bluuebunny/crossref_metadata_2025 huggingface dataset:
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]
Phase III randomized anastrozole exercise (RAE) trial: First planned interim analysis
Authors: Macfarlane R. J. , Lohrisch C. , Truong P. , McKenzie D. , Jespersen D. , Nuraney S. , Gaul K. , Gelmon K. , Kennecke H.
Published: August 2020

e20674

Background: Adjuvant anastrozole (aA) is associated with arthralgias/myalgias (A/M), bone density loss, and hot flushes. Analgesics offer limited relief of musculoskeletal (MSK) symptoms and are associated with side effects of their own. The benefit of exercise on bone health, muscle strength, hot flushes, and quality of life (QOL) has been demonstrated; the objective of this trial is to determine if an exercise program improves anastrozole related A/M. Methods: This is a phase III, randomized trial of standard of care (observation) vs 48 weeks (wks) of exercise for women with BC on aA. Subjects in the control group receive literature about AIs (information on bone health, management of SEs of AIs). Subjects in the intervention group participate in a semi-supervised, individualized, and graduated 3x/wk exercise program (aerobic, resistance training, stretching) for 24 wks. From wks 25–48 independent exercise is recommended 3x/wk. The 10 endpoint is change in MSK symptoms as measured by 12 wk SF-36v2 bodily pain scores, NCI CTG toxicity, and visual analogue scale. 20 endpoints are QOL, hot flushes, bone density, and body mass. Physical activity and compliance with aA was monitored in both arms. The 1st interim analysis was planned after 10 patients were enrolled to evaluate accrual, compliance, and rate of discontinuation. Results: Accrual commenced December, 2007. Fourteen of a planned 72 patients have been enrolled (baseline data available for 13); 7 pts in the control arm (A) and 6 in the exercise arm (B). Median age was 59 (A) and 58 (B). Nine pts had baseline and 12 wk data available [5 (A), 4 (B)]. There were no withdrawals and compliance with scheduled exercise was 100%. Of the NCI CTG A/M deemed probably/definitely related to aA, there is no change in the number reported at baseline vs wk 12 in Arm A. In Arm B, 2 of 4 pts report a decrease in the number of A/M at wk 12. Mean norm-based wk 12 SF-36v2 bodily pain domain scores worsened by 4.1 in Arm A; an improvement of 1.9 in mean scores was observed in Arm B. Conclusions: Interim results show that a structured exercise program is well tolerated and compliance is high among women with aA related MSK symptoms. Early results point to a positive impact of exercise on MSK symptoms in women with early BC. Updated data will be presented.

[Table: see text]
Rater
Authors: Rangarajan B. , Prabhash K. , Nair R. , Menon H. , Jain P. , Kannan S. , Jeevangi N. K. , Bagal B. , Parikh P. M. , Kurkure P. A.
Published: August 2020

e20678

Background: Management of neutropenic fever is based on risk stratification of the episode which helps in optimizing treatment. MASCC is the most commonly used for risk stratification Patients with a score of > 21 were regarded as low risk; patients with a score of <21 were regarded as high risk. We tried to validate the MASCC index for our ethnic population. Methods: Patients were recruited throughout a 12 month period. Inclusion criteria were diagnosis of hematolymphoid malignancy, neutropenic febrile episode secondary to chemotherapy or during induction therapy of acute leukemia and more than 18 years of age All patients were risk stratified, hospitalized and treated with broad-spectrum, empiric, intravenous antibiotic therapy until recovery or outcome of the event. The incidence of medical complications in both groups and death related to the neutropenic infection was recorded. The data was entered on SPSS software and MASCC criteria was analyzed for sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Results: A total of 81 febrile neutropenic episodes were included; 34 classified as low risk and 47 as high risk according to MASCC risk index score. The sensitivity, specificity, PPV, NPV and accuracy of MASCC risk index score were 45.5%, 40%, 11%, 82%, 40.7%. We subsequently analyzed the subset of Acute Myeloid Leukemia (AML) patients as they were the majority comprising of 62/81 episodes. The subset of AML patients risk stratified according to MASCC risk index showed sensitivity, specificity, PPV, NPV and accuracy of 71%, 25.5%, 11%, 87.5%, 31% respectively. Conclusions: In our patient group, the value of MASCC score is limited with poor sensitivity, specificity and PPV. This trend is also seen in the subset analysis of AML patients. The value of the MASCC index with the score of 21 as the cut-off between low risk and high risk seems limited in our patients and requires confirmation with larger set of patients.

No significant financial relationships to disclose.
Review of neoplastic brachial plexopathy at the Mater Misericordiae University Hospital, Ireland
Authors: Noonan A. M. , Carney D. N. , McCaffrey J.
Published: August 2020

e20681

Background: Neoplastic brachial plexopathy (NBP) may occur with benign or malignant neoplasms. Symptomatic NBP is estimated to occur in about 0.4% of all patients with cancer. Despite therapy NBP is often irreversible. The aim of this review was to determine the incidence of brachial plexopathy occurring in patients with cancer at our centre. Methods: A retrospective review was done of the MRIs (magnetic resonance images) of brachial plexus performed at the Mater Misericordiae University Hospital over a 5 year period from 1st January 2004 to 31st December 2008. Results: A total of 66 MRIs of brachial plexus were performed during this period. 29 were performed for assessment of suspected traumatic injuries to the brachial plexus. 18 MRIs were performed in patients with a known cancer diagnosis, 1 was performed in a patient with a benign thymoma, 1 with a neurofibroma and the remaining 17 MRIs were ordered for other conditions. In total, 13 MRIs were positive for brachial plexopathy (7 traumatic, 5 due to cancer, 1 neurofibroma). Of the 20 MRIs performed (18 in patients with cancer, 2 in patients with a history of benign neoplasms), 6 (30%) confirmed a diagnosis of NBP. 27.8% (5/18) of patients with a diagnosis of cancer had NBP (3 had metastatic breast cancer, 2 had non-small cell lung cancer (NSCLC). Female to male ratio was 5:1. Median age at diagnosis was 67 years (range 35 to 86 years). 80% of patients had MRI of cervical spine also performed. Radiotherapy was the treatment of choice for 5 patients with cancer diagnosis, followed by chemotherapy also for one patient. Data was missing on treatment for the patient with neurofibroma. Some improvement in pain control was achieved with radiotherapy. However, there was no improvement in neurology. Conclusions: In our series in the past 5 years, 9% (6/66) of total number of MRIs of brachial plexus performed were positive for a diagnosis of NBP. NBP is devastating diagnosis. Physicians should have a high degree of suspicion for NBP in patients presenting with upper limb pain, paraesthesia and weakness.

No significant financial relationships to disclose.
Vinorelbine, cisplatin, and continuous infusion of 5-fluorouracil (ViFuP regimen) in carcinoma of unknown primary
Authors: Fumagalli L. , Locatelli M. , Curigliano G. , Ghisini R. , Fazio N. , Nolè F. , Goldhirsch A.
Published: August 2020

e20682

Background: Carcinoma of unknown primary (CUP) is rarely encountered in clinical practice, 3–5% of all new cancers, and several types of chemotherapy regimens have not yielded satisfactory results. Methods: We evaluated feasibility and efficacy of combined vinorelbine 20 mg (V) on day 1 and 3, continuous infusion 5-fluorouracil (5-Fu) 200 mg/m2 days 1–21 and cisplatin (C) 60 mg/ m2 day 1, 21 (ViFuP regimen) therapy in patients (pts) with CUP. Each course was repeated every 21 days for up to six cycles, followed by 5-FU continuous infusion in case of response or clinical benefit. Results: Twenty-six consecutive pts with CUP were enrolled in the study, 14 females and 12 males. Median age was 58 years (range 35–72). All pts are evaluable for response and toxicity. All pts were chemotherapy-naïve with the exception of 2 who had received prior 5-Fu and folinic acid (1 pt) and paclitaxel and adriamicin (1 pt). Objective responses were observed in 27% [6 PR (23%), 1 CR (4%)], while SD in 35% (9) of the pts (overall clinical benefit 52%). Ten patients had PD (38%). The median time to progression TTP was 4.0 months (range 1–98). Data on overall survival will be presented. Toxicity profile was particularly favorable. The most frequent grade 3–4 adverse events were leukopenia (8%), neutropenia (11 %) and anemia (3%). Conclusions: ViFuP was found to be an effective and well tolerated regimen in patients with CUP. Efficacy, control of symptoms and lack of significant alopecia were particularly appreciated. This regimen may be viewed as a standard of care in patients with fair good performance status, alternative to other systemic platinum-based chemotherapy regimens, in cases in which anthracyclines are contraindicated, or when patient's preference leads to the choice of a combination of drugs which does not cause significant alopecia.

No significant financial relationships to disclose.
Emetogenicity of multiday chemotherapy regimens: Drug and patient factors affecting control of CINV
Authors: Howell J. D. , Brown H.
Published: August 2020

e20683

Background: Multi-day chemo regimens have particular advantages in increasing tolerability and maintaining dose intensity of combination cytotoxic therapy. However repeated daily insults of therapy can make control of CINV challenging. Increased knowledge of factors affecting poor control of multi-day chemo, under current CINV prevention conditions, would be beneficial. Methods: A dataset of 621 patients treated in a blinded, randomised non-inferiority study (Grunberg SM, Gabrial NY, Clark G, MASCC 2007, Abstract # 18) of a granisetron transdermal patch (TDS, Sancuso) and oral granisetron, was analysed. As TDS was shown to be non-inferior to oral granisetron, data from both arms were used. All patients had received 3–5 days of moderately or highly emetogenic chemotherapy. Total Control of CINV over Day 1 and Days 1–3 was used as the efficacy endpoint. Stepwise logistic regression analysis was used to assess the predictive performance of patient and chemotherapy factors. Wald chi-squared statistics and Akaike criteria were used to measure significance of predictive factors and model fit, respectively. Results: The simple sum of emetogenicity scores of each cytotoxic (Grunberg SM,(2005) Evaluation of new antiemetic agents_an update. Support Care Cancer (2005) 13: 80–84) provided best overall prediction of emetogenicity of the multiday regimen. Cisplatin was more emetogenic and doxorubicin less so compared to established scoring (Grunberg SM,(2005) Evaluation of new antiemetic agents_an update. Support Care Cancer (2005) 13: 80–84). Age and gender were significant in predicting control: females <60 and males <40years being at risk. A genitourinary site of cancer was also an independent risk factor. Smoking, alcohol use, previous chemotherapy and performance score had no significant effect on risk of CINV. Conclusions: Established emetogenicity scores, derived from historical data on untreated patients, are relevant to multi-day chemo but could be revised to improve prediction of CINV. Cisplatin has a stronger impact on poor control in multi-day than single-agent scoring predicts. Age and gender factors remain important; but with different age breaks for male and female. These and tumour site factors should be taken into account when designing clinical trials or analysing data relating to antiemetics and CINV.

[Table: see text]
CPORT: Effective partnership working to optimize chemotherapy capacity in the UK
Authors: Basar A. A. , Whittome J.
Published: August 2020

e20687

Background: Capacity planning in a complex environment such as a chemotherapy unit is a difficult task; combined with ever increasing patient numbers and limited budgets, time and ability to plan is scarce. This project demonstrates how partnership working between the pharmaceutical industry and NHS service providers can optimise chemotherapy capacity in UK centres. Methods: CPORT stands for “Chemotherapy-Planning Oncology Resource Tool”. The tool is a simulator allowing chemotherapy planners to model how different drugregimens, patient flows, resource levels and ways of working influence the performance of a chemotherapy unit in terms of how many patients are treated, how long they wait, and how much care they receive. A small dedicated team at Roche has been working closely with a team of NHS Facilitators, with the full approval and backing of the National Cancer Action Team. The integrated team have been helping with the roll out of the tool, focusing on supporting cancer units implement CPORT from concept through change and sharing best practice. Results: To date more than 2800 simulations have been run through the tool. Service redesign options have been assessed in minutes and hours, as opposed to weeks and months. The simulator has enabled combinations of several service improvement initiatives to be modelled simultaneously, giving managers the ability to model cancer service delivery in a simulated online environment which is both cost free and risk free. Early results include the better coordination of pharmacy and nursing workload to optimise the available capacity; utlising CPORT to plan the merger of two units and model subsequent resource requirements; modelling the relocation of a unit and predicted caseload of patients. Conclusions: This model represents a successful new form of partnership working between the NHS and the industry to increase capacity within chemotherapy services. It promotes equity of service, better access and an improved experience for all patients receiving chemotherapy, embedding and sustaining the concept of capacity planning within the clinical service.

No significant financial relationships to disclose.
Pleurodesis with systemic chemotherapy in cancer patients
Authors: Gonzalez H. A.
Published: August 2020

e20688

Background: Pleural effusions are a common complication in cancer. All tumors, except CNS tumors, can produce pleural effusions. Pleural effusions are usually caused by direct tumor pleural involvement. Diagnosis is clinical and paraclinical. In cancer patients, in pneumonia absence, most of pleural effusions are malignant, regardless cytology results. Among different treatment modalities, chemical pleurodesis is the oftenest, but it is not etiologic nor physiologic. Chemotherapy in chemosensitive cancers is a good management approach. The objective of this study was measure systemic chemotherapy effectiveness in cancer pleural effusion after drainage and emphasize this method as treatment. Methods: Beginning 1/March/2001 and finalizing 30/July/2006, patients with chemosensitive cancers, malignant pleural effusions, no previous chemotherapy, KI > 80, life expectancy > 6 months, were included. Procedure: Chest X - ray, chest tube insertion for draining pleural effusion, systemic chemotherapy application, generally IV, tube remotion the day after ending chemotherapy, clinical and paraclinical follow up. No effusion reproduction minimum per six months. Effectiveness goal was 80% minimum. General statistic analysis was used. Results: 42 patients were studied, male: 38,09%, female: 61,91%. Median age: 59. Cancers: bronchogenic carcinoma: 42,8%, breast carcinoma: 28,5%, ovarian carcinoma: 14,2 %, carcinoma of unknown origin: 9,52%, others: 4,76%. Clinical stages: III B: 57,2%, most of them bronchogenic carcinoma, IV: 42,8%. Total effectiveness: 85,7%. Effectiveness in known origin cancers: 92,1%. Effectiveness in unknown origin cancers: 25%. Pleural effusion recurrence 14,3%. Drugs employed in appropriate drug regimens: cisplatin, carboplatin, etoposide, gemcitabine, vinorelbine, cyclophosphamide, doxorubicin, docetaxel, capecitabine. Conclusions: Systemic chemotherapy after draining effusions is a good approach for treating chemosensitive cancer pleural effusions, because can produce pleurodesis, is etiologic, has a high effectiveness and can improve survival.

No significant financial relationships to disclose.
Phase II/III study of Auron Misheil Therapy (AMT) versus placebo to evaluate clinical benefit response (CBR) in patients with advanced solid tumors
Authors: Drevs J. , Lohrmann R. , Niazi F. , Scheele J. , Diergarten K.
Published: August 2020

e20696

Background: CBR is used as clinical trial endpoint in patients (pts) with advanced cancers. Auron Misheil Therapy (AMT) contains approved pharmaceuticals in low therapeutic doses (human insulin and chlorpheniramine) and herbal components (aqueous camomile extract). Safety and CBR-efficacy of AMT have been confirmed in phase I and II trials. The multicenter randomized double blind phase III study AMT/P2CA/001 compares CBR efficacy and safety of AMT with placebo in patients with advanced solid tumors. Methods: Pts with inoperable advanced disease refractory to standard therapy or for which no standard therapy existed were included.. Pts were randomized to receive placebo or AMT (0.066 ml/kg body weight) twice daily i.m. Patients on placebo had the possibility to switch to AMT under certain conditions. CBR was evaluated after two weeks of treatment with randomized AMT/placebo and after two weeks of open AMT, confirmed 4 weeks later. One week screening period for the assessment of the baseline CBR was necessary. Results: 45 pts were evaluable in this first analysis for CBR at 2 and 6 weeks. 6 out of 45 patients showed an overall CBR response (response at week 2 and week 6). The general adverse event profile (related and not related events) reflects the advanced cancer disease of the patients, and no relevant differences were observed between the AMT-groups and the Placebo-group. The most serious adverse events under AMT were hypoglycaemia. Local side effects were slightly more frequent in the AMT arm. Conclusions: This study shows that CBR can be achieved with AMT after 2 respectively 6 weeks of treatment even in patients with advanced solid tumors and a clinically relevant number of patients seem to have a benefit from the study treatment.

[Table: see text]
Identification of supportive care needs in a sample of Puerto Rican cancer patients with the Supportive Care Needs Survey-34 (SCNS-34)
Authors: Gonzalez V. , Velez M. , Pedro E. , Cruz C. , Cotto M. , Colon M. , Romaguera J. , Chevere-Mourino C. , Delgado- Mateu L. A. , Tirado-Gomez M.
Published: August 2020

e20697

Background: The assessment of supportive care needs is important in the management of cancer patients. The Supportive Care Needs Survey (SCNS-34) was administered to a population of Puerto Rican cancer patients to assess their perceived needs in five domains (psychological, health system and information, physical and daily living, patient care and support, and sexuality.) Methods: Patients attending the surgical, radiation and medical oncology clinics at the Puerto Rico Medical Center participated in the study. After informed consent, patients completed the Spanish- Puerto Rican translation of the SCNS-34. A second instrument to measure the quality of the SCNS-34 was administered. Demographic and clinical data was obtained from medical records. Descriptive, univariate and multivariate analysis was performed to assess correlation between reported needs and demographic and clinical data. To assess the validity and consistency of the Spanish Puerto Rican translation of the SCNS-34, the Cronbach's alpha test was used. Results: A total of 103 patients participated in the study (female n=66; male n=37). Median age was 54 years. The most common malignancies were breast cancer (29 patients), gynecologic cancers (22 patients), prostate cancer (17 patients) and gastrointestinal cancers (14 patients). The overall internal consistency of the instrument was 0.882. Patients perceived needs were highest in the domains of sexuality (67%), physical and daily living (55.3%), and psychological (38.8%). Logistic regression analysis demonstrated that younger age was an independent predictor of perceived needs in the psychologic domain (p=0.010). Also, a diagnosis of breast cancer was a significant predictor of perceived needs in the health system and information domain (p=0.020). Being a female was correlated with reporting needs in the domain of physical and daily living (p=0.009). Educated patients were more prone to perceive needs in the domains of sexuality (p=0.045). Conclusions: The Spanish- Puerto Rican translation of the Supportive Care Needs Survey (SCNS-34) showed satisfactory internal consistency and validity. The supportive care needs of Puerto Ricans cancer patients seem to be affected by age, gender, and cancer site.

No significant financial relationships to disclose.
Tolerance to treatment in elderly patients with colon cancer
Authors: Pilnik Prof N. G. , Ibero M. A.
Published: August 2020

e20710

Background: About 60% of all colorectal cancers occur after the age of 50. This tumor is the second most common cause of cancer and the death by neoplasm. Beside, aging may affect several aspects of pharmacology due to a progressive reserve deteriorations and the comorbidities presence which may influence the tolerance to treatment. Methods: 90 colorectal cancer pts, aged 65–78 years, who underwent surgery and Ch/Rt were included . Pts were divided in two groups: I: ≤ 70 and II > 70 years. Pts selection was conducted using General Geriatric Assessment . All pts had adequate cardiac, hepatic, renal and bone marrow functions. Comorbidities studied were: hypertension, diabetes, COPD, cardiac disease,and gastrointestinal disease.Toxicities were studied following the WHO criteria and correlated according to age, Activity of Daily Living (ADL),Instrumental Activity of Daily Living (IADL), PS, WL, comorbidities, and the use of more than 3 drugs in addition to Ch/ Rxt. QoL was studied through the evaluation of ADL, IADL, and PS evolution. Statistical Methods: Pearson´s Chi-Square test, Kaplan Meier´s curves. Results: The most frequent level in the whole sample was Grade I. No relationship was found between toxicities and age. Toxicity level was found to be higher in the pts who used more than 3 other medications p=0,01. Statistically significant association was found between comorbidities and toxicity levels p = 0,04. WL and toxicity level were statistically associated, p = 0,01. There was improvement in Qol through the evaluation of ADL, PS,and IADL evolution p= 0.03. PS and IADL were statistically correlated with survival p = 0.02 Conclusions: Older Colon cancer pts in good general condition and with controlled comorbidities may receive Ch/ Rxt. The reason why the majority of pts had low toxicities may be attributed to the fact that all of them were properly selected.

No significant financial relationships to disclose.
caBIG: Proof of concept platform for personalized cancer care
Authors: Buetow K.
Published: August 2020

e20712

Background: Numerous factors including enhanced understanding of the molecular basis of disease and the availability of sophisticated information technology are catalyzing a “rapid learning healthcare system,” where knowledge obtained from clinical outcomes can drive research discoveries that can be can be brought rapidly to the bedside. Benefits from such an iterative process may include earlier detection, more efficient drug discovery and development, and individualized patient care leading to better clinical outcomes. Methods: The National Cancer Institute (NCI) identified the need for an informatics initiative in recognition of the growing clinical and economic burden of cancer; the transformation of research catalyzed by multiple genomics technologies that were generating massive amounts of data; and recognition that the “essential unity” of research and clinical care had powerful potential to improve the outcomes of all cancers, as it had done in the field of pediatric oncology. In response, NCI pioneered caBIG (cancer Biomedical Informatics Grid), a network of interconnected data, individuals, and organizations, designed to share data and knowledge, simplify collaboration, and speed research. Results: caBIG is being deployed and used in numerous research and clinical facilities, including almost 60 NCI-designated cancer centers and the NCI's National Community Cancer Center Program (NCCCP). This widespread implementation provides the framework for collaborative research projects and data sharing that will accelerate basic and clinical research and improve clinical care. Programs enabled by caBIG technologies are included in the table . Conclusions: The benefits of an interconnected cancer community will multiply as the collective knowledge and expertise of its members is harnessed and their findings are shared. Researchers and clinicians must be fully aware of opportunities to connect data, individuals and institutions to achieve their goals.

[Table: see text]

No significant financial relationships to disclose.
Cancer in pregnancy: Trends and research
Authors: McKain L. F. , Albano J. D. , Desai M.
Published: August 2020

e20720

Background: Treatment advances for some cancers have allowed reproductive opportunities that would not have otherwise been possible. Optimal cancer treatment in pregnancy balances maternal needs with concerns for the developing fetus, often relying upon case report and retrospective study data which are subject to confounding factors. Study objectives were to estimate trends in cancer incidence during pregnancy and to describe current research methodology. Methods: The number and rate of pregnancies affected by cancer in 1990 and 2004 were estimated by applying age-specific incidence data from the Surveillance, Epidemiology, and End Results Program to pregnancy data from the National Center for Health Statistics for women 15–44 years. In addition, public trials registries were searched for actively enrolling studies related to “cancer in pregnancy.” Investigators were contacted for detail regarding methodology and descriptive statistics tabulated. Results: The incidence of cancer complicated pregnancies has increased overall between 1990 and 2004 from 1/1,560 to 1/1,180 pregnancies, and individually for breast, melanoma, and thyroid cancers. Seven studies actively enrolling pregnant patients with cancer were identified. Six studies are observational registries, two of which prospectively study specific drug therapies. Three enroll patients receiving care at single institutions whereas the others allow open-enrollment. Three studies focus on breast cancer during pregnancy including the only interventional study. Both maternal and pediatric outcomes are of interest. Conclusions: The shift in the distribution of pregnancies towards older women coupled with an overall increased incidence of cancer puts more women at risk of having a pregnancy complicated by cancer. Current studies are few and dominated by observational registries which maximize the eligible study population through open enrollment. Registries can efficiently provide outcome and follow-up data for this special population but have limited ability to assess effectiveness of specific treatment regimens. Oncologists must recognize the trend in the incidence of cancer in pregnancy and become stakeholders in the process of contributing to ongoing research by engaging their patients in existing studies and initiating new projects.

[Table: see text]
Phase II trial comparing darbepoetin alfa every 3-week versus weekly epoetin alfa for the treatment of chemotherapy-induced anemia
Authors: Hassan M. A. , Sleem M. M.
Published: August 2020

e20724

Background: Anemia is common in patients receiving chemotherapy and may adversely affect health-related quality of life. Erthyrpiotic factors darbepoetin alfa (DA) and epoetin alfa (EA) are currently approved for the treatment of anemia in patients with nonmyeloid malignancies who receive chemotherapy. Methods: Forty patients with a diagnosis of nonmyeloid malignancy with 8 weeks of planned chemotherapy, age 18 years, and anemia (hemoglobin 10 g/dL). 20 patients received DA 500 μg every three weeks (Q3W) and the others 20 patients received EA 40,000 units every week (QW) for up to 18 weeks. Treatment was hold at week 6 for nonresponse, which was defined as failure to achieve a hemoglobin increment of at least 2 g/dL above the baseline measurement. Efficacy was assessed by the incidence of RBC transfusion. Results: Forty patients with a diagnosis of nonmyeloid malignancy, the median age was 49 years and 52 years for DA and EA groups respectively, The majority of patients had solid tumors: Common cancer types for (DA - EA) groups were gastrointestinal (8 -5), breast (3–6), lung (3–3), soft tissue sarcoma (2–1), genitourinary (2–1), non-Hodgkin's lymphoma (1–1), multiple myeloma (1–1), Hodgkin's lymphoma (0–1), and metastatic with unknown primary in (1–0) respectively . 75% 0f the patients in both group achieved the target hemoglobin level. Transfusion incidence from week 6 to the end of the treatment phase (the primary end point) was required in 5 patients (25%) in both groups. The side effects reported in this study were thromboembolic in two patients in both groups 10%. Nausea, diarrhea and neutropnia were 25%, 15% and 10% for DA group respectively compare to 20%, 10%, and 15% in AE group respectively. Conclusions: This study demonstrates comparable efficacy and safety of DA 500 μg every three weeks (Q3W) and EA40, 000 units every week (QW).

No significant financial relationships to disclose.
Erythropoiesis-stimulating agents for cancer patients: Increasingly restrictive guidelines and policies in the United States and Europe
Authors: Samaras A. T. , Lai S. Y. , Kim B. , West D. P. , McKoy J. M. , Henke M. , Silver S. M. , Bennett C. L.
Published: August 2020

e20725

Background: Erythropoiesis stimulating agents (ESAs) have transformed the treatment of cancer-associated anemia worldwide. However, recent reports of venous thromboembolism (VTE), tumor progression, and mortality risks associated with ESA administration to cancer patients have resulted in reassessments of the safety and appropriate usage of these agents. The present study investigated the disparate factors that contributed to the transformation of ESA policies. Methods: We reviewed meta-analyses, advisory committee recommendations, manufacturer label revisions, clinical guidelines, reimbursement policies from the Centers for Medicare and Medicaid Services (CMS), updated clinical guidelines, and ESA usage trends. Results: See Table . Conclusions: The risks and benefits of ESAs for cancer patients have been reassessed, resulting in increasingly restrictive guidelines and labels in the U.S. and Europe. In response to the 2008 ESA labeling change mandated by the U.S. Food and Drug Administration (FDA), the European advisory committee, Committee for Medicinal Products for Human Use (CHMP), convened to reassess the risk-benefit profile of ESAs and determined that for patients with reasonably long life expectancies, the benefits of ESAs do not outweigh the risks. Additionally, the U.S. National Comprehensive Cancer Network (NCCN) revised clinical guidelines in accordance with the FDA labeling change. Therefore, FDA actions combined with the CMS reimbursement policy have provided the impetus for increasingly restrictive use of ESAs.

[Table: see text]

[Table: see text]
Cardiac anthracycline risk: Prognostic value of troponin I (TnI) and B-natriuretic peptide (BNP)
Authors: Bertolini A. S. , Croce A. , Fusco O. , Berardi E. , Malugani F. , Fiumanò M. , Deligiannis P. , Menatti E.
Published: August 2020

e20726

Background: In patients with cancer who are undergoing to high-dose chemotherapy (HDC), even minimal elevation of TnI is associated with late left ventricular dysfunction. A TnI increase soon after HDC is a strong predictor of poor cardiological outcome. BNP elevation seems to have same prognostic value. Patients treated by standard Anthracycline-based chemotherapy (ADM-CT) doses could not have benefit from TnI/BNP evaluation; on the contrary the method could adsorb too much resources and may not be rational. Methods: To evaluate cardio toxicity trend we studied TnI and BNP in plasma samples of 28 breast cancer pts (female, adjuvant setting, mean age 50), treated with ADM-CT. The samples were detected before (a) one hour (b) and ten days (c) after each course. TnI was considered positive for values ≥ 0.044 ng/mL; BNP for values ≥ 100pg/mL .Comparison between TnI and BNP values were made with the ANOVA method. A probability value < 0.05 was considered statistically significant. Each patient was followed also with LVEF (basal & 3 months after). Results: At present we observed 135 events, mean TnI: (a) 0,00672, (b) 0,006512, (c) 0,005791; BNP (a) 33.8, (b) 36.4, (c) 35.2. We performed 405 detections for both tests; costs: 8.707$ BNP, 10.327$ TnI. No significant difference in test values has been observed between the different time periods. We can't indicate a trend referring to therapy or a particular time period. No patients had LVEF variation. Conclusions: TnI and BNP release pattern after ADM-CT doesn't identify patients at different risk of cardiac events. The program appears useful for HDC treatments, while in normal chemotherapy the data are ongoing and expensive.

No significant financial relationships to disclose.
Evaluation of neurological symptoms in oncologic patients at the emergency department
Authors: Ferrer A. , López D. , Vidal M. , Tobeña M. , Serrano S. , Pajares I. , Millastre E. , Ruiz-Echarri M. , Lambea J. , Tres A.
Published: August 2020

e20728

Background: Neurological symptoms in cancer patients are common and some of them represent a potentially serious situation. They are a frequent cause of complaint at the Emergency Department (ED). The aim of the study is to describe the profile of cancer patient who consult at ED for neurological symptoms, their diagnosis and management. Methods: From October 2007 to October 2008, all cancer patients treated at the ED of our hospital were prospectively collected. The reasons for consultation, diagnosis and clinical management are described. Results: A total of 560 cancer patients were enrolled. Of them, 61 patients (11%) consulted for a neurologic symptom: 50 of these patients (82%) were stage IV disease and 30 (49,2%) were receiving chemotherapy treatment. Of the total of patients, 14 (23%) had lung cancer; 10 patients (16%) had colorectal cancer; and 8 patients (13%) had primary central nervous system tumor. Most frequent causes of complaint were: low level of consciousness, 13 patients (21%); mobility deficit, 12 patients (19%); syncope, 9 patients (15%) and comitial crisis, 6 patients (10%). Of the patients who consulted for a neurological symptom, 52% of cases (32 patients) the cause was a structural lesion of central nervous system. Tumor progression was the diagnosis made in 27 patients (44,3%), in 14 patients (23%) the diagnosis was a metabolic alteration. A 69% of patients (42 patients) required hospitalization, 26% was discharged (16 patients) and 5% (3 patients) needed to be under observation during at least 24 hours. Conclusions: Neurological symptom is a frequent cause of complaint at ED for cancer patients. especially in patients in advanced stages. The most frequent diagnosis made because of these symptoms is tumor progression. Metabolic alterations are also an important diagnosis because of their frequency and because they can be solved by medical treatment. Most patients who consult for neurological symptoms need hospitalization.

No significant financial relationships to disclose.
Systematic review of toxicities of lineage-specific hematopoietic growth factors toxicities: Implications for biosimilar erythropoietins, thromopoietic receptor agonists, and continuous erythropoietin receptor agonists
Authors: Polish A. , Samaras A. T. , McKoy J. M. , West D. P. , Trifilio S. M. , Tallman J. , Talman M. S. , Bennett C. L.
Published: August 2020

e20733

Background: Erythropoiesis stimulating agents (ESAs) and the granulocyte and granulocyte macrophage colony stimulating factors (G-CSF/GM-CSF) have been widely used for the past two decades. Recently, thrombopoietin receptor agonists, romiplostim and eltrombopag, biosimilar erythropoietins, and a continuous erythropoietin receptor agonist were licensed. Although lineage specific hematopoietic growth factors play important roles in the treatment of cancer and chronic kidney disease, recent basic and clinical research studies have identified toxicities. Herein, we compared toxicities of ESAs, thrombopoietins and G-CSF/CSFs and the implications of these findings. Methods: Meta-analyses, reviews, clinical guidelines, and FDA transcripts for G-CSF, GM-CSF, and ESAs were reviewed. For MGDF, romiplostim, and eltrombopag, clinical trial reports, reviews, and FDA transcripts were reviewed. The study period was 2000 to 2008. Results: See Table . Conclusions: Commonalities in toxicities exist across lineage specific hematopoietic growth factors. Delayed recognition of adverse effects with ESAs and G-CSF highlights the importance of anticipating toxicities with biosimilars and thrombopoietin receptor agonists.

[Table: see text]

No significant financial relationships to disclose.
Methadone rotation and initiation in outpatient cancer pain
Authors: Moura G. L. , Padilha S. , Vianna K. , Giublin M.
Published: August 2020

e20734

Background: Methadone is an effective mu opioid agonist. Delta receptor affinity, monoamine reuptake inhibition an antagonism in N-methyl-D-aspartate receptor have been described. Because of itst long half-life and lack of standart conversion ratio outpatient use is chalinging. Methods: Retrospective review of consecutive medical reports were performed from 2002 to 2007. Patients with methadone as exclusive drug for the first two months were selected. A total of 143 patients were analyzed. Symptoms, toxicities, clinical caraceristics rotation e neuropatic pain were acessed. Results: 89 (62.2%) were female, 54 (37.7%) were male, all patients had solid tumors and were under palliative care only. 52 (36.6%) had neuropathic pain. Median age was 67 years. Median pain score at baseline was 7. After four follow-up with intervals of four days in average, 78% patients had score zero. At the end of two months we found a median (range) of 18 follow-ups performed. 127 (88.8%) patients had score zero. The remaining patients were rotated to other opioid. Neuropathic pain was improved in 36 (73%) of patients only with methadone. 16 (17%) had to use adjuvant drugs. Mean methadone dose was 10mg/day at baseline and 20mg/day at the end of two months.Sedation, obstipation and neurologic symptoms were mild and no major complication was observed. Conclusions: Methadone as initial opioid opyion showed excelent and safe response rates. Its capacity of blocking NMDA receptors may explain the high rate control for neuropathic pain. This finding was not observed in others studies. The low cost, lack of active metabolites, good tolerance in older patents and the finding in neuropathic pain should be better explored in well prospective randomized future clinical trials.

No significant financial relationships to disclose.
Prevention of stomal complications
Authors: Phadke M. V.
Published: August 2020

e20745

Background: Ileostomy/Colostomy operations are associated with a high rate of infections and complications resulting in increased morbidity, mortality and litigation. Pathogenesis of each complication and role of Nature was observed. Technique of stomal maturation was modified. Surgeon must maintain control over the stoma at all times. Primary maturation of stoma is unnecessary and potentially harmful. Opening stomal lumen in O.R. is unscientific and allows bacteria to contaminate stomal and main wounds. Methods: Concept was evolved by serendipity in April 1986. Since then it has been used on all patients requiring an Ileostomy or Colostomy. Bacterial migration is prevented by keeping the lumen obstructed. Iatrogenic obstruction of small/large intestine has no deleterious effect on post-operative course. Obstructed bowel is brought out of opening at proposed site of stoma. Mesenteric corner of obstructed stoma is always above the skin. Anti-mesenteric surface is pulled out till the anti-mesenteric corner becomes the apex of a conical stoma. Serosa is sutured to a round opening in the rectus sheath. Stoma is covered by an appliance with a transparent pouch. Peristalsis starts in about 48–72 hours. When obstructed stoma bulges, it is opened with electrocautery as a minor bedside procedure. Diet is started. Peristalsis pushes mucosal cuff which protrudes, everts and auto-grafts over angiogenesis. This is based on Delayed-Primary (DP) wound healing. Mucosal cuff comes in contact with dermis of skin opening at stomal site completing Self-Maturation (SM). During SM, mucosal tube separates from serosal tube. Peristalsis continues to exert its effect on serosal tube but not on mucosal tube. Lumen of stoma remains concentric. Results: 65 Colostomies and 15 Ileostomies were performed using DPSM technique. Infection and complications were prevented. Minor complications were handled easily. Patient satisfaction was excellent. Conclusions: Primary maturation of stoma is unnecessary and potentially harmful and should be replaced by DPSM. It can be performed in all types of stoma construction, end or loop, temporary or permanent. It prevents infection and complications in all patients.

No significant financial relationships to disclose.