bluuebunny/crossref_metadata_2025_split huggingface dataset:
The value of personalized treatment (Rx) planning (PTP): Cost savings (sav) by the Microculture Kinetic (MiCK) chemosensitivity (CS) assay, evidence from a large American self-insured company (ASIC)
Authors: Latimer R. G. , Presant C. A. , Hallquist A. E. , Perree M. , Agapitos D. 
Published: August 2020

e17541 Background: Costs of cancer (CA) patient (PT) Rx are high. A novel CS assay MiCK was predictive of chemotherapy (CT) activity and survival in leukemia PTs (Blood. 2001;98:241b) and is in solid tumor testing. We performed a cost sav analysis for CS assay in a large ASIC population. Methods: An ASIC of 48,927 employees submitted 3.5 years claims data on all PTs with diagnoses of CA lung, breast, colon or ovary. Analysis of average Rx costs was made based upon total CT usage, Rx of selected PTs including therapeutic drug administration (admin), CT admin, supportive care (SC) drugs, CT drugs, biotherapy (BT) drugs, growth factors, home infusion costs, and cost of the MiCK assay. Average CT and BT drug costs were determined. We assumed high MiCK predictability for CT activity from solid tumor pilot studies and leukemia results. 4 models were evaluated: CT with a single active drug from MiCK for the duration actually given (ASC); CT with active drugs for the entire time (AC100); CT for 50% of the time period (AC 50) assuming a CT “holiday” for the other 50% of time; and CT with active drugs plus BT for 50% of the time (ACB 50). The costs in these 4 models were compared to actual claims payments. Results: 196 PTs had CA during the 3.5 year period. 55 had CT. Total costs for CT were $5,647,165. Costs for IV CT drugs, SC drugs and drug admin were $1,149,404. Assuming the use only of active CT selected by MiCK assay, under model ASC average sav/PT was 85.3% of CT, SC and admin costs. Under model AC100, the average sav/PT were 26.0%. Under model ACB 50, the sav were 48.6%. In model AC 50, the sav were 62.7%. When the overall costs were evaluated, model ASC sav were 17.4%, model AC 100 5.3%, model ACB 50 9.9% and model AC 50 12.8%. Conclusions: PTP using the MiCK CS assay could save a high percentage of CT costs, and a substantial percentage of overall costs of CA care in an ASIC. Sav varied from 9.9% to 62.7% depending on effectiveness and duration of Rx, and necessity for continuing BT not testable by MiCK. The true value of PTP with MiCK could be higher, since use of active CT would increase quality of life and employment, and reduce disability and side effects. [Table: see text]
Academic cancer researchers’ perspective on a federally mandated centralized comprehensive database of all cancer clinical trials results
Authors: Novik Y. , Escalon L. , Rolnitzky L. 
Published: August 2020

e17576 Background: Campbell et al. (2002) examined the data sharing habits of geneticists and other life scientists from universities that receive funding from the NIH and found that genetics researchers are refusing to share results with colleagues, hindering the ability to replicate published results. This has not been explored in cancer research. Data sharing, data transparency, and collaboration adds value to research by reducing redundancy (time, resources, exposing trial participants to unnecessary risk). In cancer research there are existing results databases from the NCI to caBIG. The purpose of this study is to ascertain from the perspective of academic cancer researchers whether there is a need for a federally mandated comprehensive database of all cancer clinical trial results. Methods: The 11 question online questionnaire addressed data sharing. Responses are presented as percents of respondents who agree with each statement accompanied by 95% confidence intervals (CI). The 24 respondents included physicians, research nurses, regulatory staff, data management, and administration who work in cancer research in an academic setting. Results: Overall, 92% (95% CI, 74–98%) agree that a centralized comprehensive database will reduce redundancy, 100% (95% CI, 86–100%) agree that disclosing results to fellow researchers will help researchers to design better cancer clinical trials, and 96% (95% CI, 80–99%) agree that there is a need for a federally mandated comprehensive database of all clinical trial results. On database access 100% (95% CI, 86–100%) agree for academic researchers, 58% (95% CI, 39–76%) agree for the pharmaceutical industry, 50% (95% CI, 31–69%) agree for trial participants, 29% (95% CI, 15–49%) agree for the public, and 21% (95% CI, 9–40%) agree for media. Conclusions: This study is a step in exploring how the academic cancer research community feels about data sharing. The study population is small and limited to a single institution. To support generalizability of the findings, it is necessary to enlarge the population by increasing the number of participants from the chosen institution and/or to include other academic institutions in future studies. No significant financial relationships to disclose.
Phase II trial of erlotinib maintenance therapy after platinun-based chemotherapy in advanced non-small cell lung cancer (NSCLC)
Authors: Cobo M. , Martinez J. , Montesa A. , Gil-Calle S. , Villar-Chamorro E. , Ales I. , Gutierrez V. , Durán G. , Carabantes- Ocón F. , Benavides M. 
Published: August 2020

e19013 Background: phase II trial-efficacy & toxicity of sequential erlotinib in advanced NSCLC after platinum-based CT Methods: Pts with adv NSCLC, PS 0/1, adequate renal, hepatic and bone marrow function, no PD after CT. Treatment: erlotinib 150 mg/day starting 3–4 weeks after CT until progression. Safety was evaluated monthly and tumor evaluation bimonthly. Results: 47 pts enrrolled:42(89%)stageIV & 5(11%)wet IIIB, all valid for response & toxicity. Median age 62 y(r:39 -77): 39(83%) males and 8(17%) females. Histology: adenocarcinoma 8(61.7%), bronquioloalveolar 3(6.4%), large cell 3(6.4%), squamous12(25.5%). PS 0: 23(49%), PS 1:24(51%). 38(81.9%) completed 6 cycles of CT. Response: CR: 1(2.1%), PR: 2(51.1%), EE: 22 (46%). Sequential erlotinib improved RR in 6 (12.8%), 23 (48.9) prolonged stabilization, 18 (38.3%) had progression. Median TTP and OS were 9.4 m (95% CI, 4.96–13–84), and 19.23 m (95% CI, 8.82–29.64). No significant differences in TTP according to age, sex, PS, histology or previous response to CT, but yes depending on RR to erlotinib: PR: 31.5 m (95% CI 15.37–47.63), EE: 12.8 m (95% CI, 10.58–15.03), PD: 6.3 m (95% CI, 5.36–7.3), p < 0.001; and moreover depending on smoking status: Never: 21.67 m(95% CI, 5.39–37.94), previous smoker > 5 years: 14.03 m(95% CI, 10.77–17.30), previous smoker 1 year: 7.77 m(95% CI, 7.62–7.91), current smoker: 5.9 m(95% CI, 5.12–6.34), p <0.001. In Cox-regression model, smoking status ( p< 0.001), and response to erlotinib (p=0.002) were associated with a significant difference in TTP. Similar results in OS, although in Cox-regression model only never smoker or > 5 years previous smoker pts had a significant better survival. Toxicity: The most frequent was skin rash, grade (g) 1 in 11(23.4%), g 2: 16(34%) and g 3: 3(6.4%). Only 1 p had diarrea g 3, and no other side effects were observed. We found a significant benefit in p with g 2–3 skin toxicity respect g 0–1, in both TTP( p= 0.0003) and OS (p= 0.0014). Conclusions: Erlotinib-maintenance therapy after platinum-based CT had promising results. Pts with the best benefit were those with response to erlotinib, in never or past (> 5 years) smokers and with g 2–3 skin toxicity. No significant financial relationships to disclose.
Analysis of long-term treatment outcomes and toxicty of HL
Authors: Ngeow J. Y. , Quek R. , Tao M. , Tan H. C. , Lim L. , Tan I. , Kaneswaran R. , Lim S. T. 
Published: August 2020

e19536 Background: Prognosis of patients with Hodgkin lymphoma (HL) has substantially improved but therapy of HL can however contribute to delayed toxicity. Long term treatment outcomes of HL in our local population were evaluated. Methods: Clinical and treatment data was prospectively collected from all patients with a histological diagnosis of HL. Patients were all fully staged with CT scan and bone marrow biopsy. Results: On the basis of 217 patients seen at the National Cancer Centre Singapore between 1990–2008, we found that there was a peak in young adulthood with 103 patients who were diagnosed before the age of 30 (48%), median age of presentation 32 (range 17–84). Patients who were young (< 30 years) were more likely to present with nodular sclerosis HL (p=0.0001). Treatment outcomes were comparable to other published series, 85% of cases received ABVD based treatment. 5 year OS for early stage HL was 92% and 88% for advanced stage HL. Overall FFTF was 93% at 5 years. Of note, comparing patients with early stage (Stage I/ II) HL (n=114) who had ABVD 4 cycles followed by involved field radiotherapy (IFRT) with those who received 6–8 cycles of ABVD, there was no difference in OS, FFTF (p= 0.99, 0.48 respectively). Bulky early stage HL who received 6 cycles of ABVD and IFRT had better FFTF rates than those who had just 4 cycles of ABVD followed by IFRT (p=0.06). In contrast, patients patients with advanced HL (Stage III/ IV) (n=70) who completed 6–8 cycles of ABVD did not benefit from additional IFRT even in the presence of bulky disease (n=15). Acute toxicities included that of bleomycin induced pneumonitis (BIP) seen in 15% of cases. Neither the omission of bleomycin nor the presence BIP adversely affected treatment outcomes. Hematological malignancies were seen in 1% of survivors appearing after a median of 7.3 years. Hypothyroidism was noted in 3% of cases. Conclusions: 1) Epidemiology of HL in Singapore is increasingly similar to that of developed countries with a peak in young adults. 2)Young age was predictive of a nodular sclerosis subtype 3) Abbreviated chemotherapy using 4 cycles of ABVD followed by IFRT performed similarly to 6 cycles of ABVD in early stage HL, but in patients with bulky disease this may not be sufficient. 4) BIP occurred in 15% of cases. BIP and the omission of bleomycin did not adversely affect treatment outcomes. No significant financial relationships to disclose.
A randomized phase II trial comparing two doses of lenalidomide for the treatment of stage IV ocular melanoma
Authors: Zeldis J. B. , Heller C. , Seidel G. , Yuldasheva N. , Stirling D. , Shutack Y. , Libutti S. K. 
Published: August 2020

e20012 Background: Ocular melanoma is the most common primary intraocular malignancy in adults with an incidence of 4.3 new cases per million. Approximately 50% of patients will develop metastases and the mean survival of those with liver metastases is 8–10 months. There are no effective systemic therapies. Pre-clinical studies of the antiangiogenic and immunomodulatory agent, lenalidomide, have shown promise in animal models of human ocular melanoma. We therefore conducted a phase II trial comparing two doses of oral lenalidomide. Methods: Patients with stage IV ocular melanoma, who met eligibility criteria and demonstrated disease progression, were enrolled on an IRB approved prospective random assignment trial comparing 5 mg and 25 mg of lenalidomide administered once a day orally for 21 days with a 7 day recovery (one cycle). Lesions were measured at baseline and every 3 months and scored for response by RECIST criteria. Patients who completed 3 cycles were eligible for response evaluation. Patients with responding lesions or with stable disease could continue receiving the agent. Toxicity was assessed using the NCI Common Toxicity Criteria. Results: Seventeen patients (13 female, 4 male; mean age 53) met eligibility criteria and were randomized to 5 mg (9 patients) or 25 mg (8 patients) of lenalidomide. The agent was well tolerated at both doses with only three grade 3 toxicities (two decreased ANC and one rash/puritis) requiring dose adjustments. Sixteen patients were eligible for response assessments. Nine patients had progressive disease by RECIST criteria following 3 cycles of therapy. Seven patients (44%) had stable disease for a mean of 7 months (range 6–12 months). There were no RECIST defined responders. There were no differences between the two dose groups with respect to toxicity or disease stabilization. Conclusions: Lenalidomide is well tolerated at doses of 5 mg and 25 mg orally for a 21 day cycle by patients with stage IV ocular melanoma. While no responses were seen, disease stabilization for a mean of 7 months was seen in 44% of patients. This effect was consistent with the pre-clinical animal data. Based on these results, further development of lenalidomide in combination with other agents should be considered for the treatment of metastatic ocular melanoma. [Table: see text]
Comparing health-related quality of life (HRQL) of cancer patients undergoing chemotherapy with family members in a tertiary hospital
Authors: Papadopoulos A. , Vrettos I. , Kamposioras K. , Charitos D. , Giannopoulos G. , Pectasides D. , Niakas D. , Economopoulos T. 
Published: August 2020

e20535 Background: In Greece there is limited information concerning the HRQL of cancer patients undergoing chemotherapy. The aim of this study was to estimate and compare the HRQL of cancer patients and their relatives during the period of chemotherapy and to investigate potential differences in HRQL. Methods: 122 family members (45 men and 77 women) of mean age 48.3 ±14.5 and 122 cancer patients undergoing chemotherapy (49 men and 73 women) of mean age 56.6 ±15.4 1SD completed the SF-36 health survey by personal interview. The SF-36 health survey was used to evaluate and compare HRQL which contains eight scales measuring physical functioning (PF), role physical (RP), bodily pain (BP), general health perception (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH), with higher scores (0–100 range) reflecting better-perceived health. Two component summary scores capture the overall physical and mental health (Physical Component Summary or PCS and Mental Component Summary or MCS). Data analysis was performed with SPSS version 13.0 while statistical analysis was performed with Wilcoxon signed ranks test. Results: The table below summarizes the results of our study. Conclusions: Although the physical health was significantly higher in the family members as it was expected for a healthy population, the mental health and especially MCS was significantly lower from the cancer patients undergoing chemotherapy. It seems that medical condition of the patients affects severely the mental HRQL of family members. Supportive psychological programs for both the patients and the family members seem mandatory. [Table: see text] No significant financial relationships to disclose.
Dose escalation of low molecular weight heparin to manage recurrent venous thromboemblic events despite systemic anticoagulation in cancer patients
Authors: Carrier M. , Le Gal G. , Cho R. , Tierney S. , Lee A. Y. 
Published: August 2020

e20580 Background: Cancer patients with venous thromboembolism (VTE) are at high risk of recurrent VTE. The rate of recurrent VTE ranges from 9 to 17% despite therapy with low molecular weight heparins (LMWH) or vitamin K antagonists (VKA) respectively. To date, no published evidence is available to guide treatment of cancer patients with recurrent VTE. We sought to evaluate the benefit and risk of LMWH dose escalation in cancer patients with recurrent VTE. Methods: Retrospective cohort study was conducted in consecutive cancer outpatients referred for management of an objectively confirmed, symptomatic, recurrent VTE while receiving an anticoagulant. Patients were treated with either dose escalation of weight-adjusted LMWH in patients already anticoagulated with LMWH or initiation of a therapeutic dose LMWH in patients who were taking a VKA. All patients were followed for a minimum of 3 months after the index recurrent VTE. Results: Seventy cancer patients with a recurrent VTE despite ongoing anticoagulation were included. The median time between the initial VTE to the index recurrence was 3.5 months (range 0.3 to 193 months). At the time of the recurrence, 67% of patients were on LMWH, while 33% were on VKA. Following the treatment with either dose escalation or initiation of LMWH, a total of 6 patients (8.6%; 95% confidence interval (CI): 4.0% to 17.5%) had a second recurrent VTE during the three-month follow-up period, at an event rate of 9.9 per 100 patient-years (95% CI: 2.0 to 17.8). The median time between the index and second recurrent VTE was 1.9 months (range 0.6 to 3.0 months). One patient (1.4%; 95% CI: 0.3% to 7.7%), or 1.6 per 100 patient-years (95% CI: 0.0% to 4.8%) of follow-up, had a major bleeding event. The median time between the index recurrent VTE to death was 11.4 months (range 0 to 83.9 months). Conclusions: Patients with recurrent VTE have a poor prognosis. Escalating the dose of LMWH can be effective for treating cases that are resistant to standard, weight-adjusted doses of LMWH or a VKA. [Table: see text]
Components of early intervention outpatient palliative care consultation in patients with incurable NSCLC
Authors: Jackson V. A. , Jacobsen J. , Greer J. , Dahlin C. , Billings J. A. , Pirl W. , Perez Cruz P. , Admane S. , Blinderman C. , Temel J. 
Published: August 2020

e20635 Background: Many experts recommend palliative care consultation early in the course of oncology treatment; however little is known about the components of this type of intervention. We sought to better define the components of early palliative care consultation in patients with recently diagnosed incurable cancer. Methods: As part of a larger randomized study of integrated versus standard palliative care in an ambulatory thoracic oncology clinic, we analyzed data from 47 patients who received early palliative care consultation within eight weeks of diagnosis of incurable NSCLC with a performance status of 0–2. Prior to randomization, patients completed questionnaires on quality of life (FACT-L) and mood (HADS) as well as illness understanding. The FACT-L Trial Outcome Index which is a combined score of physical, functional well being, and lung cancer symptoms was calculated and used in correlations to more fully assess quality of life. After the consultation, palliative care clinicians recorded how time was spent during the encounter. Results: Seven palliative care clinicians provided consultation to 47 patients. The mean total time spent with each patient was 59.5 minutes (SD 28.6). The major components of each consultation were symptom management 25.7 minutes (SD 15.8), patient and family coping 19.6 minutes (SD 14.7), and illness understanding and education 10.4 minutes (SD 7.6). Greater total consultation time was correlated with poorer performance status (r=0.30, p=0.04) and lower quality of life scores on the FACT-L TOI which is a combined score of physical, functional wellbeing, and lung cancer symptoms (r=0.36, p=0.01). Symptom management time was also correlated with lower quality of life scores on the FACT-L TOI (r-0.52, p<0.001) and higher depression scores on the HADS (r=0.33, p=0.02). Conclusions: Initial palliative care consultation near the time of diagnosis in patients with incurable NSCLC is lengthy and comprised primarily of symptom management, patient and family coping, and illness understanding and education. Patients with poorer performance status and quality of life received longer total time in consultation and in time devoted to symptom management No significant financial relationships to disclose.
Development of phenotypic indexes for the description of morphological injury in breast cancer cell mitochondria
Authors: Putignani L. , Raffa S. , Pescosolido R. , Signore F. , Menichella D. , Boldrini R. , Torrisi M. , Grammatico P. 
Published: August 2020

e22055 Background: Mitochondriopathy has been recently rekindled as new cancer theory. We report on structural damage of breast-infiltrating ductal carcinoma (IDC) mitochondria characterised by reduced expression levels of the oxidative phosphorylation system (OXPHOS). Methods: Mitochondria from HMC-1 (human mammary carcinoma) and HMEC (human mammary epithelial cell) cultures, traced by Mitotracker, were assayed for OXPHOS expression levels using cryo-immunoelectron microscopy (CIEM) quantitative labelling and fluorescence immunolabelling on unfractionated HMC-1 and HEMC cells. Convolution degeneration was established by transmission electron microscopy (TEM). Twenty different cell sections for both HMC-1 and HEMC cells, including 65 and 72 mitochondria, respectively, were randomly recorded and quantitatively analyzed for the percentage of area occupied by intact cristae to provide a grading of mitochondrial damage (cristae loss index). Results: Depressed expression levels were detected for all HMC-1 OXPHOS complexes by CIEM. Normalized labelling density (HEMC/HMC-1), expressed as colloidal gold particles/mitochondrial area (ρ) provided the following values: 1.77 for the NADH-ubiquinone oxidoreductase complex I NDUFS3; 1.86 for the succinate- dehydrogenase complex II SDH-B protein; 1.63 for the ubiquinol cytochrome c reductase complex III UQCRC2; 4.88 and 1.58 for the cytochrome-oxidase complex IV (CO) subunit I and IV, respectively; 2.70 for the ATP-synthase complex V F1β protein. Fluorescence immunolabelling confirmed CIEM quantitative data. MitoTracker's co-staining showed altered membrane potential and permeability. Injury grading was categorised assigning three levels of morphological damage: i) severe, ii) moderate, iii) slight, corresponding to 0 % (6.2 % and 1.4 % for HMC-1 and HMEC, respectively), 1–50 % (21.5 % and 2.8 % for HMC-1 and HMEC, respectively) and 51–75 % (44.6 % and 15.3 % for HMC-1 and HMEC, respectively) of area occupied by intact cristae (p<0.0001, χ2Test). The entire HMC-1 mitochondrial damage resulted 3.7 times higher than that observed for HMEC cells (72.3HMC-1 %/19.5HMEC %). Conclusions: New phenotypic harm indexes for IDC cell mitochondria might provide new hallmarks in breast cancer cell biology. No significant financial relationships to disclose.