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Clinical Index of Stable Febrile Neutropenia

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101. HIV, viral hepatitis and STIs - a guide for primary care

, so that they are able to persist throughout the life of the host. During latency, the genome of the invading virus is maintained in stable form in the infected neural cell with no production of progeny virus for variable periods of time and no apparent cytotoxic effects. Periodically, reactivation of virus replication occurs with virus migrating back down axons to surface sites. The clinical severity of herpes simplex infections and the host’s capacity to control viral replication depends very (...) – A GUIDE FOR PRIMARY HEALTH CARE iii HIV , VIRAL HEPATITIS & STIs A GUIDE FOR PRIMARY CARE 2014 EDITION EXPERT REFERENCE GROUP (EDITORIAL OVERSIGHT) Dr Michael Burke Nepean Sexual Health & HIV Clinic Ms Tracey Cabrie Victorian Infectious Diseases Service, Melbourne Health Associate Professor Ben Cowie Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, University of Melbourne Professor Greg Dore The Kirby Institute, UNSW Australia Dr Seamus Duffy Tuggerah Medical Centre Dr

2014 Clinical Practice Guidelines Portal

102. Central Venous Catheter Care for the Patient With Cancer

Update of the Clinical Practice Guideline for the use of Antimicrobial Agents in Neutropenic Patients with Cancer. Information on the management of febrile neutropenia in the outpatient setting can be found at . Specific therapy with standard antimicrobial agents should be initiated as soon as possible. Catheter-related BSIs are most commonly caused by coagulase-negative staphylococci, Staphylococcus aureus , and Candida species and less commonly with Bacillus species, Corynebacterium jeikeium (...) source of infection. Many approaches to quantify the number of organisms cultured from each site have been proposed. Although not specific to patients with cancer, there are recommendations for culturing and treatment in the IDSA 2009 Update of the Clinical Practice Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infection (pocket card can be found at ). The use of antimicrobial agents in patients with cancer and/or neutropenia are also clearly addressed in the IDSA 2010

2013 American Society of Clinical Oncology Guidelines

103. Guidelines for the diagnosis and antibiotic treatment of endocarditis in adults: a report of the working party of BSAC

continue to be a problem. 2 For this reason we have attempted to highlight key clinical scenarios where IE should be considered. Initial investigation in this context may involve appropriate blood culture or echocardiography or both, depending on the index of suspicion or the situation. The clinical presentation is highly variable, according to the causative microorganism, the presence or absence of pre-existing cardiac disease, and the presence of co-morbidities and risk factors for the development (...) cases.Clinicaljudgementremainsessential,especiallyinsettings where the sensitivity of the modi?ed Duke criteria is diminished, e.g. when blood cultures are negative, when too few blood A febrile illness and a murmur of new valvular regurgitation; A febrile illness, a pre-existing at-risk cardiac lesion (see Figure 2) and no clinically obvious site of infection; A febrile illness associated with any of: Predisposition and recent intervention with associated bacteraemia, Evidence of congestive heart failure, New conduction disturbance

2012 British Infection Association

104. Investigation and management of Chronic Lymphocytic Leukaemia

the course of the disease (Shanafelt et al , , ; Evans et al , ). The issue of patient communication from both the haematologist's and patient's perspective is discussed on the UK CLL Forum website ( ). Patients with early CLL should be reviewed at least twice within the first year from diagnosis to assess the rate of disease progression. For those with stable disease, particularly if they have ‘good risk’ clinical and/or laboratory features, monitoring can be extended to an annual check. This may (...) + cyclophosphamide; FCR, fludarabine + cyclophosphamide + rituximab; O, ofatumumab; BR, bendamustine + rituximab; NA, not available. Recommendation FCR is recommended as initial therapy for previously untreated fit patients outside clinical trials (Grade A1). Patients who progress after one cycle of FCR or who have stable disease after two cycles have high‐risk disease and should be managed accordingly (section 4.5.5 ). Initial treatment of unfit patients with no TP53 abnormality Chlorambucil remains widely used

2012 British Committee for Standards in Haematology

105. FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

: Granulocyte colony-stimulating factor (G-CSF) The use of G-CSF will not be mandatory as primary prophylaxis, but will be allowed at investigators' discretion. If febrile neutropenia occurs, than the use of G-CSF will be mandatory after each following cycle of treatment. Other Names: Filgrastim Cytokine Outcome Measures Go to Primary Outcome Measures : Objective Radiographic Response Rate (ORR) [ Time Frame: Up to 36 months ] The primary efficacy endpoint is objective response rate as determined (...) participants equally into two cohorts (first-line versus beyond first-line). Condition or disease Intervention/treatment Phase Gastro-enteropancreatic Neuroendocrine Tumor Pancreatic Cancer Neuroendocrine Carcinomas of Pancreas Islet Cell Carcinoma Drug: FOLFIRINOX Drug: Granulocyte colony-stimulating factor (G-CSF) Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 2 participants Intervention Model: Single Group Assignment Masking

2017 Clinical Trials

106. Breast Cancer Treatment (PDQ®): Health Professional Version

).[ ] Aromatase inhibitors or inactivators.[ , ] Risk-reducing mastectomy.[ ] Risk-reducing oophorectomy or ovarian ablation.[ - ] (Refer to the PDQ summary on for more information about factors that decrease the risk of breast cancer.) Screening Clinical trials have established that screening asymptomatic women using mammography, with or without clinical breast examination, decreases breast cancer mortality. (Refer to the PDQ summary on for more information.) Diagnosis Patient evaluation When breast cancer (...) is suspected, patient management generally includes the following: Confirmation of the diagnosis. Evaluation of the stage of disease. Selection of therapy. The following tests and procedures are used to diagnose breast cancer: Mammography. Ultrasound. Breast magnetic resonance imaging (MRI), if clinically indicated. Biopsy. Contralateral disease Pathologically, breast cancer can be a multicentric and bilateral disease. Bilateral disease is somewhat more common in patients with infiltrating lobular

2016 PDQ - NCI's Comprehensive Cancer Database

107. Gastric Cancer Treatment (PDQ®): Health Professional Version

reduction 32%). The median OS was significantly longer for patients who received DCF compared with patients who received CF (9.2 months; 95% CI, 8.4–10.6; vs. 8.6 months; 95% CI, 7.2–9.5; HR, 1.29; 95% CI, 1.0–1.6; log-rank P = .02; risk reduction = 23%).[ ][ ] There were high toxicity rates in both arms.[ ] Febrile neutropenia was more common in patients who received DCF (29% vs. 12%), and the death rate on the study was 10.4% for patients on the DCF arm and 9.4% for patients on the CF arm. Whether (...) the CF regimen should be considered as an index regimen for the treatment of patients with metastatic gastric cancer is the subject of debate.[ ] The results of a study that randomly assigned 245 patients with metastatic gastric cancer to receive CF, FAMTX, or ELF demonstrated no significant difference in response rate, progression-free survival, or OS between the arms.[ ] Grades 3 and 4 neutropenia occurred in 35% to 43% of patients on all arms, but severe nausea and vomiting was more common

2016 PDQ - NCI's Comprehensive Cancer Database

108. Adult Hodgkin Lymphoma Treatment (PDQ®): Health Professional Version

areas. Presence of . Early favorable group: Clinical stage I or II without any of the adverse prognostic factors listed above. Early unfavorable group: Clinical stage I or II with one or more of the adverse prognostic factors listed above. Advanced-stage adverse prognostic factors: For patients with advanced-stage HL, the International Prognostic Factors Project on Advanced Hodgkin's Disease developed the International Prognostic Index with a score that is based on the following seven adverse (...) is rarely seen. Risk Factors Risk factors for adult HL include the following: Being in early adulthood (aged 20–39 years) (most often) or late adulthood (aged 65 years and older) (less often). Being male. Having a previous infection with the Epstein-Barr virus in the teenage years or early childhood. Having a first-degree relative with HL. Clinical Features These and other signs and symptoms may be caused by adult HL or by other conditions: Painless, swollen lymph nodes in the neck, axilla, or inguinal

2016 PDQ - NCI's Comprehensive Cancer Database

109. Oral Complications of Chemotherapy and Head/Neck Radiation (PDQ®): Health Professional Version

Therapies: Oral Care Study Group Systematic Reviews, MASCC/ISOO Complication Reference Citation Weighted Prevalence Bisphosphonate osteonecrosis [ ] 6.1% for all studies (mean) Studies with documented follow-up = 13.3% Studies with undocumented follow-up = 0.7% Epidemiological studies = 1.2% Dysgeusia [ ] CT only = 56.3% (mean) RT only = 66.5% (mean) Combined CT and RT = 76% (mean) Oral fungal infection [ ] Of clinical oral fungal infection (all oral candidiasis): Pretreatment = 7.5% During treatment (...) = 39.1% Posttreatment = 32.6% Of oral candidiasis clinical infection by cancer treatment: During HNC RT = 37.4% During CT = 38% Oral viral infection [ ] In patients treated with CT for hematologic malignancies: Patients with oral ulcerations/sampling oral ulcerations = 49.8% Patients sampling oral ulcerations = 33.8% Patients sampling independently of the presence of oral ulcerations = 0% In patients treated with RT: Patients with RT only/sampling oral ulcerations = 0% Patients with RT and adjunctive

2016 PDQ - NCI's Comprehensive Cancer Database

110. Jevtana - cabazitaxel

of quantitation BM Bone metastasis BMI Body Mass Index BSA Body surface area CBZ Cabazitaxel CL Clearance CR / PR Complete response / partial response CT Computed tomography DoE Design of Experiment ECG Electrocardiography ECOG PS Eastern Cooperative Oncology Group performance status EU European Union GALT gut-associated lymphoid tissue GCP Good clinical practice GLP Good laboratory practice GMP Good manufacturing practices HCPC or mHRPC Hormone-resistant prostate cancer or metastatic hormonoe-resistant (...) ICH guidelines conditions is chemically stable for the proposed shelf life. At the time of the CHMP opinion, there were two quality issues that will be resolved as Follow-up Measures within an agreed timeframe. However, none of them is expected to have a negative impact on the Benefit Risk balance of the product. 2.3. Non-clinical aspects 2.3.1. Introduction Cabazitaxel (also known as XRP6258, RPR116258A) is a semi synthetic derivative from 10-deacetyl Baccatin III, which is extracted typically

2011 European Medicines Agency - EPARs

111. Teysuno - tegafur / gimeracil / oteracil

product quality characteristics, and these in turn lead to the conclusion that the product should have a satisfactory and uniform performance in the clinic. Stability tests indicate that the product under ICH guidelines conditions is chemically stable for the proposed shelf life. 3 6.32 of Vol. 4 Part I of the Rules Governing Medicinal Products in the European Union Teysuno CHMP ASSESSMENT REPORT EMA/CHMP/831565/2010 Page 14/67 2.3. Non-clinical aspects 2.3.1. Pharmacology Primary pharmacodynamic (...) Product 12 2.2.4. Discussion and conclusions on chemical, pharmaceutical and biological aspects 13 2.3. Non-clinical aspects 14 2.3.1. Pharmacology 14 2.3.2. Pharmacokinetics 16 2.3.3. Toxicology 18 2.3.4. Ecotoxicity/environmental risk assessment 25 2.3.5. Discussion and conclusions on non-clinical aspects 25 2.4. Clinical aspects 28 2.4.1. Introduction 28 2.4.2. Pharmacokinetics 31 2.4.3. Pharmacodynamics 34 2.4.4. Discussion and Conclusions on clinical pharmacology 35 2.5. Clinical efficacy 35

2011 European Medicines Agency - EPARs

112. Buprenorphine Transdermal System (Butrans)

Corticosteroids were to have been allowed if stable for at least 6 weeks prior to the screening visit. Glucosamine and/or chondroitin sulfate were to have been allowed if the dose was stable for at least 2 months prior to the study entry and is continued at the same dose for the duration of the study. Clinical Review by Robert Levin, M.D. NDA 21-306 BuTrans TM (Buprenorphine Transdermal System) 70 Ancillary Therapy: Ongoing transcutaneous electrical nerve stimulation (TENS), biofeedback, physical therapy (...) of the Schedule of Visits from the final protocol. Table 5.3.2.2: Schedule of Visits and Procedures for Study BUP3015 Based on the Final Protocol Reference: Table1. Schedule of Visits and Procedures, pg 46 CSR BUP3015 Clinical Review by Robert Levin, M.D. NDA 21-306 BuTrans TM (Buprenorphine Transdermal System) 73 Screening Period (Visit 1) Subjects were to have signed an informed consent form at Visit 1 prior to undergoing the following evaluations: • Confirmation that subjects were taking a stable dose

2010 FDA - Drug Approval Package

113. LCL161 Plus Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies

dose not to exceed 1200 mg/week. topotecan: orally, for first 5 days of each 21-day cycle. Maximum dose not to exceed 2.3 mg/m2 per day. Pegylated GCSF (PEG-GCSF) on-body injector (OBI) or daily GCSF (e.g. filgrastim) will be given according to institutional policy after Day 5 of topotecan. Because patients treated with topotecan are at high risk of developing febrile neutropenia, GCSF will be given in the prophylactic setting. Dose Expansion: 24 additional patients will be treated at the MTD in 2 (...) . pegfilgrastim) on-body injector (OBI) or daily GCSF (e.g. filgrastim) will be given according to institutional policy after Day 5 of topotecan. Because patients treated with topotecan are at high risk of developing febrile neutropenia, GCSF will be given in the prophylactic setting. Other Name: pegfilgrastim Outcome Measures Go to Primary Outcome Measures : The incidence of dose-limiting toxicities (DLTs) as a measure of safety and tolerability [ Time Frame: 21 days (one cycle) ] The maximum tolerated dose

2016 Clinical Trials

114. Irinotecan or oxaliplatin combined with 5-fluorouracil and leucovorin as first-line therapy for advanced colorectal cancer: a meta-analysis

and leucovorin versus oxaliplatin combined with fluorouracil and leucovorin as first-line treatment for advanced or metastatic colorectal cancer were eligible for inclusion. Trials not analysed on intervention-to-treat basis were excluded. Outcome measures were clinical efficacy (complete and partial response, stable and progressive disease, response rate, time to progression, duration of response, overall survival) and adverse effects (grade 3 or 4 toxicities according to the National Cancer Institute (...) ; seven RCTs); diarrhoea (RR 1.71, 95% CI 1.34 to 2.18; seven RCTs); and alopecia (RR 14.56, 95% CI 4.11 to 51.66; n=791 patients; two RCTs). No differences between groups were found in the incidence of mucositis and febrile neutropenia. However, the incidence of neurotoxicity (RR 0.06, 95% CI 0.03 to 0.14; n=2,095; seven RCTs), neutropenia (RR 0.70, 95% CI 0.55 to 0.91; seven RCTs) and thrombocytopenia (RR 0.18, 95% CI 0.05 to 0.61; n=1,151; four RCTs) were lower in the irinotecan group compared

2010 DARE.

115. A Study Of The Safety And Effects Of One Or More Doses Of HSP-130 Injected Under The Skin In Women With Breast Cancer That Has Not Spread To Distant Sites In The Body.

the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 1 and Cycle 4 [ Time Frame: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose ] Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood. Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4 [ Time Frame: Cycle (...) 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose ] Febrile Neutropenia was defined as tympanic or axillary body temperature greater than (>) 38.5 °C for >1 hour and ANC less than (<) 1.0 *10^9/L. Incidence of Severe Neutropenia: Cycle 1 and Cycle 4 [ Time Frame: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose ] Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9/L. Time to ANC Recovery: Cycle 1 and Cycle 4

2016 Clinical Trials

116. Lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinomas of the Salivary Glands: ACC-LEN14

entry. Previous therapy with lenvatinib (E7080) Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed) Major surgery within 2 weeks of start of study Use of biologic response modifiers, such as G-CSF, within 3 week of study entry [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may (...) in these parameters exists) Previous systemic therapy for metastatic disease is allowed for a maximum of 1 previous line of chemotherapy and/or 1 previous line of TKI Signed written informed consent Exclusion Criteria: Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry Subjects having > 1+ proteinuria on urine dipstick

2016 Clinical Trials

117. Axitinib in R/M Salivary Gland Cancers of the Upper Aerodigestive Tract

or within 4 weeks of study entry. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed) Major surgery within 2 weeks of start of study Use of biologic response modifiers, such as G-CSF, within 3 week of study entry [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted (...) with Inlyta®. These results prompted a phase II study to test the activity of axitinib in relapsed and/or metastatic and progressive ACC patients. Results were 9% of partial responses and 75% of stable disease as best overall response. Inlyta®, a potent VEGFR specific-inhibitor, has been approved by FDA as second line treatment for renal cancer. Based on preclinical and clinical data, we believe that targeting VEGFR might represent a rational basis to further test Inlyta® in patients with relapsed

2016 Clinical Trials

118. Safety, Tolerability and Pharmacokinetics of AZD1775 Plus MEDI4736 in Patients With Advanced Solid Tumours

Limiting Toxicities (DLTs) [ Time Frame: Up to 28 Days ] DLTs are defined as: Grade 4 haematologic toxicity for ≥7 days, including infection with febrile neutropenia, or Grade 4 thrombocytopenia. Grade 3 thrombocytopenia associated with Grade ≥2 bleeding. Non-haematologic toxicity ≥Grade 3. Grade 3 nausea, vomiting, or diarrhoea that does not respond within 48 hours. Grade 4 nausea, vomiting, and diarrhoea. ALT or AST ≥5 x but ≤8 x ULN that does not resolve to Grade 2 within 5 days. ALT or AST >8 x ULN (...) appropriate. The first day of Cycle 1 in Schedules B, C, and D will be preceded by a lead-in period of AZD1775 monotherapy to enable serial sampling for assessment of pharmacokinetic parameters. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 56 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase I Study Assessing the Safety

2015 Clinical Trials

119. Oral Complications of Chemotherapy and Head/Neck Radiation

-up = 0.7% Epidemiological studies = 1.2% Dysgeusia [ ] CT only = 56.3% (mean) RT only = 66.5% (mean) Combined CT and RT = 76% (mean) Oral fungal infection [ ] Of clinical oral fungal infection (all oral candidiasis): Pretreatment = 7.5% During treatment = 39.1% Posttreatment = 32.6% Of oral candidiasis clinical infection by cancer treatment: During HNC RT = 37.4% During CT = 38% Oral viral infection [ ] In patients treated with CT for hematologic malignancies: Patients with oral ulcerations (...) a setting in which novel classes of chemotherapeutic drugs, used at increased doses, could lead to enhanced cancer cure rates and durability of disease remission. As has been , it is essential that a multidisciplinary approach be used for oral management of the cancer patient before, during, and after cancer treatment. This collaboration is pivotally important for the advancement of basic, clinical, and translational research associated with oral complications of current and emerging cancer therapies

2012 PDQ - NCI's Comprehensive Cancer Database

120. Lymphoma, Adult Hodgkin

of . Early favorable group: Clinical stage I or II without any of the adverse prognostic factors listed above. Early unfavorable group: Clinical stage I or II with one or more of the adverse prognostic factors listed above. Advanced-stage adverse prognostic factors: For patients with advanced-stage HL, the International Prognostic Factors Project on Advanced Hodgkin's Disease developed the International Prognostic Index with a score that is based on the following seven adverse prognostic factors (...) a previous infection with the Epstein-Barr virus in the teenage years or early childhood. Having a first-degree relative with HL. Clinical Features These and other signs and symptoms may be caused by adult HL or by other conditions: Painless, swollen lymph nodes in the neck, axilla, or inguinal area. Fever defined as 38ºC or higher. Drenching and recurrent night sweats. Weight loss of 10% or more of baseline weight in the previous 6 months. Pruritus, especially after bathing or after ingesting alcohol

2012 PDQ - NCI's Comprehensive Cancer Database

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