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  • Title: [Revision of the informed consent form for patients based on investigation of adverse events of mFOLFOX6 regimen].
    Author: Kato T, Matsunaga Y, Motokawa S, Nakagaki S, Nagata N, Yoshida T, Muramatsu T, Kimura H, Ohashi Y, Kudou Y, Shino M, Yamazaki K, Boku N.
    Journal: Gan To Kagaku Ryoho; 2009 Oct; 36(10):1697-702. PubMed ID: 19838030.
    Abstract:
    We retrospectively investigated the frequency and severity of adverse events in 124 patients with colorectal cancer who were treated by mFOLFOX6 regimen from August, 2005 to December, 2006. The incidences of grade 3/4 adverse events were; leucopenia 16%, neutropenia 40%, anemia 11%, thrombocytopenia 7%, febrile neutropenia 7%, nausea 3%, vomiting 2%, anorexia 2%, diarrhea 4%, fatigue 7%, and alopecia 0%. The incidences of all grades and grade 3/4 hypersensitivity reaction were 35% and 4%, and the median number of course when it firstly appeared was 6(range, 1-21). The incidences of all grade and grade 3 peripheral sensory neuropathy were 74% and 6%, and the median number of course when it firstly appeared 11(range, 6-16). The incidences of adverse events in this cohort were similar or lower than those reported in Western countries. Our investigation shows that mFOLFOX6 regimen is tolerable in clinical practice in Japan. The informed consent form was revised based on these results. The incidences of adverse events were renewed to provide useful information and improve self-care ability. The symptoms and the time to appearance of the hypersensitivity reaction and peripheral sensory neuropathy were added. We think it is important to provide the information based on the clinical practice.
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