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RAS status between plasma and tissue samples from metastatic colorectal cancer (mCRC) patients.Methods: We conducted a study to evaluate the concordance of RAS status between plasma and tissue samples of 301 patients from several hospitals in Galicia, Northwest of Spain. RAS genotyping in plasma was performed using the OncoBEAM RAS CRC kit (Sysmex) and compared to the standard of care technology for FFPE-tissue analysis. Clinical data were collected from electronic reports from each patient. We analyzed the clinical profiles of the mCRC patients to investigate the causes of discordance.Results: The overall percent of RAS agreement was 84.4%, with a sensitivity of 81.3% and a specificity of 88.5%. Evaluating the clinical features of the patients, the absence of liver metastasis was a significant factor of discordance of RAS status (71% vs 28%, p<0.0001). Patients with peritoneal disease alone showed the lowest level of agreement (71.4%), followed by those with lung metastasis alone (72%), as compared with patients with liver metastasis alone (88.9%). Taking into account the diagnosis timing of stage IV, the concordance (75.9% vs 88.4%) and the sensitivity (68.1 vs 86.3) were significantly lower in metachronous than synchronous patients. Conclusion:The overall concordance between plasma and tissue RAS mutation supports liquid biopsy technology as an alternative to tissue testing for RAS characterization in mCRC patients, especially in patients with liver metastasis. The RAS status obtained from plasma of patients with peritoneal or lung diseases, and particularly with those of metachronous stage IV, should be considered cautiously. These results reinforce the use of liquid biopsy as a non-invasive tool for guiding targeted therapy in selected patients.Legal entity responsible for the study: The author.

TEAEs occurring in !15% of pts and grade 3e4 TEAEs occurring in !5% of pts are shown. TEAEs were defined as adverse events that started or worsened on or after the day of the first TAZ dose up to 30 days after the last dose. abstracts Annals of Oncology Volume 31 -Issue S4 -2020 S981

Background: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS) is a validated and reproducible tool to assess the magnitude of clinical benefit from drugs for solid tumors. Here, we evaluate characteristics and outcomes of clinical trials supporting drugs used in advanced Soft Tissue Sarcomas (STS) and GIST and their association with ESMO-MCBS.Methods: We reviewed publications between January 1990 and December 2020 that support the recommendations of NCCN (National Comprehensive Cancer Network) guidelines version 1.2021 for treatment of advanced STS and GIST. We collected data on trial characteristics, efficacy, toxicity and quality of life (QoL). For each trial, ESMO-MCBS grades were applied. Substantial clinical benefit was defined as a grade 4 or 5 (in a scale from 1 to 5).Results: Among the 23 trials for which the ESMO-MCBS could be applied (23/57 -40.4%-), 13 (56.5 %) were randomized controlled trials (RCT; 8 phase III and 5 phase II trials), and 10 (43.5%) were single arm trials. Eighteen (78.2%) involved STS and 5 (21.8%) GIST. Six trials (26.1% of all trials and 46.1% of RCT) demonstrated improvement in overall survival. QoL was reported in 7 (30.4%) trials. Among these, only 3 (42.9%) showed improvement in QoL. Only 9 (39.1 %) trials met the ESMO-MCBS substantial benefit threshold (5/18 involving STS and 4/5 involving GIST). Of these 9 trials, 8 (88.8%) were RCT (4 phase III and 4 phase II). All 3 trials that demonstrated improvement in QoL showed substantial benefit according to the scale.Conclusions: Only 39.1% of trials supporting the use of drugs in patients with advanced STS and GIST meet the threshold for substantial benefit using ESMO-MCBS. These results suggest that randomized trials with QoL assessment are more likely to achieve the ESMO-MCBS substantial benefit threshold. Only a quarter of the trials showed improvement in OS.