ObjectivesMore than 50% patients develop emesis during induction therapy for acute myeloid leukaemia (AML). The addition of aprepitant for emesis control in children receiving induction for AML have not been explored.MethodsA single-institutional randomised, open-label trial (NCT02979548) was conducted where children between 5 and 18 years with the diagnosis of AML being planned for 3+7 induction regimen were included. All study participants received ondansetron (0.15 mg/kg) every 8 hours for 8 days starting 30 min prior to chemotherapy. Children belonging to aprepitant group additionally received aprepitant capsules (15–40 kg=days 1–3, 80 mg; >40 kg=day 1, 125 mg and days 2–3, 80 mg) starting from 1 hour prior to chemotherapy. The proportion of patients with complete response (CR) in chemotherapy induced vomiting (CIV) in acute phase (day 1–8), delayed phase (day 9–13), overall and initial 96 hours were recorded along with severity of vomiting and adverse effects.ResultsTotal 78 children were randomised (Aprepitant group: 37 and control group: 41). The proportion of patients with CR in CIV was significantly higher in Aprepitant group in acute phase (p=0.007), overall phase (p=0.007) and in initial 96 hours (p<0.001) but it was not different in delayed phase (p=0.07). The first episode of vomiting was also significantly delayed in aprepitant group (p=0.02). Adverse effect profile was similar in two groups.ConclusionAprepitant significantly improves emesis control in children receiving induction therapy for AML, especially in acute phase and should be routinely incorporated as part of antiemetic prophylaxis.Trial registration numberThe study was registered at ClinicalTrials.gov (NCT02979548).
e22555 Background: The approved dose of pazopanib in advanced STS is 800 mg/day and is not weight based. After initial patients who couldn’t tolerate pazopanib we started pazopanib at lower doses escalating to higher doses. There is already preliminary data about low dose pazopanib in asian patients. Methods: We retrospectively analysed the prospectively kept data base of patients with advanced non adipocytic STS who were treated with pazopanib at AIIMS sarcoma medical oncology clinic between September 2015 and February 2019. After start of pazopanib we get CT scan done every 3 monthly as institutional protocol. Statistical analysis was done by SPSS 23. Results: There were total of 66 patients with median age 40 yrs (17 – 81)and majority were males who (60). ECOG Performance status (PS) was PS 1 in 63% and PS 2 in 23%. Most common diagnosis was synovial sarcoma (22%), leiomyosarcoma (18 %), angiosarcoma (9%), MPNST(8%) and others (43%). Most of the patients received pazopanib as second line (59%) and third line (31%). 90% of patients received dose of 400 mg and remaining 10% of the patients received 600 mg of dose (in which it could be escalated after 1 month). Median weight was 63kg and median height in our patients was 160cm while the median BSA was 1.6. Dose escalation was attempted, but was not feasible due to toxicities. Out of total 66 patients, 57 were available for response assessment. RECIST responses were complete response (CR) was present in 2.9%, partial response (PR) in 17% , stable disease (SD) in 28%. The median progression free survival (PFS) was 5 months and median overall survival was 18 months after a median duration of follow up of 20 months. Grade 3 and grade 4 toxicities were present in 31% of the patients. Grade 3 hand foot syndrome (HFS) was present in 12% of patients.4.5% had hypertension. Other grade 3 and 4 toxicities were oral mucositis (6%) , transaminitis (4%) Cardiomyopathy (3%) and cholestasis jaundice (1.5%) with bilirubin elevated to the level on 19.1 mg/dl. This resolved after stoppage of Pazopanib. Conclusions: Pazopanib at low doses in our series was as efficacious and with similar toxicity as previous literature The option of lower dose pazopanib needs to be explored in Asian population who have lower body weight.
e22538 Background: Renal Ewing’s sarcoma constitutes a rare subset of extraskeletal ewings with aggressive clinical course and dismal outcomes. The purpose of our study was to review our experience in the management of patients with Renal Ewing’s Sarcoma. Methods: We retrospectively analysed patients with Renal Ewing’s Sarcoma who were registered in Sarcoma Medical Oncology Clinic at AIIMS, New Delhi between September 2016 and January 2019. Results: A total of eight patients were registered in the study period, one of which was diagnosed with wilms tumor post nephrectomy and was excluded from our study. Of seven patients included in analysis, five (71.4%) were males. The commonest symptoms were flank pain (57.1%) and hematuria (57.1%). The median age was 28 years (range, 18 to 50 years). The mean Hemoglobin was 10.4 g/dl (range, 6-14 g/dl). The median tumor size was 13 cm (range, 5-25 cm). Four patients (57.1%) were non-metastatic while three (42.9%) had metastases in bone, lung and liver, and peritoneum respectively. Diagnosis was established by an upfront nephrectomy in four patients (57.1%) and biopsy in three patients (42.9%). Translocation for EWSR1 was done in 5 patients of which four (80%) were positive and one patient (20%) were negative. The test was not carried out in two patients due to inadequate tissue sampling. Three patients received neoadjuvant chemotherapy with VAC and the rest (four) received it after surgery. Ifosfamide-etoposide (IE) was added to VAC regimen in first two patients, in one being added post nephrectomy. This patient developed Ifosfamide-induced renal failure resulting in death. Radiotherapy was given in two patients, one pre-operative owing to large inoperable mass, and post operative in the other due to positive margins. At last follow up, three patients (42.9%) are alive and are on chemotherapy after radical nephrectomy. Four patients (57.1%) have died, three due to disease (all metastatic) and one due to chemotoxicity. The median survival was 15 months. Conclusions: Unlike extremity, renal ewings sarcoma more commonly presents in higher age and with advanced disease. Translocation studies are a prerequisite in a suspected case of Renal Ewings Sarcoma, especially due to possibility of discrepancies in pre and post-operative diagnoses. Our institutional protocol does not recommend the use of Ifosfamide in the subset of patients with single kidney, post nephrectomy. Caution must be exercised before instituting the drug and should be given only pre-operatively in absence of renal dysfunction.
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