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TPS471 Background: Oesophagogastric (OG) cancers represent a significant health burden and leading cause of cancer related death. Prognosis in advanced disease is poor and novel therapies are needed to improve outcomes. Molecular features of advanced OG cancer suggest that assessment of DDR (DNA damage repair) targeted agents is warranted. Specifically, ATM and ARID1A defects and mutational scars indicative of homologous recombination defects are present in a subset of OG cancers and are associated with polyadenosine 5’diphosphoribose polymerase inhibitor (PARPi) sensitivity. Methods: SOlar is a multi-centre, open-label, single arm, phase II study of olaparib, a PARPi, in patients with advanced oesophageal, gastro-oesophageal junction and gastric adenocarcinoma. The trial will use a single-arm Simon two-stage design to evaluate the anti-tumour activity of olaparib in advanced OG cancers. The primary endpoint is disease control rate (DCR) at 8 weeks by RECIST v1.1. To rule out a DCR of ≤15% while aiming for DCR ≥30% (alpha = 0.09, power = 89%), 54 patients must be recruited it total. An interim analysis will take place when 27 patients have been accrued, dosed and followed until the 8-week disease evaluation. If 4 or fewer patients have disease control (DC) the study will be terminated. If 5 or more patients have DC, an additional 27 patients will be enrolled to a total of 54 patients. If ≥12/54 have DC in the final analysis then it will be concluded that the treatment has shown anti-tumour activity compatible with 30% and an investigation of potential biomarkers of response will be carried out. Secondary endpoints are ORR, DoR, OS, PFS, time to radiological progression and safety. This highly translational study incorporating serial tumour biopsies will investigate candidate predictive biomarkers of PARPi sensitivity with the aim of identifying responder/non-responder subpopulations. Further exploratory objectives will investigate the predictive role of early FDG-PET/CT in assessing tumour response and the creation of an organoid biobank. The trial opened to recruitment in July 2019 and will recruit up to 54 patients over 3 years. Clinical trial information: NCT03829345.

Wake Forest Baptist Medical Center (WFBMC) experienced a vacancy of both data managers simultaneously and it was three months before these vacancies were filled. During this time, WFBMC also received a first warning for not achieving the required 90% of forms completion for the CIBMTR Continuous Improvement Project (CPI) and by the time the full time data managers had been hired, there were over 450 forms that were either behind or had errors that required correction. Both of the newly hired data managers had experience with data entry and were internal transfers within the organization. One of the data managers was familiar with hematology terms and neither data manager had experience with form entry for CIBMTR or CIBMTR itself. The new data managers began a couple of weeks before a CPI period opened. In order to train and orient the data managers, they were shown the CIMBTR Manuals and followed the manuals as they entered data. They set up their computers that the manuals are up at all time on one of their screens and refer to the manuals as they enter data. The CIBMTR Clinical Research Coordinator (CRC) was (and remains to be) available for almost daily emails and calls regarding questions. The CRC mentioned requesting to receive the CIBMTR Forms Due Report, which is sent on the weekly basis. The data managers use this report to determine which forms to focus on as well as which forms had errors requiring correction. The previous data managers had separated work into TED forms through first 6 months and post 6 month as well as sitting in different areas of the office. The work was not divided up for the new data managers; they sit next to each other in the office and serve as a resource for the others. If they discover that there is an error, they confirm what the correction should be in the manual or by reaching out to the assigned CRS and share this with the other data manager. The data managers have found that using the weekly CIBMTR Forms Due Report has been a very useful tool in keeping up with the required forms for CPI and by the second week of the CPI period, greater than 90% of the forms have been entered. The BMT program had anticipated and received approval of overtime in order to maintain CPI status; however, due to using the weekly report, there has not been any use of overtime in over a year. They have reduced the number of required forms due from 450 forms to around 130 forms due at one time. The weekly report also assisted with identification of corrections, which the data managers correct immediately. Despite being in this position over a year, the data managers remain to have the CIBMTR Manual open on one of their screens and refer to the it frequently. As a result, they are able to share this information with the physicians and the rest of the team. The calls and emails to the assigned CRC remain but have decreased from daily to a couple of times weekly; however, the assigned CRC is always available and a tremendous resource for the team.

Background The Hematopoietic Cell Transplantation (HCT) – Specific Comorbidity Index (HCT-CI) measures the risk of transplant related mortality and predicts overall survival (OS) based on co-morbidities. In a prospective validation study of the HCT-CI by the Center for International Blood and Marrow Transplant Research (CIBMTR), HCT-CI ≥ 3 was associated with lower OS in both allogeneic (allo) and autologous (auto) HCT regardless of diagnoses, age, or conditioning. In contrast to the patients (pts) analyzed in the CIBMTR study, pts transplanted at Wake Forest more often have HCT ≥3. Methods We retrospectively analyzed data from pts transplanted from Sep 2014 to Sep 2016. 2-yr OS was observed for all pts. Results from 3 tools were used to compare predicted vs observed OS: HCT-CI, Disease Risk Index (DRI), and the CIBMTR survival calculator. Results Over 2 yrs, 216 pts were transplanted – 132 auto, median age 62 (26-78) and 84 allo, median age 55.5 (16-74). 59% of pts had a HCT-CI ≥3. In both groups, predicted and observed OS were not statistically different for those with HCT-CI 0. In contrast, predicted and observed OS for HCT-CI ≥3 were significantly different (p Conclusions Compared to the dataset utilized by the CIBMTR for validation of the HCT-CI, scores ≥ 3, largely accounted for by poor pulmonary function, are over represented in our population. Further analysis will need to be done to determine if the regional prevalence of poor pulmonary function is contributing to a significant difference in the predicted vs observed OS in our allo pts.

94 Background: During quarterly MM&I Conferences, a recurrent systems problem identified was the underreporting of chemotherapy infusion reactions. Attendees acknowledged difficulty in obtaining accurate data regarding adverse events and justifications for treatment cessation, which may lead to under dosing of effective therapies. Methods: MM&I conference is an interactive multidisciplinary forum that emphasizes discussion to improve system-based problems. Attendees include faculty, fellows, residents, nursing staff, informatics and pharmacy representatives. Participants used the Ickwaka Fishbone Diagram to identify issues that led to underreporting of reactions. Through discussion of the issues and identification of potential improvement activities, participants recognized that improved nursing documentation could accurately capture data related to adverse drug events. Representatives from the informatics department identified a report that could be generated automatically when infusions are stopped that would require nursing staff to identify the type of reaction and give justification for not completing the infusion. Reports would also include actions taken and patient responses. Results: Implementation of electronic nursing documentation revealed that the prevalence of infusion reactions were much higher than previously identified. During the first 6 months of electronic documentation there were 71 identified reactions compared to 46 reactions documented during the 6 months prior to implementation. Paclitaxel (22%) and Rituximab (39%) were identified as the two most common agents associated with infusion reactions. Twenty (28%) infusion reactions resulted in cessation of that particular chemotherapy. Conclusions: The format of the MM&I Conference engaged members of a multidisciplinary team to promote collaboration for system-based improvements in patient care and safety. Electronic nursing documentation has put a mechanism in place to capture data related to infusion reactions that will allow us to evaluate the effectiveness of future interventions to decrease the prevalence of infusion reactions, as well as the number of therapies that are stopped indefinitely due to these reactions.