bluuebunny/crossref_metadata_2025 huggingface dataset:
Pain severity and impairment of activity between pegfilgrastim (P) and fixed-dose filgrastim (F) in women with early-stage breast cancer receiving chemotherapy.
Authors: Leung Mova , Eustaquio Joy , Kano Jessica , Marr Tiffany , Higgins Brian Patrick , Myers Robert Edward , Kim Jenny , Jones Glenn
Published: March 2020

e19570

Background: In comparative trials of P and F, bone and joint pain are evident and with similar incidences. Also, muscle pain is clinically noted. Pain severity may differ between P and F, especially when a short fixed-dose regimen of F is used. Methods: This is a prospective observational and ethics-approved study. It compares the incidence & severity of muscle and/or joint pain (MJP) in patients (pts) receiving P (6mg SC for 1 day) or fixed-dose F (300mcg SC for 7-8 days) initiated 24 hours after chemotherapy. Eligible were women with breast cancer receiving neo- or adjuvant chemotherapy, and P or F. Choice of P or F were at the oncologist’s discretion based on patient preference & insurance coverage. Pts were ineligible if they could not complete the pain diary, or had received P or F in the past 6 months. Efficacy of P and F was evaluated by comparing febrile neutropenia (FN) and neutropenia (N) requiring delay of the second cycle of chemotherapy. Patient & treatment characteristics were captured to assess for risk factors for developing MJP. A pain diary assessed MJP severity, its management and impact on everyday activities. It was completed starting the evening of chemotherapy for 14 consecutive days. Statistical analysis was performed with Stata 12, including multi-level longitudinal mixed models for MJP scores. Results: 140 pts were enrolled with mean age 52 yr and 58% receiving docetaxel-based chemotherapy. One-third received F and two-thirds received P. Both diary muscle and joint pain peaked in prevalence and severity on days 3 to 6. Over 50% of pts reported MJP at the peak. Pain that increased ≥3 points from baseline was reported by 48% of pts. Daily activities were affected in 48% of 1,960 reporting-days, with 26% reporting moderate or severe impairment. Despite similar incidences of pain, P was associated with lower mean muscle (p=0.0049) and joint (p=0.014) pain scores by regression analyses. FN and N were not different. Use of docetaxel was the sole baseline risk factor for developing MJP. Conclusions: Patients experience substantial MJP with impairment of daily activities but pts receiving pegfilgrastim experience less pain and less burden relating to pain.
Prevalence and impact of hypogonadism in cancer patients with severe muscle wasting in phase IIb enobosarm trial.
Authors: Steiner Mitchell S. , Dobs Adrian , Johnston Mary Ann , Hancock Michael L. , Morton Ronald A. , Dodson Shontelle
Published: March 2020

e19582

Background: Hypogonadism has been associated with weight loss and poor outcomes in cancer patients. Up to 50% of males with advanced cancer are hypogonadal at presentation or during the course of treatment. Wasting in cancer patients has also been associated with a decline in physical function and performance status and has major public health significance. We conducted a Phase IIb randomized, double blind, placebo controlled, multi-center study to evaluate the effect of enobosarm on muscle wasting and physical function in cancer patients. Methods: Patients (n=159) were randomized to oral enobosarm (1 or 3 mg) or placebo daily for 16 wks. Patients were males >45 y and postmenopausal females, had ≥2% weight loss in the 6 mths prior to randomization, BMI <35 and either NSCLC, colorectal cancer, non-Hodgkins lymphoma, chronic lymphocytic leukemia or breast cancer. We report on the incidence and impact of hypogonadism (T<300 ng/dL) in this population. Results: Baseline testosterone levels were available for 93 of 103 men. 60% of male patients were hypogonadal at randomization. Distribution of hypogonadism was similar across cancers; however hypogonadal men were less likely to complete the study. Baseline T levels were positively correlated with weight loss (r=0.32, p=0.002,) with hypogonadal men demonstrating greater weight loss in the previous six months (median, -9.5%). Baseline physical function as measured by stair climb power was higher among eugonadal males compared to hypogonadal males (84.5 watts vs 70.6 watts; p=0.016). Enobosarm significantly improved physical function in this population regardless of baseline gonadal status (hypogonadal: 18.7%, p=0.0061; eugonadal: 13.2%, p=0.0032). The magnitude of improvement was greater in hypogonadal men. Conclusions: Hypogonadism is common in male cancer patients and is correlated with weight loss and diminished physical function. In this randomized, placebo controlled trial, enobosarm improved physical function in both hypogonadal and eugonadal men despite poorer baseline physical function in hypogonadal patients. These data provide evidence that enobosarm may play an important role in the management of cancer related muscle wasting.
Efficacy and safety of lipegfilgrastim compared with pegfilgrastim in patients with breast cancer who are receiving chemotherapy.
Authors: Bondarenko Igor , Gladkov Oleg , Elaesser Reiner , Buchner Anton , Bias Peter
Published: March 2020

e19587

Background: Cancer chemotherapy frequently causes neutropenia, leading to an increased risk of infections and delays in subsequent chemotherapy treatments. Pegfilgrastim is a pegylated recombinant form of granulocyte colony stimulating factor (G-CSF) that extends the half-life and requires less frequent dosing than nonpegylated G-CSF. Lipegfilgrastim is a glycosylated and pegylated G-CSF. The objective of this study was to compare the efficacy and safety of lipegfilgrastim and pegfilgrastim in chemotherapy-naïve patients with breast cancer who are candidates to receive docetaxel/doxorubicin. Methods: In this double-blind, randomized, active-controlled, noninferiority trial, patients with high-risk stage II, III, or IV breast cancer and an absolute neutrophil count ≥1.5x109 cells/L were randomly assigned to lipegfilgrastim 6 mg (n=101) or pegfilgrastim 6 mg (n=101). Study medication was injected subcutaneously on day 2 of the chemotherapy cycle (4 cycles maximum). Primary efficacy endpoint was the duration of severe neutropenia (days with an absolute neutropenia count <0.5x109 cells/L) during cycle 1. Secondary endpoints included the incidence of febrile neutropenia. Efficacy analysis population included patients who were randomized but did not have major protocol violations. Results: Overall, 37%, 46%, and 17% of patients had stage II, III, and IV breast cancer, respectively. The mean duration of severe neutropenia in cycle 1 was 0.7 days in the lipegfilgrastim group and 0.8 days in the pegfilgrastim group (poisson regression least squares mean [95% CI] -0.218 [-0.498 to 0.062]). 56% and 49%, respectively, did not experience severe neutropenia in cycle 1. Three patients experienced febrile neutropenia; all were in the pegfilgrastim group during cycle 1. 28% of patients in the lipegfilgrastim group and 26% in the pegfilgrastim group had adverse events that the investigator considered to be related to study medication. Three and 7 patients, respectively had serious adverse events. Conclusions: The results of this study confirm that the efficacy of lipegfilgrastim is comparable with pegfilgrastim. No unexpected safety events were observed.
Risk factors for complicated grief (CG) and utilization of a hospice bereavement program.
Authors: Henry Elizabeth , Guo Rong , Ansari Aziz , Kristopaitis Theresa , Speyer Mark , Kiel Nancy , Bleeg Mary Lou , DeLongis Susan , Kareb Jacalyn , Shanahan Marie , Taylor Sally , Rundle Twana , Lo Shelly S.
Published: March 2020

e19588

Background: The Medicare hospice benefit mandates that bereavement services be provided to a surviving caregiver for a period of one year following a patient’s (pt) death. Identifying caregivers at risk for CG is essential so that appropriate interventions can be provided. Methods: Our objective was to identify specific features predicting for CG in surviving caregivers of pts with a malignancy enrolled in an academic based hospice program and determine utilization of Medicare’s bereavement services. Hospice charts for 65 patients whose caregivers were consecutively discharged from bereavement follow-up between January 2009 and December 2011 were reviewed. Assessments for CG features were performed with use of chaplain and social worker visits, and phone calls from a trained bereavement volunteer to caregivers at 6-8 wks and 6 months after a pt’s death. A discharge assessment was completed at 13 months. Results: Fifty (77%) hospice pts had a cancer (ca) diagnosis and tended to have a shorter average length of hospice enrollment than non-ca pts (34 vs 60 days, p=0.11). There was no difference in risk of caregiver CG between ca vs non-ca diagnoses (p=0.12). Twenty-one (42%) of ca pt caregivers were identified at risk for CG. Ca pts ≤ 50 yrs at the time of hospice enrollment were more likely to have caregivers identified at risk for CG compared to those ≥ 50 yrs (3, 100% vs 18, 38%, p=0.07). At risk ca caregivers had a lower average pt age at time of hospice enrollment than lower risk caregivers (mean pt age 67 vs 76 yrs, p=0.03). Eight ca caregivers (38%) identified at risk for CG received intensive bereavement counseling; 13 (62%) subsequently received routine bereavement follow up; none were lost to follow up. Length of enrollment, caregiver employment status and caregiver relationship did not predict for risk of CG. No ca caregivers required intensive bereavement services beyond 12 months post pt death. Conclusions: Young patient age at time of hospice enrollment is associated with an increased risk of caregiver CG.Intensive bereavement counseling was required by 38% of ca caregivers, and none required >1 yr of service. Further study needs to be done to see if caregivers are receiving adequate bereavement support through the hospice benefit.
Association between prayer activity, inflammation, and survival in advanced cancer patients (ACPs): A preliminary study.
Authors: Paiva Carlos Eduardo , Paiva Bianca Sakamoto Ribeiro , Souza Crovador Camila , Yennurajalingam Sriram , Hui David
Published: March 2020

e19602

Background: Prayers represent an important coping strategy among ACPs. The Religion Practice Questionnaire (RPQ) is a self-reported measure of religiosity validated in the Brazilian population, and includes a question assessing prayer activity. In this cross sectional prospective study, we determined the association among prayer activity, inflammation and survival in ACPs. Methods: Consecutive ACPs presenting for initial consultation at our Palliative Care Outpatient Clinic between March and December 2011 were enrolled. RPQ was administered by a research nurse, and consists of 15 items rated on a 5-point Likertscale (0=none, 5=very much). High prayer score (HPS) was defined as >3/5 for question 11 ("I make personal prayers – spontaneous communications with God"). Inflammatory markers included white blood cell (WBC), albumin and C-reactive protein (CRP). Correlation analysis was performed using Spearman test. Survival was calculated from study enrolment until death, and analyzed with log rank test and Cox regression model including age, sex, KPS, treatment type and HPS. Results: 112 patients were enrolled: average age 59 y (range 21-85), female 53% (N=59), Karnofsky performance status (KPS) ≤70 46% (N=51), most common cancers breast and upper GI (N=41, 37%), no longer on active cancer treatments 48% (N=54). All patients were Christians, and 77 (69%) had HPS. RPQ was not associated with WBC, albumin, CRP nor survival. HPS correlated with WBC (r=-0.24, p=0.02), and CRP (r=-0.26, p=0.01) but not albumin (r=0.18, p=0.08). Patients with HPS survived longer (median 198 d vs. 121 d, p=0.040), which remained significant in multivariate analysis (Table). Conclusions: The act of praying was associated with decreased inflammation and improved survival in ACPs. Further studies are necessary to confirm these findings. [Table: see text]
Targeted agent (TA) use at the end of life (EOL).
Authors: Karuturi Meghan Sri , Tanco Kimberson , Kwon Jung Hye , Zhang Tao , Rhondali Wadih , Kang Jung Hun , Chisholm Gary B. , Bruera Eduardo , Hui David
Published: March 2020

e19603

Background: Chemotherapy in the last days of life has questionable benefit and has been proposed as an indicator of poor quality of EOL care. The use of TAs at the EOL has not been examined. We determined the proportion and predictors of TA use in the last 30 days of life. Methods: All adult patients in the Houston area who died of advanced cancer between 9/1/2009 and 2/28/2010 while under the care of our institution were included. We collected baseline demographics and data on chemotherapy and TAs. Multivariate logistic regression was used to identify predictors of targeted therapy use. Results: 912 patients were included: average age 63 (range 21-98), female 49%, Caucasian 63%. Within the last 30 and 14 days of life, 117 (13%) and 56 (6%) patients received TAs, respectively, while 148 (16%) and 65 (7%) received chemotherapy. The interval between last TA use and death was 49 (21-106) days. Regimens given in the last 30 days of life included a median of 2 (1-2) chemotherapeutic/targeted agents, and the most common TAs were erlotinib (N=22), bevacizumab (N=19), rituximab (N=9), gemtuzumab (N=9) and temsirolimus (N=8). 43/117 (37%) patients who received TAs within the last 30 days of life had concurrent chemotherapy. In multivariate analysis, younger age and hematologic malignancies were associated with increased TA use (Table). Conclusions: TAs were used as often as chemotherapy at the EOL, particularly among younger patients and those with hematologic malignancies. Use of TAs in the last 30 days of life may have implications for quality of EOL care. [Table: see text]
Etiologic agents in 54 consecutive febrile neutropenia (FN) isolates in a general hospital in Medellín, Colombia.
Authors: Betancur Carlos Alberto , Lema Mauricio , Arcila Giovanna
Published: March 2020

e19604

Background: The etiology of FN is well established in the US and the EU. Less is known about it in Colombia. This cohort attempts to fill this void. Methods: We collected prospectively the information on all FN cases with an established etiology that were admitted to the Clínica SOMA (A 160 bed-facility in Medellín, Colombia) from September 2010 to October 2011. FN was defined as the coexistence of an absolute neutrophile count (ANC) <500 and a temperature >38.3 degrees Celsius following cytotoxic chemotherapy for cancer. Results: Fifty four cases of FN with known etiology were found. Twenty four in males and 30 in females. Age range from 16 to 73 years-old (median: 42). Acute lymphoblastic leukemia was the underlying diagnosis in 16 (30%), acute myelogenous leukemia in 13 (24% ), and non-Hodgkin’s lymphoma in 11 (20%). HyperCVAD (with o without rituximab), IdaFlag, bortezomib and HiDAC account for 17 (31%), 12 (22%), 7 (13%), and 5 (9%) cases, respectively. FN occurred 2 to 32 days after chemotherapy (average of 10 days). In 20 (37%) cases ANC on admission was 0, and the average ANC on admission was 120. In 51 cases germs were isolated in the blood (94%). Gram-negative bacilli were isolated in 38 cases (76%), S. aureus in 4 (7%), Candidemia was established in 4 patients (2 with C. krusei and 2 with C. parapsilosis). Pulmonary aspergillosis was established in one case. Of note, two cases of hospital-acquired Legionella pneumophila were found (Table). All patients recovered to non-neutropenic ANC with resolution of the infections. No deaths due to FN occurred in this group of patients. Conclusions: In this cohort from Colombia we found a large predominance of gram-negative bacilli and the isolation of L. Pneumophilla, an unusual pathogen in FN. This pattern differs from the usual germ mix reported in other series. [Table: see text]
Khorana risk score: Is the body mass index a predictable factor for thromboembolism in European countries? A retrospective analysis.
Authors: Barni Sandro , Labianca Roberto , Verso Melina , Gasparini Giampietro , Bonizzoni Erminio , Mandala Mario , Brighenti Matteo , Petrelli Fausto , Bianchini Carlo , Perrone Tania , Agnelli Giancarlo
Published: March 2020

e19612

Background: Five variables (site of cancer, platelet count, haemoglobin level, leukocyte count, and body mass index-BMI) define the Khorana risk score (KS), predicting the high (≥ 3), the moderate (1-2) and the low (0) risk of thromboembolic events (TEs) in cancer outpatients. Nadroparin has been demonstrated to reduce the incidence of TEs by about 50% in cancer outpatients receiving chemotherapy (PROTECHT study) and patients receiving chemotherapy including gemcitabine, platinum analogues or their combination are at higher risk of TEs. Methods: 378 patients enrolled in the PROTECHT study didn’t receive thromboprophylaxis (placebo group) and were evaluable for the KS. The aim of this retrospective analysis was to assess the distribution of the five KS variables and if the replacing of BMI variable, in the KS, with a chemotherapy variable (administration of platinum compound or gemcitabine added 1point and their association 2points) in a PROTECHT score (PrS) could better predict high risk patients. A receiver operating characteristic (ROC) curve has been used to assess the accuracy of both scores. Results: Among patients the five KS variables were distributed as follow: 15% of stomach/pancreas cancer (2points), 33% with lung/gynecologic cancer (1point), 24% with platelet count of ≥350x10^9/L, 7.9% hemoglobin <10g/dL , 14.3% leukocyte count >11x10^9/L (1point each variable) and only 1.3% with BMI ≥ 35 (1point). 15 TEs occurred in the 378 pts, below the TEs distribution according to KS and PrS (see table). The area under the ROC curve was larger with PrS in comparison with KS (0.70 and 0.65 respectively). Conclusions: BMI ≥ 35 seems not to be a predictable factor for TEs in European cancer patients and the use of a chemotherapy variable could be more useful to identify patient at high risk of TE. A formal study is needed to evaluate which score could have a higher predictability to identify high risk patients for TEs. [Table: see text]
Predictive modeling of adverse events in chemotherapy.
Authors: Maguire Roma , van Berkel Cees , Cowie Julie , Blake Robert L. , Kearney Nora
Published: March 2020

e19617

Background: Patients with cancer receiving chemotherapy are at risk of developing severe or life threatening adverse events (AEs). The aim of this study was to develop and test a risk model for six common toxicities based on a detailed analysis of daily self-reported symptoms. The retrospective study was performed on a data set of 33 breast cancer patients who self reported symptoms over multiple therapy cycles. The monitored symptoms were diarrhoea, hand-foot syndrome, mucositis, nausea, vomiting and fatigue. Methods: The data analysis focused on four toxicity aspects: the occurrence patterns, the severity distributions, the duration and the interrelationship between symptoms. The clustering of symptoms was a key aspect of the modeling. The data analysis was supported and augmented with knowledge from an expert group of clinicians and an advisory group of patients. The final model is a Bayesian network in which the probability of toxicity on a given day, depends on the probability of that toxicity on a previous day and on the probability of others with which it is linked. Personalized predictions are made by feeding patient self reported observations from a particular patient into the model. Results: The different toxicities show quite marked and varied time (day to day) behaviors and there are strong and significant interrelations between fatigue / nausea, vomiting / nausea and fatigue / vomiting. The model provides effective prediction of toxicity over the entire set of symptoms. The Area Under the Curve (AUC) values for personalized prediction over different forecasting periods ranged from one day ahead (AUC=0.89) to 7 days ahead (AUC=0.82). Non personalized prediction gives an AUC of 0.78 for all time periods. Conclusions: Personalized prediction based on real-time self-reported symptoms is effective on timescales up to one week. These predictions may be useful for patient care. If communicated appropriately to patients, they can be used to target information sharing on side effects, support self-care and plan activities of daily living in advance. For clinicians the information can be useful to identify patients who are at greater risk of developing certain AEs, facilitating more efficacious, timely and cost-effective interventions.
Perceptions of chemotherapy influencing treatment decisions in women with hormone-positive tumors.
Authors: Proverbs-Singh Tracey , Fei Kezhen , Franco Rebeca , Bickell Nina
Published: March 2020

e19621

Background: Women with hormone receptor positive (HR+) breast cancer can benefit from chemotherapy (CTX). Unnecessary therapy can adversely affect patient morbidity.. While tumor biology affects decision making, patient perception of cancer recurrence is also important. In this study we determine whether women with HR+ tumors (>1cm) who undergo CTX, have stronger beliefs in the efficacy of CTX than women who do not get therapy. Methods: Women participating in a Breast Cancer Patient Assistance Trial in 2006-2010 were surveyed about their cancer knowledge and beliefs about its treatment; charts were abstracted 6 months later to measure treatments received. A Nottingham Prognostic indicator (NPI), which uses stage, tumor size, and lymph node involvement was calculated. Chi-square and logistic regression analyses examined associations between receipt of CTX and tumor stage, NPI, physician recommendation, patient demographics and beliefs about CTX. Results: Women with HR+ tumors 130/211(62%) received CTX and 197/211(93%) received hormonal therapy. Gene array analysis was performed in 46/211 (22%), and of these (7/46 [15%]) had high recurrence scores and received CTX. Women treated with CTX vs those without CTX were younger (mean 52.5 yrs vs 62.3 yrs, p<0.0001), had higher stage cancer (stage II: 65% vs 23%, p<0.0001), worse NPI (poor prognosis:15% vs 2% p<0.0001), more physician recommended CTX (92% vs 34%, p<0.0001) and increased concern about recurrence without CTX (very worried 70% vs 15%; p<0.0001). Multivariate analysis found that physician recommendation, poor NPI and moderate NPI were most strongly associated with receiving CTX [RR= 3.2, (95% CI:1.8-5.6), 1.7, (95%CI:1.3-2.2); 1.6, (95%CI:1.2-2.0)], respectively, followed by women’s worry (RR=1.3; 95%CI: 1.0-1.6), and belief that CTX allows women to live longer (RR=1.1; 95%CI: 1.0 - 1.2). Older age was associated with less use of CTX (RR= 0.99; 95%CI: 0.978-.995). Conclusions: Physician recommendation, disease severity, concerns about recurrence and beliefs about CTX’s effectiveness influence the utilization of CTX in HR+ breast cancer. Patients may benefit from education to make informed decisions.
Deciding to withhold or withdraw (WH/WD) anticancer therapy (ACT) in advanced cancer patients: Physicians and patients points of view and interactions.
Authors: Beaussant Yvan , Tournigand Christophe , Pazart Lionel , Mathieu-Nicot Florence , Cretin Elodie , Deconinck Eric , Bouleuc Carole , Godard Aurelie , Maindrault-Goebel Frederique , Cuynet Patrice , Aubry Regis
Published: March 2020

e19623

Background: ASCO highlighted the need to improve communication with and decision making for pts with advanced cancer. This study explores the decision-making process for pts with advanced cancer when the question to WH/WD ACT is raised, with a cross-analysis of physicians and pts points of view. Methods: Multi-center qualitative study in 5 oncology and hematology units, based on semi-structured single interviews with referent oncologists and their pts. An epidemiological survey was performed to identify the prevalence of such decisions. Results: Of the 839 pts hospitalized during a given week, the question to WH/WD ACT was raised in 3.4% of cases (n=29) and in 12,8% when excluding ambulatory pts (n=26 of 202). All 29 referent physicians and 21 pts were interviewed. Futility and poor general condition were the most frequently cited reasons to WH/WD ACT. Subjective determinants related to the physician/patient relationship and their respective experiences were also predominant in all interviews. Although most physicians reported attempting to fully inform pts about their poor prognosis and treatment options, only a minority were able to anticipate the option to WH/WD ACT in these discussions. The fear to remove pts’ hope and to increase anxiety, and a feeling of capitulation and abandonment were the main obstacles they pointed out. For pts, hope and struggle attitudes were predominant, as well as anxiety about their situation and confidence in the physicians’ decisions. More than 80% of pts declared leaving the physician to decide alone. Most of them expected to be involved in the decisions, but only 1/3 reported being actually aware of this questioning. Conclusions: In this study, oncologists faced the difficult decision whether to continue, WH/WD ACT for 1/7 hospitalized patient. The uncertainty of the benefit/risk assessment seemed to strengthen the subjective determinants of the questioning. Pts and physicians mutual willingness to maintain hope reinforced an attitude of “not giving up”. Communication training of health professionals and integrative palliative care could favor the ethical questioning and improve care through the respect of pts’ preferences.
Risk factors for fractures in patients on hormonal therapies for breast cancer and DCIS.
Authors: Ladha Abdullah , Mathew Josy
Published: March 2020

e19627

Background: Hormonal therapy with aromatase inhibitors (AI) or tamoxifen (TAM) is standard of care for hormone receptor positive breast cancer and DCIS. Fractures are a complication of treatment with AI due to accelerated bone loss. Risk factors for fracture in patients on hormonal therapy (HT) for breast cancer and DCIS are poorly defined. Methods: All 71 patients with breast cancer or DCIS seen in the bone and mineral clinic of our institution from 2000 to 2010 were analyzed. Data on demographics, pathology, type and duration of HT, bone mineral density studies (BMD), number and site of fractures were collected. Statistical analysis: t test, chi square test and Fisher’s exact test for categorical data. Results: The age of the patients ranged 40 to 97 years. 65 patients had ER positive breast cancer, 6 patients had DCIS. 9 patients had fractures.41 patients were on an AI alone, 8 were on TAM alone and 14 were on both sequentially. Fractures involved: vertebral compression, femur, hip, distal radioulnar, rib, hand and feet bones. Patients who had osteoporosis at the femur, osteoporosis or osteopenia in the lumbar spine or forearm in the initial BMD study were found to have an increased risk of fracture (P<0.05). Patients who were on TAM and AI sequentially had an increased risk of fracture (P<0.05) compared AI alone. The use of bisphosphonates and the duration of use were significantly associated with fracture (P<0.05) as these patients already had osteoporosis. The age, race, duration of AI use and the use of calcium and vitamin D were not found to be significantly different in patients who had fractures compared to those who did not. In the 24 patients who had two BMD studies, there was no significant change in the BMD overall. Conclusions: Patients with osteoporosis or osteopenia at baseline have an increased risk of fracture with the use of hormonal therapies for breast cancer and DCIS. This risk was not eliminated by the use of bisphosphonates. Sequential use of tamoxifen and aromatase inhibitors increase the risk of fractures. Bone mineral density studies done prior to the initiation of hormonal therapy for breast cancer maybe useful estimating the risk of fracture while on treatment.
Fatigue control in metastatic colon cancer treated with capecitabine and oxaliplatin.
Authors: Peria Fernanda Maris , Sá Lilian Andrade , Oliveira Harley Francisco , Vettori Josiane Cheli , Tirapelli Daniela Pretti da Cunha , Vieira Nivaldo Farias , Perdona Gleici da Silva Castro
Published: March 2020

e19628

Background: Fatigue is one of the most frequent symptoms in cancer patients, characterized by profound fatigue that is not relieved by rest. This symptom can be identified at the time of diagnosis and could affects up to 90% of patients undergoing cancer treatment. There are some instruments available in the literature that can characterize the presence of fatigue through clinical questioning. Methods: Considering the large population of patients with metastatic colorectal cancer treated with chemotherapy and the prevalence of fatigue in these patients, this study evaluated the presence of fatigue in 27 metastatic colon cancer patients before the first, second, third and fourth cycles of fist line palliative chemotherapy regimen containing CAPOX (capecitabine and oxaliplatin) by applying the evaluation questionnaire FACIT-F fatigue. Results: The results post Friedman chi-squared test demonstrated that there was no improvement of fatigue during these four cycles of CAPOX palliative chemotherapy (p=0,2574). The FACIT-G analysis demonstrated no worsening of quality of life (p=0,2411) during and between the four cycles of chemo. All different parameters included in FACIT-F questionnaires: emotional (p=0,2629), physical (p=0,3199), familiar (p=0,1456), functional (p=0,8662) and specific fatigue topic (p=0,7569) confirmed no difference between the cycles. Conclusions: Despite the metastatic stage of colon cancer patients and concurrent chemotherapy treatment, there was no fatigue improvement during the four first CAPOX chemo cycles courses and there was the maintenance of quality of life.
Trends in hepatitis B virus screening in a large U.S. cancer center.
Authors: Hwang Jessica , Fisch Michael , Lok Anna , Zhang Hong , Vierling John , Suarez-Almazor Maria
Published: March 2020

e19631

Background: In the past 5 years, national hepatitis B virus (HBV) screening recommendations differed with respect to populations that should be screened to prevent reactivation, which may occur in patients with hematologic or solid malignancies. Previous studies showed that up to 60% of oncologists are not screening. We sought to compare the HBV screening patterns over time in a large US cancer center in relationship to the 2010 ASCO Provisional Clinical Opinion (PCO) which includes recommendations to screen patients with hematologic malignancies prior to receipt of certain cancer therapies. Methods: Retrospective cohort study of patients with newly diagnosed cancer registered at MD Anderson (1/04 - 4/11) who received chemotherapy. Screening was defined as testing for hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc) before chemotherapy. We compared screening rates among patients with hematologic malignancies vs. solid tumors. Using Chi-square tests, we compared screening rates before and after the PCO. A generalized linear regression model was used to detect changes in the rates of HBV screening over time for patients based on cancer type. Results: During our study period, 141,877 patients were registered, and 13% (n=18,877) received chemotherapy. Of these, 18% (n=3475) had HBV screening: 1% (n=42) were HBsAg+/anti-HBc+, while 7% (n=242) were HBsAg-/anti-HBc+. The overall screening rate significantly increased from 18% before the PCO to 23% after the PCO (p<0.01). After the PCO, the screening rate among patients with hematologic malignancies increased from 69% to 79% (p<0.01), and among patients with solid tumors from 3.8% to 5% (p=0.05). Overall, the rate of increase of HBV screening among patients with hematologic malignancies was higher than for patients with solid tumors (p<0.01). Conclusions: Rates of HBV screening increased after the PCO, although the rate of increase was greater among patients with hematologic malignancies than solid tumors. Because reactivation is an important and preventable cause of morbidity and mortality in patients with either hematologic or solid malignancies, further efforts are needed to screen patients at risk by identifying predictors of reactivation of HBV infection.
Testosterone replacement for fatigue in male hypogonadic patients with advanced cancer: A preliminary double-blind placebo-controlled trial.
Authors: Pulivarthi Kalyan , Dev Rony , Garcia Jose , Palmer J. Lynn , Bruera Eduardo , Del Fabbro Egidio
Published: March 2020

e19643

Background: Hypogonadism affects two thirds of men with advanced cancer. Uncontrolled studies show fatigue, anorexia, depression,and insomnia are associated with low testosterone in men with cancer. Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions. The primary goal of this study was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)at day 29. Methods: Randomized, double-blinded placebo controlled at two centers. Clinic outpatients with advanced cancer, bioavailable testosterone (BT) <70ng/dL, hemoglobin>9g/dL, and moderate to severe fatigue assessed by a score >3/10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible.Contraindications to testosterone therapy or other causes of fatigue such as hypothyroidism, hypercalcemia, or chronic kidney disease excluded subjects. Weight-based intra-muscular testosterone or a sesame seed oil placebo administered every 14 days to achieve a BT level 70-270ng/dL. Initial sample size was for fifty evaluable patients per group. One-sided t test was used to analyze differences in FACIT scores between arms. Results: Accrual was slower than anticipated with a final total of 43 eligible males randomized to testosterone(19) or placebo(24). Neither age nor site was statistically significant (<0.05) between arms. 14 placebo and 12 testosterone treated patients were evaluable for the primary outcome.No statistically significant difference was found for FACIT-F total scores between arms, with a trend for testosterone to improve scores (-5.5±19 for placebo, 3.9±14 for testosterone, p=0.09) using a one-sided t test. Adverse events were similar between groups. There were no significant differences in secondary outcomes of ESAS scores, Hospital Anxiety and Depression Scale, hand-grip or 6 minute walk. Conclusions: Testosterone replacement in hypogonadal male patients with advanced cancer had a trend to improve fatigue and quality of life in this preliminary trial.
Moderate-to-severe symptoms among survivors of early-stage breast cancer.
Authors: Zonder Helene B. , Mortimer Joanne E. , Behrendt Carolyn E. , Smith Robin , Zomorodi Meghan
Published: March 2020

e19644

Background: This cross-sectional survey describes the prevalence of moderate/severe symptoms among patients in a survivorship clinic. Methods: We administered QoL questionnaires (FACT-B, SF-36, HADS) to pts. treated for stage I-III disease at a survivorship visit. For symptoms reported by at least 18/55 subjects, we identified risk factors using logistic regression. Results: Subjects (n=55) were age 55.9(+8.9) yrs at study, age 52.6(+9.3) at dx, and median 23.7 (range 6.3-157.2) mos. from dx of stage I (30.9%), II (54.5%), or III (14.6%) disease. Systemic treatment included chemotherapy only (20.0%), endocrine therapy only (30.9%), or both therapies (49.1%). Currently, 65.5% were on endocrine therapy. Symptoms experienced “quite a bit” or “very much” during the past wk were: hot flashes (45.5%), joint pain (30.9%), weight gain (30.9%), loss of libido (30.9%), vaginal dryness (27.3%), and night sweats (27.3%). In the past mo., 43.6% accomplished less than they would have liked due to physical health, and 30.9% felt worn out at least “a good bit of the time”. Sleep quality was rated “fairly to very bad” (32.7%), and 25.5% felt fatigued at least half the day during the past week. Vigorous activities were “limited a lot” for 36.4%, and increased with age at dx. Fre-quent hot flashes were associated with age < 50 years (6.40, 1.75-23.35) and being within 1year of dx (10.67, 1.05-108.69). Adjusted for age at dx, poor quality of sleep increased with stage of disease (9.68, 2.25-41.69, per step increase) and was associated with having received endocrine therapy only (9.98, 1.40-71.03) and being within the first year after dx (9.54, 0.76-119.47). Conclusions: Limitation in activities, poor quality of sleep, and symptoms of hormonal suppression are common among survivors of early stage breast cancer. Poor quality sleep and frequent hot flashes appear to decrease in prevalence 1 yr after dx, but other common symptoms do not. A longitudinal cohort study is underway.
Ovarian tissue cryopreservation in a prepubertal girl after fertility impairing therapy.
Authors: Gosiengfiao Yasmin C. , Reynolds Marleta , Rajaram Veena , Lockart Barbara , Smith Kristin , Xu Min , Woodruff Teresa K.
Published: March 2020

e20001

Background: Advances in cancer therapy have improved the long-term survival of patients suffering from malignancies. High doses of alkylating agents and radiation are known to cause infertility in cancer survivors. Ovarian stimulation is not an option for prepubertal females, leaving experimental ovarian tissue cryopreservation (OTC) as the only option for preserving the reproductive potential of prepubescent girls. Little data is available regarding the condition of a prepubertal ovary after cancer treatment is received. This case study demonstrates the possibility of OTC post cancer treatment in a prepubertal female. Methods: A 9-year-old girl with multiply recurrent vaginal rhabdomyosarcoma presented for fertility preservation upon local recurrence of her tumor. Prior therapy included 32,200 mg/m2 of cyclophosphamide, 9,000 mg/m2 of ifosfamide and vaginal brachytherapy after ovarian transposition. A unilateral oophorectomy was performed with therapeutic partial vaginectomy, total hysterectomy and bilateral salpingectomy. A 1 cm section of the ovary was dissected and sent to pathology. The ovarian tissue planes were separated and the cortical tissue removed from the medulla. The cortical tissue was then cut into approximately 2 cm x 0.5cm x 0.1cm strips. 80% of this tissue was cryopreserved using a slow-freeze method for the patient’s future reproductive use and 20% was provided to the Oncofertility Consortium for research as per the ovarian tissue cryopreservation protocol. Results: Follicle stimulating hormone (FSH) level prior to oophorectomy was 0.5 mIU/mL (Normal 1-6 mlU/mL).The ovary was small and fibrotic. Microscopically, primordial follicular density was 1.41/mm2. No follicles of more mature stage were noted. There was no evidence of malignancy in the tissue. Conclusions: The presence of viable follicles in the ovarian tissue suggests that fertility preservation may still be possible even in patients who have received therapy that is considered to be likely to impair fertility. For this patient, who was scheduled to have an invasive surgery, adding on ovarian tissue cryopreservation presented a very minimal risk with a potential for a great benefit.
Country specific serum IgE reactivity profile and concordance with allergic history among acute lymphoblastic leukemia children and controls.
Authors: Lariou Maria Stella , Dikalioti Stavroula , Dessypris Nick , Pourtsidis Apostolos , Baka Margarita , Polychronopoulou Sophia , Piperopoulou Fani Athanasiadou , Moschovi Maria , Fragandrea Ioanna , Kalmanti Maria , Germenis Anastassios , Petridou Eleni
Published: March 2020

e20002

Background: Allergy has been studied as a risk factor for several malignancies, including childhood leukemia; yet, the tentative etiological nature of this association needs to be further explored. Published studies suffer inappropriate study design and accuracy of exposure variables. In response to the latter need, this study aims to use country specific biological markers, namely levels of the most prevalent allergen-specific immunoglobulin E (IgE) antibodies in Greece as an alternative exposure measurement to history of allergy and compare their concordance with allergic history. Methods: Allergen-specific-IgEs against 24 most prevalent inhalant and food allergens were determined for 199 incident childhood acute lymphoblastic leukemia (ALL), newly diagnosed cases across Greece and registered in the Nationwide Registry for Childhood Hematological Malignancies (NARECHEM) and 113 hospital controls. K statistic was used to check the concordance between serum IgE specific allergens and allergic history overall, as well as among cases and controls. Results: Concordance between self-reported food allergy and food IgE levels in the same individual among both cases and controls was 87% and 83% for respiratory allergens. Among cases, concordance between self reported food allergies and food IgEs was 92% and 80% for controls (p-value 0.003) and the respective κ statistics were 0.28 for cases and 0.10 for controls. Concordance between self reported respiratory allergies and respiratory IgEs was 84% for cases and 81% for controls (p-value 0.57); κ statistics 0.09 for cases and 0.07 for controls. Conclusions: Much of the discordance among cases and controls (self-report false positives) might probably be a reflection of non allergic food hypersensitivity, an allergy that was surpassed or extended allergen avoidance. Other discordance (self-report false negatives) seems to be the result of food sensitization, either hypoclinical or not acknowledged as a type of allergy by mothers of the children. Nevertheless, these measurements jointly analyzed are valuable in exploring the stated hypothesis, especially in well designed prospective studies.
An oncogenetics consultation dedicated to children suffering from cancer.
Authors: Mari Véronique , Met Domestici Marie Amelie , Soler Christine , Deville Anne , Sirvent Nicolas , Poiree Maryline , Frenay Marc
Published: March 2020

e20006

Background: When a child suffers from a cancer, parents worry about a probable hereditary cause. If a cancer occurs in the context of a genetic mutation, this can worsen the situation and make it more complicated. On the other hand, when the hereditary cause is rejected, the reinsurance for the family is clear. Methods: A partnership has been set between the Oncogenetics department in Centre Antoine Lacassagne Hospital in Nice and the Archet hospital in Nice (CHU) who takes in charge the children suffering from a cancer. Fifty little patients are seen every year in the paediatric oncology service at the Archet hospital (CHU). A consultation in oncogenetics is suggested to each family and insistently when a known syndrome is suspected. This consultation is also about to provide an other kind of care, in an other hospital, focused on the family with the aim to free of guilt the parents. Psychological care for families is in backdrop as they can express freely their questioning. Results: Twenty one families have been seen and fifteen different types of cancers recorded: mostly haematological cancers and neurological cancers. For each family, a pedigree was drawn. Data concerning the child’s disease and familial data were gathered. Most of the time, these information led to reassure the families. Therefore two Li and Fraumeni syndrome have been evoked. The first child suffered from a plexus choroid carcinoma and the second one had two distinct cancers: a nephroblastoma and a medulloblastoma. On the other hand, 2 children had had a LAL within a family with history of malignant haemopaties. Interestingly, 3 children with isolated LAL in the family where suggested to contribute to a research trial. Conclusions: This oncogenetic pediatric consultation allows to detect known hereditary predisposition syndromes and to contribute to researches in paediatric oncology. Above all, this strong bound between the oncogentics department and the pediatric oncology service permitted to reach an objective: offering families a specialised consultation with psychological support with a gap from disease.
A comprehensive comparison of circulating tumor cell capturing technologies by apheresis of cancer patients.
Authors: Stratmann Antje , Fischer Johannes C. , Niederacher Dieter , Raba Katharina , Schmitz Arndt , Kim Phillip Sangwook , Singh Sharat , Stoecklein Nikolas H. , Krahn Thomas
Published: March 2020

e21017

Background: Obtaining tumor tissue from cancer patients for diagnosis and biomarker assessment for patient selection is challenging. Circulating tumor cells (CTCs) may represent an attractive alternative as a “liquid biopsy”. However, capturing these rare cells from whole blood is a major challenge that still needs significant improvement. Here we present preliminary data of an ongoing study comparing different CTC capturing technologies. Methods: A collaboration network between Bayer Pharma AG, the University of Düsseldorf as clinical partner and providers of CTC capture methods was established. In addition logistics were organised to guarantee a fast and reliable sample transfer. For optimal comparison, CTC preparations from the same patient were used. The required high amounts of sample aliquots and CTCs was obtained by apheresis. Breast and pancreatic cancer patients (non- and metastatic) were enrolled. Blood samples were obtained, as well as buffy coat by apheresis. Samples were shipped within 48 h to partner companies for CTC analysis. At two sites the CellSearch system by Veridex was performed. Today’s standard was compared with another antigen-based method, a filter method and an approach depending on electrophysiological properties. Downstream analysis of the isolated CTCs was performed at Prometheus using their sensitive immunoassay. Results: Significantly higher CTC amounts were detected in buffy coats obtained by apheresis in comparison with CTC counts obtained from a blood draw. In contrast to the blood samples, all methods were able to detect CTCs in buffy coats from both non-metastatic and metastatic cancer patients. The included novel approaches showed in general a better yield of CTCs in comparison to CellSearch. Downstream analysis revealed individual signalling pathway activity profiles. Conclusions: Apheresis is a suitable procedure to capture high amounts of CTCs and therefore to enable an optimal technology comparison. The isolated CTCs are viable and stimulatable. The preliminary results of our study show that an improvement in CTC capturing is taken place, indicating an important step forward regarding the use of CTCs as “liquid biopsy” in a clinical setting.
Capture of EpCAM-negative and vimentin-positive circulating cancer cells (CCCs) from blood of metastatic breast cancer patients using ApoStream.
Authors: Neal Christopher , Sukumaran Sujita , Gupta Vishal , Jafferji Insiya , Hasegawa Dave , Melnikova Vladislava O. , Davis Darren W.
Published: March 2020

e21029

Background: Up-regulation of epithelial mesenchymal transition (EMT) and the reduction of epithelial marker expression is associated with invasion, cancer progression, resistance to conventional therapies and poor prognosis. ApoStream, a novel continuous flow dielectrophoresis field-flow fractionation (DEP-FFF) device, was used to enable antibody-independent capture of circulating cancer cells (CCCs,also referred to as circulating tumor cells, CTC) for subsequent phenotyping of EMT markers. Methods: A side-by-side comparison of CellSearch and ApoStream was performed on 10 metastatic breast cancer patients. A multiplexed immunofluorescent assay and laser scanning cytometry analyses were used to unambiguously identify CK+/CD45–/DAPI+ CCCs and quantify their EpCAM and vimentin expression. Results: ApoStream recovered CK+/CD45–/DAPI+ CCCs from each breast cancer patient sample tested (mean=255 CCCs per 7.5 ml blood, see Table). ApoStream consistently recovered significantly higher number of CCCs compared to CellSearch (p=0.024). ApoStream recovered both EpCAM+ and EpCAM– CCCs in 50% and 90% of patients, respectively. Vimentin+ CCCs were isolated from 90% of patients. Conclusions: ApoStream’s higher capture efficiency demonstrated the majority of CCCs from breast cancer patients were EpCAM negative and vimentin-positive. ApoStream technology can be used to monitor CCCs undergoing EMT. [Table: see text]