Assessment of the economic relevance of the use of single-use digital flexible ureteroscopes: A systematic review.

INTRODUCTION: Breakages and repairs related to flexible digital reusable ureteroscopes (flURS) are expensive. Thus, we aimed to assess the cost-effectiveness of single-use flexible digital ureteroscopes (SUDFU). METHODS: We conducted a literature review on MEDLINE and EMBASE until September 19, 2018. Systematic reviews and guidelines were assessed for methodologic quality by using standardized grids (R-AMSTAR and AGREE-II). Original studies were analyzed according to local customized grids. The CAPS (Critical Appraisal Skills Program) tool enabled the assessment of the economic aspects in the literature. We also collected local data over a year in 2017-2018 and conducted an economic evaluation by cost minimization, comparing SUDFU and flURS in our center. By generating different flURS breakage reduction scenarios, we aimed to demonstrate the budgetary impact that would have SUFDU introduction in our center. RESULTS: Five economic studies were included. Data on flURS showed breakage rates between 6.4% and 13.2%, and mean numbers of interventions before breakage between 7.5 and 14.4. Four of the five economic analyses suggested a higher cost per intervention with SUDFU. Our local data demonstrated similar results (6.4% and 11.8 cases) and enabled us to estimate the annual number of ureteroscopies for which SUDFU would become profitable: 11-26 (depending on the chosen device). Furthermore, we illustrated how selective use of SUFDU can reduce annual costs by avoiding breakages in different scenarios. CONCLUSIONS: The mean cost per intervention with SUDFU is usually higher than with flURS in high-volume centers and exclusive use becomes unprofitable from a small number of cases.

Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group.

Controversies regarding the benefits of breast cancer screening programs have led to the promotion of new strategies taking into account individual preferences, such as decision aid. The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. Women aged 50 to 74 years, were randomly assigned to receive either a decision aid or the usual invitation letter. Primary outcome was the participation rate 12 months after the invitation. 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. The participation rate in the intervention group was 40.25% (3174/7885 women) compared with 42.13% (3353/7959) in the control group (p = 0.02). Previous attendance for screening (RR = 6.24; [95%IC: 5.75-6.77]; p < 0.0001) and medium household income (RR = 1.05; [95%IC: 1.01-1.09]; p = 0.0074) were independently associated with attendance for screening. This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated.

Cervical epidural anesthesia is associated with increased cancer-free survival in laryngeal and hypopharyngeal cancer surgery: a retrospective propensity-matched analysis.

BACKGROUND AND OBJECTIVES: Regional anesthesia preserves perioperative immune competence and may reduce the risk of recurrence and metastasis after cancer surgery. Cervical epidural anesthesia provides adequate analgesia for head and neck cancer surgery, but its impact on cancer recurrence is unknown. METHODS: This study was a single-center retrospective cohort study of patients undergoing larynx or hypopharynx cancer surgery between January 1984 and December 2008. One hundred eleven patients had general anesthesia combined with intraoperative and postoperative cervical epidural; 160 had general anesthesia alone with postoperative morphine. From this cohort, matched pairs were selected using a propensity score to balance potential confounders of receiving epidural anesthesia. The primary end point was the length of cancer-free survival after surgery until September 2009. RESULTS: Propensity-based matching produced 65 pairs. Matching was effective in achieving balance between groups for each of the preoperative variables collected. Combined epidural and general anesthesia (68% 5-year cancer-free survival; 95% confidence interval [CI], 57%-82%) was associated with significantly increased cancer-free survival compared with general anesthesia alone (37% 5-year cancer-free survival; 95% CI, 25%-54%) with a corresponding adjusted hazard ratio of 0.49 (95% CI, 0.25-0.96; P = 0.04). Patients in the epidural group had an increased overall survival compared with the non-epidural group (P = 0.03). CONCLUSIONS: The association between cervical epidural anesthesia and increased cancer-free survival found in this retrospective study should be an important hypothesis to further investigate in head and neck cancer surgery.

Factors associated with weight loss during radiotherapy in patients with stage I or II head and neck cancer.

BACKGROUND: The purpose of the study was to identify factors associated with weight loss during radiotherapy (RT) in patients with stage I or II head and neck (HN) cancer. METHODS: This study was conducted as part of a phase III chemoprevention trial. A total of 540 patients were randomized. The patients were weighed before and after RT. Patients' characteristics, dietary intake, health-related quality of life (HRQOL), tumor characteristic, treatment characteristics, and acute adverse effects of RT were evaluated at baseline and during RT. Factors independently associated with weight loss during RT were identified using the multiple linear regression (P ≤ 0.05). RESULTS: The mean weight loss during RT was 2.2 kg (standard deviation, 3.4). In bivariate analyses, the occurrence of adverse effects of RT and most of the HRQOL dimensions evaluated during RT were correlated with weight loss. In the multivariate analysis, eight factors were associated with a greater weight loss: all HN cancer sites other than the glottic larynx (P < 0.001), TNM stage II disease (P = 0.01), higher pre-RT body weight (P < 0.001), dysphagia before RT (P < 0.005), higher mucosa adverse effect of RT (P = 0.03), lower dietary energy intake during RT (P < 0.001), lower score of the digestive dimension on the Head and Neck Radiotherapy Questionnaire (P < 0.001) and a higher score of the constipation symptom on the EORTC QLQ-C30 during RT (P = 0.02). CONCLUSIONS: The results underline the importance of maintaining energy intake in early stage HN cancer patients during RT and the importance of preventing and treating adverse effects.

Phase II trial of pegylated liposomal doxorubicin in combination with gemcitabine in metastatic breast cancer patients.

OBJECTIVE: To assess the efficacy and toxicity of pegylated liposomal doxorubicin combined with gemcitabine as first-line chemotherapy in metastatic breast cancer patients in a phase II trial. PATIENTS AND METHODS: All breast cancer patients with HER2-negative status, hormone refractory tumor, assessable targets, with preserved performance status, and who had not received chemotherapy earlier as treatment for their metastatic disease were eligible. The patients received pegylated liposomal doxorubicin (30 mg/m(2), venous injection, day 1) concurrently with gemcitabine (1000 mg/m(2), venous injection, days 1 and 8), 1 cycle every 3 weeks. RESULTS: Although 38 patients should have been included, this study was prematurely discontinued after recruiting 20 patients because of excessive toxicity: 75% of the patients experienced grade 3 or 4 treatment-related toxicity, including neutropenia, thrombopenia, hand-foot syndrome, and stomatitis, which significantly affected the quality of life. Cardiac toxicity was mild. With regard to efficacy, 50% of the patients (95% confidence interval, 26%-74%) experienced tumor response. The response rate was 40% in patients who had earlier received anthracyclines as adjuvant therapy. Median progression-free survival and median overall survival were 8.8 months and 19 months, respectively. CONCLUSIONS: This combination was efficient, but not well tolerated. From these results, we could not recommend these doses for further assessment and lower doses should be preferred.

[Assessment of daily physical activity of breast cancer patients and comparison with two control populations]. / Quantification de l'activité physique journalière des patientes traitées pour un cancer du sein et comparaison avec deux populations témoins.

OBJECTIVE: The purpose is to assess the physical activity of breast cancer patients using a questionnaire, the Population Physical Activity Questionnaire (POPAQ) and to compare the data with those from two female populations: one healthy population and one with a previous history of cardiovascular disease. PATIENTS AND METHODS: This prospective study included 104 consecutive breast cancer patients who were addressed at the radiation oncology department, Institut de cancérologie de la Loire from March to July 2010. A questionnaire using factorial method was used for assessment of physical activity. RESULTS: In the study population, the rest energetic expenditures of physical energy related to both rest activity and low intensity activity were higher than in the healthy patients (5,292±1,376 versus 5,520±1,248 kJ/24 h, P<0.05 and 2,583±681 versus 2,494±558 kJ/24 h, P<0.05, respectively). Conversely, the energetic expenditures of physical energy related to both high physical activity and intensive physical activity were lower than in the healthy population (882±441 versus 1,560±868 kJ/24 h, P<0.05 et 210±274 versus 340±621 kJ/24 h, P<0.05, respectively). CONCLUSION: The POPAQ allows quantifying the daily physical activity and seems feasible in clinical routine in breast cancer patients. In our study, it was found that the physical activity of those patients was significantly different from that of a healthy population. Further investigations are necessary for better defining the true impact of such differences in terms of incidence and prognostic for mammary carcinoma.

Recommendations for a lifestyle which could prevent breast cancer and its relapse: physical activity and dietetic aspects.

External factors such as eating habits and physical activity have an important impact on breast cancer risk. This paper reviews the literature on the relationship between breast cancer and lifestyle. It aims to produce recommendations regarding physical activity and dietary intake for clinical practice. Although strong clinical evidence of the impact of lifestyle modifications is still lacking, practising healthy eating should be encouraged for the prevention of cancer, its occurrence or relapse. Physical activity is recommended to avoid excessive weight gain. For example, the beneficial effects on the risk of breast cancer could be achieved by walking half an hour per day. Three to five hours per week of moderate physical exercise therefore should be recommended for optimising the reduction of the risk of cancer. For most women, moderate to intense activity, such as heavy housework, brisk walking, or dancing, could provide an effective level of activity to keep reduce the risk of breast cancer.

[Screening and early diagnosis of cancers: 2 ways for a same goal]. / Dépistage et diagnostic précoce des cancers: deux démarches pour un même objectif.

Early diagnosis is the most efficient way to decrease mortality rate, side effects and sequelae due to cancer. The first step consists in anticipating diagnosis by simultenaously taking into consideration non specific clinical symptoms and risk of cancer estimated by the combination of individual risk factors. Screening is a different way to anticipate diagnosis of cancer. Screening is a systematic investigation performed without clinical symptoms. Organised cancer screening programs allow quality control, evaluation and efficiency measure of the screening policy. Opportunist screenings as developed in some countries or for particular tumours are decided by practitioners and patients following practice recommendations. Side effects of these approaches have to be kept in mind: overdiagnosis and socio-economic inequalities must be controlled for both opportunistic and organised screenings.

Predictors of weight loss during radiotherapy in patients with stage I or II head and neck cancer.

BACKGROUND: The purpose of the study was to identify predictors of weight loss during radiotherapy (RT) in patients with stage I or II head and neck (HN) cancer. METHODS: This study was conducted as part of a phase 3 chemoprevention trial. A total of 540 patients were randomized. The patients were weighed before and after RT. Their baseline characteristics, including lifestyle habits, diet, and quality of life, were assessed as potential predictors. Predictors were identified using multiple linear regressions. The reliability of the model was assessed by bootstrap resampling. A receiver operating characteristics curve was generated to estimate the model's accuracy in predicting critical weight loss (>or=5%). RESULTS: The mean weight loss was 2.2 kg (standard deviation, 3.4). Five factors were associated with a greater weight loss: all HN cancer sites other than the glottic larynx (P<.001), higher pre-RT body weight (P<.001), stage II disease (P = .002), dysphagia and/or odynophagia before RT (P = .001), and a lower Karnofsky performance score (P = .028). There was no association with pre-RT lifestyle habits, diet, or quality of life. The bootstrapping method confirmed the reliability of this predictive model. The area under the curve was 71.3% (95% confidence interval, 65.8-76.9), which represents an acceptable ability of the model to predict critical weight loss. CONCLUSIONS: These results could be useful to clinicians for screening patients with early stage HN cancer treated by RT who require special nutritional attention.

Endovascular treatment for carotid artery stenosis after neck irradiation.

BACKGROUND: To lower the risk of complications, carotid angioplasty and stenting (CAS) has been proposed as an alternative to open surgery for carotid artery stenosis after neck irradiation. However, there are little postoperative data to support the benefits of this strategy. This study evaluated the outcome of CAS in patients who had undergone neck irradiation. METHODS: This retrospective study was conducted at 15 vascular surgery or interventional radiology centers in France between January 1998 and July 2006. A total of 135 patients (115 men) with a mean age of 67 +/- 8 years (range, 43-88) underwent CAS for 149 irradiation-induced lesions. The interval between irradiation and discovery of the lesions was 12 +/- 8 years. Mean diameter reduction was 81% (range, 50%-95%), and stenosis was symptomatic in 34%. Contralateral carotid lesions were observed in 48% of patients, including thrombosis in 18 and stenosis >50% in 53. RESULTS: Technical failure occurred during CAS in three cases. The overall technical success rate was 98%. A cerebral protection device was used in 59%. No death, one transient ischemic attack, and two strokes occurred during the first postoperative month. Mean follow-up was 30 months. Six patients were lost to follow-up. Survival rates were 93.9% at 1 year and 75.3% at 3 years. Complications after the first postoperative month included neurologic events in six, carotid thrombosis in nine, and restenosis in 18. The rates of freedom from neurologic and anatomic events were, respectively, 96.2% and 93.2% at 1 year and 93.1% and 85.9% at 3 years. CONCLUSION: The immediate outcome of CAS for irradiation-induced carotid artery stenosis was satisfactory. Medium-term neurologic outcome was acceptable, but the incidence of anatomic events such as thrombosis and restenosis was high. A randomized study is needed to confirm that the outcome of the endovascular and surgical therapy is comparable in this indication.