the revised McCorkle symptom distress scale and used for alert and oriented patients. Symptoms evaluated included nausea, mood, appetite, shortness of breath (SOB), insomnia, pain, mobility, fatigue, constipation, decreased LOC, and delirium. For patients unable to SR, an advanced practice nurse rated symptoms using the Detroit Medical Center non-verbal pain scale and proxy symptom distress measures adapted from the Common Toxicity Criteria Manual, version 2. Rated symptoms included pain, vomiting, constipation, tachypnea, depressed LOC, and agitated delirium. Results: A total of 259 patients with data from visits 1 and 2 were included in the analysis. On visit 1, 46% (61/133) of PR patients were male, 70% (94/134) were ≥60yrs and 73% (98/134) were Caucasian. Symptom distress scores varied by rater and visit (Table). Conclusions: There is a need for proxy symptom distress measurement in the palliative care patient population as LOC fluctuates. Variability in symptom distress ratings between the SR and PR groups, with a trend toward lower scores in PR patients, is in accordance with the current literature. Of note, there was a consistent improvement in scores, regardless of rater, when visit 2 was compared to visit 1. We plan a prospective study of inter-rater reliability and validity of this novel symptom scoring system.

[Table: see text]

No significant financial relationships to disclose.
What is the value added of patient reported outcomes relative to physician rated symptom assessments?
Authors: Mandrekar S. J. , Huschka M. M. , Schaefer P. L. , Jett J. R. , Adjei A. A. , Sloan J. A.
Published: April 2020

8580

Background: This pooled analysis examined the relationship between single-item and multiple-item quality of life (QOL) measures and assessed the agreement between changes in QOL and patient-reported adverse events (AE). Methods: Data from six lung cancer clinical trials involving 358 patients were pooled. All trials incorporated the UNISCALE and one of three multiple-item assessments: the Functional Assessment for Cancer Therapy-Lung, the Lung Cancer Symptom Scale, or the Symptom Distress Scale. A clinically significant decline (CSD) in QOL was defined as a 10-point drop from baseline. A CSD in AE was defined as a change from ≤ grade 2 at baseline to ≥ grade 3 post-baseline. Spearman rank correlations and Bland-Altman approach were used to assess agreement. The Kaplan-Meier method was used to evaluate the time to the first occurrence of a severe (grade 3+) AE and first CSD in QOL. Results: Correlations between the UNISCALE and multi-item assessments were modest (rho=0.49–0.66). At least one 10-point decline in the UNISCALE and multi-item assessments were reported by 58% and 40% respectively. At least one severe AE was reported in 44% of patients post-baseline. The percent agreement between experiencing a severe AE and a CSD in QOL was 49% and 59% for UNISCALE and the multi-item tools. For individual AE, the percent agreement between a CSD in AE and a CSD in QOL ranged from 37% to 50% for UNISCALE and 44% to 69% for the multi-item tools. The median time to the first CSD in QOL for UNISCALE and multi-item tools was 67 and 142 days respectively. The median time to the first occurrence of a severe AE was 304 days. Conclusions: QOL and AE provide quantifiably different information. A 10-point decline in QOL occurs earlier than CTC AE reporting. Patient reported outcomes may be more sensitive in identifying clinically relevant problems than physician rated symptom assessments.

No significant financial relationships to disclose.
Symptom clusters in irradiated brain tumor survivors
Authors: Saconn P. A. , Ip E. , Rapp S. , D’Agostino R. B. , Naughton M. J. , Gleason J. , Shaw E. G.
Published: April 2020

8581

Background: Symptom clusters, whereby ≥2 symptoms coexist within patients, occur with cancer and its treatment. Identification and treatment of symptom clusters may improve functional status and health-related quality of life (HRQL). We report the characterization of symptom clusters occurring in irradiated brain tumor survivors. Materials/Methods: 34 adult survivors of primary or metastatic brain tumors following partial or whole brain irradiation ≥6 months prior were enrolled in an open-label Phase II study of donepezil, an acetylcholinesterase inhibitor (Rapp et al and Shaw et al, Neuro-Oncology 6:357 and 358, 2004). Eligibility criteria included life expectancy ≥30 weeks, no imaging evidence of progressive brain disease ≥3 months, stable/decreasing steroid dose, Karnofsky Performance Status (KPS) ≥70, and no brain tumor therapy during the study period. Patients received donepezil 5mg/day for 6 weeks, then 10mg/day for 18 weeks, followed by 6 weeks observation off drug. Symptoms were assessed at baseline, 6, 12, 24, and 30 weeks with the Functional Assessment of Cancer Therapy - Brain (FACT-Br) and Profile of Mood States (POMS). Factor analysis, multidimensional scaling and multivariate cluster analysis were used to characterize symptom clustering. Results: Of 34 patients enrolled, 24 remained on study for 24 weeks and 21 remained for the entire 30 weeks. Utilizing the HRQL data, all three methods of analysis demonstrated 3 distinct symptom clusters: mood, cognition and energy. The factor analysis table below illustrates such findings. Conclusions: Three symptom clusters with symptoms related to mood, cognitive function and energy were identified in this group of irradiated brain tumor survivors. Further research should focus on therapeutic interventions for symptom clusters rather than the traditional emphasis on single-symptom therapy. This study was supported by NCI grant 1 U10 CA81851.

[Table: see text]

No significant financial relationships to disclose.
Evaluation of quality of life (QoL) in 1,210 patients (pts) with metastatic colorectal cancer (MCRC) treated with capecitabine (X) in Brazil: Udated results from a large pt cohort with analysis as a function of pts’ ECOG PS
Authors: Beato C. A. , Van Eyll B. , Federico M. H. , Skare N. , Perdicaris M. R. , Franke F. A. , Oliveira C. , Cabral S. , Ribeiro R. , Gampel O.
Published: April 2020

8586

Background: The oral fluoropyrimidine X has superior efficacy and improved safety vs. 5-FU/LV in MCRC and early-stage colon cancer. Consequently, X is replacing 5-FU/LV as the backbone of MCRC therapy and is moving into the adjuvant setting. The QoL benefits of oral agents like X over traditional i.v. drugs are becoming more important in MCRC. Methods: Pts with MCRC who received standard oral X (1,250 mg/m2 twice daily on days 1–14, every 3 weeks) until progressive disease or unacceptable toxicity completed EORTC QLQ C-30 (v3.0) and CR-38 questionnaires at baseline, before cycle 1, at weeks 7 and 13, and at end of treatment. The proportion of pts with improvement, stabilization or worsening of QoL scores from week 7 was analyzed using linear models with repeated measures (generalized estimating questions technique) and SAS (v8.2). Each questionnaire item was analyzed as a function of pts’ ECOG status before first cycle and the evaluation periods. Results: Here we report QoL findings in 1210 pts (male/female, 51%/49%); median age 60 years (range 20–91); 53% of males and 57% of females had ECOG 0 at baseline. Almost half of the pts completed QoL questionnaires through to the end of treatment. Around 42% of pts who presented ECOG ≥1 had ECOG 0 at the end of treatment. Regardless of the baseline ECOG score, pts had significant improvements (p<0.0001 unless stated) in pain (p<0.0002), stoma-related problems (p=0.0003), defecation problems (p=0.0112), appetite loss (p=0.001), weight loss, insomnia (p=0.0074), constipation, body image (p=0.0142), emotional functioning, social functioning (p=0.0170), financial problems (p=0.0407), future perspective, and global health status (p=0.0003). Conclusions: X was associated with improved QoL, with significant benefits observed in most functional/symptomatic QoL domains. The efficacy, safety and convenience benefits of X as reported previously appear to have a direct impact on QoL. These data support its increasing use in the first-line and adjuvant settings.

No significant financial relationships to disclose.
National survey of advanced prostate cancer patients reveals disparity between perceptions and reality of treatment
Authors: Kirk T. N. , Moyad M. A.
Published: April 2020

8590

Background: Over 50,000 men developed hormone refractory prostate cancer (HRPC) in 2005 (CancerMetrics 2005). The objective of this analysis is to understand patient attitudes towards advancing prostate cancer (PC) and treatment. Methods: Patients were recruited from NexCura’s database of users and links from PC websites: UsTOO, PCRI, PCF and PAACT. Board certified physicians who treat HRPC were recruited by J. Reckner & Assoc. Responses were collected via online survey and analyzed by TSC, a division of Yankelovich. Grant funding from Abbott. The scale was “agree”, strongly agree”, “disagree” or “strongly disagree.” Results: 409 HRPC patients (P), 236 caregivers (C), 100 urologists (U) and 104 oncologists (O) participated. 45% of patients have metastatic HRPC. Mean patient age was 65.7 and age at diagnosis was 60.2. Conclusions: Many patients and caregivers have difficulty with advancing PC. Respondents recognize the survival benefit associated with chemotherapy, but attitude on its impact on quality of life varies significantly. Disparity exists between patients, caregivers and physicians on the impact of treatment on quality of life. Additional education, enhanced dialogue and additional treatment options are needed for HRPC patients, caregivers and physicians.

[Table: see text]

[Table: see text]
The time taken to complete quality of life questionnaires in an advanced cancer trial
Authors: Stockler M. R. , Heritier S. , Nowak A. K. , Goldstein D. , Turner J. , Jefford M. , Glasgow A. , Abdi E. , Beale P. J. , Carter C.
Published: April 2020

8592

Background: Respondent burden is important when designing trials in advanced cancer. We determined the time taken to complete a set of quality of life questionnaires (TTTCQ) in a randomized trial of sertraline in advanced cancer. Methods: Participants recorded the times they started and finished an 11 page questionnaire of 187 items including the Centre for Epidemiologic Studies Depression Scale, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy General and Fatigue scales, and 4 other validated instruments. Determinants of the TTTCQ were sought amongst the self-ratings of anxiety, depression, fatigue, trouble concentrating, other aspects of quality of life, and other characteristics including age, Karnofsky Performance Status (KPS) and treatment. Distributions are summarised by their median, interquartile range (25th to 75th percentiles, IQR) and interdecile range (10th to 90th percentiles, IDR). Associations were assessed with Spearman’s rank correlation coefficient (r), and differences with the Mann-Whitney test. All p-values are two-sided. Results: The TTTCQ was available for 128 of 150 subjects (85%). Median age was 66 (IQR 59 to 73), median KPS was 80 (IQR 70 to 90), and 63% were male. The median TTTCQ was 30 mins (IQR 23 to 40, IDR 15 to 50), equating to a median of 10 secs per item (IQR 7 to 13, IDR 5 to 16). The TTTCQ was modestly correlated with age and KPS (r = 0.19, p = 0.04 for both). Age and KPS were not correlated (r = 0.03, p = 0.8). Subjects aged 60 or older had a median TTTCQ 10 mins longer than those 59 or younger (35 v 25 mins, p = 0.002). Subjects with a KPS of 100, 90, 80, and 70 or less had a median TTTCQ of 20, 25, 31, and 35 mins respectively. TTTCQ was modestly correlated with self-ratings of: problems coping with treatment, dry mouth, feeling dizzy or lightheaded (r = 0.22 to 0.25, p = 0.01). Correlations were weak or non-existent with all measures of depression, anxiety, trouble concentrating, emotional well-being, and overall well-being (r = 0.10 to 0.18, p = 0.04 to 0.25). TTTCQ was unaffected by gender, opioids, steroids and number of previous cytotoxic regimens. Conclusions: Respondent burden was less of a problem than anticipated and little affected by treatments or self-rated psychological problems.

No significant financial relationships to disclose.
Quality of life (QoL) improvements in 1,464 patients (pts) with metastatic breast cancer (MBC) receiving capecitabine (X) in Brazil: Updated results from a large pt cohort, including analysis as a function of pts’ ECOG PS
Authors: Oliveira C. , Ribeiro R. , Segalla J. G. , Tessaro S. , Cabral S. , Franke F. A. , De Paula U. , Moura G. L. , Perdicaris M. R. , Garicochea B.
Published: April 2020

8599

Background: The oral fluoropyrimidine capecitabine is highly active and well tolerated as single-agent therapy and extends survival when added to docetaxel in pretreated MBC. QoL data would enhance understanding of X’s pt benefits. Methods: QoL was evaluated in women with anthracycline ± taxane-pretreated MBC while receiving X (baseline, before cycle 1, at weeks 7 and 13, and at treatment end) using EORTC QLQ C-30 (v3.0) and BR-23 questionnaires. We used linear models with repeated measures (generalized estimating questions technique) and SAS (v8.2) to determine improvement, stabilization or worsening of QoL scores from week 7 onwards. Each questionnaire item was analyzed as a function of pts’ ECOG status before first cycle and the evaluation periods. Results: Baseline characteristics of the 1,464 evaluable pts were: median age 54 years (range 22–92); 42% had ECOG 0. As expected, pts with worse initial PS (ECOG ≥2) had lower mean scores during treatment. Regardless of baseline ECOG score, X therapy was associated with significant (p<0.0001 unless stated) improvements in pts’ perception of: role functioning (p=0.001), pain, nausea/vomiting, fatigue, constipation, emotional functioning, and global health status. Capecitabine was also associated with significant improvements in pts’ perception of systemic therapy side effects (p<0.0001), breast symptoms (p<0.0001), arm symptoms (p=0.0047), hair loss (p<0.0001), and future perspective (p<0.0001). Conclusions: Pts receiving X had substantial improvements in almost all functional and symptomatic QoL domains. These findings highlight the importance of considering QoL and other measurable benefits of oral treatments alongside well-established measures of clinical evaluation in pts with metastatic disease. The QoL benefits, together with other proven clinical outcomes, suggest that early use of X in MBC would be of benefit to pts.

No significant financial relationships to disclose.
The Life Tape Project, an existential intervention for cancer patients: A report on perceived benefits and changes in quality of life
Authors: Rosenbaum E. H. , Garlan R. W. , Siegel A. L. , Henderson S. , Hirschberger N. , Butler L. D. , Spiegel D.
Published: April 2020

8604

Background: Facing cancer, most patients struggle with mortality and threats to their emotional equilibrium and that of their families. Families may become closer, but often communication difficulties and isolation increase. The Life Tape Project (LTP) is an intervention—involving a two hour video-taped genealogy and life story in the presence of family—designed to help patients and families confront this existential crisis. An important aspect is the cultivation of Symbolic Immortality—that some important part of the person continues to exist symbolically, even after death—helping patients identify with things greater and more enduring than themselves, and providing a sense of what will remain with the family after they are gone. Observation and pilot data suggested patients receive substantial benefits from the LTP. Results from an ongoing study designed to quantify and extend these observations are reported. Method: Adults with any cancer diagnosis are recruited from the general population. Patients complete baseline questionnaires before the LT interview and follow-up packets two and ten weeks after. Measures include the FACT-G for Quality of Life (QOL) and a Perceived Benefits Questionnaire covering eight themes suggested by previous research. A final semi-structured interview probes for unwanted effects. Results: At first follow-up (N = 23 as of 1/8/06) repeated measure t-tests revealed significant increases in FACT-G Functional and QOL (Total) scales; and a majority of patients reported substantial benefits (endorsing “very” or “extremely true for me”) in at least one theme. Final interviews revealed no unwanted effects. Conclusions: The LTP is a powerful, safe, and accessible intervention that can improve family communication and connectedness, promote personal growth, and reduce existential anxiety through the creation of symbolic immortality. Requiring minimal equipment and time, it would make an excellent addition to any supportive care program.

[Table: see text]

No significant financial relationships to disclose.