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Background The REGOMA trial showed that regorafenib significantly improved overall survival in patients with recurrent glioblastoma compared with lomustine. Patients treated with regorafenib experienced a higher occurrence of grade 3–4 drug-related adverse events than those receiving the standard treatment. Because this safety profile was expected, it was considered of great importance to assess the patient point of view regarding the disease and treatment impact on different aspects of life and patient well-being. We here report the final results of the health-related quality of life (HRQoL) assessment, a secondary end-point of the study. This trial is registered with ClinicalTrials.gov , NCT02926222 . Methods Patient-reported outcomes were assessed, within a prospective, randomised, multicentre, open-label phase II trial, by the European Organisation for Research and Treatment of Cancer core questionnaire and brain module at baseline and every 8-weekly neuroradiological assessment till disease progression. Mixed-effect linear models were fitted for each of the HRQoL domain to examine the change over progression-free time within and between arms. Furthermore, differences were also classified as clinically meaningful changes. To correct for multiple comparisons and avoid type I errors, the level of significance was set at P = 0.01 (2-sided). Results Of 119 enrolled patients, 56/59 (95%) patients and 58/60 (97%) patients treated with regorafenib and lomustime completed questionnaires at baseline, respectively. No significant differences were observed in any generic or cancer-specific domain during treatment in both arms, or between the two arms, except for the appetite loss and diarrhoea scales which were significantly worse in patients treated with regorafenib. The rate of patients with a clinically meaningful worsening for appetite loss, diarrhoea and for any other domain was not statistically different between the two arms. Conclusions Regorafenib did not negatively affect HRQoL in patients with recurrent glioblastoma. These data combined with the survival benefit shown in the REGOMA trial support the use of regorafenib as a treatment option for these patients.

Italy was the first European country to be hit by COVID-19 pandemic. As a consequence, Italian oncologists had to guarantee essential treatments although minimizing exposure to the virus, and accidental infection, of patients and healthcare professionals. As Department of Medical Oncology of the University Hospital of Udine, in this short report, we describe the measures that we have taken, and gradually updated, since February 26, 2020. All accesses to our Oncology facilities are currently regulated by entrance check-points where patients are screened for infections following dedicated algorithms. Up to date, after 6 weeks of systematic execution of swabs no physician, nurse or other individual of the staff has been found positive to COVID-19. Only one patient admitted for therapy has been identified as COVID-19 positive. The aim of our work is to propose a model, made up of a set of operative procedures, that may be adopted by all the oncologists that daily struggle to guarantee safety and care in Oncology during this COVID-19 emergency.

BACKGROUND REGOMA trial showed that regorafenib (REG) significantly improved OS and PFS in patients (pts) with relapsed GBM with respect to lomustine (LOM). REG showed a different toxicity profile compared to LOM. Here, we report final results of the HRQoL assessment, a secondary end point. MATERIAL AND METHODS HRQoL was measured using the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) and brain module (QLQ-BN20) administered before any MRI assessments, every 8 weeks (+/- 2 weeks) until disease progression. To evaluate treatment impact on HRQoL, questionnaires at progression were excluded. Mixed-effect linear models were fitted for each of the HRQOL domain to examine the change over progression-free time within and between arms. The models included the time of questionnaire assessment, the treatment group and their interaction, as fixed effects, and a compound symmetry covariance structure for the random effects. Differences of at least 10 points were classified as a clinically meaningful change. To correct for multiple comparisons and to avoid type I error, the level of significance was set at P=0.01 (2-sided). RESULTS Of 119 randomized pts, 117 partecipated in the HRQoL evaluation, and 114 had a baseline assessment (n=56 REG; n=58 LOM). No statistically significant differences were observed in any generic or cancer specific domain during treatment in the REG and LOM arms, or between the two arms, except for the appetite loss scale which was significantly worse in PTS treated with REG (Global mean 14.7 (SD=28.6) vs 7.6 (SD=16.0); p=0.0081). The rate of pts with a clinically meaningful worsening for appetite loss was not statistically different between the two arms (9 out of 24 and 0 out of 13 in the REG and LOM arm, respectively;p=0.02). CONCLUSION In the REGOMA trial, HRQoL did not change during regorafenib treatment. Pts treated with regorafenib and lomustine reported no significant difference in HRQoL.

e13520 Background: Since its outbreak in January 2020, the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic dramatically affected health systems worldwide and a prompt realignment of clinical activities had to be thought. International Oncology guidelines recommended that routine oncology care continued to be delivered, ensuring triage procedures to prevent COVID-19 diffusion alongside treatments prioritization. Aim of this study was to assess the variation of activity volumes due to COVID-19 pandemic in the Oncology Department of the Academic Reference Cancer Center of Udine, Italy. Methods: We extracted activity volumes from the electronic “Data Warehouse” accountability system and compared activity in 2020 with historical activity in 2019. We then narrowed the analysis to the peak of COVID-19 pandemic, comparing data of a four-months period (February-May 2020 vs 2019). In accordance with the Italian Association of Medical Oncology guidelines, the activities analyzed included: new patients referrals, first consultations, new therapy assignments, treatment prescriptions and therapy administrations, disease re-assessments, follow-up visits, tele-examinations, unplanned visits and ward discharges. Results: Overall, throughout COVID-19 pandemic a negligible reduction in the number of first consultations (-5%) and new patients referrals to our Oncology Department (-10%) was detected. Of note, a significant reduction in the number of unplanned oncologic visits was observed (-23%). The replacement of follow up visits with telephonic interviews with the interpretation of laboratory and radiologic examinations (tele-examinations) led to a substantial reduction in follow-up visits throughout 2020 (-25%). Conversely, treatment-related activities, including new therapy assignments (+1%), treatment prescriptions and therapy administrations (+2% and +3%, respectively), confirmed the increasing trend of the previous year. Interestingly, similar trends were observed in the four-months peak period with a substantially higher decrease in follow-up visits in 2020 vs 2019 (-51%), whereas treatment-related activities remained stable. Conclusions: In the context of COVID-19 pandemic, our Oncology Department maintained stable performances on critical oncology activities. Strict triage procedures, serial swabs for patients and healthcare professionals and strategic follow-up visits remodulation were crucial. Notwithstanding the significant decrease in cancer treatments observed in several published reports, our experience demonstrates that the reorganization of oncology departments during a global pandemic is feasible and it should be pursued to preserve patients’ safety without compromising the continuum of care.

The purpose of this study was to retrospectively evaluate the use of carmustine wafers (CWs) in the management of high-grade gliomas (HGGs). The data from our monoinstitutional series was compared with studies reported in the literature. Special emphasis was placed on the evaluation of side effects and the analysis of extent of resection and molecular profile as risk factors. The implantation of CWs into the resection cavity during HGG treatment to deliver localized chemotherapy, followed by the Stupp protocol, remains debated in a clinical setting, largely due to the lack of appropriate phase III studies. Given the high expense and poorly characterized side effects associated with CW treatment, identification of patients most likely to benefit from this therapy could be clinically relevant. CWs may represent an effective and safe first-line treatment for patients with HGG that exhibit complete tumor resection and harboring a methylated MGMT promoter. Our investigation showed a much larger group of patients exhibiting long-term survival (> = 36 months), strongly supporting a potential survival benefit conferred via CW treatment. The pre-surgical definition of the MGMT promoter status could be of clinical use in identifying “good responders” to CW implantation.

Background There is currently no predictive biomarker for anti-angiogenic drugs which could be used for patient selection purposes. Pre-clinical studies show that anti-angiogenic therapy exacerbates tumor hypoxia and activatesliver kinase B1 (LKB1)/AMP kinase (AMPK), a pathway involved in the regulation of tumor metabolism. Inspired by these findings, we investigated whether certain angiogenesis- and metabolism-related in situ biomarkers could predict response to regorafenib in the context of the phase 2 randomized REGOMA trial.

Background REGOMA trial showed that regorafenib (REG) significantly improved OS and PFS in patients (pts) with relapsed GBM with respect to lomustine (LOM). REG showed a different toxicity profile compared to LOM. Here, we report final results of the HRQoL assessment, a secondary end point. Methods HRQoL was measured using the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) and brain module (QLQ-BN20) administered before any MRI assessments, every 8 weeks (+/- 2 weeks) until disease progression. To evaluate treatment impact on HRQoL, questionnaires at progression were excluded. Mixed-effect linear models were fitted for each of the HRQOL domain to examine the change over progression-free time within and between arms. The models included the time of questionnaire assessment, the treatment group and their interaction, as fixed effects, and a compound symmetry covariance structure for the random effects. Differences of at least 10 points were classified as a clinically meaningful change. To correct for multiple comparisons and to avoid type I error, the level of significance was set at P = 0.01 (2-sided). Results Of 119 randomized pts, 117 participated in the HRQoL evaluation, and 114 had a baseline assessment (n = 56 REG; n = 58 LOM). No statistically significant differences were observed in any generic or cancer specific domain during treatment in the REG and LOM arms, or between the two arms, except for the appetite loss scale which was significantly worse in PTS treated with REG (Global mean 14.7 (SD = 28.6) vs 7.6 (SD = 16.0); p = 0.0081). The rate of pts with a clinically meaningful worsening for appetite loss was not statistically different between the two arms (9 out of 24 and 0 out of 13 in the REG and LOM arm, respectively; p = 0.02). Conclusions In the REGOMA trial, HRQoL did not change during regorafenib treatment. Pts treated with regorafenib and lomustine reported no significant difference in HRQoL. Legal entity responsible for the study Giuseppe Lombardi. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Introduction: Integrated care pathways (ICPs) have been proposed as effective strategies for quality improvement. To date, limited data are available that detail the methodology to design an optimal care pathway for patients with non–small-cell lung cancer (NSCLC). The main aim of this study was to assess the quality of health care delivered to lung cancer patients referred to a hub university hospital. Methods: All professionals involved with the management of NSCLC patients, in cooperation with health care researchers, identified 11 quality indicators and associated benchmarks. These were used to estimate the quality and efficiency of health care delivered to a cohort of 175 NSCLC patients. Results: The gap between "desired" and "actual" performance has been measured by benchmarking current practice against key quality indicators. Diagnostic workup, multidisciplinary team care and medical treatment of advanced disease have emerged as areas of good performance. Conversely, the management of early-stage disease offers room for improvement, in terms of both accuracy of nodal staging and surgical timeliness. Conclusions: Analyzing the process of caring for NSCLC patients is feasible and offers room for improvement. Acquired knowledge may be shared with hospital administrators, guide the revision of ICPs, and enable the delivery of consistent, high-quality clinical standards.

Aim: MGMT gene is epigenetically silenced by its promoter hypermethylation in GBM. Hypermethylation is relevant predictor of response to temozolomide. Yet, there is debate around the best technique for MGMT assessment. One of the most interesting methods is pyrosequencing (PyroS) that allows defining a cut-off value for MGMT methylation Aim of our retrospective analysis was to explore if predefined levels of MGMT methylation could impact on overall survival (OS) in a cohort of GBM patients. We also analyzed the potential prognostic role of isocitrate dehydrogenase-1 (IDH1) by PyroS. Methods: Clinical and pathological data of 108 consecutive GBM patients referred to our Department between January 2008 and December 2013 were retrieved. Three groups of patients were identified: unmethylated with MGMT methylation 29% (HM). We calculated median (m) OS and compared the Kaplan Mayer survival curves across the groups through log rank test. Results: 51 cases (47.2%) were UM, 24 (22.2%) IM and 33 (30.6%) HM. The median follow-up is 38.5 months. mOS, months (95%CI) N 108 mOS, months (95%CI) Standard Stupp regimen, N 66 MGMT methylation 13.2 (8.3-15.2) 15.1 (12.8-17.4) MGMT methylation 9-29% 15.8 (9.8-30.8) 25.9 (6.93-53.5) MGMT methylation >29% 19.5 (11.5-47.1) 47 (18.5-57.6) P = 0.0002 P = 0.0001 mOS of IDH1 mutated patients (11 out of 108) was 53.5 months compared to 14.2 months in those wild type (p = 0.01). Conclusions: Our study confirms that a cut-off level of 9% in MGMT methylation has prognostic and predictive value in GBM patients treated with standard therapy. IDH1 mutation may have a prognostic role, although the small patient number does not allow drawing definitive conclusions. Disclosure: All authors have declared no conflicts of interest.

e16573 Background: ICPs are structured multidisciplinary care plans for a specific clinical condition; they describe the tasks to be carried out together with their timing and sequence and the disc...