Psychological Outcomes of Living Liver Donors From a Multicenter Prospective Study: Results From the Adult-to-Adult Living Donor Liver Transplantation Cohort Study2 (A2ALL-2).

Although single-center and cross-sectional studies have suggested a modest impact of liver donation on donor psychological well-being, few studies have assessed these outcomes prospectively among a large cohort. We conducted one of the largest, prospective, multicenter studies of psychological outcomes in living liver donors within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study2 (A2ALL-2) consortium. In total, 271 (91%) of 297 eligible donors were interviewed at least once before donation and at 3, 6, 12, and 24 mo after donation using validated measures. We found that living liver donors reported low rates of major depressive (0-3%), alcohol abuse (2-5%), and anxiety syndromes (2-3%) at any given assessment in their first 2 years after donation. Between 4.7% and 9.6% of donors reported impaired mental well-being at various time points. We identified significant predictors for donors' perceptions of being better people and experiencing psychological growth following donation, including age, sex, relationship to recipient, ambivalence and motivation regarding donation, and feeling that donation would make life more worthwhile. Our results highlight the need for close psychosocial monitoring for those donors whose recipients died (n=27); some of those donors experienced guilt and concerns about responsibility. Careful screening and targeted, data-driven follow-up hold promise for optimizing psychological outcomes following this procedure for potentially vulnerable donors.

Social and Financial Outcomes of Living Liver Donation: A Prospective Investigation Within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study 2 (A2ALL-2).

Because results from single-center (mostly kidney) donor studies demonstrate interpersonal relationship and financial strains for some donors, we conducted a liver donor study involving nine centers within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study 2 (A2ALL-2) consortium. Among other initiatives, A2ALL-2 examined the nature of these outcomes following donation. Using validated measures, donors were prospectively surveyed before donation and at 3, 6, 12, and 24 mo after donation. Repeated-measures regression models were used to examine social relationship and financial outcomes over time and to identify relevant predictors. Of 297 eligible donors, 271 (91%) consented and were interviewed at least once. Relationship changes were positive overall across postdonation time points, with nearly one-third reporting improved donor family and spousal or partner relationships and >50% reporting improved recipient relationships. The majority of donors, however, reported cumulative out-of-pocket medical and nonmedical expenses, which were judged burdensome by 44% of donors. Lower income predicted burdensome donation costs. Those who anticipated financial concerns and who held nonprofessional positions before donation were more likely to experience adverse financial outcomes. These data support the need for initiatives to reduce financial burden.

Risk factors for measles among infants in Tianjin, China.

OBJECTIVES: Infants aged <8 months are ineligible for measles vaccination in China but represent a disproportionate number of cases. We examined the risk factors for measles among infants in Tianjin, China. STUDY DESIGN: Case-control study. METHODS: Cases were enrolled from a surveillance system, and IgG-negative controls were sampled from registries at immunization clinics. A logistic regression model assessed for risk factors. RESULTS: Among 82 cases and 485 controls, exposure to a municipal hospital (OR [odds ratio]: 5.21; 95% confidence interval [CI]: 1.19-22.82) or a specialty hospital (OR: 13.22; 95% CI: 6.13-28.51) was associated with the disease, whereas visiting a township or district hospitals was not associated with increased odds of measles. CONCLUSIONS: Hospitals were an important focal point of measles transmission for infants. Hospitals, particularly higher-level municipal and specialty hospitals, should enforce infection control programs to separate infants with highly communicable diseases to prevent transmission.

Emotional well-being of living kidney donors: findings from the RELIVE Study.

Following kidney donation, short-term quality of life outcomes compare favorably to US normative data but long-term effects on mood are not known. In the Renal and Lung Living Donors Evaluation Study (RELIVE), records from donations performed 1963-2005 were reviewed for depression and antidepressant use predonation. Postdonation, in a cross-sectional cohort design 2010-2012, donors completed the Patient Health Questionnaire (PHQ-9) depression screening instrument, the Life Orientation Test-Revised, 36-Item Short Form Health Survey and donation experience questions. Of 6909 eligible donors, 3470 were contacted and 2455 participated (71%). The percent with depressive symptoms (8%; PHQ-9>10) was similar to National Health and Nutrition Examination Survey participants (7%, p=0.30). Predonation psychiatric disorders were more common in unrelated than related donors (p=0.05). Postdonation predictors of depressive symptoms included nonwhite race OR=2.00, p=0.020), younger age at donation (OR=1.33 per 10 years, p=0.002), longer recovery time from donation (OR=1.74, p=0.0009), greater financial burden (OR=1.32, p=0.013) and feeling morally obligated to donate (OR=1.23, p=0.003). While cross-sectional prevalence of depression is comparable to population normative data, some factors identifiable around time of donation, including longer recovery, financial stressors, younger age and moral obligation to donate may identify donors more likely to develop future depression, providing an opportunity for intervention.

Morbidity and mortality of live lung donation: results from the RELIVE study.

The Renal and Lung Living Donors Evaluation Study assesses outcomes of live lung (lobectomy) donors. This is a retrospective cohort study at University of Southern California (USC) and Washington University (WASHU) Medical Centers (1993­2006), using medical records to assess morbidity and national databases to ascertain postdonation survival and lung transplantation. Serious complications were defined as those that required significant treatment, were potentially life-threatening or led to prolonged hospitalization. The 369 live lung donors (287 USC, 82 WASHU) were predominantly white, non-Hispanic and male; 72% had a biological relationship to the recipient, and 30% were recipient parents. Serious complications occurred in 18% of donors; 2.2% underwent reoperation and 6.5% had an early rehospitalization. The two centers had significantly different incidences of serious complications (p < 0.001). No deaths occurred and no donors underwent lung transplantation during 4000+ person-years of follow-up (death: minimum 4, maximum 17 years; transplant: minimum 5, maximum 19). Live lung donation remains a potential option for recipients when using deceased donor lungs lacks feasibility. However, the use of two live donors for each recipient and the risk of morbidity associated with live lung donation do not justify this approach when deceased lung donors remain available. Center effects and long-term live donor outcomes require further evaluation.

Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades.

While cautious criteria for selection of living kidney donors are credited for favorable outcomes, recent practice changes may include acceptance of less than ideal donors. To characterize trends in donor acceptance, the Renal and Lung Living Donors Evaluation (RELIVE) Study evaluated 8,951 kidney donors who donated between 1963 and 2007 at three major U.S. transplant centers. Over the study interval, there was an increase in the percentage of donors >40 years old from 38% to 51%; donors >60 years varied between 1% and 4%. The proportion of donors with obesity increased from 8% to 26% and with glucose intolerance from 9% to 25%. The percentage of hypertensive donors was consistent (5-8%). Accepted donors ≥60 years old were more likely to have obesity, glucose intolerance, and/or hypertension compared to younger donors (p<0.0001). Our results demonstrate important trends in acceptance of older and more obese donors. The fraction of older donors accepted with glucose intolerance or hypertension remains small and for the majority includes mild elevations in glucose or blood pressure that were previously classified as within normal limits.

Health-related quality of life in kidney donors from the last five decades: results from the RELIVE study.

Live donation benefits recipients, but the long-term consequences for donors remain uncertain. Renal and Lung Living Donors Evaluation Study surveyed kidney donors (N = 2455; 61% women; mean age 58, aged 24-94; mean time from donation 17 years, range 5-48 years) using the Short Form-36 Health Survey (SF-36). The 95% confidence intervals for White and African-American donors included or exceeded SF-36 norms. Over 80% of donors reported average or above average health for their age and sex (p < 0.0001). Donors' age-sex adjusted physical component summary (PCS) scores declined by half a point each decade after donation (p = 0.0027); there was no decline in mental component summary (MCS) scores. White donors' PCS scores were three points higher (p = 0.0004) than non-Whites'; this difference remained constant over time. Nine percent of donors had impaired health (PCS or MCS score >1 SD below norm). Obesity, history of psychiatric difficulties and non-White race were risk factors for impaired physical health; history of psychiatric difficulties was a risk factor for impaired mental health. Education, older donation age and a first-degree relation to the recipient were protective factors. One percent reported that donation affected their health very negatively. Enhanced predonation evaluation and counseling may be warranted, along with ongoing monitoring for overweight donors.

Oral contraceptive use and risk of vulvodynia: a population-based longitudinal study.

OBJECTIVE: To assess whether the risk of vulvodynia is associated with previous use of oral contraceptives (OCs). DESIGN: Longitudinal population-based study. SETTING: Four counties in south-east Michigan, USA. POPULATION: A population-based sample of women, aged 18 years and older, enrolled using random-digit dialling. METHODS: Enrolled women completed surveys that included information on demographic characteristics, health status, current symptoms, past and present OC use, and a validated screen for vulvodynia. The temporal relationship between OC use and subsequent symptoms of vulvodynia was assessed using Cox regression, with OC exposure modelled as a time-varying covariate. MAIN OUTCOME MEASURE: Vulvodynia, as determined by validated screen. RESULTS: Women aged <50 years who provided data on OC use, completed all questions required for the vulvodynia screen, and had first sexual intercourse prior to the onset of vulvodynia symptoms were eligible (n = 906). Of these, 71.2% (n = 645) had used OCs. The vulvodynia screen was positive in 8.2% (n = 74) for current vulvodynia and in 20.8% (n = 188) for past vulvodynia. Although crude cross-tabulation suggested that women with current or past vulvodynia were less likely to have been exposed to OCs prior to the onset of pain (60.7%), compared with those without this disorder (69.3%), the Cox regression analysis identified no association between vulvodynia and previous OC use (HR 1.08, 95% CI 0.81-1.43, P = 0.60). This null finding persisted after controlling for ethnicity, marital status, educational level, duration of use, and age at first OC use. CONCLUSION: For women aged <50 years of age, OC use did not increase the risk of subsequent vulvodynia.

Database comparison of the adult-to-adult living donor liver transplantation cohort study (A2ALL) and the SRTR U.S. Transplant Registry.

Data submitted by transplant programs to the Organ Procurement and Transplantation Network (OPTN) are used by the Scientific Registry of Transplant Recipients (SRTR) for policy development, performance evaluation and research. This study compared OPTN/SRTR data with data extracted from medical records by research coordinators from the nine-center A2ALL study. A2ALL data were collected independently of OPTN data submission (48 data elements among 785 liver transplant candidates/recipients; 12 data elements among 386 donors). At least 90% agreement occurred between OPTN/SRTR and A2ALL for 11/29 baseline recipient elements, 4/19 recipient transplant or follow-up elements and 6/12 donor elements. For the remaining recipient and donor elements, >10% of values were missing in OPTN/SRTR but present in A2ALL, confirming that missing data were largely avoidable. Other than variables required for allocation, the percentage missing varied widely by center. These findings support an expanded focus on data quality control by OPTN/SRTR for a broader variable set than those used for allocation. Center-specific monitoring of missing values could substantially improve the data.

Significance of self-reported sleep quality (SQ) in chronic kidney disease (CKD): the Renal Research Institute (RRI)-CKD study.

BACKGROUND: There has been limited research on sleep quality (SQ) in CKD. METHODS: This prospective cohort study of adults with CKD Stages 3 - 5 at four US centers collected self-reported SQ information from the Kidney Disease Quality of Life (KDQOL) instrument, including an estimated SQ score (0 - 100), and 3 SQ-related questions. "Poor" SQ was defined as SQ score < or = 60. Logistic and multiple linear regression assessed associations between SQ and its potential predictors. Times to death and end stage renal disease (ESRD) were examined using Cox regression. A comparison with SQ in ESRD patients from the Dialysis Outcomes and Practice Patterns Study (DOPPS), was additionally performed. RESULTS: Mean SQ score was 59.4 +/- 23.6 (n = 689), and "poor" SQ was reported by 57%. Mean estimated glomerular filtration rate (eGFR) was 24.9 +/- 10.6 ml/min/1.73 m2. Higher SQ significantly correlated with KDQOL mental and physical component summary scales. Significant predictors of lower SQ score included--younger age, presence of dyspnea, self-reported depression, pain, and itchness. There were no significant pairwise differences in SQ from CKD Stage 3 through ESRD. Self-reported daytime sleepiness was significantly associated with higher risk of mortality prior to ESRD (HR = 1.85, p = 0.02). CONCLUSION: Self-reported "poor" SQ was common in a CKD cohort (Stages 3 - 5) and was not only associated with lower quality of life scores and several modifiable symptoms, but also with higher risk of pre-ESRD mortality. Greater attention to this clinical problem is highly recommended in this high-risk population.

Recipient morbidity after living and deceased donor liver transplantation: findings from the A2ALL Retrospective Cohort Study.

Patients considering living donor liver transplantation (LDLT) need to know the risk and severity of complications compared to deceased donor liver transplantation (DDLT). One aim of the Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL) was to examine recipient complications following these procedures. Medical records of DDLT or LDLT recipients who had a living donor evaluated at the nine A2ALL centers between 1998 and 2003 were reviewed. Among 384 LDLT and 216 DDLT, at least one complication occurred after 82.8% of LDLT and 78.2% of DDLT (p = 0.17). There was a median of two complications after DDLT and three after LDLT. Complications that occurred at a higher rate (p < 0.05) after LDLT included biliary leak (31.8% vs. 10.2%), unplanned reexploration (26.2% vs. 17.1%), hepatic artery thrombosis (6.5% vs. 2.3%) and portal vein thrombosis (2.9% vs. 0.0%). There were more complications leading to retransplantation or death (Clavien grade 4) after LDLT versus DDLT (15.9% vs. 9.3%, p = 0.023). Many complications occurred more commonly during early center experience; the odds of grade 4 complications were more than two-fold higher when centers had performed 40). In summary, complication rates were higher after LDLT versus DDLT, but declined with center experience to levels comparable to DDLT.

Risk factors for group B streptococcal colonization: potential for different transmission systems by capsular type.

PURPOSE: Group B Streptococcus (GBS) is a common inhabitant of the bowel and vaginal flora, with known transmission routes including sexual contact and vertical transmission from mother to infant. Food-borne transmission is also possible, as GBS is a known fish and bovine pathogen. We conducted a prospective cohort study in order to identify risk factors for acquisition. METHODS: We identified risk factors for GBS acquisition among college women (n = 129) and men (n = 128) followed at 3-week intervals for 3 months. RESULTS: A doubling in sex acts significantly increased incidence of GBS capsular type V by 80% (95% confidence interval [CI]: 1.19, 2.58), and other non-Ia or -Ib types combined by 40% (95% CI: 1.00, 2.06; incidence of capsular type Ia (odds ratio [OR] = 1.2; 95% CI: 0.71, 1.88; p = 0.57) and Ib (OR = 1.5, 95% CI: 0.75, 2.86; p = 0.27) were elevated, although not significantly. After adjustment for sexual activity and sexual history, gender, and eating venue, fish consumption increased risk of acquiring capsular types Ia and Ib combined 7.3 fold (95% CI: 2.34, 19.50), but not of acquiring other capsular types. Beef and milk were not associated with GBS incidence. CONCLUSIONS: Different GBS capsular types may have different transmission routes.

Patterns of absolute risk of lung cancer mortality in former smokers.

BACKGROUND: It is well known that the relative risk (RR) of lung cancer mortality decreases following smoking cessation compared with the risk in persons who continue to smoke. However, changes in the absolute risk of lung cancer death following smoking cessation are not well documented. Further, few studies have examined the effect of age at smoking cessation on subsequent lung cancer death risk. PURPOSE: The purpose of this study was to examine and compare absolute and relative lung cancer death risks in former smokers as a function of age at cessation. METHODS: Using the American Cancer Society's Cancer Prevention Study II, a prospective cohort study with 6 years of follow-up, we modeled absolute risk of lung cancer mortality in individuals who had never smoked and in current and former smokers. The model was fit with the use of person-years logistic regression analysis. RESULTS: Similar patterns of absolute risk of lung cancer death by age were found for all ages of smoking cessation up to the mid-60s. Lower lung cancer death risk was observed for those quitting earlier in life, and the risk for all former smokers was significantly lower than that for current smokers. For those quitting between ages 30 and 49, lung cancer death risk rose gradually with age at a rate slightly greater than that for those who had never smoked. Lung cancer death risk for former smokers quitting between ages 50 and 64 leveled off near the risk attained at the time of quitting until around age 75, when it rose sharply. At age 75, the RR for former smokers compared with current smokers was approximately 45% for those quitting in their early 60s, approximately 20% for those quitting in their early 50s, and less than 10% for those quitting in their 30s. For those who had never smoked, the RR at age 75 is less than 5%. CONCLUSIONS: In terms of reduced risk of lung cancer mortality, smoking cessation is beneficial at any age, with much greater benefits accruing to those quitting at younger ages. Unlike previous research, which has primarily examined the effects of cessation as a function of years since quitting, our results demonstrate that age at cessation has a major impact on subsequent lung cancer risks. IMPLICATIONS: Smokers of all ages should be encouraged to quit because cessation at any age decreases lung cancer risk relative to that of current smokers.

Estimating the impact of renal replacement therapy choice on outcome in severe acute renal failure.

BACKGROUND: Mortality in severe acute renal failure (ARF) requiring renal replacement therapy (RRT) approximates 50% and varies with clinical severity. Continuous RRT (CRRT) has theoretical advantages over intermittent hemodialysis (IHD) for critical patients, but a survival advantage with CRRT is yet to be clearly demonstrated. To date, no prospective controlled trial has sufficiently answered this question, and the present prospective outcome study attempts to compare survival with CRRT versus that with IHD. METHODS: Multivariable Cox-proportional hazards regression was used to analyze the impact of RRT modality choice (CRRT vs. IHD) on in-hospital and 100-day mortality among ARF patients receiving RRT during 2000 and 2001 at University of Michigan, using an "intent-to-treat" analysis adjusted for multiple comorbidity and severity factors. RESULTS: Overall in-hospital mortality before adjustment was 52%. Triage to CRRT (vs IHD) was associated with higher severity and unadjusted relative rate (RR) of in-hospital death (RR = 1.62, p = 0.001, n = 383). Adjustment for comorbidity and severity of illness reduced the RR of death for patients triaged to CRRT and suggested a possible survival advantage (RR = 0.81, p = 0.32). Analysis restricted to patients in intensive care for more than five days who received at least 48 hours of total RRT, showed the RR of in-hospital mortality with CRRT to be nearly 45% lower than IHD (RR = 0.56, n = 222), a difference in RR that indicates a strong trend for in-hospital mortality with borderline statistical significance (p = 0.069). Analysis of 100-day mortality also suggested a potential survival advantage for CRRT in all cohorts, particularly among patients in intensive care for more than five days who received at least 48 h of RRT (RR = 0.60, p = 0.062, n = 222). CONCLUSION: Applying the present methodology to outcomes at a single tertiary medical center, CRRT may appear to afford a survival advantage for patients with severe ARF treated in the ICU. Unless and until a prospective controlled trial is realized, the present data suggest potential survival advantages of CRRT and support broader application of CRRT among such critically ill patients.

Impact of tumor control on survival in carcinoma of the lung treated with irradiation.

The long-term results in tumor response, intrathoracic tumor control and survival are reported in patients with medically inoperable or unresectable non-oat cell and small cell carcinoma of the lung. In 376 patients with stages T1-3, NO-2 carcinoma of the lung tumors, accessioned to a Radiation Therapy Oncology Group (RTOG) randomized study to evaluate different doses of irradiation, a higher complete response rate (24%), intrathoracic tumor control (67%) and three year survival (15%) was observed with 6000 cGy, compared with lower doses of irradiation (4000 or 5000 cGy). Increased survival was noted in patients with complete tumor response. Three year survival in complete responders was 23%, in partial responders, 10%, and in patients with stable disease, 5%. Patients treated with 6000 cGy had an overall intrathoracic failure rate of 33% at 3 years, compared with 42% for those treated with 5000 cGy, 44% for patients receiving 4000 cGy with split course, and 52% for those treated with 4000 cGy continuous course (p = 0.02). Patients surviving 6 or 12 months exhibited a statistically significant increased survival when the intrathoracic tumor was controlled. Patients treated with 5000-6000 cGy, showing tumor control, had a three year survival of 22%, versus 10%, if they had intrathoracic failure (p = 0.05). In patients treated with 4000 cGy (split or continuous), the respective survival was 20% and 10%, if the intrathoracic tumor was controlled (p = 0.001). In patients surviving 12 months after treatment with 5000-6000 cGy, on whom the intrathoracic tumor was controlled, the median survival was 29 months, in contrast to 18 months, if they developed intrathoracic failure (p = 0.05). In patients treated with 4000 cGy, the median survival was 23 months with control and 18 months without control of the intrathoracic tumor [corrected] (p = 0.008). In another RTOG study for patients with more advanced tumors (T4 or N3), those with local tumor control at 12 months had a three year survival rate of 25%, compared with 5% for those with thoracic failures. These differences are statistically significant (p = 0.006). Higher doses of irradiation yield a greater proportion of complete response, higher intrathoracic tumor control and better survival in non-oat cell medically inoperable or unresectable carcinoma of the lung.(ABSTRACT TRUNCATED AT 400 WORDS)

An outcome study of the RTOG Cancer Control program.

The Cancer Control program, funded by the National Cancer Institute, was initiated with the goal of involving community hospitals in multi-institutional clinical trials. The Radiation Therapy Oncology Group (RTOG) began participating in this program in 1976. This investigation compares the survival of patients treated by protocol in RTOG Full Member versus Cancer Control institutions between 1976 and 1985. The RTOG has 28 Full Members which are major treatment centers and enter at least 50 patients on RTOG protocols each year. The 11 Cancer Control members, which are mostly community hospitals, must enter at least 12 patients on RTOG protocols each year. A comparison of survival between Full Members and Cancer Control members was made for five RTOG studies. No difference in data quality or protocol compliance was observed for these studies between Cancer Control and Full Member institutions. Overall survival comparisons, as well as comparisons adjusted for prognostic factors, were made for each of the five studies. No differences in survival between Cancer Control and Full Members were observed in either analysis.

Neutron therapy in cervical cancer: results of a phase III RTOG Study.

Between October 1976 and May 1984, 156 patients with locally advanced cervical cancer were entered into a Phase III trial with the participation of five institutions. Patients were randomly assigned to receive photons only (50 Gy in 25 fractions over 5 weeks plus intracavitary applications or external-beam boost) or mixed-beam radiotherapy (2 fractions a week of neutrons, 3 fractions a week of photons to a total RBE-adjusted dose of 50 Gy over 5 weeks plus intracavitary applications or external mixed-beam boost). Only patients with squamous carcinoma of FIGO Stages IIB, III, or IVA with negative para-aortic nodes on lymphangiogram were eligible. Ten patients were excluded from the analysis because of ineligibility or cancellation. Of the 146 patients analyzed, 80 were treated with mixed-beam radiotherapy and 66 with photons. Patients were grouped by stage and institution. The percentage of patients undergoing intracavitary applications was 50% on mixed beam and 75% on photons (p less than 0.01). Tumor clearance was 52% and 72% for mixed beam and photons, respectively (p less than 0.03). Local control at 2 years was 45% for mixed beam and 52% for photons. Median survivals were 1.9 years on mixed beam and 2.3 years on photons. Severe complications occurred in 19% and 11% in mixed beam and photons respectively (p less than 0.13). The inferior outcome with neutron therapy in this study may have resulted from the use of horizontal neutron beams of varying energy and penetration. A new randomized trial using high-energy hospital-based cyclotrons with gantry-mounted beam-delivery systems has recently been activated to evaluate more rigorously the role of fast-neutron therapy for advanced cervical cancer.

Predicting the response of head and neck cancers to radiation therapy with a multivariate modelling system: an analysis of the RTOG head and neck registry.

Two thousand and sixty-six patients with primary head and neck cancers were entered in the RTOG Head and Neck Cancer Registry between 1977 and 1980. Nine hundred and ninety-seven (997) evaluable patients were treated initially with radiation therapy alone. Tumor site, T-stage, N-stage, histology, degree of infiltration, degree of differentiation, patient age, sex and Karnofsky performance score were all prospectively recorded. T-stage (p less than .001), N-stage (p = .007), primary site (p less than .001), and initial Karnofsky performance score (p less than .001) proved to be significant factors independently predictive of primary tumor clearance. Using these factors, a multivariate response model was constructed to predict primary tumor response. The predictive accuracy of the model proved to be highly reliable, and was tested by comparing the predicted vs. observed complete tumor clearance rates for each independent variable. For primary sites, the predicted number of complete responses vs. observed were: oral cavity, 139.8 predicted vs. 139 observed; nasopharynx, 51.8 predicted vs. 51 observed; oropharynx, 174.8 predicted vs. 176 observed, supraglottic larynx, 314.4 predicted vs. 318 observed; glottic larynx, 314.4 predicted vs. 318 observed; and hypopharynx, 49.4 predicted vs. 46 observed. For the entire group of patients predicted to have a 90% or better complete primary tumor response (including T3 and T4 tumors), 94% remained in initial complete remission at the primary site at one year, and 87% at two years. An accurate multivariate response model, such as the one presented in this paper, should prove to be a useful tool in selecting patients with head and neck cancers suitable for treatment with radiation therapy alone.

Is misonidazole neurotoxicity altered by the use of phenytoin and/or dexamethasone in RTOG 79-18 and RTOG 79-16?

An analysis of Misonidazole (MISO) neurotoxicity in RTOG 79-16 and RTOG 79-18 was undertaken to evaluate the incidence of neurotoxicity relative to dexamethasone dose and phenytoin use. MISO was administered as follows: 79-16 arm A, 1 gm/m2 5 days a week for a total of 10 gm/m2 in 2 weeks; 79-16 arm B, 2 gm/m2 twice weekly for a total of 12 gm/m2 in 3 weeks; and 79-18, 2.5 gm/m2 once a week for a total of 15 gm/m2 in 6 weeks. Practically all patients were on dexamethasone, and 240 out of 550 were on phenytoin for seizures. CNS toxicity and ototoxicity rates were no different between treatment groups with overall rates of 2.7 and 1.1%, respectively. Peripheral neuropathy (PN) was 5.1% in 79-16 arm A, 5.9% in 79-16 arm B, and 8.7% in 79-18. Phenytoin did not significantly alter CNS and PN toxicity rates. All ototoxicities occurred in patients not on phenytoin. There was no correlation between dexamethasone dose and incidence of neurotoxicity within each study. However, the incidence of (PN) for the combined studies was 6.4% (35/550) which is lower than 18.9% (85/449) for non-brain Phase III protocols where patients are rarely, if ever, on dexamethasone or other corticosteroids. Four hour and 24 hour plasma MISO levels, and 24 hour/4 hour MISO ratios did not correlate with toxicity.

Sociopathy, gender, and treatment outcome among outpatient substance abusers.

Antisocial personality disorder (ASPD) may predict poor prognosis but gender/sociopathy relationships to prognosis remain unclear. This study investigated the effects of ASPD upon psychiatric and substance-related outcomes among 235 addiction treatment center outpatients. Prevalence rates for ASPD were similar for males (16%) and females (22%). At baseline, women and ASPD patients displayed greater substance-related and psychiatric severity. At 6-month follow-up, ASPD patients had greater severity on both measures than did patients without ASPD, but women now had equivalent psychiatric severity to men. After controlling for initial severity, ASPD was related to worse substance-related outcomes, but not to worse psychiatric outcomes.