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Context: Persons at risk of human immunodeficiency virus 1 (HIV-1) infection, have been classified incorrectly as HIV infected because of Western blot results, but the frequency of false-positive Western blot results is unknown.Objectives: To determine the frequency of false-positive HIV-1 Western blot results in US blood donors and to make projections to other screened populations. Secondarily, to validate an algorithm for evaluating possible false-positive cases.Design: A retrospective cohort study of HIV-1 enzyme immunoassay (EIA) and Western blot results from large blood donor screening programs in which donors with suspected false-positive Western blot results underwent HIV-1 RNA polymerase chain reaction (PCR) testing and follow-up HIV-1 serology.Setting: Five US blood centers participating in the Retrovirus Epidemiology Donor Study.Participants: More than 5 million allogeneic and autologous blood donors who successfully donated blood at 1 of the 5 participating centers from 1991 through 1995.Main Outcome Measures: Rate of false positivity by Western blot and true HIV-1 infection status as determined by HIV-1 RNA PCR and by serologic follow-up of blood donors more than 5 weeks after donation.Results: Of 421 donors who were positive for HIV-1 by Western blot, 39 (9.3%) met the criteria of possible false positivity because they lacked reactivity to p31. Of these, 20 (51.3%) were proven by PCR not to be infected with HIV-1. The false-positive prevalence was 4.8% of Western blot-positive donors and 0.0004% (1 in 251000) of all donors (95% confidence interval, 1 in 173000 to 1 in 379000 donors).Conclusions: A false diagnosis of HIV-1 infection can result from the combination of EIA and Western blot testing in blood donor and other HIV-1 screening programs. Individuals with a positive Western blot result lacking the p31 band should be counseled that, although they may be HIV infected, there is uncertainty about this conclusion. These individuals should be further evaluated by RNA PCR testing (if feasible) and HIV serologic analysis on a follow-up sample. [ABSTRACT FROM AUTHOR]

Abstract Background HTLV-I infection has been linked to lung pathology and HTLV-II has been associated with an increased incidence of pneumonia and acute bronchitis. However it is unknown whether HTLV-I or -II infection alters pulmonary function. Methods We performed pulmonary function testing on HTLV-I, HTLV-II and HTLV seronegative subjects from the HTLV outcomes study (HOST), including vital capacity (VC), forced expiratory volume in one second (FEV1), and diffusing lung capacity for carbon monoxide (DLCO) corrected for hemoglobin and lung volume. Multivariable analysis adjusted for differences in age, gender, race/ethnicity, height and smoking history. Results Mean (standard deviation) pulmonary function values among the 257 subjects were as follows: FVC = 3.74 (0.89) L, FEV1 = 2.93 (0.67) L, DLCOcorr = 23.82 (5.89) ml/min/mmHg, alveolar ventilation (VA) = 5.25 (1.20) L and DLCOcorr/VA = 4.54 (0.87) ml/min/mmHg/L. There were no differences in FVC, FEV1 and DLCOcorr/VA by HTLV status. For DLCOcorr, HTLV-I and HTLV-II subjects had slightly lower values than seronegatives, but neither difference was statistically significant after adjustment for confounding. Conclusions There was no difference in measured pulmonary function and diffusing capacity in generally healthy HTLV-I and HTLV-II subjects compared to seronegatives. These results suggest that previously described HTLV-associated abnormalities in bronchoalveolar cells and fluid may not affect pulmonary function.

Background and Objectives: Converting first-time donors to become regular donors continues to be a challenge facing blood centres. We examined whether first-time donors with frequent return in the first 12 months were more likely to become regular donors., Subjects and Methods: The donation histories of 179 409 community whole-blood donors, whose first-time donation in 1991 was negative on donor screening tests, were evaluated. Donors were categorized by the number of donations made in the 12 months after (and including) their first donation. The donor return pattern in the subsequent 6 years, and its association with first-year donation frequency and demographics, was evaluated by using logistic regression analysis. A 'regular donor' was defined as one who returned to donate in at least 4 of the 6 years of follow-up., Results: First-year donation frequency was significantly correlated with long-term donor return (P < 0.0001). Among those giving 1, 2, 3, 4 and > or = 5 donations in the first year, 4%, 11%, 21%, 32% and 42%, respectively, became regular donors (P < 0.0001). Similar associations between donation pattern and donor return behaviour were observed after adjusting for demographic variables (P < 0.0001)., Conclusions: Strategies aimed at encouraging current donors to donate more frequently during the first year may help to establish a regular donation behaviour.

Human T-lymphotropic virus types I and II (HTLV-I and -II) cause myelopathy; HTLV-I, but not HTLV-II, causes adult T-cell leukemia. Whether HTLV-II is associated with other diseases is unknown. Using survival analysis, we studied medical history data from a prospective cohort of HTLV-I- and HTLV-II-infected and -uninfected blood donors, all HIV seronegative. A total of 152 HTLV-I, 387 HTLV-II, and 799 uninfected donors were enrolled and followed for a median of 4.4, 4.3, and 4.4 years, respectively. HTLV-II participants had significantly increased incidences of acute bronchitis (incidence ratio [IR] = 1.68), bladder or kidney infection (IR = 1.55), arthritis (IR = 2.66), and asthma (IR = 3.28), and a borderline increase in pneumonia (IR = 1.82, 95% confidence interval [CI] 0.98 to 3.38). HTLV-I participants had significantly increased incidences of bladder or kidney infection (IR = 1.82), and arthritis (IR = 2.84). We conclude that HTLV-II infection may inhibit immunologic responses to respiratory infections and that both HTLV-I and -II may induce inflammatory or autoimmune reactions.

Background: Recruitment of young donors is critical to expand the donor base and sustain the blood supply. Nevertheless, there is concern that younger blood donors may have a higher risk profile than their older counterparts., Study Design and Methods: The prevalence of behavioral risks associated with transfusion-transmissible viral infections and the incidence of viral markers were compared between younger and older donors. Behavioral risks included unreported deferrable risks (UDRs) and HIV test seeking estimated from anonymous donor surveys administered in 1993 and 1998. The incidence of HIV, HCV, or HBV was estimated from donors giving at five US blood centers between 1996 and 2000., Results: Donors younger than 25 years of age were significantly more likely to report a UDR or HIV test seeking than those 25 years or older. ORs comparing donors 18 to 19 and 20 to 24 years of age to those 25 years or older were 2.0 (95% CI, 1.5-2.6) and 1.5 (95% CI, 1.2-1.9) for UDR and 4.5 (95% CI, 3.0-6.9) and 5.5 (95% CI, 4.2-7.1) for test seeking, respectively. Although incidence estimates did not significantly differ between age groups, HIV incidence appeared to be highest in 18- to 19-year-old donors, whereas HBV incidence was highest in 20- to 24-year-old donors., Conclusions: Donors younger than 25 years of age appeared to have a higher behavioral risk profile than older donors. The message not to donate when a behavioral risk is present or for obtaining HIV tests needs to be reinforced in younger donors.

Background: HTLV-I infection has been linked to lung pathology and HTLV-II has been associated with an increased incidence of pneumonia and acute bronchitis. However it is unknown whether HTLV-I or -II infection alters pulmonary function., Methods: We performed pulmonary function testing on HTLV-I, HTLV-II and HTLV seronegative subjects from the HTLV outcomes study (HOST), including vital capacity (VC), forced expiratory volume in one second (FEV1), and diffusing lung capacity for carbon monoxide (DLCO) corrected for hemoglobin and lung volume. Multivariable analysis adjusted for differences in age, gender, race/ethnicity, height and smoking history., Results: Mean (standard deviation) pulmonary function values among the 257 subjects were as follows: FVC = 3.74 (0.89) L, FEV1 = 2.93 (0.67) L, DLCOcorr = 23.82 (5.89) ml/min/mmHg, alveolar ventilation (VA) = 5.25 (1.20) L and DLCOcorr/VA = 4.54 (0.87) ml/min/mmHg/L. There were no differences in FVC, FEV1 and DLCOcorr/VA by HTLV status. For DLCOcorr, HTLV-I and HTLV-II subjects had slightly lower values than seronegatives, but neither difference was statistically significant after adjustment for confounding., Conclusions: There was no difference in measured pulmonary function and diffusing capacity in generally healthy HTLV-I and HTLV-II subjects compared to seronegatives. These results suggest that previously described HTLV-associated abnormalities in bronchoalveolar cells and fluid may not affect pulmonary function.

It has been reported that human T cell lymphotropic virus (HTLV)-I-infected persons in Japan have decreased delayed hypersensitivity skin test reactivity to tuberculin purified protein derivative (PPD), but HTLV-I- or -II-infected persons do not generally develop opportunistic infections. We administered standardized intradermal testing with PPD, mumps, and Candida albicans antigens to 31 HTLV-I, 48 HTLV-II, and 143 seronegative subjects in the United States. Reactivity at 48 hr was compared among the three groups. Response rates to PPD were very low in all subjects. Fifty-five percent of seronegative subjects did not react to mumps antigen, compared with 55% of HTLV-I [adjusted odds ratio (OR) = 0.79, 95% confidence interval (CI) 0.27-2.33] and 38% of HTLV-II (OR = 0.73, 95% CI 0.33-1.64). Fifty-one percent of seronegatives did not react to Candida albicans antigen, compared with 34% of HTLV-I (OR = 0.37, 95% CI 0.15-0.93) and 46% of HTLV-II (OR = 0.71, 95% CI 0.34-1.52). Anergy was present in 33% of seronegatives, 28% of HTLV-I (OR = 0.60, 95% CI 0.20-1.78), and 19% of HTLV-II (OR = 0.56, 95% CI 0.22-1.44). HTLV-I- and -II-infected persons appear to have intact delayed hypersensitivity skin test responses to mumps and Candida albicans antigens.

Injection drug use (IDU) is a known risk factor for hepatitis C virus (HCV) infection, but the strength of other parenteral and sexual risk factors is unclear. In 1997, we performed a case-control study of 2,316 HCV-seropositive blood donors and 2,316 seronegative donors matched on age, sex, race/ethnicity, blood center, and first-time versus repeat-donor status. Odds ratios (OR) and 95% confidence intervals (CIs) were calculated using conditional logistic regression. Questionnaires were returned by 758 (33%) HCV(+) and 1,039 (45%) control subjects (P =.001). The final multivariate model included only the following independent HCV risk factors: IDU (OR = 49.6; 95% CI: 20.3-121.1), blood transfusion in non-IDU (OR = 10.9; 95% CI: 6.5-18.2), sex with an IDU (OR = 6.3; 95% CI: 3.3-12.0), having been in jail more than 3 days (OR = 2.9; 95% CI: 1.3-6.6), religious scarification (OR = 2.8; 95% CI: 1.2-7. 0), having been stuck or cut with a bloody object (OR = 2.1; 95% CI: 1.1-4.1), pierced ears or body parts (OR = 2.0; 95% CI: 1.1-3.7), and immunoglobulin injection (OR = 1.6; 95% CI: 1.0-2.6). Although drug inhalation and a high number of lifetime sex partners were significantly more common among HCV seropositives, they were not associated with HCV after controlling for IDU and other risk factors. IDU, blood transfusion among non-IDU, and sex with an IDU are strong risk factors for HCV among United States blood donors. Weaker associations with incarceration, religious scarification, being stuck or cut with a bloody object, pierced ears or body parts, and immunoglobulin injection must be interpreted with caution.

Background: To determine whether human T-lymphotropic virus type II (HTLV-II) infection is associated with an increased incidence of bacterial infections, we prospectively observed cohorts of HTLV-I- and HTLV-II-infected and seronegative subjects in 5 US cities., Methods: Of 1340 present and former blood donors examined at enrollment, 1213 (90.5%) were re-examined after approximately 2 years, including 136 HTLV-I- and 337 HTLV-II-seropositive subjects and 740 demographically stratified HTLV-seronegative subjects. All subjects were seronegative for human immunodeficiency virus. Odds ratios (ORs) for incident disease outcomes were adjusted for covariates, including age, sex, race or ethnicity, education, and, if significantly associated with the outcome, blood center, donation type, income, smoking, alcohol intake, and injected drug use., Results: Compared with seronegative status, HTLV-II infection was associated with an increased incidence of bronchitis (OR, 1.81; 95% confidence interval [CI], 1.20-2.75), bladder and/or kidney infection (OR, 1.94; 95% CI, 1.26-2.98), oral herpes infection (OR, 9.54; 95% CI, 3.33-27.32), and a borderline increased incidence of pneumonia (OR, 2.09; 95% CI, 0.92-4.76); HTLV-I infection was associated with an increased incidence of bladder and/or kidney infection (OR, 2.79; 95% CI, 1.63-4.79). One incident case of HTLV-I-positive adult T-cell leukemia was observed (incidence, 348 per 100,000 HTLV-I person-years), and 1 case of HTLV-II-positive tropical spastic paraparesis-HTLV-associated myelopathy was diagnosed (incidence, 140 per 100,000 HTLV-II person-years)., Conclusions: These data support an increased incidence of infectious diseases among otherwise healthy HTLV-II- and HTLV-I-infected subjects. They are also consistent with the lymphoproliferative effects of HTLV-I, and with neuropathic effects of HTLV-I and HTLV-II.

Background: Latex allergy has been recognized as a medical problem with increasing frequency since the mid 1980s. Although certain groups of individuals, such as health care workers, have been recognized as having increased risk for latex allergy, little is known about the prevalence of latex allergy in the general population., Methods: To estimate the prevalence of latex allergy among healthy adults, we measured anti-latex IgE antibodies in residual serum samples from 1000 volunteer Red Cross blood donors. The 1000 samples were from a sample of blood units collected from workplace mobile sites throughout Southeastern Michigan. Samples collected from mobile sites operating at health care institutions were excluded to minimize sampling of health care workers. Anti-latex IgE antibodies were measured by using the AlaSTAT assay (Diagnostic Products Corp., Los Angeles, Calif.) according to the manufacturer's directions. Samples with anti-latex IgE concentrations of 0.35 IU/ml or greater were classified as positive and samples with IgE concentrations of 1.50 IU/ml or greater were classified as strongly positive. All positive samples were assayed a second time to confirm the result. All positive samples were also measured with the CAP assay (Pharmacia Diagnostics, Dublin, Ohio)., Results: The samples tested were from donors with a mean age of 37.8 years, and 47% were women. Sixty-four (6.4%, 95% confidence interval = 4.9-8.1%) of the samples were confirmed as repeatedly positive for anti-latex IgE, and 23 of the 64 positive samples were strongly positive (2.3% of the 1000). Sixty-one percent of the samples positive as determined by the AlaSTAT assay were also positive as determined by the CAP assay. Samples from male donors were more likely to be positive than those from female donors (8.7% vs 4.1%, p = 0.003). Prevalence of positive samples was not related to age or race., Conclusions: We conclude that the prevalence of detectable anti-latex IgE antibodies, in a large and relatively unselected adult population, is higher than previous estimates have suggested. Although the clinical significance of these observations needs further evaluation, the data suggest that latex allergy is not confined to individuals in previously recognized high-risk groups.

Objective: To measure demographic determinants of hepatitis C virus (HCV) seroprevalence among blood donors in the United States., Design: Cross-sectional epidemiological study., Setting: Five blood centers in different regions of the United States., Subjects: A total of 862,398 consecutive volunteer blood donors with one or more nonautologous donations from March 1992 through December 1993., Methods: Demographic data collection, serological screening with second-generation anti-HCV enzyme immunoassay, and confirmation with anti-HCV recombinant immunoblot., Results: There were 3126 donors with at least one blood donation confirmed HCV-seropositive, for a crude prevalence of 3.6 per 1000. Age-specific HCV seroprevalence rose from 0.5 per 1000 donors younger than 20 years to a maximum of 6.9 per 1000 in donors aged 30 to 39 years and declined in older age groups. There was interaction between age and educational attainment, with 30- to 49-year-olds with less than a high school diploma at highest risk of HCV infection (odds ratio [OR], 33.0; 95% confidence interval [CI], 23.0 to 47.2 compared with those younger than 30 years with a bachelor's degree or higher degree). Other independent risk factors for HCV seropositivity included male sex (OR, 1.9; 95% CI, 1.8 to 2.1), black race (OR, 1.7; 95% CI, 1.6 to 1.9), Hispanic ethnicity (OR, 1.3; 95% CI, 1.1 to 1.5), previous blood transfusion (OR, 2.8; 95% CI, 2.5 to 3.1), and first/only time donor status (OR, 4.2; 95% CI, 3.9 to 4.5 compared with repeat donors). Seropositivity for human T-lymphotropic virus types I and II, human immunodeficiency virus, or hepatitis B core antigen was highly associated with HCV seropositivity (OR, 10.4; 95% CI, 9.6 to 11.4 for one vs no marker)., Conclusions: Despite a low overall HCV prevalence in blood donors in the United States, there is a marked variation in HCV seroprevalence by demographic subgroup, even after controlling for prior blood transfusion, a recognized risk factor for HCV. Further study of the prevalence of other parenteral risk factors such as past injection drug use among blood donors is needed.

Background: Most blood centers utilize a confidential unit exclusion (CUE) process, intended to reduce the risk of transfusion-associated infectious diseases by allowing high-risk donors confidentially to exclude their blood from use for transfusion. The effectiveness of this method remains controversial., Study Design and Methods: Confirmatory or supplemental test results for antibodies to human immunodeficiency virus, human T-lymphotropic virus type I, and hepatitis C virus, as well as hepatitis B surface antigen and syphilis and screening test results for antibodies to hepatitis B core (antigen) and alanine aminotransferase levels were obtained for approximately 1.8 million units donated during 1991 and 1992 at five blood centers within the United States. The prevalences of these infectious disease markers in units that the donors confidentially excluded (CUE+) and units that the donors did not exclude (CUE-) were calculated and examined within demographic subgroups., Results: Units that were CUE+ were 8 to 41 times more likely to be seropositive for antibodies to human immunodeficiency virus and hepatitis C virus, hepatitis B surface antigen, and syphilis and three to four times more likely to react for antibody to hepatitis B core (antigen) or to have elevated alanine aminotransferase levels than units that were CUE- (p < 0.001). The positive predictive value of CUE (the percentage of CUE+ units that were confirmed seropositive for any marker) was 3.5 percent, and the sensitivity of CUE (the percentage of confirmed-seropositive units that were CUE+) was 2.3 percent., Conclusion: The current CUE process has low sensitivity and apparently low positive predictive value, and in many cases, it appeared that donors misunderstood it. Yet, CUE was not a "random process," as CUE+ units were more likely to be seropositive for any infectious disease marker than CUE- units. This suggests that efforts to improve the CUE system may be warranted. As risk factors for transfusion-transmitted infection become more difficult to identify by history-based screening, however, such efforts may have limited effect.

Patients undergoing irradiation treatment for head and neck cancer need not lose their teeth. Careful treatment planning improves patients' quality of life.

A total of 559 women with primary breast cancer treated by modified radical mastectomy were followed for a mean of 74.8 months to evaluate the relationship of sex hormone receptor content in the tumor with time to first recurrence and to death due to breast cancer. The prognostic significance of progesterone receptor (PgR) status was evaluated in terms of estrogen receptor (ER) status, age (less than or equal to 49 years, greater than or equal to 50 years), extent of lymph node involvement, tumor size, and morphologic characteristics. Overall, patients with PgR positive (greater than 9 femtomoles/10 mg wet weight tissue) tumors experienced a significantly longer period to both first recurrence and death due to breast cancer, but this advantage was restricted to those whose cancer had metastasized to their axillary lymph nodes. For women with nodal involvement, the extent of this involvement and the size of the primary lesion had the greatest predictive value followed by nuclear grade and PgR status. In these node-positive patients, PgR positivity, although strongly associated with ER positivity, had a greater predictive value than that of the estrogen receptor per se.

In this study, the characteristics of 646 patient's primary breast carcinomas, including histologic grade (HG), nuclear grade (NG), mitotic grade (MG), final grade (FG), estrogen receptor (E2R) status, and patient's lymph node status (LN) at the time of surgery were correlated with recurrence-free interval and patient survival in order to determine whether any one parameter or group of parameters serve as adequate predictors of tumor behavior and, therefore, patient's prognosis. The authors' results showed that LN, tumor size, and tumor grade were themselves significant predictors of early recurrence and breast cancer death. Each unit increase in LN or MG increased the risk of death by a factor of 1.5 and 2.0, respectively. However, prediction of time to recurrence or death was considerably more accurate when those parameters were used in conjunction, rather than individually. E2R was also significant in predicting death. MG separated patients within a single LN group or E2R group into two subsets having clinically and statistically different prognoses. It was found that patients who had negative lymph nodes and whose tumors were MG1 had a better prognosis than those with MG2,3 tumors; in these latter patients recurrence and death patterns were similar to those of patients with MG1 tumors having one to three positive lymph nodes. Similarly, whereas patients with four or more positive lymph nodes had bad prognoses, those bearing MG1 tumors tended to behave more like those with MG2,3 tumors and having only one to three positive lymph nodes.

We examined the records of women with primary breast cancer for a history of pregnancy and live births. The patients were all histopathologic T1, 2, N0, M0 white females, untreated post modified radical mastectomy. Patients with a history of interrupted pregnancies have a significantly shorter time to recurrence than those with normal pregnancy history. A trend toward a lower incidence of highly differentiated histological pattern is also observed in cancers from these patients.

Serum concentrations of IgG, IgA, IgM, IgE, and allergen-specific IgE were measured in presurgical serum samples from 400 women admitted to a multidisciplinary study of primary breast cancer. The relationships between the serum immunoglobulins and patient survival were analyzed with the use of a Cox proportional hazards linear model. After adjustment for TNM stage, tumor histopathologic grade, and estrogen receptor (E2R) status, lower IgM concentrations were associated with longer survival. Lower IgE concentrations were also associated with longer survival, but only in patients whose tumors were E2R positive. IgG and IgA were not related to survival. Serum IgM and IgE concentrations, allergen-specific IgE scores, and the tumor E2R status were combined to construct a three-level risk classification that was more prognostic than any of the individual components. Cox model analysis demonstrated that this combination of immunologic and hormonal variables provided significant new information beyond that obtained from TNM staging and histopathologic grading of the tumors (P = .01). This new information may be useful to physicians in advising patients with primary, operable breast cancer about the relative risks and benefits of adjuvant therapy and in designing clinical trials of adjuvant therapy.

Seasonal variations were observed in tumor size and a number of immunologic responses among patients entered in the Breast Cancer Prognostic Study. A significantly larger number of cases were diagnosed with smaller tumors, less than 2 cm, during December through February. It was also noted that elevated inflammatory reactions were seen in breast tumors removed during November, December and January. Seasonal changes were also observed in the serum IgM and IgE concentrations at the time of the patient's mastectomy. Elevated fall-winter leukocyte migration inhibition response to MCF-7 extracts correlated with the same seasonal elevations observed with serum IgM response. Implications of seasonal variation as a reflection of immune events are considered.

As a part of a major study on the pathophysiologic indices for recurrence of human breast cancer, preoperative eosinophil and lymphocyte counts were determined on 419 and 581 primary breast cancer patients, respectively. Patients with lymphocyte counts less than or equal to 1500/mm3 and/or eosinophil counts of less than 55/mm3 had significantly higher risk of recurrent disease than those patients who had normal or high levels of eosinophils and/or lymphocytes. These findings may indicate that the immunologic activities of eosinophils and lymphocytes enhance the patients' ability to respond against disease.

One thousand seventy-eight patients diagnosed with primary breast cancer were examined for racial differences in histopathologic and clinical parameters. There were no observed differences in tumor histopathologic type or tumor endocrine status between races. There were no differences with respect to time to breast tumor recurrence observed between black and white patients. However, differences were observed in factors that contributed to tumor stage at diagnosis and to tumor grade. Survival differences observed in univariant analysis of blacks vs. whites were explainable by the presence of more severe skin involvement, tumor grade, and tumor size at diagnosis in the black patients.

Serum IgE was measured in presurgical sera from 166 nonallergic women admitted to a comprehensive, multidisciplinary study of primary, operable breast cancer. During the follow-up period, which averaged 48 months, there were 71 recurrences. Patients were divided into two groups: those with IgE levels greater than the geometric mean value of 24 I.U. and those with levels less than the mean. The rate of tumor recurrence was significantly greater for the IgE greater than 24 group (p less than 0.03). IgE remained a significant prognostic indicator when evaluated by Cox regression analysis in conjunction with other known prognostic factors including: number of positive lymph nodes, clinical stage, menopausal status, estrogen receptor status, mitotic grade, tumor diameter, breast feeding history, and age of patient (p less than 0.015). IgE was not correlated with any of these known prognostic factors in individual analyses. We conclude that serum IgE level is a significant, independent prognostic indicator in primary breast cancer.

The present study attempts to identify poor prognosis subgroups of women with node-negative breast cancer that might benefit from systemic adjuvant therapy. The cases were collected through a cooperative effort of 57 surgeons at eight hospitals in the Detroit area and coordinated by the Michigan Cancer Foundation where data collection and analyses were completed. The primary treatment of all patients was a modified radical mastectomy. Of the 1,078 cases accessioned between October 1975 and April 1983, 537 were found to have no microscopic lymph node involvement and 462 of these cases received no adjuvant antineoplastic therapy. The period of follow-up of these cases (alive, n = 358) has been 78.75 +/- 24.6 months (mean +/- SD). Overall, the cumulative 6-year recurrence rate as calculated by life table analysis was 26%, with 16.8% dying of their disease. Tumor size was an important prognostic factor; the recurrence rate was 16.2% for those with primaries measuring less than or equal to 1 cm, with only a 6.3% mortality. Patients with tumors measuring greater than 5 cm also did well: 13.7% recurrence and 13.7% mortality rates at 6 years. The premenopausal women did slightly, but not statistically significantly, better than those who were postmenopausal. The presence or absence of quantifiable estrogen receptor protein (ER) was of little predictive value as far as rates of recurrence were concerned, but patients with an ER-positive tumor survived significantly longer. In postmenopausal women, those whose tumor lacked ER (n = 112) fared poorly: 30.4% experienced a recurrence by 6 years and 28% died of their disease. Recurrence rates and death rates were also high in a small group (n = 35) of postmenopausal women with ER+ tumors exhibiting nuclear pleomorphism (nuclear grade [NG]3) (38% and 24.3%, respectively). No poor prognosis group of premenopausal women was identified.

We have determined the levels of prostaglandin E (PGE) and PGF in 94 and 111 primary breast carcinoma specimens, respectively. Tumor specimens were obtained at the time of surgery for primary breast cancer from women without detectable metastatic disease (other than local lymph nodes). Prostaglandins were solvent extracted from tissue homogenates, separated into class by silicic acid chromatography and PG levels determined by radioimmunoassay. These findings were compared to clinically established prognostic indicators. All samples analyzed contained measurable amounts of both PG with a high correlation between levels of PGE and PGF. No association was seen between PG levels and either degree of lymph node involvement, or estrogen receptor. With increasing tumor grade (less differentiation, more pleomorphic nuclei, numerous mitotic figures) higher levels of both PGs were seen, but this association was not statistically significant. These women have been observed for an average of 30 months postsurgery. During that period 20% of tumors have recurred. No significant association were seen between either prostaglandin and the development of recurrent disease or death due to breast cancer. In contrast to published findings, we saw lower than average levels of both E and F in tumors metastasizing to the bone.

One hundred nine cases involving patients who had received radiation therapy for head and neck cancer were reviewed. Osteoradionecrosis of the mandible developed in only three patients in this group. Postirradiation extractions were not identified as a significant risk factor for such necrosis.