ABSTRACT:The phase 2 ALYCANTE trial aimed to evaluate the investigator-assessed complete metabolic response at 3 months from the axicabtagene ciloleucel (axi-cel) infusion as a primary end point in patients with high-risk relapsed/refractory large B-cell lymphoma who are ineligible for autologous stem cell transplantation (ASCT). This study showed a significant improvement in complete metabolic response rate at 3 months based on historical controls. This study reports the health-related quality of life (HRQoL) results as a secondary end point. HRQoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) cancer-specific questionnaire, the Quality of Life Questionnaire high-grade non-Hodgkin lymphoma 29 (QLQ-NHL-HG29) , and the EuroQol Quality of Life Scale-5 dimensions-5 levels of severity (EQ-5D-5L) generic questionnaire at baseline and 1, 3, 6, and 12 months after axi-cel infusion. Among the 62 patients included, 60 (97%) completed a baseline and at least 1 postbaseline HRQoL assessment. At 1 month infusion, adjusted mean change in HRQoL scores from baseline showed a clinically significant deterioration (greater than the clinical threshold) in physical, role, social functioning, and fatigue. However, all HRQoL dimensions recovered by 3 months after infusion and remained stable or continued to improve by 12 months. In an exploratory analysis, adjusted mean change in HRQoL score from baseline in ALYCANTE was similar to or better than in ASCT-eligible patients who received axi-cel in the phase 3 ZUMA-7 trial. Finally, the global health status and fatigue scores of the ALYCANTE population improved to levels comparable to the general French population of similar age by 3 months after infusion. These findings indicate that axi-cel improves HRQoL regardless of transplant eligibility, supporting its use across a broad patient population. This trial was registered at www.clinicaltrials.gov as #NCT04531046.

BACKGROUND:QUALIOR-phase 2 multicenter trial explored the feasibility of a home-based supervised physical exercise program (SPEP) in metastatic cancer patients receiving oral targeted therapies. METHODS:Patients with metastatic cancers receiving oral targeted therapies were randomized (2:1) to a 3-month home-based SPEP (with a coach at home) or recommended adapted physical exercises (booklet). Primary endpoint was feasibility defined as the rate of patients who performed at least 50% of the theoretically planned sessions in the SPEP arm. Main secondary endpoints were fatigue and pain evaluated by visual analogue scales (VAS) during the program. RESULTS:Among 112 patients, 74 and 38 were included in the SPEP and control arms, respectively. Median age was 59 (range: 31-83) years and the majority of patients were women. Main primary tumor location was breast (57%) and kidney (16%). Thirty-three (30%) patients were treated with anti-angiogenic tyrosine kinase inhibitors, and 53 (47%) received epidermal growth factor receptor or cell cycle inhibitors. Forty-five (61%) patients performed at least 50% of the SPEP. Median fatigue decreased from 4 to 3 (range: 0-10) after 3 months in the SPEP group with maintain of pain control. The percentage of patients with high level VAS of fatigue at 3 months was lower in SPEP arm than in the control arm (27% vs. 62%, P = .004). CONCLUSIONS:QUALIOR showed that SPEP with a coach at home was feasible in patients with metastatic cancers treated with oral targeted therapies. This program could mitigate the fatigue induced by oral targeted therapies.

Introduction En France, plusieurs stratégies nationales évoquent l’importance de repérer et d’accompagner les proches aidants. Étant donné l’impact multidimensionnel majeur de la situation d’aidance en cancérologie, le centre de lutte contre le cancer (CLCC) de Lyon, a implémenté une consultation dédiée à l’évaluation des besoins des proches aidants et à leur accompagnement. La présente étude vise à recueillir l’adhésion des proches aidants à cette consultation et à décrire ses spécificités. Méthode Les données ont été recueillies à l’aide d’auto-questionnaires et de formulaires de récolte de données. Résultats Le taux d’adhésion des 45 participants est élevé (96 %). Ils sont majoritairement venus sur recommandation des professionnels du centre ou grâce à la communication autour de la consultation, avec pour principal motif de faire « le point sur sa situation avec des professionnels ». Deux besoins sont ressortis de la consultation, liés au « soutien psychologique ou psychiatrique » et à « l’information sur les traitements et/ou l’organisation des soins du proche malade ». Pour répondre à ces besoins, les proches aidants ont été orientés majoritairement vers des professionnels (ex. médecins, psychologues) ou des associations. Conclusion L’accompagnement des proches aidants en cancérologie est une réelle préoccupation dans le cadre des parcours de santé et de soins et représente un enjeu de santé publique majeur en termes de prévention. Cette étude révèle une adhésion élevée des proches aidants à une consultation dédiée. Elle fournit des éléments encourageants pour poursuivre son développement et proposer aux proches aidants un accompagnement ajusté à leurs besoins.

INTRODUCTION:In France, several national strategies have highlighted the importance of identifying and supporting informal caregivers. Given the major multidimensional impact of the caregiving situation in cancerology, the Cancer Center in Lyon, has set up a consultation dedicated to assessing the needs of informal caregivers and providing them with support. The aim of the current study is to assess the uptake of this consultation by informal caregivers and to describe its specific features. METHOD:Data were collected using self-questionnaires and data collection forms. RESULTS:The 45 participants had a high take-up rate (96%). Most of them came on the recommendation of the center's professionals or thanks to the communication surrounding the consultation, with the main reason being to "take stock of their situation with professionals". Two needs emerged from the consultation, relating to 'psychological or psychiatric support' and 'information on treatments and/or the organisation of care for their sick relative'. To meet these needs, the majority of informal caregivers were referred to professionals (e.g. doctors, psychologists) or associations. CONCLUSION:Support for informal caregivers in cancerology is a real concern in the context of health and care pathways, and represents a major public health issue in terms of prevention. This study shows a high level of adherence among informal caregivers to a dedicated consultation. It provides encouraging evidence for continuing to develop this service and offering support tailored to the needs of informal caregivers.

AbstractChimeric antigen receptor T cells (CAR T cells) can induce prolonged remission in a substantial subset of patients with relapse/refractory lymphoma. However, little is known about patients' life after CAR T‐cell therapy. We prospectively assessed the multidimensional recovery of lymphoma patients in remission, before leukapheresis, before CAR T‐cell infusion, and 3, 6, and 12 months thereafter. Validated tools were used to measure lymphoma‐related and global health‐related quality of life (HRQoL; Functional Assessment of Cancer Therapy‐Lymphoma [FACT‐Lym] and EQ‐5D‐5L), cognitive complaint (FACT‐Cognition), fatigue (FACIT‐Fatigue subscale), psychological status (Hospital Anxiety and Depression Scale, Post‐Traumatic Check List Scale), and sexuality (Relationship and Sexuality Scale). Beyond 12 months of remission, we also surveyed physical, professional, sexual, and general life status. At 3, 6, and 12 months, 53, 35, and 23 patients were evaluable, respectively. Improvement in lymphoma‐related HRQoL was clinically relevant at 3, 6, and 12 months with a mean change from baseline of 10.9 (95% confidence interval [CI]: 5.8; 16.1), 12.2 (95% CI: 4.2; 20.1), and 11.72 (95% CI: 2.06; 21.38), respectively. Improvement in global HRQoL, fatigue, and anxiety was clinically relevant, but 20%–40% of patients experienced persistent fatigue, psychological distress, and cognitive complaints over time. Beyond 12 months after CAR T cells, 81.8% of 22 evaluable patients were satisfied with their daily life. Physical activity, professional, sexual, and global well‐being had returned to prediagnosis levels in nearly half of the patients. We found an improvement in HRQoL after CAR T‐cell therapy including anxiety, depression, sexual satisfaction, and general well‐being. However, not all patients recover a “normal life.” Further research is needed to determine which patients are at risk of quality‐of‐life impairment to improve recovery after CAR T‐cell infusion.

This study assessed the influence of intrapersonal (one’s own emotions) and interpersonal (emotions of others) emotional competence (EC) of informal caregivers on their quality of life (QoL) at the beginning of cancer care. Participants completed two questionnaires assessing their intrapersonal and interpersonal EC (S-PEC) as well as their QoL (SF-36) at the beginning of treatments. Multivariate ANCOVA regression analyses were then performed to explore the influence of EC on QoL. The questionnaires were completed by 203 caregivers. As expected, intrapersonal EC was associated with a better QoL in all sub-dimensions (p < 0.01). More surprisingly, interpersonal EC was associated with worse QoL in terms of physical role (− 8.97 [95

This cross-sectional study explored the associations between intrapersonal and interpersonal emotional competence (EC) and the unmet supportive care needs (SCN), anxiety, and depression of informal caregivers at the beginning of gastrointestinal or haematological cancer care, i.e. during chemotherapy and within 6 months after diagnosis. The participants completed a self-reported questionnaire, comprising the Short Profile of Emotional Competence (S-PEC), the SCN survey for partners and caregivers (SCNS-P C), and the Hospital Anxiety and Depression Scale (HADS). Multivariate logistic regression models were performed to explore the influence of EC on unmet SCN and the presence of moderate/severe anxiety or depression. Most of the 203 caregivers were women (n = 141, 69.80

IntroductionAdolescent and young adult (AYA) survivors who have been treated for cancer during childhood and adolescence are at great risk of the physical, psychological, and social consequences of cancer and its associated treatments. However, compliance with long-term follow-up is low. One possible explanation is that follow-up care fails to meet the expectations of AYA survivors. This study explored the specific supportive care needs of AYA survivors of childhood and adolescent cancer five years post-diagnosis.MethodsSemi-structured interviews were conducted with 15 AYA aged 15 to 25 years old. Thematic analyses were conducted to establish categories of supportive care needs and classify them as being met or unmet.ResultsParticipants reported between 2 and 20 specific needs (M = 11), including needs concerning fertility issues and reassurance regarding relapse (each mentioned by 67% of AYA), followed by the need for locomotor care, follow-up coordination and multidisciplinary care (60% of AYA for each). Participants also reported needs regarding social relationships, administration and finance, and academic and professional domains. Most (69%) of these needs were reportedly unmet, including need of information about cancer repercussions and follow-up, support in managing fatigue and sleep problems, psychological assistance, and support from peers.DiscussionThe supportive care needs are still considerable and varied in AYA survivors of childhood and adolescent cancer 5 years post-diagnosis and are largely unmet. As unmet supportive care needs highlight the gap between available care in follow-up and the real needs of AYA survivors, a better understanding of their supportive care needs and unmet needs, thanks to systematic needs assessment, would enable long-term follow-up care to be adapted, thereby improving compliance and quality of life.

Introduction: The ALYCANTE phase II trial, a LYSA study (ClinicalTrials.gov number NCT04531046), aimed to evaluate the investigator-assessed complete metabolic response at 3 months from the axi-cel infusion as a primary endpoint in patients with high-risk relapsed/refractory large B-cell lymphoma who are ineligible for autologous stem cell transplantation (Houot et al, Nature Medicine 2023). This study showed a significant improvement in complete metabolic response rate at 3 months based on historical controls (primary endpoint). However, there is little data on health-related quality of life (HRQoL) in this population of frail patients treated with CAR T-cells. The present study reports the HRQoL results as a secondary endpoint. Methods: HRQoL was assessed using the EORTC QLQ-C30 cancer-specific questionnaire, the QLQ-NHL-HG29 high grade non-Hodgkin lymphoma module, and the EQ-5D-5L generic questionnaire at baseline, immediately before lymphodepletion, and at 1, 3, 6, 12, 24 and 36 months after CAR-T cell infusion. HRQoL scores were reported using mean and 95% confidence interval (95% CI) at baseline and at 3 months after infusion. Proportion of patients with deteriorated, stable and improved HRQoL at 3 months was reported for each HRQoL score. Adjusted mean change in HRQoL level using mixed model for repeated measure (MMRM) was described at each follow-up time up to 12 months and compared to baseline with a 95% CI. Clinically relevant change was defined as a change of at least 10 points for the QLQ-C30 and QLQ-NHL-HG29, 7 points for the EQ-5D-5L visual analogue scale (VAS), and 0.06 points for the EQ-5D-5L utility score. Unadjusted comparisons between ALYCANTE and ZUMA-7 phase III trial (Axi-cel arm) results were done as exploratory analysis at similar timepoints. Three dimensions (EORTC QLQ-C30 global health status, physical functioning and EQ-5D-5L VAS) were prespecified for the MMRM analyses. Results: Among the 62 patients included in the ALYCANTE trial, 61 patients (98%) completed baseline and at least one post-baseline HRQoL evaluation. Patients presented a lower symptomatic level (lower HRQoL score) at 3 months compared to baseline with a clinically significant difference (greater than the clinical threshold of 10 points) for pain (mean = 11.9 [95% CI 5.4;18.4] at 3 months vs 25.1 [95% CI 17.7;32.6] at baseline), emotional impact (mean = 12.9 [95% CI 8.6;17.2] vs 23.8 [95% CI 17.9;29.6]) and worries/fears about health and functioning (mean = 22.1 [95% CI 16.8;27.3] vs 33.0 [95% CI 27.2;38.8]). At 1 month post-infusion, we observed a clinically and statistically significant deterioration (greater than the clinical threshold) in HRQoL for 4/22 dimensions and stable states (i.e. within the pre-defined clinical threshold) for the other 18/22 dimensions compared to baseline. Regarding the three prespecified dimensions, patients presented a significant deterioration for physical functioning (adjusted mean = -14.2 [95% CI -19.7;-8.7]) and stable states for global health status (-5.9 [95% CI -10.3;-1.5]) and VAS (0.4 [95% CI -4.0;4.7]) compared to baseline. At 3 months post-infusion, 45% of patients (N=18) and 73% of patients (N=30) presented a stable global health status and physical functioning, respectively, and 58% of patients (N=22) experienced an improvement in VAS compared to baseline. At 12 months, we observed a clinically and statistically significant improvement in HRQoL for 3/22 dimensions, including VAS (15.4 [95% CI 10.2;20.6]), and stable states in all other dimensions. In the exploratory analyses, baseline HRQoL level was similar between ALYCANTE and ZUMA-7, except for VAS (meanALYCANTE = 63.5 [95% CI 58.7;68.3] vs meanZUMA-7 = 72.4 [95% CI 69.5;75.2], with a difference exceeding the 7 points) in favor of ZUMA-7 patients and utility score (meanALYCANTE = 0.87 [95% CI 0.82;0.92] vs meanZUMA-7 = 0.80 [95% CI 0.77;0.84], with a difference exceeding the 0.06 points) in favor of ALYCANTE patients. Regarding the MMRM analysis for the three prespecified dimensions, similar results were observed over time between ALYCANTE and ZUMA-7. Conclusions: Transplant-ineligible patients with high-risk relapsed/refractory large B-cell lymphoma treated with Axi-cel in second-line experienced an initial deterioration of HRQoL at 1 month after CAR-T cell infusion in a few dimensions, followed by either a return to the baseline score (stability) or an improvement after 3 months.

The main objective was to assess the link between emotional competence (EC) and adjustment outcomes such as supportive care needs (SCN) and anxious-depressive symptoms in cancer patients starting chemotherapy. The second objective was to assess the interaction effect between EC and the COVID-19 pandemic (i.e. patients included before or during the pandemic) on these outcomes. At the beginning of care, 255 patients with digestive or hematological cancer, recruited before the pandemic began (n = 156, 61.2%) or during the pandemic (n = 99, 38.8%), completed the Short Profile of Emotional Competence, the Hospital Anxiety and Depression Scale, and the Supportive Care Needs Survey Short Form. Partial correlations and multiple regressions were used. Intrapersonal EC showed negative significant correlations with psychological unmet SCN (r = -.32, p < .001), anxiety (r = -.37, p < .001), and depression (r = -.46, p < .001). Interpersonal EC showed only significant interaction effects (p < .05): it was only associated with fewer unmet physical and daily SCN (p < .002) and fewer depressive symptoms (p < .004) during pandemic. Results show significant associations between intrapersonal EC and better adjustment of cancer patients from the early stage of care. Interpersonal EC seems to be a significant resource to deal with illness only in difficult contexts such as the COVID-19 pandemic.

Background:Sunitinib, a multitarget tyrosine kinase inhibitor, showed encouraging antitumor activity and manageable toxicity in patients with advanced midgut neuroendocrine tumors (NETs) in earlier results from phase I and II trials. Patients and methods:In this phase II trial, patients with a nonresectable grade 1 or 2 midgut progressive NET and Eastern Cooperative Oncology Group performance status 0-1 were randomly assigned 1:1 to receive 37.5 mg sunitinib or a placebo, combined with 120 mg lanreotide autogel every 28 days. The planned sample size was 104 patients. The primary outcome was investigator-assessed progression-free survival (PFS). Results:The study was stopped early because of insufficient patient recruitment. Between January 2013 and December 2016, 44 patients were enrolled and received sunitinib (n = 22) or placebo (n = 22). The median age was 63.7 years (Q1-Q3 range, 56.6-68.1) and 26 patients (59.1%) were male. The main localization was ileum (N = 37, 84.1%) and the majority were grade 2 (n = 25, 56.8%). The median follow-up was 36.7 months (95% confidence interval (CI) 34.6-48.2). The median PFS was 9.84 months (95% CI 6.8-23.3) with sunitinib and 11.47 months (95% CI 5.4-15.3) with placebo (hazard ratio (HR) = 0.80, 95% CI 0.41-1.56, p = 0.51). There was no difference in overall survival between treatment arms (HR = 0.81, (95% CI 0.32-2.01), p = 0.64). The objective response rate was 9.1% with sunitinib and 0.0% with placebo, and 19 patients (86.4%) had stable disease. Thirty-nine patients (88.6%) completed the baseline QLQ-C30 questionnaire. Baseline health-related quality of life level was similar between treatment arms, except for physical and emotional functioning which were higher (p = 0.089) and lower (p = 0.023) in the sunitinib arm, respectively. Trends toward longer time until a definitive deterioration in favor of the sunitinib arm were observed for 10 out of 15 dimensions (HRs < 1), with a significant result for financial difficulties (HR = 0.31, (90% CI 0.10-0.94)). Twenty-seven patients (61.4%) had at least one adverse event grade ⩾3 (sunitinib: 72.7%, placebo: 50.0%), with only one patient grade 4 for hypertension and vomiting. Eleven deaths non-related to treatment occurred (sunitinib arm: n = 5, placebo arm: n = 6). Conclusion:Our study does not provide enough evidence to conclude the role of sunitinib in advanced midgut NETs, primarily due to a lower-than-expected number of enrolled patients. While we cannot entirely rule out the efficacy of sunitinib, lanreotide alone may play a significant role. Trial registration:EudraCT: 2012-001098-94.

INTRODUCTION:Considering the notable advances made in the treatment of lymphoma, assessment of health-related quality of life (HRQoL) of lymphoma patients has become a critical aspect to consider both in clinical research and routine practice. However, there is paucity of information about lymphoma specific HRQoL profile at diagnosis. PATIENTS AND METHODS:HRQoL at diagnosis was assessed for 3922 adult patients with newly diagnosed high-grade (HG) (n = 1994), low-grade (LG) (n = 1053) non-Hodgkin (NHL) and Hodgkin (HL) (n = 875) lymphomas included in REal world dAta in LYmphoma and Survival in Adults (REALYSA, NCT03869619), a prospective non-interventional multicentric cohort in France. Disease-specific HRQoL aspects were assessed with three validated EORTC questionnaires, namely, the QLQ-NHL-HG29, the QLQ-NHL-LG20 and the QLQ-HL27, for patients with NHL-HG, NHL-LG and HL, respectively. RESULTS:We confirmed the high-level of completion of these questionnaires in REALYSA cohort, ranging from 84 % for QLQ-HG29 to 88 % for QLQ-HL27. The proportion of patients with impaired global health status was as follows: T-cell NHL, 67 %; diffuse large B-cell (DLBCL), 62 %; Burkitt, 61 %; HL, 53 %; marginal zone, 49 %; mantle cell, 48 %; follicular, 47 %. Multivariable regression analyses for DLBCL, follicular and HL showed that gender, performance status and B symptoms were independently associated with all HRQoL dimensions. However, a variable effect of age and stage were observed among these three subtypes. CONCLUSIONS:A comprehensive analysis was made describing the HRQoL profile of newly diagnosed patients with different types of lymphomas. Our data may help to enhance the interpretation of HRQoL results in future studies using the recently validated EORTC lymphoma specific questionnaires.

Introduction Peu de données sur la qualité de vie (QdV) sont disponibles pour les patients atteints de lymphome diffus à grandes cellules B (DLBCL) au cours de la première année du diagnostic notamment l'adaptabilité des patients par rapport à leur état de santé pouvant entrainer un effet de changement de réponse (« response shift », RS). Cette étude a pour objectif de décrire le niveau de QdV des patients DLBCL au moment du diagnostic et à un an, et d’évaluer l'occurrence potentielle d'un effet RS. Méthodes La population d'analyse correspond à l'ensemble des patients porteurs de DLBCL inclus dans la cohorte multicentrique française REALYSA («REal world dAta in Lymphoma and Survival in Adults »), ayant reçu un schéma standard d'immunochimiothérapie de première ligne, vivant et indemne de rechute à un an (afin d’éviter tout biais lié à une seconde ligne pouvant impacter la réponse au questionnaire) avec des données de QdV disponible à l'inclusion et à un an. La QdV a été mesurée au moment du diagnostic et à un an par les questionnaires EORTC QLQ-C30 et QLQ-NHL-HG29. Le questionnaire spécifique QLQ-NHL-HG29 récemment validé évalue cinq dimensions symptomatiques. La prévalence des problèmes/symptômes cliniquement importants sur les échelles QLQ-C30 a été reportée en utilisant les seuils validés (Giesinger et al. J Clin Epidemiol. 2020). Un modèle de régression multivariable a été réalisé pour expliquer le score de QdV à un an en fonction de l’âge, le genre, le stade Ann Arbor, le « performance status », la présence de symptôme B et le score de QdV à l'inclusion. L'occurrence d'un effet RS a été explorée par la procédure d'Oort en utilisant des modèles à équations structurelles (Oort, Qual Life Res, 2005). La recalibration (i.e., changement dans les références internes) et le changement de valeurs (i.e., importance des différentes dimensions) sont les deux composantes de RS explorées parmi les dimensions fonctionnelles du QLQ-C30 et symptomatiques du QLQ-NHL-HG29. Résultats De novembre 2018 à décembre 2021, 3116 patients ont été inclus dans REALYSA, dont 1198 (38 %) DLBCL. Parmi les 964 patients sans rechute à un an, 523 (54 %) ont rempli les questionnaires à l'inclusion et à un an. La médiane d’âge des patients était de 65 ans (range 19-93). A l'inclusion, 57,2 % présentaient une QdV globale altérée contre 42,6 % à un an. Les modèles de régression montraient que le score à un an était principalement associé au genre et à la présence de symptômes B, au-delà du score à l'inclusion. Parmi le QLQ-NHL-HG29, l'effet RS le plus élevé a été observé pour la neuropathie, suggérant qu'il n'y a pas d'augmentation du niveau de NP à un an par rapport à l'inclusion (changement moyen de -1 point (SD=1)). Si l'effet RS n'avait pas été pris en compte, nous aurions conclu que le niveau de NP avait augmenté à un an par rapport au diagnostic (changement moyen observé de 12 points (SD=11)). Une recalibration (coefficient=14,66) et une augmentation de l'importance de cette dimension (coefficient=-1,51) ont été identifiées par le modèle de Oort. Conclusion Ces résultats sont les premiers obtenus sur une cohorte de vraie vie de patients DLBCL avec un questionnaire spécifique sur les lymphomes. Nous avons montré qu'un effet RS était observé pour plusieurs dimensions de QdV. Cet effet peut avoir des conséquences importantes en termes d'interprétation de l’évolution de la QdV au cours du temps. Ces résultats seront utiles pour la pratique clinique et la conception de futures études axées sur la QdV.

Topic: 35. Quality of life and palliative care Background: CD19 CAR-T cells have been approved for the treatment of relapse/refractory (R/R) lymphoma. Although CAR T-cells are able to induce prolonged remission (and potentially cure) in a significant number of patients, little is known about patients’ life after CAR-T cells. Here, we conducted a prospective study to evaluate health-related quality of life (HRQol), as well as physical, social and professional outcomes after CAR-T cell therapy. Aims: Primary objective was to describe HRQol changes during the first year after CAR-T cell treatment. Secondary objectives were to describe psychological factors and to evaluate satisfaction about normal life recovery. Methods: This prospective study was conducted at the University Hospitals of Rennes and Toulouse (France). All adult patients with R/R lymphoma treated with CAR T-cells, including Axicabtagene ciloleucel (axi-cel), Tisagenlecleucel (tisa-cel) and Brexucabtagene autoleucel (brexu-cel), were eligible. HRQol changes were assessed using the FACT-Lym questionnaire. Other questionnaires evaluated cognitive state (FACT-Cog), fatigue (FACT-Fatigue), anxiety and depression (HAD scale), post-traumatic stress disorder (PTSD), and sexuality (VICAN). Questionnaires were collected at baseline (before leucapheresis), immediately before CAR-T infusion, 3, and 6 months after CAR T-cell infusion. Patients were censored in case of relapse or death. Among patients in remission after 12 months, professional, physical, social, sexual and global life information were collected. Results: From March 2020 to August 2022, 59 patients were included in the study, including 46 LBCL (78.0%), 5 MCL (8.5%) and 8 FL (13.5%). Median age was 63 years (range, 19-78). Patients were treated with axi-cel (n=37, 62.7%), tisa-cel (n=18, 30.5%) or brexu-cel (n=3, 5.1%). The median follow-up after CAR T-cell infusion was 11 months. At 3 months and 6 months respectively, there were 53 and 38 patients still in remission. The FACT-Lym score showed a clinically relevant improvement of HRQoL at 3 and 6 months after CAR T-cell infusion, with a mean change from baseline of 10.94 points (95%CI 5.83;16.05) and 12.16 (95%CI 4.19;20.12), respectively. The fatigue subscale showed a clinically relevant improvement at 3 and 6 months, with a mean change from baseline of 5.87 points (95%CI 2.93;8.8) and 4.70 (95%CI 0.2;9.2), respectively. The FACT-Cog score did not show any clinically relevant change for perceived cognitive impairments. The HAD score showed that 43% and 24% of patients presented anxiety and depression at baseline, respectively, versus 26% and 7% after 6 months. Overall, 26% of patients presented a significant PTSD (i.e. >44) at 6 months. Sexual life satisfaction improved from 30% at baseline to 50% after 6 months. After 12 months with a median follow-up of 19 months, 22 patients were in remission. Among the working age population (n=10), 50% patients returned to work in a median time of 9 months (range, 3-13). All patients practiced a physical activity again, although less intensively. Overall, 54% of patients felt less fit than before initial diagnosis. Three patients out of 8 (37.5%) return to their social activity. Most patients were satisfied with their sexual life (68.2%) and, in comparison with before initial diagnosis 59.1% considered that it was back to normal. Overall, 54.5% of the patients considered that their life was back to normal, i.e. similar to what it was before lymphoma diagnosis. These results are shown in the figure below. Summary/Conclusion: Our study shows an clinically significant improvement in HRQol after CAR-T cells therapy with an improvement in anxiety, depression, sexual satisfaction.. Nevertheless, half of the working age population returned to work and 54% considered their life back to normal.Keywords: Lymphoma, Quality of life, CAR-T

BACKGROUND:Investigation of the disparities in the access to experimental treatment in early-phase clinical trials is lacking. The objective of the EGALICAN-2 study was to identify the factors underpinning such inequalities. METHODS:A national prospective survey was conducted in 11 early-phase clinical trial centers (CLIP2) certified by the French National Cancer Institute. Sociodemographic, socioeconomic and medical data were collected. Univariate logistic regression models were carried out to estimate odds ratios and 90% confidence intervals associated with the effect of each study variable. A multivariate logistic regression model was built to explore the independent factors associated with the administration of the experimental treatment (C1D1). A post hoc analysis was carried out excluding female cancer patients. RESULTS:Between 2015 and 2016, 1355 patients referred from 11 CLIP2 centers in France were included in the study. Eight hundred and forty-eight patients received C1D1 (73%) and 320 patients (27%) were screening failure. Median age was 58 years (range 17-97 years) and 667 patients (54%) were female. Most patients had a metastatic disease (n = 751, 87%). In the multivariate logistic regression analysis, the significant independent factors associated with C1D1 were male sex, initial care received in a hospital with an early-phase unit and living in wealthy metropolitan areas (P values <0.05). In the post hoc analysis, the sex factor was no longer significant [odds ratio = 1.21 (95% confidence interval 0.86-1.70), P value = 0.271]. CONCLUSIONS:This study investigated the factors producing social inequalities in the context of early-phase clinical trials in oncology. Our research highlights factors of sex, care pathway and geographic location. Gynecological cancer was found to impact C1D1 significantly, unlike breast cancer. The results of this study should contribute to improve patient access to early-phase clinical trials.

Objectives: To apply the estimand framework in time to deterioration (TTD) analysis of patient-reported outcomes (PROs), and iden-tify the appropriate statistical methods to deal with intercurrent event (IEs) such as death. Study Design and Setting: Data from phase II randomized trial were used. We estimated TTD using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 questionnaire with death as the IE, by applying Kaplan -Meier (K.M.) estimator and Cox proportional hazards (PH) model. The Fine-Gray approach was explored, accounting for death as a competing risk. The estimands targeted by the aforementioned methods were defined. Results: We analyzed the data of 64 patients with available questionnaires at baseline. The most notable differences in TTD estimates were observed for deterioration in physical functioning: the hazard ratios were 0.44 [95% CI 0.22-0.90] and 0.62 [95% CI 0.36-1.07] by either ignoring death (31 events) or considering it as deterioration (58 events), respectively (Cox-PH model). When considering death as a competing event (Fine-Gray model), the sub-HRs was 0.51 [95% CI 0.26-1.01]. Conclusion: Depending on the proportion and distribution of deaths occurring before deterioration between arms, the Fine-Gray competing risks model should be considered rather than KM estimator and Cox PH model to reflect the patient's experience of the disease and treatment burden. (c) 2023 Elsevier Inc. All rights reserved.

Introduction: Few quality of life (QoL) data are available for diffuse large B-cell lymphoma (DLBCL) patients during the first year of diagnosis. Due to the disease and treatment, patients can adapt to their condition and then change their criteria to assess QoL over time, resulting in a response shift (RS) effect. This study aims to provide QoL level for DLBCL patients at diagnosis and after 1 year, and to assess the occurrence of a RS effect. Methods: Data from DLBCL patients prospectively included in the French multicentric cohort REALYSA were used. QoL was collected at diagnosis and at 1 year using the EORTC QLQ-C30 and QLQ-NHL-HG29 (non-Hodgkin high-grade lymphoma) questionnaires. The recently validated QLQ-NHL-HG29 specific questionnaire assesses 5 symptomatic dimensions: symptom burden (SB), neuropathy (NP), physical condition/fatigue (PC), emotional impact (EI), worries/fears about health and functioning (WF). A score is generated per dimension on a 0 to 100 scale. Analyses were done on patients who received standard first-line immunochemotherapy regimen, with QoL questionnaire at diagnosis and at 1 year, and without relapse before 1 year questionnaire completion to avoid bias related to second line therapy. Scores were reported according to age, gender, performance status (PS) and disease stage. We examined the prevalence of clinically important problems/symptoms on QLQ-C30 scales at patient level using validated thresholds (Giesinger et al. J Clin Epidemiol. 2020). The potential occurrence of a RS effect was explored using the Oort procedure. Results: Between Nov 2018 and Dec 2021, 3116 patients were enrolled in REALYSA including 1198 DLBCL. Among 964 patients without relapse at 1 year, 523 had completed questionnaires at baseline and 1 year. For Global QoL, 57% of patients presented clinically important problems at baseline and 42% at 1 year. Regarding the QLQ-NHL-HG29, the mean PC score was 32 (SD 25) [PS 0–1 vs. 2: 29 (SD 24) vs. 47 (SD 25)] at baseline and 23 (SD 21) [PS 0–1 vs. 2: 22 (SD 20) vs. 27 (SD 22)] at 1 year; the mean NP score was 12 (SD 20) [PS 0–1 vs. 2: 11 (SD 19) vs. 16 (SD 26)] at baseline and 23 (SD 28) [PS 0–1 vs. 2: 23 (SD 27) vs. 24 (SD 29)] at 1 year. Among the QLQ-NHL-HG29, a RS effect was observed for NP, PC and WF. The highest effect was observed for NP (Figure 1), suggesting that there is no increase in NP level at 1 year compared to baseline (mean change of -1 points (SD 1)). If no RS effect was considered, it would have been concluded that the NP level had increased at 1 year compared to diagnosis (mean change of 12 points (SD 11)). The research was funded by: Institut National du Cancer (INCa, N°2021-130) Keyword: Aggressive B-cell non-Hodgkin lymphoma No conflicts of interests pertinent to the abstract.

Introduction: The existing literature shows a significant impact of cancer on caregivers' quality of life (QoL) and divergent results according to associated factors. To better understand the experience of cancer patients' care-givers, the present study aimed at comparing caregivers' QoL according to cancer care pathway and type of cancer, and at identifying the factors associated with their QoL. Methods: Caregivers were included in the study either during chemotherapy or follow-up to assess their QoL (CARGOQoL), unmet supportive care needs (SCNS-P&C), and anxiety and depression levels (HADS). CARGOQoL scores were then compared using ANOVA or Mann-Whitney non-parametric tests (objective 1). Based on uni-variate analyses, a multivariate analysis of covariance or linear regression model was performed for each CARGOQoL dimension (objective 2). Results: Among 583 participants (57.29% included during the follow-up phase), 523 completed the question-naires. There was no effect of treatment phase and little effect of cancer site or disease stage on caregivers' QoL. Although significant factors associated with caregivers' QoL varied according to the dimensions assessed, the main associated factors were psychological experience (p < 0.05), satisfaction with the patient's care and sup-portive care needs (p < 0.01), and age of the patient or caregiver (p < 0.005). Conclusion: This study shows the necessity to support caregivers during both active treatment and follow-up. It highlights the crucial role of emotional distress, supportive care and age in caregivers' QoL, regardless of the patients' oncological status.