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BACKGROUND: There is an immunologic rationale to evaluate immunotherapy in the older glioblastoma population, who have been underrepresented in prior trials. The NUTMEG study evaluated the combination of nivolumab and temozolomide in patients with glioblastoma aged 65 years and older. METHODS: NUTMEG was a multicenter 2:1 randomized phase II trial for patients with newly diagnosed glioblastoma aged 65 years and older. The experimental arm consisted of hypofractionated chemoradiation with temozolomide, then adjuvant nivolumab and temozolomide. The standard arm consisted of hypofractionated chemoradiation with temozolomide, then adjuvant temozolomide. The primary objective was to improve overall survival (OS) in the experimental arm. RESULTS: A total of 103 participants were randomized, with 69 in the experimental arm and 34 in the standard arm. The median (range) age was 73 (65-88) years. After 37 months of follow-up, the median OS was 11.6 months (95% CI, 9.7-13.4) in the experimental arm and 11.8 months (95% CI, 8.3-14.8) in the standard arm. For the experimental arm relative to the standard arm, the OS hazard ratio was 0.85 (95% CI, 0.54-1.33). In the experimental arm, there were three grade 3 immune-related adverse events which resolved, with no unexpected serious adverse events. CONCLUSIONS: Due to insufficient evidence of benefit with nivolumab, the decision was made not to transition to a phase III trial. No new safety signals were identified with nivolumab. This complements the existing series of immunotherapy trials. Research is needed to identify biomarkers and new strategies including combinations.

Sarcopenia is a geriatric syndrome characterized by losses of quantity and quality of skeletal muscle, which is associated with negative outcomes in older adults and in cancer patients. Different definitions of sarcopenia have been used, with quantitative data more frequently used in oncology, while functional measures have been advocated in the geriatric literature. Little is known about the correlation between frailty status as assessed by comprehensive geriatric assessment (CGA) and sarcopenia in cancer patients. We retrospectively analyzed data from 96 older women with early breast cancer who underwent CGAs and Dual X-ray Absorptiometry (DXA) scans for muscle mass assessment before cancer treatment at a single cancer center from 2016 to 2019 to explore the correlation between frailty status as assessed by CGA and sarcopenia using different definitions. Based on the results of the CGA, 35 patients (36.5%) were defined as frail. Using DXA Appendicular Skeletal Mass (ASM) or the Skeletal Muscle Index (SMI=ASM/heightˆ2), 41 patients were found to be sarcopenic (42.7%), with no significant difference in prevalence between frail and nonfrail subjects. Using the European Working Group on Sarcopenia in Older People (EWGSOP2) definition of sarcopenia (where both muscle function and mass are required), 58 patients were classified as “probably” sarcopenic; among these, 25 were sarcopenic and 17 “severely” sarcopenic. Only 13 patients satisfied both the requirements for being defined as sarcopenic and frail. Grade 3-4 treatment-related toxicities (according to Common Terminology Criteria for Adverse Events) were more common in sarcopenic and frail sarcopenic patients. Our data support the use of a definition of sarcopenia that includes both quantitative and functional data in order to identify frail patients who need tailored treatment.

Objectives: We aim to assess short and long term effects of chemotherapy on patient-reported quality of life (QOL) and patient versus clinician symptom reporting in older patients with breast cancer adjusted for tumour and aging parameters. Material and Methods: In this prospective, multicentre, non-interventional, observational study, women aged ≥ 70 years were enrolled after surgery and assigned to a TC chemotherapy (docetaxel and cyclophosphamide) group or a control group depending on their planned adjuvant treatment. Longitudinal multivariate models were used to assess the statistical and minimal clinically important difference (MCID) in the impact of TC chemotherapy over time on QOL and symptom burden adjusted for baseline aging and tumour parameters. Statistical significance was set at 5% and MCID at 10 points. Results: In total, 57 patients were enrolled in the chemotherapy and 52 patients in the control group. Within the chemotherapy group, clinical deterioration was reported at 3 months for Fatigue (17.73), Dyspnoea (17.05), Diarrhoea (12.06) and Appetite Loss (17.05) scores (all p < 0.001). However, the scores had returned to baseline (or even better for Role Functioning) at year 1. No clinical deterioration was reported in the control group. Symptom scores as reported by patients were significantly (p < 0.05) higher than those reported by the clinicians, even more so for Fatigue, Dyspnoea, and Pain. Conclusion: Our results show that symptom burden and diminished QOL in an older breast cancer population receiving adjuvant TC chemotherapy are short-lived and disappear after a while with no long-term differences compared to a similar population not receiving chemotherapy., SCOPUS: ar.j, info:eu-repo/semantics/published

We aim to assess short and long term effects of chemotherapy on patient-reported quality of life (QOL) and patient versus clinician symptom reporting in older patients with breast cancer adjusted for tumour and aging parameters. In this prospective, multicentre, non-interventional, observational study, women aged ≥70years were enrolled after surgery and assigned to a TC chemotherapy (docetaxel and cyclophosphamide) group or a control group depending on their planned adjuvant treatment. Longitudinal multivariate models were used to assess the statistical and minimal clinically important difference (MCID) in the impact of TC chemotherapy over time on QOL and symptom burden adjusted for baseline aging and tumour parameters. Statistical significance was set at 5% and MCID at 10 points. In total, 57 patients were enrolled in the chemotherapy and 52 patients in the control group. Within the chemotherapy group, clinical deterioration was reported at 3months for Fatigue (17.73), Dyspnoea (17.05), Diarrhoea (12.06) and Appetite Loss (17.05) scores (all p<0.001). However, the scores had returned to baseline (or even better for Role Functioning) at year 1. No clinical deterioration was reported in the control group. Symptom scores as reported by patients were significantly (p<0.05) higher than those reported by the clinicians, even more so for Fatigue, Dyspnoea, and Pain. Our results show that symptom burden and diminished QOL in an older breast cancer population receiving adjuvant TC chemotherapy are short-lived and disappear after a while with no long-term differences compared to a similar population not receiving chemotherapy.