New Options for Early-Stage Lung Cancer, Thyroid Cancer, Incontinence

The Eclipse System-Fecal Incontinence

The Food and Drug Administration (FDA) has approved marketing for The Eclipse System for the treatment of fecal incontinence (FI) in adult women.¹

The device works by way of a balloon that releases pressure on the vaginal wall and rectal area, which relieves episodes of FI in patients. Upon insertion by a clinician, patients can take the device home and inflate it themselves for self-treatment. ¹

To test the device’s efficacy, researchers conducted a clinical trial of 65 women with FI using the device. After 1 month, researchers found that 80% of the patients had a 50% decrease in episodes of FI compared to baseline. ¹

The investigators noted that adverse reactions to the treatment included pelvic cramping, discharge, redness, vaginal abrasion, pelvic pain, and urinary incontinence. ^{1
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Lenvatnib – Thyroid Cancer

The FDA has announced approval for the use of lenvatnib (Lenvima) to treat patients with progressive, differentiated thyroid cancer (DTC).²

Lenvatnib works by thwarting various proteins that allow cancer cells to grow and divide; the drug is a kinase inhibitor designed for patients whose disease has progressed after undergoing radioactive iodine therapy. ²

The drug is being approved 2 months in advanced to the original prescription drug user fee goal date (April 15, 2015). ²

In a clinical study including 392 patients with progressive, radioactive iodine-refractory DTC, researchers randomly assigned participants to receive lenvatnib or placebo. The study showed that 65% of lenvatnib-treated patients had a reduction in tumor size compared to placebo. ²

The most common side-effects observed were hypertension, joint and muscle pain, decreased appetite, fatigue, nausea, diarrhea, decreased weight, stomatitis, vomiting, excess protein in the urine, abdominal pain, and headache. ²

Serious side effects included liver and kidney damage, blood clot, cardiac failure, fistula formation, QT interval prolongation, hypocalcemia, and simultaneous episodes of headache, seizures, and confusion.

LuCID – Lung Cancer

Leicester University announced plans to test the efficacy of the lung cancer indicator detection program (LuCID) that uses a breath test to detect lung cancer in patients.³

Researchers designed the device to offer a non-invasive detection for the early stages of lung cancer. The device measures volatile organic compounds at low concentrations in the patient’s breath and allows a smaller and cheaper alternative to other pre-existing technologies. ³

The clinical study will be led by Salman Siddiqui, MD, a clinical senior lecturer and adult chest physician at Leicester University and Glenfield Hospital; Siddiqui and his colleagues from of the lung cancer clinical team at Leicester will have the results of the study in early 2016. ³

According to researchers, a health economic analysis conducted by Owlstone Nanotech Ltd (the company behind the device), suggested that early-stage lung cancer detection could be increased from 14.5% to 25% by 2020. The technology could save over 10,000 lives and £250m of NHS money. ³

—Michelle Canales Butcher

References:

1. FDA. FDA permits marketing of fecal incontinence device for women [press release]. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm434130.htm. Accessed February 17, 2015.

2. FDA. FDA approves Lenvima for a type of thyroid cancer [press release]. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm434288.htm. Accessed February 17, 2015.

3. University of Leicester. Ground-breaking breath test for lung cancer in clinical trial [press release]. www2.le.ac.uk/news/blog/2015-archive-1/february/ground-breaking-breath-test-for-lung-cancer-in-clinical-trial. Accessed February 17, 2015.