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Background: We evaluated the value of pre-treatment positron-emission tomography–computed tomography (PET-CT)-based radiomic features in predicting the locoregional progression-free survival (LR-PFS) of patients with inoperable or unresectable oesophageal cancer. Material and Methods: Forty-six patients were included and 230 radiomic parameters were extracted. After a principal component analysis (PCA), we identified the more robust radiomic parameters, and we used them to develop a heatmap. Finally, we correlated these radiomic features with LR-PFS. Results: The median follow-up time was 17 months. The two-year LR-PFS and PFS rates were 35.9% (95% CI: 18.9–53.3) and 21.6% (95%CI: 10.0–36.2), respectively. After the correlation analysis, we identified 55 radiomic parameters that were included in the heatmap. According to the results of the hierarchical clustering, we identified two groups of patients presenting statistically different median LR-PFSs (22.8 months vs. 9.9 months; HR = 2.64; 95% CI 0.97–7.15; p = 0.0573). We also identified two radiomic features (“F_rlm_rl_entr_per” and “F_rlm_2_5D_rl_entr”) significantly associated with LR-PFS. Patients expressing a “F_rlm_2_5D_rl_entr” of

618 Background: Muscle metastases (MM) are among rare secondary locations in renal cell carcinoma (RCC). Current guidelines do not provide specific advice on the management of these patients. There is a lack of scientific literature on the subject, mainly based on case reports or small retrospective monocentric cohorts. To date, therefore, there remains uncertainty about the clinical history, prognosis, and appropriate management of patients with MM. Methods: ARTEMIS is an ambispective national French multicenter, non-interventional study. It was opened to patients with metastatic RCC who had MM. The study was designed to assess overall survival (OS), progression-free survival (PFS), describe diagnostic and treatment modalities, and treatment-related serious adverse events in case of local treatments (TR-SAEs). Results: Median follow-up was 74.4 months IC95% [38.7-84.1]. The 146 enrolled patients were 73.6% male, with a median age of 57.6 years at diagnosis. They were initially diagnosed with stage IV RCC for 40.4% of them and had a favorable (36.2%), intermediate (45.7%), or poor (18.1%) IMDC risk score at the onset of metastases. Initially, metastases were mainly located in the lungs (55.5%), lymph nodes (26.7%), and bones (24.0%). Patients had a history of partial or total nephrectomy in 78.8% of cases. There were 30.0% of patients with synchronous MM. The median times from initial diagnosis or metastatic status to MM discovery were 25.5 [16.8-35.7] months and 8.4 [5.0-13.5] months, respectively. The majority (69.0%) of MM were discovered on conventional injected CT scans, whereas 8.3% were diagnosed clinically. Survival data are displayed on the table. Thirty-seven (25.3%) patients received local treatment of their MM which consisted of: external radiotherapy (48.6%), surgery (27.0%), cryotherapy (27.0%), stereotactic radiotherapy (5.4%), embolization (2.7%). Among them, local treatments prevented local relapse of MM in 28 patients (75.7%). Local TR-SAEs were seen in two patients (5.4%). Conclusions: ARTEMIS is the largest published cohort describing the disease history of patients with RCC suffering from MM. To our knowledge, this is the first study reporting the diagnostic and treatment modalities, also survival data. Despite its low incidence, the issue of these patients is not so rare in physicians’ practice. This work thus allows a greater understanding of clinical features and treatment of this pathology. [Table: see text]

700 Background: Pts with aPDAC often have general health impairment due to high symptom burden at diagnosis. We investigated prospectively the clinical benefit (CB) of an EISCP followed by CTx as early as suspicion of aPDAC in pts with ECOG performance status (PS)≥2. Methods: In this multicenter study, PS≥2 pts with pathologically confirmed or suspected aPDAC on imaging were included at first oncology visit (V1) in a personalized 14-d EISCP including pain, nutritional, diagnostic/stenting procedures. Post-EISCP PS≤1 pts received mFOLFIRINOX or gemcitabine(Gem)/Nab-paclitaxel(NP), PS≥2 received mFOLFOX7 or investigator choice CTx or best supportive care (BSC). The primary endpoint was the 14-EISCP success on both feasibility of procedures within 14-d±2 and CB defined by post-EISCP PS≤1, ≥5 points improvement of either fatigue/pain/global health EORTC QLQ-C15-PAL quality of life (QOL) scores, or CTx start ≤30d, aiming 59% success for clinical relevance. Secondary endpoint included uni/multivariate median overall survival (mOS) analyses. Results: As of 07/2022, 106 pts were included; 93 pts were evaluable for primary endpoint: male 46%, mean age 74 yrs, PS2/3 79%/21%, metastases (M1) 62%, pathological diagnosis needed 53%, biliary stenting 16%. V1 mean QOL global health score was 48±23. mOS was 4.1 months (IC95 2.8-5.7). The 14-d feasibility was achieved in 71%. Post-EISCP CB was observed in 82% of pts: 13%, PS improvement to 0/1, 23% QOL improvement and/or 73% CTx start ≤30-d. Eight pts (9%) died during the EISCP. The primary endpoint was achieved in 59% of pts (n=55). Overall, 17 pts (16%) received mFOLFIRINOX/GemNP, 32 (30%) FOLFOX, 29 (27%) Gem or 5FU alone, and 28 (27%) BSC. OS analyses are shown. At d30, pts receiving CTx had a mean change of QOL global health score from 51±23 to 60±23. Conclusions: In PS≥2 pts with aPDAC, a personalized 14-EISCP is feasible and lead to a meaningful CB allowing the administration of doublet/triplet CTx in nearly half of the pts. Pts starting CTx within 30d had improved OS. Clinical trial information: NCT02979483 . [Table: see text]

4108 Background: D (anti-PDL1) plus T (anti-CTLA-4) combination immunotherapy showed encouraging results in hepato-biliary cancers. Its efficacy in non-Asian Pts with pretreated BTC is unknown. Methods: IMMUNOBIL GERCOR-D18-1 PRODIGE-57 was initially a 2-arm, open-label, randomized non-comparative phase II study. Pts with recurrent/advanced pathologically proven BTC (intrahepatic cholangiocarcinoma [iCCA]/extrahepatic CCA [eCCA]/gallbladder cancer [GC]), ECOG PS 0-1, pre-treated with platinum-based CTx were randomized (1:1) to D (1500 mg Q4W) plus T (75 mg Q4W x 4 cycles [T75]) (Arm A) or D plus T in combination with weekly paclitaxel (Arm B). Arm B was closed prematurely for toxicity after inclusion of 10 Pts. The study continued with Arm A only. It was further amended to modify the T schedule (300 mg at cycle 1 [T300], amended Arm A) due to higher efficacy reported in other tumors as compared to T75 mg x 4. The new primary endpoint was the overall survival (OS) rate at 6 months (M6) in amended Arm A (D + T300) with a Fleming two-stage design (H0: 50%, H1: 65%, one-sided alpha: 5%, power: 90%). A total of 100 evaluable Pts were required (efficacy threshold: 59%). We present here the efficacy data of Arm A (D + T75). Results: From 12/2018 to 12/2020, 106 Pts were included in Arm A; 103 were evaluable for OS at M6. Median age was 66 years, 47% were male, 46% had ECOG PS 0, 69%/18%/13% had iCCA/eCCA/GC, 76% had metastatic disease, and 28% had prior tumor resection. First-line CTx was GEMCIS/GEMOX/5-FU-based/other in 63%/22%/4%/11%. The M6-OS rate was 59.2%. With a median follow-up of 12 months (95% Cl 11.4-14.9), the median OS was 8.0 months (95% Cl 5.7-11.7) and median PFS was 2.5 months (95% Cl 2.0-3.2). Complete response (CR) was observed in 2 (1.9%) Pts, partial response (PR) in 8 (7.8%), and stable disease (SD) in 32 (31.1%), resulting in an objective response rate of 9.7% and a disease control rate of 40.8%. Absence of progression (PD, iRECIST) after 2 cycles (M6-OS rate: 84% vs 41%, median OS: 17.9 months vs 4.4 months) and CR/PR as a best overall response (M6-OS rate: 100% vs 84% and 39% for SD and PD, respectively) were associated with markedly prolonged OS. 65 (63.1%) Pts had ≥1 grade 3-4 (G3-4) adverse event (AE) and 22 (21.4%) had ≥1 G3-4 treatment-related AE (TRAE). The most commonly reported G3-4 AEs were fatigue (12.6%), abdominal pain (5.8%), and aspartate aminotransferase increase (5.8%) and G3-4 TRAEs were fatigue (4.9%) and diarrhea (2.9%). One death was possibly related to treatment. Conclusions: Although no statistical conclusions can be drawn from this exploratory analysis of Arm A, D+T75 reached the pre-defined threshold for efficacy, with no unexpected toxicity. Results from amended Arm A (D+T300, N = 106 additional Pts), quality of life, and ancillary studies are pending. Clinical trial information: NCT03704480.

Background and objective : Longitudinal analysis of patient-reported outcome (PRO) data remains challenging, as no standardization of statistical methods has been proposed, making comparison of PRO results between clinical trials difficult. In this context, the time to deterioration approach has recently been proposed and is regularly used as a modality of longitudinal PRO analysis in oncology. Methods : Two new SAS macro programs were developed, %TTD and %TUDD , which implement longitudinal analysis of PRO data according to the time to deterioration approach. These programs implement the recommended deterioration definitions. We described the programs with their different functionalities. Results : The %TTD macro calculates the time to first or transient deterioration, and the %TUDD macro calculates the time until definitive deterioration. These macros allow to obtain the survival variables from the time to deterioration approach. We illustrate our programs by presenting different applications on the randomized phase II AFUGEM GERCOR clinical trial. Conclusion : The implementation of the deterioration definitions in SAS software allows the dissemination of this approach, in order to move toward the goal of standardization of longitudinal PRO analysis in oncology clinical trials.