{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T06:45:17Z","timestamp":1770360317396,"version":"3.49.0"},"reference-count":17,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2010,3,8]],"date-time":"2010-03-08T00:00:00Z","timestamp":1268006400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2010,5]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>This study compared two schedules of low\u2010dose gemtuzumab ozogamicin (GO) as induction monotherapy for untreated acute myeloid leukaemia in older patients unfit for intensive chemotherapy, to identify the more promising regimen for further study. Patients were randomized to receive either best supportive care or a course of GO according to one of two schedules: 3\u2003mg\/m<jats:sup>2<\/jats:sup> on days 1, 3 and 5 (arm A), or GO 6\u2003mg\/m<jats:sup>2<\/jats:sup> on day 1 and 3\u2003mg\/m<jats:sup>2<\/jats:sup> on day 8 (arm B). Primary endpoint was the rate of disease non\u2010progression (DnP), defined as the proportion of patients either achieving a response or maintaining a stable disease following GO induction in each arm. Fifty\u2010six patients were randomized in the two GO arms (A, <jats:italic>n\u2003<\/jats:italic>=\u200329; B, <jats:italic>n<\/jats:italic>\u2003=\u200327). The rate of DnP was 38% [90% confidence interval (CI), 23\u201355] in arm A, and 63% (90% CI, 45\u201378) in arm B. Peripheral cytopenias were the most common adverse events for both regimens. The all\u2010cause early mortality rate was 14% in arm A and 11% in arm B. The day 1\u2003+\u20038 schedule, which was associated with the highest rate of DnP, met the statistical criteria to be selected as the preferred regimen for phase III comparison with best supportive care.<\/jats:p>","DOI":"10.1111\/j.1365-2141.2010.08095.x","type":"journal-article","created":{"date-parts":[[2010,3,9]],"date-time":"2010-03-09T03:26:36Z","timestamp":1268105196000},"page":"376-382","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":47,"title":["Randomized trial of two schedules of low\u2010dose gemtuzumab ozogamicin as induction monotherapy for newly diagnosed acute myeloid leukaemia in older patients not considered candidates for intensive chemotherapy. 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