bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of an outpatient interdisciplinary team (IDT) consultation on symptom clusters in advanced cancer patients seen at a supportive care outpatient clinic (OSC) in a tertiary cancer center
Authors: Yennurajalingam S. , Urbauer D. L. , Chacko R. , Hui D. , Amin Y. A. , Evans A. C. , Orihuela C. , Casper K. L. , Poulter V. , Coldman B. , Bruera E.
Published: August 2020

e20542

Background: Advanced cancer patients develop severe physical and psychosocial symptom clusters. There is limited data on the impact of an outpatient interdisciplinary team (IDT) consultation lead by palliative care specialists on symptom clusters. Cluster composition and consistence, response rate and predictors of response are unknown. Methods: 914 consecutive patients with advanced cancer presenting in the OSC from Jan 2003 to Oct 2008 with a complete Edmonton symptom assessment scale at the initial and follow-up visit (median 14 days, range 1–4 wks), and CAGE status (alcohol screening) were reviewed. Wilcoxon ranked sign test was used to determine whether symptoms changed over time. Principal components factor analysis with varimax rotation was used to determine clusters of symptoms at baseline and at follow-up. The number of factors calculated was determined based upon the number of eigen values that were greater than one. Results: Median age was 59 yrs, female were 46%. The most common primary cancer was Lung (19%). Baseline and follow-up visit scores (mean, SD) were: fatigue 5.7 (2.1) and 5.2 (2.2, p<0.0001), pain 4.9 (2.6) and 4.1 (2.6 p<0.0001), nausea 1.8 (2.4) and 1.7 (2.3, p=0.1), depression 2.6 (2.5) and 2.2(2.4,p<0.0001), anxiety 2.9 (2.7) and 2.4 (2.4, p<0.0001), drowsiness 3.2 (2.8) and 3.2 (2.6, p=0.7), dyspnea 2.6 (2.7) and 2.4 (2.6), p=0.0027), appetite 4.2(2.7) and 3.9 (2.7, p<0.0001), sleep 4.2 (2.6) and 3.8 (2.6, p<0.0001) and well being 4.3 (2.5) and 3.9 (2.3, p<0.0001). During the follow- up the symptom clusters varied from a 3 factor to a 2 factor model, reflecting the impact of the IDT on symptom burden. CAGE positive and CAGE negative patients had a significantly different symptom cluster model. Conclusions: Cluster composition differs when patients are assessed and managed by an IDT and among patients who screen positive for alcoholism.

[Table: see text]

No significant financial relationships to disclose.
Effect of oral aprepitant in management of delayed chemotherapy-induced nausea and vomiting (DCINV) after high-dose chemotherapy (HDC) and hematopoietic stem cell transplant (HCT)
Authors: Isola L. M. , Goldberg G. , Chandra G.
Published: August 2020

e20548

Background: This study assessed the safety and efficacy of Aprepitant, a neurokinin 1 receptor antagonist, in the management of DCINV associated with HCT. Methods: Pilot phase I-II RCT, adult patients undergoing ablative HCT. Eligibility Criteria: Presence of DCINV (>1 episode of vomiting/24 hrs or >25 mm on nausea visual analogue scale (VAS) on day 2–14 post- HCT). Control arm: ondansetron + metoclopramide. Aprepitant arm: Same regimen + aprepitant 125 mg on d1 and 80 mg d2–3. Controls with DCINV persisting >72 hours were crossed to treatment arm. Safety endpoints: Primary: myeloid engraftment (ANC>500/μL by d15.) Secondary: platelet engraftment (plts >20,000/μL by d21.) Efficacy endpoints: Primary: no episodes of emesis. Secondary: VAS reduction ≥ 25 mm Results: 12 pts, ages 23–62 yrs, were randomized, 9 to treatment arm. Two of 3 controls crossed over. The study was interrupted prior to completion of accrual to control arm. Results are summarized as median ± SD in the table below. Treatment arm showed no delay in granulocyte and platelet engraftment, less emesis, and little difference in VAS compared to control. No patients in either group developed unexpected grade III-IV toxicities, including VOD or IPS. Conclusions: The use of aprepitant for control of DCINV after myeloablative HCT decreased the frequency of DCINV and had no adverse effect on granulocyte and platelet engraftment. This pilot study supports the safety and efficacy of aprepitant for DCINV in the setting of HCT.

[Table: see text]

[Table: see text]
Survival prediction and frequency of anticancer treatment (ACT) near the end of life in patients hospitalized due to acute conditions (AC)
Authors: Numico G. , Occelli M. , Fea E. , Granetto C. , Di Costanzo G. , Colantonio I. , Gasco M. , Garrone O. , Polla V. , Merlano M.
Published: August 2020

e20558

Background: Recent literature suggests that ACT near the end of life is increasingly common. Although the reason is complex, we hypothesize that AC impair the formulation of prognosis. The PaP score was shown to predict 1-month survival for terminally ill pts. Its application to pts with AC is object of debate. We evaluated the frequency of ACT near the end of life and assessed the value of PaP score and of other clinical parameters in predicting survival in pts with AC. Methods: All pts admitted due to AC in a Department of Medical Oncology in a 9-month period were included. Pts and disease features (site of primary, stage of disease, disease control), previous and current ACT, cause of admission (diagnosis without a previous history of cancer; treatment-related toxicity; cancer- related symptoms) were assessed. The PaP score was calculated using physicians’ survival prediction, Performance Status (PS), anorexia and dyspnea, total WBC and lymphocyte percentage. Results: 208 pts were evaluated: local disease 24%, advanced 76%; ACT 60%, off-treatment 40%; disease controlled 9%, non controlled 91%; cause of admission: diagnosis 19%, toxicity 17%; symptoms 64%. PaP score: group A 78%, B 18%, C 4%. Overall, median survival was 19 weeks (95% I.C. 13,3 to 24,6) and 12-week survival was 59,6%. Of the pts admitted during ACT 11% died within 4 weeks and 32% within 12 weeks. Among the 39 pts died within 4 weeks, 33% were on ACT. Cause of admission, disease control, treatment, and PaP score predicted 12-week survival in the multivariate analysis. However, only PS < 30, and PaP group B and C identified pts with a 12-week survival lower than 30%. Conclusions: ACT in the last period of life is common. During AC only a minority of pts has such a dismal prognosis that treatment withdrawal is justified. The potential reversibility of AC renders prognostic measures inadequate to make treatment decisions.

No significant financial relationships to disclose.
Radiographic and clinical factors associated with improved outcomes in cancer patients with bowel obstruction
Authors: Contreras C. M. , Badgwell B. D. , Askew R. L. , Feig B. W. , Cormier J. N.
Published: August 2020

e20564

Background: The purpose of this study was to identify clinical and radiographic factors relevant to treatment outcomes in cancer patients presenting with bowel obstruction. Methods: Clinical and radiographic factors were retrospectively abstracted from records of inpatients referred for surgical consultation for suspected bowel obstruction (2000–2006). Patients were stratified by treatment: surgical treatment (ST), minimally invasive (percutaneous/endoscopic) procedures (MIP), or bowel rest (BR). Clinical outcomes such as status at discharge and median overall survival (OS) were examined. Results: Of 194 patients, 25% had a primary diagnosis of colorectal cancer. Computed tomography, plain radiographs, enteral contrast studies, and other modalities were used for diagnosis in 59%, 26%, 12%, and 3% of patients, respectively. 62% of obstructions were located in the small bowel, with the remaining 23% and 12% identified as gastric outlet and colon, respectively. Over 90% of patients treated with ST (n = 60) were discharged home and tolerated enteral feeding. In contrast, for patients treated with MIP and BR, 48% and 68% were discharged home, and 70% and 72% were able to tolerate enteral feeding, respectively. OS was similar for patients treated with ST (6.3 months) and for those whose bowel obstruction resolved with BR (6.4 months). For patients treated with MIP, however, OS was 1.4 months. Though significant differences in OS for patients treated with ST and MIP were observed (p<0.0001), 30-day readmission rates were similar across treatment groups. Radiographic images demonstrating low grade obstruction, absence of ascites, and the absence of peritoneal carcinomatosis were associated with improved OS. Additional relevant clinical factors affecting OS included serum albumin level; however, no association was observed for age, tumor type, site of obstruction, previous bowel obstruction, or abdominal exploration. Conclusions: Clinical and radiographic factors affect treatment outcomes for cancer patients with bowel obstruction. Given that factors such as ascites, peritoneal carcinomatosis and low serum albumin result in poor OS, non-invasive procedures should be considered.

No significant financial relationships to disclose.
Triticum vulgare mouthwashes (TVM) for patients (pts) with oral mucositis (OM) induced by chemotherapy and chemoradiotherapy (ONCOLGroup study)
Authors: Carrasco-Chaumel E. , Cardona A. F. , Ospina E. G. , Montaño L. M. , Noemí R. , Bleda M. , Carranza H. , Vargas C. , Otero J. M. , Castro C.
Published: August 2020

e20570

Background: OM is a frequent complication of cancer therapy in Colombia. Triticum vulgare has been reported to effectively treat mucosal and skin disturbances. Methods: To evaluate the safety and efficacy of TVM for the control of OM induced by chemoradiotherapy in pts with head and neck cancer (HNC) and by chemotherapy in pts with haematological malignancies (HM). Thirty-one pts received TVM delivered in a spray four times daily to the whole oral cavity until the OM being resolved. The primary endpoint was the OM grade evaluated daily using the Nebraska scale (NS). Secondary endpoints were OM duration, weight loss, pain and TVM tolerance; the latter two were evaluated using a visual analogue scale (VAS). Results were compared with data from 42 pts with OM treated with saline mouthwashes (SM) in a previous clinical trial. Results: Nineteen pts had HM and 12 had HNC; those with HM developed OM on day 9 of chemotherapy (range, 7–14), whilst those having HNC did so towards day 17 of chemoradiation (range, 13–26). Using NS 38% of pts developed GI OM, 46% GII OM and 16% GIII OM. Moderate and severe OM occurred more frequently amongst HNC pts (8 vs 1, p = 0.047), mean OM duration in HNC pts was 12±4.5 days, whilst it was 7 ±3 days (p = 0.047) in pts with HM. Median OM duration in pts treated with TVM was 5.4 days (range, 2–9) vs 7 days (range 1–17) for pts treated with SM (p = 0.048). TVM appears to reduce weight loss, especially in pts with HNC (p = 0.058); however, no changes were documented regarding saliva characteristics and production, mucosal bleeding and voice properties. Evaluation of pain did not reveal differences between the groups (VAS 5.5 for the TV compared to VAS 6.2 for SM; p = 0.27) but the proportion of pts suffering from pain VAS≥7 differed between both populations (8% TV vs 23% SM; p = 0.043). There are no significant adverse events with TVM. Conclusions: TVM is safe and has therapeutic activity against OM. Further phase III study is needed to confirm these results.

No significant financial relationships to disclose.
Cognitive functioning in breast cancer patients during and following chemotherapy
Authors: Janelsins M. C. , Roscoe J. A. , Jean-Pierre P. , Morrow G. R.
Published: August 2020

e20571

Background: The development of cognitive difficulties, including memory loss, confusion, and difficulty concentrating following cancer treatment is a significant concern in patients receiving chemotherapy. Methods: This secondary analysis of a study assessing the effects of a RCT of paroxetine on fatigue in cancer patients investigated changes in self-report cognitive functioning over four cycles of chemotherapy and then approximately two years later. Approximately half of the patients were chemotherapy naïve. Questions on 5 point scales anchored by 1 = “absence of” and 5 = “a great deal” evaluating whether patients experienced heavy headedness, muddled thoughts, difficulty thinking, trouble concentrating, and forgetfulness. Each was answered seven days after each treatment and scores from each cycle were summed. Results: Fifty-eight of 84 patients completed questionnaires for all four cycles and are included herein. Paired t-tests showed cognitive difficulties were highest following the 1st on-study chemotherapy cycle (mean=7.9) and were significantly improved at the 3rd (mean=6.9) and 4th (mean=6.6) on-study cycles (both, p<0.005). Independent sample t-tests revealed that paroxetine had no effect on cognitive functioning when compared to placebo at all 4 cycles (all, p>0.54). Fifteen participants were reassessed two years after completing treatement. There was an increase in reported cognitive difficulties from the last cycle (mean=5.9) to the follow-up time-point (mean=7.8) that was not significant (p=0.18). Patients with ≥2 point change in score from the last on-study cycle to follow-up were categorized as “better” or “worse”. Those with <2 point change in score were classified as “no change”. Four (27 %) patients got worse (mean change=9.0), 2 (13 %) got better (mean change=-3.5), and 9 (60%) did not change. Conclusions: These data suggest that self-report cognitive difficulties related to cancer treatment are most pronounced following initial cycles of chemotherapy treatment and improve during the treatment course. Further studies need to include objective neuropsychological examinations and biological correlates of cognitive functioning to understand the extent of cognitive decline due to chemotherapy. Funding: DOD DA17–96-C-6106, NCI R25CA10618.

No significant financial relationships to disclose.
Effect of 25 hydroxy vitamin D status on serological response to influenza vaccine in cancer patients
Authors: Chadha M. K. , Fakih M. G. , Tian L. , Mashtare T. , Nesline M. , Davis W. , Silliman C. , Trump D. L.
Published: August 2020

e20575

Background: Increasing epidemiologic data suggest association of vitamin D deficiency with influenza epidemic. Vitamin D acts as an immune modulator and stimulates the expression of protective anti-microbial peptides. We conducted a prospective influenza vaccination study to determine the influence of vitamin D status on serological response to flu vaccine in cancer patients. Methods: Cancer patients at Roswell Park Cancer Institute were offered trivalent (H1N1, H3N2, B/Malaysia) Flu vaccine (Fluzone, 2006–7) and sera collected for hemagglutination inhibition (HI) assay titers. Response to vaccination was defined as ≥ 1:40 titer ratio or a 4 fold increase in HI titer at 3 months post vaccination, against any of the 3 strains. Chi-square tests were performed to compare serological response between the groups with lowest and highest quartiles of baseline 25 (OH) vitamin D (D) level. Logistic regression model was used using other covariates such as age, gender, cancer type, and chemotherapy (CT) as controls. Results: 85 patients with colorectal, 35 with prostate, 1 with anal and 1 with gastric adenocarcinoma participated in the study. Median age was 62 years (range: 24–87 years), 85 (70%) were males. Overall serological response was 59%. Median baseline D level was 42.9 ng/mL (range: 4.0–92.8 ng/mL); lowest and highest quartiles were 26.9 and 53.4 ng/mL. There was no association between serological response and baseline D level (p=0.42) or the lowest and highest quartiles of D level (p=0.6). The odds of response did not vary by sex (p=0.95). CRC patients (OR-0.051; 95% CI-0.013 to 0.209; p<0.0001) were less likely to respond. Few patients (n=20; 16%) were D deficient (<20ng/mL), 43 had D < 32ng/mL .70 patients (54.7%) were on vitamin D supplements. Among those in whom the dose of supplement was known (46),the median daily vitamin D supplement dose was 2000 IU (800–9000 IU).There was no association between serological response and dose (p=0.09). There was no difference in the response rates among patients on D supplement 44/70 (62.9%) versus those not on any D supplement 28/52 (53.8%)(p=0.32). Conclusions: Vitamin D status, in a population in which vitamin D supplementation was commonly used, did not affect serological response to influenza vaccine.

No significant financial relationships to disclose.
Health-related quality of life indicators and overall quality of life: Results from a cluster analysis on baseline EORTC QLQ-C30 data from 6,739 cancer patients
Authors: Coens C. , Martinelli F. , Quinten C. , Cleeland C. S. , Greimel E. , King M. , Ringash J. , Schmucker-Von Koch J. , Shi Q. , Bottomley A.
Published: August 2020

e20576

Background: Increasingly randomized controlled trials in cancer research include Health-related Quality of Life (HRQoL) alongside traditional biomedical outcome measures. The majority of these trials focus on a general cancer HRQoL measure. The objective of this meta-analysis was to identify which HRQoL indicators influence a patient's overall quality of life, in order to better understand the changes in such a generic scale. Methods: Retrospective pooling of 29 European Organisation for Research and Treatment of Cancer (EORTC) clinical trials, among 10 cancer sites, yielded baseline EORTC QLQ-C30 data for a total of 6,739 patients. A cluster analysis, using Ward's method, was performed to determine how the 15 HRQoL indicators, and the Global Health scale (GH) in particular, cluster overall and by cancer characteristics. Cronbach's alpha coefficient (α) was used to measure internal consistency. Dendrograms of the HRQoL indicators were plotted for each cancer type. Results: Three main clusters emerged: a physical function related cluster (physical functioning, role functioning, fatigue and pain, α = 0.83), a psychological function related cluster (emotional functioning, cognitive functioning and insomnia, α = 0.64) and a gastrointestinal cluster (nausea and vomiting and appetite loss, α = 0.68). The GH scale was found to be part of the physical function cluster in the overall dataset (α = 0.85). This result was reproduced for both metastatic and non-metastatic patients. When looking across the 10 different cancer sites, the GH scale was mainly linked with a physical component in brain, head and neck, lung, melanoma, ovarian, pancreatic and prostate cancer. However, in breast and testicular cancer, GH was more strongly associated with the emotional scales. Conclusions: This study shows that the GH scale of the EORTC QLQ-C30 is most strongly linked with a patient's physical status. This result is consistent across stage of disease and most cancer sites. The different results seen in patients with breast and testicular cancer deserve additional investigation.

No significant financial relationships to disclose.
Prevalence and management of oropharyngeal candidiasis in cancer patients: Results of a prospective French multicentric survey
Authors: Azria D. , Gligorov J.
Published: August 2020

e20590

Background: Oropharyngeal candidiasis (OPC) is usually considered as a frequent and manageable complication of cancer treatments. International guidelines recommend the use of broad spectrum local antifungal agents as first line treatment using old published data. In 2008, we elaborated a prospective pharmaco- epidemiological survey (Candidoscope) to update the prevalence and the management of OPC in France. Methods: Candidoscope concerned patients suffering from solid tumors or non-Hodgkin's lymphoma (NHL) and still under treatments. Thirty-five French centres participated in this survey. Patients were screened during a consecutive period of 15 days and were included in a registry to estimate OPC prevalence. Exclusion criteria was the use of antifungal agents within the last 15 days before the beginning of the the present study. OPC was defined clinically. Patients diagnosed for OPC were selected to the second part of the study detailing OPC treatments. Results: Overall, 2,027 patients were registered. OPC prevalence was 9.6% (n=195). Breast cancer population was the most frequent disease presenting untreated OPC (n= 47, 24%). The prevalence of OPC in head and neck, digestive cancer, and NHL patients was 30%, 20%, and 20%, respectively. Patients with combined treatments presented the highest OPC prevalence (nearly 22%). The most common clinical presentation for OPC was the erythematous form (62%). Main OPC symptoms were dry mouth (63%), altered taste (60%), pain (43%), dysphagia (42%), and appetite disorders (31%) with an average weight loss of 4kg. Local antifungal agents (amphotericin B, nystatin, and miconazole muco-adhesive buccal tablet (MBT)) were given in 75% of patients (41%, 12%, and 22%, respectively). Compliance to treatment was respectively 19%, 40%, and 88% for nystatin, amphotericin B with mouthwashes, and MBT. Conclusions: The prevalence of OPC in treated cancer patients is frequent with important clinical consequences. Systemic treatment compliance delivered according to the international guidelines is often poor and are strongly improved by the use of daily MBT.

No significant financial relationships to disclose.
Expressed emotion, depression, and survival in patients diagnosed with hepatobiliary carcinoma
Authors: Steel J. L. , Hammond J. , Carr B. I. , Gamblin T. C.
Published: August 2020

e20597

Background: The aims of the present study were to (1) investigate the association between expressed emotion, health related quality of life, and depression, and (2) explore the association between expressed emotion and survival in patients diagnosed with hepatobiliary carcinoma. Methods: The study was prospective in design. Ninety-six patients diagnosed with hepatobiliary carcinoma were administered a battery of questionnaires that measured depression, health-related quality of life, and expressed emotion. Medical chart review was used to gather disease specific information. Mann Whitney U and Kruskal Wallis tests were performed to test differences between groups and Cox regression analyses were performed to test predictors of survival. Results: At diagnosis, 54% of the patients reported a CES-D score ≥ 16 (clinical range). Patients who reported CES-D scores in the clinical range were found to have significantly lower overall health related quality of life (Mann Whitney U= 506, p = 0.003) and in particular lower emotional (Mann Whitney U=551, = 0.009) and functional well being (Mann Whitney U=507.5, p = 0.003). Patients who reported CES-D scores in the clinical range also reported a higher frequency of cancer-related symptoms (Mann Whitney U=503.5, p= 0.002) at diagnosis using the FACT-Hepatobiliary module. Patients who reported lower levels of emotional expression were found to have higher levels of depression (Mann Whitney U-6.6, p=0.04) and lower social and family well-being (Mann Whitney U=6.4, p=0.04). Using Cox regression, sociodemographic and disease-specific characteristics, depression, and expressed emotion were entered into a model. Significant predictors of survival included greater number of lesions (p=0.04), larger size of tumor (p=0.02), and lower levels of emotional expression (p=0.03). Conclusions: Preliminary findings suggest that patients with low levels of emotional expression reported higher rates of depression, poorer quality of life, and shorter survival. Interventions should be developed to treat symptoms of depression to improve quality of life. Expression of both positive and negative emotions should be encouraged by health care professionals.

No significant financial relationships to disclose.
Level of fatigue in colorectal cancer patients (ccp) receiving adjuvant chemotherapy
Authors: Heras P. , Hatzopoulos A. , Kritikos K. , Karagiannis S.
Published: August 2020

e20612

The aim of the study was to assess the level of fatigue during and after adjuvant chemotherapy in ccp. Methods: 52 patients (age 30–73 years) with colorectal cancer were recruited between May 2005 and November 2008. Fatigue intensity was measured according to 10-score visual analog scale (VAS, 0-no fatigue, 10-fatigue as bad as it could possibly be) before the start of adjuvant chemotherapy, once weekly during chemotherapy, 20 days and 6 months after. Results: Over half of the patients (56%) demonstrated no fatigue before the start of adjuvant chemotherapy. Fatigue intensity increased gradιιally during chemotherapy. It highest in the last week of treatment 20 days after the end of chemotherapy, fatigue intensity was still higher than before treatment, but 6 months after it was lower than the pretreatment level (mean fatigue-VAS was 1.17, 2.41, 1.45 and 0.61, respectively). However, 17% of the patients defined their fatigue as 2 or more in VAS six months after chemotherapy had ended. About 1/4 of the patients reported nο fatigue during chemotherapy. Increased level of fatigue was associated with an increased need of rest. Patients with pain (pain-VAS 1 or more) manifested higher fatigue level in comparison with individuals without pain (mean fatigue-VAS 3.20 vs 1.02 in the last week of treatment). Older patients (>65 years) estimated their fatique in the last week of treatment on lower level than younger patients (fatigue-VAS 1.79 vs. 2.83

No significant financial relationships to disclose.
Biological profile of oestrogen receptor alpha positive (ERalpha+) primary breast cancers in the elderly and their response to primary endocrine therapy
Authors: Okunade G. , Green A. R. , Ying M. , Agrawal A. , Paish E. C. , Winterbottom L. , Hassell K. , Morgan D. A. , Ellis I. O. , Cheung K.
Published: August 2020

e20622

Background: Aromatase inhibitors (AIs) have been shown to be superior to tamoxifen in several settings. However, it is unclear whether this superiority extends to its use as primary endocrine therapy in elderly patients with early operable primary breast cancer. Biological characteristics of the tumours may aid in selecting the most suitable agent. Methods: Primary endocrine therapy with one of the AIs (anastrozole) in 64 women >70 years with ERα+ breast cancer was compared to that in 84 treated with tamoxifen during the same period. Their selection was entirely based on contraindications e.g. thromboembolic risks. Needle core biopsies were assessed, by immunohistochemistry, for expression of biomarkers as described below. Results: There was no significant difference between the two groups (anastrozole vs tamoxifen) in terms of response at 6 months (clinical benefit (objective response + stable disease) rates = 97 vs 100%, p=0.099) or progression free survival (median = 16.5 vs 22.5 months, p=0.376). There were no withdrawals due to side effects from anastrozole, compared to four with tamoxifen. For all patients progesterone receptor (PgR), ERβ2, human epidermal growth factor receptor 2 (HER2), epidermal growth factor receptor (EGFR) and Ki-67 were over-expressed in 48%, 99%, 8%, 4% and 64% respectively. HER2 (18 vs 21 months, p=0.003) and Ki-67 (17.5 vs 23 months, p=0.042) over-expression were significantly associated with shorter progression free survival. Conclusions: These results thus far show that primary endocrine therapy with anastrozole in elderly patients with early operable ERα+ breast cancer is similar to tamoxifen in terms of efficacy, but may be better tolerated. In this population, ERα+ breast cancer also appears to have a less aggressive biological profile favouring better hormone sensitivity.

[Table: see text]
Pediatric sibling donor bone marrow transplant: Assessing distress in donors and family members
Authors: Hinds P. S. , Pelletier W. , Alderfer M. A. , Davies S. , Pentz R. D.
Published: August 2020

e20625

Background: When a child is diagnosed with cancer, the entire family is affected. In qualitative studies, 28–81% of siblings of children with cancer display behavioral maladjustment. Quantitative studies show similar findings, documenting up to a three-fold increase in clinically significant behavioral problems among siblings of children with cancer. Methods: In order to better understand sibling distress we conducted 3–4 interviews using grounded theory methodology (a qualitative strategy to explore common themes and develop theory) with each family member over 9 years old of 7 families with a child undergoing a sibling donor bone marrow transplant for cancer or sickle cell anemia. Participants also completed standardized scales related to coping. Results: Of the 29 subjects interviewed, 6 were African American, 4 Hispanic and 19 white. Six parents had at least a college degree and income was evenly distributed from $5,000 to >$80,000 a year. Children, including 4 patients, 6 donor siblings and 5 other siblings, ranged in age from 9 to 18. Based on the grounded theory analysis of each interview, we theorize that siblings experience less distress if the parents share the patient care giving. Our data support this hypothesis, with analysis of interviews indicating improved coping in families that shared care giving for the transplant recipient, and increased distress in families in which all the patient care giving was performed by the mother, a commonly used strategy. Conclusion: In order to potentially facilitate increased family functioning and decrease caregiver burden, parents should be encouraged to share care giving when feasible. Our study shows that systematic interviews can explore the family experience of pediatric transplantation and allow development of improved support systems for families of children undergoing sibling donor bone marrow transplantation.

No significant financial relationships to disclose.
Management of adverse skin reactions to anticancer agents: The Gustave Roussy Institute experience
Authors: Giacchero D. , Mateus C. , Frigui F. , Arnault J. P. , Maksimovic L. , Thuillier B. , Celebic A. , Auperin A. , Escudier B. , Robert C.
Published: August 2020

e20638

Background: Anticancer therapies are associated with various and multiple cutaneous side effects frequently impacting patients’ quality of life and sometimes impairing treatment continuation. Some new skin syndromes and their potential relationship with drug efficacy have been the subject of hundreds of publications over the last few years. Methods: All physicians in our institution were informed by mail about the creation of a weekly consultation and the availability of an emergency call number specifically devoted to the management of adverse cutaneous reactions to anticancer agents. Patients could be referred to us from our institute or from other french institutes. All cutaneous side effects were recorded. Type, severity, and duration of symptoms were described. Imputability of the drugs was evaluated according to semiological, chronological and bibliographical criteria. Results: Over a 4 months period, 215 visits have been performed for a total of 128 patients. 169 events were reported among which 123 were considered to be imputable to the drugs. Several new cutaneous side effects were identified. Hiring a beautician and a pedicure for aesthetic complaints or hand foot skin reactions has been necessary in several cases. Causative agents were mostly targeted therapies (76.4%). Topical (n=132) or systemic treatments (n=45) were prescribed. Temporary dose reduction or treatment interruption was recommended in 18 cases (10.6%). This pilot experience was highly appreciated by both patients and physicians. It was consolidated as a permanent organization at the frontier between oncology and dermatology with the creation of an adapted case report form (CRF). Conclusions: There is a real need for dermatological management of skin side effects in a cancer institute, especially if early trials testing new agents are performed. Dedicated collaboration between oncologists and dermatologists should be promoted as well as the creation of a global skin-oriented CRF in order to facilitate international collaborations and to evaluate the impact of this dermatological management on compliance to treatment.

No significant financial relationships to disclose.
Chemotherapy-induced suppression of serum holotranscobalamin
Authors: Tisman G. , Kutik S. J. , Khan Y. A.
Published: August 2020

e20639

Purpose: Chemotherapy-induced damage to the stomach and small intestine may inhibit the absorption of vitamin B12. To assess the risk of chemotherapy causing acute vitamin B12 deficiency, we primarily measured the active form of vitamin B12, holotranscobalamin, but also total serum B12, methylmalonic acid, and total homocysteine. Experimental Design: We studied 21 patients that were actively on chemotherapy and recorded values for holotranscobalamin, total serum B12, methylmalonic acid, total homocysteine, and cystatin-c. Measurements were taken both before and after four doses of chemotherapy. T-tests were employed to determine statistical significance. Results: There was a statistically significant drop in holotranscobalamin after chemotherapy in eighteen out of twenty-one patients (p = 2.64x10–3). Three patients were vitamin B12 deficient as defined by total B12 < 300 pg/ml. Neither methylmalonic acid (p = 3.95x10–1), nor total homocysteine (p = 4.34x10–1), showed any significant changes. Conclusions: Chemotherapy caused an acute deficiency of the only metabolically active form of vitamin B12, holotranscobalamin, despite B12 supplementation. We suggest monitoring patients for changes in holotranscobalamin to ensure that prolonged deficiency does not occur. The clinical implications of acute lowering of holotranscobalamin remain unknown.

No significant financial relationships to disclose.
Barber test as a screening tool in multidimensional geriatric evaluation in elderly women with early breast cancer
Authors: Molina-Garrido M. , Guillen-Ponce C. , Santiago J. , Muñoz M. , Olaverri A. , Haro L. , Carrato A.
Published: August 2020

e20645

Background: The Comprehensive Geriatric Assessment (CGA) is a key component of the treatment approach for older cancer patients, but it is time consuming. In this study, we have evaluated the validity of a brief frailty screening tool, the Barber test (BT), for identifying disability in older patients with early breast cancer (BC) in the University General Hospital in Elche. Methods: Between January 2007 and December 2007, a total of 41 patients older than 65 years who were actively receiving chemotherapy for early BC, were enrolled in our study. Eligible patients were screened with the Barber test and completed a standardized CGA (Activities of Daily Living measured by Barthel Scale, Instrumental Activities of Daily Living measured by Lawton-Brody Scale, cognitive evaluation measured by Pfeiffer Test, comorbidity (Charlson´s index), risk of malnutrition (Nutritive Initiative Screening), and ECOG). The validity of the BT in this population was assessed by comparing the BT results with results from a simultaneous CGA. A receiver operating characteristic (ROC) analysis was employed. The ROC evaluated the BT as a screening measure for impairment compared with the CGA (using the definition of impairment on the CGA as deficits on ≥2 individual tests within the battery, and on the BT as a score >0). The area under the ROC curve (AUC) was calculated to reflect the predictive value of the BT for identifying impairment. Results: Forty-one women were recruited. Median age was 72.88 years (range 65.03 to 85.46). 30 patients (73.2%) were older than 70 years. 36.6% were dependent in Barthel Scale, and 46,3% were dependent in Lawton-Brody Scale. 19,5% had cognitive impairment. The Barber test was moderate predictive for identifying impairment compared with the CGA, with an AUC of 0.730 (standard error, 0.081; 95% confidence interval for detecting asymptomatic normals, 0.571–0.889); p=0.012). Conclusions: Functional impairments are prevalent among older patients with early BC who receive adjuvant chemotherapy treatment. The current results indicate that the brief Barber test performed nearly as well as a conventional CGA in detecting geriatric impairment in this population.

No significant financial relationships to disclose.
Prospective evaluation of oral mucositis in solid tumor patients undergoing chemotherapy and its clinical implication
Authors: Kim J. , Cha Y. , Han S. , Oh D. , Lee S. , Kim D. , Im S. , Kim T. , Heo D. S. , Bang Y.
Published: August 2020

e20650

Background: Oral mucositis (OM) induced by chemotherapy is a troublesome and debilitating adverse effect in solid tumor patients. OM might influence the complicated aspects such as the poor oral intake and malnutrition over just oral symptom. Therefore we prospectively evaluated the actual incidence of OM and its clinical significance in solid tumor patients. Methods: From October 16, 2007 to September 3, 2008, we consecutively enrolled 344 patients with solid tumor who initiated new chemotherapy. Each patient was prospectively evaluated for two cycles. The data were collected from physician-to-patient interview. And patients’ diary for OM symptom was used as patient-reported measurement. The visual analog scale (VAS) was used to quantify the degree of adverse effects (VAS: 0 point = no symptoms, 4 point = the worst symptom) and FACT-G was used for assessment of the quality of life (QOL). Results: Finally, 322 patients were analyzed. The median age was 51. Breast cancer was the most common (51%). And, stage IV was 137 (43%). OM was 28% per each cycle and 45% per patient during two cycles. Patient-reported OM symptom had peak in one week and was recovered in 9.14±6.77 days. Oral dryness was the most prevalent symptom out of symptoms related with OM such as oral pain, poor oral intake, dysphagia, oral bleeding, scalloping of tongue and ulceration (VAS score 1≤; 47%, 27%, 39%, 15%, 7%, 14%, 13%, respectively). In QOL measured by FACT-G, physical well-being and emotional well-being were significantly dropped in OM-occurred group than in no-OM group (19.09±6.48 vs 22.47±5.95, p<0.001; 16.74±4.10 vs 17.97±3.38, P<0.001, respectively). In addition, higher VAS score for other adverse effects was showed in OM-occurred group than in no-OM group (activity, nausea, vomiting, fever, myalgia and nervous system; p=0.0038, p<0.0001, p=0.0007, p=0.0062, p<0.0001, p<0.0001, respectively). Conclusions: Forty five percent of patients with solid tumor experience OM during 2 cycles of chemotherapy. In case of patients with OM, QOL is worse and the other adverse effects are more prevalent. OM could be an indicator of QOL and other adverse effects during chemotherapy.

No significant financial relationships to disclose.
Relationships among patient-level factors, religious coping, use of complementary and alternative medicine, and psychological outcomes in men with advanced cancer
Authors: Rand K. , Cripe L. D. , Monahan P. , Tong Y. , Schmidt K. , Rawl S.
Published: August 2020

e20652

Background: Religious coping and complementary and alternative medicine (CAM) are two resources frequently used to manage distress associated with advanced cancer. However, the relationships among these coping strategies and psychological outcomes in men with advanced cancer are not well studied. We hypothesized that patient-level factors (e.g., demographics, personality) would predict religious coping and CAM use, which would then predict psychological outcomes. Methods: 81 men with advanced cancer were recruited from oncology clinics for this cross-sectional study. Patients completed surveys which included demographic questions, personality measures (Adult Hope Scale, Life Orientation Test-Revised), CAM use, religious coping (Brief R-COPE), and psychological outcomes (Hospital Anxiety and Depression Scale, Post-Traumatic Growth Inventory). Hierarchical regression analyses were conducted with anxiety, depression, and post-traumatic growth as the criterion variables. Results: Higher anxiety scores were predicted by more negative RC (β = 0.50, p = .002), hope-pathways (β = 0.37, p = .033), and less hope-agency (β = -0.55, p = .002). Depression was predicted by lower hope-agency (β = -0.48, p = .021) and less education (β = -0.37, p = .044). Greater post-traumatic growth was predicted by greater positive RC (β = 0.54, p = .003). CAM use did not predict any psychological outcomes. Greater positive RC was predicted by less education (β = -0.39, p = .025). More negative RC was predicted by lower optimism (β = -0.43, p = .006). CAM use was predicted by greater hope-pathways (β = 0.42, p = .046). Conclusions: Religious coping, but not CAM use, was associated with psychological outcomes. Positive RC predicted greater growth, whereas negative RC predicted greater anxiety. Psychological outcomes were related to patient-level factors including hope and education. However, the two dimensions of trait hope had opposite effects. Higher hope-agency predicted less anxiety and depression, whereas higher hope-pathways predicted greater anxiety. These relationships merit further investigation.

No significant financial relationships to disclose.
Adverse drug reactions and drug interactions as causes of hospital admission in oncology
Authors: Del Giglio A. , Miranda V. , Fede A. , Nobuo M. , Miranda M. , Ayres V. , Riechelmann R. P.
Published: August 2020

e20656

Background: Previous studies have shown that cancer patients are at risk of drug interactions. But the proportion of potential adverse events that turn into clinical consequences is unknown. We sought to evaluate how many hospital admissions in oncology are due to drug-drug interactions (DDI) or adverse drug reactions (ADR). Methods: All cancer patients admitted to an oncology ward during an 8-month period had their charts retrospectively evaluated for reasons of hospitalization. Clinical trial patients were excluded. Each hospital admission was independently evaluated by two blinded investigators using a 4-point scale that was developed to classify sadmissions by their probability to be associated with either a DDI or an ADR (definitely, probably, possibly or unlikely associated). All medical records were thoroughly reviewed and discussed by experts. Results: From September 2007 to May 2008, there were 550 hospital admissions and 458 were eligible. Among unplanned admissions (N=298), 39 (13.0%, 95% CI 9.4 - 17.4%) were considered to be associated with an adverse drug event: 33 (11.0%, 95% CI 7.7 - 15.2%) were associated with an ADR and 6 (2.0%, 95% CI 0.7 - 4.3%) with a DDI. The most common DDI involved warfarin, captopril and anti-inflammatory agents and the most frequent ADR was neutropenic fever post chemotherapy. Most patients were discharged completely recovered but 2 patients died. Use of chemotherapy within 4 weeks of hospital admission (Odds Ratio 10.8, 95% CI 5.3 - 22.1; p < 0.0001) and presence of hematological tumors (Odds Ratio 12.1, 95% CI 5.9 - 25; p < 0.0001) were risk factors for being hospitalized to treat an ADR. Conclusions: Approximately one in 10 unplanned hospitalizations of cancer patients is associated with an adverse drug event. Prospective and population-based studies are warranted to evaluate their magnitude in oncology.

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Disparity of reported risk of hypersensitivity reactions (HSR) for platinum chemotherapeutic agents
Authors: DeMoor P. , Barnachea L. , Bazhenova L.
Published: August 2020

e20662

Background: HSR are observed with multiple chemotherapeutic agents and patients should be counseled regarding risk. A wide variation in frequency of platinum HSR is reported in the literature. We sought to confirm the frequency of HSR in the modern era and examine the cause for disparity in reported versus observed risk. Methods: We conducted a retrospective analysis of Quality Variance Reports from 06/2006 to 02/2008 to investigate incidence of HSR to platinum-based therapy at Moores UCSD Infusion Center (IC) and compared data to those historically reported. HSR were graded according to CTCAE v. 3.0. Results: 1,753 doses of platinum agents were administered over this time period. Our IC assumes 0% risk of HSR to cisplatin (0 events in 701 doses), 0.7 % risk to carboplatin (5 events in 689 doses: 2 grade II, 2 grade III, 1 grade V), and 1.4 % risk to oxaliplatin (5 events in 363 doses: 2 grade II, 1 grade III, 2 grade IV). Review of the literature showed a 1 - 20% risk of HSR to cisplatin, provisional to whether it is administered as single agent or in combination. Carboplatin infers a 0.8 - 50% risk of HSR with increased risk after 6 cycles and with longer platinum-free interval. Finally, oxaliplatin bears a 0.5 - 19% risk of HSR with increased risk after 6 infusions. Conclusions: Our own experience is not entirely consistent with the reported frequency of platinum reactions because of the 62-fold disparity of reported percent risk. We found several factors that may explain the disparity: use of emesis prophylaxis may circumvent HSR, authors’ misinterpretation of data or citation errors, under-reporting of adverse events, and differences in defining percent risk of HSR. Some publications document risk of HSR based on the number of patients that react versus documenting risk based on the number of reactions per number of doses. The table below, using our IC data, underscores this point. This data reveals the necessity of standardizing the way in which we report percent risk, since treatment decisions are often based on percent risk.

[Table: see text]

No significant financial relationships to disclose.
Hepatobiliary (HB) safety of eltrombopag administered after carboplatin+paclitaxel (Carb+Pac) in patients (pts) with solid tumors
Authors: Kellum A. , Jagiello-Gruszfeld A. , Bondarenko I. , Rafi R. , Giangiulio P. , Messam C. , Mostafa Kamel Y.
Published: August 2020

e20667

Background: Eltrombopag is an oral, small molecule, non-peptide, TPO-receptor agonist studied for the treatment of thrombocytopenia (TCP) due to various causes, including chemotherapy (CT)-induced TCP and is approved for the treatment of chronic ITP in the US. Since eltrombopag is excreted primarily through the liver and liver function is an important safety parameter, HB lab values and AEs were analyzed in a double-blind, placebo (pbo)-controlled, multicenter ph II study. Methods: The safety of eltrombopag was evaluated in adults with advanced solid tumors (mainly NSCLC and ovarian). Pts received up to 8 cycles of Carb (AUC 5–6 IV) + Pac (175–225 mg/m2 IV), both administered on day 1 q 21 days. 183 pts were randomized to eltrombopag 50, 75, 100mg, or pbo (1:1:1:1). Eltrombopag or pbo were taken from Day 2 - 11 in each cycle of CT. Results: Baseline characteristics, prior medical conditions and number of CT cycles during the study were similar between the treatment groups. At baseline, one pt reported liver metastases (75mg group). Similar numbers of pts had HB lab abnormalities in all groups ( table ). Additionally, HB AEs (34 AEs) occurred in 15 pts across all treatment groups ( table ). Conclusions: In this study, eltrombopag did not increase the incidence of HB AEs or HB lab abnormalities compared to pbo.

[Table: see text]

[Table: see text]