Massive cancerous ascites causes severe abdominal distention, dyspnea and appetite loss, resulting in loss of patients' activities of daily living (ADL) and discontinuation of their cancer treatment such as chemotherapy.
To improve the symptoms, we have developed a novel cell-free and concentrated ascites reinfusion therapy (KM-CART) which is modified from a conventional CART approved by the Ministry of Health, Labor and Welfare in Japan. KM-CART is easier to use and can be applied for massive malignant ascites. It is performed by removing the entire volume of ascitic fluid (maximum, 27 L) and administering the recovered autologous proteins (maximum, 420g) into blood vessels by infusion.
A total of 2940 patients, including 458 ovarian cancer, 457 pancreatic cancer, 441 gastric cancer, 335 colon cancer patients, and 1249 patients with other disorders, underwent KM-CART between February 2009 and March 2016. Ascitic fluid was removed to the greatest extent possible (0.8–27.0 L; mean, 6.5 L).The mean processing rate was 10.4 min/L, and between 100 and 2500 mL (mean, 560 mL) of filtered concentrate was created and administered by intravenous infusion. Side effects consisted of only mild fever, with no serious side effects observed. In all 87 patients for whom a questionnaire survey could be conducted on both the day before and the day after KM-CART, symptom scores improved for 10 items, including abdominal fullness, respiratory discomfort, decreased appetite and gait impairment. In addition, some patients resumed chemotherapy as a result of regaining the motivation to fight disease. These patients were able to transition to their homes over the long-term. Furthermore, many cancer cells were recovered from the membrane filter washing fluid and these cells were able to be used for dendritic cell (DC) vaccine therapy.
KM-CART system was considered easy to use and safe, and the recovery of large volumes of autologous proteins was possible to improve general status, nutrition, and immune status, as well as subjective symptoms. In addition, the recovered cancer cells were able to be used for immune cell therapy etc.
Clinical trial identification
No trial number
Legal entity responsible for the study
Asahi Kasei Medical Co.Ltd
K. Matsusaki: Patent fee from Asahi Kasei Medical CO.,LTD. All other authors have declared no conflicts of interest.