Phase I clinical trial of interleukin 2 and alpha-interferon: toxicity and immunologic effects.

Because recombinant interleukin 2 (rIL-2) and recombinant alpha-interferon (rIFN-alpha) exhibit synergistic antitumor activity in C3HMT1820 T-cell lymphoma and B16 melanoma tumor systems, we have performed a Phase I study of this combination in 55 patients with advanced malignancies for whom no standard therapy exists. Successive groups of greater than or equal to 4 patients have been entered into 12 dose levels (1A-3D), with dose levels 1-3 referring to doses of rIL-2 of 0.1, 0.5, and 2.0 x 10(6) units/m2, respectively, and dose levels A-D referring to doses of recombinant human alpha 2a-interferon (rHuIFN-alpha 2a) of 0, 0.1, 1.0, and 10.0 x 10(6) units/m2. Both agents were given on Mondays, Wednesdays, and Fridays, with rIL-2 being given as i.v. bolus injections and rHuIFN-alpha 2a being given intramuscularly. Myelosuppression was dose-limiting and was related primarily to the dose of rHuIFN-alpha 2a. The maximum-tolerated dose level was reached at a dose of rIL-2 of 2.0 x 10(6) units/m2 and of rHuIFN-alpha 2a of 10.0 x 10(6) units/m2 (dose level 3D). At this dose level, 3/6 patients developed grade 3 neutropenia (absolute granulocyte count less than 1 x 10(9)/liter). Myelosuppression was transient, with no documented infections being associated with neutropenia. Hypotension was mild; a single patient was treated with a vasopressor, but all other cases of hypotension responded to fluid administration. No significant pulmonary toxicity was produced. Fever, chills, and malaise were universal but not dose-limiting. Three partial responses and one minor response were observed in patients with malignant melanoma, renal cell carcinoma, and breast cancer. Immunological studies suggested that natural killer activity was related to both the dose of rIL-2 and the dose of rHuIFN-alpha 2a, with natural killer activity being positively related to the dose of rIL-2 and maximal at the lowest dose of rHuIFN-alpha 2a of 0.1 x 10(6) units/m2.

Phase I trial of natural human interferon beta in metastatic malignancy.

A phase I trial of natural human beta-interferon (nHuIFN-beta) was initiated to evaluate its biological activity, maximum tolerated dose, and toxicity in patients with refractory malignancies. nHuIFN-beta was administered to successive groups of 4-6 patients as an i.v. bolus on days 1 and 4, for 4 consecutive weeks. Dose levels were 0.1, 1.0, 10, 30, 60, 100, and 200 x 10(6) units/m2. Thirty-five patients were entered, and 34 patients were evaluable for toxicity, immunomodulatory, and antitumor effects. Toxicity was mild to moderate and included fever and chills, fatigue, arthralgias, nausea, transient renal and hepatic dysfunction, and leukopenia. No dose-limiting toxicity was observed, and no responses were seen. Significant immunological changes included the following: an increase in natural killer activity on day 5 when compared to pretreatment values (P less than 0.01) and an increase in activated T-cells (CD3+/HLA-DR+) with increasing doses of nHuIFN-beta (P less than 0.01). Pharmacokinetic data demonstrated a short alpha half-life of 12.1 +/- 2.5 (SE) min and a beta half-life of 129.7 +/- 14.7 min. Neutralizing serum antibodies were detected in 2 of 27 patients receiving nHuIFN-beta. In conclusion, toxicity of nHuIFN-beta given twice weekly was moderate, and further dose escalation is possible. The immunological changes and pharmacokinetic behavior of nHuIFN-beta resemble those reported with rHuIFN-beta ser.

High-level aminoglycoside-resistant enterococci. Colonization of nursing home and acute care hospital patients.

Enterococci with high-level resistance (HLR) to gentamicin sulfate and other aminoglycosides have emerged as pathogens in recent years. More than half of all current isolates of enterococci at the Ann Arbor (Mich) Veterans Administration (VA) Medical Center are HLR strains. We determined the rate of colonization with HLR enterococci in patients in the acute care hospital, the attached nursing home, and a private nursing home. We also studied the factors related to colonization and the molecular relatedness of strains of HLR enterococci in these settings. In the VA facilities, 47.4% of patients in the nursing home and 36.1% of patients in the acute care hospital were colonized, compared with a 4.3% colonization rate in the private nursing home. Intravenous or Foley catheters and bedridden status were associated with colonization in the acute care setting; the need for advanced nursing care and prior antibiotic therapy were associated with colonization in the nursing home. Environmental surfaces were contaminated with HLR enterococci in both VA settings. Plasmid analysis of HLR strains revealed identity between both patient and environmental strains in the nursing home care unit and the acute care hospital. Nursing home patients, with their high rate of colonization with HLR enterococci and their frequent movement into the acute care hospital, may play a role as a reservoir for subsequent transmission of HLR enterococci.

Magnetic resonance imaging lesion enlargement in multiple sclerosis. Disease-related activity, chance occurrence, or measurement artifact?

Magnetic resonance imaging (MRI) may demonstrate disease activity in a number of ways in patients with multiple sclerosis. Newly appearing MRI lesions, gadolinium-enhancing lesions, and enlargement of preexisting lesions are frequently taken as evidence of disease activity. Furthermore, serial MRI studies have been stated to be more sensitive than repeated neurologic examinations in detecting disease activity. We assessed the validity of using lesion enlargement as a measure of disease activity by repeatedly measuring the area of all MRI lesions in four patients with multiple sclerosis. The size-frequency distribution in all patients was similar, with 80% of the lesions measuring less than 0.67 cm2. The median coefficient of variation for three successive lesion measurements was inversely related to lesion area, ranging from 22.6% for the more common smaller lesions (less than 0.67 cm2) to 12.1% for larger lesions. Based on these coefficients of variation, a change in a particular lesion exceeding 45.2% for a baseline lesion smaller than 0.67 cm2 and 24.2% for a baseline lesion greater than or equal to 0.67 cm2 should be required to exclude a change due to measurement variability. It remains necessary to determine the number of lesions that must change when multiple lesions are present in the baseline MRI to reliably exclude chance occurrence when establishing MRI-evident disease activity. Guidelines for determining these criteria are presented, as are the limitations inherent in the statistical model employed to make these determinations.

Supplementary motor seizures mimicking pseudoseizures: some clinical differences.

Supplementary motor seizures (SMS) are among the group of frontal lobe seizures that may often be misdiagnosed as pseudoseizures (PS). We designed this study to determine the value of clinical phenomena in distinguishing between the two. In a series of patients with SMS, we identified those with symptoms mimicking PS and compared the clinical phenomena with those of clinically similar PS. We found that SMS are short in duration, stereotypic, tend to occur in sleep, and often present with a tonic contraction of the upper extremities in abduction. This sign was specific for SMS, particularly when occurring at the onset. Conversely, PS are long in duration, nonstereotypic, and occur in the awake state. We conclude that clinical phenomena may be useful in distinguishing PS from SMS, although the final diagnosis must be documented by neurophysiologic means.

The response of the KHT sarcoma to radiotherapy as measured by water proton NMR relaxation times: relationships with tumor volume and water content.

The potential application of magnetic resonance imaging (MRI) to predict tumor response to radiotherapy is investigated. The water proton spin-lattice and spin-spin relaxation times (T2 and T2, respectively) of murine sarcomas (designated KHT) were measured shortly after excision. This study has demonstrated significantly different responses in T1 and T2 between the control and the irradiated tumors at various times following single doses of X rays. Quite generally, the changes in relaxation times correlated with the changes in tumor water content, indicating that the MR relaxation-time probes are fairly sensitive to radiation-induced edema and dehydration. The possible relationships between the T1 and T2 responses and radiobiological effects such as those on tumor blood flow, vascular permeability, physiological state of cells, and cell death are discussed. It is conceivable that the findings obtained from this investigation could be extended to in situ studies for potential applications in clinical radiotherapy.

Analysis of cardiac symptoms preceding cardiac arrest.

Prodromal symptoms and cardiac history were examined in 227 patients with coronary artery disease who were successfully resuscitated after out-of-hospital cardiac arrest. Cardiac arrest was sudden--with either no symptoms or symptoms for less than 1 hour--in 71% of the patients. Nonsudden death--death occurring after more than 1 hour of symptoms--occurred in 29% of the patients. A history of cardiovascular disease was present in 85% of patients with sudden cardiac arrest and in 83% with nonsudden arrest. Cardiac arrest occurred without symptoms in 38% of the patients with sudden cardiac arrest and was the first expression of coronary artery disease in 4% of the entire study group. This study indicates that cardiac arrest usually occurs with symptoms and almost always in the setting of a history of cardiovascular disease.

Significance of perioperative blood transfusions in patients undergoing resection of stage I and II non-small-cell lung cancers.

Perioperative blood transfusions (BT) have been reported to reduce survival in patients undergoing curative resection of lung cancers. It is postulated that a state of BT-mediated immunosuppression favors the proliferation of tumor cells not resected during surgery. To evaluate this hypothesis and to determine factors influencing the administration of BT, we retrospectively studied the charts of 127 patients who underwent surgery for stage I and II non-small-cell carcinoma. Thirty (23.6 percent) patients received BT and 97 (76.4 percent) did not. Sex, age, race, smoking history, size and stage of the tumor, histology, extent of resection and preoperative hemoglobin values were analyzed. Only age (p = 0.01) and preoperative hemoglobin values (p less than 0.01) were related to transfusion status. Neither survival nor event-free survival differed significantly between the two groups (p = 0.29 and 0.26 respectively). Our results do not support the hypothesis that perioperative BTs have a significant detrimental effect on survival. A prospective study could clarify this controversial issue; however, such a study would be complex considering the multiple variables that affect survival in patients with non-small-cell lung cancers.

The impact of thoracoscopy on the management of pleural disease.

STUDY OBJECTIVE: To describe the diagnostic efficacy, morbidity, and patient outcome of thoracoscopy; to quantify the direct impact of thoracoscopy on clinical management; and to determine preoperative variables associated with finding malignancy at thoracoscopy to aid patient selection. DESIGN: Retrospective chart review of consecutive cases of thoracoscopy for pleural disease. SETTING: Single tertiary medical center. PATIENTS: One hundred eighty-two consecutive patients who underwent thoracoscopy for pleural disease over a 5-year period (from 1987 through 1992). MEASUREMENTS AND RESULTS: Final diagnoses were 98 (54%) malignant, 58 (32%) benign, and 26 (14%) idiopathic. Thoracoscopy had a diagnostic sensitivity of 95% for malignancy and 100% for benign disease. Malignancy was shown by thoracoscopy in 27 of 41 (66%) patients who had a preoperative nondiagnostic closed pleural biopsy, and in 24 of 35 (69%) patients who had at least 2 preoperative negative pleural cytologic specimens. Chart review by preestablished criteria showed information obtained from thoracoscopy directly influenced treatment in 155 (85%) patients. Thirty-seven (20%) patients, however, had at least one perioperative complication (15% major, 8% minor). Ten (6%) patients died during the same hospitalization in which a thoracoscopy was performed, although none died within 48 h. There was one thoracoscopy-related death. Sixty-two (34%) patients died within 6 months of thoracoscopy (death by all causes). Forty-seven (48%) patients who had intrathoracic malignancy present at thoracoscopy died within 6 months. Patients found to have malignant pleural disease by thoracoscopy were more likely to have a preoperative history of a malignancy (p = 0.001). Age more than 50 years was associated with finding malignancy at thoracoscopy (p = 0.04). A combined lymphocytic and hemorrhagic effusion was associated with malignancy (p = 0.004). Preoperative pleural data showed that idiopathic effusions had a significantly lower median lactate dehydrogenase (LDH) value (192, which was normal) compared with malignant or benign effusions. CONCLUSIONS: (1) Thoracoscopy increases yield for malignant and benign disease when thoracentesis and closed pleural biopsy are nondiagnostic. (2) Thoracoscopy directly affects clinical management in 85% of patients. (3) Significant complications can occur in patients receiving tertiary care. (4) For the evaluation of suspected malignant pleural disease, thoracoscopy has its greatest diagnostic yield in older patients who have a history of malignancy and who present with a lymphocytic, hemorrhagic, high LDH effusion.

Stage II esophageal carcinoma: the significance of T and N.

OBJECTIVE: Stage II esophageal carcinomas are a heterogeneous group of uncommon malignant tumors that include both node-negative (IIA; T2 N0 M0 and T3 N0 M0) and node-positive (IIB; T1 N1 M0 and T2 N1 M0) carcinomas. The purpose of this study was to evaluate this heterogeneity and to identify predictors of improved survival. RESULTS: Ninety-four of 345 patients undergoing esophageal resection at the Cleveland Clinic Foundation between 1985 and 1994 had stage 11 carcinomas; 70 stage IIA (24 T2 N0 M0 and 46 T3 N0 M0) and 24 stage IIB (9 T1 N1 M0 and 15 T2 N1 M0). Pathologic stage and T and N status were the only identifiable predictors of survival. Stage IIA survival was significantly better than stage IIB (p = 0.01). T2 N0 M0 survival was not different from T1 N0 M0 survival (p = 0.83). T3 N0 M0 survival was significantly worse than T1 N0 M0 (p = 0.03) and intermediate between T2 N0 M0 survival (p = 0.06) and T1 N1 M0 and T2 N1 M0 survivals (p = 0.07). T1 N1 M0 and T2 N1 M0 survival was not significantly different from T3 N1 M0 survival (p = 0.63). CONCLUSIONS: (1) N1 disease is the principal predictor of reduced survival and N1 is independent of T. Therefore the distinction between T1 N1 M0, T2 N1 M0, and T3 N1 M0 carcinomas is not warranted. (2) N0 disease is the principal predictor of improved survival but N0 is not independent of T. T1 N0 M0 and T2 N0 M0 survivals are similar and therefore distinction between these subgroups is not warranted. T3 N0 M0 survival is intermediate between T1 N0 M0 and T2 N0 M0 carcinomas and between T1 N1 M0, T2 N1 M0, and T3 N1 M0 carcinomas. Therefore stratification by T for N0 carcinomas is warranted.

Prognostic significance of flow cytometry in non-small-cell lung cancer.

To clarify the value of deoxyribonucleic acid (DNA) ploidy analysis, we prospectively studied single-parameter flow cytometric findings of fresh tissue from 272 patients with primary non-small-cell lung cancer from whom adequate tissue from the lung cancer was available. The mean age of the patients was 65.5 years; 65.8% were men. Histologic types were as follows: adenocarcinoma, 107 (39.3%); squamous cell, 100 (36.8%); large cell, 56 (20.6%); adenosquamous, 8 (2.9%); and giant cell, 1 (0.4%). Histologic grades were as follows: I (well differentiated), 15 (5.5%); II, 100 (36.8%); and III, 157 (57.7%). American Joint Committee on Cancer stages were as follows: I, 151 (55.5%); II, 38 (14%); III, 74 (27.2%); and IV, 9 (3.3%). Survivals at 1 year and 3 years were 74.2% +/- 2.8% and 52.4% +/- 4.8%, respectively. For non-squamous cell lung cancer, multivariate analyses with the Cox proportional hazards regression model for survival showed (1) that increasing American Joint Committee on Cancer stage (p < 0.001), male gender (p = 0.02), and histologic grades II and III (p = 0.04) were of independent (negative) prognostic significance and (2) that the presence and absence of DNA aneuploidy (p = 0.91), the classification of DNA histogram (p = 0.81), the DNA index (p = 0.46), and the results of cell cycle analysis in tumors with no aneuploidy (S phase, p = 0.23; S + G2M, p = 0.62) were of no prognostic significance. For squamous cell lung cancer, multivariate analyses showed that increasing American Joint Committee on Cancer stage (p = 0.003) and increasing DNA index (p = 0.009) were of independent (negative) prognostic significance.

Comparison study of the immunogenicity and safety of 5- and 10-microgram dosages of a recombinant hepatitis B vaccine in healthy children.

OBJECTIVE: To compare the immunogenicity and safety of 5 micrograms with 10 micrograms of Engerix-B recombinant hepatitis B vaccine when given to healthy children, 2 to 6 years of age. METHODS: Randomized multicenter study of serongative children 2 to 6 years of age who received Engerix-B hepatitis B vaccine either 5 micrograms/0.25 ml or 10 micrograms/0.5 ml (the current Food and Drug Administration-approved dosage of Engerix-B in children) at 0, 1 and 6 months. Serum was obtained at 1, 3, 6 and 8 months after the first vaccine dose was given for antibody measurement. RESULTS: A total of 223 subjects were screened and received the first dose of vaccine. Of these subjects 193 continued in the study. Both dosages proved to be highly immunogenic, producing high seroconversion and seroprotection rates and geometric mean antibody to hepatitis B surface antigen concentrations after 3 doses. The geometric mean concentrations of seroconverters at Months 6 and 8 were significantly greater for the 10-micrograms group compared with the 5-micrograms group. Both dosages were well-tolerated and no serious adverse events were reported. CONCLUSIONS: There was a significant reduction in geometric mean concentrations on lowering the dosage of Engerix-B from 10 to 5 micrograms in children 2 to 6 years of age. Although a high seroprotection rate was elicited by the 5-micrograms dose, the lower antibody concentrations achieved may make this lower dosage less desirable in the long term. Further studies are required to examine the need for booster doses of vaccine with both dosing schedules.

Comparison study of the immunogenicity and safety of 5- and 10-microgram dosages of a recombinant hepatitis B vaccine in healthy infants.

BACKGROUND: It has been suggested that lower dosages of hepatitis B vaccine may be adequate for vaccinating infants and would be less costly. OBJECTIVES: To compare the immunogenicity and safety of 5 and 10 micrograms of Engerix-B recombinant hepatitis B vaccine given to healthy infants. METHODS: A prospective randomized comparison of 5- and 10-micrograms doses of Engerix-B recombinant hepatitis B vaccine given to infants at 2, 4 and 6 months of age. Seroconversion (antihepatitis B surface antigen (anti-HBs) > or = 1 mIU/ ml) and seroprotection (anti-HBs > or = 10 mIU/ml) rates as well as geometric mean antibody titers were compared at 4, 6 and 8 months. RESULTS: A total of 190 healthy infants were screened and received the first dose of vaccine. Of these infants 153 were eligible to continue in the study. Both dosages proved to be highly immunogenic, producing high seroconversion and seroprotection rates and geometric mean anti-HBs concentrations after 3 doses. Although 10 micrograms induced significantly greater geometric mean concentrations (1641 mIU/ml compared 880 mIU/ml at 8 months of age), the seroprotection rates were identical (98.5%). CONCLUSIONS: Both dosages were well-tolerated and no serious adverse experiences were reported. However, the 5 micrograms of Engerix-B administered at 2, 4 and 6 months of age did not induce as great an anti-Hbs concentration as did 10 micrograms. Long term studies are required to determine whether using the lower dosage would sacrifice long term efficacy.

Comparative study of the immunogenicity and safety of two dosing schedules of Engerix-B hepatitis B vaccine in neonates.

A randomized multicenter study compared the routine hepatitis B vaccine schedule of 0, 1, 6 months with an accelerated schedule of 0, 1, 2 months in newborns. Two hundred ninety-nine infants whose mothers were seronegative for hepatitis B were enrolled in the study and randomized to either the routine or accelerated schedule. All infants had blood drawn for antibody titers to hepatitis B at 2, 3, 6 and 7 months of age. For 222 infants data were evaluable, at least for safety; 193 of these 22 had antibody titers that were evaluable. The infants vaccinated on the accelerated schedule developed seroprotective concentrations of antibody more quickly than the infants vaccinated on the routine schedule; 92.6% vs. 66.1% had seroprotective concentrations (> or = 10 mIU/ml) at 3 months of age (P < 0.001). However, infants in the accelerated schedule had lower geometric mean antibody titers at 7 months, 420.0 vs. 3141.8. We conclude that the accelerated vaccination schedule resulted in the more rapid development of seroprotective concentrations of antibody, but levels of antibodies were not as high as in the routinely vaccinated infants at 7 months. These data suggest that an accelerated vaccine schedule can be used in the newborn period. The effectiveness of the accelerated schedule in preventing perinatal infections compared to the standard schedule and the necessity for booster doses of vaccine remain to be studied.

Association between bicycle helmet legislation, bicycle safety education, and use of bicycle helmets in children.

OBJECTIVE: To determine the association between bicycle helmet legislation and bicycle safety education and the use of bicycle helmets by children under age 16 years. DESIGN: Anonymous questionnaire and direct observations of bicycle helmet use. SETTING: Four predominantly white, upper-middle class suburbs of Cleveland, Ohio. PARTICIPANTS: All students in grades 1 through 7 attending public school on the day of the survey and children riding bicycles in a direct observational study. INTERVENTIONS: Beachwood had bicycle helmet legislation and safety education. Orange had only bicycle helmet legislation. Pepper Pike and Moreland Hills did not have bicycle helmet legislation or safety education. RESULTS: In Beachwood, 416 (67.6%) of 615 children who owned a bicycle reported always wearing their helmets, and 72 (85%) of 85 children directly observed were wearing bicycle helmets. In Orange, 103 (37.2%) of 277 children who owned bicycles reported always wearing helmets, whereas 41 (17.9%) of 229 children in Moreland Hills and 78 (21.5%) of 362 children in Pepper Pike reported always wearing helmets. Helmet use was significantly (P < .001) higher in Beachwood, with legislation and education, than in the other communities; helmet use was significantly (P < .001) higher in Orange, with legislation alone, than in Moreland Hills and Pepper Pike, with no programs. CONCLUSIONS: There was a dramatic association between reports of increased helmet use and bicycle helmet legislation plus education; the association was stronger than that found with legislation only.

Expression of blood group antigen A by stage I non-small cell lung carcinomas.

To clarify the significance of blood group antigen A (BAA) expression by neoplastic cells, we studied patients who had curative resections of stage I non-small cell lung carcinomas. Immunohistochemical staining using monoclonal antibodies was used to detect BAA expression by paraffin-embedded carcinoma cells. One hundred three patients were studied; mean age was 62.6 years, and 70 (68%) were male. Histologic types were as follows: adenocarcinoma, 52 (50.5%); squamous cell, 25 (24.3%); large cell, 24 (23.3%); and adenosquamous, 2 (1.9%). Histologic grades were as follows: I, 13 (12.6%); II, 26 (25.3%); and III, 64 (62.1%). All patients had American Joint Committee on Cancer stage I tumors: 65 patients (63.1%) had T1 tumors, and 38 (36.9%) had T2 tumors. Recurrences developed in 25 (24.3%) and metachronous malignancies in 4 (3.9%). Survival was 75% +/- 4.8% at 3 years and 66.6% +/- 7.5% at 5 years. Eighty-nine patients (86.4%) were blood group A and 14 (13.6%) were AB. Ninety-five (92.2%) were secretors of BAA and 8 (7.8%) were not. The expression of BAA by neoplastic cells was not detectable in 34 (33%), trace (1% to 5% of neoplastic cells) in 10 (9.7%), 1+ (6% to 25%) in 8 (7.8%), 2+ (26% to 50%) in 12 (11.7%), 3+ (51% to 75%) in 12 (11.7%), and 4+ (76% to 100%) in 27 (26.2%). The pattern of neoplastic cell staining was homogeneous in 14 patients (20.3%) and heterogeneous in 55 (79.7%). Carcinoma recurrence, overall survival, and event-free survival were not related to secretor status, BAA expression, or pattern of staining.(ABSTRACT TRUNCATED AT 250 WORDS)

Superficial esophageal carcinoma.

BACKGROUND: The detection of superficial esophageal carcinomas by surveillance endoscopy and the downstaging of advanced carcinomas to superficial carcinomas by induction therapy have increased the number of patients with these carcinomas undergoing resection. The natural history of these carcinomas is not well defined. METHODS: To evaluate the results of surgical resection and identify predictors of improved survival, a retrospective review of (1) patients with superficial esophageal carcinoma at presentation (SECP) and (2) patients with advanced carcinomas that were downstaged to no residual carcinoma or superficial esophageal carcinoma after induction therapy (SECD) was conducted. RESULTS: There were 54 patients with SECP (19 Tis and 35 T1). Survival was significantly better for patients with Tis carcinomas (85.3% at 5 years) and patients with intramucosal T1 carcinomas (79.4%) than for patients with submucosal T1 carcinomas (16.3%) (p = 0.007 and p = 0.045, respectively). Survival at 5 years for the 49 patients without regional lymph node metastases (N0) was 65.2%, whereas none of the 5 patients with regional lymph node metastases (N1) have survived more than 3 years (p = 0.054), and 3 died of recurrent disease. There were 21 patients with SECD (13 T0, 2 Tis, and 6 T1). Survival at 4 years was 58.2%. In this group, survival was not related to depth of tumor invasion (p = 0.76) or regional lymph node status (p = 0.68). CONCLUSIONS: We conclude that (1) patients with Tis and intramucosal T1 SECP have a significantly better survival than those with submucosal T1 SECP, (2) patients with N0 SECP have a significantly better survival than those with N1 SECP, and (3) survival of patients with SECD is not related to depth of tumor invasion or regional lymph node status.

Risk factors for early readmission among veterans.

This study was undertaken to identify demographic, clinical, and social risk factors for early readmission in the veteran population. Readmissions within 30 days of discharge were considered "early." A randomly selected 50 percent sample of 6,317 veterans discharged consecutively from one Department of Veterans Affairs medical center (VAMC) was used to build a logistic regression model for early readmission. Of these patients, 22 percent had early readmissions. The adjusted odds ratios (OR) of greater magnitude for early readmission (p less than .05) were associated with discharge from a geriatrics/intermediate care bed (OR = 2.75 relative to medical ward), discharge diagnosis of a chronic disease (OR = 2.03-2.67 relative to acute or self-limiting disorders), and two or more surgical procedures performed during the index admission (OR = 1.87 relative to no surgery). Increasing distance from the VA hospital and increasing age also added readmission risk (OR = 1.18 and 1.10, respectively). Length of stay and the social risk factors of marital status and place of disposition were not sufficiently predictive to enter the model. The model was validated successfully on the second 50 percent sample of patients. We conclude that clinical and demographic factors are more predictive of early readmission than are social factors. Early readmission models could be used to improve VA discharge planning and to focus quality assurance and utilization review efforts on providers whose early readmission rates exceed those predicted by the models.

Squamous cell carcinoma of the paranasal sinuses: the Cleveland Clinic experience 1977-1986.

Fifty-four of 103 malignancies of the paranasal sinuses treated at the Cleveland Clinic Foundation between 1977 and 1986 were squamous cell carcinomas. Six arose from the ethmoid sinus and 48 from the maxillary sinus. Of the maxillary sinus patients, 11 presented with T1 or T2 lesions, 20 with T3, 16 with T4, and 7 of these had nodal disease. Treatment was surgery and/or radiation therapy. There was local recurrence in 25 of 48 maxillary sinus patients and in 1 of 6 ethmoid patients. Overall 5-year survival was 38.2% in the maxillary sinus group: T1, 100.0%; T2, 85.7%; T3, 31.8%; and T4, 6.7%. Three of six patients with ethmoid tumors were cured. There was a statistical trend for better prognosis in those patients presenting with ethmoid primaries, with early lesions, treated with both radiation and surgery, and with history of inverting papilloma. There were complications of treatment in 10 patients, four of which resulted in death. Local control was the major problem for these patients; therefore, early detection and aggressive local treatment are desirable.

Prospective ultrasonographic evaluation of intraoperative and delayed postoperative suprachoroidal hemorrhage from glaucoma filtering surgery.

PURPOSE: To determine the incidence of, visual loss from, and perioperative risk factors for suprachoroidal hemorrhage (SCH) occurring during or after glaucoma filtering surgery. METHODS: Contact B-Scan ultrasonography was used to evaluate at a median of 15 days postoperatively, one eye of 158 patients who underwent various glaucoma filtering procedures during an 18 month period. RESULTS: Ultrasonography detected SCH in 13 patients (8.2%). SCH was recognized during surgery in two cases; 11 were detected postoperatively. Preexisting aphakia (odds ratio 12.9, 95% confidence interval 3.6 to 46.2) and intraoperative anterior vitrectomy (odds ratio 5.2, 95% confidence interval 1.2 to 22.4) were significantly associated with SCH. A significant negative association was found for combined cataract/glaucoma procedures with posterior chamber intraocular lens implantation (odds ratio 0.08, 95% confidence interval 0.01 to 0.69). No significant association between SCH and age, sex, race, diabetes, obesity, systemic hypertension, right versus left eye, type of glaucoma, surgeon, number of preoperative antiglaucoma medications, 5-fluorouracil/mitomycin-C therapy-or previous vitrectomy was found. For some risk factors the power of the study may not be sufficient to establish a correlation: with SCH. Two patients with SCH had serious visual acuity loss and 2 had mild visual acuity loss. Eyes of three patients were surgically drained of SCH. Most patients with SCH did not experience pain, and only one presented-with elevated intraocular pressure at the time SCH was recognized. CONCLUSION: Pre-existing aphakia and concurrent vitrectomy were significant risk factors identified. Combined cataract and glaucoma filtering procedures correlated negatively with suprachoroidal hemorrhage. Most patients with suprachoroidal hemorrhage experienced little or no visual loss, pain, or intraocular pressure elevation.