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Clinical Index of Stable Febrile Neutropenia

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121. Stomach (Gastric) Cancer

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 (...) group. In contrast to the overall stable trend for noncardia gastric cancers, earlier studies demonstrated an increased incidence of adenocarcinomas of the gastric cardia of 4% to 10% per year from the mid-1970s to the late 1980s.[ ] Similarly, the incidence of gastroesophageal junction adenocarcinomas increased sharply, from 1.22 cases per 100,000 individuals (1973–1978) to 2.00 cases per 100,000 individuals (1985–1990).[ ] Since that time, the incidence has remained steady at 1.94 cases per

2012 PDQ - NCI's Comprehensive Cancer Database

122. Breast Cancer

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 carcinoma. At 10 years after diagnosis, the risk of a primary breast cancer in the contralateral breast ranges from 3% to 10%, although endocrine therapy decreases that risk.[ - ] The development of a contralateral breast

2012 PDQ - NCI's Comprehensive Cancer Database

123. Cefepime for Injection USP and Dextrose Injection USP in the Duplex® Container

in the treatment of pneumonia, chemotherapy-induced febrile neutropenia, urinary tract infections, uncomplicated skin infections, and complicated intra- abdominal infections. The Duplex ® container is a novel drug delivery system which contains both drug substance (cefepime) and diluent (dextrose) in a sterile, single use, dual- chamber bag. The chambers are separated by a peelable seal which is removed activated prior to constitution of the drug substance with the diluent. During the first review cycle (...) ; these included articles describing isolation techniques, bacterial strain epidemiology, and the pharmacokinetics/pharmacodynamics of cefepime. The clinical safety issues B. Braun was asked to address in this application did not include review of the Yahav meta-analysis 2 , which had suggested an increase in 30-day mortality in patients with fever and neutropenia treated with cefepime versus other beta- lactam antibiotics, since extensive review of this issue by the Agency was ongoing. The safety issues

2009 FDA - Drug Approval Package

124. Phase I/Ib Dose Escalation & Biomarker Study of Ceritinib (LDK378) + Everolimus for Locally Advanced or Metastatic Solid Tumors With an Expansion in Non-Small Cell Lung Cancer (NSCLC) Characterized by Abnormalities in Anaplastic Lymphoma Kinase (ALK) Expr

to Primary Outcome Measures : Maximum Tolerated Dose (MTD) of Ceritinib plus Everolimus [ Time Frame: 28 days ] MTD defined as the highest dose level in which 6 patients were treated with at most 1 experiencing a dose limiting toxicity (DLT). DLT defined as hematologic grade 4 neutropenia lasting > 7 days or any febrile neutropenia; Delay of treatment > 14 days due to hematologic toxicity; Platelet count < 10K; non-hematologic toxicity grade 3 or higher; however nausea/vomiting, diarrhea and electrolyte (...) within the 2 week prior to study entry to manage CNS symptoms. Non-ALK-positive NSCLC patients with CNS metastasis should have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids. Negative serum or urine pregnancy test beta-Human Chorionic Gonadotropin (beta hCG) within 2 weeks prior to receiving the first dose of study medication for women

2014 Clinical Trials

125. Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections

or chronic obstructive pulmonary disease at baseline, and, in the opinion, of the investigator is not stable on current therapy; the subject has acute severe pain, uncontrolled with conventional medical management; the subject has active peptic ulcer disease; the subject has parkinson's disease; the subject has myasthenia gravis; the subject has history of seizure disorder requiring medications for control. this does not include a history of childhood febrile seizures; the subject has any evidence (...) to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 126 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment Official Title: A Phase II, Randomized, Two-Part, Multicenter, Dose-Ranging Study in Adult Subjects Evaluating the Safety, Tolerability, and Efficacy of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial

2014 Clinical Trials

126. A Phase IB Trial With OTX015, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Patients With Selected Advanced Solid Tumors

is 100 mg. Drug: MK-8628 MK-8628 10, 20 and/or 40 mg oral capsules Other Name: OTX105 Outcome Measures Go to Primary Outcome Measures : Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 [ Time Frame: Up to Cycle 1 Day 21 (Up to 21 days) ] A DLT was defined as any of the following toxicities that were considered by the investigator to be related to MK-8628: Hematologic toxicity: Grade 4 hematologic toxicity or febrile neutropenia, Grade 3 neutropenia with infection (...) . malabsorption) deemed to jeopardize intestinal absorption of MK-8628; Persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.4.0 is accepted. Known primary central nervous system (CNS) malignancy or CNS involvement; History of prior or concomitant malignancies (other than excised non-melanoma skin cancer or cured in situ

2014 Clinical Trials

127. Lymphoma, Mantle Cell (Overview)

ibrutinib 560 mg daily plus palbociclib 100 mg days 1-21 of each 28-day cycle. The dose-limiting toxicity was grade 3 rash. The most common grade 3-4 toxicities included neutropenia (41%), thrombocytopenia (30%), hypertension (15%), febrile neutropenia (15%), and lung infection (11%). The overall and complete response rates were 67% and 37%, respectively, and with a median follow-up of 25.6 months, the 2-year progression-free survival was 59.4% and the 2-year response duration was 69.8%. A phase II (...) be useful for determing clinically indolent MCL; may also help in diagnosis of CCND1-MCL Risk stratification The European Society for Medical Oncology (ESMO) recommends the 2008 MCL International Prognostic Index (MIPI) for risk stratification. [ ] The MIPI includes the following risk factors [ ] : Age: 50-59 (1 point); 60-69 (2 points); ≥70 (3 points) Eastern Cooperative Oncology Group (ECOG) performance status ≥2 (2 points) Lactate dehydrogenase level (ratio to upper limit of normal): 0.67-0.99 (1

2014 eMedicine.com

128. Agranulocytosis (Overview)

with solid tumors who have undergone mild- to moderate-intensity chemotherapy, who appear to be clinically stable, and who are in close proximity to an appropriate medical facility that can provide 24-hour access, the Clinical Index of Stable Febrile Neutropenia (CISNE) may be used as an additional tool to determine the risk of major complications. [ ] Splenectomy In individuals with neutropenia and Felty syndrome who have recurrent, life-threatening bacterial infections, splenectomy is the treatment (...) in neutropenic patients: effect of augmented gram-positive activity on infectious morbidity. National Cancer Institute of Canada Clinical Trials Group. Ann Intern Med . 1996 Aug 1. 125(3):183-90. . Freifeld A, Marchigiani D, Walsh T, Chanock S, Lewis L, Hiemenz J, et al. A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy. N Engl J Med . 1999 Jul 29. 341(5):305-11. . [Guideline] Taplitz RA, Kennedy EB, Bow EJ

2014 eMedicine.com

129. Granulocytopenia (Overview)

with solid tumors who have undergone mild- to moderate-intensity chemotherapy, who appear to be clinically stable, and who are in close proximity to an appropriate medical facility that can provide 24-hour access, the Clinical Index of Stable Febrile Neutropenia (CISNE) may be used as an additional tool to determine the risk of major complications. [ ] Splenectomy In individuals with neutropenia and Felty syndrome who have recurrent, life-threatening bacterial infections, splenectomy is the treatment (...) in neutropenic patients: effect of augmented gram-positive activity on infectious morbidity. National Cancer Institute of Canada Clinical Trials Group. Ann Intern Med . 1996 Aug 1. 125(3):183-90. . Freifeld A, Marchigiani D, Walsh T, Chanock S, Lewis L, Hiemenz J, et al. A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy. N Engl J Med . 1999 Jul 29. 341(5):305-11. . [Guideline] Taplitz RA, Kennedy EB, Bow EJ

2014 eMedicine.com

130. Lymphoma, Mantle Cell (Diagnosis)

ibrutinib 560 mg daily plus palbociclib 100 mg days 1-21 of each 28-day cycle. The dose-limiting toxicity was grade 3 rash. The most common grade 3-4 toxicities included neutropenia (41%), thrombocytopenia (30%), hypertension (15%), febrile neutropenia (15%), and lung infection (11%). The overall and complete response rates were 67% and 37%, respectively, and with a median follow-up of 25.6 months, the 2-year progression-free survival was 59.4% and the 2-year response duration was 69.8%. A phase II (...) be useful for determing clinically indolent MCL; may also help in diagnosis of CCND1-MCL Risk stratification The European Society for Medical Oncology (ESMO) recommends the 2008 MCL International Prognostic Index (MIPI) for risk stratification. [ ] The MIPI includes the following risk factors [ ] : Age: 50-59 (1 point); 60-69 (2 points); ≥70 (3 points) Eastern Cooperative Oncology Group (ECOG) performance status ≥2 (2 points) Lactate dehydrogenase level (ratio to upper limit of normal): 0.67-0.99 (1

2014 eMedicine.com

131. Lymphoma, Mantle Cell (Follow-up)

ibrutinib 560 mg daily plus palbociclib 100 mg days 1-21 of each 28-day cycle. The dose-limiting toxicity was grade 3 rash. The most common grade 3-4 toxicities included neutropenia (41%), thrombocytopenia (30%), hypertension (15%), febrile neutropenia (15%), and lung infection (11%). The overall and complete response rates were 67% and 37%, respectively, and with a median follow-up of 25.6 months, the 2-year progression-free survival was 59.4% and the 2-year response duration was 69.8%. A phase II (...) be useful for determing clinically indolent MCL; may also help in diagnosis of CCND1-MCL Risk stratification The European Society for Medical Oncology (ESMO) recommends the 2008 MCL International Prognostic Index (MIPI) for risk stratification. [ ] The MIPI includes the following risk factors [ ] : Age: 50-59 (1 point); 60-69 (2 points); ≥70 (3 points) Eastern Cooperative Oncology Group (ECOG) performance status ≥2 (2 points) Lactate dehydrogenase level (ratio to upper limit of normal): 0.67-0.99 (1

2014 eMedicine.com

132. Mesothelioma (Follow-up)

was 50%. The most common nonhematologic toxicities included fatigue (20%), constipation (10%), vomiting (10%), and dehydration 10%. Hematologic toxicities included neutropenia (60%) and febrile neutropenia (10%). [ ] Single-agent pemetrexed Single-agent pemetrexed therapy showed a response rate of 10.5%, a median time to progressive disease of 6 months, and a median survival time of 14 months in chemo-naive patients. Of the pretreated patients, the response rate was 12.1% and median time (...) as possible is important to prevent postoperative complications. Pulmonary physiotherapy is very helpful because of the extensive lung resection in patients with malignant pleural mesothelioma. Follow-up Regular follow-up visits with an internist, pulmonary specialist, medical oncologist, and radiation oncologist are recommended. Next: Chemotherapy Currently, cisplatin as a single drug has been used as the standard drug for phase III clinical trials. None of the standard treatment options has improved

2014 eMedicine.com

133. Granulocytopenia (Diagnosis)

with solid tumors who have undergone mild- to moderate-intensity chemotherapy, who appear to be clinically stable, and who are in close proximity to an appropriate medical facility that can provide 24-hour access, the Clinical Index of Stable Febrile Neutropenia (CISNE) may be used as an additional tool to determine the risk of major complications. [ ] Splenectomy In individuals with neutropenia and Felty syndrome who have recurrent, life-threatening bacterial infections, splenectomy is the treatment (...) in neutropenic patients: effect of augmented gram-positive activity on infectious morbidity. National Cancer Institute of Canada Clinical Trials Group. Ann Intern Med . 1996 Aug 1. 125(3):183-90. . Freifeld A, Marchigiani D, Walsh T, Chanock S, Lewis L, Hiemenz J, et al. A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy. N Engl J Med . 1999 Jul 29. 341(5):305-11. . [Guideline] Taplitz RA, Kennedy EB, Bow EJ

2014 eMedicine.com

134. Agranulocytosis (Diagnosis)

with solid tumors who have undergone mild- to moderate-intensity chemotherapy, who appear to be clinically stable, and who are in close proximity to an appropriate medical facility that can provide 24-hour access, the Clinical Index of Stable Febrile Neutropenia (CISNE) may be used as an additional tool to determine the risk of major complications. [ ] Splenectomy In individuals with neutropenia and Felty syndrome who have recurrent, life-threatening bacterial infections, splenectomy is the treatment (...) in neutropenic patients: effect of augmented gram-positive activity on infectious morbidity. National Cancer Institute of Canada Clinical Trials Group. Ann Intern Med . 1996 Aug 1. 125(3):183-90. . Freifeld A, Marchigiani D, Walsh T, Chanock S, Lewis L, Hiemenz J, et al. A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy. N Engl J Med . 1999 Jul 29. 341(5):305-11. . [Guideline] Taplitz RA, Kennedy EB, Bow EJ

2014 eMedicine.com

135. Septic Shock (Treatment)

source of sepsis,” with daily reevaluation of the anti-infective therapy for potential de-escalation. [ , ] Generally, a 7- to 10-day treatment course is followed. Longer treatment regimens may be warranted in the presence of a slow clinical response, undrainable foci of infection, and immunologic deficiencies (eg, neutropenia). The use of procalcitonin or similar biomarkers may facilitate discontinuance of antibiotics in patients with clinical improvement and no further evidence of infection (...) host responses. Source control is an essential component of sepsis management. Venous access In all cases of septic shock, adequate venous access must be ensured for volume resuscitation. When sepsis is suspected, 2 large-bore (16-gauge) intravenous (IV) lines should be placed if possible to allow administration of aggressive fluid resuscitation and broad-spectrum antibiotics. Central venous access is useful when administering vasopressor agents and in establishing a stable venous infusion site

2014 eMedicine.com

136. Lymphoma, Mantle Cell (Treatment)

ibrutinib 560 mg daily plus palbociclib 100 mg days 1-21 of each 28-day cycle. The dose-limiting toxicity was grade 3 rash. The most common grade 3-4 toxicities included neutropenia (41%), thrombocytopenia (30%), hypertension (15%), febrile neutropenia (15%), and lung infection (11%). The overall and complete response rates were 67% and 37%, respectively, and with a median follow-up of 25.6 months, the 2-year progression-free survival was 59.4% and the 2-year response duration was 69.8%. A phase II (...) be useful for determing clinically indolent MCL; may also help in diagnosis of CCND1-MCL Risk stratification The European Society for Medical Oncology (ESMO) recommends the 2008 MCL International Prognostic Index (MIPI) for risk stratification. [ ] The MIPI includes the following risk factors [ ] : Age: 50-59 (1 point); 60-69 (2 points); ≥70 (3 points) Eastern Cooperative Oncology Group (ECOG) performance status ≥2 (2 points) Lactate dehydrogenase level (ratio to upper limit of normal): 0.67-0.99 (1

2014 eMedicine.com

137. Mesothelioma (Treatment)

was 50%. The most common nonhematologic toxicities included fatigue (20%), constipation (10%), vomiting (10%), and dehydration 10%. Hematologic toxicities included neutropenia (60%) and febrile neutropenia (10%). [ ] Single-agent pemetrexed Single-agent pemetrexed therapy showed a response rate of 10.5%, a median time to progressive disease of 6 months, and a median survival time of 14 months in chemo-naive patients. Of the pretreated patients, the response rate was 12.1% and median time (...) as possible is important to prevent postoperative complications. Pulmonary physiotherapy is very helpful because of the extensive lung resection in patients with malignant pleural mesothelioma. Follow-up Regular follow-up visits with an internist, pulmonary specialist, medical oncologist, and radiation oncologist are recommended. Next: Chemotherapy Currently, cisplatin as a single drug has been used as the standard drug for phase III clinical trials. None of the standard treatment options has improved

2014 eMedicine.com

138. Septic Shock (Follow-up)

source of sepsis,” with daily reevaluation of the anti-infective therapy for potential de-escalation. [ , ] Generally, a 7- to 10-day treatment course is followed. Longer treatment regimens may be warranted in the presence of a slow clinical response, undrainable foci of infection, and immunologic deficiencies (eg, neutropenia). The use of procalcitonin or similar biomarkers may facilitate discontinuance of antibiotics in patients with clinical improvement and no further evidence of infection (...) host responses. Source control is an essential component of sepsis management. Venous access In all cases of septic shock, adequate venous access must be ensured for volume resuscitation. When sepsis is suspected, 2 large-bore (16-gauge) intravenous (IV) lines should be placed if possible to allow administration of aggressive fluid resuscitation and broad-spectrum antibiotics. Central venous access is useful when administering vasopressor agents and in establishing a stable venous infusion site

2014 eMedicine.com

139. Shock, Septic (Treatment)

source of sepsis,” with daily reevaluation of the anti-infective therapy for potential de-escalation. [ , ] Generally, a 7- to 10-day treatment course is followed. Longer treatment regimens may be warranted in the presence of a slow clinical response, undrainable foci of infection, and immunologic deficiencies (eg, neutropenia). The use of procalcitonin or similar biomarkers may facilitate discontinuance of antibiotics in patients with clinical improvement and no further evidence of infection (...) host responses. Source control is an essential component of sepsis management. Venous access In all cases of septic shock, adequate venous access must be ensured for volume resuscitation. When sepsis is suspected, 2 large-bore (16-gauge) intravenous (IV) lines should be placed if possible to allow administration of aggressive fluid resuscitation and broad-spectrum antibiotics. Central venous access is useful when administering vasopressor agents and in establishing a stable venous infusion site

2014 eMedicine Emergency Medicine

140. Transplants, Liver (Treatment)

months, risk of infection is similar to that of the general population. However, a high index of suspicion should always be maintained in transplant recipients. The most common causes of infection in the outpatient setting are the typical community-acquired pathogens, which are treated with the antimicrobials typically prescribed for nonimmunosuppressed patients (with caution regarding drug interactions). Incidence declines after 6-12 months if the recipient is on a stable immunosuppressant regimen (...) is suspected Cultures of blood, urine, pharynx, and/or sputum: Obtain if infection is suspected Imaging studies Chest radiography: Obtain in the presence of fever, cough, dyspnea, or abnormalities on chest examination Abdominal ultrasonography, computed tomography scan, or endoscopic retrograde cholangiopancreatography, as indicated Management of rejection or infection Every clinical complaint by the transplant patient should be taken seriously, and the transplant team should at least know of every

2014 eMedicine Emergency Medicine

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