Background: Comprehensive Geriatric Assessment (CGA) is essential for evaluating older cancer patients, but significant gaps persist in both research and clinical practice. This study aimed (I) to identify the CGA elements that most influence anti-cancer treatment decisions in older patients and (II) to explore the predictive value of CGA components for mortality. Methods: This observational study included older patients with newly diagnosed, histologically confirmed solid or hematological cancers, recruited consecutively from 2003 to 2023. Participants were followed for four years. The data collected included CGA measures of functional (Activities of Daily Living-ADL), cognitive (Mini-Mental State Examination-MMSE), and emotional (Geriatric Depression Scale-GDS) domains. Patients were categorized into frail, vulnerable, or fit groups based on Balducci's criteria. Statistical analyses included decision tree modeling and Cox regression to identify predictors of mortality. Results: A total of 7022 patients (3222 females) were included, with a mean age of 78.3 ± 12.9 years. The key CGA factors influencing treatment decisions were ADL (first step), cohabitation status (second step), and age (last step). After four years, 21.9% patients had died. Higher GDS scores (OR 1.04, 95% CI 1.01-1.07, p = 0.04) were independently associated with survival in men and living with family members (OR 1.67, 95% CI 1.35-2.07, p < 0.001) in women. Younger patients (<77 years) showed both MMSE and GDS as significant risk factors for mortality. Conclusions: Functional capacity, cohabitation status, and GDS scores are crucial for guiding treatment decisions and predicting mortality in older cancer patients, emphasizing the need for a multidimensional geriatric assessment.

Background/Objectives: Chemotherapy can negatively affect cognitive functioning through direct and indirect mechanisms, with 15-50% of patients experiencing a decline that impacts quality of life. While neurocognitive tests are the main assessment tool, self-reported measures provide valuable additional insights. The aim of this study was to evaluate the cognitive decline of patients during the early stages of chemotherapy treatment and its impact on their quality of life, as well as to outline future perspectives for an early intervention model. Materials and Methods: This prospective longitudinal study was conducted on 40 patients aged 18 to 64 years. Data were collected using the FACT-Cog v.3 questionnaire, administered at the beginning of the first chemotherapy cycle (T0), and then again after approximately 3-4 weeks (T1) and 6-8 weeks (T2). Results: The data show a progressive decline in perceived cognitive abilities (PCI: 72.10 → 64.43; PCA: 25.70 → 20.90) and overall quality of life (9.73 → 8.75) from T0 to T2. A significant positive correlation was found between perceived cognitive abilities and quality of life, supporting the link between cognitive decline and quality of life. Questionnaire variables reliably predicted changes in quality of life two months after chemotherapy [F(4, 35) = 3.91, p = 0.01]. Conclusions: The findings show a decline in quality of life as chemotherapy progresses. However, this decline can be predicted from the second month of treatment using the FACT-Cog v.3 questionnaire. The findings further highlight even more the value of integrating early empowerment, rehabilitative and psychoeducational programs to mitigate cognitive decline and improve quality of life.

IntroductionPituitary adenomas can show a tendency to grow, despite multimodal treatment. Temozolomide (TMZ) has been used in the last 15 years in patients with aggressive pituitary tumors. TMZ requires a careful balance of different expertise, especially for selection criteria.Areas coveredWe conducted: (1) a systematic review of the published literature from 2006 to 2022, collecting only cases with a complete description of patient follow-up after TMZ discontinuation; (2) a description of all patients with aggressive pituitary adenoma or carcinoma treated in Padua (Italy).Expert opinionThere is considerable heterogeneity in the literature: TMZ cycles duration ranged from 3 to 47 months; the follow-up time after TMZ discontinuation ranged from 4 to 91 months (mean 24 months, median 18 months), at least a stable disease has been reported in 75% of patients after a mean 13 months (range 3-47 months, median 10 months). The Padua (Italy) cohort reflects the literature. Future directions to explore are to understand the pathophysiological mechanism of TMZ resistance escape, to develop predicting factors to TMZ treatment (especially through the delineation of the underlying transformation processes), and to further expand the therapeutic applications of TMZ (as neoadjuvant, combined with radiotherapy).

Abstract BACKGROUND Glioblastoma (GBM) is associated with the activation of multiple signaling pathways, including the receptor tyrosine kinases, VEGFR, FGFR and PDGFR. The potential response to anti-angiogenic agents makes GBM an attractive target for regorafenib (REG). Antitumor activity of REG in recurrent GBM patients was shown in the phase II REGOMA trial. Interestingly, in “in vivo” studies, beneficial effects were observed with the combination of REG and temozolomide (TMZ) in subcutaneous xenografts. MATERIAL AND METHODS This phase I open-label multicentric study in progress is evaluating the addition of REG to standard of care treatment with TMZ as adjuvant therapy (cohort A), and in combination with TMZ + radiotherapy (RT) as concomitant therapy (cohort B), in newly diagnosed MGMT-methylated, IDH wildtype GBM patients. Primary objectives are: to determine the safety and tolerability of REG and to establish the maximum tolerated dose (MTD) of REG in these two cohorts. Secondary objectives are: the assessment of pharmacokinetics of REG, TMZ, and possible pharmacokinetic interactions between TMZ and REG in cohort A; the assessment of preliminary antitumor activity; the evaluation of quality of life during the treatment. The dose escalation is being explored according to a “3 + 3” design, starting from cohort A and following 3 dose levels of REG [80 mg, 120 mg and 160 mg]. After finding the MTD in cohort A, the cohort B dose escalation will start, exploring escalating oral doses of REG in combination with concomitant TMZ + RT (60 Gy/30 fractions). In the adjuvant phase of cohort B, REG will be given with TMZ at MTD shown in the prior adjuvant phase dose escalation.The DLT (dose-limiting toxicity) evaluation period will be two cycles from the start of cycle 1 of adjuvant phase (in cohort A) and from day 1 to the last day of the concomitant phase (in cohort B). Recruitment started in May 2022; Level 1 in cohort A (3 patients) has been completed without DLT. Approximately 36 subjects will be enrolled.

BACKGROUND:Approximately 50% of colorectal cancers occur in older patients. International societies recommend geriatric tools to optimise treatment of older patients. Comprehensive Geriatric Assessment (CGA) is a multidimensional assessment used to classify patients as fit, vulnerable, or frail. The CGA-based oncological multidimensional prognostic index (onco-MPI) also classifies patients as high-, intermediate-, or low-risk based on tumour characteristics. We investigated the role of CGA and onco-MPI in older patients with metastatic colorectal cancer (mCRC) in a real-world setting. METHODS:Data for consecutive mCRC patients aged ≥70 years were retrieved from a prospectively maintained database from 2010 to 2020. We analyzed patients' and tumours' characteristics, and the CGA domains. Onco-MPI was calculated by a validated algorithm derived from CGA domains. Pearson's test was used to verify whether onco-MPI scores and chemotherapy administration were correlated. RESULTS:The study included 488 mCRC patients with a mean age of 76.1 years. According to CGA, 52% of patients were fit, 28% vulnerable, and 20% frail. According to onco-MPI, 9% were low, 54% intermediate, and 37% high-risk. The median OS was 22.7 months. The following factors improved OS: 0-1 ECOG PS, low onco-MPI, fit based on CGA, chemotherapy administration, and doublet regimen. Chemotherapy administration significantly correlated with onco-MPI scores, leading to a survival gain regardless of the risk subgroups. First-line regimen had no impact on survival across the CGA and onco-MPI categories. CONCLUSION:CGA and onco-MPI scores confirmed their prognostic impact in older mCRC patients and may aid in decision-making and subgroup stratification in dedicated trials.

About 50% of colorectal cancers occur in elderly patients (pts). The oncological societies suggest using geriatric tools to customize treatment. Comprehensive Geriatric Assessment (CGA) is a multidimensional assessment, classifying pts as fit, vulnerable or frail. Oncological multidimensional prognostic index (oncoMPI) is a CGA-based score which includes also tumour characteristics, classifying pts in high-, intermediate- and low-risk group. We investigated the role of CGA and oncoMPI in metastatic colorectal cancer (mCRC) elderly pts in a real-world setting. Consecutive mCRC pts aged ≥70 years were prospectively evaluated at Istituto Oncologico Veneto from 2010 to 2020. Pts' demographics, CGA (ECOG PS, comorbidities, medications, pain, caregiver presence, BMI, ADL and IADL, Mini Mental Status Examination, Geriatric Depression Scale), tumor characteristics (primary tumor location, RAS/BRAF status, metastases' number), lines and regimens of chemotherapy (CT) were analysed. OncoMPI was calculated by a validated algorithm from the CGA domains. Correlation between onco-MPI and first-line decision-making was investigated by Pearson's chi-squared test. A total of 488 mCRC pts were included, 287 males. Mean age was 76.1 years, ECOG PS was < 2 in 84%. According to CGA, 52% of pts were classified as fit, 28% vulnerable and 20% frail. According to oncoMPI score, 9%, 54% and 37% of pts were low, medium and high risk, respectively. Median overall survival (OS) was 22.7 months. The following factors were significantly associated with OS: ECOG PS (0-1 vs > 1, HR 2.4), CGA (fit vs frail, HR 2.4), oncoMPI score (low vs high risk, HR 1.7), metastases' number (1 vs > 1, HR 2.1), CT administration (none vs at least one line, HR 0.63), first-line regimen (monotherapy vs doublet, HR 0.7). CT administration correlated with oncoMPI scores (Pearson's test p-value < 0.0001) providing a survival gain in all the risk subgroups. CGA and oncoMPI confirmed their prognostic role in mCRC elderly pts. CGA-derived oncoMPI may help to drive decision-making in clinical practice and to standardize subgroups of the heterogenous population of elderly in clinical trials.

e24015 Background: Colorectal cancer (CRC) is the second most frequent malignancy in patients (pts) aged 70. Elderly patients are often excluded by clinical trials; however, improvements in quality of life and comorbidities management led to expand the access to anticancer treatments irrespectively of age per se. Finding new tools to stratify vulnerability in elderly pts is crucial to guide clinicians in therapeutic decisions. G8 and timed up and go test (TUG) have been related to prognosis and functional decline in patients affected by several solid tumors. However, no studies focused on TUG and G8 prognostic value in CRC pts are available. In this study, we assessed the prognostic value of G8 and TUG in a cohort of real-life elderly pts with metastatic CRC (mCRC). Methods: GOLD was a multicentre, observational, prospective study in which pts aged 70 with mCRC and eligible to 1st line therapy were enrolled. G8 and TUG were performed at screening and at the first documented disease progression (PD). G8 cutoff was 14, as reported in literature; TUG8,5 sec (cutoff set with ROC curve using MedCalc software v 20.027). PFS and OS were described with Kaplan-Meyer curve. All analyzed variables were then compared with multivariate models. Primary endpoint of the study was to assess prognostic value of G8 in OS and PFS. Secondary endpoints were to assess prognostic value of TUG in OS and PFS. Results: Since Oct 2017 to Apr 2019, 109 pts were evaluated in 4 different Oncology Units in Veneto (IT); 4 were not eligible to anticancer treatments and where thus excluded. 105 pts were finally enrolled. Clinical, histological and molecular characteristics were well balanced between pts with G814 vs > 14, with the exception of RASmut, more represented in the G8 > 14 group (p = 0,0195). 39 (37%) pts were aged80; 46 (44%) had ECOG PS1; 55 (53%) had RASmut; 15 (15%) had BRAFmut. 81 (77%) had G814; 78 (75%) had TUG8,5. At a median follow up time of 41,2 months, median OS was 19,41 months (95%CI 15,46-23,19) and median PFS 8,78 months (95% CI 7,53-10,07). OS was longer in patients with G814 (HR 0,61; 95%CI 0,39-0,97; p= 0,0584) and TUG8,5 (HR 0,55; 95%CI 0,35- 0,86; p= 0,0201). PFS was not influenced by G8 (HR 0,86; 95%CI 0,55-1,34; p= 0,5125) nor by TUG (HR 0,71; 95%CI 0,47-1,08). G814 and TUG8,5 conferred better OS also in the subgroup of RASmut (respectively p= 0,0133 and p= 0,0088). Worse OS was observed in presence of > 1 metastatic site (HR = 1,71; 95%CI 1,11 to 2,64; p= 0,0161). At the multivariate analysis, G814 ( p= 0,0202) and single metastatic site ( p= 0,0200) were related to better OS; none of the analysed variables had effect on PFS. Conclusions: In our study G814 and TUG8,5 had prognostic value in OS, but not in PFS, in a real-life population of elderly pts affected by mCRC. G8 and single metastatic site involvement were related to better OS, irrespectively of other clinical, histological and molecular variables.

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. 2021 Elsevier Ltd. All rights reserved.

Background: There is poor data on the prognostic role of Comprehensive Geriatric Assessment (CGA) in older patients with metastatic renal cell carcinoma (mRCC) treated with first line Tyrosine Kinase Inhibitors (TKIs). Materials and Methods: We retrospectively reviewed the clinical charts of mRCC patients older than 70 years treated at our Institute with first-line Sunitinib or Pazopanib for at least 6 months. Every patient received a CGA at baseline and was identified as fit, vulnerable or frail according to Balducci's Criteria. We then assessed the impact of CGA category on survival, disease control and tolerability of TKIs. Results: We identified 86 eligible patients. Median age: 74.5 years, 56% males; 45.4% were fit, 37.2% vulnerable and 17.4% frail at CGA. There were no significant differences in the rate of Grade (G)1-2 and G3-4 toxicities, dose reduction rates, PFS and OS between Sunitinib and Pazopanib. Fit, vulnerable and frail patients achieved significantly different median PFS (18.9 vs 11.2 vs 5.1 months; p < 0.001) and OS (35.5 vs 14.6 vs 10.9 months; p < 0.001). Patients categorized as fit had higher chance of receiving a second-line treatment (66.6% vs 28.9% in vulnerable/frail; p = 0.002). The incidence of G3/4 events was significantly lower in the fit subgroup (19% vs 45% in vulnerable/frail; p = 0.0025). Conclusions: In our retrospective single-center experience, CGA could accurately discriminate patients with higher risk of experiencing G3/4 toxicities, shorter PFS, and lower chance of receiving a second line treatment. CGA strongly impacted on OS, independently from International mRCC Database Consortium (IMDC) classification. (C) 2020 Elsevier Ltd. All rights reserved.

Anaplastic Astrocytoma(AA) is a malignant, diffusely infiltrating, primary brain tumor. According to the WHO 2016 classification of central-nervous-system tumors, AA has been described as a glial tumor with no co-deletion of 1p/19q, and is divided into IDH mutated tumor, characterized by better prognosis, and IDH wild-type form, with worse prognosis. The standard of care is maximal safe resection followed by radiotherapy and chemotherapy with temozolomide. Several efforts have been made to evaluate, according to molecular selection, which is the best post-surgical treatment. At recurrence, the treatment remains challenging and some trials are ongoing to evaluate new potential drugs, alone or in combination with chemotherapy. We performed a description of the status of the art on diagnosis, molecular characteristics and treatment of AA. In particular, we focused our details on new drugs; indeed, a deeper knowledge of the molecular characteristics of gliomas could lead to to development of active personalized treatments according with precision medicine.

563 Background: At least 75% of bladder cancer (BC) are diagnosed in adults aged ≥65 years, with a median of 72 years. Older adults have poor outcomes but are also an heterogeneous population in which the functional status often does not reflect the chronological age. ASCO and SIOG recommend the use of geriatric assessment (GA) to guide management of these patients (pts) but very few data are present to date. Methods: We investigated the role of GA and an oncological version of MPI in pts ≥70 years old affected by advanced/metastatic urothelial carcinoma. Data were retrieved from a prospectively maintained database from 2010 to 2022. Comprehensive GA (CGA) is a multidimensional tool used to classify pts as fit, vulnerable and frail according to Balducci’s criteria. Onco-MPI was calculated by a validated algorithm derived from different GA domains and tumour characteristics. We also collected characteristics of pts, tumors and treatment regimens. Correlation between GA and treatments used and oncological outcomes were analysed. Results: Complete data and follow up were available for 181 patients. Pts characteristics are reported in Table 1. According to Onco-MPI all the pts but 7 were at high risk. The mFU was 46.2 months, while mOS was 8.2 months. Balducci’s CGA and Bellmunt groups had a concordance of 58%, p<0.01. Strong correlations between these scores and type of treatment received were found (pts fit or 0 score received more often a platinum-based treatment without reduction dose while frail or 2-3 score received more often treatment with a reduced dose or no treatment at all, p<0.01). The two scores have a strong prognostic value (18.5 vs 10.8 vs 3.8 months, p<0.01; 21.9 vs 8.5 vs 4.1 months, p<0.01, respectively for CGA and Bellmunt subgroups). At univariate analysis also timing of mets, number of sites, type of treatment and dose were good prognostic variables. All these variables retained their prognostic value at a multivariate analysis incorporating each of the two scores separately. Conclusions: CGA has a great prognostic value in older adults with metastatic urothelial cancer. This tool could help in decision making and patients stratification but validation in prospective cohort is needed. Onco-MPI could also be useful but new cut offs must be set in this specific population.[Table: see text]

Background Treatment for GBM elderly patients (pts) is a challenge in neuro-oncology. The CGA is currently used for assessing elderly pts and its score correlates with outcome in many types of tumors. We have reported some general outcomes of CGA in GBM pts. Here we performed a large retrospective analysis for identifying specific CGA category correlations with PFS and OS Methods Pts aged ≥65 years, with histological diagnosis of GBM and availability of CGA result were enrolled. The CGA was administered before starting radio/chemotherapy (RT/CH) or palliative care Results we enrolled 113 pts; median age was 71.7 years. Radical surgery was performed in 33% of cases; 80% of pts were treated with RT/CH combination; median number of maintenance temozolomide (TMZ) cycles was 3.9. Most pts had a high Karnofsky Perfrmance Score (80%). According to CGA score, 35% of pts were categorized as “fit”, 30% as “vulnerable” and 35% were “frail”, and median overall survival was 16.5 vs 12.1 vs 10.3 months (p = 0.1). On multivariate analysis, CGA score proved an independent predictor of survival: vulnerable and frail pts reported an HR of 1.5 and 2.2, respectively, compared to fit pts (p = 0.04). Moreover, we demonstrated a statistical association between CGA and type of treatment, fit pts being more frequently treated with RT/CT (98% vs 90% and 52% of vulnerable and frail pts, respectively, p Conclusions CGA score was shown to be a significant predictor of mortality in elderly GBM pts. The score can classify pts into three categories statistically correlating with survival. It could be a useful treatment decision tool suggesting the more appropriate treatment. However, a prospective study is warranted. Legal entity responsible for the study Veneto Institute of Oncology IOV IRCCS. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Background: Treatment of elderly glioblastoma patients (EGP) is a challenge in neuro-oncology. The comprehensive geriatric assessment (CGA) is currently used to assess geriatric oncological patients with other types of tumors. We performed a large retrospective study to analyze its predictive role in EGP. Methods: Patients aged ≥65 years with histologically confirmed diagnosis of glioblastoma were enrolled. CGA included the following tests: the Cumulative Illness Rating Scale-Comorbidity and Severity Index, Activities of Daily Living, Instrumental Activities of Daily Living, the Mini Mental State Examination, and the Geriatric Depression Scale. Based on CGA results, each patient was categorized as fit, vulnerable, or frail. Results: We enrolled 113 patients. According to the CGA scores, 35% of patients were categorized as “fit”, 30% as “vulnerable”, and 35% as “frail” patients. Median overall survival was 16.5, 12.1, and 10.3 months in fit, vulnerable, and frail patients (p = 0.1), respectively. On multivariate analysis, the CGA score resulted an independent predictor of survival; indeed, vulnerable and frail patients had a hazard ratio of 1.5 and 2.2, respectively, compared to fit patients (p = 0.04). No association between CGA and progression-free survival (PFS) was demonstrated. Conclusions: The CGA score proved to be a significant predictor of mortality in EGP, and it could be a useful treatment decision tool.

2045 Background: REGOMA trial showed that regorafenib (REG) significantly improved OS and PFS in relapsed glioblastoma (GBM) patients (pts) 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 proportion 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 = 0.0146). Conclusions: In the REGOMA trial, HRQoL did not change during REG treatment. Pts treated with REG and LOM reported no significant difference in HRQoL. Clinical trial information: NCT02926222. [Table: see text]

Treatment for GBM elderly PTS is still a challenge in neuro-oncology. Clinical tools, including CGA, are needed for improving treatment decision and outcome. The aim of this study was to evaluate CGA as a prognostic tool in terms of PFS and OS in elderly GBM PTS. We performed a retrospective analysis of elderly PTS ≥ 65 years, treated at Veneto Institute of Oncology between January 2011 and January 2018, with newly histologically diagnosed GBM and receiving a baseline CGA after 3–4 weeks from surgery. CGA included the following domains: age, activities and instrumental activities of daily living (ADL, IADL), cognitive status (MMSE), mood (GDS), nutritional status (MNA), number of drugs, comorbidity (cumulative Illness Rating Scale-CIRS), presence of geriatric syndromes, presence of caregiver. PTS were classified according to Balducci’s criteria into Fit or Unfit (Frail and Vulnerable). 113 PTS were enrolled: 72(64%) were male, KPS were ≥ 70 in 90 PTS(80%); 37 PTS(33%) had a radical surgery, 63% partial surgery and 4% received a biopsy. 90 PTS(80%) received Stupp treatment, 16 (14%) temozolomide or radiotherapy alone and, only 7(6%) received no treatment. MGMT methylation status was analyzed in 96 PTS: 44% were metMGMT. According to CGA evaluation: 40 PTS(35.4%) were classified as Fit and 73 PTS(64.6%) Unfit. PFS was 11.2(95% CI 6.0–16.4) and 7.2(95% CI 5.8–8.6) months for Fit and Unfit PTS (p=0.1). On multivariate analysis, adjusted for type of surgery, MGMT methylation status and type of therapy, PFS was significantly different between the two groups (HR=0.6, 95% CI 0.2–0.9; p=0.04). OS was 16.4(95% CI 14.6–18.2) and 10.6(95% CI 8.3–12.8) ms for Fit and Unfit PTS (p=0.04); on multivariate analysis the HR was 0.51(95% CI 0.2–0.9; p=0.04). CONCLUSIONS: CGA demonstrated significant outcome prediction in terms of OS and PFS, regardless of therapy and it could be a useful treatment decision-tool.

Glioblastoma is the most common and aggressive primitive brain tumor in adults. Temozolomide (TMZ) administered daily with radiation therapy, followed by adjuvant TMZ has become the standard treatment. Although TMZ treatment has been considered to have a low toxicity profile, studies have noted the development of a severe myelosuppression, especially during the concomitant treatment; this toxicity may in some cases be prolonged and consequently treatment must be definitively discontinued. We analyzed two cases treated at our oncological center who developed severe and prolonged hematological toxicity during concomitant chemoradiotherapy treatment with TMZ. Hypothesizing that radiation therapy and daily TMZ could be the major causes of severe hematological toxicity during the concomitant phase, we decided to treat both patients with maintenance TMZ at the time of recovery of hematological values. Patients showed good tolerability without important myelosuppression. In conclusion, we suggest that glioblastoma patients with severe myelotoxicity during daily TMZ and radiation therapy be treated with maintenance TMZ at the time of blood value recovery.

2047 Background: There is no established treatment regimen for recurrent GBM. GBMs have activation of multiple signaling pathways in the tumor microenvironment, including the receptor tyrosine kinases, VEGFR, FGFR, and PDGFR. REG, an oral multikinase inhibitor, inhibits these angiogenic kinases and the mutant oncogenic kinases KIT, RET, and B‐RAF. Methods: We present, after the first analysis, the updated results of REGOMA trial. The primary aim of this trial was to assess REG activity in prolonging overall survival (OS) in PTS with relapsed GBM after surgery and Stupp regimen (α = 0.2, 1-sided; β = 0.2). Secondary objectives were PFS, disease control rate (DCR), safety, quality of life (QoL); exploratory objectives included analysis of metabolic tissue biomarkers as possible predictors of response. PTS with histologically confirmed GBM, ECOG PS 0‐1, documented disease progression were randomized 1:1 to receive REG 160 mg/day (3 weeks on, 1 week off) or lomustine (LOM) 110 mg/m2 (every 6 weeks) until disease progression or unacceptable toxicity. Tumor response was evaluated by brain MRI every 8 weeks according to the RANO criteria. Results: 119 PTS were randomized (n = 59 REG; n = 60 LOM) and stratified for surgery at recurrence; baseline characteristics, including MGMT methylation status, were balanced. Median age was 57.3 yrs; 27 PTS (22.7%) had surgery at recurrence, 22% and 23.3% in REG and LOM arm. At the time of analysis (cut-off date: Dec 31, 2017), median follow up was 15.4 months(m), 99 PTS had died. Median OS was 7.4m (95% CI 5.8-12.0) for REG and 5.6m (95% CI 4.7-7.3) for LOM (HR = 0.50, 80%CI 0.38-0.65; p = 0.0007; 1-sided Log-rank test); 12m-OS rates were 38.9% and 15.0% for REG and LOM. 6m-PFS rates were 16.9% and 8.3% (HR = 0.65; 95% CI 0.45‐0.95; p = 0.0223) for REG and LOM , DCR was 44.8% and 21.1% (p = 0.009) for REG and LOM. Grade ≥3 adverse events were reported in 56% and 40% for REG and LOM, no treatment-related deaths were reported. Conclusions: In this multicenter, randomized study, REG significantly improved OS, PFS and DCR in recurrent GBM PTS. REG treatment was feasible and well tolerated. QoL and biomarker analyses are ongoing. A phase 3 study will be planned. Clinical trial information: NCT02926222.

Background: Health-related quality of life (HRQoL), cognitive function, and psychological status represent an important focus during the treatment of glioblastoma patients. Nevertheless, few randomized, prospective clinical trials have analyzed these factors, and very little is known in the real-clinical world. We evaluated these characteristics in glioblastoma patients treated with standard first-line therapy outside clinical trials. Patients and Methods: In total, 111 newly, histologically diagnosed glioblastoma patients treated at our oncology center with radiotherapy and temozolomide were prospectively enrolled. No patient was enrolled in an experimental clinical trial. We assessed HRQoL, cognitive function, and psychological status before starting treatment, at the end of radiotherapy, and every 3 months until 9 months after the end of radiotherapy using EORTC QLQ-C30, BN20, MMSE, and HADS questionnaires. Results: Global health status, physical, cognitive, and social functioning remained unchanged throughout the study period. A statistically significant change was found in emotional functioning as well as a clinically meaningful amelioration in role functioning between the baseline assessment and 9 months after radiotherapy. Patients older than 65 years reported greater impairment on the bladder control scale than younger patients. When considering tumor location, global health status, communication deficit, and drowsiness, scores were significantly different between the right and left hemispheres. Female patients had a clinically relevant lower score for physical functioning at baseline and 3 months after radiation therapy. Female patients also had a clinically relevant lower depression score at 9 months after radiation therapy. Conclusions: In routine neurooncology practice, HRQoL, cognitive function, and psychological status did not worsen during first-line treatment in glioblastoma patients receiving standard radiotherapy and temozolomide treatment. However, some patient subgroups, such as elderly and female patients, may have different experiences with treatment, and further investigation is required.

Background: In cancer patients, malnutrition is associated with treatment toxicity, complications, reduced physical functioning, and decreased survival. The Prevalence of Malnutrition in Oncology (PreMiO) study identified malnutrition or its risk among cancer patients making their first medical oncology visit. Innovatively, oncologists, not nutritionists, evaluated the nutritional status of the patients in this study.Methods: PreMiO was a prospective, observational study conducted at 22 medical oncology centers across Italy. For inclusion, adult patients (> 18 years) had a solid tumor diagnosis, were treatment-naive, and had a life expectancy > 3 months. Malnutrition was identified by the Mini Nutritional Assessment (MNA), appetite status with a visual analog scale (VAS), and appetite loss with a modified version of Anorexia-Cachexia Subscale (AC/ S-12) of the Functional Assessment of AnorexiaCachexia Therapy (FAACT).Findings: Of patients enrolled (N= 1,952), 51% had nutritional impairment; 9% were overtly malnourished, and 43% were at risk for malnutrition. Severity of malnutrition was positively correlated with the stage of cancer. Over 40% of patients were experiencing anorexia, as reported in the VAS and FAACT questionnaire. During the prior six months, 64% of patients lost weight (1-10 kg).Interpretation: Malnutrition, anorexia, and weight loss are common in cancer patients, even at their first visit to a medical oncology center.