Full text loading...
薬理と治療
Abstract
Background Radiotherapy and concomitant daily temozolomide chemotherapy(Rad+TMZ)in patients with primary high−grade glioma is approved under the Ministry of Health, Labourand Welfare of Japan by means of bridging study through data pooling of non−Japanese smallstudies with comparative subjects. There are few reports on the adverse events of Rad+TMZ under from clinical practice in the Japanese population.Objectives We conducted a retrospective study to evaluate the clinical safety of Rad+TMZprescribed for the treatment of primary high−grade glioma.Methods We evaluated 36 patients with primary high−grade glioma given temozolomide(75mg/m2/d)for 6 weeks concomitant with fractionated radiotherapy(60 Gy total dose:2 Gy×5 d/wk for 6 weeks). Patient records collected over a period of 70 days(maximum 77 days)from the first day of the treatment were summarized and analyzed based on the frequencyand severity of hematological toxicities, nonhematological toxicities, gender, age and dosage.Results Grade 3 hematological toxicities included lymphopenia(41.7%), severity of leukocytopenia(11.1%), and neutropenia(8.3%). Multi−way layout analysis of variance revealedthat lymphopenia was significantly increased in female and younger patients(<60 yrs). Commonnonhematological toxicities included constipation(91.7%), anorexia(77.8%), nausea(47.2%), vomiting(11.1%), headache(36.1%), and fatigue(19.4%).Conclusion From our retrospective analysis, higher frequency of adverse events of Rad+TMZ were observed compared to event rates from a short−term phaseII trial with temozolomideadministered as single therapy on anaplastic astorocytoma at first relapse. A low inci-dence of serious adverse events without requiring treatment cessation were observed in thisstudy(2.8%). Our analysis supports the tolerability of Rad+TMZ in Japanese patients withprimary high−grade glioma, with an acceptable overall toxicity profile.(Jpn Pharmacol Ther 2009;37:931−8)KEY WORDS Temozolomide, Adverse events, Primary high−grade glioma
Data & Media loading...