Michael A. Maddaus

Adjuvant Paclitaxel Plus Carboplatin Compared With Observation in Stage IB Non–Small-Cell Lung Cancer: CALGB 9633 With the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups

PURPOSE Adjuvant chemotherapy for resected non-small-cell lung cancer (NSCLC) is now accepted on the basis of several randomized clinical trials (RCTs) that demonstrated improved survival. Although there is strong evidence that adjuvant chemotherapy is effective in stages II and IIIA NSCLC, its utility in stage IB disease is unclear. This report provides a mature analysis of Cancer and Leukemia Group B (CALGB) 9633, the only RCT designed specifically for stage IB NSCLC. PATIENTS AND METHODS Within 4 to 8 weeks of resection, patients were randomly assigned to adjuvant chemotherapy or observation. Eligible patients had pathologically confirmed T2N0 NSCLC and had undergone lobectomy or pneumonectomy. Chemotherapy consisted of paclitaxel 200 mg/m(2) intravenously over 3 hours and carboplatin at an area under the curve dose of 6 mg/mL per minute intravenously over 45 to 60 minutes every 3 weeks for four cycles. The primary end point was overall survival. RESULTS Three hundred-forty-four patients were randomly assigned. Median follow-up was 74 months. Groups were well-balanced with regard to demographics, histology, and extent of surgery. Grades 3 to 4 neutropenia were the predominant toxicity; there were no treatment-related deaths. Survival was not significantly different (hazard ratio [HR], 0.83; CI, 0.64 to 1.08; P = .12). However, exploratory analysis demonstrated a significant survival difference in favor of adjuvant chemotherapy for patients who had tumors > or = 4 cm in diameter (HR, 0.69; CI, 0.48 to 0.99; P = .043). CONCLUSION Because a significant survival advantage was not observed across the entire cohort, adjuvant chemotherapy should not be considered standard care in stage IB NSCLC. Given the magnitude of observed survival differences, CALGB 9633 was underpowered to detect small but clinically meaningful improvements. A statistically significant survival advantage for patients who had tumors > or = 4 cm supports consideration of adjuvant paclitaxel/carboplatin for stage IB patients who have large tumors.

Surgery for Early-Stage Non-Small Cell Lung Cancer: A Systematic Review of the Video-Assisted Thoracoscopic Surgery Versus Thoracotomy Approaches to Lobectomy

Video-assisted thoracoscopic surgery (VATS) for lobectomy has been touted to provide superior outcomes, compared with thoracotomy, for patients with early-stage non-small-cell lung cancer (NSCLC). However, supporting data are limited to case series and small observational studies. We hypothesized that a systematic review of the literature would enable a more objective evaluation of the evidence in order to determine the potential superiority of the VATS approach, compared with thoracotomy, in terms of short-term morbidity and long-term survival. To identify relevant articles for inclusion in our analysis, we performed a systematic review of the MEDLINE database. We looked for randomized controlled trials, observational studies, and case series that reported outcomes after VATS or thoracotomy lobectomy for NSCLC. For statistical testing, we used a two-sided approach (alpha = 0.05) under the hypothesis that VATS lobectomy is superior to thoracotomy lobectomy. We screened 17,923 studies. After independent review of the abstracts by 2 reviewers, we included 39 studies (only one randomized controlled trial) in our analysis. In aggregate, these 39 studies involved 3256 thoracotomy and 3114 VATS patients. The characteristics of the two groups were not significantly different. Compared with thoracotomy, VATS lobectomy was associated with shorter chest tube duration, shorter length of hospital stay, and improved survival (at 4 years after resection), all statistically significant. Compared with lobectomy performed by thoracotomy, VATS lobectomy for patients with early-stage NSCLC is appears to favor lower morbidity and improved survival rates.

Video-Assisted Thoracoscopic Lobectomy Is Less Costly and Morbid Than Open Lobectomy: A Retrospective Multiinstitutional Database Analysis

BACKGROUND The Premier Perspective Database (Premier Inc, Charlotte, NC) was used to compare hospital costs and perioperative outcomes for video-assisted thoracoscopic surgery (VATS) and open lobectomy procedures in the United States. METHODS Eligible patients underwent a lobectomy for cancer by a thoracic surgeon, by VATS or open thoracotomy and were captured in the database between third quarter of 2007 and through 2008. Multivariable logistic regression analyses were performed for binary outcomes. Ordinary least-squares regressions were used to estimate continuous outcomes. All models were adjusted for patient and hospital characteristics. RESULTS A total of 3,961 patients underwent a lobectomy by a thoracic surgeon by open (n = 2,907) or VATS (n = 1,054) approach. Hospital costs were higher for open versus VATS;

Role of intestinal anaerobic bacteria in colonization resistance

21,016 versus

Survival After Lobectomy Versus Segmentectomy for Stage I Non-Small Cell Lung Cancer: A Population-Based Analysis

20,316 (p = 0.027). Adjustment for surgeon experience with VATS over the 6 months prior to each operation showed a significant association between surgeon experience and cost. Average costs ranged from

Endobronchial Ultrasound-Guided Fine-Needle Aspiration of Mediastinal Lymph Nodes: A Single Institution's Early Learning Curve

22,050 for low volume surgeons to

Surgical Therapy for Pulmonary Aspergillosis in Immunocompromised Patients

18,133 for high volume surgeons. For open lobectomies, cost differences by surgeon experience were not significant and both levels were estimated at

Thoracoscopic Versus Thoracotomy Approaches to Lobectomy: Differential Impairment of Cellular Immunity

21,000. Length of stay was 7.83 versus 6.15 days, for open versus VATS (p = 0.000). Surgery duration was shorter for open procedures at 3.75 versus 4.09 for VATS (p = 0.000). The risk of adverse events was significantly lower in the VATS group, odds ratio of 1.22 (p = 0.019). CONCLUSIONS Lobectomy performed by the VATS approach as compared with an open technique results in shorter length of stay, fewer adverse events, and less cost to the hospital. Economic impact is magnified as the surgeons experience increases.

Esophageal stents for anastomotic leaks and perforations

The purpose of this study was to clarify the role of the intestinal anaerobe bacteria in colonization resistance. Germfree mice were associated withEscherichia coli C25 and either (a) no other species; (b) enterococcus; (c)Escherichia coli M14 andProteus mirabilis, or (d)Bacteroides fragilis andBacteroides vulgatus. All species colonized the cecum in high numbers, but only enterococcus significantly limited the translocation ofEscherichia coli C25 to mesenteric lymph nodes. However, the overall translocation rates were similar in all groups and ranged from 60% to 100%, due to translocation of other intestinal flora in addition toEscherichia coli C25. Conventionally reared mice were given either streptomycin, bacitracin/streptomycin or metronidazole which selectively eliminated facultative gramnegative bacteria, nearly all bacterial species or strictly anaerobic bacteria respectively. Only metronidazole significantly increased the rates of translocation of normal intestinal bacteria into mesenteric lymph nodes. Cohort groups of mice were then orally inoculated with drug resistantEscherichia coli C25, which actively colonized the cecum of all drug treated mice and translocated to the mesenteric lymph nodes of approximately half the streptomycin and metronidazole treated mice and nearly all the bacitracin/streptomycin treated mice. These results indicate that anaerobic bacteria play a pivotal role in limiting the translocation of normal intestinal bacteria, but that other bacterial groups also have a role in preventing the intestinal colonization and translocation of potential pathogens.

Determination of the minimum number of lymph nodes to examine to maximize survival in patients with esophageal carcinoma: data from the Surveillance Epidemiology and End Results database.

BACKGROUND Data comparing survival after lobectomy versus that after segmentectomy for stage I non-small cell lung cancer (NSCLC) are limited to single-institution observational studies and 1 clinical trial. We sought to determine if lobectomy offers a survival advantage over segmentectomy for stage I NSCLC based on population-based data. METHODS Using the Surveillance Epidemiology and End Results (SEER) database (1998 to 2007), we identified patients who underwent either anatomic segmentectomy or lobectomy. Wedge resections were excluded. Analysis was limited to patients with stage I adenocarcinoma or squamous cell carcinoma. After stratifying patients based on tumor size (less than or equal to 2.0 cm, 2.1 to 3.0 cm, and 3.1 to 7.0 cm), we assessed for association between extent of resection and survival using the Kaplan-Meier method. To adjust for potential confounding variables, we used Cox proportional hazards regression models. RESULTS There were 14,473 patients who met our inclusion criteria. Lobectomy conferred superior unadjusted overall (p < 0.0001) and cancer-specific (p = 0.0053) 5-year survival compared with segmentectomy. Even after adjusting for patient factors, tumor characteristics, and geographic location, we noted that patients who underwent lobectomy had superior overall and cancer-specific survival rates, regardless of tumor size. Squamous cell histologic type, male sex, low lymph node counts, and increasing age, tumor size, and grade were all independent negative prognostic factors. CONCLUSIONS Using a population-based data set, we found that lobectomy confers a significant survival advantage compared with segmentectomy. Our results provide additional evidence supporting the role of lobectomy as the standard of care for resection of stage I NSCLC regardless of tumor size.