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Clinical Index of Stable Febrile Neutropenia

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221. 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

222. Pain

40 years. Ann Oncol 18 (9): 1437-49, 2007. Green CR, Hart-Johnson T: Cancer pain: an age-based analysis. Pain Med 11 (10): 1525-36, 2010. Gutgsell T, Walsh D, Zhukovsky DS, et al.: A prospective study of the pathophysiology and clinical characteristics of pain in a palliative medicine population. Am J Hosp Palliat Care 20 (2): 140-8, 2003 Mar-Apr. Caraceni A, Portenoy RK: An international survey of cancer pain characteristics and syndromes. IASP Task Force on Cancer Pain. International (...) Association for the Study of Pain. Pain 82 (3): 263-74, 1999. Barbera L, Molloy S, Earle CC: Frequency of non-cancer-related pain in patients with cancer. J Clin Oncol 31 (22): 2837, 2013. Childers JW, King LA, Arnold RM: Chronic Pain and Risk Factors for Opioid Misuse in a Palliative Care Clinic. Am J Hosp Palliat Care 32 (6): 654-9, 2015. Massaccesi M, Deodato F, Caravatta L, et al.: Incidence and management of noncancer pain in cancer patients referred to a radiotherapy center. Clin J Pain 29 (11): 944

2012 PDQ - NCI's Comprehensive Cancer Database

223. Nutrition in Cancer Care

support and leads to progressive functional impairment.”[ ] They classified three stages of cachexia and provided diagnostic criteria: Precachexia: early signs (clinical and metabolic) that precede substantial weight loss. Cachexia: the presence of significant weight loss or sarcopenia in the absence of simple starvation. Weight loss >5% over the past 6 months; or Body mass index <20 and degree of weight loss >2%; or Sarcopenia and any degree of weight loss >2%. Refractory cachexia: cachexia (...) cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol 31 (12): 1539-47, 2013. Huhmann MB: Nutrition management of the surgical oncology patient. In: Leser M, Ledesma N, Bergerson S, et al., eds.: Oncology Nutrition for Clinical Practice. Chicago, Ill: Oncology Nutrition Dietetic Practice Group, 2013, pp 135-42. August DA, Huhmann M: Nutrition support of the cancer patient. In: Ross AC, Caballero B, Cousins RJ, et al., eds

2012 PDQ - NCI's Comprehensive Cancer Database

224. Myeloid Leukemia, Childhood Acute/Other Childhood Myeloid Malignancies

with hepatosplenomegaly, lymphadenopathy, fever, and skin rash along with an elevated white blood cell (WBC) count and increased circulating monocytes.[ ] In addition, patients often have an elevated hemoglobin F, hypersensitivity of the leukemic cells to granulocyte-macrophage colony-stimulating factor (GM-CSF), monosomy 7, and leukemia cell mutations in a gene involved in RAS pathway signaling (e.g., NF1 , KRAS/NRAS , PTPN11 , or CBL ).[ - ] (Refer to the section of this summary for more information.) Chronic (...) congenita. Bloom syndrome. Syndromes of growth and cell survival signaling pathway defects: Neurofibromatosis type 1 (particularly JMML development). Noonan syndrome (particularly JMML development). Severe congenital neutropenia (Kostmann syndrome). Shwachman-Diamond syndrome. Diamond-Blackfan anemia. Congenital amegakaryocytic thrombocytopenia. CBL germline syndrome (particularly in JMML). Li-Fraumeni syndrome ( TP53 mutations). Acquired syndromes Severe aplastic anemia. Paroxysmal nocturnal

2012 PDQ - NCI's Comprehensive Cancer Database

225. Ovarian Epithelial Cancer

origin and are staged and treated similarly to ovarian cancer. Since 2000, FTC and PPC have usually been included in ovarian cancer clinical trials.[ ] Clear cell and endometrioid ovarian cancers that are linked to endometriosis have different gene-expression signatures, as do mucinous subtypes.[ ] Stromal and germ cell tumors are relatively uncommon and comprise fewer than 10% of cases. (Refer to the PDQ summaries on and for more information.) Incidence and Mortality Epithelial carcinoma (...) ).[ , ] Endometriosis.[ - ] Hormone therapy.[ , ] Postmenopausal hormone replacement therapy. Obesity.[ - ] High body mass index. Tall Height.[ - ] Family history and genetic alterations The most important risk factor for ovarian cancer is a history of ovarian cancer in a first-degree relative (mother, daughter, or sister). Approximately 20% of ovarian cancers are familial, and although most of these are linked to mutations in either the BRCA1 or BRCA2 gene, several other genes have been implicated.[ , ] The risk

2012 PDQ - NCI's Comprehensive Cancer Database

226. Skin Cancer, Melanoma

cell carcinoma and squamous cell carcinoma, respectively. The separation between epidermis and dermis occurs at the basement membrane zone, located just inferior to the basal cell keratinocytes. Screening Refer to the PDQ summary on for more information. Clinical Features Melanoma occurs predominantly in adults, and more than 50% of the cases arise in apparently normal areas of the skin. Although melanoma can occur anywhere, including on mucosal surfaces and the uvea, melanoma in women occurs more (...) the following:[ , - ] Thickness and/or level of invasion of the melanoma. Mitotic index, defined as mitoses per millimeter. Ulceration or bleeding at the primary site. Number of regional lymph nodes involved, with distinction of macrometastasis and micrometastasis. Systemic metastasis. Site—nonvisceral versus lung versus all other visceral sites. Elevated serum lactate dehydrogenase level. Patients who are younger, who are female, and who have melanomas on their extremities generally have better prognoses

2012 PDQ - NCI's Comprehensive Cancer Database

227. 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

228. Gastrointestinal Stromal Tumors

, the prognosis appears to be influenced by genetic events other than kinase mutations, although a particular kinase mutation may help to define the initial clinical course of a GIST. Based on retrospective studies from time periods that predated the clinical use of kinase inhibitors, current recommendations for assessing the risk of progression for a newly diagnosed primary GIST rely on three parameters (see ):[ , - ] Mitotic index (mitoses per 50 high-power fields). Tumor size. Tumor location. Table 1. Risk (...) recommendations are, therefore, based upon expert opinion and clinical judgment taking into account tumor site, size, and mitotic index. For surgically treated patients with localized disease, routine follow-up schedules may differ across institutions and may depend on the risk status of the tumor.[ ] Abdominal/pelvic CT may be performed every 3 to 6 months, but very low-risk lesions may not need routine follow-up testing.[ ] CT or 18F-FDG PET are used to monitor therapeutic effects in patients receiving

2012 PDQ - NCI's Comprehensive Cancer Database

229. Langerhans Cell Histiocytosis

successful.[ , ] One study has shown that 1% of patients have a positive family history for LCH.[ ] Clinical Presentation LCH most commonly presents with a painful bone lesion, with skin being the second most commonly involved organ. Systemic symptoms of fever, weight loss, diarrhea, edema, dyspnea, polydipsia, and polyuria relate to specific organ involvement and or disease presentation, as noted below. Specific organs are considered high risk or low risk when involved with disease presentation. Risk (...) mutation within a marrow or circulating precursor cell, while localized disease arises from the mutation occurring in a precursor cell at the local site.[ ] The above findings have led all clinicians to agree that LCH is a myeloid neoplasm; however, discussion remains about whether it is a malignant neoplasm with varying clinical behavior. The same BRAF V600E mutation has been found in other cancers, including malignant melanoma; however, V600E-mutated BRAF is also present in benign nevi, possibly

2012 PDQ - NCI's Comprehensive Cancer Database

230. Lymphoma, Adult Hodgkin

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 (...) 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

2012 PDQ - NCI's Comprehensive Cancer Database

231. 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

232. Afinitor (everolimus)

Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted Page 2 of 75 TABLE OF CONTENTS 1. BACKGROUND INFORMATION ON THE PROCEDURE 3 1.1 Submission of the dossier 3 1.2 Steps taken for the assessment of the product 3 2 SCIENTIFIC DISCUSSION 5 3.1 Introduction 5 3.2 Quality aspects 6 3.3 Non-clinical aspects 12 3.4 Clinical aspects 23 3.5 Pharmacovigilance 64 3.6 Overall conclusions, risk/benefit assessment and recommendation 71 Page 3 of 75 1. BACKGROUND (...) is a complete dossier composed of administrative information, complete quality data, non-clinical and clinical data based on applicants’ own tests and studies and/or bibliographic literature substituting/supporting certain test(s) or study(ies). Information relating to Orphan Market Exclusivity Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000 and Article 3 of Commission Regulation (EC) No 847/2000, the application contained a critical report addressing the possible similarity with authorised

2009 European Medicines Agency - EPARs

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

; 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 (...) 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

2009 FDA - Drug Approval Package

234. 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

235. 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

236. 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

237. Duration of ANtibiotic Therapy for CEllulitis

at day 28 (no fever; stable or further improved combined score; no new antibiotics for cellulitis) Recurrence at day 90 [ Time Frame: 90 days ] Recurrence of cellulitis by day 90, defined as the need for additional antibiotic therapy for cellulitis Objective speed of recovery [ Time Frame: Up to 90 days ] Improvement in cellulitis severity score (a 7 item scoring system, each with a score between 0-3; items are erythema, warmth, tenderness, edema, ulceration, drainage and fluctuance). Determined (...) (for flucloxacillin) Phase 4 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 151 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: Duration of Antibiotic Therapy for Cellulitis (DANCE): a Randomized Controlled Trial Comparing 6 to 12 Days of Antibiotic Therapy for Patients Hospitalized

2014 Clinical Trials

238. Toxicity, Cocaine (Diagnosis)

Management The general objectives of pharmacotherapeutic intervention in cocaine toxicity are to reduce the CNS and cardiovascular effects of the drug. These are accomplished by using benzodiazepines initially and then controlling clinically significant tachycardia and hypertension while simultaneously attempting to limit deleterious drug interactions. Hyperthermia and rhabdomyolysis If psychostimulant-intoxicated patients do not die as a result of cardiac or cerebrovascular complications (...) . Hyperthermia, which may also be caused by downregulation of dopamine receptors, increases the incidence of fatal excited delirium. Death from excited delirium is more common in the summer months than at other times (55% vs 33% for other accidental cocaine toxicity deaths); therefore, high ambient temperature and humidity may play roles in the development of hyperthermia. An independent risk factor for fatal excited delirium is a body mass index (weight in kilograms/height in square meters) in the upper 3

2014 eMedicine.com

239. Lymphoma, Follicular (Diagnosis)

and varies across racial groups. See the image below. Follicular lymphoma, low-power view. Note the nodular pattern reminiscent of germinal centers. Photograph courtesy of Aamir Ehsan, MD. Signs and symptoms Follicular lymphoma is a type of non-Hodgkin lymphoma that most commonly presents as a painless, slowly progressive adenopathy. Systemic symptoms, such as fever, drenching night sweats, or weight loss in excess of 10% of ideal body weight, or asthenia, are infrequent at presentation but can (...) . A complete blood cell count (CBC) with differential should be obtained, including examination of the peripheral blood smear if the differential is abnormal. A chemistry panel and lactate dehydrogenase (LDH) level should be obtained. A computed tomography (CT) scan of the chest, abdomen, and pelvis can determine whether abdominal or pelvic adenopathy is present. Positron emission tomography (PET) scanning may also be useful in certain clinical settings, such as localized disease or when transformed

2014 eMedicine.com

240. Lymphoma, Mediastinal (Diagnosis)

in fingertips and toes. Motor neuropathy is unusual. Myelosuppression (bone marrow suppression) and moderate pancytopenia occur after every treatment cycle. Blood counts typically reach their nadir approximately 10 days after the completion of a treatment cycle. Fatigue is common. Neutropenic fever and infection are common complications of chemotherapy and require immediate treatment. Approximately 10-20% of patients develop excessive neutropenia or an infectious complication. Primary prophylaxis (...) recommended. Rituximab is generally safe. It can cause fever and chills, particularly during the first administration. Rare cases of anaphylactic reactions have been reported. Cases of hepatitis B virus (HBV) reactivation that have resulted in fulminant hepatitis and death have been reported. Persons at high risk of HBV infection should be screened before the initiation of rituximab. Carriers of HBV should be closely monitored for clinical and laboratory signs of active HBV infection and hepatitis during

2014 eMedicine.com

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