bluuebunny/crossref_metadata_2025 huggingface dataset:
Distress screening and follow-up: Multidisciplinary routine toward a personalized approach.
Authors: Bergerot Cristiane Decat , Buso Marco Murilo
Published: March 2020

e19504

Background: Cancer care still fails to address psychosocial problems, which can compromise the effectiveness of health care and thereby adversely affect cancer patients. The present retrospective study explores a routine of distress screening, followed by a multidisciplinary discussion, in order to devise strategies for intervention and treatment. Methods: Over two years, 328 patients from a private cancer center, located in Brasilia, the capital of Brazil, participated in a longitudinal study. They were evaluated three times over a 6-month period using the Distress Thermometer and the Hospital Anxiety and Depression Scale. The data of each evaluation were discussed between oncologist assistant and psychologist, establishing appropriate intervention. Descriptive statistics, Pearson’s correlation and a logistic regression were employed to analyze the data. Results: There was a prevalence of female patients (64%). They were between 18 - 86 years (M = 54.7, SD = 15.8). Gastrointestinal (28%), breast (23.8%) and hematologic cancer (22.6%) were the main diagnosis, being 29% with early disease stage and 59.1% with late stage. The distress level progressively decreased along the evaluations: first day (55.8%), middle (27%) and last day of chemotherapy (13.4%). The same decrease occurred in anxiety and depression scale. There was a significant association (p < .001) between distress vs. anxiety and distress vs. depression over phases of evaluation: first day (r = 0.8, t(328) = 21.6; r = 0.8, t(328) = 16.2; R2 = 0.85), middle (r = 0.8, t(285) = 18.4; r = 0.8, t(285) = 20.9; R2 = 0.86) and last day of chemotherapy (r = 0.8, t(261) = 14.7; r = 0.8, t(261) = 20.8; R2 = 0.82). The incidence of distress shows to be related to anxiety, depression, gender, emotional and physical problems. Conclusions: Preliminary results suggest that distress, anxiety and depression scores tends to reduce during the 6-months period of evaluation. This results support the multidisciplinary discussion in order to propose the best intervention and treatment tailored to each case, being more assertive. In our experience we note the importance of distress screening and the health team integration to understand patient's experiences and to improve cancer care.
Retrospective study of febrile neutropenia.
Authors: Martinez Lago Nieves , Vieito Maria , Anido Urbano , Candamio Sonia , Lopez Rafael , Barón Francisco J. , Vidal Yolanda , Aguin Losada Santiago , Campos Marta Carmona , Rodriguez Lopez Carmela , Leon Luis , Varela Ponte Rafael
Published: March 2020

e19505

Background: Although its mortality has decreased in the last years, neutropenic fever is still one of the most important oncological emergencies. Methods: We have assessed the epidemiological data on patients admitted or evaluated for neutropenic sepsis in a third level cancer center from January 2009 to December 2010. Results: We have found 68 patients who had at least one episode of febrile neutropenia, of them 66% were male and 34% female, and the mean age was 59 years. The performance status was 0 and 1 in 80% of patients and only 19% percent had serious comorbilities such as renal dysfunction, cirrhosis, diabetes mellitus or chronic pulmonary disease. 36% of our patients had a high risk neutropenic fever per MASCC criteria. The majority of patients were lung cancer (31%) breast cancer (22%); and gastrointestinal cancer (28%) and 53% where treated with palliative intention. The episodes of febrile neutropenia were more frequent in patients in first line of treatment (72%) and first cycle of any treatment (42%). 8% of patients were treated with chemorradiation and 35% of the patients were receiving prophylaxis with GCSF. There was no found the source of the infection in 45% of patients. 25% had positive cultures. The porcetaje of infections with gram-positive and-negative was very similar. Patients were treated with a combination of amikacine and ceftacidime in 63% of times, further addition of vancomicine or antifungical therapies were only needed in minority of patients, 88% percent of patients received granulocyte stimulating factors. The mean duration of the neutropenia was of 2 days. Following chemotherapy treatment doses were reduced in 44% of patients and delayed in 26%. Thirteen percent of patients received secondary prophylaxis with GCSF, treatment regimen changed was changed in only 2% of patients and 29% received no further treatment. Conclusions: The mortality rate was of 3%, and the time of hospitalization was short (mean of 7 days). Febrile neutropenia remains a serious complication that we have to decrease.
Return to primary service among bone marrow transplant rehabilitation inpatients: An index for predicting outcomes.
Authors: Fu Jack Brian , Lee Jay Ted , Smith Dennis Wesley
Published: March 2020

e19509

Background: Inpatient rehabilitation bone marrow transplant patients can be challenging due to their medical fragility. Methods: One hundred forty-seven bone marrow transplant patients admitted to inpatient rehabilitation at a major national cancer hospital between January 1, 2002, and April 15, 2009, regardless of the patient’s primary cancer were retrospectively studied. Return to primary service and factors including age, gender, race, presence of graft-versus-host disease, type of hematopoietic stem cell transplant, type of primary cancer, white blood cell count upon rehabilitation admission, platelet count, albumin level, prealbumin level, creatinine level, and presence of antimicrobial agents were analyzed. Results: Forty-one percent (61/147) of bone marrow transplant patients were transferred from the inpatient rehabilitation unit back to the primary service. Of those transferred back, 38% died after being transferred back to the primary service; 53%, 36%, and 39% of leukemia, lymphoma, and multiple myeloma transplant patients were transferred back to the primary service, respectively. No breast, germinoma, renal, testicular, or Waldenstrom macroglobulinemia patients were transferred back to primary service. Significant relationships were found with a platelet count < 43 (p<.01), a creatinine level > 0.9 (p<.05), the presence of an antibacterial agent (p<.05), the presence of an antifungal agent (p<.05) and leukemia, lymphoma or multiple myeloma type (p<.05). Using these 4 of these factors the Fu index was formulated to determine the likelihood of return to the primary team. Conclusions: Bone marrow transplant patients have a high rate of transfer from the inpatient rehabilitation unit back to the primary service and many of them eventually died while in the hospital. A low platelet count, a high creatinine level, the presence of an antibacterial agent, and the presence of an antifungal agent significantly increased the risk of return to primary. Close follow-up by the primary team while on the inpatient rehabilitation unit is recommended.
Persistent oxaliplatin (OX) induced peripheral neuropathy in patients (pts) with colorectal cancer: A descriptive study.
Authors: Vatandoust Sina , Joshi Rohit , Broadbridge Vy , Pittman Kenneth B. , Adams Jacqueline , Singhal Nimit , Colbeck Margaret , Yeend Susan , Price Timothy Jay
Published: March 2020

e19513

Background: Available data suggest that the OX-induced neuropathy is usually reversible and a minority of pts will have persistent severe (grade 3) side effects (24.1% any grade and 0.7% grade 3 at 18 months follow up from MOSAIC trial). We have explored the frequency of persistent peripheral neuropathy in pts who received OX for colorectal cancer at 2 local centres in South Australia. Methods: Pts who completed treatment with OX for colorectal cancer at least 20 months prior to entering the study were eligible and were sent consent and questionnaire. Neuropathy questions were adapted from the FACT/GOG-Ntx (V.4) questionnaire. No pts received Calcium and Magnesium with OX. Statistical tests used to analyze the data were t-test and chi- square. Results: Of the 56 eligible pts, 27 consented to enrol in the study. Median age was 66 yrs. 19 were stage 3, 8 stage 4. Mean total OX dose was 712.1 mg/m2 (range: 170 - 1200 mg/m2); mean number of OX cycles was 8.2 (range 2 - 13), median time between last dose of OX and completing the questionnaire was 37 months (range 20 - 93). 7 pts (25.9%) had a history of diabetes mellitus and 7 had significant alcohol intake. No pts had neuropathic symptoms prior to treatment with OX. 25 pts (92.7%) experienced neuropathic symptoms during their treatment, 11 had grade 2, and 2 had grade 3 symptoms (limiting self care activities of daily living). At the time of completing the questionnaire, 17 pts (63%) were still symptomatic with 9 pts (33.3%) having grade 2 and 3 pts (11.1%) having grade 3 neuropathic symptoms. In the cohort of pts with persistent grade 2 symptoms, 3 pts had walking difficulty and 2 pts could not drive safely due to side effects. Persistent grade 2/3 symptoms were more common in pts who received total OX doses of 722 mg/m2 or more (p < 0.05). Conclusions: Our observation indicates that a majority of pts will have persistent neuropathy more than 20 months after completing treatment with OX and a significant proportion will still have grade 2/3 symptoms. Higher total OX dose might be one of the risk factors in this group. These results should be further prospectively evaluated in a larger population as these long term side effects may affect pts’ daily activities and safety.
An innovative approach to post-treatment cancer care: The After Cancer Treatment Transition Clinic (ACTT).
Authors: Townsley Carol A. , Moura Shari , Fitzgerald Barbara , Hawker Gillian , Mosley Jane , Barrett Cris , Fox Catharine , Moore Malcolm J.
Published: March 2020

e19522

Background: Improvements in early detection and cancer therapy have led to better survival rates. Integration of cancer survivorship initiatives as part of cancer care is gaining momentum. However, post cancer treatment follow up care may not be best met in acute cancer clinics. Visits to a large urban cancer centre in Canada have increased by 30% in the past 5 years. These increased volumes have lead to prolongation of patient wait times and increased stress for health care providers. This cancer centre is undergoing a transformative change that focuses on improving the patient cancer care experience. Methods: The development of the ACTT clinic has been a partnered initiative between two academic healthcare centres: an urban cancer centre and a community ambulatory hospital with a focus in chronic disease management. It is being managed by an advanced practice nurse and a GP Oncologist. The ACTT clinic delivers high quality, safe specialized physician and advanced nursing patient care, with engagement of patients/families, oncologists and primary care. The target population is patients who have completed cancer therapy, are well and are at moderate to low risk for cancer recurrence. The initial phase of the project involved transitioning patients with Testes, Melanoma, Breast and Colorectal cancers. Each cancer site group identifies the appropriate processes for clinic functioning at the ACTT, and if required, for appropriate linkages back to acute cancer care and primary care. Results: Over 1,000 patients have been transitioned to ACTT since April 2010 with 10-20 additional patients referred weekly. Essential components of the model include: standard surveillance protocols for recurrence or secondary cancers, management of long term and late effects of cancer treatment, monitoring for distress and health promotion. Standard reporting includes patient assessment and a defined plan of care communicated to their oncologist and primary care. Patient experience evaluation of the program is ongoing. Conclusions: The ACTT clinic initiative has been successful in developing a novel clinic model and has successfully transitioned over 1,000 patients from an acute care cancer clinic.
Pattern of use of complementary alternative medicine (CAM) among cancer patients in Saudi Arabia.
Authors: Al-Dalee Abdelmuniem , Aljubran Ali Husain
Published: March 2020

e19525

Background: Use of complementary alternative medicine CAM is prevalent among cancer patients in Saudi Arabia. However, there is yet no clear knowledge about the pattern and magnitude of use of CAM. This study explored that area. Methods: The subjects were adult cancer patients who attended the outpatient clinics at King Faisal cancer center in Riyadh, Saudi Arabia. They completed a validated questionnaire of six sections. In this abstract, we only present the data of the fourth section which enquires about the pattern of CAM use. Ingestion or topical application of therapeutic materials as well as recitation of prayers or attending spiritual sessions are all considered CAM. Results: 234 patients participated. Age range: 15-86, median: 40.5 y. Males were 61.5%. 12.4% lived in suburban areas. 41.5% had higher than high school education, and 76% had annual income less than $32,000. 53% of the studied population used CAM before starting conventional therapy, and 47% of them were actually on CAM while on conventional therapy. Honey, whether mixed with herbs or not, was the most commonly used (84% before and 86% after starting conventional therapy). 92% used the holly Quran recitation or Ruqia (Recitation of special prayers). 53 % went at least once to attend a session with a sheikh (spiritual/ religious healer), and 9% of the responding participants attended sessions to undo magic or expel jinn (possessing demon spirit). 92% of CAM users believed that conventional therapy is effective but wanted to try other possible options. Conclusions: Use of CAM is prevalent among cancer patients before starting and while on conventional therapy. Because of the religious nature of the society, attending spiritual healing sessions is very common. Since this study was done among patients who already had chosen to be treated by conventional therapy, the results may under estimate the prevalence of CAM use. A similar study in the community is recommended to include patients who do not seek conventional treatments.
Predictive value of clinical and laboratory findings for overt bone marrow metastasis in patients with solid tumor.
Authors: Filanovsky Kalman , Shvidel Lev , Idelevich Efraim , Feldberg Edit , Shtalrid Mordechai
Published: March 2020

e19529

Background: Bone marrow (BM) involvement is not a rare finding in advanced stages of solid tumors, it may have a profound influence on prognosis and affect a treatment approach. Methods: 103 patients (pts) with an advanced metastatic solid tumor were included in retrospective study. BM metastasis were diagnosed in 72 cases according to Bone marrow biopsy (BMB) ; 31 other metastatic pts. didn't have a marrow spread. We analyzed a basic demographic characteristics, localization of primary tumors and metastasis, laboratory tests, blood smears, BM aspirates (BMA) and biopsies reports.Results: Pts in both groups had comparable median age, gender distribution, pattern of primary tumor and metastatic spread. Hematological parameters' strong correlated with marrow metastasis were: anemia 83% vs. 61% p=0.015 ,thrombocytopenia 55% vs.16% p<0.001 with higher MPV p=0.01, hypocellular/ dry tap marrow aspirate 58% vs.14% p=0.001 and leukoerythroblastic blood smear 82% vs.0% p<0.0001. Leukoerythroblastosis(LEB) in 92% reflected hypocellular aspirate was not included in final analysis because of low rate recorder blood smears. Analysis of biochemical finding showed higher increase by 2 upper limits (>2ULN) of LDH and ALP in the metastatic BM cohort: 50% vs. 16% and 35% vs. 9%, p=0.002 and p=0.007 respectively. Factors predicted metastatic BM by multivariate analysis were: thrombocytopenia <50x109/L OR 14.4 95%CI (1.6-128), hypocellular BMA OR 7.0 95%CI (1.82-21.2) and alkaline phosphatase >2ULN levels OR 6.5 95%CI ( 1.2-35.3). Causes which influenced the survival of pts with BM metastasis: thrombocytopenia < 50X109/ L median survival 0.8 month 95% CI (0.1-1.5) vs. 4.1m 95%CI( 2.0-6.1), LDH level >2ULN 1.8m 95%CI(0.5-3.0) vs.4.7m 95%CI(3.0-6.3) and tumor presenting with BM metastasis vs. previously recognized carcinoma with BM involvement 1.8m 95% CI(0.3-3.0) vs.4.0 m.95%CI(1.3-6.7).Conclusions: Our study demonstrated that thrombocytopenia , alkaline phosphatase level>2ULN and probably LEB reflect hypoplastic BM predict BM metastasis in cancer patients; furthermore, thrombocytopenia, LDH>2ULN and BM metastasis in a clinical presentation affect their survival.
Emotional reactions of children and adolescents to the advanced oncologic disease of the parents: Preliminary results.
Authors: Rodriguez-Morera Anna , Limonero Joaquin T. , del Barco Sonia , Porta Rut
Published: March 2020

e19542

Background: To describe perceptions of children and adolescents on advanced or terminal oncological disease of their parents, and some factors affecting these perceptions. Methods: Sample of 30 children and adolescents, aged between 5 to 18 years old, whose parents were in treatment or follow-up for advanced oncological disease. We used a semi-structured interview, reflecting the perceptions of ill parents, healthy parents and children. Also, parents were asked for the information they thought their children had about the disease. All participants older than 12 years old, gave Informed Consent to participate in the study. Results: Children and adolescents, described the disease of their parents mixing objetivable data (88.9%) and subjective perceptions (66.7%) with the expression of wishes (44.4%). Up to 76.7 % of ill parents and 82.6% of healthy parents, tended to minimize the capacity of understanding of the disease by their children. The perception that the patient and the healthy parent had of the information of the children correlates positively and significantly (r=0.59; p<0.01) and (r=0.53, p<0.01) respectively with the minimization or maximization of the capabilities of coping that the parents had of their children. There was a significant correlation (r=0.50, p<0.05), between the perceptions from the patient and his partner regarding the information and knowledge that their children have from the disease. Mothers, were the ones usually to decide the type, quality and quantity of information to provide to their children. Conclusions: Most parents and patients tend to underestimate the capacity of understanding of the children and teenagers, being mothers the ones to decide, in most cases, the amount and quality/quantity of the information given to their children about the illness. It would be necessary to attend from the beginning of the disease, the needs of parents with minor children, as well as the needs of their children, in order to help the adaptation to the serious illness from one of their parents, and detect and treat if necessary, cases of psychological vulnerability that can develop psychopathology symptoms.
Venous thromboembolism as a relevant toxicity in cancer patients treated in phase I studies.
Authors: Mandala Mario , Grosso Federica , Vitalini Cristina , Corradino Irene , Labianca Roberto , Colombini Sonia , Sanfilippo Roberta , De Pascale Antonella , Marsoni Silvia
Published: March 2020

e19549

Background: To investigate the risk factors and the relevance of venous thromboembolism (VTE) among the reported toxicities in advanced cancer patients treated in phase I studies. Methods: Patients enrolled and treated in phase I studies conducted by SENDO (Southern Europe New Drugs Organization) Foundation between 2000 and 2010 in 15 experimental centres were considered for the study. Clinical data, including adverse events, were prospectively collected during the studies and retrospectively pooled for VTE analysis. Results: Data of 1,415 pts were considered for analysis. 526 (37.2%) patients were males, median age was 57.3 years (range: 13-85). 85% of patients had metastatic disease, while the remaining had locally advanced irresectable disease. For 706 (49.9%) of the patients the study treatment was with cytotoxic agent(s) only, for 314 with target therapy(ies) only, while the remaining patients received a target therapy in combination with a cytotoxic drug. 56 (3.96%) patients who developed a VTE, almost all (89.3%) during the course of treatment, the remaining during the follow-up. At multivariate analysis gynecologic (HR: 2.7, p< 0.012; 95% CI: 1.241 - 5.889) and gastrointestinal tumors (HR 3.32, p< 0.019; 95% CI: 1.22 - 9.08) as well as cytotoxic plus antiangiogenic agents (HR 2.5, p< 0.038; 95% CI: 1.05 - 5.96) were statistically correlated with VTE development. The adverse events were the main reason for discontinuation in 230 pts. VTE was the fourth most common cause of drug discontinuation among this subgroup of patients. The median time from first drug administration to discontinuation was 1.4 for VTE and 2.3 months for the other AEs, respectively (p=0.02) Conclusions: VTE is a relatively common complication among patients treated in the context of phase I studies and may influence the early drug discontinuation. Tumour site and the combination of chemotherapy and antiangiogenic therapy predict VTE development.
Attitudes regarding informing clinical study result to participants in Japan.
Authors: Miki Izumi , Sato Keiko , Nakahama Hiroko , Katsumata Noriyuki , Watanabe Toru
Published: March 2020

e19557

Background: Informing the participants about study result is increased demand in recent years. Some studies reported that almost all participants want to receive study result. However, how much information do participants want and how do researcher offer were not mentioned. Moreover there were concerned about resource for providing study result and the attitude regarding informing result to participants in Japan was not studied. The purpose of this study was aimed to discuss and propose the way of informing study results to Japanese participants. Methods: Summarizing study result and a self-administrated questionnaire survey were conducted. Summary was created from abstract of academic paper with lay language and illustration using color. Objective study was Oral Uracil and Tegafur Compared With Classic Cyclophosphamide, Methotrexate, Fluorouracil As Postoperative Chemotherapy in Patients With Node-Negative, High-Risk Breast Cancer: National Surgical Adjuvant Study for Breast Cancer 01 Trial “N-SAS-BC01 trial”(J Clin Oncol 2009). Objective subject was participants of N-SAS-BC01 trial in National Cancer Center Hospital. A cross table and inductive analyze were performed. Results: Summary of result was made A4 (letter size) form 4sheet. 58 patients responded to questionnaire of 116 patients (50%). In 58 responders, 92% of them preferred to be informed of the result. About 80% of responders answered that summary was clear to understand and 30% of them reported that the document should contain more information. The way of receive result preferred by the mail. When the result included bad news, 67% of responders wanted to receive result; on the other hand, three patients answered that they would not to receive because of psychological harmful influence. Conclusions: These answers suggested that participants in Japan desired to inform study result. Therefore, Clinical study result should be provided participants whenever it takes time to get results, including bad news in a careful way. Summary of result should be created using lay language and illustration. Planning the cost, keeping participant contact list, and noticing participants that study result would be informed were needed at the start of the study.
Treatment of patients with chemotherapy-induced PPE using a prevention ointment containing high concentrations of antioxidants.
Authors: Lademann Juergen , Martschick Anja , Darvin Maxim E. , Kluschke Franziska , Zastrow Leonhard , Chekerov Radoslav , Sehouli Jalid
Published: March 2020

e19558

Background: The palmar-plantar erythrodysesthesia syndrome (PPE) is a cutaneous side effect often observed in patients under chemotherapy, e.g., with pegylated liposomal doxorubicin. This side effect entails a reduction in the antioxidative potential of the skin due to intensive radical formation. Recently, it was demonstrated that topical treatment of patients with an ointment containing high concentrations of antioxidants is an efficient prevention strategy against PPE when applied before the beginning of chemotherapy. In a 5-year observation period at the Department of Dermatology of the Charité we selected patients, who had developed a PPE during treatment with a variety of chemotherapeutics. The aim of the present study was to investigate whether the antioxidant containing ointment is also suited to treat PPE, which occurred during treatment of 13 types of cancer with chemotherapeutics besides doxorubicin. Methods: In 5 years, 68 patients having developed PPE during treatment with 12 different chemotherapeutics, including pegylated liposomal doxorubicin, capecitabin and sorafenib applied an ointment containing antioxidants with a high radical protection factor (RPF). 46 patients exhibited PPE grade III and 22 patients PPE grade II. All patients were treated with the antioxidant-containing ointment, which was applied at least twice daily in the palmar and plantar regions. Results: Treatment with the antioxidant-containing ointment resulted in a distinct regression or disappearance of PPE. After 4 weeks of treatment the PPE grade III originally diagnosed in 46 patients had reduced to grade II in 6 and to grade I in 33 patients. In 7 patients the PPE had completely disappeared. The PPE grade II diagnosed in 22 patients had alleviated to grade I in 7, and completely disappeared in 15 patients. Conclusions: Obviously, cutaneous side effects entailing radical formation processes are also induced by other types of chemotherapeutics. An antioxidant containing ointment with high RPF is not only suited to prevent PPE in patients under doxorubicin therapy, but is also effective in treating PPE caused by other chemotherapeutics.
Triiodothyronine [T3]-induced hypothyroxinemia: Response and survival in a compassionate care cancer patient population.
Authors: Hercbergs Aleck A , Garfield David H. , Ashur-Fabian Osnat
Published: March 2020

e19573

Background: Increased survival under chemically induced hypothyroidism has been reported in cancer patients with poor prognosis, but the associated morbidity can deter patient compliance. Acting via a receptor site upon the plasma membrane avβ3 integrin, L-thyroxine (T4) in physiological concentrations non-genomically activates mitogenesis and neo-angiogenesis of cancer cells and proliferating vascular endothelium. Occlusion of the receptor by tetraiodothyroacetic acid (tetrac), a T4 derivative, induces apoptosis, inhibits angiogenesis and enhances chemotherapy and radiation. 3, 5, 3’-Triiodo-L-thyronine (T3) in physiological concentrations is significantly less mitogenic than T4 and inhibits pituitary release of thyrotropin (TSH). Absence of TSH, but with T3 support, depletes circulating T4 without resultant hypothyroidism. Methods: 21 cancer patients at dispersed clinical sites with stage 4 solid tumors and projected limited survival received T3 [n=10] only or with methimazole (MT) [n=9]. Serum TSH, free T4 (FT4) and T3 concentrations were obtained initially, then monthly. FT4 levels below lower normal range were achieved in all patients within 3 to 12 weeks. Results: See Table. Conclusions: T3 treatment with resultant hypothyroxinemia in poor prognosis cancer patients was associated with favorable response rates in 17/19 subjects. Two others with aggressive tumors had extended survival on long-term T3. [Table: see text] [Table: see text] [Table: see text]
Improvement of pharmacokinetic, pharmacodynamic and thrombopoietic activities of human interleukin-11 mutein by PEGylation.
Authors: Ho Seong-Hyun , Yu Seung Shin , Kim Jong-Mook , Kim Sunyoung , Ma Suyong , Kim Dong-Sik , Lee Hwang-Jae
Published: March 2020

e19574

Background: Chemical modification of recombinant human interleukin-11 (rhIL-11) by polyethylene glycol improved the pharmacokinetics (PK), but not remaining biological activity. Human interleukin-11 mutein (mIL-11) has been shown the improved safety and equivalent efficacy at one-third of the clinical dose of rhIL-11 in chemotherapy-induced thrombocytopenia (CIT) patients. Methods: To evaluate whether PEGylated mIL-11 (PEG-mIL-11) could reduce the toxicity and the frequency of administration without compromising biological activities, comparative preclinical studies on PEG-mIL-11 and mIL-11 in normal and myelosuppressed animals were performed. Results: In vitro biological assay showed that the ED50 value of purified mono-PEG-mIL11 was comparable to that of mIL-11. The PK parameters such as AUC of PEG-mIL-11 were at least 4-fold larger than those of mIL-11 at the same dosage. The thrombopoietic activity resulting from a single PEG-mIL-11 administration was almost similar to that achieved from multiple administrations of mIL-11 in normal rodents and monkeys. In myelosuppressed model, PEG-mIL-11 was s.c. administered twice at doses of 200, 420 or 900 μg/kg and the platelet number of each group was compared with that of control group injected with 200 μg/kg of mIL-11 once daily for 9 days. The high dose group of PEG-mIL-11 showed 2-fold increase in the nadir platelet count and the mean time to platelet recovery of PEG-mIL-11 groups was shortened up to a maximum of 7 days as compared with mIL-11 or untreated group. PEG-mIL-11 also significantly prevented the reduction of WBC and RBC counts which was considered a major hematological AE of chemotherapy and radiotherapy for cancer as compared with mIL-11 or naïve group. Conclusions: These results suggest that the PEG-mIL-11 show improved PK profile without compromising biological activities and prevent CIT more effectively with better safety profile than mIL-11.
Aprepitant in multiple-day cisplatin-based chemotherapy.
Authors: Ouellette Freve Johann-Francois , Soulieres Denis , Blais Normand , LeTarte Nathalie
Published: March 2020

e19591

Background: Aprepitant is a NK-1 inhibitor approved in combination with serotonin antagonists and dexamethasone (Dex) for highly and moderately emetogenic chemotherapy. Antiemetic regimens for multiple-day chemotherapy are not standard and guidelines recommend serotonin antagonists and Dex for each day of chemotherapy and for following days. Studies with aprepitant in that setting are ongoing. In our center, aprepitant use with multiple-day chemotherapy was prescribed at the physician’s discretion. Methods: We did a retrospective study of the use of aprepitant with cisplatin-based multiple-day chemotherapy (CBMDC) regimens from November 2008 to November 2011. Pharmacy files were used to identify patients that received at least one dose of CBMDC. Data was extracted from pharmacy and medical records. Objectives included efficacy (complete response (CR), absence of nausea and vomiting, change in antiemetics) and safety of different regimens. Results: During the study period, 39 patients (34 men) received CBMDC, mostly BEP for testicular cancer. Three patients also received second-line treatment. Patients received BEP (93%), ICE (2%), or TIP (5%) chemotherapy. Eleven patients received 3-day aprepitant, 15 patients 5-day aprepitant and 16 patients did not receive aprepitant at all as primary prophylaxis. Patients were older in the 3-day group. CR was 1% in the 3 day-group, 64% in the 5-day group and 36% in the control group (p=0,08). There was a trend that nausea and vomiting were reported more frequently in the 3-day group. In 4 patients, aprepitant was added for days 4 and 5 in subsequent cycles with better control. Rescue medication was used in 100% of patients receiving the 3-day regimen, 36% in patients receiving the 5-day regimen and 64% of patients not receiving aprepitant. Three patients receiving 5-day aprepitant had to further decrease their Dex dose for adverse events (insomnia, emotional lability, pyrosis, acne). No severe adverse events were reported with the 5-day use of aprepitant. Conclusions: Even within a small population, five-day aprepitant is effective in inducing CR, reducing vomiting and is safe in patients receiving CBMDC. It has been chosen as a standard treatment in our patients.
Effects of cancer therapy on sexuality and quality of life (QoL) of patients with gynecologic malignancies (GM): Results from 55 pts.
Authors: Pilger Adak , Richter Rolf , Fotopoulou Christina , Beteta Carmen Rosa , Ismaeel Fakher , Sehouli Jalid
Published: March 2020

e19597

Background: Sexuality is a crucial issue influenced by social norms, shame and moral taboos and is generally not discussed in the clinical day and research community. Aim of our study was to systematically evaluate the sexual function and quality of life of cancer pts after operative and systemic treatment in GM. Methods: We assessed in a prospective setting sexual function and quality of life aspects of patients with histological proven GM after completed treatment. Validated questionnaires about sexuality (Female Sexual Function Index 19 items), quality of life (SF-12) as well an additional semi-structured questionnaire consisting of 20 items were answered by all pts at the earliest 3 months after end of treatment during cancer care follow up visit. Results: Overall 55 pts with median age 61 (range, 22-74) were evaluated including 54% ovarian, 26% breast, 13% cervical cancer, 2% endometrial- and 6% vulvar cancer pts. Overall 32.7% (n=18) of the pts stated that they have sexual problems. Based on the FSFI (<26.5) more pts (58.2%) presented sexual problems. The main reasons for an impaired sexuality were a subjective lost of attractiveness (45%; n=9); vaginal dryness (25%; n=5) followed by fear of injury (20%; n=4). 36.4% (n=20) described a change of sexuality after cancer therapy, 8 pts stated positive, 12 pts negative changes. 40% of the pts stated that they have not searched for information about sexual aspects during or after cancer therapy while 25% of the pts have asked their physicians. Patients who lived in a partnership had higher SF12 scores than singles but not different global QoL-scores. Multivariate analysis revealed ovarian, endometrial, and vulvar cancer but not age, disease stage and presence of partner to negatively affect sexual function . SF12 evaluation showed significantly higher psychological functionality with increasing age. Impaired sexuality was always associated with lower scores in SF12. Conclusions: There is a high need of sexual function assessment after cancer treatment of GM patients using validated questionnaires. Only few pts have access to information about sexuality. Strategies are warranted to improve the discussion about this relevant topic.
Burnout in the Irish oncology community: Results of a single-institution study.
Authors: Smyth Lillian , Lavelle Aonghus , Salman Reem , Lucey James , McCaffrey John , Maher Michael A. , Gallagher David James
Published: March 2020

e19601

Background: Several European studies suggest that healthcare professionals working in oncology display higher levels of professional burnout than their colleagues from non-oncology units. We aimed to identify the level of burnout of professionals working in cancer care at a single institution in Dublin, Ireland. Methods: 143 oncology staff members were emailed a 3 section questionaire. We employed the Maslach Burnout Inventory, a validated, burnout-specific instrument, incorporating a three-dimensional assessment of the syndrome through its subscales: emotional exhaustion (EE), depersonalization (DP) and personal achievment (PA). Sociodemographic, protective and predisposing variables were identified in tandem, while the final section afforded respondents an opportunity to speculate on workplace stressors and their potential remediation. The primary endpoint was overall high burnout. Secondary endpoints were mean scores for each individual category. Wilcoxon rank sum and Kruskal-Wallis tests were performed on SPSS version 18. Results: The overall response rate was 41.3% (59/143) (see table). Three respondents (5.1%) reported high levels of burnout in all 3 categories. In subcategory analysis, men had significantly higher mean DP scores [9, SD: 6.03] than women [5.3,SD: 4.46](p < .05) and residents had significantly higher DP scores [8.11,SD: 4.46] than attendings [4.14,SD: 3.2]( p < .05). Regression analysis, found that being male was a significant predictor for high levels of depersonalization but found no predictor for EE or PA. Conclusions: We identified low levels of burnout among Irish cancer care professional. Protective factors such as age <35yrs (66%), religion (68%), hobbies (86%),working <50 hours (66%) and being in a relationship (74%) were at high levels, which may have biased our results. A national expansion and comparison with international figures is planned and will be presented at ASCO. [Table: see text]
Clinical and sociodemographic data of cancer patients seeking out-patient based psycho-oncological psychotherapy.
Authors: Panse Jens Peter , Athanatou Evangelia , Kayser Clarissa , Simon Marike Anna , Singer Susanne , Brummendorf Tim H. , Petermann-Meyer Andrea
Published: March 2020

e19610

Background: Although there is a defined need for out-patient psychosocial care for cancer patients, data about out-patient psycho-oncological health care services and patients’ usage of ambulatory infrastructure outside certified cancer centres are scarce. Methods: We retrospectively analyzed charts and treatment protocols from 1,369 patients treated between 1998 and 2009 in a psycho-oncology (PO) practice retrieving socio-demographic and cancer-specific data plus data regarding PO intervention. Results: Of 1,180 patients analysed so far, 808 were documented cancer patients and 372 were relatives or friends of cancer patients. Median age of cancer patients was 50 (range 21-81) years, the majority being female (91%). Although PO interventions are not generally covered by most health care insurances in Germany, 87.7% of patients had public health insurance and only 12.7% had private insurance. 62,5% of patients (n=505) were diagnosed with breast cancer, followed by colorectal cancer (n=46), ovarian cancer (n=42), leukemia/lymphoma (n=38) and lung cancer (n=34), although all types of malignancies were represented. 60.1% received curative and 20.3% palliative treatment, while 19.6% could not specify their treatment intention. 503/663 (n=186 not specified) patients had at least one child with 39.5% being less than 18 years of age. 75.9% (176/232) had received high school education, and 37.1% (151/407) were actively working, while 40.3% (164/407) were incapable of work or on retirement pay (22.6%, 92/407). Half of the patients (50.2%) were Aachen residents, while the other half resided within a 50 km radius. Median number of therapy sessions was 12 (range 1-97). Other treatment specific aspects are still being analysed and will be presented at the meeting. Conclusions: Despite the clear demand for all cancer patients, the majority of cancer patients actively seeking out-patient psycho-oncological support are women with breast cancer, while men and other cancer subtypes are clearly underrepresented. Better information, optimized resources, allocation strategies and comprehensive coverage of PO services are needed in order to address more cancer patients with psycho-social distress.
Effectiveness of complete decongestive therapy (CDT) in managing secondary lymphedema after modified radical mastectomy (MRM).
Authors: Jain Kunal , Dhinakaran Mullai , Benjamin Kamlakshi Esther
Published: March 2020

e19622

Background: Lymphedema of ipsilateral arm is one of the common complications seen after MRM with varying incidence reported in literature ranging from 5% to 56%. Several therapeutic interventions exist to treat this potentially distressing and disabling condition, but no consensus regarding definitive treatment of lymphedema has been reached. Methods: We conducted a single centre, prospective pilot study in patients with secondary lymphedema developed after treatment of breast cancer. These subjects were selected according to predefined criteria with duly signed consent form, from Outpatient Department of Physiotherapy, Christian Medical College and Hospital, Ludhiana. Lymphedema assessment with limb volume measurement was done using modified truncated cone method. A daily intervention program of CDT was implemented consisting of education about skin care, manual lymph drainage techniques, compression garments and exercise for 45 minutes per day for 10 days. The patients were assessed at baseline and on 10th day. During this10 day supervised therapy in the hospital, patients were also trained to continue this therapy at home. Results: Fifteen patients have been enrolled prospectively in this study between March 2011 and December 2011. The mean age at presentation was 43.5 yrs (range 35-58 yrs). All patients underwent MRM and the mean duration of presentation from the time of MRM to development of lymphedema was 12.5 months (3-24 months). The mean pre-treatment volumes of normal and affected arms were 332.47mL (240-425mL) and 416.62mL (277.6-535.5 mL) respectively (p=0.004). Mean post treatment volume of affected limb at the end of 10th day was 329.93mL (249-400mL) showing an absolute reduction in mean volume of affected arm by 86.69 mL (p=0.02). Conclusions: Complete decongestive therapy was helpful in significant reduction of secondary lymphedema after MRM in this small patient group. These findings need to be verified in a larger sample size comparing other modalities used in managing lymphedema. CDT needs to be tested in early post-operative setting to assess its role in decreasing incidence of lymphedema after MRM.
The role of intensive care in the changing paradigm of modern cancer care.
Authors: Connell Louise Catherine , Othman Fauzi , McCaffrey John , Carney Desmond , Marsh Brian , Kelly Catherine Margaret
Published: March 2020

e19632

Background: Many metastatic cancers are now treated like a chronic disease. Expanding treatment options, increasing age; varying co-morbid illness; and improving cancer-specific survival mean that decisions regarding the timeliness and appropriateness of transfer to the Intensive Care Unit (ICU) are complex. We sought to examine the clinical, demographic and outcome characteristics of oncology/haematology patients transferred to ICU at a large academic teaching hospital. Methods: Data was extracted from a prospectively maintained database for all patients with documented malignancy admitted to ICU between September 2009 & December 2011.Clinicopathological variables examined included; cancer type; tumour stage; time from diagnosis; age; co-morbidities; and treatment history. The Sequential Organ Failure Assessment (SOFA), an ICU-specific scoring system, was reviewed for each patient. We report 30 day and 6-month mortality. Results: A total of 52 patients have been analysed to date. The common cancer types were well represented; breast (11.5%), colorectal (11.5%), lung (11.5%) and acute leukaemia (19.2%). Mean age at time of ICU admission was 60 years (range 29-82). The maximum number of prior lines of chemotherapy (CT) was 5 (range 0-5). Approximately 50% of patients had metastatic disease at time of ICU admission. The most frequent reasons for admission were sepsis (n=16, 31%) and respiratory distress (n=15, 29 %). Use of mechanical ventilation, vasopressors and renal dialysis was 51.9%, 61.5% & 21.1% respectively. Four patients (7.7 %) received CT in the ICU setting. ICU-specific mortality was 28.8% (n=15).Thirty-day and 6-month mortality rates were 38.5% & 61.5% respectively. Conclusions: A significant proportion of patients admitted to ICU had advanced disease and had received multiple lines of CT previously. The ICU-specific mortality rate was lower than expected at 28.8% and may reflect stringent selection criteria. Patients transferred tended to have had long periods of disease remission/stabilisation or had a new diagnosis of malignancy with unknown CT sensitivity status. Analysis of patient selection at ward level is on-going and will identify other factors influencing ICU transfer decisions.
Pain assessment behavioral scale in agonic cancer patients: Experience in total care—An end-of-life care home service.
Authors: Alfaro Maricarmen , Baldeos Raquel , Rosales Beatriz , Berenguel Maria , Aguilar Alfredo
Published: March 2020

e19636

Background: Assessing pain in nonverbal, especially agonic cancer patients is a great challenge. In the absence of self-report, measurement of pain could be difficult and patient`s behavior could be useful. The aim of this work was to evaluate the Pain Assessment Behavioral Scale (PABS) in cancer agonic patients. Methods: PABS scale was used to evaluate 118 cancer patients enter in agony. Pain levels was categorized according to PABS score in Mild Pain (score 1-3), Moderate Pain (score 4-5), Severe Pain (score>6). We correlated levels of pain with age, sex, cancer metastatic site or active tumor localization with the ANOVA, Chi square or Fisher tests when were appropriated. A P<0.05 was considered significant. Results: Fifty two patients (44.1%) were male and 66 female (55.9%). The median age was 74 (Standar Deviation [SD]:13.1; Range: 30-94). Most frequent primary tumors were colorectal (16%), lung (11%), Pancreas (9.3%), Breast (8.5%), lymphomas (6.8%), prostate (6.8%) and gastric (5.6%) cancer. Involvement of primary active tumor or active metastases was present in lung (22%), Central Nervous System (CNS) (13.6%), liver (22%), and bone (7.6%). The median of PABS score was 5 (SD=1.25; range: 2 – 8). Seven cases had mild pain (5.9%), 105 moderate pain (89%) and 6 severe pain (5.1%). There was no correlation of pain levels with age (P=0.420), sex (P=0.098), active tumor or metastatic involvement of lung (P=0.321), CNS (P=0.972), Liver (P=0.575) or bone (P=0.529). Conclusions: In our experience, PABS scale is a useful tool to evaluate pain in agony cancer patients. We found no correlation between active tumor or metastatic localization with the intensity of pain.
Febrile neutropenia in hematologic malignancies: Validation of a model to select patients manageable in the outpatient setting safely.
Authors: Bains Sarina , Goy Andre , Fuchs Barry , Gadaleta Gabriella , Singavi Arun , Hurtubise Brenda , Sebti Rani , Feldman Tatyana , Goldberg Stuart , Pecora Andrew , Mato Anthony R.
Published: March 2020

e19641

Background: Febrile neutropenia (FN) is usually treated in an inpatient setting with empiric IV antibiotics. Accurate identification of low-risk hematologic malignancy (HM) pts (highest risk for life-threatening events) appropriate for outpatient management may reduce healthcare costs without impacting outcomes adversely. Prior studies using predictive models to identify low risk FN pts have not been validated in HM pts. Aim: To identify low risk HM pts as candidates for safe outpatient management. Methods: To determine parameters associated with an uncomplicated FN course in HM pts we tested the association between Talcott’s criteria (Talcott et al JCO Oct 2011) and additional candidate risk factors with the development of a medical event (ME) requiring urgent intervention. We conducted a retrospective cohort study of stable HM pts, admitted for FN management. Utilizing Cox regression, we examined the following factors: Talcott criteria, age, insurance status, prophylactic G-CSF/antibiotics, vitals signs and organ function. Results: We identified 97 consecutively admitted pts who met eligibility criteria of whom 27 pts developed a ME during the admission (validated by 2 investigators blinded to exposure status). In univariate analysis, Talcott’s criteria successfully identified pts at low risk for developing a ME (HR .4, p=.04 CI .17-.97). Additionally a preserved DPB (>65 mmHg) was also protective (HR .22 p<.01 CI .11-.51). Talcott’s criteria and DBP remained independent predictors of uncomplicated FN in a multivariate cox regression (AUROC curve=75%). Conclusions: This study provides support for the use of Talcott’s criteria in HM pts. The addition of DBP to Talcott’s model further improves its ability to identify low risk HM pts. Once prospectively validated, this approach may have important clinical and financial implications. [Table: see text]