At the dose of 50 mg/d (4 weeks on, 2 weeks off), sunitinib displays manageable toxicity. Antitumor activity supports further studies in patients with renal cell carcinoma, gastrointestinal, neuroendocrine, and stromal tumors. Future studies may consider including prospective imaging techniques such as high frequency ultrasound to monitor tumor density.
CCI-779 displayed no immunosuppressive effects with manageable and reversible adverse events at doses up to 220 mg/m(2), the highest dose tested. Based on our results, weekly doses of 25, 75, and 250 mg CCI-779 not based on classical definitions of maximum-tolerated dose are being tested in phase II trials in patients with breast and renal cancer.
Our culturally targeted website increased participants' knowledge about LDKT above and beyond transplant education and should supplement transplant center education for Hispanics. When considered at the population level, Infórmate could have a great impact on knowledge gains in this underserved population disproportionately affected by kidney disease.
Background
Kidney transplant candidates (KTCs) must provide informed consent to accept kidneys from increased risk donors (IRD), but poorly understand them. We conducted a multisite, randomized controlled trial to evaluate the efficacy of a mobile web application, Inform Me, for increasing knowledge about IRDs.
Methods
KTCs undergoing transplant evaluation at 2 transplant centers were randomized to use Inform Me after routine transplant education (intervention) or routine transplant education alone (control). Computer adaptive learning method reinforced learning by embedding educational material, and initial (Test 1) and additional test questions (Test 2) into each chapter. Knowledge (primary outcome) was assessed in person after education (Tests 1 and 2), and 1-week later by telephone (Test 3). Controls did not receive Test 2. Willingness to accept an IRD kidney (secondary outcome) was assessed after Tests 1 and 3. Linear regression Test 1 knowledge scores were used to test the significance of Inform Me exposure after controlling for covariates. Multiple imputation was used for intention-to-treat analysis.
Results
Two hundred-eighty-eight KTCs participated. Intervention participants had higher Test 1 knowledge scores (mean difference=6.61; 95% CI, 5.37–7.86) than control participants, representing a 44% higher score than control participants’ scores. Intervention participants’ knowledge scores increased with educational reinforcement (Test 2) compared to control arm Test 1 scores (mean difference=9.50; 95% CI, 8.27–10.73). After 1 week, intervention participants’ knowledge remained greater than controls’ (mean difference=3.63; 95% CI, 2.49–4.78) (Test 3). Willingness to accept an IRD kidney did not differ between study arms at Tests 1 and 3.
Conclusion
Inform Me use was associated with greater KTC knowledge about IRD kidneys above routine transplant education alone.
Web-based education for patients undergoing dialysis can effectively increase Hispanics' knowledge about transplantation and living kidney donation. Study limitations include small sample size and single geographic region study. Dialysis facilities could enable website access as a method of satisfying policy requirements to provide education about kidney transplantation.
This study assessed the safety, immunogenicity, and pharmacokinetics of etaracizumab, a monoclonal antibody directed against the alphavbeta3 integrin, in patients with advanced malignancies. Four cohorts of four patients received escalating dose of etaracizumab as a 30-min intravenous infusion, first as a single test dose, followed-up 2-5 weeks later by weekly doses. Sixteen patients with advanced solid tumors received a total of 309 cycles of etaracizumab at doses ranging 1-6 mg/kg. The mean number of weekly infusions was 19 (ranging 5-53). Frequently reported adverse events were grades 1-2 asthenia (15 patients) and infusion reactions (9 patients). At 1 mg/kg, one patient experienced grade 3 chills with the first infusion. Other grade 3 toxicities included reversible hyponatremia, hypophosphatemia and hyponatremia in one patient each at 1, 4 and 6 mg/kg, respectively. No patient experienced treatment delay/discontinuation due to an adverse event. The half-life of etaracizumab ranged 49-180 h with a nonlinear increase in terminal half-life with increasing doses. There was no objective response but five patients experienced a stable disease of >6-month duration. Etaracizumab was well-tolerated at doses up to 6 mg/kg with no evidence of immunogenicity. The safety profile of etaracizumab warrants further exploration in ongoing phase I/II trials.
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