Determination of liver function is crucial to assess patient’s eligibility for safe liver resection
Berlin. Humedics GmbH, a specialist for real-time and mobile measurement of the individual liver function at the bedside of the patient, today announced that two studies show the potential of the LiMAx test to better assess the eligibility of colorectal cancer patients for liver metastases resection after chemotherapy. The LiMAx test was used to explore the effects of oxaliplatin-based chemotherapy on liver function. Combining chemotherapy with subsequent partial liver resection for colorectal liver metastases has shown good results on patient survival. Furthermore, initially inoperable colorectal metastatic disease may be successfully down-staged using neoadjuvant chemotherapeutical regimens and converted into a resectable condition where potentially curative treatment can be offered. However, chemotherapy-induced liver injury is a well-known phenomenon after neoadjuvant therapy of colorectal liver metastases and contributes to postoperative morbidity and mortality. It still remains difficult to ascertain the optimal time interval between cessation of chemotherapy and liver resection. No common guidelines for the optimal timing of liver surgery after the application of systemic chemotherapy have been established and the effects on individual liver function remain unexplored.
Another unmet need for colorectal metastatic patients is also addressed by dedicated researchers and authorities (3). Today, patients with colorectal liver metastases are often being considered for liver resection, but a reliable approach to determine whether the metastasis is resectable is still yet in position. This may cause psychological pressure to the patients and extensive economic burden to the healthcare system. Humedics believes the reported LiMAx studies in liver surgery and systematic chemotherapy in colorectal liver metastasis herald the way to solve these unmet needs.
Two studies with the LiMAx test showed that the liver function of patients with colorectal cancer liver metastases was significantly reduced after chemotherapy treatment due to the toxicity of oxaliplatin-based anti-cancer regimens. Study results also revealed that liver function recovery after cessation of chemotherapy highly varies among the patients and may take four to more than eight weeks until regaining pre-chemotherapy function. The remnant liver function is the key to perform a surgery in such patient. The LiMAx test has the potential to better assess patients scheduled for partial liver resection after chemotherapy.
Erwin de Buijzer, CEO of Humedics GmbH, stated: “The exact determination of chemotherapy-associated liver impairment has been difficult so far. At the same time an evaluation of the liver function is mandatory for a well-founded decision if a patient is eligible for the resection of liver metastases. The recent studies show the potential of our LiMAx test to bridge this critical gap and point out the direction towards a new approach estimating optimal timing of safe liver surgery for colorectal liver metastatic patients.” Researchers are further investigating this point to see if the clinical practice on such disease can be improved with the assistance of LiMAx test. PR-001-R02-v00
The LiMAx test, in combination with the corresponding FLIP device and the diagnostic drug offers a clinically proven significant added value for patients with liver diseases and liver surgery. The LiMAx test is already being used in 17 top-tier university clinics in Europe.
1. Effects of oxaliplatin-based chemotherapy on liver function – an analysis of impact and functional recovery using the LiMAx test. Jara M, Bednarsch J, Malinowski M, Pratschke J, Stockmann M. Langenbecks Arch Surg 2016; 401(1):33-41.
2. Bednarsch et al. BMC Research Notes (2015) 8:99. DOI 10.1186/s13104-015-1055-6
3. NICE guidelines [CG131]; Colorectal cancer: diagnosis and management; https://www.nice.org.uk/guidance/cg131
Humedics has developed a breath test based diagnostic system (LiMAx test), which comprises a CE-marked medical device, breath masks and a diagnostic drug. More than 100 million people world-wide suffer from liver diseases (i.e. cirrhosis, hepatitis, fatty liver, metabolic disorders and liver tumors). The LiMAx test enables the clinician to quantitatively determine the individual liver function capacity for a patient within minutes. This allows for selection of treatment strategies that are optimally adapted to the individual patients liver status. Current applications published in highly respected scientific journals include diagnosis of the liver function before and after liver transplantation, liver surgery planning (e.g. assessment of the amount of liver to be resected without potentially increasing the risk of liver failure) and assessment of diseases such as liver cirrhosis. The LiMAx test has been used about 15,000 times in clinical practice. The phase III multi-center clinical trial required for marketing authorization of the LiMAx test has been closed successfully. Humedics has submitted the marketing authorization application for the diagnostic agent, which was developed by Humedics and can be used for performing the LiMAx test, in April 2016.
The underlying principle of the LiMAx test involves the following steps: Firstly, the diagnostic drug solution is administered intravenously and the drug is metabolized in the liver to paracetamol and 13CO2. The latter is exhaled in the breath. The exhaled air is collected via a respiratory mask. Subsequent continuous measurement of 13CO2 in the patients’ breath in the FLIP device provides a quantitative determination of the liver capacity and thus reflects the liver function.
Erwin de Buijzer MD MBA
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