Cognitive assessment in patients treated by immunotherapy: the prospective Cog-Immuno trial.

BACKGROUND: The discovery of the importance of the immune system and its role in oncogenesis led to the development of immunotherapy, a treatment that represents a major advance in oncology management. Due to the recent nature of immunotherapy, little is known about its side effects and their impact on quality of life. To date, there is no published study that accurately assesses the impact of immunotherapy on cognition, mood and/or fatigue in patients treated for cancer, despite potential neurological toxicities. The purpose of this study is to prospectively assess the incidence of cognitive impairment and cognitive complaints among cancer patients naïve for immunotherapy without concomitant anti-cancer treatment. METHODS: The Cog-Immuno trial is a multicentre longitudinal study addressing patients with cancer candidate to receive immunotherapy alone (n = 100). Immunotherapy treatment will include either anti-PD1/PDL1 or anti-CTLA4 monotherapy or combination therapy. Cognitive and quality of life assessment, electrocardiogram (ECG) and biological tests will be performed at baseline, thereafter 3, and 6 months after immunotherapy initiation. The primary endpoint is the proportion of patients treated by immunotherapy who will experience a decline in cognitive performances or in Montreal Cognitive Assessment (MoCA) score within 3 months after inclusion. Secondary endpoints concern: anxiety, depression, fatigue, clinical characteristics, biological data and neurophysiological measures (heart rate variability and hemispheric lateralization). A pre-clinical study will be conducted in cancer bearing mice receiving checkpoint inhibitors (ICI) with the evaluation of cognitive functions and emotional reactivity, collection of blood samples and investigation of neurobiological mechanisms from brain slices. DISCUSSION: Assessing and understanding the incidence and the severity of cognitive impairment and its impact on quality of life in cancer patients treated by immunotherapy is a major issue. The results of this study will provide information on the impact of these treatments on cognitive functions in order to help the physicians in the choice of the treatment. TRIAL REGISTRATION: NCT03599830, registered July 26, 2018. PROTOCOL VERSION: Version 5.1 dated from 2020/10/02.

Optimisation of chemotherapy prescription and preparation in an ambulatory unit: Validation of the OPTIMA program.

OBJECTIVE: We implemented the two-step OPTIMA program to anticipate chemotherapy prescription which aims to assess the discrepancy rate between anticipated and real prescription and its impact on waiting time and quality of care. METHODS: This prospective study included cancer patients receiving any intravenous chemotherapy. The OPTIMA program consists in a nurse phone call and a blood sample two days before the planned treatment. Collected information and biological results were used by a physician to issue a non-effective (step 1) or effective (step 2) anticipated prescription the day before the consultation. The real prescription was given as usual by another physician on the day of the consultation. Waiting time was collected, and patients' satisfaction with care was assessed with the OUT-PATSAT35 questionnaire. RESULTS: Respectively, 540 and 979 consultations (283 and 294 patients) were analysed in both steps. The discrepancy rate was 8.7% (step 1). In routine practice, the OPTIMA program (step 2) reduced patients' waiting time (median time 55 vs. 95 min, p < 0.001). A high general care satisfaction score was observed in both steps (80.7% and 80.2%). CONCLUSIONS: This anticipation program demonstrated the accuracy of chemotherapy prescription, whatever the regimen and cancer site, and its impact on waiting time optimisation.

Prospective comparison of the Montreal Cognitive Assessment (MoCA) and the Mini Mental State Examination (MMSE) in geriatric oncology.

INTRODUCTION: Among the various instruments recommended by the International Society of Geriatric Oncology, the Mini Mental State Examination (MMSE) is the most commonly used cognitive screening test before oncological treatment. Although the Montreal Cognitive Assessment (MoCA) has been shown to be more sensitive than the MMSE in several pathologies, no specific data exist for older patients with cancer. We aimed to compare the proportions of older patients with cancer who had screened positive for cognitive impairment according to the MMSE and MoCA scores obtained during a pretherapeutic geriatric assessment (GA) in oncology. PATIENTS AND METHODS: This prospective study was conducted among 66 patients older than 70 years who were candidates for a first-line treatment for either a solid tumor or hematological malignancy. Patients with brain tumor or previously known dementia were ineligible. During GA, cognitive function was assessed using both the MoCA and the MMSE tests administered in a random order. RESULTS: Median age was 78 years. Most patients (n = 43, 65.2%) had a solid tumor. The median scores were 26 [11-30] for MMSE and 24 [8-30] for MoCA. Thirteen (19.7%) and 44 (66.7%) patients were screened positive for cognitive impairment according to MMSE and MoCA scores, respectively. Overall, 55 (66.7%) patients were screened positive: 12 (21.8%) on both scores, 32 (70.5%) with the MoCA only, and one patient with MMSE only (p < 0.0001). CONCLUSION: The MoCA test seems to be most relevant to screen for cognitive impairment in older patients with cancer.