asco@alo33:162032 JSONTXT

{"project":"ASCO_abstracts","denotations":[{"id":"T1","span":{"begin":57,"end":59},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T2","span":{"begin":97,"end":117},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T3","span":{"begin":119,"end":122},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T4","span":{"begin":252,"end":254},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T5","span":{"begin":354,"end":361},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T6","span":{"begin":415,"end":422},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T7","span":{"begin":595,"end":597},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T8","span":{"begin":870,"end":872},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T9","span":{"begin":1012,"end":1014},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T10","span":{"begin":1015,"end":1019},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T11","span":{"begin":1174,"end":1176},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T12","span":{"begin":1244,"end":1253},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T13","span":{"begin":1442,"end":1444},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T14","span":{"begin":1489,"end":1497},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T15","span":{"begin":1516,"end":1525},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T17","span":{"begin":1554,"end":1558},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T18","span":{"begin":1559,"end":1567},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T19","span":{"begin":1625,"end":1637},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T20","span":{"begin":1685,"end":1687},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T21","span":{"begin":1788,"end":1791},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T22","span":{"begin":1807,"end":1809},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T23","span":{"begin":2310,"end":2317},"obj":"DiseaseOrPhenotypicFeature"}],"attributes":[{"id":"A1","pred":"mondo_id","subj":"T1","obj":"0016019"},{"id":"A2","pred":"mondo_id","subj":"T2","obj":"0018078"},{"id":"A3","pred":"mondo_id","subj":"T3","obj":"0100137"},{"id":"A4","pred":"mondo_id","subj":"T4","obj":"0016019"},{"id":"A5","pred":"mondo_id","subj":"T5","obj":"0005089"},{"id":"A6","pred":"mondo_id","subj":"T6","obj":"0005089"},{"id":"A7","pred":"mondo_id","subj":"T7","obj":"0016019"},{"id":"A8","pred":"mondo_id","subj":"T8","obj":"0016019"},{"id":"A9","pred":"mondo_id","subj":"T9","obj":"0016019"},{"id":"A10","pred":"mondo_id","subj":"T10","obj":"0009994"},{"id":"A11","pred":"mondo_id","subj":"T11","obj":"0016019"},{"id":"A12","pred":"mondo_id","subj":"T12","obj":"0002251"},{"id":"A13","pred":"mondo_id","subj":"T13","obj":"0016019"},{"id":"A14","pred":"mondo_id","subj":"T14","obj":"0001673"},{"id":"A15","pred":"mondo_id","subj":"T15","obj":"0000888"},{"id":"A16","pred":"mondo_id","subj":"T15","obj":"0020579"},{"id":"A17","pred":"mondo_id","subj":"T17","obj":"0002531"},{"id":"A18","pred":"mondo_id","subj":"T18","obj":"0002254"},{"id":"A19","pred":"mondo_id","subj":"T19","obj":"0005044"},{"id":"A20","pred":"mondo_id","subj":"T20","obj":"0016019"},{"id":"A21","pred":"mondo_id","subj":"T21","obj":"0100137"},{"id":"A22","pred":"mondo_id","subj":"T22","obj":"0016019"},{"id":"A23","pred":"mondo_id","subj":"T23","obj":"0005089"}],"text":" Background: We investigated the activity and safety of RE in doxorubicin-pretreated metastatic soft tissue sarcomas STS . Methods: REGOSARC NCT01900743 consisted of 4 independent cohorts of patients pts ho ere randomized 1:1 to receive either RE 160 mgd, 2128 d or PL, ith optional cross-over. Key-eligibility criteria ere age 18, metastatic sarcoma, x2264; 3 previous lines of treatment for metastatic sarcoma. The primary endpoint as progression-free survival PFS ith blinded central radiological revie. Statistical assumptions ere PFS = 1.6 months mo ith PL, PFS = 4.6 mo ith RE, 1-sided x3B1; = 0.1 and x3B2; = 0.05 0.2 in SYN cohort . Results: From July 2013 to December 2014, 181 pts previously exposed to doxorubicin 178, 98 percent , ifosfamide 107, 59 percent , trabectedin 70, 38 percent , and pazopanib 6, 3 percent ere enrolled 89 ith RE and 92 ith PL; including 70 cross-over . Activity endpoints are displayed in the Table belo. Four partial responses have been confirmed in RE arms, one in SYN pts and three in OTH pts 2 angiosarcomas and 1 solitary fibrous tumour . The drug-related maximal toxicity grade distribution by patient ith RE n=89 and PL n=92 as Grade 5 1 vs. 0; 1 percent vs. 0 percent; hepatitis , Grade 4 3 vs. 0; 3 percent vs. 0 percent , Grade 3 51 vs. 8; 57 vs. 9 percent , Grade 2 18 vs. 22; 20 vs. 24 percent and Grade 1 7 vs. 13; 8 vs. 14 percent . The most common AEs in RE-treated pts ere: asthenia 58, 63 percent , diarrhea 39, 44 percent , mucositis 39, 44 percent , Hand-Foot skin syndrome 39, 44 percent , anorexia 34, 38 percent and arterial hypertension 32, 36 percent . Conclusions: Excluding LIPO, RE is an active drug providing statistically and clinically significant PFS improvement in pre-treated STS pts. Safety of RE is as expected. Clinical trial information: lta href=http:clinicaltrials.govshoNCT01900743 NCT01900743ltcaption class=mtgabstract-table-title Survival outcomes in STS.CohortsArmnPFS mo HRpOS mo HRpLIPORE201.11.130.704.71.570.21LIPOPL231.78.8LMSRE283.70.450.00521.00.500.06LMSPL281.89.1SYNRE135.60.09lt 0.000113.40.870.79SYNPL141.06.7OTHRE292.90.450.00612.10.750.38OTHPL271.09.5Non-LIPORE704.00.36lt0.000113.40.670.06Non-LIPOPL691.09.0,J Clin Oncol 34, 2016 suppl; abstr 11003 ,NCT01900743,00:00.0,Sarcoma \n"}