韩国达珂经验分享暨中国AESAE管理1节.pptVIP

* * * After the 45th patient was enrolled, more patients were increasingly treated with decitabine schedule of 20mg/m2 IV 5-day since it showed a higher CR rate than the other 2 arms. At the 65th patient, this scheduled was chosen according to the statistical design of the trial as the one most likely to be associated with the highest CR rate. Therefore, the remaining 30 patients were all treated on this dose schedule. Overall, 39% of patients in the 20mg/m2 IV 5-day treatment arm achieved a CR compared to 21% and 24% of patients randomized to the SQ group or IV 10-day treatment group, respectively. * * Response results were: 32 patients (34%) achieved CR, 1 (1%) had PR, 23 (24%) had marrow CR without (n=10, 11%) or with other HI responses (n=13, 14%), and 13 (14%) had HIs including two or more HIs in 5 (5%). Overall, 69 of 95 patients (73%) demonstrated objective response. The median number of courses to CR was 3 (range 1-7). * * 51 patients were evaluable for cytogenetic response. A complete cytogenetic response after therapy was observed in 17 (33%). A partial cytogenetic response (decrease by at least 50%) was noted in 12 patients, for a total cytogenetic response rate of 57%. Survival from start of therapy was longer among the 38 of 53 patients achieving response by whether or not they had a persistence of the cytogenetic abnormality or partial cytogenetic response or not (P=.14). The median time to cytogenetic response was 2.1 months. The estimated 18-month survival rates by a landmark analysis at 3 months for the 38 patients achieving a response by modified IWG criteria were 87% with complete cytogenetic response, 54% with partial cytogenetic response, and 37% without a cytogenetic response (P=.017). * * Severe (grade 3-4) drug related extramedullary toxicities were uncommon, including transient liver toxicities (mostly elevations of liver enzymes) in 4 pts (4%). None required treatment interruptions or recurred with dose reductions. Myelosuppres