The SABRTooth feasibility trial protocol: a study to determine the feasibility and acceptability of conducting a phase III randomised controlled trial comparing stereotactic ablative radiotherapy (SABR) with surgery in patients with peripheral stage I non-small cell lung cancer (NSCLC) considered to be at higher risk of complications from surgical resection.

Background Stage I non-small cell lung cancer (NSCLC) is potentially curable, and surgery is considered to be the standard of care for patients with good performance status and minimal co-morbidity. However, a significant proportion of patients with stage I NSCLC have a poorer performance status and significant medical co-morbidity that make them at higher risk of morbidity and mortality from surgery. Stereotactic ablative radiotherapy (SABR), which uses modern radiotherapeutic techniques to deliver large doses of radiation, has shown superiority over conventional radiotherapy in terms of local control and toxicity and is a standard of care for patients with stage I NSCLC who are at too high risk for surgery. However, it is not known whether surgery or SABR is the most effective in patients with stage I NSCLC who are suitable for surgery but are less fit and at higher risk surgical complications. Previous randomised studies have failed to recruit in this setting, and therefore, a feasibility study is required to see whether a full randomised control trial would be possible. Methods/design SABRTooth is a UK-based, multi-centre, open-label, two-group individually (1:1) randomised controlled feasibility study in patients with peripheral stage I NSCLC considered to be at higher risk from surgical resection. The study will assess the feasibility of conducting a definitive large-scale phase III trial. The primary objective is to assess recruitment rates to provide evidence that, when scaled up, recruitment to a large phase III trial would be possible; the target recruitment being 54 patients in total, over a 21-month period. There are multiple secondary and exploratory objectives designed to explore the optimum recruitment and data collection strategies to help optimise the design of a future phase III trial. Discussion To know whether SABR is a better, equivalent or inferior alternative to surgery for higher risk patients is a key question in lung cancer. Other studies comparing SABR to surgery have closed early due to poor recruitment, and therefore, the SABRTooth feasibility study has been designed around the UK National Health Service (NHS) cancer pathway incorporating many design features in order to maximise recruitment for a future definitive phase III trial

Treatment of Gastric Adenocarcinoma May Differ Among Hospital Types in the United States, a Report from the National Cancer Data Base

The concept that complex surgical procedures should be performed at high-volume centers to improve surgical morbidity and mortality is becoming widely accepted. We wanted to determine if there were differences in the treatment of patients with gastric cancer between community cancer centers and teaching hospitals in the United States. Data from the 2001 Gastric Cancer Patient Care Evaluation Study of the National Cancer Data Base comprising 6,047 patients with gastric adenocarcinoma treated at 691 hospitals were assessed. The mean number of patients treated was larger at teaching hospitals (14/year) when compared to community centers (5–9/year) (p < 0.05). The utilization of laparoscopy and endoscopic ultrasonography were significantly more common at teaching centers (p < 0.01). Pathologic assessment of greater than 15 nodes was documented in 31% of specimen at community hospitals and 38% at teaching hospitals (p < 0.01). Adjusted for cancer stage, chemotherapy and radiation therapy were utilized with equal frequency at all types of treatment centers. The 30-day postoperative mortality was lowest at teaching hospitals (5.5%) and highest at community hospitals (9.9%) (p < 0.01). These data support previous publications demonstrating that patients with diseases requiring specialized treatment have lower operative mortality when treated at high-volume centers

In-hospital mortality after stomach cancer surgery in Spain and relationship with hospital volume of interventions

<p>Abstract</p> <p>Background</p> <p>There is no consensus about the possible relation between in-hospital mortality in surgery for gastric cancer and the hospital annual volume of interventions. The objectives were to identify factors associated to greater in-hospital mortality for surgery in gastric cancer and to analyze the possible independent relation between hospital annual volume and in-hospital mortality.</p> <p>Methods</p> <p>We performed a retrospective cohort study of all patients discharged after surgery for stomach cancer during 2001–2002 in four regions of Spain using the Minimum Basic Data Set for Hospital Discharges. The overall and specific in-hospital mortality rates were estimated according to patient and hospital characteristics. We adjusted a logistic regression model in order to calculate the in-hospital mortality according to hospital volume.</p> <p>Results</p> <p>There were 3241 discharges in 144 hospitals. In-hospital mortality was 10.3% (95% CI 9.3–11.4). A statistically significant relation was observed among age, type of admission, volume, and mortality, as well as diverse secondary diagnoses or the type of intervention. Hospital annual volume was associated to Charlson score, type of admission, region, length of stay and number of secondary diagnoses registered at discharge. In the adjusted model, increased age and urgent admission were associated to increased in-hospital mortality. Likewise, partial gastrectomy (Billroth I and II) and simple excision of lymphatic structure were associated with a lower probability of in-hospital mortality. No independent association was found between hospital volume and in-hospital mortality</p> <p>Conclusion</p> <p>Despite the limitations of our study, our results corroborate the existence of patient, clinical, and intervention factors associated to greater hospital mortality, although we found no clear association between the volume of cases treated at a centre and hospital mortality.</p

The Incidence and Risk Factors of Metachronous Colorectal Cancer: An Indication for Follow-up

BACKGROUND: Patients with colorectal cancer are at risk for developing metachronous colorectal cancer. The purpose of posttreatment surveillance is to detect and remove premalignant lesions to prevent metachronous colorectal cancer. OBJECTIVE: The aim of this study was to investigate the incidence of and predictive factors for metachronous colorectal cancer in patients with newly diagnosed colorectal cancer. DESIGN AND PATIENTS: The data on all patients with newly diagnosed colorectal cancer between 1995 and 2006 were obtained from the Rotterdam Cancer Registry in The Netherlands and studied for metachronous colorectal cancer. MAIN OUTCOME MEASURES: The annual incidence rate and the standardized incidence ratios were calculated. RESULTS: In total, colorectal cancer was diagnosed in 10,283 patients; there were 39,974 person-years of follow-up. The mean annual incidence rate of metachronous colorectal cancer was 314/100,000 person-years at risk during 10 years of follow-up, corresponding with a mean annual incidence of 0.3% and a cumulative incidence of 1.1% at 3 years, 2.0% at 6 years, and 3.1% at 10 years. The incidence of metachronous colorectal cancer after resection of a first colorectal cancer is significantly highe CONCLUSIONS: Despite the availability of colonoscopy, metachronous colorectal cancer is still seen during follow-up in patients with colorectal cancer; the highest risk is during the first 3 years after initial diagnosis. For this reason, a follow-up colonoscopy is useful at a short-term interval after colorectal cancer diagnosis. The presence of synchronous colorectal cancer at the time of first colorectal cancer diagnosis is the only predictive risk factor for developing metachronous colorect