47O Association of systemic corticosteroids with overall survival in patients receiving cancer immunotherapy for advanced melanoma, non-small cell lung cancer or urothelial cancer in routine clinical practice
ConclusionBaseline CS was associated with shorter survival for pts treated with CIT and not explained by measured confounders. These results suggest that avoidance of CS should be considered at the initiation of treatment, when possible and appropriate, to maximize the potential benefits of CIT. Further studies are needed to confirm these observations. Table: 47OPatient characteristics by BL CS use, OS by CS useaNSCLC (n  = 862)aMel (n = 742)aUC (n = 609)CS (n = 258)No CS (n = 604)CS (n = 182)No CS (n = 560)CS (n = 116)No CS (n = 493)Age at CIT start, mean (SD), years68.2 (9.6)68.5 (9.8)...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

161P Regulatory interacting network between the immunomodulatory non-coding RNAs: miR-17-5p, MALAT1 and H19 lncRNAs in modulating the tumour microenvironment in TNBC
ConclusionmiR-17-5p/MALAT-1/H19/TNF- α represents an immunomodulatory loop that diverts the host immunity in favour of anti-tumour response.Legal entity responsible for the studyGerman University in Cairo.FundingHas not received any funding.DisclosureAll authors have declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

48P A retrospective, observational study of telomerase peptide immunotherapy in heavily treated solid cancer patients
ConclusionIn conclusion, riavex as an anti-cancer vaccine is relatively safe in heavily pre-treated solid cancer patients and is assessed to improve quality of life, although the treatment response is not promising.Legal entity responsible for the studyThe author.FundingHas not received any funding.DisclosureThe author has declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

162TiP A phase I study evaluating BI 765063, a first in class selective myeloid SIRPa inhibitor, as standalone and in combination with BI 754091, a programmed death-1 (PD-1) inhibitor, in patients with advanced solid tumours
This study comprises a dose escalation (step 1) to determine the Dose-Limiting Toxicities, Maximum Tolerated Dose (MTD), and Recommended phase II Dose (RP2Ds) of BI 765063 monotherapy and with BI 754091, and dose-confirmation expansion cohorts (step 2). In Step 1, ascending doses of BI 763063 every 3 weeks intravenously (iv) using a Bayesian approach with overdose control are tested. When MTD determined, BI 763063 will be tested with BI 754091, a PD-1 mAb inhibitor. In step 2, 2 parallel randomized, non-comparative mono and combination cohorts will further confirm the RP2Ds and assess the safety and preliminary efficacy (R...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

49P Thromboembolic risk assessment in patients receiving combination of anti-angiogenic plus anti-PD1 or anti-PD-L1: A descriptive study
ConclusionThese results suggest that pts treated with combo AA plus anti-PD(L)1 seem to be more at risk of developing TE compare to single therapy anti-PD(L)1, according to a KS higher in this cohort. Further prospective study're warranted to investigate the risk of TE in pts receiving AA plus anti-PD(L)1 and to investigate the benefit of preventive anticoagulants therapy.Legal entity responsible for the studyThe authors.FundingHas not received any funding.DisclosureAll authors have declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

129O Resistance to immunotherapy is associated with high parenchymal PD1+CD8+/CD8+ T cells (PD1tR) driven by tumour CD155
ConclusionOur findings are the first to demonstrate that tumor CD155 underpins the accumulation of dysfunctional PD1hiCD8+ T cells in human tumors and propose pretreatment PD1tR as a potential biomarker of response to ICB.Legal entity responsible for the studyThe Council of the Queensland Institute of Medical Research.FundingBristol-Myers Squibb.DisclosureP.A. Ascierto: Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (self): Roche-Genentech; Advisory / Consultancy, Research grant / Funding (self): Array; Advisory / Consultancy, Travel / ...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

50P Predicting onset and continuity of patient-reported symptoms in cancer patients undergoing immune checkpoint inhibitor (ICI) therapies using machine learning
ConclusionML based modeling of ePRO data on ICI treated cancer patients is feasible in predicting onset and continuation of symptoms related to ICI toxicities. The study suggest that ML based approaches could be used in early detection of toxicities. The results should be validated with a dataset collected in a prospective clinical trial.Legal entity responsible for the studyKaiku Health Oy.FundingOulu University and Finnish Cancer Society.DisclosureJ. Ekstr öm: Full / Part-time employment: Kaiku Health Oy. H. Virtanen: Full / Part-time employment: Kaiku Health Oy; Shareholder / Stockholder / Stock options: Kaiku Health O...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

2OStrategic inhibition of CEP55 in aggressive breast cancer leads to mitotic catastrophe
ConclusionsCollectively, we propose a novel treatment strategy of MEK1/2 -PLK1 dual combination for selectively targeting CEP55 over-expressing BC in the clinics.Legal entity responsible for the studyThe author.FundingNHMRC.DisclosureThe author has declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

235PStudy on the socioeconomic and clinical factors affecting the proportion of breast conserving surgery in Chinese women breast cancer
ConclusionsIn China,we should gradually reduce the influence of socioeconomic factors on the proportion of breast conserving surgery in the future. Preoperative MRI should be encouraged in patients preparing for BCS. Clinicopathological characteristics and MRI findings are significantly associated with a positive resection margin in breast cancer patients.Legal entity responsible for the studyThe author.FundingThe National Natural Science Foundation of China (81672623).DisclosureThe author has declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

457PFirst-in-human study of ABBV-621 in patients (pts) with previously treated sold tumours: Dose-optimization cohorts
ConclusionsAdministration of ABBV-621 in pts with R/R CRC and pancreatic cancer shows an acceptable safety profile at all DL and evidence of antitumor activity.Clinical trial identificationNCT03082209.Editorial acknowledgementMedical writing support was provided by Yanci M. Baker, PhD, from Aptitude Health, Atlanta, GA, and funded by AbbVie.Legal entity responsible for the studyAbbVie Inc.FundingAbbVie Inc.DisclosureE. Calvo: Honoraria (self): HM Hospitales Group; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Nanobiotix; Advisory / Consu...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

1130PSevere oral mucositis (SOM) mitigation by genetically modified lactococcus lactis bacteria (LLB) producing human trefoil factor 1 (hTFF1; AG013) in patients being treated with concomitant chemoradiation (CRT) for oral and oropharyngeal cancers (OCOPC)
ConclusionsObservations based on blinded data suggest that AG013 offers a safe, well-tolerated, and potentially efficacious platform to deliver an effective protein intervention for SOM mitigation.Clinical trial identificationAG013-ODOM-201.Legal entity responsible for the studyOragenics, Inc.FundingOragenics, Inc.DisclosureS. Sonis: Advisory / Consultancy, consultant: Oragenics. All other authors have declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

1577PAnalysis of the tumour microenvironment and tumour genotype through different stages of lung adenocarcinoma
ConclusionsSupporting the concept of TP53 as a passenger mutation, we detected significantly more TP53 mutations in late stage disease. In addition, we found a pronounced B cell response in tumors carrying driver mutations. Characterization of the tumor microenvironment might become an integral part of biomarker assessment in solid tumors in the future.Legal entity responsible for the studyHematopathology Hamburg.FundingHas not received any funding.DisclosureM. Tiemann: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory /...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

236PClinical decision making and multidisciplinary team meetings (MDMs) in early breast cancer. Is the agreement between planned and applied therapeutic program?
ConclusionsThe results of our study could be useful for enhance the role of MTD and identify unmet needs in decision making process in EBC.Legal entity responsible for the studyThe authors.FundingHas not received any funding.DisclosureAll authors have declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

1578PDoes progress achieved in the treatment of patients with metastatic non-small cell lung cancer (NSCLC) reach the elderly population?
ConclusionsWe observed a significant improvement in OS over the past 10 years in young patients, whereas a similar benefit was not found for the elderly. Our findings highlight a strong need in studying this growing population separately in elderly specific clinical trials.Legal entity responsible for the studyThe authors.FundingHas not received any funding.DisclosureS. Schmidt: Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: MSD; Research grant / Funding (institution): BMS; Research grant / Funding (institution): AstraZeneca; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: ...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

458PSafety, efficacy, PK and PD biomarker results of the first-in-human study of mutant isocitrate dehydrogenase 1 (mIDH1) inhibitor BAY 1436032 in patients (pts) with mIDH1 advanced solid tumours
ConclusionsBAY is well tolerated as anticipated due to specificity for mIDH1. BAY inhibited mIDH1-R132X activity as evidenced by a PD effect in pts with measurable 2-HG, with objective response in 3 pts (all gliomas).Clinical trial identificationNCT02746081.Editorial acknowledgementMedical writing assistance was provided by Laura Valenzo, PhD, of Complete Health Vizion and funded by Bayer AG.Legal entity responsible for the studyBayer AG.FundingBayer AG.DisclosureW. Wick: Non-remunerated activity/ies, patent: IDH vaccine; Non-remunerated activity/ies, patent: IDH diagnostic; Non-remunerated activity/ies, patent: APG diagno...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research