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[PMID]: 29435950
[Au] Autor:Krzyzanski W; Hu S; Dunlavey M
[Ad] Address:Department of Pharmaceutical Sciences, University at Buffalo, Buffalo, NY, USA. wk@buffalo.edu.
[Ti] Title:Evaluation of performance of distributed delay model for chemotherapy-induced myelosuppression.
[So] Source:J Pharmacokinet Pharmacodyn;45(2):329-337, 2018 Apr.
[Is] ISSN:1573-8744
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:The distributed delay model has been introduced that replaces the transit compartments in the classic model of chemotherapy-induced myelosuppression with a convolution integral. The maturation of granulocyte precursors in the bone marrow is described by the gamma probability density function with the shape parameter (ν). If ν is a positive integer, the distributed delay model coincides with the classic model with ν transit compartments. The purpose of this work was to evaluate performance of the distributed delay model with particular focus on model deterministic identifiability in the presence of the shape parameter. The classic model served as a reference for comparison. Previously published white blood cell (WBC) count data in rats receiving bolus doses of 5-fluorouracil were fitted by both models. The negative two log-likelihood objective function (-2LL) and running times were used as major markers of performance. Local sensitivity analysis was done to evaluate the impact of ν on the pharmacodynamics response WBC. The ν estimate was 1.46 with 16.1% CV% compared to ν = 3 for the classic model. The difference of 6.78 in - 2LL between classic model and the distributed delay model implied that the latter performed significantly better than former according to the log-likelihood ratio test (P = 0.009), although the overall performance was modestly better. The running times were 1 s and 66.2 min, respectively. The long running time of the distributed delay model was attributed to computationally intensive evaluation of the convolution integral. The sensitivity analysis revealed that ν strongly influences the WBC response by controlling cell proliferation and elimination of WBCs from the circulation. In conclusion, the distributed delay model was deterministically identifiable from typical cytotoxic data. Its performance was modestly better than the classic model with significantly longer running time.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1802
[Cu] Class update date: 180310
[Lr] Last revision date:180310
[St] Status:In-Data-Review
[do] DOI:10.1007/s10928-018-9575-z

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[PMID]: 28749042
[Au] Autor:Hooi KS; Lemetayer JD
[Ad] Address:Department of Clinical Studies, Ontario Veterinary College, University of Guelph, Guelph, ON, N1G 2W1, Canada.
[Ti] Title:The use of intravesicular alteplase for thrombolysis in a dog with urinary bladder thrombi.
[So] Source:J Vet Emerg Crit Care (San Antonio);27(5):590-595, 2017 Sep.
[Is] ISSN:1476-4431
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:OBJECTIVE: To describe the use of alteplase for intravesicular thrombolysis in a dog after development of urinary tract obstruction from a blood clot in the urinary bladder. CASE SUMMARY: A 5.8 kg, 6.5-year-old female neutered Bichon Frise was presented for signs of acute hematuria. A complete blood count (CBC) revealed marked thrombocytopenia and leukopenia, and nonregenerative anemia. Bone marrow aspirate cytology revealed mild hypercellularity, mild megakaryocytic hyperplasia, mildly left-shifted erythroid maturation, and moderately left-shifted myeloid maturation, suggesting ongoing recovery from an acute bone marrow insult. Thrombocytopenia and hematuria resolved concurrently; however, stranguria and oliguria developed acutely. Ultrasonography identified two large presumed thrombi within the urinary bladder. A urinary catheter was placed and 4 doses of 0.5 mg of alteplase diluted in 10 mL of 0.9% sodium chloride were instilled into the bladder with a 4-hour dwell time at 12-hour intervals. Prothombin and activated partial thromboplastin times were monitored during therapy and remained within normal limits. One thrombus was successfully dissolved after 48 hours of therapy and the remaining thrombus was reduced in size and was voided upon removal of the urinary catheter. NEW OR UNIQUE INFORMATION PROVIDED: This report describes the use of alteplase in a dog for thrombolysis of intravesicular thrombi. In patients that develop intravesicular thrombi, intravesical instillation of alteplase can be considered as a method for dissolution of these thrombi.
[Mh] MeSH terms primary: Fibrinolytic Agents/therapeutic use
Thrombocytopenia/veterinary
Tissue Plasminogen Activator/therapeutic use
Urinary Bladder Diseases/veterinary
[Mh] MeSH terms secundary: Administration, Intravesical
Animals
Dogs
Female
Fibrinolytic Agents/administration & dosage
Thrombocytopenia/drug therapy
Thrombosis/drug therapy
Tissue Plasminogen Activator/administration & dosage
Urinary Bladder Diseases/drug therapy
[Pt] Publication type:CASE REPORTS
[Nm] Name of substance:0 (Fibrinolytic Agents); EC 3.4.21.68 (Tissue Plasminogen Activator)
[Em] Entry month:1803
[Cu] Class update date: 180309
[Lr] Last revision date:180309
[Js] Journal subset:IM
[Da] Date of entry for processing:170728
[St] Status:MEDLINE
[do] DOI:10.1111/vec.12627

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[PMID]: 29521151
[Au] Autor:Sleijfer S; Rizzo E; Litière S; Mathijssen RHJ; Judson IR; Gelderblom H; Van Der Graaf WTA; Gronchi A
[Ad] Address:a Department of Medical Oncology , Erasmus MC Cancer Institute , Rotterdam , The Netherlands.
[Ti] Title:Predictors for doxorubicin-induced hematological toxicity and its association with outcome in advanced soft tissue sarcoma patients; a retrospective analysis of the EORTC-soft tissue and bone sarcoma group database.
[So] Source:Acta Oncol;:1-10, 2018 Mar 09.
[Is] ISSN:1651-226X
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:INTRODUCTION: As both anti-tumour effects and toxicity are thought to be dose-dependent, patients with the greatest toxicity may also have the best outcome. We assessed whether severity of doxorubicin-induced hematological toxicity is associated with outcome in advanced soft tissue sarcoma (STS) patients. In addition, risk factors for hematological toxicity were explored. METHODS: Worst haematological toxicities (anaemia, leukopenia, neutropenia and thrombocytopenia) seen during treatment were scored according to CTCAE toxicity score. Differences in overall survival (OS), progression free survival (PFS) and response rate (RR) between patients with or without high haematological toxicity (grades 0-2 vs. 3-4) were assessed using conventional statistical tests. Associations between baseline characteristics and hematological toxicity were established using logistic multivariate regression. RESULTS: In 557 patients eligible for this analysis, 47.2% of the patients received at least six cycles of treatment; 45% stopped treatment early due to progression, 3% because of toxicity. Relative dose intensity (RDI) was constant over the cycles. OS, PFS, and RR did not differ between patients with grade 3/4 toxicity during treatment versus those with grade 1/2. Risk factors for grade 3/4 haematological toxicity, in particular neutropenia, were age above 60 years, low BMI, and female gender. CONCLUSION: In this large series, risk factors for haematological toxicity in STS patients receiving doxorubicin monotherapy were revealed. The finding that there was no association between outcome and haematological toxicity during doxorubicin treatment may be useful to reassure advanced STS patients that failure to experience haematological toxicity during treatment does not equate to under-treatment.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180309
[Lr] Last revision date:180309
[St] Status:Publisher
[do] DOI:10.1080/0284186X.2018.1449248

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[PMID]: 29519865
[Au] Autor:Zhu Y; Yin D; Su Y; Xia X; Moriyama T; Nishii R; Liao F; Zhang S; Guo X; Hou Q; Ai Y; Zhou X; Sun S; Zhang D; Zhang Y; Lin C; Deng Y; Lu X; Wang Y; Ma Z; Wang H; Liu B; Yang L; Zhang W; Yang JJ; Shu Y; Gao J; Xu H
[Ad] Address:Dept. of Pediatric Hematology/Oncology, West China Second Hospital, Sichuan Univ, Chengdu, China.
[Ti] Title:Combination of common and novel rare NUDT15 variants improves predictive sensitivity of thiopurine-induced leukopenia in children with acute lymphoblastic leukemia.
[So] Source:Haematologica;, 2018 Mar 08.
[Is] ISSN:1592-8721
[Cp] Country of publication:Italy
[La] Language:eng
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180309
[Lr] Last revision date:180309
[St] Status:Publisher

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[PMID]: 29500276
[Au] Autor:Matei D; Ghamande S; Roman LD; Alvarez Secord A; Nemunaitis J; Markham MJ; Nephew KP; Jueliger S; Oganesian A; Naim S; Su XY; Keer HN; Azab M; Fleming G
[Ad] Address:Hematology-Oncology, Northwestern University daniela.matei@northwestern.edu.
[Ti] Title:A Phase 1 Clinical Trial of Guadecitabine and Carboplatin In Platinum-Resistant, Recurrent Ovarian Cancer: Clinical, Pharmacokinetic And Pharmacodynamic Analyses.
[So] Source:Clin Cancer Res;, 2018 Mar 02.
[Is] ISSN:1078-0432
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:PURPOSE: Epigenetic changes are implicated in acquired resistance to platinum. Guadecitabine is a next-generation hypomethylating agent (HMA). Here we report the clinical results, along with pharmacokinetic (PK) and pharmacodynamic analyses of the phase 1 study of guadecitabine and carboplatin (G+C) in patients with recurrent, platinum resistant high-grade serous ovarian cancer (OC), primary peritoneal carcinoma (PPC), or fallopian tube cancer (FTC). EXPERIMENTAL DESIGN: Guadecitabine was administered once daily on Days 1-5 followed by carboplatin IV on Day 8 of a 28-day cycle. Patients had either measurable or detectable disease. Safety assessments used CTCAE v4. RESULTS: Twenty patients were enrolled and treated. Median age was 56 years (38-72). Median number of prior regimens was 7 (1-14). In the first cohort (N=6), the starting doses were guadecitabine 45 mg/m and carboplatin AUC5. Four patients experienced dose-limiting toxicity (DLT; neutropenia and thrombocytopenia) leading to dose de-escalation of guadecitabine to 30 mg/m and of carboplatin to AUC4. No DLTS were observed in the subsequent 14 patients. Grade ≥3AEs ≥10% were neutropenia, leukopenia, anemia, nausea, vomiting, ascites, constipation, hypokalemia, pulmonary embolism, small intestinal obstruction, and thrombocytopenia. Three patients had a partial response (PR) and six patients had stable disease (SD) >3 months, for an overall response rate (ORR) and clinical benefit rate of 15% and 45%, respectively. LINE-1 demethylation in PBMCs and promoter demethylation/gene re-expression in paired tumor biopsies/ascites were recorded. CONCLUSIONS: G+C was tolerated and induced clinical responses in a heavily pretreated platinum resistant OC population, supporting a subsequent randomized phase 2 trial.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180309
[Lr] Last revision date:180309
[St] Status:Publisher

  6 / 15470 MEDLINE  
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[PMID]: 29516114
[Au] Autor:Nashan D; Dengler S
[Ad] Address:Hautklinik, Klinikum Do, Beurhausstr. 40, 44137, Dortmund, Deutschland.
[Ti] Title:Akute Notfälle in der Onkologie. [Acute emergencies in oncology].
[So] Source:Hautarzt;, 2018 Mar 07.
[Is] ISSN:1432-1173
[Cp] Country of publication:Germany
[La] Language:ger
[Ab] Abstract:The spectrum of dermato-oncological emergencies is multifaceted. They are particularly observed in cases with malignant melanoma due to the large number of patients and prolonged survival rates that are associated with new therapies for advanced disease. Dermato-oncological patients present to the hospital with symptoms like nausea and emesis, unexpected neurological deficits, various gastrointestinal problems, and even acute abdomen, acute breathlessness, or hemoptysis. Furthermore, emergencies can be caused by hematological problems like anemia and leukopenia. In addition to standardized care for medical emergencies, there are many other problems caused by metastases and/or therapeutic side effects that need interdisciplinary skills to optimize procedures and deliberate on surgical interventions, radiotherapy, and medical therapeutic choices with regard to the overall situation of the patient. The article deals with a spectrum of acute organ-specific emergencies, including recommendations for medical treatment and considerations for therapeutic decisions. Recommendations for supportive care in patients who are severely ill are summarized. In addition to stage-adapted pain therapy, supportive measures such as nutritional supplementation, the use of dronabinol in cases of loss of appetite, and antipruritic therapies are outlined. This article provides a succinct summary of the most frequently observed dermato-oncological emergencies with references to the respective detailed literature of associated medical societies and guidelines.
[Pt] Publication type:ENGLISH ABSTRACT; JOURNAL ARTICLE; REVIEW
[Em] Entry month:1803
[Cu] Class update date: 180308
[Lr] Last revision date:180308
[St] Status:Publisher
[do] DOI:10.1007/s00105-018-4141-6

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[PMID]: 29514712
[Au] Autor:Takeuchi T; Yamanaka H; Harigai M; Tamamura R; Kato Y; Ukyo Y; Nakano T; Hsu B; Tanaka Y
[Ad] Address:Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.
[Ti] Title:Sirukumab in rheumatoid arthritis refractory to sulfasalazine or methotrexate: a randomized phase 3 safety and efficacy study in Japanese patients.
[So] Source:Arthritis Res Ther;20(1):42, 2018 Mar 07.
[Is] ISSN:1478-6362
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:BACKGROUND: Sirukumab, a high-affinity human monoclonal antibody that selectively binds to interleukin-6, has demonstrated efficacy in the treatment of rheumatoid arthritis (RA) in global phase 1 and phase 2 studies. The present study evaluated the safety and efficacy of sirukumab, as monotherapy in Japanese patients with RA refractory to methotrexate or sulfasalazine. METHODS: In this phase 3, double-blind study, 122 patients (age ≥ 20 years) were randomized (1:1, 61 patients in each arm) to sirukumab administered subcutaneously: 50 mg once every 4 weeks (q4w) or 100 mg once every 2 weeks (q2w) through 52 weeks. Disease-modifying anti-rheumatic drugs were allowed after 24 weeks. Safety was assessed and efficacy was evaluated using American College of Rheumatology (ACR) responses, Disease Activity Score C-reactive protein (DAS28-CRP) and Health Assessment Questionnaire-Disability Index (HAQ-DI). RESULTS: Amongst the 122 randomized patients, 99 (81.1%) patients completed the study. Adverse events (AEs) were reported in 114/122 (93.4%) patients and serious AEs were reported in 9/122 (7.4%) patients. No deaths, major cardiovascular AEs, serious gastrointestinal perforations or tuberculosis cases were reported during this study period. Grade 3 hematologic abnormalities (neutropenia and leukopenia) were reported in seven patients and no grade 4 abnormalities were observed. ACR20 responses were observed within 2 weeks, achieved in 47/61 (77.0%, 50 mg q4w) patients and 44/61 (72.1%, 100 mg q2w) patients at week 16 and maintained through week 52. ACR50/70, DAS28-CRP and HAQ-DI responses were also maintained through week 52 in both groups. CONCLUSIONS: Safety findings were comparable between the two treatment groups. The 52-week administration of sirukumab at 50 mg q4w and 100 mg q2w was generally tolerable and with measurable efficacy in Japanese patients with RA refractory to methotrexate and sulfasalazine. TRIAL REGISTRATION: NCT01689532 . Registered 18 September 2012.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180308
[Lr] Last revision date:180308
[Cl] Clinical Trial:ClinicalTrial
[St] Status:In-Data-Review
[do] DOI:10.1186/s13075-018-1536-9

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[PMID]: 29363458
[Au] Autor:Kadkhoda K; Semus M; Jelic T; Walkty A
[Ad] Address:Department of Immunology, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
[Ti] Title:Case Report: A Case of Colorado Tick Fever Acquired in Southwestern Saskatchewan.
[So] Source:Am J Trop Med Hyg;98(3):891-893, 2018 Mar.
[Is] ISSN:1476-1645
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:Colorado tick fever virus is transmitted by ticks. In Canada, these ticks are found in the southern regions of British Columbia (Rocky Mountains) and Alberta, as well as southwestern Saskatchewan. Colorado tick fever should be clinically suspected in patients presenting with a biphasic febrile illness and leukopenia following tick exposure in the appropriate geographic area.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1801
[Cu] Class update date: 180308
[Lr] Last revision date:180308
[St] Status:In-Data-Review
[do] DOI:10.4269/ajtmh.17-0761

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[PMID]: 29512471
[Au] Autor:Xin DS; Zhou L; Li CZ; Zhang SQ; Huang HQ; Qiu GD; Lin LF; She YQ; Zheng JT; Chen C; Fang L; Chen ZS; Zhang SY
[Ad] Address:Department of Pharmacy, Cancer Hospital of Shantou University Medical College, Raoping Rd, Shantou, Guangdong, 515041. China.
[Ti] Title:TC > 0.05 as a Pharmacokinetic Parameter of Paclitaxel for Therapeutic Efficacy and Toxicity in Cancer Patients.
[So] Source:Recent Pat Anticancer Drug Discov;, 2018 Mar 05.
[Is] ISSN:2212-3970
[Cp] Country of publication:United Arab Emirates
[La] Language:eng
[Ab] Abstract:BACKGROUND: Paclitaxel (PTX) has remarkable anti-tumor activity, but it causes severe toxicities. There is an urgent need to seek an appropriate pharmacokinetic parameter of PTX to improve treatment efficacy and reduce adverse effects. OBJECTIVE: To evaluate the association of pharmacokinetic parameter TC>0.05 of paclitaxel (PTX) and its therapeutic efficacy and toxicity in patients with solid tumors. METHOD: A total of 295 patients with ovarian cancer, esophageal cancer, breast cancer, and non-small cell lung cancer (NSCLC), who were admitted to the Tumor Hospital of Shantou University Medical College, China, were recruited for this study. Patients received 3 weeks of PTX chemotherapy. The plasma concentrations of PTX were examined using the MyPaclitaxelTM kit. The patients' PTX TC>0.05 (the time during which PTX plasma concentration exceed 0.05 µmol/L) were calculated based on pharmacokinetic analysis. RESULTS: The results showed that: (1) the concentrations of PTX in these 295 patients ranged from 0.0358-0.127 µmol/L; (2) the PTX TC> 0.05 ranged from 14 to 38 h with a median time of 27 h; (3) among all treatment cycles, there was a statistically significant difference in the PTX TC>0.05 between CR+PR and SD+PD; (4) with the increasing value of TC>0.05, level of leukopenia and leukopenic fever increased; (5) high PTX TC>0.05 led to the occurrence of neutropenia, neutropenic fever, severe anemia, and severe peripheral neurotoxicity. Taken together, our results indicated that the pharmacokinetic parameter PTX TC>0.05 was an effective measure of treatment efficacy and toxicity in patients with solid tumors. Maintaining PTX TC>0.05 at 26 to 30 h could improve its efficacy and reduce the incidence of leukopenia, neutropenia, anemia, and peripheral neurotoxicity in these patients. CONCLUSION: PTX TC>0.05 is a key pharmacokinetic parameter of PTX which should be monitored to optimize individual treatment in patients with solid tumors.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180307
[Lr] Last revision date:180307
[St] Status:Publisher
[do] DOI:10.2174/1574892813666180305170439

  10 / 15470 MEDLINE  
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[PMID]: 29499653
[Au] Autor:Ikeda S; Kato T; Ogura T; Sekine A; Oda T; Masuda N; Igawa S; Katono K; Otani S; Yamada K; Saito H; Kondo T; Hosomi Y; Nakahara Y; Nishikawa M; Utumi K; Misumi Y; Yamanaka T; Sakamaki K; Okamoto H
[Ad] Address:Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, Japan. isatoshi0112@gmail.com.
[Ti] Title:Phase II study of bevacizumab, cisplatin, and docetaxel plus maintenance bevacizumab as first-line treatment for patients with advanced non-squamous non-small-cell lung cancer combined with exploratory analysis of circulating endothelial cells: Thoracic Oncology Research Group (TORG)1016.
[So] Source:BMC Cancer;18(1):241, 2018 03 02.
[Is] ISSN:1471-2407
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:BACKGROUND: Preclinical studies have demonstrated that docetaxel and bevacizumab may act synergistically by decreasing endothelial cell proliferation and preventing circulating endothelial progenitor mobilization. The objective of this study was to assess the efficacy and safety of a combination therapy of bevacizumab, cisplatin, and docetaxel in chemotherapy-naive Japanese patients with advanced non-squamous non-small-cell lung cancer (NSCLC). METHODS: Eligible patients were chemotherapy-naive and had advanced/recurrent non-squamous NSCLC. The patients received 4 cycles of docetaxel (60 mg/m ), cisplatin (80 mg/m ), and bevacizumab (15 mg/kg) once every 3 weeks, followed by bevacizumab as maintenance therapy, every 3 weeks until disease progression or attainment of unacceptable toxicity level. The primary endpoint was objective response rate (ORR). The numbers of circulating endothelial cells (CEC) were also estimated on days 1 and 8 of the first cycle for the exploratory analysis of efficacy prediction. RESULTS: A total of 47 patients were enrolled from October 2010 to April 2012. Bevacizumab as maintenance therapy was administered to 41 patients (87.2%), and the median number of total treatment cycles was 9 (range: 1-36). ORR, median progression-free survival (PFS), and median overall survival of the patients were 74.5%, 9.0 months, and 27.5 months, respectively. The most common grade 3/4 adverse event was neutropenia (95.7%), followed by leukopenia (59.6%) and hypertension (46.8%). PFS was longer in patients with ≥10 count increase in CECs than that in patients with < 10 count increase in CECs (respective median PFS of 11.0 months versus 6.90 months) although the difference was not statistically significant (p = 0.074). CONCLUSIONS: A combination therapy of bevacizumab, cisplatin, and docetaxel, followed by bevacizumab as maintenance was highly effective in patients with non-squamous NSCLC despite the high incidence of grade 3/4 neutropenia. The increase in CEC count between days 1 and 8 may predict the efficacy of our bevacizumab-contained treatment regimen. TRIAL REGISTRATION: UMIN Clinical Trial Registry; UMIN000004368 . Registered date; October 11, 2010 (Retrospectively registered).
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180307
[Lr] Last revision date:180307
[St] Status:In-Process
[do] DOI:10.1186/s12885-018-4150-y


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