Randomized trial of paclitaxel plus supportive care versus supportive care for patients with advanced non-small-cell lung cancer

BACKGROUND: In phase II trials, paclitaxel has been shown to have antitumor activity in patients with advanced non-small-cell lung cancer (NSCLC). However, the survival and quality-of-life (QOL) benefits of paclitaxel used as a single agent compared with supportive care alone have not been assessed in a randomized clinical trial. METHODS: A total of 157 patients with stage IIIB or IV NSCLC who had received no prior chemotherapy were randomly assigned to receive either best supportive care alone (78 patients) or paclitaxel plus supportive care (79 patients). Paclitaxel was administered as a 3-hour intravenous infusion every 3 weeks. Supportive care included palliative radiotherapy and supportive therapy with corticosteroids, antibiotics, analgesics, antiemetics, transfusions, and other symptomatic therapy as required. The primary end point of the study was survival. Time to disease progression, response rate, adverse events, and QOL were secondary end points. RESULTS: Pretreatment characteristics were evenly distributed between the two arms. Survival was statistically significantly better in the paclitaxel plus supportive care arm than in the supportive care alone arm (two-sided P =.037) (median survival = 6.8 months versus 4.8 months). Cox multivariate analysis showed paclitaxel plus supportive care to be statistically significantly associated with improved survival (two-sided P =.048). QOL was similar for both treatment arms, except for the functional activity score of the Rotterdam Symptom Checklist, where QOL data statistically significantly favored the paclitaxel plus supportive care arm (two-sided P =.043). CONCLUSION: The addition of paclitaxel to best supportive care significantly improved survival and time to disease progression compared with best supportive care in patients with advanced NSCLC and may improve some aspects of QOL.     

Colorectal hemangioma: radiologic findings

The authors correlated radiographs with the clinical and histologic data of 12 patients with colorectal hemangioma. All patients presented with rectal bleeding, which was chronic in seven. Phleboliths were also visible in seven cases, which correlated with chronic bleeding in five. On barium studies, three masses were soft and three produced rigid narrowing. The atypical features of rigid luminal narrowing, which might mimic a carcinoma, and hypovascularity correlated with chronic bleeding or visible phleboliths, which suggest the correct diagnosis of colorectal hemangioma.     

Cyanobacteria and prawn farming in northern New South Wales, Australia--a case study on cyanobacteria diversity and hepatotoxin bioaccumulation

Harmful cyanobacteria pose a hazard to aquatic ecosystems due to toxins (hepatotoxic microcystins, nodularins, and cylindrospermopsin) they produce. The microcystins and nodularins are potent toxins, which are also tumor promoters. The microcystins and nodularins may accumulate into aquatic organisms and be transferred to higher trophic levels, and eventually affect vector animals and consumers. Prawn farming is a rapidly growing industry in Australia. Because information regarding effects of cyanobacteria at prawn farms was lacking, we examined diversity of cyanobacteria and toxin production plus bioaccumulation into black tiger prawns (Penaeus monodon) under both field (northern New South Wales, Australia, December 2001-April 2002) and laboratory conditions. Samples were analyzed for hepatotoxins using enzyme-linked immunosorbent assay (ELISA) and high-performance liquid chromatography (HPLC).The maximum density of cyanobacteria (1 × 10⁶ to 4 × 10⁶ cells/l) was reached in April. Cyanobacteria encountered were Oscillatoria sp. (up to 4 × 10⁶ cells/l), Pseudanabaena sp. (up to 1.8 × 10⁶ cells/l), Microcystis sp. (up to 3.5 × 10⁴ cells/l), and Aphanocapsa sp. (up to 2 × 10⁴ cells/l). An uncommon cyanobacterium, Romeria sp. (up to 2.2 × 10⁶ cells/l), was also observed. Contrasting earlier indications, toxic Nodularia spumigena was absent. Despite that both Oscillatoria sp. and Microcystis sp. are potentially hepatotoxic, hepatotoxin levels in phytoplankton samples remained low (up to 0.5-1.2 mg/kg dw; ELISA) in 2001-2002. ELISA was found suitable not only for phytoplankton but prawn tissues as well. Enzymatic pretreatment improved extractability of hepatotoxin from cyanobacteria (nodularin from N. spumigena as an example), but did not generally increase toxin recovery from prawn hepatopancreas.There were slightly increasing hepatotoxin concentrations in prawn hepatopancreas (from 6-20 to 20-80 μg/kg dw; ELISA) during the study. Hepatotoxin concentrations in surface sediment remained low (<5 μg/kg dw; ELISA) throughout the study. Laboratory experiments indicated that prawn hepatopancreas, heart, and brain were primary organs for hepatotoxin bioaccumulation. Toxin concentration in other organs, including muscle, was less effective. Orally administered nodularin levels in hepatopancreas rapidly decreased from initial 830 to 250 μg/kg dw in 96 h. Similarly, concentration of microcystin-LR injected in prawns decreased from 130 to 30 μg/kg dw (hepatopancreas) in 2 h.These results demonstrate that potential risks caused by cyanobacteria in prawn farming (farmers, prawns, and consumers) were not substantial in 2001-2002. Although prawns may act as vectors for toxin transfer, they did not accumulate alerting amounts of hepatotoxins and were able to effectively detoxify them. Because bloom toxicity may vary, low-frequency toxin monitoring is recommended.     

Rates of refracture associated with external fixation in pediatric femur fractures

We conducted a small retrospective study of rates of early complications associated with external fixation of pediatric femur fractures and compared rates at our institution with those reported in the literature. In our series of 22 patients, early complications included 12 pin-track infections (54.5%), 2 cases of loss of reduction (9.1%), 1 pin-track abscess (4.5%), and 1 refracture (4.5%). Overall rates (ours combined with those reported by other investigators) were 4.7% (34/719) for refractures and 33.1% (224/677) for pin-track infections. Factors that correlated with refractures were open fracture, bilateral fracture, and longer time in fixator. Factors with inconclusive correlations were fracture pattern, dynamization status, fixator type, pin size, and number of pins.