New algorithm reduces systemic sclerosis PAH screening costs

By jeremyc | October 7, 2015

A new screening algorithm has been developed by the Australian Scleroderma Interest Group (ASIG) for pulmonary arterial hypertension (PAH). It screens for PAH in systemic sclerosis patients and lowers costs by reducing the need for right heart catheterization (RHC) and transthoracic echocardiography (TTE).

The algorithm is called ASIGPROPOSED and uses pulmonary function tests as well as the N-terminal pro-B-type natriuretic peptide (NT-proBNP) blood biomarker. It was applied to 643 sclerosis patients identified from the Australian Scleroderma Cohort Study. None of the patients were screened before. The algorithm achieved 64 percent fewer TTEs and 10 percent fewer RHCs as compared to the conventional screening algorithm, ASIGSTANDARD, based on pulmonary function and TTE tests.

ASIGPROPOSED was also linked to a 50 percent cost reduction of screening and a 22 percent reduction in the combined cost of screening as well as RHC.

A total of 40 percent of the patients in the study were screened positive by ASIGSTANDARD, while the ASIGPROPOSED algorithm found 36 percent to be positive. The researchers said, “The use of the ASIGPROPOSED algorithm reduces the cost of screening for [systemic sclerosis]-PAH, without compromising diagnostic accuracy.”

They added, “The proposed algorithm also carries the benefit of greater convenience. NT-proBNP levels are easily measured with a simple blood test that can be performed at the time of each annual screening visit.”

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Cabozantinib or nivolumab could benefit RCC patients

By jeremyc | October 6, 2015

The combination of cabozantinib or nivolumab was found to have improved results over everolimus in treating advanced renal cell carcinoma (RCC), according to recent clinical trial results.

Findings from two studies of patients undergoing vascular endothelial growth factor receptor (VEGFR) inhibitor therapy were reported at the same time. The METEOR trial’s results were presented by author Toni Choueiri, from Dana-Farber Cancer Institute in Boston. The phase III, open label, randomized study had 375 patients.

After at least 11 months, the progression-free survival (PFS) was 7.4 months on average for the 187 patients who took 60mg per day of cabozantinib. In comparison, the 188 patients who received 10mg of everolimus per day had a PFS of just 3.8 months. The response rate was also higher, with 21 percent versus 5 percent.

Meanwhile, author Padmanee Sharma, from MD Anderson Cancer Center in Houston presented the CheckMate 025 study. The PFS was 25 months on average for the 410 patients given nivolumab, as compared to 19.6 months for the patients given everolimus. The objective response rate was also higher at 25 percent versus 5 percent.

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New combination effective in poor-prognosis melanoma

By jeremyc | October 5, 2015

A combination of nivolumab and ipilimumab could prove effective in treatment patients of advanced melanoma with a poor prognosis, according to a new study.

The study was presented by author James Larkin, from the Royal Marsden Hospital in London, who said, “[W]e believe that the data will give confidence to patients and their healthcare providers that the combination of nivolumab and ipilimumab will be effective regardless of advanced age, the presence of a BRAF mutation, or poor prognostic factors.”

In the last reported CheckMate 067 phase III trial results, the median PFS was 11.5 months for the 314 patients who were previously untreated and received the combination treatment, as compared to just 6.9 months for the patients who received nivolumab plus placebo and 2.9 months for the patients who received ipilimumab plus placebo.

In this latest subgroup analysis, the combination remained effective regardless of the patient age, extend of the metastatic diseases, BRAF mutation status and serum lactate dehydrogenase level. The median PFS among patients 75 years or older was higher among the combination treatment users than those who took ipilimumab alone. The combination treatment group did not reach their median PFS, while the median PFS for the ipilimumab-only group was 4 months, and 5.3 months for the nivolumab alone group.

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New study supports everolimus for treating NETs

By jeremyc | October 4, 2015

Results from the RADIANT-4 and NETTER-1 trials has indicated that the mTOR inhibitor everolimus and the peptide receptor radionuclide therapy lutetium (Lu)177-dotatate could improve progression-free survival (PFS) rates for neuroendocrine tumor (NET) patients.

In the RADIANT-4 trial, 205 patients with NETs of the lung or gastrointestinal track were randomly given 10mg of everolimus per day. The follow-up period was 11 months. On analysis, the PFS of the patients was 14 months as compared to 5.5 months in the placebo group, along with a significant hazard ratio (HR) of 0.39 versus 0.48.

Moreover, the risk of death reduced by 36 percent in the first planned interim survival analysis. The researchers believe that analysis of the mature data in 2016 may show a statistically significant increase in risk of death.

The researchers said, “Although we knew from previous studies that everolimus could delay the growth of pancreatic NETs, this is the first time we have been able to conclusively show that it is effective in other NET sites.”

“We hope that our results will provide a new treatment option for lung and gastrointestinal NETs, and we look forward to reporting further results from the trial, including those on final overall survival and quality of life, in the future.”

As for the NETTER-1 phase III trial, 229 patients were given four doses of 177Lu-dotatate on first-line somatostatin analogue (SSA) therapy. The median PFS was unreached for this group, as compared to the 8.4 months among the non-user group.

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New combination could benefit advanced melanoma treatment

By jeremyc | October 3, 2015

According to updated COMBI-v trial results, the combination treatment of dabrafenib and trametinib could benefit the survival rates of advanced melanoma cases, as compared to vemurafenib.

The phase III trial has patients with BRAF V600E/K mutation-positive metastatic or un-resectable melanoma. The presenting author was Caroline Robert, from the Institut Gustave Roussy in Paris, France.

Robert noted that a previous interim analysis with an 11-month follow-up showed that the combination had a significant improvement in survivability. In this recent analysis, the 352 patients assigned the combination had a medium survivability of 25.6 months, longer than the 18 months seen in the 352 patients who received the vemurafenib. This also marked the “longest ever reached” survivability in a randomized phase III trial in the patient population. Dabrafenib is a BRAF inhibitor and trametinib is an MEK inhibitor, while vemurafenib is a BRAF inhibitor.

The two-year survival rate was higher among the combination treatment group as compared to the single treatment group, at 51 percent versus 38 percent. Median PFS was longer as well, with 12.6 months versus 7.3 months. Overall response rate and duration improved significantly, with 66 percent versus 53 percent and 13.8 versus 8.5 months, respectively.

All-grade adverse event incidence remained high during the added follow-up, with the most commonly reported one being pyrexia at 55 percent in the combination group. Arthralgia was the most common side effective at 52 percent in the vemurafenib group.

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Brain metastatic disease show branched evolution

By jeremyc | October 2, 2015

Preliminary data from a new large-scale study has found that brain metastatic disease has a branched evolution from the primary tumor, evolving ‘clinically actionable’ mutations.

The study found genetic mutations that were specific to brain metastases from different primary tumor types and increased the possibility of treating that target these mutations. The presenting author of the study was Priscilla Brastianos, from Massachusetts General Hospital. She said that the matched samples of brain metastases, distant disease and primary tumor indicated a ‘common ancestor’ but had site-specific mutations, which indicate a divergent evolution.

Of the 104 brain metastases that were sequenced, 56 percent were found to have a clinically actionable mutation not present in the primary tumor. Also, 51 percent of the mutations indicated that the metastasis may be sensitive to CDK inhibitors and 43 percent of them indicated possible efficacy of mTOR, AKT and PI3K inhibitors.

A further analysis found that metastases from “regionally, anatomically and temporally distinct areas of the brain” had similar clinically actionable mutations.

Brastianos said, “Genetic divergence between primary and metastatic samples poses a major challenge to clinical decision-making for precision medicine in oncology in brain metastases.”

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Preoperative MRI becomes more common in breast cancer

By jeremyc | October 1, 2015

According to a Canadian research team, the usage of preoperative MRI over the past ten years in women with newly diagnosed breast cancer has increased substantially.

Preoperative MRIs were used in 3 percent of women with a primary breast cancer diagnosis in 2003. The women underwent a related surgery within three months of their diagnosis. This percentage rose to 24 percent in 2012, marking an eightfold rise observed in all stages of the disease.

The increased usage of preoperative MRI was found to be due to a higher socioeconomic status and younger age of patients, higher disease stage, recent completion of training by surgeons and surgery performed at teaching hospitals.

The study was led by Angel Arnaout of the Ottawa Hospital, Ontario, and it used data on 53,015 women using the Ontario Cancer Registry. There was a significant correlation found between short-term surgical outcomes and postoperative MRIs. Women who underwent a postoperative MRI had a 2.52 times greater chance of a 30-day or longer wait for surgery, as compared to those who did not undergo an MRI. They also had a 1.73 times higher risk of mastectomy and 1.48 times higher chance of a contralateral prophylactic mastectomy.

Preoperative MRI was linked to a greater risk of post-diagnosis breast imaging and biopsies, as well as staging imaging for the detection of distant metastases.

Topics: Breast cancer | No Comments »

FDA approves Lonsurf for colorectal cancer

By jeremyc | September 30, 2015

The US Food and Drug Administration (FDA) has approved a new medication with the brand name Lonsurf (trifluridine and tipiracil) for colorectal cancer.

The new medication is approved for treating advanced cancer in patients who have not responded positively to other forms of treatment.

Richard Pazdur, director, Office of Hematology and Oncology Products, in the Center for Drug Evaluation and Research, FDA, said, “The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease. But there are many patients who still need additional options, and today’s approval is a testament to the FDA’s commitment to work with companies to develop new drugs in disease areas where unmet needs remain.”

Lonsurf has been developed by Taiho Oncology and is an oral medication. It was approved based on its safety and efficacy proven in in a trial of over 800 advanced colorectal cancer patients who received previous treatments. As compared to a placebo, Lonsurf users survived 2.2 months longer on average.

The drug was associated with some side effects such as anemia, immune system weakness, fever, vomiting and others.

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Apples most popular among US youth

By jeremyc | September 29, 2015

According to a recent survey of US teenagers and children, apples are the most popular fruit, especially among children in the age group of 6-11 years.

The study was led by Kirsten Herrick, of the Division of Health and Nutrition Examination Surveys at the National Center for Health Statistics, who said, “Fruits and vegetables are important sources of nutrients that promote health and protect against chronic disease. These findings provide insight into what fruits US youth are consuming and sociodemographic factors that may influence consumption.”

For this study, the researchers looked at data from a survey of 3,129 children in the age group of 2-19 years. They found that most of the fruit intake was from 100 percent fruit juice and from whole fruits. Whole fruits made up a little more than half of their daily fruit intake, and 34 percent was from fruit juice.

Apple was the most common choice among all age groups. Fruit intake habits changed by a large margin between the age groups of 2-5 years and 6-11 years. Older kids ate more whole apples and less apple juice than the younger children. Habits also changed with ethnicity, with black children eating less whole fruits Hispanic and white children.

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USPSTF releases cigarette smoking healthcare guidelines

By jeremyc | September 28, 2015

The US Preventive Services Task Force (USPSTF) has released its latest cigarette smoking healthcare guidelines. The new guidelines call for doctors to screen all pregnant women and adults and to advice smokers to quit their habit using proven interventions.

For these guidelines, the USPSTF reviewers looked at 114 articles on smoking cessation and tobacco usage, and the final analysis included 54 reviews. The new guidelines apply to all people above 18 years of age.

Doctors are recommended to screen for all forms of tobacco usage, including smoking cigarettes and cigars, electronic cigarettes and snuff. If a patient uses tobacco, the doctor should advice quitting the habit.

Options for intervention include smoking cessation medications and behavior modification. Various smoking cessation drugs and methods are available, but the USPSTF claims that there is lack of evidence for it to recommend certain therapies. It particularly notes the lack of data to recommend electronic cigarettes. The task force only recommends behavior modification in case of pregnant women.

Topics: Smoking Cessation | No Comments »

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