Further Studies On The Side Effects Of Imatinib In The Treatment Of Patients With GIST

Background: The side effects of imatinib mesylate in treatment gastrointestinal stromal tumors and chronic myelogenous leukemia has been recognized, but its side effects were mainly seen in pre-market clinical studies. In addition,the factors,duration and treatment of drug side effects are few reports in the literature. The large sample results is lack in domestic,so it is necessary for further observation.Objective: To further observe the side effects of imatinib in the treatment of patients with GIST, and to explore the factors,duration of side effects.We compared the side effects with chronic myeloid leukemia patients to clear that the similarities and differences of side effects from the same drug treatment different diseases.Methods: 128 patients received imatinib mesylate 400mg/day,dosage in some patients with disease progression increased to 600mg/day,the remaining patients continued treatment in other ways. Patients made self-observation diary,in advance by the treating physician to give the necessary counseling, including drug reactions and appearance time of discomfort after receive treatment. Patients checked blood routine, liver and kidney function,urine routine,ECG, blood pressure,thyroid function and so on once every 3 months.If the test results were not normal, the results were reviewed weekly or monthly until the results are stable. as appropriate, weekly or monthly review until the results are stable.Observed the adverse events by CTCAE3.0 when patients receive treatment,until death or end of follow-up.SPSS 13.0 software package used for statistical analysis,count data were compared by x2 test, P <0.05 was considered statistically significant. Results: In an received treatment with imatinib mesylate in 128 patients, 104patients had recurrence or distant metastasis,24 cases were postoperative adjuvant therapy. All patients were followed up for 7 to 74 months, with a median follow-up time of 28 months, 112 patients were followed up more than 1 year.The side effects often occurred in the first one year of treatment, most of the rate of toxicities and its severity were not increase remarkably in long-term.The side effects were mostly gradeⅠ～Ⅱ,it were not increase Significantly in high-dose arm. We observed some new side effects,such as memory decline, language delay, scrotal edema, uneven nails,subcutaneous ecchymosis, the performance of nephrotic syndrome; gastrointestinal bleeding and tumor lysis syndrome were not been observed. Original disease site,dose level,with or without liver metastasis had no effect on the incidence of side effects (P> 0.05),sex and age to some extent affect the incidence of side effects: women with a high incidence of neutropenia (P <0.05), fatigue in elderly patients were higher (P <0.05).Conclusion: The side effects usually were slightl, mostly gradeⅠ～Ⅱ, most of the rate of toxicities and its severity were not increase remarkably in long-term;Original disease site,dose level,with or without liver metastasis had no effect on the incidence of side effects, sex and age to some extent affect the incidence of side effects; The side effects were different between GIST and CML, significantly in hematologic toxicity;specially that were not mentioned by package insert and literature.