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.

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.

Cognitive complaints in cancer: The French version of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), normative data from a healthy population.

Cancer patients often report cognitive changes after chemotherapy. The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) is a self-report questionnaire that assesses these changes. The aims of the present study were (1) to establish normative data, and (2) to compare the scores of patients and healthy controls to assess whether or not the questionnaire is able to discriminate between these populations. The normative sample included 213 healthy participants. The patient group included 63 cancer patients treated with chemotherapy, who were compared to a subsample of 63 matched healthy controls. The questionnaire had good internal consistency reliability (Cronbach's alphas = .74-.91). The oldest patients had significantly more cognitive complaints (p < .001). Cognitive complaints were significantly related with Trail Making Test scores (p < .001). Furthermore, the FACT-Cog subscales correlated significantly with anxiety and depression. Patients had more complaints than matched controls on the subscales Perceived Cognitive Impairments (p = .01), Impact on Quality of Life (p = .001) and Perceived Cognitive Abilities (p = .027). The reference values from the healthy population reported here could be used for comparison with the values measured in French-speaking cancer patients. The values provide a benchmark against which clinicians can evaluate the impact of the disease and/or the treatments on cognitive complaints and help to improve quality of life by providing appropriate care.