CHICAGO–Pembrolizumab plus low-dose ipilimumab combination therapy was considered to have an acceptable safety profile in patients with advanced melanoma or renal cell carcinoma during an initial safety run-in period, a study presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, has shown.

Researchers conducted an assessment of the safety and tolerability of pembrolizumab 2 mg/kg plus low-dose ipilimumab 1 mg/kg every 3 weeks for four doses, followed by pembrolizumab 2 mg/kg every 3 weeks for up to 2 years, among participants of the ongoing phase I/II KEYNOTE-029.

Twenty-two patients were enrolled, of which 12 had melanoma and 10 had renal cell carcinoma.

Results showed that dose-limiting toxicities occurred in six of 19 evaluable patients.

“All dose-limiting toxicities were of grade 3 severity except for one episode of grade 4 lipase elevation,” said Michael B. Atkins, MD, lead author and Deputy Director of the Georgetown Comprehensive Cancer Center in Washington, DC.

Specifically, dose-limiting toxicities included ALT/AST elevation, colitis, uveitis, elevation of pancreatic enzymes, hyperthyroidism, lipase elevation, and pneumonitis. Two patients experienced two dose-limiting toxicities each.

“All dose-limiting toxicities had resolved except for elevated lipase, which was ongoing at the time of data cutoff,” Dr. Atkins said.

Assessment of antitumor activity is ongoing with 14 patients remaining on pembrolizumab at the time of data cutoff.

Due to the positive findings, researchers have initiated a protocol-specified, single-arm expansion cohort to further assess the safety, tolerability, and efficacy of pembrolizumab plus low-dose ipilimumab in patients with advanced melanoma.

Reference

1. Atkins MB, Choueiri TK, Hodi FS, et al. Pembrolizumab (MK-3475) plus low-dose ipilimumab (IPI) in patients (pts) with advanced melanoma (MEL) or renal cell carcinoma (RCC): Data from the KEYNOTE-029 phase 1 study. J Clin Oncol. 2015:33(suppl; abstr 3009).

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Dialysis patients discharged from hospitals on Fridays or Saturdays are at increased risk of readmission within 30 days compared with those who are discharged on other days, according to findings presented at the 52^nd congress of the European Renal Association-European Dialysis and Transplant Association in London.

The finding suggests that intensified medical attention and monitoring, such as expanded weekend coverage by a dialysis-specific case manager may be needed for patients discharged on Friday or Saturday, researchers concluded.

Len Usvyat, PhD, and colleagues at Fresenius Medical Care North America, studied 1,305 dialysis patients in West Virginia, Kentucky, and Ohio. The cohort had 3,206 index hospitalizations and 1,123 readmissions within 30 days of discharge, for a mean readmission rate of 35%. The 30-day readmission rates for patients discharged on Friday and Saturday were 35% and 37%, respectively. The rates were 32%, 31%, 34%, 34%, and 33% for those discharged on Sunday, Monday, Tuesday, Wednesday, and Thursday, respectively. Compared with Sunday through Thursday discharges, Friday and Saturday discharges were associated with a significant 22% increased risk of 30-day readmission, the investigators reported.

“In light of the substantial rural nature of this population, further investigations of other geographically distributed populations are warranted to confirm the findings of this study,” they concluded in their study abstract.

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High body mass index (BMI) may identify patients who are at increased risk of progressive chronic kidney disease (CKD), British researchers reported at the 52^nd congress of the European Renal Association-European Dialysis and Transplant Association in London.

Rupert W. Major, MBChB, a Kidney Research U.K. Fellow at the University of Leicester in the U.K., and colleagues studied a cohort of 31,274 patients with an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² (mean 51.1) as calculated using the Modification of Diet in Renal Disease study equation. Of these patients, 64.7% had 2 eGFR results more than 3 months apart. The cohort had a mean BMI of 28.2 kg/m², and 28.7%, 38.8%, and 30.8% had a BMI of 18–25 (normal), 25-30 (overweight), and greater than 30 kg/m² (obese or severely obese). Results showed that the mean decline in eGFR was greater in the higher BMI categories. The mean eGFR declined by 0.11 and 0.08 mL/min/1.73 m² per year in patients with a BMI of 30–35 and greater than 35 kg/m², respectively, compared with no change or even slight increases in eGFR in the other BMI categories. The decline in eGFR in the higher BMI categories was especially pronounced in younger patients with higher levels of proteinuria, according to the investigators.

“The association we found suggests that reducing BMI might slow the progression of CKD,” Dr. Major told Renal & Urology News. “Lifestyle interventions, such as exercise and dietary programs, are potential areas for intervention in this area, particularly in primary care. At the University of Leicester, and other international renal research centers, we are running structured exercise program clinical trials in CKD to investigate the effect on outcomes, including CKD progression.”

Dr. Major noted that previous studies have focused on the relationship of BMI and the diagnosis of CKD, including a study by his colleagues suggesting that waist circumference may be a potential CKD screening tool. In contrast, the current study, funded by the U.K.'s National Institute for Health Research, focused on progression of disease in patients with known CKD, and the study included what is probably the largest cohort to date to examine the association, he said.

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WATCH ABOVE: Four patients who received dialysis treatments at the Royal Alexandra Hospital are now being closely monitored by health officials after it was discovered that disinfectant accidentally made it into the water supply that’s used in the machines. Shallima Maharaj reports. 

EDMONTON – Four dialysis patients are being closely monitored at the Royal Alexandra Hospital after a chemical was released into the water supply that’s used in the machines during treatment.

The incident happened at the hospital around 11 a.m. Friday when a valve was “accidentally turned during regular system cleaning,” according to Alberta Health Services.

“Inadvertently, some disinfectant got into that water supply,” said Curtis Johnston, facility medical director at the Royal Alexandra Hospital. “We need very pure water to use for dialysis treatments so there’s a system in place to purify the water. Periodically those systems need to be cleaned with this disinfectant.”

AHS would not say exactly what the chemical was, but Johnston said patients who may be exposed to the chemical could develop breathing problems.

“It’s expected that any adverse consequences from this exposure would happen in the first few hours. We don’t think there will be any long-term affects from this,” he said.

Once the chemical release was discovered, AHS said the water supply was immediately shut off and the patients were taken in for assessment.

“We recognize that an error occurred and our apologies have gone out to the patients and their families,” said Johnston. “Our first priority is always to look after the patients and to make sure that they’re safe and that they’re getting the type of care that they need to.”

Rose Laboucan’s close friend and colleague was one of the four affected patients. She said her friend, who is currently going through dialysis and chemo therapy, was on her way home to Sucker Creek—a four-hour drive—when she received a phone call to come back to the hospital.

“It’s very worrisome,” Laboucan said from outside the hospital Friday night. “We don’t know what the outcomes are going to be. We hope it doesn’t impact anything that’s going on with her treatment right now.

“She’s feeling some anger and she also has to keep faith and say, ‘We’ll get over this one too.’ She’s been through so much.”

Laboucan said she understands errors occur, but she hopes the hospital takes responsibility for the error to ensure it never happens again.

“There is no need for such an incident to happen at a hospital, in my opinion,” she said. “When it comes to lives of people that are being already in stressful situations, undergoing dialysis for kidney failure and then they have to go through that stress again…it’s just adding to the pressure. It’s ridiculous.”

Johnston said a full internal review will be conducted. AHS said the water supply would be cleaned and portable dialysis units would be used until the cleaning was complete.

© Shaw Media, 2015

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