In the era of precision medicine, despite mounting evidence that women might be more susceptible to toxicity from chemotherapy (CT), sex influence on treatment effects and the biology of non-sex-related cancers have largely been ignored. Due to their rarity, data on patients (pts) with sarcoma are scarce. We reviewed data of pts with sarcoma treated between 2015 and 2022 at Veneto Institute of Oncology. Delays/reductions were evaluated in the first 9 weeks of CT and expressed as relative dose intensity (RDI): ratio of delivered dose intensity (mg/m2 per week) to theorical dose intensity. Kaplan-Meier, log-rank and Cox regressions were used. Sex differences in RDI, adverse events (AEs) and impact of RDI on disease-free survival (DFS), progression-free survival (PFS) and overall survival (OS) were analyzed. Overall, data for 197 pts were available (109 treatments for localized disease: 69 neoadjuvant/40 adjuvant setting; 127 first -line treatments for advanced disease). Median age was 57 years, males were 112 (57%). Soft tissue sarcomas were 167 (85%), bone sarcomas were 30 (15%). Grade ≥ 3 AEs were observed in 60% of pts. Male had a lower risk of severe non-hematologic AEs (OR 0.5; p=0.04), while no significant sex differences were observed for all severe AEs. Dose was reduced upfront in 46% of female Vs 28% of males (p=0.007). Also, males less often had RDI <85% (OR 2.4; p=0.002). Survival outcomes were similar in both sexes, though comparisons might suffer from biases due to different distribution of histotypes within sexes. In the localized disease setting, worse survival was observed for males receiving RDI <85% compared to ≥85% (median OS 36.6 m Vs 63.7 m, p=0.004; median DFS 11.1 m Vs 26.3 m, p=0.03) whereas no significant differences at the 85% threshold of RDI were found for females. Greater risk of AEs and lower RDI in women treated for sarcoma add to the evidence that a sex-difference in treatment delivery and outcomes exists. Despite a global lower RDI, survival outcomes for female were not worse compared to male. Interestingly, RDI <85% did not negatively affect survival outcomes in women (standard dosing based on "male" standards?). Such data call for optimization of drug dosing by sex to be considered in trial design.

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.

Early palliative care improves symptoms and quality of life for patients (pts) with advanced cancer. At Veneto Institute of Oncology - IOV in Padua (Italy) a simultaneous care outpatient clinic (SCOC) has been active since 2014, in which pts with advanced-stage disease are evaluated by an oncologist with palliative care team. Pts have been referred to the SCOC through a referral form, scored to prioritize pts' access, since 2018. We prospectively assessed SCOC pts' characteristics and SCOC outcomes through the internal procedure indicators. Pts referred to SCOC by IOV Oncology Unit 1 physicians were eligible. Data were retrieved from the SCOC prospectively maintained database. Eligible pts were 753. Median age was 68 years; 73.6% pts had gastrointestinal cancer, 13.7% had urological cancer and 12.7% had other types of cancer. Disease stage was metastatic in 90.9% of pts. Predominant symptoms were psychological disorders (69.4%), appetite loss (67.5%) and pain (65.9%). Full awareness of cancer diagnosis was detected in 95.3% of pts, of whom 58.5% had also a full awareness of prognosis. Median survival from SCOC visit was 7.3 months. The proportion of pts with survival <6 months increased during the years from 40.3% in 2018, to 65.9% in 2021 (p<0.0001). Survival estimates provided by the oncologist in the referral form was significantly different from the actual survival. Psychological intervention was deemed required and undertaken in 34.6% of pts and nutritional support in 37.9% of pts. Based on ESAS detected needs, activation of palliative care services was undertaken for 77.7% of pts. After SCOC visit, 22.6% pts had unplanned emergency room admissions. Out of 357 pts whose place of death is known, 69.2% died in a proper location (home, hospice and residential care). The indicator's threshold was reached for 9 out of 11 parameters requested by procedure. This study confirms the importance of close collaboration between oncologists and palliative care team to respond to all cancer pts' needs. The introduction of a procedure with indicators allowed us to evaluate the performance of the team so as to improve it.

Advanced biliary tract adenocarcinoma (BTA) is a rare tumor with a poor prognosis. Since no standard salvage chemotherapy regimen exists, we explored the activity of capecitabine alone or combined with mitomycin C.

ABSTRACT Aim: Although CRT is considered the worldwide standard of treatment in LARC, this strategy in elderly patients (pts 370 years) is not often feasible due to morbidity, performance status and compliance. Methods: We reviewed clinical and pathological features of a large series of elderly pts with T3-T4 N0/N+ rectal carcinoma (within 12 cm from anal verge). All patients received CRT with fluoropyrimidines +/- oxaliplatin concomitant to pelvic radiation (45-50.4 Gy). Surgery was scheduled within 6-8 weeks after the end of CRT. Aim was to evaluate safety and outcome results in a retrospective series of elderly pts with LARC. Results: 389 pts from 7 centers were collected. Demographic characteristics were as follows: M/F 251/138, median age 74 (range 70-89); clinical stage was T3 in 321 (82%) and T4 in 52 (13%); 207 pts (53%) showed suspicious nodes, while in 12 pts (3%) stage was unknown. Comorbidities were present in 214 out of 294 pts on which the information was known (73%). Cardiovascular diseases, primarily hypertension, affected 132 out of 294 pts while metabolic and neurological disorders was present in 57 and 17 cases respectively. Continuous infusion of 5-FU was given to 208 pts (53%), capecitabine in 86 (22%) while 89 pts (22%) had oxaliplatin-based combination. Any grade toxicities were reported in 307 patients (78%): diarrhoea (48%), skin toxicity (17%) and dysuria (21%) were the most frequently side effects. Surgery was performed in 349 pts (89%): low anterior resection in 247 cases, Miles resection in 75, Hartmann resection in 7, local excision in 19, missing in 1. Pathologic report showed a complete remission in 59 cases (17%), ypT1-T2: 145, ypT3: 119, ypT4: 9, while 81 pts had ypN1-2 tumor. Downstaging rate was 60% and sphincter preserving surgery rate was 77%. At the time of analysis, 76 pts (22%) relapsed locally or at a distant site. Conclusions: Even though potential bias of selection, this retrospective study suggest that CRT is feasible in elderly patients with mild toxicities with results similar to those reported in younger pts. However prospective trials focusing on the older population are lacking. Disclosure: All authors have declared no conflicts of interest.

A. Galiano1, F. Daniel1, G. Ramondo2, M. Polacco3, F. Battaglin1, A. Roma1, E. Pizzirani2, F. Bergamo1, G. Crivellari1, E. Gringeri3, S. Lonardi1, U. Cillo3, V. Zagonel1, C. Aliberti2 Oncologia Medica 1, Istituto Oncologico Veneto IRCCS, Padua, ITALY Radiologia Interventistica, Istituto Oncologico Veneto IRCCS, Padua, ITALY Chirurgia Epatobiliare e dei Trapianti Epatici, Università degli Studi di Padova, Padua, ITALY

Aim: Although CRT is considered the worldwide standard of treatment in LARC, this strategy in elderly patients (pts 370 years) is not often feasible due to morbidity, performance status and compliance.

e11509 Background: The addition of BEV to chemotherapy in the first-line treatment of HER2-negative MBC has been evaluated in several trials, resulting in an improvement in progression-free survival (PFS), but not overall survival (OS); moreover, concerns have been raised about the safety since some bevacizumab-related events, although rare, could be life-threatening. Further data could clarify the risk/benefit balance of BEV in MBC. Methods: Inclusion criteria included: histologically confirmed HER2-negative MBC, age ≤ 75 years, PS ECOG ≤2, no previous cytotoxic treatment for metastatic disease; patients (pts) with uncontrolled hypertension, clinically significant cardiovascular disease, bleeding, or concurrently treated with anticoagulants/thrombolytic agents for therapeutics purposes were excluded from the trial. Brain metastases were not an exclusion criterion. Presuming a PFS of 6 months for pts treated with TXL alone, the calculated sample size with minimax design was 39 to detect a 50% improvement (from 6 to 9 months) by the addition of BEV with a statistical power of 80% and alpha error ≤5%. Therefore, we prospectively treated 39 pts with: BEV (10 mg/kg, d 1, 15) and TXL (90 mg/m2, d 1, 8, 15) every 28 days. Results: Overall response rate was 58.8%, median PFS 11 months and OS 33 months. Main G3-4 toxicities were neutropenia (9%), hypertension (8%), fatigue (6.5%) and paresthesiae (6.5%). Noteworthy, 5 deaths occurred during the treatment, 2 for bowel perforation, 1 for febrile neutropenia, 1 for liver failure and 1 for brain haemorrhage, and might be treatment-related. Both bowel perforations occurred in pts with peritoneal carcinosis whereas brain haemorrhage occurred in a patient without known central nervous system metastases. Conclusions: Consistently with data from phase III studies, our results suggest that BEV plus TXL is an effective treatment for HER2-negative MBC; however, a possible 12.8% treatment-related mortality deserves extreme caution when using BEV in this context and claims for a careful pts selection.