Prostate cancer clinical trials of the Southwest Oncology Group

The changing clinical dynamics of prostate cancer have resulted in a broadening of the research focus of the Genitourinary (GU) Cancer Committee of the Southwest Oncology Group (SWOG). Beginning with an emphasis on hormone-refractory disease in its early years, SWOG prostate cancer trials now cover the entire spectrum of the disease: localized, locally advanced, metastatic and hormone-refractory disease. As the world's largest GU cancer research group, the GU committee of SWOG has pioneered studies in combined androgen therapy for metastatic disease, quality-of-life (QOL) assessments for patients with localized and advanced disease, adjuvant therapy models, and prostate cancer chemoprevention. The committee has also formed the GU Global Group, whose purpose is to convene the chairs of the GU committees of all the major national and international oncology cooperative groups. Meeting semiannually, this group discusses activities within their respective organizations, plans collaborative strategies and protocols, and establishes global strategy in prostate cancer clinical research. The future directions of national and international prostate cancer trials will build on this broad foundation of well-conceived, logically sequenced studies.     

Cosleeping (bedsharing) among infants and toddlers

This study was designed to investigate the effect of retaining coronal tooth substance on the performance of post-retained core materials, and to compare the fracture resistance of the system with an intact tooth prepared to similar dimensions. Ten teeth restored with post-retained silver amalgam, and 10 teeth restored with silver-glass cermet, all with a retained single wall of coronal tooth substance, were compared with 10 unrestored teeth prepared to similar dimensions when subjected to a shearing load. The results showed no statistically significant difference between the unrestored teeth and those restored with a silver-glass cermet. Whilst the teeth restored with silver amalgam had a significantly higher fracture resistance (P > 0.01) there was greater tendency to root fracture.     

Recent developments in the understanding of antinuclear autoantibodies

Cytological identification of soybean mitotic metaphase chromosomes (2n = 40) has been severely limited by their small size and uniform karyomorphology. We have developed fluorescent in situ hybridization (FISH), PCR-primed in situ labelling (PCR-PRINS) procedures, and molecular probes for routine cytological identification and for the physical mapping of soybean somatic chromosomes. Chromosome preparation has been achieved by modifications of previous protocols and through the preparation of root-tip protoplasts prior to chromosome spreading. Initially our probe selection focused on highly repeated DNAs that provide very intense localized hybridization signals. Repetitive gene probes that have proven valuable include the rDNA loci (5S and 45S) which are chromosome specific. We have also developed satellite DNA probes for two different sequence families: the SB92 and the STR120 satellites. Both of these are tandemly arranged at multiple chromosomal loci. By using different cloned examples of each family, we have been able to selectively label unique subsets of soybean chromosomes. Double hybridization with biotin and digoxigenin labeled probes has allowed us to determine the chromosomal overlap between different probes. In addition, we have joined portions of the metaphase chromosome painting patterns with the genetic map by single-copy FISH and PCR-PRINS detection of the RFLP loci G8.15, G17.3, and A199a and A199b. Total genomic DNA in situ hybridization (GISH) patterns were also used to characterize the soybean chromosomes.     

Recurrence and death in non-small cell lung carcinomas: a prognostic model using pathological parameters, microvessel count, and gene protein products

Optimized stent expansion by high-pressure inflations of oversized balloons has initially been derived from experience obtained with the Palmaz-Schatz stent, whereas there is little experience with this strategy in the Wallstent. By using this approach with quantitative coronary angiographic guidance, 20 Wallstents and 20 Palmaz-Schatz stents were implanted in 34 patients and consecutively examined by conventional two-dimensional (2D) intracoronary ultrasound (ICUS) and three-dimensional (3D) ICUS on the basis of the application of a pattern recognition algorithm. Ultrasound criteria of adequate stent expansion were defined as a complete apposition of the stent to the vessel wall, a stent symmetry index (SSI = minimum/maximum lumen diameter) > or = O.7, and a stent-reference lumen area ratio (SRR = Minimum intrastent lumen area/Average of proximal and distal reference lumen area) > or = O.8. In all cases a smooth angiographic lumen and a negative diameter stenosis, on the basis of a distal reference, was achieved. For the Wallstents ICUS showed a higher SSI (2D, 0.95 +/- 0.04 vs 0.85 +/- 0.09; p < 0.001; 3D, 0.90 +/- 0.09 vs 0.82 +/- 0.11, p < 0.05) and a lower SRR (2D, 0.66 +/- 0.12 vs 0.81 +/- 0.13, p < 0.005; 3D, 0.63 +/- 0.14 vs 0.74 +/- 0.15, p < 0.05) than for the Palmaz-Schatz stents. Ninety percent of failure in meeting these criteria resulted from a low SRR. The incidence of incomplete stent apposition (one in both stents) or SSI <0.7 was low and generally associated with an SRR <0.8. The Wallstents met the ICUS criteria less often (2D, 2(1O%) vs 10(50%), p < 0.01; 3D, 3(15%) vs 9(45%), p < 0.05), were significantly longer (35.1 +/- 7.7 mm and 14.3 +/- 3.3 mm, p < 0.0001), and generally demonstrated a larger vessel tapering, measured as proximal minus distal ICUS reference lumen area (1.33 +/- 2.91 mm2 vs 0.44 +/- 1.97 mm(2), not significant). Wallstents meeting the ICUS criteria, however, showed less vessel tapering (0.18 +/- 1.64 mm(2)). Thus optimized stent expansion was followed by excellent angiographic results for both Palmaz-Schatz and Wallstent. Although angiographic results and visual assessment of the ICUS examination suggested a good outcome, few Wallstents met the ICUS criteria in contrast to the Palmaz-Schatz stents. The low value of the SRR in the Wallstents is likely to be caused by vessel tapering, suggesting that this criterion may be unsuitable in assessing the adequacy of the expansion of relatively long stents such as the Wallstent.     

Abrupt (< 1 day), acute (< 1 week), and early (< 1 month) vessel closure at the angioplasty site. Morphologic observations and causes of closure in 130 necropsy patients undergoing coronary angioplasty

While abundant clinical and angiographic data are available regarding features of acute or abrupt closure at the site of balloon angioplasty, little morphologic information is available. This study discusses morphologic-histologic causes for acute closure after angioplasty in 130 necropsy patients. Intimal-medial flaps, elastic recoil, and primary thrombosis were the three leading morphologic causes for closure. Data were subdivided into time categories: abrupt (< 1 day), acute (< 1 week), and early (< 1 month). Intimal-medial flaps remained the most common cause for angioplasty closure despite time from angioplasty to documented occlusion. Morphologic recognition of types and frequencies of angioplasty closure are discussed, and specific mechanical, pharmacologic, or combined treatments are reviewed.     

Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B

BACKGROUND: About 65 percent of previously untreated adults with primary acute myeloid leukemia (AML) enter complete remission when treated with cytarabine and an anthracycline. However, such responses are rarely durable when conventional postremission therapy is administered. Uncontrolled trials have suggested that intensive postremission therapy may prolong these complete remissions. METHODS: We treated 1088 adults with newly diagnosed AML with three days of daunorubicin and seven days of cytarabine and randomly assigned patients who had a complete remission to receive four courses of cytarabine at one of three doses: 100 mg per square meter of body-surface area per day for five days by continuous infusion, 400 mg per square meter per day for five days by continuous infusion, or 3 g per square meter in a 3-hour infusion every 12 hours (twice daily) on days 1, 3, and 5. All patients then received four courses of monthly maintenance treatment. RESULTS: Of the 693 patients who had a complete remission, 596 were randomly assigned to receive postremission cytarabine. After a median follow-up of 52 months, the disease-free survival rates in the three treatment groups were significantly different (P = 0.003). Relative to the 100-mg group, the hazard ratios were 0.67 for the 3-g group (95 percent confidence interval, 0.53 to 0.86) and 0.75 for the 400-mg group (95 percent confidence interval, 0.60 to 0.94). The probability of remaining in continuous complete remission after four years for patients 60 years of age or younger was 24 percent in the 100-mg group, 29 percent in the 400-mg group, and 44 percent in the 3-g group (P = 0.002). In contrast, for patients older than 60, the probability of remaining disease-free after four years was 16 percent or less in each of the three postremission cytarabine groups. CONCLUSIONS: These data support the concept of a dose-response effect for cytarabine in patients with AML who are 60 years of age or younger. The results with the high-dose schedule in this age group are comparable to those reported in similar patients who have undergone allogeneic bone marrow transplantation during a first remission.     

Questionnaire for the identification of back pain for epidemiological purposes

OBJECTIVES: To design a questionnaire for the identification and assessment of severity of back pain for epidemiological purposes, and gain preliminary experience of its use. METHODS: A group of specialists, experienced in the epidemiology and clinical assessment of back pain, designed the questionnaire, and tested it individually. It was also given cross sectionally by interview to a population of male coal mine workers. RESULTS: The questionnaire comprised a maximum of 12 questions on the presence, radiation, frequency, and severity of back pain with reference to difficulty with specific activities, interference with normal work, and absence from work. 471 coal miners answered the questionnaire (66% of those invited). 56% (265 men) of the responders reported pain or ache in the back during the previous 12 months, and the incidence of first ever attacks during the same period was reported to be 34%. 69% reported having had back pain at some time. The responses to the questionnaire were partially validated by comparison with certified sickness absence for two days or more attributed to back pain. In men who were symptomatic in the previous 12 months, for the question relating to absence from work because of back pain, the sensitivity was 82% and specificity was 84%. CONCLUSION: The questionnaire is easy to administer and generates clear cut data that could be useful for epidemiological or screening purposes. Preliminary, limited, studies of its validity are reasonably encouraging, although further validation is required. It is hoped that researchers will find the questionnaire useful, will extend its validation, and continue to develop it.