bluuebunny/crossref_metadata_2025 huggingface dataset:
Treatment patterns among cancer patients with anemia who do not respond to erythropoietin-stimulating agents.
Authors: Girvan Allicia C , Lau Yiu-Keung , Bowman Lee , Pohl Gerhardt , Landsman-Blumberg Pamela , Shi Nianwen , Varker Helen
Published: March 2020

e20525

Background: While broadly utilized for treatment of anemia in cancer patients, treatment with Erythropoetin Stimulating Agents (ESAs) is contraindicated in patients who fail to respond within 6-8 weeks. This study examined rates of ESA response and rates of continued ESA use following non-response in five cancer cohorts treated by community-practice oncologists. Methods: Patients with breast, head and neck, cervical, non-small cell lung cancer, or multiple myeloma initiating ESAs on or before 7/1/2011 were identified from EMRs in the ACORN Data Warehouse (ACORN, Memphis TN). The study included those with at least 6-8 weeks of ESA use and documented hemoglobin (Hb) values ≤28 days before start of ESA (“baseline”) and anytime during day 43-70 of ESA treatment. Per ASCO/ASH guidelines, patients were noted as responders if Hb increased ≥1g/dL between baseline and the Hb value closest to day 56 in the 43-70 day window, and non-responders if Hb increased <1g/dL. Non-responders were further classified as continuing or discontinuing therapy based on record of ESA treatment following determination of non-response. Results: A total of 2,197 patients were studied. ESA response rate was 45%. For non-responders, 83% continued ESAs after determination of non-response. Hb increase at end of therapy among non-responders remained lower than for patients who demonstrated initial response. Additionally, non-responders received nominally longer treatment, with a mean exposure of 169 days. Conclusions: Among cancer patients, a majority of ESA non-responders remained on ESA treatment beyond the recommended response window as defined by ASCO/ASH guidelines. Moreover, non-responders remained on treatment longer than those who demonstrated an initial response. [Table: see text]
Characteristcs associated with complementary and alternative medicine use among racially and ethnically diverse long-term cancer survivors.
Authors: Sohl Stephanie Jean , Weaver Kathryn E. , Birdee Gurjeet , Kent Erin E. , Danhauer Suzanne , Hamilton Ann S.
Published: March 2020

e20532

Background: To identify the prevalence and predisposing, enabling and need for care characteristics of long-term adult cancer survivors who use complementary and alternative medicine (CAM) modalities. Methods: We analyzed data from the Follow-up Care Use among Survivors (FOCUS) Survey, a cross-sectional population-based investigation of the follow-up care experiences among racially and ethnically diverse long-term (i.e., five years or more post-diagnosis) cancer survivors recruited from California NCI SEER registries. Ever and last year use of CAM modalities, as well as reasons for use, were assessed. Multivariable logistic regression models were applied to identify if predisposing, enabling and need for care characteristics described in the CAM Healthcare Model were associated with CAM use in the past year. Results: Long-term cancer survivors in the study (N=1,666) were predominately female (62%) and older (mean age=69.5), with breast (24%), prostate 26(%), colorectal (25%), ovarian (13%) and endometrial cancers (12%). Forty-two percent of survivors used CAM in the past year to relieve stress (28%), treat or prevent cancer from coming back (22%), relieve cancer-related symptoms (18%) and help deal with another medical condition (18%). Certain predisposing (i.e., female gender, higher optimism) and need for care factors (i.e., experienced cancer-related symptoms in the past two years, ever had depression/anxiety) were significantly associated with CAM use (p-values<0.05). Insurance coverage, financial resources, and receipt of cancer-related follow-up care were not associated with CAM use. Conclusions: Cancer survivors report a high prevalence of CAM use even years after their initial diagnosis. It is important for healthcare providers to be aware of the higher prevalence of CAM use among subgroups of cancer survivors (i.e., female, high in optimism, have experienced cancer-related symptoms, have a history of anxiety/depression) in order to communicate effectively about these modalities with their patients.
Prospective study of the effects of adjuvant breast cancer chemotherapy on taste function and food hedonics.
Authors: Boltong Anna , Aranda Sanchia , Keast Russell , Wynne Rochelle , Francis Prudence A. , Chirgwin Jacqueline H. , Gough Karla
Published: March 2020

e20536

Background: "Taste changes" are commonly reported by people receiving chemotherapy. It is unclear to what extent this relates to altered taste function or changes to other aspects of the eating and drinking experience such as food liking or appetite. Methods: Women (n = 52) prescribed adjuvant chemotherapy underwent testing of taste perception, appetite and food liking before, during and after chemotherapy. Taste sensitivity was measured by correct or incorrect identification of prototypical tastants sweet, salt, sour, bitter and umami. Perceived intensity of each tastant was measured on a 10cm Visual Analogue Scale. Liking of standard sweet and savory foods was measured on the 9-point hedonic scale. Appetite was measured on a 10-point scale. McNemar’s test was used to determine whether proportion of correctly identified tastants changed significantly from baseline at follow-up assessments. Mixed-effects models were used to estimate and test change in mean taste intensity, food liking and appetite from baseline at follow-up assessments. Results: Significant adverse effects were observed for taste identification, liking of sweet food and appetite close to chemotherapy administration. Notably different patterns of change were observed for identification of individual tastants. Conclusions: The demonstrated changes in taste function and food hedonics could be used to guide pre-chemotherapy education and have implications for dietary choice and nutritional outcomes. [Table: see text]
Comparison of the effects of subcutaneous APF530, intravenous granisetron, moxifloxacin, and placebo on the QT interval in humans.
Authors: Mason Jay , Moon Thomas E , O'Boyle Erin , Dietz Albert J
Published: March 2020

e20539

Background: This study evaluated effects of subcutaneous (SC) APF530 (sustained-release granisetron) and intravenous (IV) granisetron on placebo-adjusted change from baseline in QT corrected with the Fridericia method (QTcF) over 48 h (ddQTcF), using moxifloxacin as an active control. The FDA recently required a label warning regarding risk of QT prolongation by granisetron and other 5-HT3antagonists for chemotherapy-induced nausea and vomiting on the basis of anecdotal reporting. Methods: Normal healthy subjects received 1 of 4 treatments in a 4-period crossover: APF530 1 g SC (20 mg granisetron; 2 x therapeutic dose), IV granisetron 50 µg/kg (5 x therapeutic dose), oral (PO) moxifloxacin 400 mg, or placebo. Drugs were given at the start of each 10-day period. 12-lead ECGs and blood samples for pharmacokinetic evaluations were taken at prespecified times. Results: 51 subjects completed the study. APF530 had no clinically significant effect on QTcF. Maximum adjusted mean change (ddQTcF) was 3.75 ms for APF530 1 g at 3 h (Table). While CI excluded 0 at 3 and 12 h, upper boundaries of 6.89 and 6.70 ms were well below the level of FDA concern (10 ms). Mean APF530 Cmaxwas 35.8 ng/mL, twice that observed in patients receiving the standard dose. IV granisetron also had minimal effect on ddQTcF, while moxifloxacin produced the expected large change. Pharmacokinetic and pharmacodynamic modeling revealed a very small granistetron-ddQTcF gradient; the linear model predicted a ddQTcF value of 1.37 ms at the highest concentration observed in patients (97.8 ng/mL). Conclusions: No clinically significant QT prolongation occurred with SC APF530 up to 1 g, despite achievement of mean Cmax greater than that in previous studies. APF530 was well tolerated. Clinical trial information: NCT01416259. [Table: see text]
Effects of physical activity on symptoms in prostate cancer survivors.
Authors: Shedlock Kathleen , Porock Davina , Brown Jean K. , Burton Harold , Horvath Peter , Berry Donna Lynn
Published: March 2020

e20540

Background: Physical activity (PA) in prostate cancer (PC) survivors improves general QOL and fatigue, but the relationship between PA and genitourinary symptoms in PC survivors is unknown. The incidence of sexual dysfunction may be as high as 68% during active surveillance and 78% in men receiving conventional therapies. PA has mitigated erectile dysfunction in non-prostate cancer populations. Objective: To determine the relationships among PA, age, co-morbidities, mental and physical health and symptoms, particularly related to sexual dysfunction, experienced by men with PC prior to therapy. Methods: Study Design: Correlational/cross sectional secondary analysis of de-identified data from 258 men with early stage PC prior to initiation of therapy. Variables: Habitual PA (Baecke Questionnaire- BAQ), physical (PCS) and mental health (MCS) (SF-36) and urinary, bowel and sexual dysfunctional symptoms (UCLA Prostate Cancer Index). Analysis: Descriptive statistics; correlations; hierarchical regressions to assess moderating and mediating relationships. Results: Mean Age = 63.2 + 8.1 yrs. BAQ activity scores, ranged from 2.2 to 12.1 (M and SD= 6.8+1.9), indicating low levels of PA. PCI mean scores = 92+13, urinary; 88 +13, bowel; 52 +29 for sexual. PA was negatively correlated with sexual symptoms (r=0.31; p<0.001). Physical health was negatively associated with all symptoms and age, but positively correlated with PA (r=0.21; p=0.001). Physical health mediates effects of age for urinary symptoms and partially for sexual symptoms. PA’s relationship to sexual dysfunctional symptoms was independent of age and was at least partially mediated by physical health. Conclusions: Urinary, bowel and sexual symptoms experienced by men at time of diagnosis were similar to men of similar age without PC, indicating age as the dominant predictor of symptoms. This study identified potential mechanisms of symptoms in early stage PC that warrant further testing. Symptoms related to sexual dysfunction may be especially amenable to PA.
Self report assessment and support for cancer symptoms: Impact on hospital admissions and emergency department visits.
Authors: Berry Donna Lynn , Hong Fangxin , Blonquist Traci , Halpenny Barbara , Siefert Mary Lou , Partridge Ann H.
Published: March 2020

e20552

Background: Attending to symptoms and side effects promotes safe and effective delivery of cancer therapies. Educated and supported patients (Pts) may be able to self-manage symptoms (Sx) and know when to contact the clinician, avoiding emergency department visits (EDV) or hospital admissions (HA). The web-based Electronic Self Report Assessment for Cancer (ESRA-C) is an easy-to-use, automated program for assessing and teaching about symptom and quality of life issues (SQI) and has been shown to improve communication and reduce symptom distress over the course of active therapy. The purpose of this secondary analysis was to explore the impact of the ESRA-C intervention on rates of EDV and HA. Methods: AdultPts with all cancer types and stages treated in medical and radiation oncology at a comprehensive cancer center used ESRA-C to self-report SQI during new anti-cancer therapy, with summary reports delivered to clinicians. Patients were randomized to assessment-only ESRA-C (control) or the ESRA-C intervention adding self-monitoring and education and coaching between clinic visits. We analyzed group differences on EDV and HA using descriptive statistics and a two group unequal variance t-test. Results: Among 663 Pts, 34 out of 327 control Pts made 47 EDV vs 30 out of 336 intervention Pts made 42 visits. Likewise, 36 control Pts had 59 HA vs 36 intervention Pts who had 41 HA during the study duration. The majority of EDV (87%) and HA (88%) were Sx-related. The frequency of Sx-related events (EDV or HA) was higher in the control (n=94) vs the intervention group (n=71). The mean number of unplanned events were 0.29 and 0.21 per patient in the control and intervention groups, respectively (p=0.24). Conclusions: Although the trial sample size was not planned to test differences in EDV or HA, the ESRA-C intervention, compared with assessment alone, may have reduced symptom-related EDV and HA in a large sample of patients during active cancer treatment. If we are able to reduce Sx-related unplanned visits and admissions from more than 1 of 4 patients to 1 of 5 patients with an automated, patient-centered system, we can anticipate substantial cost savings when scaled to the volume of most comprehensive cancer centers. Clinical trial information: NCT00852852.
The effect of anesthesia choice on post-operative outcomes in women undergoing exploratory laparotomy for gynecologic malignancy.
Authors: Rivard Colleen Lee , Dickson Elizabeth Louise , Vogel Rachel Isaksson , Teoh Deanna Gek Koon
Published: March 2020

e20571

Background: The goal of this study is to examine how regional anesthesia choice in women undergoing laparotomy for gynecologic malignancy affects their pain and hospital stay. Methods: This single-institution retrospective review studied women undergoing exploratory laparotomy for suspected gynecologic malignancy from May to January 2013. Patients were in 1 of 3 groups: patient controlled analgesia (PCA), transversus abdominis plane (TAP) blocks with PCA or transthoracic epidural. Narcotic use and pain scale during the first 3 days after surgery, length of surgery, complications and length of postoperative stay were compared. P-values of <0.05 are considered significant. Results: One hundred twelve women were included (44 PCA, 30 TAP + PCA, 38 epidural). Those receiving TAP or epidural tended not to use narcotic prior to surgery, though not a statistically significant result. The length of surgery and estimated blood loss were not different between groups; however, the rate of intra-operative complications differed by pain management method (p=0.020), with those who received an epidural had the lowest rate. In the epidural group, median IV narcotic use (mg) was significantly decreased for the first three post-surgical days (day 1 p =0.014; day 2 p <0.0001; day 3 p = 0.048). Those with epidurals also had significantly lower pain scales on the second and third post-operative days compared to those with TAP or PCA alone (day 2: p=0.046; day 3: p =0.008). After adjusting for age and complications arising both during and after surgery, TAP placement increased the length of hospital stay slightly by 0.35 days (95% CI: 0.07-0.62 days, p=0.014). Conclusions: The use of epidural anesthesia for post-operative pain management in surgery for gynecologic malignancy decreases narcotic analgesia use and improves pain scale measurements without increasing complications or length of hospital stay. Further investigation with prospective randomized trials is warranted to elucidate the optimal post-operative pain management technique.
Impact of age on treatment and survival in patients with small cell lung cancer.
Authors: Takhar Harminder Singh , Sukumaran Shawgi , Ly Marleesa , Karapetis Christos Stelios , Roy Amitesh Chandra , Kichenadasse Ganessan , Koczwara Bogda
Published: March 2020

e20577

Background: Elderly patients are underrepresented in clinical trials, yet account for significant group with small cell lung cancer (SCLC). We examined if the age of the patients, <70yrs vs >70yrs, impacted outcome. Methods: SCLC pts were identified by searching the hospital cancer registry from 1999 to 2009. Pt characteristics, management and outcomes were collated by reviewing clinical records. Survival analysis was performed. Results: From 168 SCLC pts, 49 (27 males, 22 females) had limited stage (LS) and 113 (71 males, 42 females) extensive stage (ES) SCLC. LS cohort, 27 pts were <70yrs and 22 were >70yrs. The overall group survival was not statistically different, with median overall survival of 12.4 months for <70yrs and 7.8 months for >70yrs (p=0.064). However, 44 pts who had active treatment, including chemoradiotherapy, chemotherapy alone, radiotherapy alone, there was statistically improved survival between <70yrs vs >70yrs of 12.8 months vs 8.2 months (p=0.05). There was no significant difference in proportion of pts who received active treatment between the two groups (96.2% vs 95.4% p =0.882). The number of pts completing treatment was not statistically different between the two age groups (70.8% vs 54.5% p = 0.53) In the ES cohort, 45 pts were <70yrs and 68 were >70yrs. The overall group survival was significantly worse in the >70yrs with MOS 3.8 months for >70yrs and MOS 6.9 for <70yrs (p=0.0087). In pts who had active treatment, significantly higher proportion of pts <70yrs received active treatment, including chemoradiotherapy, chemotherapy alone and radiotherapy alone, (77% versus 69%, p= 0.015). In pts who had active treatment, the survival was not statistically different, MOS <70yrs 7.4 months vs >70yrs 5.9 months (p= 0.088). Significantly less pts >70yrs vs <70yrs completed treatment (20% versus 39% p = 0.032). Conclusions: In LS SCLC, comparing treated patients <70yrs vs >70yrs, patients >70yrs had reduced survival, this may be related to patient factors or tumour biology. In ES SCLC, comparing patients<70yrs vs >70yrs, patients >70yrs had worse survival overall, less likely to receive active treatment and less likely to complete treatment, again this may reflect a difference in patient factors or tumour biology.
Characteristics and outcomes of patients admitted to the acute palliative care unit (APUC) from the emergency center (EC) versus inpatient transfers (IP).
Authors: Shin SeongHoon , Bruera Eduardo , Hui David , Kwon Jung Hye , Chisholm Gary B. , San-Miguel Maria Teresa , Allo Julio , Yennurajalingam Sriram , Frisbee-Hume Susan
Published: March 2020

e20581

Background: Most patients admitted to APCU are transferred from inpatient oncology units. We hypothesized that EC admissions have different symptom burden and outcomes compared to IP patients. In this retrospective cohort study, we compared the symptom burden and survival between the EC and IP groups. Methods: Among all 2,568 patients admitted to our APCU between September 1, 2003 and August 31, 2008, 312 (12%) were EC patients. We randomly selected 298 IP patients as controls. We retrieved the patient demographics, cancer diagnosis, Edmonton Symptom Assessment Scale (ESAS), discharge outcomes, and overall survival from time of admission. Results: EC patients were more like to be black (22% v 11%, p=0.0006) and less likely to have hematologic cancer (5% v 14%, p=0.0003). EC patients had higher pain (5.4 v 4.6, p=0.0004), fatigue (6.7 v 6.1, p=0.0049), nausea (2.7 v 1.6, p<0.0001), insomnia (4.8 v 4.2, p=0.03) and were less likely to be delirious (41% v 55%, p=0.001). EC patients had more public insurance (44% v 38%, p=0.0142), more home discharge (29% v 11%, p=0.0001), longer admission (8 v 7 days, p=0.0002), and were 2.3x as likely to be discharged alive as compared to IP patients (p<0.0001, Wald Chi-square test). Kaplan-Meier plots and log-rank test for survival from admission of APCU for EC and IP groups were not statistically significant (Median survival after admission were 34 v 31 days, p=0.08). In multivariate analysis, EC admission (OR= 1.9, 1.2-3.0), wellbeing (OR=1.12, 1.02-1.23), dyspnea (OR=0.85, 0.79-0.92) and delirium (OR=0.39, 0.24-0.64) were independently significant for being discharge alive. The c-statistic value was 0.71. Conclusions: EC patients have higher acute symptom burden, but more likely to be discharged alive as compared to IP transfer patients. The APCU is successful at managing symptoms and facilitating discharge to the community for EC patients. [Table: see text]
Advanced pancreas and hepatobiliary (PHB) cancer patients’ impressions regarding cardiopulmonary resuscitation (CPR).
Authors: Epstein Andrew S. , Shuk Elyse , Gary Kristen , O'Reilly Eileen Mary , Volandes Angelo E.
Published: March 2020

e20586

Background: Most cancer patients desire information about medical options at the end of life, including CPR. Such communication is part of advance care planning (ACP). Our prior studies with video educational media have produced data on patients’ categoric preferences (yes/no/unsure) for CPR, however, the thematic underpinnings of these preferences in patients with advanced cancer are not known. Methods: Qualitative thematic content analyses were performed on participants’ verbatim responses to the question “Do you have any questions or concerns?” at the end of participating in a randomized trial (quantitative data reported in full, Epstein, ASCO 2012) of an educational video (V) or narrative (N) about CPR in patients with advanced PHB cancers. Participant responses were independently coded and categorized for thematic content by two reviewers (ASE, ES). To maximize internal validity, reviewers jointly compared and reconciled differences in analyses. Results: Of 54 study participants, 26 total (41% of V arm, 56% of N arm) articulated questions, comments, or both. From these 26, 1-3 (median=1) themes were generated from each participant. There were no appreciable differences in the content or number of themes between the N and V arms. Joint analysis demonstrated thematic consensus and resulted in seven distinct themes listed in decreasing order of prevalence: (1) information about CPR affirmed existing personal beliefs/knowledge/values (many wanted to forgo CPR); (2) participants were apprehensive about ACP but wanted to discuss it; (3) ACP should be started early; (4) CPR information was helpful/acceptable; (5) physicians should be involved in ACP; (6) gaps in knowledge emerged; and (7), medical questions arose. Conclusions: The comments of these advanced PHB cancer patients demonstrate receptivity to the topic of ACP despite it being hard to discuss. These data indicate that ACP is a helpful and desired process ideally begun early by clinicians, and that video education is an appropriate and affirming conversation starter. The themes generated here will be incorporated into our future ACP studies on the relationships between cancer patient values and education about care options. Clinical trial information: NCT01105806.
Adherence reporting in phase III trials of approved oral anticancer agents: A systematic review.
Authors: Harvey R Donald , McKibbin Trevor , Behera Madhusmita , Ramalingam Suresh S
Published: March 2020

e20596

Background: With the increasing number of orally administered anticancer agents, evaluation of treatment adherence is critical to assess efficacy and adverse events. When patients enrolled in registration clinical trials do not adhere to the investigational agent(s), conclusions made regarding efficacy and safety may be inaccurate and translate poorly to broader use. We performed a systematic review of adherence reporting in phase III trials of oral anticancer agents. Methods: We selected all oral anticancer agents approved by the FDA between 1996 and 2012. A PubMed search for generic name, with limits to "title" and "clinical trials", was performed. Publications from phase III trials were identified from the results. Medication adherence data were abstracted searching for the roots “compli” and “adher” and were categorized as follows: 1) mentioned or not, 2) methods described or not and 3) results reported or not. Results: Overall, publications or reports with 24 agents were identified. The search strategy yielded 5383 articles, of which 504 reporting on phase III trials were included for analysis. Of these, 106 (21%) mentioned either adherence or compliance to medications. Only 33 (7%) publications described methods of measuring adherence (e.g., diaries, interviews, pill counts), while 37 (7%) reported medication adherence results. Trials specifically identifying quantitative or qualitative rates of adherence in phase III trials involved abiraterone, anastrozole, capecitabine, dasatinib, exemestane, imatinib, lapatinib, letrozole, tamoxifen, thalidomide, topotecan, and toremifene (50% of agents). Within the 37 trials reporting adherence, 12 were qualitative (e.g., excellent, poor), 23 were quantitative, and 2 used pharmacokinetically-defined adherence measures. Conclusions: Medication adherence is infrequently reported in phase III trials of oral anti-cancer agents, leading to a knowledge gap in translation to clinical use. Our study underscores the need for standard metrics on measuring and reporting adherence to oral anticancer agents.
Results from a structured interprofessional palliative care rehabilitation program in oncology.
Authors: Chasen Martin Robert , Feldstain Andrea , Gravelle Debbie , MacDonald Neil , Pereira Jose
Published: March 2020

e20598

Background: Post-treatment patients with active cancer face considerable burden from the effects of both disease and treatment. The Palliative Rehabilitation Program was designed to ease those challenges and to improve the patient’s functioning. The current study evaluated the changes in function scores of patients with advanced cancer upon completion of the structured program and examined the medical predictors of program completion. Methods: Referrals for 173 patients who were finished anticancer therapy were received. One hundred and thirty six patients were eligible and enrolled in the eight-week interprofessional palliative rehabilitation program. Of those, 84 completed the program. Measures of physical, nutritional, social and psychological functioning were evaluated at entry and completion of the program. Results: Significant improvements were experienced in physical performance (P =0.000), nutrition (P =0.000), symptom severity (P=0.005 to P= 0.000), symptom interference in functioning (P =0.001 to P=0.000), and fatigue (P=0.001 to P=0.000). Reasons for not completing the program were: disease progression, geographical inaccessibility, being too well, dying, and personal/unknown reasons. A normal CRP level (<10mg/L; P=0.013) was a predictor of program completion. Conclusions: Patients living with advanced heterogeneous cancers who underwent an interprofessional palliative rehabilitation program experienced significant improvement in their functioning in many domains. Program completion can be predicted by normal CRP level.
Recurring breast and arm cellulitis in patients with early breast cancer.
Authors: Cheema Faisal , Agloria Maliha , Mills Glenn Morris , Shi Runhua , Li Benjamin , Chu Quyen , Kim Roger Hoon , Ampil Fred , Burton Gary Von
Published: March 2020

e20600

Background: Breast and arm cellulitis (BAC) is a recognized risk following treatment for early stage breast cancer with case reports suggesting an incidence <3%. However, there is limited information relative to risk factors, management, recurring BAC and outcome. We reviewed all incidences of BAC in patients (pts) with early stage breast cancer seen at our institution and correlate with co-morbid conditions, recurrent BAC events and treatment outcomes. Methods: A review of all pts with Stage I-III breast cancer seen between 2001-2011 identified pts with at least 1 episode of BAC. Data on age, race, stage, treatments, co-morbid conditions, lymphedema, incidence and recurrence of cellulitis, and antibiotic (Abx) therapy was extracted. We defined incident BAC to occur >30 days post chemotherapy/radiation completion. Chi-square test was used to assess variables associated with BAC recurrence. Results: 391,603 breast cancer pts (2.5%) were identified with BAC with median age 59 years. The median interval between completion of primary treatment and incident cellulitis was 330 days (30 – 3,650 days). 13 out of 39 pts (33%) had recurring BAC (range 1-7 events). Median duration of Abx therapy was 30 days (7 – 2,190). Lymphedema (p=0.04), chemotherapy (p=0.01), Stage > I (p=0.02) and initial poor response to Abx (p=0.003) were significantly associated with recurring BAC. Positive bacterial cultures were obtained in 4 of 62 BAC events. Initial Abx failure was lowest with vancomycin (Vanc). A protracted course (30 days) of oral Abx after initial Vanc was associated with a lower risk of early recurrence. Chronic Abx therapy, for pts with 3 episodes, appeared to reduce subsequent recurrent episodes. Conclusions: Results indicate that while BAC is relatively uncommon following breast cancer therapy, pts with BAC are at significant risk for recurring events. Lymphedema, higher stage and initial poor response to Abx proofed as parameters for recurrence. Despite treatment with Abx a significant number will have recurring events. For pts presenting with these variables we recommend a protracted course of initial Abx. Pts with recurring BAC should receive chronic Abx suppressive therapy. This approach was associated with good long term control in our pts.
Effect of chemotherapy on fatigue and presence of TNF- in breast cancer patients.
Authors: Fonseca Fernando Affonso , Cruz Felipe Melo , Lerner Tatiana Goberstein , Cubero Daniel Iracema , Alves Beatriz da Costa Aguiar , Souza Flavia , Kunyioshi Renata , Del Giglio Auro
Published: March 2020

e20601

Background: Chemoterapy induced fatigue (CRF) is a common complain and few studies assessed so far the role of inflammatory biomarkers as predictors of CRF. OBJECTIVE: The primary objective of our study is to evaluate potential biomarkers of CRF in breast cancer (BC) patients receiving adjuvant Chemotherapy (CHT). Methods: Thirty-seven localized BC patients (clinical stages I-III) consecutively treated at the oncology service of Faculdade de Medicina da Fundação ABC were enrolled in this study. All patients received doxorubicin and cyclophosphamide based chemotherapy. Before the beginning of chemotherapy and before the second cycle, all patients answered the BFI (Brief Fatigue Inventory) questionnaire. The following inflammatory markers were collected: C-reactive protein (CRP), tumor necrosis Factor alpha (TNF-α) and interleukin 6 (IL-6). We correlated these inflammatory markers with BFI scores of each patient before and after cycle 1 and cycle 2 of chemotherapy. Results: The mean values of the inflammatory markers were: CRP 4.58 mg/dL (IC 95% 3.17-5.90), TNF-α 11 mg/dL ( IC 95% 8.84-13.79) and IL-6 3.74 (IC 95% 1.93-5.54). We observed a positive correlation between the BFI scores and TNF-α (p=0.0201). Conclusions: TNF-α may represent a potential CRF biomarker. Future studies may elucidate the potential usefulness of TNF-α for monitoring the anti-fatigue effects of new drugs for the treatment of CRF.
Traditional Chinese medicine (TCM) utilization among cancer survivors.
Authors: Chien Chun-Ru , Shih Ya-Chen T. , Liao Yu-Min , Su Shan-Yu
Published: March 2020

e20604

Background: We investigated the utilization patterns of traditional Chinese medicine (TCM) among general cancer survivors before and after their cancer diagnosis when compared to normal population. Methods: Using population-based claim database, we identified 87249 cancer survivors diagnosed within 2000-2004 and 87,237 matched controls. We obtained information on TCM utilization 2 years before and after their diagnosis. We quantified the utilization of TCM in two ways: initiation (any use in a specific year) and intensity (visit counts per year). Descriptive analysis was applied to explore the trends in initiation and intensity for all cancer and controls as well as each major cancer sites separately. Results: TCM intensity (mean annual visits, with 95%CI) was increased substantially (23%) for general cancer survivors after diagnosis: from 1.58 (1.55-1.61) for 1~2 years before diagnosis to 1.94 (1.9-1.98) for 2nd years after diagnosis, in contrast to the minor increase (10%) for the control group. For most of the major cancer sites, the initiation rate of TCM among cancer survivors increased before diagnosis then gradually returned to around baseline afterward, whereas the intensity increased gradually after diagnosis. The initiation and intensity for the control groups was relatively stable during the corresponding periods. Conclusions: We found that the initiation of TCM was increased in the pre-diagnostic period and the intensity of TCM gradually increased after diagnosis when compared to normal population. Further research is needed to explore whether TCM, or more broadly CAM, can either serve as a clinical alter or bring additional benefits to these patients.
Fosaprepitant-induced phlebitis: A focus on patients receiving doxorubicin/cyclophosphamide therapy.
Authors: Leal Alexis D. , Kadakia Kunal C. , Looker Sherry , Hilger Crystal , Sorgatz Kristine , Anderson Kari , Jacobson Alison , Grendahl Darryl , Seisler Drew K. , Hobday Timothy J. , Loprinzi Charles L.
Published: March 2020

e20605

Background: Intravenous (IV) fosaprepitant is a potent antiemetic, commonly used in patients receiving chemotherapy. The purpose of this study was to investigate the incidence of IV fosaprepitant-associated infusion site adverse events (ISAEs) among a cohort of breast cancer patients receiving doxorubicin and cyclophosphamide (AC) chemotherapy at Mayo Rochester. Methods: A retrospective review of electronic medical record (EMR) data was performed for all patients who were initiated on AC chemotherapy from January 2011 to April 2012. Data collected from the EMR included baseline demographics, antiemetic regimen, documentation of ISAEs and type of IV access (peripheral vs. central). Descriptive statistics (mean and standard deviation or percentages) were summarized overall and by type of IV access and initially administered antiemetic. Results: 148 patients were included, with a median age of 54 years (range 28-76). 98 patients initially received IV fosaprepitant; 44 oral aprepitant; 6 neither. 132 (89%) initially had peripheral IV access and 16 (11%) had central venous access. Overall, 33 patients (34%) experienced an IV fosaprepitant associated ISAE including: erythema (n=22), pain (n=26), swelling (n=12), infusion site hives (n=5), extravasation (n=4), deep venous thrombosis (n=3), superficial thrombosis (n=7), phlebitis/thrombophlebitis (n=5), venous discoloration (n=1), venous engorgement (n=1), venous hardening/induration (n=4) and local scarring (n=1). Only 1 patient (2%) experienced an oral aprepitant associated ISAE, which was infusion site pain. This patient had previously had a fosaprepitant associated ISAE at the same site. All experienced ISAEs occurred in patients with peripheral IV access. Conclusions: The incidence and severity of ISAEs associated with IV fosaprepitant administration among a group of patients receiving doxorubicin/cyclophosphamide chemotherapy is significant and is appreciably higher than what has been noted in other reports. The higher incidence observed is likely related to the predominance of peripheral venous access used in the studied cohort.
Platinum-containing regimens as front-line treatment of advanced non-small cell lung cancer in two groups of elderly (≥ 70 year old) patients of different age.
Authors: Giuliani Jacopo , Bonetti Andrea , Mercanti Anna , Furini Lara , Durante Emilia , Greco Filippo , Trolese Anna Rita , Piacentini Paolo , Moratello Giacomo , Tognetto Michele
Published: March 2020

e20617

Background: Elderly patients with advanced Non-Small Cell Lung Cancer (NSCLC) are underrepresented in clinical trials. Therefore we sought to evaluate the impact of a platinum-based doublet, given as a front-line chemotherapy, in two groups of elderly patients of different age with advanced NSCLC. Methods: A retrospective analysis of all consecutives elderly patients ( ≥70 year old) with advanced NSCLC who received a platinum based doublet as front line therapy at our Medical Oncology Unit from February 2005 to September 2011 was performed. The general case study was divided in two groups of patients of different age: “young-old” patients (70-74 year-old) and “old-old” patients (75-81 year-old). Results: Sixty-two consecutive elderly patients with advanced NSCLC were included in this study. Forty patients (65%) were “young-old” patients (group 1, median age 72 years) and 22 (35%) were “old-old” patients (group 2, median age 77 years). Overall, a total of 249 cycles were administered to the 62 patients; 164 cycles were administered to patients in group 1 and 85 cycles were given to patients in group 2; median number of administered cycles per patient was 4 (range 1-6) in both groups. Relevant clincal variables such as sex, stage, ECOG PS, Charlson score and histology were evenly distributed between the two subgroups. Regarding the type of first line chemotherapy, the great majority (92%) was treated with a carboplatin-containing regimen while only five patients (8%) received a cisplatin-based doublet: notably, all these patients are in group 1. Toxicity was mild, with grade 3-4 neutropenia in 17% of group 1 patients and in 9% of group 2 patients. Median OS was 9.8 months in both groups. Conclusions: This retrospective evaluation shows the safety and efficacy of a platinum-based doublet given as first-line chemotherapy in elderly advanced NSCLC patients. For several reasons, including the ease of administration, carboplatin is the preferred platinum analogue. The combination with vinorelbine or gemcitabine is associated with a very good toxicity profile that does not seem to have a detrimental effect on efficacy.
Iyengar yoga compared to exercise in women with stage I-III breast cancer: Feasibility of therapeutic interventions during adjuvant cytotoxic or endocrine therapy.
Authors: Wiedemann Florian , Buessing Arndt , Halle Martin , Kiechle Marion , Kohls Nikola , Ostermann Thomas , Sattler Daniel , Ettl Johannes
Published: March 2020

e20623

Background: Exercise and mind/body intervention studies have shown benefits when undertaken during cancer treatment. This ongoing trial aims to elucidate the different effects of yoga and conventional exercise on physical and psychological factors in breast cancer patients undergoing endocrine or cytotoxic therapy. This first interim analysis presents feasibility data comparing the two mentioned interventions. Methods: Patients are randomly assigned to receive Iyengar-yoga or conventional exercise on a 1:1 ratio during adjuvant therapy. The intervention consists of a weekly 60-minute yoga or physiotherapy exercise session together with individual home-based, self-contained 20-minute sessions twice a week. Data assessments via questionnaires are done at baseline, right after the 12-week intervention period and 2 months after the end of intervention. Patient accrual within two breast care units started in April 2011 with 66 patients being on study to date (2013, Jan 25). Results: So far, 57 patients (yoga: n=28; exercise: n=29) have completed the trial, while 9 patients dropped out (yoga: 5 patients; exercise: 4 patients). 46 patients received cytotoxic therapy (mean age: 48 y) and 11 patients received endocrine therapy (mean age: 60 y). 8 women participating either in yoga or exercise intervention were younger than 35 years (14%) and 6 women were older than 65 years (11%). Mean number of attended sessions is 9.0 (yoga: 9.3; exercise: 8.8; age >65: 10.3). Overall 19 patients (33%) attended 11-12 out of 12 sessions (yoga: 32%; exercise: 35%; age >65: 67%), 20 patients (35%) attended 8-10 sessions (yoga: 54%; exercise: 17%; age >65: 17%), while 18 women (32%) participated only in 5-7 sessions (yoga: 14%; exercise: 48%; age >65: 17%). 10 out of 51 participants accomplished 40 minutes of home-based training per week (yoga: 11%; exercise: 29%; age >65: 50%). Conclusions: Yoga and exercise interventions are feasible during cancer treatment, although amount and frequency of training should be accommodated to individual condition. Both interventions seem to be practicable for elderly (> 65 years) patients and for patients undergoing cytotoxic therapy.
A phase II pilot study of fosaprepitant (F) for the rescue of acute nausea and vomiting with moderately (MEC) or highly emetogenic chemotherapy (HEC) in adults.
Authors: Bubalo Joseph S. , Schnadig Ian D. , Meyers Gabrielle , Chen Andy I. , Hayes-Lattin Brandon M. , Ryan Christopher W. , Digregorio Jocelyn , Maziarz Richard T.
Published: March 2020

e20627^

Background: Patients receiving MEC or HEC continue to have breakthrough nausea and emesis despite antiemetic prophylaxis. Few trials have evaluated the efficacy of rescue antiemetics after failed prophylaxis. F, a prodrug of the neurokinin-1 antagonist (NK1a), aprepitant is FDA-approved for the prevention of acute and delayed nausea and vomiting associated with MEC and HEC. F’s safety and efficacy in the prophylactic setting make F an attractive potential rescue therapy. Methods: F 150mg was infused as the initial rescue agent in eligible patients receiving MEC or HEC who had either emesis or nausea despite guideline-based prophylaxis with a 5HT-3 antagonist and dexamethasone. The primary endpoint was improved nausea on a visual analogue scale (VAS) at 2 hours. Secondary endpoints included: VAS at 12 and 24 hrs, rescue medication use, emesis, nutritional intake, adverse events, and proof of the study design as a viable methodology. Results: Eleven adult patients, 6 males and 5 females, were treated per protocol and evaluable for the 24 hour study period. Chemotherapy regimens included HiDAC, R-CHOP, epirubicin/ifosfamide, EPOCH, R-ICE, 7+3, VAC, and HyperCVAD. 3 patients were treated for emesis and 8 for nausea. 91% of patients had improved nausea at 2 hrs, 100% at 12 hrs and 63.6% at 24 hrs. F prevented further emesis in 2 of 3 patients and no patient with initial nausea had subsequent emesis. 9 of 11 (81.8%) patients required additional rescue medication during the study period, mainly due to nausea. Appetite was improved in 8/11 patients. Food and fluid intake improved in 5/11. Adverse effects included headache 18%, dizziness 18%, hiccups 9%, indigestion 9%, and 1 case ifosfamide encephalopathy. The study design required greater than anticipated consented patients due to the success rates of standard antiemetic therapy. Conclusions: F improves breakthrough nausea and related symptoms, and may prevent further emesis but was suboptimal as a single agent in that the majority of patients required a second rescue agent within 24 hrs. Complete response, defined as no emesis and no rescue therapy, may be a more clinically relevant primary endpoint in future trial designs. Clinical trial information: NCT00939302.
Health care worker attitudes about clinical trials at a comprehensive cancer center.
Authors: Campagnaro Erica Leigh , Margevicius Seunghee , Daly Barbara J. , Eads Jennifer Rachel , Kinzy Tyler G. , Liu Tasnuva Munir , Manne Sharon , Miller Dawn M. , Schluchter Mark D. , Meropol Neal J.
Published: March 2020

e20633

Background: Cancer patient (pt) participation in clinical trials (CT) is low. Little is known about the beliefs and attitudes of health care workers (HCW) and how they impact intention to discuss CT with pts. The overall goal of this project was to develop a conceptual model to guide future interventions to enhance communication about CT between HCW and cancer pts. Methods: Two email surveys of non-physician HCW at an NCI-designated comprehensive cancer center were conducted. The first was sent to a random sample of 150 HCW. The second was sent to 80 who completed the first survey. Based on our prior work (Eads et al. ASCO 2011) and Ajzen’s Theory of Planned Behavior, domains of the first included CT knowledge (19 items, agree/disagree) and attitudes (27 items, 5-point Likert); the second included normative beliefs about institutional attitudes toward CT (6 items, 5-point Likert), self-efficacy about engaging in discussion about CT (14 items, 5-point Likert), and intention to discuss CT with pts (4 items, 7-point Likert). Results: 41 HCW completed both anonymous surveys; 27 could be matched by demographics. Median age of matched respondents was 44.3 yrs (range 24-63), 26 female, 22 caucasian, 9 nurses. Overall, CT knowledge was high (median 17/19 items correct). There were strong associations between attitudes and self-efficacy (Spearman r=-0.425, p=0.03), as well as perceived normative beliefs and self-efficacy (r=0.651, p=0.0002). These associations were strong amongst nurses (r=-0.818, p=0.007 and r=0.656, p=0.05, respectively), with a particularly strong correlation between self-efficacy and intention to discuss clinical trials with pts (r=0.891, p=0.001). Conclusions: In spite of a small sample size, these pilot data strongly support a behavioral framework to understand and address the impact of HCW attitudes and beliefs about CT on discussions of CT with pts. Insofar as HCW (especially nurses) have substantial pt contact, and serve as a resource for pts regarding treatment decisions, educational interventions to address HCW barriers to discussing CT with pts (i.e. attitudes, beliefs, and self-efficacy) could positively impact pt attitudes and improve decision making.
Samarium-153 effectiveness in the quality of life of bone metastatic cancer patients.
Authors: Tsoukalas Grecory , Tzovaras Alexandros , Tsoukalas Nikolaos , Stamatopoulou Sofia , Gatsos George , Kountourakis Pantelis , Mpaziotis Nikos , Mystakidou Kuriaki
Published: March 2020

e20635

Background: Osseous metastases in patients suffering from cancer, is a multifactor symptom which affects quality of life. Methods: The Samarium group (SG) n=53 patients received a single bolus infusion of (153)Sm (37 MBq/kg), and we compared with a Control group(CG) n=37. Both groups of patients who had metastatic bone cancer requiring analgesia answered the following questionnaires: Greek Brief Pain Inventory (GBPI), Brief Multidimensional Life Satisfaction Scale (BMLSS), Hospital Anxiety Depression Scale (HADS), ECOG/WHO/Zubrod score and Hospital Satisfaction Scale (HSS),day 0 and 30±3 days after the intervention start.There was no statistically significant(SS) difference for the variables(V-) sex, age, pain’s localization and lodging. Results: Pain severity and pain interference change over time was the same for both groups P= 0.0005. For the V- HADS-anxiety, SG showed no SS improvementP= 0.397, something which was achieved for the CG,P= 0.031. The V- HADS improved SS for both groups P= 0.031 and P= 0.003 respectively which changed over time with the same way. This may show the strong relation between pain and depression. The V- ECOG also changed over time in the same way for both SG(P=0.005) and CG (P=0.014). The percentage of patients who changed scale towards improvement for their quality of life was 24,3% for the CG and 15,1% for the SG. The V-BMLSS change over time was similar for both groups. There was no SS difference for the V-HSS towards medical and nursing personnel for both groups (P=1.000). Myelotoxicity for the SG was moderate and reversible, as well as the side effects for the CG. Finally an equivalence test between the two groups, showing that both treatment regimens were equivalent for all variables: Pain severity=0.034, Pain interference=0.009, HAD-anxiety P=0.048, HAD-depression=0.033, BMLSS=0.016, ECOG=0.0005. During our study among the patients of the SG in some cases the stabilization of bone lesions was observed, and in one case partial and/or complete remission. Conclusions: Administration of (153)Sm is another equivalent option for those patients who are intolerant or resistant to medication treatment having a better cost-effectiveness result.