bluuebunny/crossref_metadata_2025_split huggingface dataset:
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.