Report From the International Ewing 2008R3 Trial
0008b / #1061 Value of High Dose Chemotherapy With Treosulfan and Melphalan in Patients With Disseminated Ewing Sarcoma. This benefit is consistent across all baseline parameters. No major differences in toxicity: 68% s in Arm A and 67% in Arm B.Ĭonclusions: VDC/IE chemotherapy is superior to VIDE for EFS and OS, with no excess toxicity. Subgroup analyses showed no evidence that this benefit differed in baseline features, with no HT being close to significance. The HRs (95% CrI) were 0.70 (0.51, 0.95) for EFS and 0.64 (0.42, 0.96) for OS in favour of Arm B, with posterior probabilities of 98% for both that Arm B was better. Results: The number of MS-indels in pediatric RRD cancers were comparable to adult MMR-deficient cancers, and significantly higher than all MMR-proficient cancers (p200 ml) country (37% UK, 31% France, 32% other). Methods: We applied MSMuTect to all RRD samples, and compared their MS-indels to adult RRD tumors and pediatric replication repair-proficient tumors. Seven (17%) patients in the metoclopramide arm crossed over to the olanzapine arm and none crossed over in the olanzapine arm (P10-years, AML and Lymphoma were significantly associated with TEs, and the first two retained significance on multivariate analysis with OR-2.33(95%CI:1.59-3.41,p10years(OR-2.60,95%CI:1.52-4.54,p20,000,000 genomic microsatellite loci in each tumor and germline sample. CR rates were significantly higher in the olanzapine arm compared to the metoclopramide arm for vomiting (72% vs. Results: Eighty-patients were analyzed (39 in olanzapine arm and 41 in metoclopramide arm). A sample size of 80 (40/arm) was required to show a superiority of olanzapine over metoclopramide with a power of 80% and an alpha of 5%. We assumed that the CR rates in the metoclopramide arm would be 40% and this would improve to 70% in the olanzapine arm. The primary end-point of the study was the proportion of patients who achieved a complete response (CR), defined as no vomiting or retching and no nausea during the 72-hours after the administration of the first dose of metoclopramide or olanzapine. Methods: Children aged 5-18 years who developed breakthrough CINV after receiving moderately or highly emetogenic chemotherapy, were randomly assigned to the metoclopramide or olanzapine arm. We conducted an open-label, single-center, phase III randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CINV. Olanzapine and metoclopramide are two drugs recommended for the treatment of breakthrough CINV in children, without adequate evidence.
It affects 30-50% of children receiving chemotherapy. Sagar 1ġCancer Institute, Chennai, India, Medical And Pediatric Oncology, Chennai, India 2Cancer Institute, Chennai, India, Biostatistics And Epidemiology, Chennai, Indiaīackground and Aims: Breakthrough chemotherapy-induced nausea and vomiting (CINV) is defined as CINV occurring after adequate anti-emetic prophylaxis. AWARD SESSION SIOP AWARD SESSION 10-15-2020 5:00 PM - 6:30 PM 0002 / #202 Olanzapine Versus Metoclopramide for the Treatment of Breakthrough Chemotherapy-Induced Vomiting in Children: An Open-Label, Randomized Phase 3 Trial