bluuebunny/crossref_metadata_2025 huggingface dataset:
Cancer survivors’ challenges with ostomy appliances and self-management.
Authors: Sun Virginia , Bojorquez Octavio , Raza Sabreen , Grant Marcia , Hornbrook Mark C , Krouse Robert S.
Published: May 2019

e23091

Background: Ostomies adversely affect health-related quality of life among cancer survivors. Survivors and their families must engage in ostomy self-management, make substantial behavior changes, and adjust to the consequences of their condition. We explored long-term cancer survivors’ challenges with ostomy appliances and ostomy self-management. Methods: Pooled qualitative data from two studies were used. These included 1) written responses from long-term (≥5 years) rectal cancer survivors describing their greatest challenges with ostomy appliances and associated repercussions; and 2) intervention session notes and greatest challenge responses from an ongoing RCT of a telehealth intervention with ostomy survivors. Using content analysis, several coauthors reviewed all responses related to ostomy wafers/appliances and self-management techniques, and coded each by theme. The themes were reviewed and agreed upon by the research team. Counts were tallied for each theme based on the number of times they were mentioned by respondents. Results: Eight themes emerged: bleeding, pain, leakage, skin problems/irritation/rash, wafer-related issues, materials getting under the wafer, time needed to care for ostomy, and solutions to clean the stoma. Collectively, the eight themes were mentioned 106 times by respondents. Overall, the most commonly mentioned ostomy appliance problem was leakage (27%), followed by skin problems (20%), and pain (14%). For these common problems, respondents described challenges with successfully fitting the wafer to prevent leakages, poor wafer adherence to the skin area surrounding the stoma, allergic reactions to adhesives, and painful sores around the stoma site. Respondents described how their anxiety related to leakage, odor, and/or skin irritation greatly inhibited their social activities and self-confidence with ostomy self-management. Conclusions: Cancer survivors living with an ostomy experience multiple obstacles with ostomy appliances and self-management. These obstacles undermine their ability to gain confidence in caring for their ostomy. Interventions to improve self-management and self-efficacy may ease the psychological and social burden of living with an ostomy.
Incidence of Infection-related mortality in cancer patients: Trend and survival analysis.
Authors: Elfaituri Muhammed Khaled , Morsy Sara , Tawfik Gehad Mohamed , Abdelaal Abdelaziz , El-Qushayri Amr Ehab , Faraj Hazem Abdelkarem , Hieu Truong Hong , Huy Nguyen Tien
Published: May 2019

e23095

Background: Infectious diseases are the second leading cause of death in the field of oncology. Around 60% of deaths are infection related to cancer patients, especially with underlying hematological malignancies. This study assesses the changing trends of mortality in cancer patients from infectious causes in the past 40 years. Methods: This is a retrospective analysis on 151440 cancer patients who died from infectious causes between 1973 and 2014, identified in the Surveillance, Epidemiology, and End Results (SEER) Program database. Results: Pneumonia and influenza were the most common infections (n = 72133) followed by parasitic diseases and other infections (n = 47310) and septicemia (n = 31119), respectively. The average survival was 65.31 months, while pneumonia and influenza had the highest survival of all. Prostate cancer was the most common cancer associated with infectious diseases (n = 20068) followed by breast cancer (n = 16676) and Kaposi sarcoma (n = 13046), respectively. During 1998-2001, an overshoot in infection-related mortality was significantly noted (APC = 26.74%; 95%CI = 3.7:54.9). However, since 1973, the greatest reduction in infection-related mortality was recorded during 2012-2014 (APC = -37.15; 95%CI = -48.6: -23.2). Compared to other infectious diseases, ‘parasitic and other infections including HIV’ accounted for the highest incidence (SIR = 1.77; 95% CI = 1.69:1.84), where blood vessel tumors occurred the most in this category (SIR = 88.83; 95%CI = 2.25:494.9). Afterward, septicemia was the second most common infectious disease (SIR = 0.84; 95%CI = 0.81:0.88). Except for leukemia, lymphoma, plasma cell tumors, and mast cell tumors, hematologic tumors revealed the highest incidence of septicemia (SIR = 51.9; 95%CI = 1.31:289.16). Gender, race, marital status, an infectious organism, and tumor characteristics (behavior and grade); all accounted for significant differences in survival (P < 0.0001). The nomogram has outstanding discrimination ability (c-index = 0.85) with very minimal differences from the actual observations of 1-, 3-, and 5-year survival probabilities. Conclusions: Infection-related mortality in cancer patients declined from 1973 to 2014. The most common infections in cancer patients were Pneumonia and influenza, followed by parasitic diseases, other infections, and septicemia. Prostate cancer was the most common cancer associated with infectious diseases, followed by breast cancer and Kaposi sarcoma.
Investigation of the efficacy of imidazolyl ethanamide pentandioic acid (IEPA) to reduce chemotherapy-induced myelosuppression (CIM) in breast cancer patients.
Authors: Mayer Frank , Pleimes Dirk , Schmidt Marcus , Fasching Peter A. , Jackisch Christian , Flunkert Kathrin , Asang Corinna , Razoux Florence , Moebus Volker
Published: May 2019

e23098

Background: Neutropenia is a major toxicity of myelosuppressive chemotherapy (CTX). Treatment and prophylaxis of CTX-induced neutropenia with granulocyte colony-stimulating factors is mainly recommended in patients with high risk of febrile neutropenia. IEPA, a hemoprotective small molecule for oral use, may constitute a safe alternative. The main objective of the study was to assess the efficacy of IEPA in reducing CIM in breast cancer patients. Methods: Randomized, double-blind, placebo-controlled, parallel group study in female adults diagnosed with invasive breast cancer receiving epirubicin/cyclophosphamide CTX. Patients took one tablet daily of IEPA 100 mg or placebo starting 5 days prior to the first CTX cycle until 3 days prior to the second CTX cycle. Two batches of study medication were used sequentially in the study. Hematologic and other variables were tightly measured during the first CTX cycle. Results: After no significant treatment effect was observed in the total study results, post-hoc analyses revealed a significant batch effect. Treatment with Batch 1 IEPA was superior to placebo in treating CIM (Table). Conclusions: Although the presence of a batch effect precludes final conclusions and calls for a formulation optimization of the compound, the efficacy of Batch 1 IEPA in reducing CIM consistent with prior non-clinical and clinical studies invites further investigation of the hemoprotective properties of IEPA. Area over the curve (AOC) integrates extent and duration of decreased absolute neutrophil counts [(ANC/nL)*days] below thresholds corresponding to grade 1 (ANC < 2.0x10^9/L) and 3 neutropenia (ANC < 1.0x10^9/L); CI: confidence interval; LS: least squares; DN3: duration of grade 3 neutropenia in [days]. Clinical trial information: NCT02692742. [Table: see text]
Acupuncture: Real-world patient-reported outcomes of treatment-related symptoms in breast cancer survivors.
Authors: Zayas Jacqueline , Ruddy Kathryn Jean , Olson Janet E. , Couch Fergus , Bauer Brent , Mallory Molly , Yang Ping , Zahrieh David , Loprinzi Charles L. , Cathcart-Rake Elizabeth Jane
Published: May 2019

e23111

Background: Acupuncture has been shown to reduce aromatase inhibitor-induced arthralgias, as well as possibly hot flashes and fatigue, but research has been limited. The purpose of this study was to evaluate real world perceived benefit of acupuncture for commonly experienced symptoms among breast cancer survivors. Methods: Breast cancer survivors who had used acupuncture for cancer- or treatment-related symptoms were identified using an ongoing prospective Mayo Clinic Breast Disease Registry (MCBDR) cohort. In addition, Mayo Clinic electronic health records (EHR) were queried to identify additional participants. All identified patients were mailed a survey with acupuncture-related questions. Respondents were also asked to recall their severity of arthralgia, myalgia, post-surgical pain, hot flashes, nausea/vomiting, fatigue, depression, anxiety, insomnia, lymphedema, headache, and neuropathy from 1 to 5 (1 = mild, 5 = severe) before and after acupuncture treatment. Results: Acupuncture use was reported among 413 participants in MCBDR (12% of all enrollees) and 73 patients were identified in the Mayo EHR. 241 eligible women returned surveys (median age at diagnosis 50 yrs). Mean symptom severity scores decreased from before to after acupuncture by at least 1 point for all queried symptoms (Table). Conclusions: Acupuncture is frequently used by patients for a variety of breast cancer-related symptoms. Those who do pursue acupuncture usually perceive few toxicities and substantial benefits. Cost may be a barrier to treatment for some. [Table: see text]
Association of the quality of psychosocial support and quality of life in patients with chronic oncological pain.
Authors: Gonzalez-Guerrero Juan Francisco , Alcorta-Garza Antonia Gloria , Alcorta-Nuñez Fernando , Melgoza-Alcorta Emma María , Gonzalez-Rodriguez Melany , Gonzalez-Alcorta Celia Beatriz , Alcorta-Garza Adelina
Published: May 2019

e23113

Background: Most studies report that tumor related pain occurs between 46% and 92%. The prevalence of pain by clinical stage is 15% in initial stages, 30% in middle stages, 74% in metastatic cancer and, 87% in terminal disease. In the face of chronic diseases such as cancer, patient's relationships with their social networks are affected; among them the interpersonal relationships between the patient and his networks and these towards the patient. With this, the patient’s quality of life is affected. Most of the recent studies on health-related quality of life come from pharmaceutical groups, so it is necessary for other groups to be vigorously involved in the study of the effect of medical interventions on the quality of life, as well as on the impact on health and on the social support of patients with chronic diseases. Methods: In order to obtain the data, validated questionnaires were used as instruments to evaluate the quality of life, measuring psychosocial and health variables, as well as for the detection of the type and quality of psychosocial support perceived by the subjects. The instruments were applied to 207 patients of the Oncology Service of the University Center Against Cancer of the University Hospital “Dr. Jose Eleuterio Gonzalez” in Nuevo Leon, Mexico, during a session of 25 to 30 minutes. Results: Data were collected from 207 patients with chronic oncological pain. The satisfaction index with psychosocial support had a high linear correlation ( r = .640) with the quality of life index. On the other hand, the number of caregivers was not correlated with this last index. Fatigue was the symptom most frequently associated with a decrease in the quality of life index. In addition, pain correlated with all variables except the cognitive index. Conclusions: Satisfaction with the perceived social support is a factor associated with the quality of life in patients with chronic oncological pain; however, the number of caregivers is not. There was no relationship between the size of the network and satisfaction with it. Also, the symptoms associated with chronic oncological pain affect quality of life, identity and social functionality and roles, which in turn impact on the quality of life perceived by patients.
The effect of a structured weekly patient meeting on patient reported outcomes (PRO) and resource utilization for patients with metastatic breast cancer (MBC).
Authors: Rosenzweig Margaret Q. , Resier Victoria , Heckman Rachel , Welch Ann , Ren Dianxu
Published: May 2019

e23116

Background: Women with MBC experience unmet unique symptom management and psychosocial needs due to chronic treatment for an eventually life ending illness. Methods: The MBC Program of Care is a 1 hour weekly, nurse led review of scheduled clinic patients by an interdisciplinary team incorporating structured needs appraisal and referral for supportive, palliative care resources. Outcomes included referral rates to supportive services, patient reported outcomes (PRO) of symptom distress, generalized anxiety and overall well-being. Health care utilization outcomes included clinic calls as well as inpatient and emergency room visits. A prospective, paired pre and post experimental design. One hundred and eighteen women with MBC who visited an urban outpatient breast cancer clinic from September 2016-November 2016 (pre) and from January 2017-March 2017 (post). Validated instruments of symptoms ( Adapted Memorial Symptom Assessment), anxiety (Generalized Anxiety Scale), and overall well-being scores (0-10 Likert) assessed PROs. Electronic chart review evaluated social work and palliative care referrals, hospital admissions, emergency room visits and phone calls to the outpatient clinic pre and post program implementation. T test and chi squared test for paired comparison of mean was performed. Results: Following program implementation, referrals to palliative care (p = .000) and social work (p = .001) increased significantly. PROs of symptoms (p = .001); anxiety (p = 0.002); and overall well-being (p = .002) improved significantly. Health care utilization including emergency department visits (p = .001) and patient calls (p = .005) decreased significantly post program implementation, although hospital admissions increased (p = .003). Cost of program was $750 weekly. Conclusions: Systematic review of patient needs and referral to existing supportive services improved MBC PROs and decreased emergency room visits and clinic calls. Post hospital admission increase may be attributed to MBC disease progression. This is a cost effective MBC model of palliative care implementation.
Implementation of the VA Symptom Assessment Scale (VSAS): Five-year experience.
Authors: Friedman Daphne Ruth , Patil Vikas , Rasmussen Kelli Marie , Sauer Brian C , Kelley Michael J. , Halwani Ahmad Sami
Published: May 2019

e23120

Background: Cancer patients experience symptoms which may precede diagnosis, occur during therapy, and persist into survivorship. Symptom assessments and patient reported outcomes have been shown to improve quality of life and extend survival in cancer patients. The Veterans Administration Symptom Assessment Scale (VSAS) is a clinical tool to document cancer-related symptoms. Here, we report VSAS adoption in five Veterans Health Administration (VHA) hematology-oncology sites during a five-year period. Methods: Data was collected from the Corporate Data Warehouse (CDW): VSAS data, date of birth, gender, race, ethnicity, vital status, year of cancer diagnosis, ICD-O-3, VHA facility, and clinic stop codes. Descriptive analyses of patient demographics, disease characteristics, and VSAS utilization was performed. VSAS is comprised of 13 symptoms, rated on a 0 to 10 scale. A VSAS visit was defined as the date the VSAS was administered to a patient. Results: From January 2013 through June 2018, there were 41,917 instances of VSAS administered to 9,409 unique patients at five VHA facilities: 8,512 (90.5%) were male; 5,241 (56%) were non-Hispanic White, 3,743 (40%) were Black, and 297 (3%) were other racial categories or not available. The median age at the first VSAS visit was 67 years. In patients whose oncologic diagnosis was recorded by a cancer registrar (4,536), the most common diagnoses were prostate cancer, lung cancer (all histologies), colon cancer, and multiple myeloma. The number of VSAS administrations increased annually, from 866 in 2013 to 12,775 in 2017, which may be attributed to increased adoption of VSAS across and within VHA facilities. Individual patients completed the VSAS 1-57 times (median 2). At the five VHA facilities utilizing VSAS in 2017, VSAS was administered at 56% of hematology-oncology clinic visits. Conclusions: VSAS is a tool to measure and document patient symptom burden, and has been successfully adopted in the last five years at select VHA facilities. Expanded use of VSAS throughout the VHA is an important step in improving the quality of life and extending survival of veterans with cancer and blood disorders.
Complementary medicine and cancer: A French multicenter survey.
Authors: Correard Florian , Blanc-léger Françoise , Roux Clarisse , Lobrot Florence , Pinguet Frédéric , Pourrat Xavier , Pourroy Bertrand , Donamaria Catherine , Kopferschmitt Jacques
Published: May 2019

e23127

Background: There have been few reports about Complementary Therapy (TC) use in outpatients who are on active cancer chemotherapy in France. TC may interact with cancer treatments, reduce efficacy, or enhance adverse effects. Methods: This is a cross-sectional survey on TC use in 7 French hospitals (outpatient chemotherapy, conventional hospitalization and medical consultation departments). Eligible patients had to be followed for a cancer and be over 18. Results: 415 patients answered the questionnaire. 54% were female, More than 80% of patients were over 50. 230 patients (55.4%) reported using TCs. TCs were prescribed or recommended for 180 patients. The main TC users were patients with melanoma or other cutaneous cancer (90% of them) and bone and soft tissues sarcomas (86% of them). Most patients used only one TC (52.6%). The most used TCs were Phytotherapy (48%), Homeopathy (40%), supplemental dietary (35%) and aromatherapy (21%). 110 patients (47, 8% of patients with TC) used phytotherapy. The most used plants (≥5% of use) were: Curcuma and its derivative curcumine (13.9%), desmodium (7.4%), thymus (5%). 93 patients used homeopathy (40.4% of patients with TC). Only 48 patients used aromatherapy (20.9% of patients with TCM or 11.6% of the whole population). 81 patients used Supplemental dietary (35.2% of patients with TCM or 19.5% of the whole population). Only 27 patients used oligo-elements (11.7% of patients with TCM or 6.5% of the whole population),). Interestingly, 20% of patients declared to use others TCs (Physical activity, Acupuncture, Somatotherapy, Sophrology, Chinese traditional Medecine, Specific diet, Psychotherapy…). Patient who used TC were mainly under chemotherapy regimen.For each TC, most patients considered that they were useful or very useful. The main reasons for using TCs were “Wellbeing and psychological support” (35.8%), “Clinical symptoms and chemotherapy tolerance improvement” (34.6%) and “Treatment of cancer” (17.7%). Conclusions: To protect cancer patients from the potential hazard of combining their cancer treatment with TCs, patients should systematically be encouraged to report their TC use, while oncologists and pharmacists should be trained on evidence of TC, and patient guidance for a safer TC use.
Depression and health care utilization and costs in patients diagnosed with cancer.
Authors: Steel Jennifer Lynne , Richards Geena , Billiar Timothy , Procopio Judith , Miceli Jessica , Hecht Carol Lynn , Kucinski Barbara , Tsung Allan , Murphy Emily , Marsh J. Wallis , Antoni Michael , Vodovotz Yoram , Layshock Mikhaila , Spring Michael , Pathak Ritambhara , Cheng Hannah , Geller David A.
Published: May 2019

e23128

Background: The aims of this study were to examine the associations between depression and complications, health care utilization and costs in patients with cancer. Methods: Patients diagnosed with cancer were administered a battery of questionnaires, including the Center for Epidemiological Studies-Depression (CES-D) Scale. Health care utilization and costs for patients was collected for one year after the administration of the CES-D. Descriptive statistics, Chi-square and ANOVA, and ordered restricted inference analyses were performed. Results: Of the 100 patients, the mean age was 64.0 years (SD = 10.3), the majority of patients were male (51%), Caucasian (89%), diagnosed with hepatocellular or cholangiocarcinoma (47%) and stage III and IV cancer (60%), and 34% of patients had clinical levels of depressive symptoms (CES-D > 16). No demographic or disease specific variables were associated with depressive symptoms or outcomes. Surgical patients with clinical levels of depression had a greater number of complications [Chi-square = 4.4, p = 0.036] and a greater severity of complications using Clavien-Dindo classification [Chi-square = 4.5, p = 0.033]. Patients undergoing chemotherapy, who reported depressive symptoms in the clinical range, were more likely to require medical intervention for chemotherapy side effects [Chi-square = 4.2, p = 0.04]. Patients with clinical levels of depressive symptoms also had a greater number of emergency room visits [F(1,99) = 8.4, p = 0.005]. Patients who reported clinical levels of depressive symptoms had significantly higher median costs associated with the loss of work force productivity (Median = $7154 versus $2104; p = 0.015), hospital costs (Median = $29,917 versus $8292, p = 0.019), and cost per registration (Median = $3324 versus $1247, p = 0.017) but lower physician costs (Median = $6171 versus $10,821; p = 0.026) than patients with non-clinical levels of depressive symptoms. Conclusions: Depressive symptoms are associated with increased complications and health care utilization and costs. There is an urgent need for effective and scalable interventions to reduce depressive symptoms in patients diagnosed with cancer to improve quality of life and reduce health care utilization and costs.
Efficacy of different TCM treatment techniques combined with standardized step therapy for cancer pain: A network.
Authors: Lv Peng , Li Ya , Zhang Zhenzhu , Shi Fengqin , Hou Li
Published: May 2019

e23131

Background: Comparative study results between the efficacies of traditional Chinese medicine (TCM) therapy with Western medicine therapy in the treatment of cancer pain remain controversial. We use the standardized step treatment as a common control to compare the effectiveness of different Chinese medical methods combined with standardized step therapy for cancer pain using a network meta-analysis. Methods: Randomized controlled trials of the effectiveness of various Chinese medical methods and standardized ladder treatments in PubMed, The Cochrane Library, EmBase, Web of Science, CNKI, VIP, and Wan-Fang databases were searched. Stata14.0 and WinBUGS1.4.3 software were used for statistical analysis. Risk ratio(RR) with their 95% confidence interval were estimated as effect size between treatments. Results: Seventy RCTs were included, a total of 6,936 patients with cancer pain, involving five treatments.The results of network meta-analysis showed that there were significant statistical differences between the four Chinese medical methods combined with standardized step treatment and simple standardized step treatment: Chinese medicine orally combined with standardized step treatment vs simple standardized step treatment: RR = 2.60, 95% CI (2.09, 3.30); Chinese medicine external application combined with standardized ladder treatment vs simple standardized ladder treatment: RR = 2.83, 95% CI (2.31, 3.50); acupuncture physiotherapy combined with standardized ladder treatment vs simple standardized ladder treatment: RR = 3.56, 95% CI (1.92, 7.26); Chinese medicine injection combined with standardized ladder treatment vs simple standardized ladder treatment: RR = 2.22, 95% CI (1.63, 3.05). Conclusions: There are significant statistical differences between different Chinese medical methods combined with standardized step treatment and simple standardized step treatment. For patients with cancer pain, standardized step therapy combined with acupuncture physiotherapy or external application of traditional Chinese medicine can be preferred. Due to the lack of existing research, the conclusions of the study need to be confirmed by high quality RCT.
Delphi consensus on the follow-up of cancer patients with breakthrough pain under opioid treatment.
Authors: Gonzalez Larriba Jose Luis , Cayuela Diego , Fernandez Calvo Ovidio , Garcera Salvador , Molina Raquel , Reina-Zoilo Juan José , Guillem Vicente , Camps Carlos , Feyjoo Margarita
Published: May 2019

e23135

Background: Breakthrough cancer pain (BTcP) is one of the most common symptoms related with the disease and its treatment. Its management differs from that of chronic pain but there is not a wide consensus about fundamental aspects of BTcP definition, diagnosis, follow-up, and management. The objective of this study promoted by ECO Foundation, is to reach a consensus on the follow-up of patients with BTcP under opioid treatment. Methods: This work was conducted using a modified Delphi method organized in two rounds and involving a panel of 84 medical oncologists. A questionnaire of 66 items was developed. The items proposed to reach a consensus included the following topics: 1) When to perform the first and subsequent BTcP treatment evaluations; 2) What to assess at the first follow-up visit and how; and 3) What to assess in the following visits and how. Results: After two rounds, a consensus was reached on 80.3% of the items proposed. The main agreements reached include: The first follow-up visit should preferably be face-to-face; increase the number of visits after detecting poor control of BTcP; assess pain control episodes of BTcP in the first and following visits; adjust treatment dose of opioids due to poor control of BTcP; and adopt measures to prevent aberrant opioid-induced behaviors when treating BTcP in patients with cancer. Conclusions: This Delphi consensus highlights the different points of view of medical oncologists regarding the follow-up of patients with BTcP under opioids treatment. Nonetheless, the conclusions reached can facilitate optimizing monitoring of these patients and promote long-term effectiveness of BTcP control.
Clinical outcomes of manual aspiration thrombectomy for Ilio-femoral venous thrombosis in cancer patients.
Authors: Lee Myung Ah , Kim Eu Hyun , Lee Hae Giu , Oh Jung Suk , Chun Ho Jong , Choi Byung Gil
Published: May 2019

e23145

Background: To determine the outcomes and feasibility of manual aspiration thrombectomy (MAT) for treatment of symptomatic ilio-femoral deep vein thrombosis (IFDVT) in cancer patients. Methods: In this retrospective study, one hundred and thirty-five consecutive patients (56 men; mean age, 63 years; 149 limbs) with acute (n = 113; 83.7%), subacute (n = 14; 10.4%), and chronic (n = 8; 5.9%) symptomatic IFDVT underwent MAT-based endovascular treatment, with adjunctive balloon angioplasty and stent placement performed in 94 patients. Degree of thrombus removal on venography and symptom improvement was assessed for evaluation of technical and clinical success, respectively. Results: Technical success (thrombus removal > 50%) was achieved in 90.4%, and clinical success was observed in 71.5%. The primary patency rates were 88.1%, 81.6%, 76.0%, 74.1% and 69.1% at 1, 3, 6, 12, and 30 months, respectively. Recurrent IFDVT occurred in 19.3% of patients, 0.79 cases per patients-years of follow up. According to the analysis by causes of IFDVT, recurrent rate was 19.3%, 21.2%, and 14.3% in unknown, compression/invasion of the vein by cancerous mass, and May-Thurner syndrome groups, respectively (p = 0.798). No procedure-related complication developed. Conclusions: MAT is a feasible treatment option with favorable outcomes and minimal risk of complication in cancer patients with symptomatic IFDVT.
Is cancer associated thrombosis (CAT) an underestimated issue in oncology clinical practice? Real-world data regarding long term management of CAT.
Authors: Tsoukalas Nikolaos , Bokas Alexandros , Bournakis Evangelos , Christopoulou Athina , Papandreou Christos , Isaakidou Athina , Koumakis Georgios , Samelis Georgios Fotios , Ntokou Anna , Andreadis Charalampos , Kalofonos Haralabos , Aravantinos Gerasimos , Sougleri Maria , Samantas Epaminondas , Makrantonakis Paris , Mauri Davide , Athanasiadis Athanasios , Ziras Nikolaos , Varthalitis Ioannis I. , Boukovinas Ioannis
Published: May 2019

e23150

Background: Cancer is associated with thrombosis due to different pathophysiological processes. CAT is the 2nd cause of death in oncology patients and can occur anytime during the natural history of cancer. CAT is not rare complication, can delay anti-cancer therapy and increase health systems costs. Methods: A prospective observational study (Greek Management of Thrombosis-GMaT) conducted by HeSMO in Greek Oncology units for two years aiming to record clinical practice of CAT management. Patients with active cancer who received CAT treatment or thromboprophylaxis were enrolled after signing informed consent. Results: 546 patients were enrolled from 18 oncology units. Primary cancers were: lung 23.9%, pancreas 13.3%, breast 7.6%, colorectal 8.9%, stomach 8.3%, ovarian 7.6% and other 30.5%. 120 patients received LMWH for Venus Thombo-Embolism (VTE) treatment (Group A) and 426 for thromboprophylaxis (Group B). Group A: 89/120 (74.17%) patients continued in 2nd year and 58.6% received CAT treatment (6.9±4.4 months). Only 2 had VTE recurrence in 2nd year (versus 3 in 1st year). 4/120 (3.33%) had bleeding events (grade 1) in 1st year while no bleeding events occurred in 2nd year. Group B: 345/426 (80.98%) patients continued in 2nd year. 126 (30%) had Khorana score ≥3 and 300 (70%) had Khorana score ≤2. In 2nd year, 123 (35.65%) received thromboprophylaxis (7.3±3.7 months) while 79.4% of them were initially treated with High Thrombotic Treatment Agents (HTTA: e.g. platinum, 5-FU) and 83.1% had metastatic disease. In 2nd year, 52.5% received LMWHs at prophylactic dose and 47.5% at therapeutic dose. Overall, 12 (2.82%) had thrombotic events whereas 4 were recorded in 2nd year. Notably, patients treated with therapeutic doses had lower probability to have a thrombotic event (OR: 5.8, 95% CI: 1.7 to 20.5, p < .05). Six (1.41%) bleeding events (grade 1) occurred in 1st year and one (0.81%) in 2nd year. Conclusions: LMWHs can be used for long term CAT management. Therapeutic LMWHs doses as thromboprophylaxis are safe and effective. Khorana score is a useful model for CAT risk assessment but some other factors such as disease stage and HTTA might be taken into account. CAT can occur anytime during the natural history of cancer. Oncologists should be aware about CAT and its negative influences in patients’ prognosis and quality of life.
Effectiveness and safety of ferric carboxymaltose to treat iron deficiency anemia in cancer patients.
Authors: Aktas Burak Yasin , Kayku Vildan Eda , Aslan Alma , Kertmen Neyran , Dizdar Omer , Yalçin Şuayib , Aksoy Sercan
Published: May 2019

e23153

Background: Most cancer patients are faced with anemia during the disease course. Iron deficiency (ID) is one of the major causes of anemia in cancer patients.Bleeding, malabsorption and organ dysfunction may cause iron deficiency in cancer patients. Anemia may result in a decrease in the patient's performance and delayed chemotherapy. Administration of intravenous (IV) iron is a therapeutic option in cancer patients with iron-deficiency related anemia. In this study we analyzed effectiveness and tolerability of ferric carboxymaltose in cancer patients with iron deficiency anemia Methods: This is a retrospective analysis of 603 cancer patients who were treated with ferric carboxymaltose for anemia and iron-deficiency between October 2014 and April 2017 in a tertiary cancer clinic. Demographic data, cancer diagnoses, pre- and post-treatment hemoglobin levels, pre-treatment ferritin, serum iron, and transferrin saturation (TSA) levels were recorded. Results: The median age of the population was 55 (22-90) years, and 52% were male. Of 603 patients, 47.9% (n = 289) had gastrointestinal malignancies and 17% (n = 103) had breast cancer. A total of 331 patients (55%) received cytotoxic chemotherapy and 272 patients (45%) were not on anti-cancer treatment. Median dose of the ferric carboxymaltose is 1000 mg (500-2000). The median baseline hemoglobin, ferritin and TSA were 10.7 (7-13) g/dl, 28 (2.9-2200) ng/ml and 9.3 (1-19) %, respectively. The median hemoglobin level at the 12th week of treatment was 12.7 g/dl. The median increase in hemoglobin was 2.9 (-0.10-6.9) g/dl in patients whom received cytotoxic chemotherapy. Only 2 patients had allergic reaction during IV ferric carboxymaltose administration and treatment was discontinued. Conclusions: Intravenous-iron improved hemoglobin levels both in actively treated and not-actively treated cancer patients. The effect has been shown in the first 3 months after injection. This approach is safe and tolerable. However, the impact of tumor progression on IV iron replacement is unclear, further studies are required.
Implementation of complex perioperative intervention in older patients with cancer (IMPROVED program).
Authors: Paillaud Elena , Peschaud Frederique , Cudennec Tristan , Caillet Philippe , Gisselbrecht Mathilde , De Decker Laure , De Angelis Nicola , Cattan Pierre , Plaud Benoit , Tournigand Christophe , Aparicio Thomas , Touzet Sandrine , Moszkowicz David , Laurent Marie , Canoui-Poitrine Florence , Brain Etienne
Published: May 2019

TPS11630

Background: Nearly 50% of patients are older than 70 years at diagnosis of digestive cancer. Surgical resection is the first line strategy of treatment. Despite improvement in surgical techniques and development of rehabilitation programs, the rate of postoperative complications remains high. Peri-operative involvement of geriatricians may improve care management older cancer patients. Methods: During a 6 months run-up period (emerging project), we structured a multi-professional network (digestive surgeons, anesthetists, geriatricians, digestive oncologists, epidemiologists), we elaborated a innovative peri-operative geriatric intervention (Improved program) in digestive surgery setting based on evidence-based data. We build a dedicated evaluation plan by determinate the best design for assessing geriatric intervention in this complex context and choose the more appropriate endpoints. Results: We will include 554 patients aged 75 or more with resectable digestive cancer in a stepped wedge cluster randomized trial. The intervention is based on 1/ a preoperative geriatric assessment, focusing on frailty parameters and developing a coordinated program of tailored geriatric interventions 2/ a postoperative shared care with an integrated care model where both surgeon and geriatrician share responsibility for the patient management in surgical ward. This geriatric postoperative management will be focus on prevention and correction of complications, early mobilization, optimal nutritional support. The main endpoint Is is Grade II or higher post-surgical complications rate according Clavien-Dindo classification within 30 days after the surgical procedure. Conclusion: We expected to demonstrate a benefit of a peri-operative shared management model to decrease the risk of post-surgical complications In older patients with digestive cancer.
A randomized trial of a healthy lifestyle intervention versus usual care on chemotherapy and endocrine therapy adherence rate in women with breast cancer: The Lifestyle Exercise and Nutrition Early After Diagnosis (LEANER) Study.
Authors: Sanft Tara B. , Harrigan Maura , Cartmel Brenda , Ferrucci Leah M. , Basen-Engquist Karen , Hershman Dawn L. , Ligibel Jennifer A. , Neuhouser Marian , Chagpar Anees B. , Jones Beth A. , Knobf M. Tish , Silber Andrea , Li Fangyong , Irwin Melinda L.
Published: May 2019

TPS11633

Background: The World Cancer Research Fund and the American Cancer Society provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines. Adoption of recommended lifestyle behaviors soon after diagnosis may prevent adverse changes in body composition, breast cancer biomarkers, and may improve adherence to treatment thereby improving breast cancer prognosis. The Lifestyle, Exercise, and Nutrition Early after Diagnosis (LEANER) study is testing the impact of a healthy lifestyle intervention on chemotherapy completion and endocrine therapy adherence. Secondary endpoints include changes in inflammatory and metabolic biomarkers, body composition, and patient reported outcomes. Methods: Eligible participants are women with stage I-III breast cancer undergoing chemotherapy. 250 participants are being recruited and randomized 1:1 to a yearlong, 16 session, healthy diet and exercise counseling intervention or usual care group. The intervention is delivered in person and/or via telephone by registered dietitians with training in exercise science. Materials include workbooks, videos, cookbooks, fit bits, and home-based exercise equipment. Intervention is focused on graduated goal setting to meet the recommended diet and exercise guidelines for cancer survivors. The primary endpoint, chemotherapy completion rate, is gathered from the Electronic Medical Record and the average Relative Dose Intensity for the originally planned regimen is calculated based on standard formulas. Assessments are completed at baseline, post chemotherapy, 1- and 2- year time points (to assess adherence to endocrine therapy). Body composition is measured using dual energy X-ray absorptiometry, blood samples and patient reported outcomes are collected. At time of submission, 39 women have been randomized. Discussion: If successful, this study has the potential to make healthy lifestyle interventions initiated shortly after diagnosis a standard component of breast cancer treatment. Clinical trial information: NCT03314688.
Impact of a regular exercise program on amount of exercise and QOL metrics in patients on immune therapy.
Authors: Quenelle Nicole Brenna , Bollin Kathryn Blount
Published: May 2019

TPS11636

Background: Studies show physical activity has a positive impact on fatigue and quality of life both during cancer treatment with chemotherapy and radiation and post-treatment (1, 2). There may also be a survival benefit to increasing physical activity both during and after treatment (3). To date there is no published research on the role of exercise in ameliorating the fatigue patients can experience during treatment with immune therapy. Our study proposes to use the existing framework of the LIVESTRONG at the YMCA program to objectively measure improvement in activity level and objective quality of life measurements. Methods: Randomized controlled prospective study evaluating patient participation in LIVESTRONG at YMCA program during active cancer treatment to assess change in minutes per week of self-reported physical activity over 12 weeks. Assessments will be done based on attendance of 12 week program, activity log, functional assessments of physical activity pre- and post- program (6 min walk test, % change in weight, % change in max weight lifted and flexibility), and questionnaires evaluating fatigue (PROMIS 13a FACIT-F), pain (PROMIS pain intensity scale, ASCQ-Me short form), quality of life (FACT-G), Godin Leisure Time Activity Questionnaire, and inflammatory markers (ESR, CRP). Data will be analyzed on an intention-to-treat analysis. A sample size of 100 participants per group will achieve 80% power to detect a 60 minute difference with a standard deviation of 150 minutes 1 and with a significance level (alpha) of 0.050 using a two-sided two-sample t-test. Enrollment is targeted at 108 participants per arm to allow for 8% attrition, 216 total. Secondary endpoints will be assessed at a baseline functional assessment session for all participants and a follow up session after 12 weeks, including administration of questionnaires at both sessions. For physical activity measurements and survey completions, percent change in baseline and completion measurements will be calculated for each patient, then comparison using a chi-square test will be done to determine statistical significance.(Tomlinson et al. Effect of exercise on cancer-related fatigue: a meta-analysis. Am J Phys Med Rehabil. 2014;93:675-686; Irwin et al. Effect of the LIVESTRONG at the YMCA Exercise Program on Physical Activity, Fitness, Quality of Life, and Fatigue in Cancer Survivors. 2016 (published online October 28, 2016); Li T et al. The dose–response effect of physical activity on cancer mortality: findings from 71 prospective cohort studies . Br J Sports Med. 2016;50:339-345).
The CANOPY program: Canakinumab in patients (pts) with non-small cell lung cancer (NSCLC).
Authors: Paz-Ares Luis G. , Garon Edward B. , Ardizzoni Andrea , Barlesi Fabrice , Cho Byoung Chul , Castro Gilberto , De Marchi Pedro , Felip Enriqueta , Goto Yasushi , Greystoke Alastair , Lu Shun , Lim Darren Wan Teck , Papadimitrakopoulou Vassiliki , Reck Martin , Solomon Benjamin J. , Spigel David R. , Tan Daniel Shao-Weng , Thomas Michael , Yang James Chih-Hsin , Johnson Bruce E.
Published: May 2019

TPS9124

Background: Inflammatory pathways can be pro-tumorigenic or anti-tumorigenic. The cytokine interleukin-1β (IL-1β) can promote the infiltration of immunosuppressive cells into the tumor microenvironment leading to a pro-tumorigenic microenvironment that promotes carcinogenesis, tumor invasiveness, and immunosuppression. Canakinumab is a human monoclonal antibody that binds and neutralizes IL-1β. Previous clinical data (CANTOS study) has shown that canakinumab could significantly reduce lung cancer incidence and mortality. This data along with the preclinical results that IL-1β does support tumorigenic inflammation provide the rationale to investigate the therapeutic role of canakinumab in lung cancer. Methods: Three Phase 3 trials have been designed in parallel to evaluate canakinumab in NSCLC (Table). Clinical trial information: NCT03447769, NCT03631199, NCT03626545. [Table: see text]
Chemotherapy in KRAS-mutated chemotherapy naive non-small cell lung cancer patients: A phase III comparing cisplatin-pemetrexed with carboplatin-paclitaxel-bevacizumab: NVALT 22 (NCT02743923).
Authors: Dingemans Anne-Marie C. , Smit Egbert F. , De Langen Joop , van Tinteren Harm ,   NVALT ONCOLOGY
Published: May 2019

TPS9127

Background: In a retrospective analysis of KRAS mutated non-small cell lung cancer (NSCLC) patients response and progression free survival (PFS) to first line chemotherapy was better for carboplatin-paclitaxel-bevacizumab then other first line combinations (Mellema Lung Cancer, 2015:90:249-54). Methods: Trial Design: Multi-center open label randomized phase III study. After stratification for KRAS mutation (G12V versus G12C versus other), performance status (0-1 vs. 2) and brain metastasis (yes of no) patients will be 1:1 randomized to carboplatin-paclitaxel-bevacizumab or cisplatin-pemetrexed q3wks for up to six cycles. Continuation maintenance with bevacizumab and pemetrexed is allowed until progression. Study population: histologically or cytologically confirmed stage IIIB or stage IV KRAS mutated NSCLC patients who are eligible for platinum-based chemotherapy and are chemotherapy naïve. Previous anti-PD(L1) therapy for advanced disease is allowed (amendment 25.1.2018). Response will be assessed according to RECIST 1.1, CT scans will be made every 6 weeks until progression. Blood and archival tissue will be optionally collected for translational research. This may help to identify subgroups of patients who are likely better treated with a specific treatment regimen. Statistical analysis: The trial was designed to demonstrate superiority of the carboplatin-paclitaxel-bevacizumab treatment over cisplatin-pemetrexed with an assumed hazard ratio of 0.67. In total 201 events are required for the final analysis, corresponding to a total sample size of 240 patients to be accrued. There is a single interim analysis planned after 101 events have been observed. Primary endpoint: PFS defined by the response criteria in solid tumors (RECIST) and assessed by independent review. Secondary endpoints: Overall response rate, Overall Survival, outcome according to type of KRAS mutation, response assessed by CRABB criteria. Study progress: Currently 25 sites are open across the Netherlands and 170 of the 240 required patients are randomized (February 12, 2019). Clinical trial information: NCT02743923.
Hypoglycemia After Gastric Bypass Successfully Treated With Calcium Channel Blockers: Two Case Reports
Authors: Ames Angharad , Lago-Hernandez Carlos A , Grunvald Eduardo
Published: May 2019

Postprandial hyperinsulinemic hypoglycemia is an uncommon yet well-established complication of Roux-en-Y gastric bypass (RYGB) that can result in serious morbidity and adversely affect quality of life. It is often unrecognized and may be difficult to diagnose. Management is challenging. As the number of bariatric procedures increases in parallel with the obesity epidemic, clinicians will be tasked to offer effective medical therapies for this complication. Two patients presented several years after RYGB with severe postprandial hypoglycemia. In one of the patients, we were able to document simultaneous postprandial hypoglycemia and hyperinsulinemia. Conventional treatment approaches, including medical nutrition therapy, acarbose, diazoxide, and octreotide, were either ineffective or limited by poor tolerance. Nifedipine and verapamil were used adjunctively with dietary modification, resulting in resolution of symptomatic hypoglycemic episodes. These agents are therapeutic options that can be used for some patients refractory to more traditional treatments. They should be tried before surgical procedures are considered for affected patients. These two cases demonstrate that calcium channel blockers may be efficacious and appropriate for select patients refractory to dietary interventions alone.
Lerner Symmetry: A Modern Treatment
Authors: Costinot Arnaud , Werning Iván
Published: May 2019

Which policies are protectionist and which ones are not? The Lerner Symmetry Theorem establishes that import tariffs and export taxes are equally protectionist. In this paper we provide a modern treatment of this classical result, highlighting the importance of multinational firms, global imbalances, and imperfect competition. Under perfect competition, the result follows from the separability of consumption and production across countries, ruling out tourism and some forms of multinational firms, but not others. Though we do not require trade balance, the role of initial assets is subtle: our result rules out foreign ownership of domestic assets, but does not constrain domestic ownership of foreign assets. Under imperfect competition, our result effectively rules out all multinational firms. We conclude by discussing the implications for border adjustment taxes. (JEL D41, D43, F13, F14, F23)