Objective. The aim of this study was to determine the outcomes of Stage I endometrial carcinoma patients who are managed without adjuvant radiation after comprehensive surgical staging.
Methods. A ...computerized hospital database identified women diagnosed with adenocarcinoma of the endometrium from 1993 to 1998. A chart review identified 864 women as having primary surgery for adenocarcinoma of the endometrium. A total of 670 of 864 patients (78%) underwent comprehensive surgical staging with total hysterectomy, bilateral salpingo-oophorectomy, pelvic/para-aortic lymphadenectomy, and peritoneal cytology. After 57 patients with high-risk histologic subtypes were excluded, 613 patients remained for analysis.
Results. A total of 321 of 325 Stage IB patients (99%) did not receive adjuvant radiation. Fifteen of 321 patients (5%) recurred; 9 recurred in the pelvis or vagina. All 9 local recurrences were salvaged with whole pelvic radiation (XRT) and brachytherapy (BT). Seventy-seven patients were diagnosed with Stage IC disease; 53 (69%) received no adjuvant therapy. Four patients (8%) recurred, of which 2 recurred in the vagina. Three of 4 patients (75%) were salvaged, 2 with XRT/BT and 1 with surgery and chemotherapy. For all Stage I patients, the 5-year disease-free survival was 93% and the 5-year overall survival was 98%.
Conclusions. Surgically staged patients with endometrial carcinoma confined to the uterine corpus have a small risk of recurrence and the majority of these recurrences can be salvaged with radiation therapy. Conservative management of Stage I endometrial carcinoma patients is an effective treatment strategy.
The administration of 4-hydroxybutyl(butyl)nitrosamine (OH-BBN) to male B6D2F1 mice yielded a high incidence of large palpable urinary bladder cancers. Since prior studies demonstrated ...chemopreventive effects of non-steroidal anti-inflammatory drugs (NSAIDs), we further explored the efficacy of the NSAID indomethacin using different treatment regimens. OH-BBN was administered twice per week for 12 weeks (the first week of treatment was designated week 1). In Experiment I continual indomethacin treatment (20 mg/kg diet) was initiated either prior to (week −1) or following (week 13) OH-BBN dosing. Palpable bladder masses (subsequently diagnosed as cancers) developed in 32% of carcinogen-treated only mice by 32 weeks, while mice administered indomethacin either prior to or after OH-BBN developed palpable masses in 3 and 6% of the animals, respectively. In Experiment II mice were treated with indomethacin beginning 1 week after OH-BBN for either 12 weeks (limited treatment, weeks 13–24) or for 30 weeks (weeks 13–42). Continual treatment resulted in a 77% decrease in palpable bladder masses and an 82% decrease in all cancers (palpable and microscopic), while limited treatment decreased palpable masses by 48% but failed to decrease the number of bladder cancers (palpable plus microscopic). In Experiment III OH-BBN-treated mice were followed for 61 weeks. Palpable masses developed in 66% of control mice, while 26% of mice treated with indomethacin continually from 1 week after OH-BBN (weeks 13–61) developed palpable masses. A separate group in this study treated with indomethacin beginning when 5% of the mice had palpable bladder masses continued to develop new masses for an additional 4 weeks. By 6 weeks after beginning indomethacin treatment, however, these animals showed a profound decrease in the development of additional cancers. The expressions of FHIT and survivin in normal urinary bladder epithelium and in bladder cancers were determined by immunohistochemical analysis. FHIT was expressed at high levels in normal epithelium, but was minimally expressed in cancers, and even showed decreased expression in papillomas. The anti-apoptotic protein survivin was not expressed in normal bladder epithelium, but was variably expressed in cancers. FHIT and survivin expressions were similar in cancers from indomethacin-treated and non-treated mice.
Pain is the most frequent and disabling complication of herpes zoster. The analysis of pain severity data is complicated by the nonlinear rate of resolution. Further, three distinct phases ...characterize pain resolution—acute, subacute, and chronic. Using two clinical trial datasets as the bases for analyses, the rates of baseline pain resolution were computed across each of three phases and compared for age, severity of pain at onset, and number of lesions at baseline. The results defined transition points of 24.4 ± 3.34 for the subacute phase and 110.3 ± 11.9 days for the chronic phase. The model demonstrated a treatment effect of valiciclovir (VACV) during the subacute phase as compared to acyclovir (ACV) (P = 0.006) and supports effects of age, baseline pain and number lesions on pain cessation rates in the acute phase. This model verifies three phases of zoster pain and delineates the impact of treatment and other factors on the phase-specific rates of pain cessation.
The use of preoperative tumor curettage in Mohs micrographic surgery has never been prospectively systematically assessed.
To assess the utility of preoperative tumor curettage in Mohs micrographic ...surgery for primary or recurrent, well-defined basal cell carcinoma less than 2 cm in diameter located on the head or neck.
Patients were randomized to either preoperative tumor curettage or control group and were compared in terms of percent surface area increase from tumor surface area to wound surface area, absolute surface area increase, number of tissue layers removed, types of repairs performed, and postoperative complications. Multivariate analysis was performed to see if tumor location, appearance (exophytic or flat), or histology affected any of the above.
The preoperative tumor curettage group had a 399% (95% confidence interval CI 346-452) mean surface area increase from tumor to wound surface area versus 263% (95% CI 216-311) for control group (
P
=
.0002). The preoperative tumor curettage group had a mean absolute surface area increase of 1.78 cm
2 (95% CI 1.57-1.99) versus 1.40 cm
2 (95% CI 1.15-1.65) for control group (
P
=
.02). The preoperative tumor curettage group had fewer tissue layers removed (
P
=
.3). Preoperative tumor curettage had no effect on types of repairs performed or number or type of postoperative complications. Tumor appearance and histology had no effect on any of the above end points.
Preoperative tumor curettage was associated with significantly greater percent surface area increase and absolute surface area increase from tumor surface area to wound surface area. This difference did not affect type of repair performed or postoperative complications.
NEONATAL herpes simplex virus (HSV) infection is one of the most life-threatening of all infections in newborns, affecting approximately 1500 to 2200 babies per year in the United States.
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...Although several clinical trials have documented the severity of the disease,
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they have evaluated insufficient numbers of babies and lacked a standardized data base, limiting the evaluation of prognostic factors.
The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group reported that there were no detectable differences in mortality and morbidity for vidarabine therapy as compared with acyclovir therapy of neonatal HSV infection.
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These data also provided an opportunity . . .
Many complex disease traits are observed to be associated with single nucleotide polymorphism (SNP) interactions. In testing small-scale SNP-SNP interactions, variable selection procedures in ...logistic regressions are commonly used. The empirical evidence of variable selection for testing interactions in logistic regressions is limited. This simulation study was designed to compare nine variable selection procedures in logistic regressions for testing SNP-SNP interactions. Data on 10 SNPs were simulated for 400 and 1000 subjects (case/control ratio=1). The simulated model included one main effect and two 2-way interactions. The variable selection procedures included automatic selection (stepwise, forward and backward), common 2-step selection, AIC- and SC-based selection. The hierarchical rule effect, in which all main effects and lower order terms of the highest-order interaction term are included in the model regardless of their statistical significance, was also examined. We found that the stepwise variable selection without the hierarchical rule, which had reasonably high authentic (true positive) proportion and low noise (false positive) proportion, is a better method compared to other variable selection procedures. For testing interactions, the hierarchical rule effect was obvious. The procedure without the hierarchical rule requires fewer terms in testing interactions, so it can accommodate more SNPs than the procedure with the hierarchical rule. For testing interactions, the procedures without the hierarchical rule had higher authentic proportion and lower noise proportion compared with ones with the hierarchical rule. These variable selection procedures were also applied and compared in a rheumatoid arthritis study.
Motivation: One major area of interest in analyzing oligonucleotide gene array data is identifying differentially expressed genes. A challenge to biostatisticians is to develop an approach to ...summarizing probe-level information that adequately reflects the true expression level while accounting for probe variation, chip variation and interaction effects. Various statistical tools, such as MAS and RMA, have been developed to address this issue. In these approaches, the probe level expression data are summarized into gene level data, which are then used for downstream statistical analysis. Since probe variation is often larger than chip variation and there is also a potential interaction effect between probe affinity and treatment effect, strategies such as a gene level analysis, may not be optimal. In this study, we propose a procedure to analyze probe level data for selecting differentially expressed genes under two treatment conditions (groups) with a small number of replicates. The probe level discrepancy between two groups can be measured by a difference of the percentiles of probe perfect-match (PM) ranks or of probe PM weighted ranks. The difference is then compared with a pre-specified threshold to determine differentially expressed genes. The probe level approach takes into account non-homogenous treatment effects and reduces possible cross-hybridization effects across a set of probes. Results: The proposed approach is compared with MAS and RMA using two benchmark gene array datasets. Positive predictivity and sensitivity are used for evaluation. Results show the proposed approach has higher positive predictivity and higher sensitivity. Availability: Available on request from the authors. Contact: dtchen@uab.edu
NEONATAL herpes simplex virus (HSV) infection is associated with substantial morbidity and mortality, and its incidence is increasing in the United States.
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Since 1973, the National Institute of ...Allergy and Infectious Diseases Collaborative Antiviral Study Group has performed therapeutic trials that demonstrated decreased mortality and morbidity with intravenous vidarabine therapy.
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Nevertheless, overall, only 53 percent of surviving children were developing normally one year after treatment. The development of acyclovir provided an opportunity to improve outcome by administering a selective and specific inhibitor of viral replication.
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The current study of babies with neonatal HSV infection compared mortality and morbidity after treatment . . .
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