Analysis of the incidence of severe adverse events in Japanese cancer patients receiving outpatient chemotherapy.

Abstract

e16567 Background: The outpatient chemotherapy for cancer patients is currently standardized in Japan, however the incidence of severe adverse event (SAE) of outpatient chemotherapy have not been systematically studied in a large population. To document the incidence and characteristics of outpatient chemotherapy-induced SAE, we performed a single-institute prospective study about the incidence of SAE in cancer patients receiving outpatient chemotherapy. Methods: The SAE was defined as outpatient chemotherapy related toxicity which was necessary for hospitalized care. From October 2007 to October 2010, a total of 36,034 outpatients chemotherapy were performed at National Cancer Center Hospital East. The incidence and characteristics of every SAE were analyzed. Results: The most common regimens performed as outpatient chemotherapy were gemcitabine (26%), FOLFOX with or without bevacizumab (23%), paclitaxel (10%), docetaxel (9%), FOLFIRI with bevacizumab (7%), irinotecan (5%), and cyclophosphamide plus doxorubicin (4%) and so on. The SAEs were occurred in 306 cases and the incidence of SAE was 0.85%. The most common SAE were hematologic and gastrointestinal toxicities, and infectious disease such as febrile neutropenia (19%), anorexia (16%), diarrhea (16%), and infections (14%). According to the chemotherapy regimens which were performed more than 100 cases, the incidence of SAE were 3.9% in cisplatin plus gemcitabine, 3.3% in TS-1, 2.0% in CHOP, 1.4% in amrubicin, 1.3% in vinorelbine, and 1.1% in irinotecan. Eleven patients (0.03%) experienced SAEs that resulted in death: six patients died of interstitial pneumonia, two of pneumonia, and one of each failure, liver failure and septic shock. Conclusions: This is the first report confirming a low incidence of SAE in Japanese patients undergoing outpatient chemotherapy. To manage outpatient chemotherapy safely, it is most important to control gastrointestinal and infectious toxicities. The spread of hotline service between patients and hospital which makes it possible to take any information on toxicities immediately is now promoted in Japan.