Evidence-based review of three-dimensional conformal radiotherapy for localized prostate cancer: an ASTRO outcomes initiative

PURPOSE: To perform a systematic review of the evidence to determine the efficacy and effectiveness of three-dimensional conformal radiotherapy (3D-CRT) for localized prostate cancer; provide a clear presentation of the key clinical outcome questions related to the use of 3D-CRT in the treatment of localized prostate cancer that may be answered by a formal literature review; and provide concise information on whether 3D-CRT improves the clinical outcomes in the treatment of localized prostate cancer compared with conventional RT. METHODS AND MATERIALS: We performed a systematic review of the literature through a structured process developed by the American Society for Therapeutic Radiology and Oncology's Outcomes Committee that involved the creation of a multidisciplinary task force, development of clinical outcome questions, a formal literature review and data abstraction, data review, and outside peer review. RESULTS: Seven key clinical questions were identified. The results and task force conclusions of the literature review for each question are reported. CONCLUSION: The technological goals of reducing morbidity with 3D-CRT have been achieved. Randomized trials and follow-up of completed trials remain necessary to address these clinical outcomes specifically with regard to patient subsets and the use of hormonal therapy.     

Metformin-glibenclamide versus metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy

AIM: This double-blind study evaluated the efficacy and safety of metformin-glibenclamide tablets vs. metformin plus rosiglitazone therapy in patients with type 2 diabetes inadequately controlled on metformin monotherapy. SUBJECTS AND METHODS: After an open-label, metformin lead-in phase, 318 patients were randomly assigned to treatment based on metformin-glibenclamide 500/2.5 mg tablets (initial daily dose 1000/5 mg) or metformin 500 mg plus rosiglitazone 4 mg (initial daily dose 1000-2000 mg + 4 mg, depending on previous treatment) for 24 weeks. Doses were titrated to achieve the therapeutic glycaemic target. The primary efficacy variable was the change in HbA1C. RESULTS: At week 24, metformin-glibenclamide tablets resulted in significantly greater reductions in HbA1C (-1.5%) and fasting plasma glucose [-2.6 mmol/l (-46 mg/dl)] than metformin plus rosiglitazone [-1.1%, p < 0.001; -2 mmol/l (-36 mg/dl), p = 0.03]. More patients receiving metformin-glibenclamide attained HbA1C <7.0% than did those in the metformin plus rosiglitazone group (60 vs. 47%) and had fasting plasma glucose levels <7 mmol/l (<126 mg/dl) by week 24 (34 vs. 25%). Both treatments were well tolerated. Frequency of adverse gastrointestinal events was comparable between groups. Four per cent of patients receiving metformin-glibenclamide withdrew because of symptomatic hypoglycaemia contrasted with 3% of patients receiving metformin plus rosiglitazone who withdrew because of persistent hyperglycaemia. Hypoglycaemic events were mild or moderate in intensity and were easily self-managed. CONCLUSIONS: Metformin-glibenclamide tablets resulted in significantly greater reductions in HbA1C and fasting plasma glucose compared with metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy.     

Clinical profile and long term outcomes of eyes with choroidal detachment following trabeculectomy

Purpose:To assess the long-term outcomes of choroidal detachments (CDs) in eyes following trabeculectomy.Methods:Retrospective comparative case series. Data of patients with CDs following trabeculectomy (5-year period) with or without cataract surgery with a minimum of 3 months of follow-up were included.Results:In total, 45 patients with CDs following trabeculectomy were included. The mean age was 63.27 ± 8.68 years, (M:F = 2:1); 29 of 45 eyes (64.4%) had a baseline IOP of >24 mm Hg. Patients had a median follow-up of 22.2 (IQR: 16.2–30.5) months. Further, 10 of 45 eyes (22.2%) had CDs following suture lysis. The median onset of choroidal detachment from the time of surgery was 16.0 (IQR: 11–36) days. The mean BCVA improved from 0.62 ± 0.28 to 0.24 ± 0.27 (P < 0.001) and mean IOP increased from 4.07 ± 2.66 to 11.20 ± 5.31 (P < 0.001) at last visit. The cumulative success rates were 76.4% (95% CI: 48.4–90.5) in POAG eyes and 79.3% (95% CI: 62.8–89.1) in PACG eyes (P = 0.547). Medical management was the mainstay in all patients. Four of 45 (8.88%) patients underwent subsequent choroidal drainage.Conclusion:Choroidal detachment following modern-day trabeculectomy has favorable long-term visual acuity and IOP outcomes. There was no difference in the long-term surgical success of trabeculectomy with choroidal detachments in primary angle-closure and open-angle glaucoma eyes. Long-term follow-up is essential to prevent chronic hypotony and trabeculectomy failure.     

The influence of open-heart surgery on survival of patients with co-existent surgically amenable lung cancer (stages I and II)

Objective: The evaluation of the influence of open-heart surgery on the survival of patients with co-existent surgically amenable lung cancer stages I and II. Methods: A retrospective, observational study was conducted in a tertiary centre for cardiothoracic surgery. From 1988 to 1995, 121 consecutive patients underwent pulmonary resection for stages I–II primary non-small cell bronchogenic carcinoma. Eighty seven of them had merely a lung carcinoma necessitating resection, 34 had in addition defined coronary-artery disease and consequently were also subjected to open-heart surgery. Results were statistically computed. Results: Follow-up was complete in 117/121 patients, 96.7% (83/87, 95.4% and 34/34, 100% in respective groups). Both groups were matched with regard to preoperative features possibly influencing survival. Median long term survival time was 4.3 years overall, 5.8 years for patients merely undergoing lung resection and 4.2 years for them undergoing open-heart surgery as well; this difference was not statistically significant (log-rank test: χ² 0.92, df=1, P=0.34), indicating no or limited influence of open-heart surgery on survival of patients with surgically amenable co-existent lung carcinoma. No relationship was found between survival and age, tumour stage, and histopathology. However, metastatic disease as cause of death was significantly increased in patients undergoing open-heart surgery (5/8 vs. 10/33, P=0.0898), indicating a possible promotion of metastatic spread of co-existent lung carcinoma by this procedure. Overall perioperative mortality rate was 10/121, 8.3%, for the greater part the result of a relatively high mortality rate in the group of patients undergoing heart as well as lung surgery (6/34, 17.6%), underscoring the great risks involved in these patients, the mortality rate for lung resection alone being comparably low 4/87, 4.6% (P=0.0191). Conclusion: Open-heart surgery for defined coronary-artery disease in patients with surgically amenable lung carcinoma carries a substantially higher perioperative risk, but has no influence on long term results. Metastatic spread is possibly promoted by open-heart surgery. Optimal treatment, consisting of complete revascularization and appropriate lung resection, is therefore sufficiently justified by these results.     

The value of 201thallium-SPECT imaging in childhood brainstem gliomas

Objective. To compare ²⁰¹thallium (T1) uptake and SPECT with MRI in children with brainstem gliomas. Materials and methods. Ten children with brainstem gliomas were prospectively evaluated by ²⁰¹Tl-SPECT and MRI. Histological verification was obtained in eight children – two died prior to surgery. Quantitative thallium uptake index (UI) was obtainable in five cases and was compared to tumour grade. In addition, two patients with known benign brainstem lesions (neurofibromatosis and tuberculoma) were similarly prospectively evaluated. Results. All children with brainstem glioma accumulated thallium. (Mean U1 3.23, 100 % sensitivity). The single patient with brainstem tuberculoma also accumulated thallium (UI 2.80, 91.7 % specificity). There was no correlation between thallium uptake and tumour grade. Uptake could not be conclusively correlated with the following MR features: gadolinium enhancement, exophytic or intrinsic gliomas, necrosis and location of glioma within the brainstem. Conclusions. ²⁰¹Tl-SPECT is a promising imaging adjunct in the assessment of childhood brainstem gliomas. Received: 23 May 1997 Accepted: 16 January 1998