ABSTRACT
INTRODUCTION: Precariousness has been associated with an increase in breast cancer mortality, but the links between precariousness, stage at diagnosis and care pathways are little explored. The objective of the DESSEIN study was to assess the impact of precariousness on disease and care pathways. METHODS: Prospective observational study in Île-de-France comparing precarious and non-precarious patients consulting for breast cancer and followed for 1 year. RESULTS: In total, 875 patients were included between 2016 and 2019 in 19 institutions: 543 non-precarious patients and 332 precarious patients. Precarious patients had a more advanced stage at diagnosis (55% T1 vs. 63%, 30% N+ vs 19%, P=0.0006), had a higher risk of not receiving initially planned treatment (4 vs. 1%, P=0.004), and participated less in clinical trials (5 vs. 9%, P=0.03). Non-use of supportive oncology care was 2 times more frequent among patients in precarious situations (P<0.001). During treatment, 33% of deprived patients reported a loss of income, compared with 24% of non-deprived patients (P<0.001). At 12 months from diagnosis, lay-offs were 2 times more frequent in precarious patients (P=0.0001). DISCUSSION: Precariousness affects all stages of the cancer history and care pathway. Particular attention needs to be paid to vulnerable populations, considering issues of accessibility and affordability of care, health literacy and possible implicit bias from the care providers.
Subject(s)
Breast Neoplasms , Humans , Breast Neoplasms/therapy , Breast Neoplasms/mortality , Female , Prospective Studies , Middle Aged , Aged , France , Neoplasm Staging , Vulnerable Populations/statistics & numerical data , Adult , Socioeconomic FactorsABSTRACT
OBJECTIVES: Radiation proctitis is a misunderstanding complication of chemoradiation in locally advanced cervical cancer. The objective of our study is to provide a detailed description and analysis of predictive factors associated with radiation proctitis in a retrospective cohort of patients treated by chemoradiation for locally advanced cervical cancer. METHODS: All patients treated by exclusive chemoradiation or chemoradiation followed by brachytherapy for locally advanced cervical cancer from 2011 to 2017 were included in the study. A bivariate analysis was conducted to establish correlations between the occurrence of radiation proctitis and various clinical and technical variables. RESULTS: A total of 128 patients were included in the study. The mean dose (SD) to the planning target volume was 47.1 Gy (6.2). Fifty-nine (46.1%) patients underwent brachytherapy. Sixteen patients (12.5%) developed radiation proctitis, grade 2 or higher in 12 patients (9.3%). In univariate analysis, anticoagulant or antiplatelet treatments ( P =0.039), older age ( P =0.049), rectal volume irradiated at 40 Gy ( P =0.01) and 30 Gy ( P =0.037) were significantly associated with the occurrence of a grade ≥2 radiation proctitis. The delivered dose to 2 cm 3 of rectum (D2cm 3 ) showed a potential association with the occurrence of radiation proctitis of all grades ( P =0.064). CONCLUSIONS: This study highlights clinical and technical factors that should be considered in assessing the risk of radiation proctitis. These results contribute to a better understanding of this complication.
Subject(s)
Brachytherapy , Chemoradiotherapy , Proctitis , Radiation Injuries , Uterine Cervical Neoplasms , Humans , Uterine Cervical Neoplasms/therapy , Uterine Cervical Neoplasms/radiotherapy , Uterine Cervical Neoplasms/pathology , Female , Proctitis/etiology , Retrospective Studies , Middle Aged , Chemoradiotherapy/adverse effects , Radiation Injuries/etiology , Brachytherapy/adverse effects , Aged , Adult , Radiotherapy Dosage , Risk Factors , PrognosisABSTRACT
INTRODUCTION: Fever treatment is commonly applied in patients with sepsis but its impact on survival remains undetermined. Patients with respiratory and haemodynamic failure are at the highest risk for not tolerating the metabolic cost of fever. However, fever can help to control infection. Treating fever with paracetamol has been shown to be less effective than cooling. In the SEPSISCOOL pilot study, active fever control by external cooling improved organ failure recovery and early survival. The main objective of this confirmatory trial is to assess whether fever control at normothermia can improve the evolution of organ failure and mortality at day 60 of febrile patients with septic shock. This study will compare two strategies within the first 48 hours of septic shock: treatment of fever with cooling or no treatment of fever. METHODS AND ANALYSIS: SEPSISCOOL II is a pragmatic, investigator-initiated, adaptive, multicentre, open-label, randomised controlled, superiority trial in patients admitted to the intensive care unit with febrile septic shock. After stratification based on the acute respiratory distress syndrome status, patients will be randomised between two arms: (1) cooling and (2) no cooling. The primary endpoint is mortality at day 60 after randomisation. The secondary endpoints include the evolution of organ failure, early mortality and tolerance. The target sample size is 820 patients. ETHICS AND DISSEMINATION: The study is funded by the French health ministry and was approved by the ethics committee CPP Nord Ouest II (Amiens, France). The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04494074.