451 Background: TACE induces a peripheral anti-tumor immune response, which may be amplified by immune checkpoint inhibitors (ICI). Combining TACE with dual ICI therapy has been shown to be safe and feasible. Recent data has suggested that Day 1-only anti-CTLA4 dosing could potentially lead to a stronger immune response with a tolerable safety profile though this novel schedule has not previously been combined with TACE. Methods: Patients with HCC (Childs Pugh A/B7, Barcelona clinic liver cancer stage B/C; ECOG 0/1; sorafenib-naive or experienced) were enrolled in a pilot study of tremelimumab at 2 dose levels (DL1: 75mg IV q4-weekly x 4 and DL2: 300mg IV D1 only) in combination with durvalumab (1500mg IV q-28d) and TACE (D36 +/- 96 hours) until progression of disease (per irRECIST) or off-study criteria. Peripheral immune monitoring was performed and tumor biopsies were obtained at time of TACE. Results: 13 patients enrolled on study; N = 3 at DL1 and N = 10 at DL2. M:F 10:3. Median age 70 (65-74). BCLC B/C 4/9. Extrahepatic disease 6/7. Aetiology: NASH (N = 3), alcohol-related disease (N = 1), HCV (N = 2), hemochromatosis (N = 1), unknown (N = 6). 1 patient discontinued due to G3 colitis. All patients evaluable for response with 2/10 patients on DL2 experiencing PR (at 8 weeks) and overall 8/13 SD and 3/13 PD as best response. Updated PFS and OS data to be presented. Conclusions: Tremelimumab (Day 1 only) and Durvalumab in combination with TACE is safe and feasible in patients with HCC. Follow-up is ongoing and full safety and efficacy data will be presented. Clinical trial information: 2019-002767-98.
e16175 Background: TACE induces a peripheral anti-tumor immune response, which may be amplified by immune checkpoint inhibitors (ICI). Combining TACE with dual ICI therapy has been shown to be safe and feasible. Recent data has suggested that Day-1 only anti-CTLA4 dosing, at a higher level of 300mg, could lead to a stronger immune response, and drive a greater expansion than lower dose regimens, whilst maintaining a tolerable safety profile. This novel schedule has not previously been combined with TACE. Methods: Patients with HCC (Childs Pugh A/B7, Barcelona clinic liver cancer stage B/C; ECOG 0/1; sorafenib-naive or experienced) were enrolled in a pilot study of tremelimumab at 2 dose levels (DL1: 75mg IV q4-weekly x 4 and DL2: 300mg IV D1 only) in combination with durvalumab (1500mg IV q-28d) and TACE (D36 +/- 96 hours) until progression of disease (per irRECIST) or off-study criteria. Peripheral immune monitoring was performed and tumor biopsies were obtained at time of TACE. Results: 13 patients enrolled on study; N = 3 at DL1 and N = 10 at DL2. M:F 10:3. Median age 70 (65-74). BCLC B/C 4/9. Extrahepatic disease 6/7. Aetiology: NASH (N = 3), alcohol-related disease (N = 1), HCV (N = 2), hemochromatosis (N = 1), unknown (N = 6). 1 pt discontinued due to G3 colitis. All patients evaluable for response with 2/10 pts on DL2 experiencing PR (at 8 weeks) and overall 7/13 SD and 1/13 PD as best response. Updated PFS and OS data to be presented. Conclusions: Tremelimumab (Day 1 only) and Durvalumab in combination with TACE is safe and feasible in patients with HCC. Follow-up is ongoing and full safety and efficacy data will be presented. Clinical trial information: 2019-002767-98.
e24019 Background: 11% of Ireland’s population is above the age of 65. This is projected to double to 1.4 million by 2040 corresponding to doubling of cancer cases. Clinical trials often exclude patients (pts) ≥70; therefore, it can be challenging to apply evidence based treatment (tx) to this population. Data from the National Cancer Registry of Ireland suggests under tx of older patients (pts). Comprehensive Geriatric assessment (CGA) is recommended by the National Comprehensive Cancer Network (NCCN) and the International Society of Geriatric Oncology (SIOG). In practice, CGA is limited by time constraints, lack of resources and expert interpretation. Geriatric screening tools can help identify frail pts who are most likely to benefit from CGA. The primary objective of this pilot study was to establish the prevalence of frailty (assessed by G8), presence of cognitive impairment (assessed by Mini-Cog), and risk of chemo-toxicity (assessed by Chemo-Toxicity Calculator) among pts ≥ 65 years (yrs) starting systemic anti-cancer tx. Methods: Pts ≥65yrs starting new systemic anticancer tx were identified between 1st of December 2020 to 31ST of September 2021 in St. Vincent’s University Hospital. Verbal consent was obtained. Printed versions of the G8 screening tool and Mini-Cog were used. CARG chemo-toxicity score was conducted online ( www.mycarg.org/tools ). .The assessment was conducted by consultants, specialist registrars and registrars. Data including pts’ age, type of malignancy, stage of cancer, and planned treatment were recorded. Analysis was conducted by SPSS statistical software, V.25(SPSS Institute, IBM Corp., 2017). Results: We identified 56 pts ≥65 years.27 (48.1%) were females and 29 (50.8%) were males. The majority of treated pts, N = 33 (58.1%) had metastatic cancer. The median G8 score was 12 (IQR 9.6-14). 83.9% of pts had a G8 score ≤14. Mini-Cog was found to be positive in 11 pts (19.6%). The median CARG score was 7 (IQR 6-11) and the median risk of toxicity 51% (IQR 44-78%). Of these, 44 (78.2%) received chemotherapy and 12 pts (21.4%) received non-chemotherapy systemic tx. In multi-variate analyses, age, type of cancer, planned treatment, and stage of disease did not impact G8, Min-cog, and CARG scores. Conclusions: In this single center study of elderly pts, more than 80% of pts had a positive G8 score representing a need for formal CGA assessment. The risk of toxicity was substantial with almost 50% risk of grade ≥ 3 toxicity in this cohort. Chronological age was not found to negatively impact patient’s frailty, cognition, or risk of toxicity. Interpretation of this pilot study is limited by small sample size, possible inter-operator variability, and lack of self-reported assessment.
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