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Kelly Richardson

Publications and source records attributed to Kelly Richardson.

6 recordsLinked to original sources

A Phase 2 trial of the liposomal DACH platinum L-NDDP in patients with therapy-refractory advanced colorectal cancer.

PURPOSE: L-NDDP (Aroplatin) is a liposomal formulation of cis-bis-neodecanoato-trans-R,R-1,2-diaminocyclohexane platinum (II), a structural analogue of oxaliplatin. In a Phase 1 trial, the maximum tolerated dose (MTD) of L-NDDP was 312.5 mg/m2 with myelosuppression as dose limiting toxicity (DLT). We conducted a Phase 2 trial of L-NDDP in patients (pts) with advanced colorectal cancer (CRC) refractory to 5-fluorouracil/leucovorin or capecitabine and irinotecan to investigate the anti-tumor response of L-NDDP and to further characterize its toxicity profile in this population. METHODS: L-NDDP was administered intravenously, once every 28 days. The starting dose was 300 mg/m2, with possible intra-patient dose escalation in the absence of grade 2 or higher drug-related toxicity. Patients were treated until disease progression or unacceptable toxicity. Of 20 eligible patients all were evaluable for toxicity and 18 were evaluable for response. Hematologic toxicities included anemia (grades 1-4) in 20% of pts and leucopenia, neutropenia and thrombocytopenia (grade 1/2) in 5% of patients each. Common non-hematologic toxicities included nausea (75%), vomiting (60%), and fatigue (70%), reversible infusion reactions (chest/back pain or shortness of breath; 40%), transient transaminase elevations (35%) and hyperbilirubinemia (20%). Grade 3-4 toxicities included infusion reaction (20%), vomiting (15%), fatigue (15%), anemia (10%) and ALT/AST elevation (5/15%). Peripheral neuropathy (grade 1/2) was seen in 15% of pts. One of 18 pts had a confirmed PR (5.6%), three (16.7%) had stable disease (> or =3 months) and 14 pts progressed. L-NDDP was well tolerated in this group of refractory patients and demonstrated evidence of anti-tumor activity. CONCLUSION: Further studies of L-NDDP, preferably in combination with other agents such as fluoropyrimidines, are warranted.

Aged↗

Inhaled nitrous oxide during painful procedures: a satisfaction survey.

Children with cystic fibrosis (CF) undergo repeated invasive medical procedures. This article summarises a survey of the use of nitrous oxide to minimise the psychological trauma and pain that was undertaken within the paediatric unit of a district general hospital (Williams et al 2004). Pain levels pre and post procedure, whether the treatment was effective, any adverse effects and comments by children and carers were recorded. Nitrous oxide was safe and effective in reducing pain, trauma and 'needle phobia'. It is now being offered to other children in the management of procedural pain.

Adolescent↗

Phase I and pharmacokinetics trial of ABI-007, a novel nanoparticle formulation of paclitaxel in patients with advanced nonhematologic malignancies.

PURPOSE: ABI-007 is a novel solvent-free, albumin-bound, 130-nm particle formulation of paclitaxel designed to avoid solvent-related toxicities and to deliver paclitaxel to tumors via molecular pathways involving an endothelial cell-surface albumin receptor (gp60) and an albumin-binding protein expressed by tumor cells and secreted into the tumor interstitium (secreted protein acid rich in cysteine). This study determined the maximum-tolerated dose (MTD) of ABI-007 monotherapy administered weekly (three weekly doses, repeated every 4 weeks) and assessed the pharmacokinetics of paclitaxel administered as ABI-007. PATIENTS AND METHODS: Patients with advanced nonhematologic malignancies received ABI-007 without premedication at dose levels from 80 to 200 mg/m(2) as a 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest (one cycle). RESULTS: Thirty-nine patients were treated with an average of five cycles of ABI-007; 33% of patients received > or = six cycles of treatment. MTDs for heavily and lightly pretreated patients were 100 and 150 mg/m(2), respectively; and the dose-limiting toxicities were grade 4 neutropenia and grade 3 peripheral neuropathy, respectively. Maximum paclitaxel concentration and area under the curve increased linearly with dose. Dose-dependent changes in plasma clearance did not occur. Partial responses were observed in five patients with breast, lung, and ovarian cancers, all of whom had previously been treated with paclitaxel containing polyoxyethylated castor oil in the formulation. CONCLUSION: This study demonstrated that weekly ABI-007 can be administered at doses exceeding those typically used for paclitaxel containing polyoxyethylated castor oil. Pharmacokinetics were linear over the dose range studied. Antitumor responses occurred in patients previously treated with paclitaxel containing polyoxyethylated castor oil.

Adult↗

Electrocardiographic damage scores and cardiovascular mortality.

BACKGROUND: A number of electrocardiogram (ECG) classification systems have been developed to estimate cardiac injury, infarct size, and left ventricular function. Although many studies have documented an association between clinical, imaging, and autopsy data, few have evaluated their prognostic value. METHODS AND RESULTS: ECGs from 46,933 patients were analyzed using computerized measurements and algorithms. The Simplified Selvester Score, the Cardiac Infarction Injury Score (CIIS), and a Q-wave score were calculated. Other ECG characteristics such as left ventricular hypertrophy and bundle-branch blocks were also evaluated. The main outcome was cardiovascular (CV) mortality. During a mean follow-up of 6 years, the CIIS outperformed all other ECG classifications in determining prognosis. Going from lowest to highest tertile of CIIS, each step had a hazard ratio of 1.39 (CI 1.32-1.45) or a 39% increase in risk per tertile. Using clinically based thresholds, the annual mortality for high-risk CIIS was 4.5% (CI 4.0-4.6) versus 0.3% (CI 0.0-1.3) for those in the low-risk group. CONCLUSIONS: A low-risk damage score was associated with a <1% annual CV mortality and a high-risk damage score with annual CV mortality of >4%. A damage score should be calculated as part of all computerized ECG interpretations.

Aged↗

Electrocardiographic arrhythmia risk testing.

Among the most compelling challenges facing cardiologists today is identification of which patients are at highest risk for sudden death. Automatic implantable cardioverter-defibrillators are now indicated in many of these patients, yet the role of noninvasive risk stratification in classifying patients at high risk is not well defined. The purpose of this review is to evaluate the various electrocardiographic (ECG) techniques that appear to have potential in assessment of risk for arrhythmia. The resting ECG (premature ventricular contractions, QRS duration, damage scores, QT dispersion, and ST segment and T wave abnormalities), T wave alternans, late potentials identified on signal-averaged ECGs, and heart rate variability are explored. Unequivocal evidence to support the widespread use of any single noninvasive technique is lacking; further research in this area is needed. It is likely that a combination of risk evaluation techniques will have the greatest predictive power in enabling identification of patients most likely to benefit from device therapy.

Arrhythmias, Cardiac↗