bluuebunny/crossref_metadata_2025_split huggingface dataset:
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. [Table: see text]
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]
Informed consent: Timely issues from the past. Factors motivating patients with advanced cancer to participate in phase II trials
Authors: Kardinal C. G. , Sanders J. B. , Cupper H. T. 
Published: August 2020

e20669 Background: The current regulatory burden is well intentioned, but hampers both the conduct and recruitment to clinical trials. What factors actually motivate patients to become research subjects? After “informed consent” is obtained, what is the subject's understanding of the study, and its risks and benefits? Methods: In 1973 data were collected on the factors motivating 50 consecutive patients with advanced cancer to participate in Phase II trials. The data had not been previously analyzed. Now, 35 years later, the data obtained seem surprisingly current. These patients were interviewed a few days after obtaining “informed consent”. The 60 minute interviews were semi-structured, and included the factors motivating participation, the purpose of the trial, potential side effects, and treatment options. Results: Patients seldom expressed a single reason for participation. The motivating factors fell into 5 categories. (1) Hope that the new treatment would help control their disease; expressed by all 50. (2) Avoidance of regret; i.e, if they declined they would regret not having participated (19 of 50). (3) Altruism was expressed by 29 of the 50. (4) Trust that a physician-investigator would not have suggested the trial unless he thought it might help (10 of 50). (5) Being trapped by a lack of therapeutic alternatives (14 of the 50). Potential risks and side effects were minimized or forgotten. Many developed a sense of commitment to a cause; their morale improved even if their disease did not. Conclusions: The factors motivating patients with advanced cancer to participate in Phase II trials are complex, but evolve primarily around their personal disease status rather than their understanding of the trial. Truly informed consent in this vulnerable patient population may not be possible. The ultimate responsibility for the protection of human subjects lies not with the IRB, but with the physician investigator. No significant financial relationships to disclose.
Unexpected dermatologic toxicities from anticancer therapies: Survivors’ perspectives
Authors: Gandhi M. , Calahan C. , Oishi K. , Lacouture M. 
Published: August 2020

e20673 Background: As oncologic therapies have shown improved survival, there is a growing attention to other aspects of the cancer experience from the survivors’ perspectives. Gastrointestinal, constitutional, and dermatologic toxicities are frequently experienced and further study of their impact is important to prevent inconsistent antineoplastic drug administration. This study is aimed to evaluate survivors’ perceptions of unexpected toxicities. Methods: CancerCare, a national nonprofit organization, mailed 1,369 surveys to cancer survivors completing their treatment. The survey divided into two sections asked patients to rate their concern about dermatologic, gastrointestinal, and constitutional toxicities prior to and after therapy completion. Toxicities were also rated on a 1 to 10 scale based on their negative impact. Results: 379 survivors responded to the survey, yielding a 28% response. Of those 379, 250 (66%) were diagnosed with breast cancer. The remaining 127 (33%) had ovarian, lung, colorectal, prostate, bladder, kidney, or other malignancy. Prior treatments included: chemotherapy, radiation, surgery, targeted therapies, or any combination of the preceding. The most frequently unanticipated events carrying a negative impact were dermatologic: dry skin and skin irritation. Following were constitutional (insomnia and fatigue) and gastrointestinal toxicities (diarrhea and constipation). Before undergoing treatment, skin irritation was concerning to 40%. After treatment, 80% reported concern and 47% were negatively impacted. Dry skin prior to treatment was concerning to 34%, and 79% were concerned after having undergone therapy. In retrospect, 44% reported that having dry skin caused a negative impact. Gastrointestinal and constitutional toxicities were also examined, and overall, respondents’ level of concern remained largely unchanged pre and post treatment. Conclusions: Dermatologic toxicities are least anticipated by the cancer patients prior to their treatments, when compared to gastrointestinal and constitutional events. Since dermatologic toxicities have a negative impact on survivors’ lives, pre-therapy counseling and effective interventions are crucial, in order to maximize quality of life. [Table: see text]