asco@alo33:162064 JSONTXT

{"project":"ASCO_abstracts","denotations":[{"id":"T1","span":{"begin":1883,"end":1895},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T2","span":{"begin":1897,"end":1901},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T3","span":{"begin":1905,"end":1917},"obj":"DiseaseOrPhenotypicFeature"}],"attributes":[{"id":"A1","pred":"mondo_id","subj":"T1","obj":"0021054"},{"id":"A2","pred":"mondo_id","subj":"T2","obj":"0005462"},{"id":"A3","pred":"mondo_id","subj":"T3","obj":"0002623"},{"id":"A4","pred":"mondo_id","subj":"T3","obj":"0009807"}],"text":" Background: Although oral metronomic chemotherapy is often used in progressive paediatric solid malignancies in the palliative setting, its usage is notable for scepticism and empiricism.Literature revie shos only single arm retrospective or phase III studies. Methods: We designed a phase III, double blinded, placebo controlled randomised study in primary extracranial, non- haematopoietic, paediatric solid malignancies ho had progressed after at least 2 lines of chemotherapy ith no further curative options. It as a parallel design superiority study. One group received best supportive care and placebo hile the other received best supportive care along ith a 4 drug antiangiogenic chemotherapy regimen of thalidomide, celecoxib, and alternating cycles of etoposide and cyclophosphamide. Included patients ere aged 5-18 years, had ECOG PS x2264; 3 at least ambulatory ith crutches or heel chair , normal LFT and RFT, platelets 75,000mm3 and ANC 1000mm3. Patients unable to sallo capsules ere excluded. Disease status as assessed at baseline, at 9 eeks or earlier if progressed , at 18 eeks or earlier if progressed and at 27 eeks using RECIST 1.1. The primary end point as progression free survival PFS . Secondary endpoint as overall survival OS . Results: From Oct 2013 to Dec 2015, e screened 123 patients and after informed consent enrolled 108 patients. 52 ere randomised to placebo group and 56 to metronomic group. At a median follo up of 4 months, the PFS in the placebo arm as 46 days 95 percent CI= 33-58 hile it as 49 days 95 percent CI= 43-59 in the metronomic arm, p=0.07. The median OS as also not significantly different [placebo=85 95 percentCI=61-123 days vs metronomic= 85 95 percentCI=69-113 days], p= 0.21. In a post-hoc subgroup analysis, the cohort receiving 3cycles [HR PFS =0.47 95 percent CI=0.24-0.94 , p=0.03] and those ithout a bone-sarcoma PNET or Osteosarcoma [HR PFS =0.39 95 percent CI=0.18-0.81 ,p=0.01] appeared to benefit from metronomic therapy. Conclusions: In this first prospective randomised study in pediatric metronomics, metronomic chemotherapy did not improve PFS or OS in progressive solid paediatric malignancies as compared to placebo. Clinical trial information: lta href=http:clinicaltrials.govshoNCT01858571 NCT01858571,J Clin Oncol 34, 2016 suppl; abstr 10520 ,NCT01858571,00:00.0,Pediatric Oncology \n"}