Biomedical subjects

Davide Radice

Publications and source records attributed to Davide Radice.

8 recordsLinked to original sources

PubMed2007

Superior vena cava resection for lung and mediastinal malignancies: a single-center experience with 70 cases.

BACKGROUND: The oncologic value of superior vena cava (SVC) resection for lung and mediastinal malignancies remains controversial. In this context, we have reviewed our experience in the treatment of locally advanced lung and mediastinal tumor invading the SVC system, analyzing postoperative outcome and long-term oncologic results. METHODS: The clinical data of patients who underwent SVC resection were retrospectively analyzed to assess postoperative mortality, and overall and procedure-specific morbidity. Overall survival was calculated for mediastinal and lung tumor groups. RESULTS: From 1998 to 2004, 70 consecutive patients (52 with lung cancer and 18 with mediastinal tumors) underwent SVC system resection. There were 25 replacements (36%) of the SVC system by prosthesis, whereas the remaining underwent partial resection. Major postoperative morbidity and mortality rates in lung cancer patients were 23% and 7.7%, respectively (50% and 5.6% in mediastinal tumors). In the lung cancer group, 5-year survival probability was 31%, and it was affected by mediastinal nodal status (5-year survival in N0-N1 patients 52%, 21% in N2 patients, 0 in N3 patients). Median survival for mediastinal tumors was 49 months. CONCLUSIONS: In conclusion, SVC resection may achieve permanent cure in patients who would have been defined as inoperable 10 years ago. In the case of mediastinal tumors, the need for SVC resection alone should not be considered a contraindication for surgery when prosthetic replacement is feasible. In the case of lung tumors, infiltration of SVC can achieve satisfactory long-term results after neoadjuvant chemotherapy, only when pathologic N2 disease is excluded by preoperative mediastinoscopy.

Aged↗

PubMed2006

Does chemotherapy increase the risk of respiratory complications after pneumonectomy?

OBJECTIVE: The impact of induction chemotherapy on postoperative complications after pneumonectomy remains unclear. The aim of the study was to test the hypothesis that chemotherapy may increase the risk of postoperative respiratory complications. METHODS: Data from 202 consecutive standard pneumonectomies performed for lung cancer were collected and analyzed. Postoperative and 90-day mortality, overall morbidity, and respiratory complication rates were evaluated in patients who had no induction treatment (group A, n = 103) as well as in those who received it (n = 99, group B). Preoperative chemotherapy was inserted as a variable together with 12 other variables (age, sex, smoking status, body mass index, previous cardiac event, American Society of Anesthesiologists score, preoperative forced expiratory volume in 1 second [percent], diffusion capacity for carbon monoxide adjusted for alveolar volume [percent], side of pneumonectomy, perfusion of the removed lung, operating time, and blood transfusion) into univariate and multivariate logistic regression. RESULTS: No difference in terms of mortality was recorded between group A (4.9%) and group B (3%, P > .05). Respiratory complications were more frequent in group B than in group A (19 cases, 19.2%, vs 7 cases, 6.8%, P = .008). Univariate logistic regression has demonstrated that pulmonary complications were more frequent in patients over the age of 70 than in those aged 70 or less (25.7% vs 10.2, P = .02), in those with a lower diffusion capacity adjusted for alveolar volume (18.3% vs 5.95%, P = .06), and in patients who received preoperative chemotherapy (19.2% vs 6.8, P = .008). Logistic regression confirmed the role of age (odds ratio = 6.3), preoperative chemotherapy (odds ratio = 4.4), and diffusion capacity adjusted for alveolar volume (odds ratio = 0.33) as risk factors of respiratory complications. CONCLUSIONS: Standard pneumonectomy is a safe procedure even after induction chemotherapy, with a mortality rate in the order of 5%, but this increases in patients over the age of 70 years. In the case of induction chemotherapy, the risk of respiratory complications is significantly increased, apparently not affecting the overall mortality rate.

Female↗

PubMed2005

A longitudinal survey of self-assessed health trends in a community cohort of people with multiple sclerosis and their significant others.

BACKGROUND: Studies assessing psychosocial consequences of multiple sclerosis (MS) in the community are scarce; it appears that there are no longitudinal surveys in this area. OBJECTIVES: We prospectively assessed changes in self-perceived health status over 5 years in a community cohort of MS adults. METHODS: The 251 people who participated in a 1999 postal survey were re-assessed in 2004, being sent the Multiple Sclerosis Quality-of-Life-54 (MSQOL-54), the Chicago Multiscale Depression Inventory (CMDI), and a demographic/clinical questionnaire. Health-related quality of life (Short Form-36) and CMDI were also assessed in participants' significant others. RESULTS: A total of 205 people participated: 14 (5.6%) of the original cohort MS had died and 32 (13%) did not return the questionnaires. A significant other was available for 74% of responders. The proportion requiring constant bilateral walking assistance increased from 16% to 33%. The proportion using housing adaptations increased from 17% to 27%, and the use of daily home care increased from 19% to 28%. Impaired CMDI mood affected 27% of MS and 19% of significant others. Changes in MSQOL-54 were not unidirectional: the domains change in health, physical function, and general health worsened; while social function, mental health, and health distress improved significantly. CONCLUSIONS: MS has a pervasive but inhomogeneous impact on the lives of MS sufferers: the proportion of those severely impaired doubled over the study period; nevertheless in 23% of participants the disease remained mild over a median duration of 11 years. The psychological burden affects not only people with MS but also their significant others.

Activities of Daily Living↗

PubMed2005

Q-TWiST analysis of cyclophosphamide, epirubicin, fluorouracil versus cyclophosphamide, methotrexate, fluorouracil treatment for premenopausal women with node-positive breast cancer.

OBJECTIVE: To estimate the Q-TWiST (Quality-Adjusted Time Without Symptoms and Toxicity) for premenopausal women with axillary node-positive breast cancer receiving either cyclophosphamide, epirubicin and fluorouracil (CEF) or cyclophosphamide, methotrexate, and fluorouracil (CMF), using data from a phase III clinical trial (National Cancer Institute of Canada Clinical Trials Group [NCIC-CGT.MA5]). METHODS: Restricted mean times by treatment group were computed at 3, 4 and 5 years as the area under the Kaplan-Meier survival curves for the period of treatment-related symptomatic toxicities (TOX), disease-free survival (DFS) and overall survival (OS). Restricted REL (the period of relapse) and TWiST (the period of best possible QOL after breast cancer diagnosis) mean times were indirectly computed as OS minus DFS and DFS minus TOX, respectively. It was assumed that TWiST has a utility coefficient equal to 1. Patients' utility values were arbitrarily set to 0.5 for the toxicity and relapse health states. It was assumed that the utility scores were constant over time. A threshold utility sensitivity analysis was conducted allowing the trade-off between the two treatments to be assessed for the entire range of the utility coefficients. A bootstrap empirical test distribution of the Q-TWiST difference between CEF and CMF was constructed in order to test the statistical significance of the Q-TWiST difference point estimate. RESULTS: The Q-TWiST mean differences (CEF minus CMF) were -0.37, 1.20 and 2.62 months at 3, 4 and 5 years, respectively. Positive differences are in favour of the CEF arm but none of the above differences were statistically significant. The threshold-utility analysis confirmed the indifference of treatment choice with respect to the utility values, at least at 5 years. There were no combinations of TOX and REL utility values such that the Q-TWiST for the standard therapy (CMF) was greater than the Q-TWiST of the experimental treatment (CEF). CONCLUSION: The computed Q-TWiST difference of 2.62 months in favour of CEF (p = 0.492 vs CMF), while not statistically significant, is an indicator that CEF treatment could be a better choice from the patient's perspective than CMF after 5 years of treatment. These results should be considered within the context of the methodological limitations posed by the assumptions in the study.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2004

The multiple sclerosis functional composite: different practice effects in the three test components.

BACKGROUND: The multiple sclerosis functional composite (MSFC) is a multidimensional, MS-specific outcome measure for use in clinical trials, comprising three tests: timed 25-foot walk (T25FW), paced auditory serial addition (PASAT), and 9-hole peg (9HP). OBJECTIVE: To assess interrater and intrarater reliability and practice/fatigue effects in the MSFC. METHODS: The MSFC was administered by two neurologists after a formal training session to 32 MS outpatients. Patients were assessed four times by one examiner and twice by the other. The six tests were administered in a single day, with at least 20 min of rest between them. The examiners were blinded to the results of previous assessments. Testing order was random. RESULTS: Interrater reliability was excellent, with intraclass correlation coefficients (ICC) ranging from 0.93 for 9HP (95% confidence interval [CI] 0.84-0.96) to 0.99 for T25FW (95% CI 0.97-0.99). For intrarater reliability, ICC ranged from 0.93 for PASAT (95% CI 0.82-0.97) to 0.98 for T25FW (95% CI 0.93-1.00). We found no practice effect for T25FW after the first administration. However, performance improved with testing over the first three sessions for PASAT and over the first four sessions for 9HP. CONCLUSIONS: The MSFC is characterised by excellent reliability. Practice effects for the three MSFC components differed, being negligible for T25FW and evident for PASAT and 9HP. To improve efficiency, we suggest one prebaseline administration of T25FW, three of PASAT and four of 9HP.

Adult↗

PubMed2003

Breast cancer management: quality-of-life and cost considerations.

The purpose of this article was to provide a literature-based extensive overview of the quality-of-life and cost issues posed by the management of breast cancer. Incidence and mortality rates vary widely in different countries. Breast cancer accounts approximately for one-fifth of all deaths in women aged 40-50 years. The 1994-1998 incidence rate in the US population was on average 114.3 per 100 000 women. Treatment options include surgery, radiotherapy and drug therapy (cytotoxic and endocrine drugs). All treatment options affect patients' health-related quality of life (HR-QOL) in various ways. The use of cytotoxic agents has a particularly large HR-QOL impact. HR-QOL questionnaires are complex tools, not routinely used in breast cancer trials.Worldwide, around 10 million individuals develop cancer each year; this figure is expected to increase to 15 million in 2020. For all cancers, the total economic burden of this disease worldwide was projected by the authors to be in the range of $US 300-400 billion in 2001 (about $US 100-140 billion as direct costs and the remainder as indirect costs [morbidity and mortality]). According to the National Institute of Health (NIH), the total cost of cancer was estimated at $US 156.7 billion in 2001 in US ($US 56.4 billion as direct costs, $US 15.6 as indirect morbidity costs, and $US 84.7 billion as indirect mortality costs). Based on limited information, in the US, breast cancer can be projected to account for about one-fifth/one-fourth of the total cost of cancer. Breast cancer treatment costs are higher in the US than in other developed countries. Both direct and indirect costs are dependent on disease stage. The per-patient costs for initial care in 1992 were estimated at $US 10 813, for continuing care at $US 1084 and for terminal care at $US 17 886. Stage-specific costs provide information for cost-effectiveness analyses of cancer-control initiatives, such as screening programmes. Economic studies on breast cancer are heterogeneous, and the cost estimates made are not easily generalisable. The cost of treatment for breast cancer in developing countries is < or =5% of that in developed regions.

Adult↗

PubMed2003

Quality of life and economic considerations in the management of prostate cancer.

The purpose of this article was to provide an overview of the morbidity and mortality of prostate cancer, QOL issues and the economic impact of the disease. We searched Medline (from 1990 onwards) for all studies dealing with prostate cancer epidemiology, treatment, screening and staging, and critically reviewed the most relevant articles, focusing on pharmacoeconomic issues. Prostate cancer is the most common cancer in men. In the US, new estimated cases of prostate cancer represented 14.8% of all new cancer cases for 2000, with estimated deaths from prostate cancer comprising 5.8% of all deaths from cancer. Current options for prostate cancer management include radical prostatectomy, cryosurgery, radiotherapy, hormone therapy and watchful waiting. Many of the long-term effects of treatment, such as urinary incontinence, impotence and radiation-induced proctitis, have a large impact on patients' quality of life and, in some patients, may offset the clinical benefits. Regulatory bodies and managed care organisations are assigning increasing importance to the evaluation of QOL benefits as an independent clinical endpoint and a measure of patient satisfaction. Several screening programmes for early detection of prostate cancer, mostly based on prostate-specific antigen (PSA) measurement or digital rectal examination, have been proposed, but their routine implementation in all asymptomatic elderly men has been questioned. There is still no definite proof that patient outcomes are improved by extensive PSA screening. Furthermore, the total cost of a screening programme is difficult to define since it extends well beyond the initial test. Several instruments are used for QOL assessment in prostate cancer, some of which have been specifically developed for, or adapted to, patients with this disease, such as the Functional Assessment Cancer Therapy (FACT) tool, Prostate Cancer Treatment Outcome Questionnaire (PCTO-Q) and Prostate Cancer Specific Quality of Life Instrument (PROSQOLI). More than 50% of treatment costs for prostate cancer are accrued during the patient's last year of life, and total initial care costs decrease with increasing age. In the US, initial average inpatient costs were estimated at $US 2253, in 1995, for men aged > or =80 years, compared with $US 4540 for men aged 35-64 years. In recent years, treatments based on combined modalities (i.e. radiotherapy/prostatectomy plus hormonal therapies) have emerged. Although cost-effectiveness analyses of various treatment options have been attempted, the strength of their conclusions appears to be limited by the lack of homogeneous literature data on the effects of such interventions on survival and morbidity.

Androgen Antagonists↗

PubMed2002

Cost-effectiveness analysis of exemestane compared with megestrol in advanced breast cancer: a model for Europe and Australia.

OBJECTIVE: To investigate the cost effectiveness of exemestane compared to megestrol in post-menopausal women after tamoxifen failure. DESIGN AND SETTING: A modelling study from the third-party payer perspective in Australia, Belgium, France, Germany, Italy, The Netherlands, Spain and the United Kingdom. METHODS: A model was constructed, based on and driven by data on survival from a clinical study of these agents, including costs for exemestane and megestrol and costs for other treatments. Data from an observational study were used to calculate a country-specific daily cost for the other treatments. Life-years gained was used as the measure of effectiveness. Simulations were performed for 1080 days ('within trial analysis') and for a life-time perspective, in which survival after the end of the trial was assumed to be the same as the trend during follow up. Costs were presented in 1999 values. MAIN OUTCOME MEASURES AND RESULTS: When running the model for 1080 days, the cost effectiveness of exemestane compared to megestrol varied between about EUR5000 and EUR13000 per life-year gained. In Germany it was much lower (EUR1353) due to a higher cost of megestrol. The total expected cost effectiveness (model running until no survivors left) ranged from EUR3700 (Germany) to EUR9100 (The Netherlands). The estimated cost per life-year gained is well within limits generally considered cost effective. CONCLUSIONS: Exemestane is cost effective compared with megestrol for postmenopausal women with progressive advanced breast cancer after therapy with tamoxifen.

Aged↗