Background
Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. Ageing greatly contributes to sarcopenia as may many other factors such as cancer or androgen deprivation therapies (ADT). This cohort study aims to evaluate (1) the prevalence of muscle disorders and sarcopenia in older patients before initiation of intermediate to high risk prostate cancer treatment with ADT and radiotherapy, and (2) the occurrence and/or aggravation of muscle disorders and sarcopenia at the end of cancer treatment.
Methods
This cohort study is monocentric and prospective. The primary objectives are to determine the risk factor of sarcopenia prevalence and to study the relationship between ADT and sarcopenia incidence, in patients 70 years and older with histologically proven localized or locally advanced prostate cancer, addressed to a geriatrician (G8 score ≤14) for comprehensive geriatric assessment (CGA) in Marseille University Hospital. Secondary objectives encompass, measurement of sarcopenia clinical criteria along prostate oncological treatment; evaluation of the quality of life of patients with sarcopenia; evaluation of the impact of socio-behavioral and anthropological factors on sarcopenia evolution and incidence; finally the evaluation of the impact of ADT exposure on sarcopenia. Sarcopenia prevalence was estimated to be between 20 and 30%, therefore the study will enroll 200 patients.
Discussion
The current guidelines for older patients with prostate cancer recommend a pelvic radiotherapy treatment associated to variable duration (6 to 36 months) of ADT. However ADT impacts muscle mass and could exacerbate the risks of sarcopenia. Our study intends to assess the specific effect of ADT on sarcopenia incidence and/or worsening as well as to estimate sarcopenia prevalence in this population. The results of this cohort trial will lead to a better understanding of sarcopenia prevalence and incidence necessary to further elaborate a prevention plan.
Trial registration
The protocol was registered to the French drug and device regulation agency under the number 2019-A02319-48, before beginning the study (11/12/2019). The ClinicalTrials.gov identifier is NCT04484246, registration on the ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04484246).
PurposeFew studies are currently available among elderly patients, justifying the need for better understanding of daily medical practices in terms of use of growth factors to prevent chemotherapy (CT)-induced neutropenia. The primary objective of this study was to describe the use of filgrastim in the elderly.MethodsCancer patients aged 65 years and above, undergoing CT and initiating a prophylactic treatment with filgrastim, were enrolled. Patients were followed according to routine medical practice from filgrastim initiation until the end of the CT or after a maximum of 6 cycles.ResultsOne thousand one hundred nineteen evaluable patients were documented in the study (mean age 73.9 ± 6.2 years, 52.1% men). The majority were suffering from solid tumor (73%) with ECOG 0–1 for 80% of them. Approximately two-third had a global risk for FN ≥ 20%, and one third < 20%. Through all CT cycles, no differences were observed between age classes ([65–74], [75–85], or > 85) in dose, duration, and time to first injection from CT start. Most patients (84%) received primary prophylaxis (PP) and 70% were administered during the first CT cycle. The median time from CT start until filgrastim was 4 days. The median duration of filgrastim treatment was 5 days. Dose reductions and CT delays were less frequent in patients receiving PP (4.8% and 7.1% respectively) than secondary prophylaxis (9.2% and 13.3% respectively).ConclusionsFilgrastim use was consistent with French Market Authorization terms. No difference was shown compared with younger patients. Safety data were consistent with the known safety profile.Electronic supplementary materialThe online version of this article (10.1007/s00520-019-04725-0) contains supplementary material, which is available to authorized users.
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