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Background: Discrimination is a major driver of health disparities among minority groups and can impede the reach of public health programs. In the Dominican Republic, residents of bateyes, or agricultural 'company towns,' often face barriers to health care. This study examined the extent of perceived discrimination among batey populations and places the findings within the context of disease elimination efforts., Methods: In March-April 2016, a stratified, multi-stage cluster survey that included the 9-item Everyday Discrimination Scale (EDS) was conducted among residents (n = 768) of bateyes across the Dominican Republic. Exploratory factor analysis, differential item functioning, and linear and logistic regression were used to assess associations between EDS scores, ethnic group status, reasons for discrimination, and healthcare-seeking behavior., Results: Three ethnic groups were identified in the population: Haitian-born persons (42.5%), Dominican-born persons with Haitian descent (25.5%), and Dominican-born persons without Haitian descent (32.0%). Mean EDS scores (range 0-45) were highest among persons born in Haiti (18.2, 95% confidence interval [CI] = 16.4-20.1), followed by persons with Haitian descent (16.5, 95% CI = 14.9-18.0), and those without Haitian descent (13.3, 95% CI = 12.1-14.5). Higher EDS scores were significantly associated with Haitian birth (β = 6.8, 95% CI = 4.2-9.4; p < 0.001) and Haitian descent (β = 6.1, 95% CI = 3.2-9.0; p < 0.001). Most respondents (71.5%) had scores high enough to elicit reasons for their discrimination. Regardless of ethnic group, poverty was a common reason for discrimination, but Haitian-born and Haitian-descended people also attributed discrimination to their origin, documentation status, or skin color. EDS scores were not significantly associated with differences in reported care-seeking for recent fever (β = 1.7, 95% CI = - 1.4-4.9; p = 0.278)., Conclusion: Perceived discrimination is common among batey residents of all backgrounds but highest among Haitian-born people. Discrimination did not appear to be a primary barrier to care-seeking, suggesting other explanations for reduced care-seeking among Haitian populations. Public health community engagement strategies should avoid exacerbating stigma, build active participation in programs, and work towards community ownership of disease control and elimination goals.

As cholera spread from Haiti to the Dominican Republic, Haitian migrants, a largely undocumented and stigmatized population in Dominican society, became a focus of public health concern. Concurrent to the epidemic, the Dominican legislature enacted new documentation requirements. This paper presents findings from an ethnographic study of anti-Haitian stigma in the Dominican Republic from June to August 2012. Eight focus group discussions (FGDs) were held with Haitian and Dominican community members. Five in-depth interviews were held with key informants in the migration policy sector. Theoretical frameworks of stigma's moral experience guided the analysis of how cholera was perceived, ways in which blame was assigned and felt and the relationship between documentation and healthcare access. In FGDs, both Haitians and Dominicans expressed fear of cholera and underscored the importance of public health messages to prevent the epidemic's spread. However, health messages also figured into experiences of stigma and rationales for blame. For Dominicans, failure to follow public health advice justified the blame of Haitians and seemed to confirm anti-Haitian sentiments. Haitians communicated a sense of powerlessness to follow public health messages given structural constraints like lack of safe water and sanitation, difficulty accessing healthcare and lack of documentation. In effect, by making documentation more difficult to obtain, the migration policy undermined cholera programs and contributed to ongoing processes of moral disqualification. Efforts to eliminate cholera from the island should consider how policy and stigma can undermine public health campaigns and further jeopardize the everyday 'being-in-the-world' of vulnerable groups.

Background: The island of Hispaniola, shared by Haiti and the Dominican Republic (DR), is the only remaining malaria-endemic island in the Caribbean and accounts for 95% of the lymphatic filariasis (LF) burden in the Americas. Both countries aim to eliminate the diseases by 2020. Migration from Haiti, where both diseases are more prevalent, may promote transmission in the DR. Historically, Haitian migrant labourers live in rural Dominican agricultural 'company towns' called bateyes, many of which received mass drug administration (MDA) for LF elimination. This study sought to determine the prevalence of malaria and LF in bateyes of the DR and to describe related risk factors for disease., Methods: From March to April 2016, a cross-sectional, cluster survey was conducted across Dominican bateyes stratified into three regions: southwest, north and east. A household questionnaire (n = 776), captured demographics, ethnic origin, mobility patterns, malaria intervention coverage, and knowledge, and recent fever and treatment-seeking. Two individuals per household (n = 1418) were tested for malaria parasites by microscopy and rapid diagnostic test (RDT) and LF antigen by filariasis test strip (FTS). Population-level estimates and confidence intervals (CI) were computed adjusting for the survey design. Two-sided t-tests compared differences in knowledge scores., Results: No (0%) blood sample was Plasmodium-positive by microscopy or RDT. Six individuals were FTS-positive (0.5%; 95% CI: 0.2-1.5), but none (0%) of these were microfilariae-positive. Most batey residents were born in the DR (57.8%), documented (85.0%), and permanent residents (85.1%). Very few respondents (9.4%) reported travel to Haiti in the past year. Overall, half (53.8%) of respondents owned a bed net, and 82.3% of net owners reported using it the previous night. Indoor residual spraying (IRS) differed by region (range: 4.7%-61.2%). Most of those with recent fever sought care (56.0%), yet only 30.5% of those seeking care were tested for malaria. Compared to Dominican-born populations, Haitian-born respondents more frequently reported recent fever, did not seek care for the fever, had not heard of malaria, and could not name symptoms or prevention methods., Conclusions: Malaria and LF transmission appear absent or extremely low in Dominican bateyes, which are a mixture of Haitian and Dominican residents. Travel to Haiti is rare, meaning risk of malaria and LF importation is low. Addressing identified gaps in intervention coverage, malaria knowledge, treatment seeking and service delivery will improve the quality of surveillance for these diseases, particularly among marginalized populations and promote island-wide elimination.

This mixed-method study explored the social world of Haitian migrants, examining forms of social support and social stress, as well as their relationship to mental health. Among six Haitian migrant communities in the Cibao Valley of the Dominican Republic, a community-based survey (n = 127) was conducted to assess migration experiences, current stressors, mental health, and functioning. In addition, to explore perceptions and experiences of migration, social interactions, and mental health, the study drew upon in-depth interviews and free-listing activities among Haitian migrants, as well as cognitive interviews with select survey participants. Depressive, anxiety, and mental distress survey scores were associated with 1) negative social interactions (including interrogation or deportation, perceived mistreatment by Dominicans, and overcrowding) and 2) lack of social support, including migrating alone. Mental distress scores were higher among women, and being married was associated with higher anxiety scores, potentially reflecting unmet social expectations. In qualitative data, participants emphasized a lack of social support, often referred to as tèt ansanm (literally meaning "heads together" in Haitian Creole or Kreyòl and roughly defined as solidarity or reciprocal social collaboration). The authors of the study propose that the practice of tèt ansanm-also termed konbit, and, in the Dominican Republic, convite-could be used as a means of facilitating positive-contact events among Haitians and Dominicans. These interactions could help counteract social stress and build social capital in settings similar to those of the study.

Objective: To determine whether cholera risk factor prevalence in the Dominican Republic can be explained by nationality, independent of other factors, given the vulnerability of many Haitians in the country and the need for targeted prevention., Methods: A cross-sectional, observational household survey (103 Haitian and 260 Dominican) was completed in 18 communities in July 2012. The survey included modules for demographics, knowledge, socioeconomic status, and access to adequate water, sanitation, and hygiene (WASH) infrastructure. Logistic regression assessed differential access to WASH infrastructure and Poisson regression assessed differences in cholera knowledge, controlling for potential confounders., Results: Dominican and Haitian households differed on demographic characteristics. Haitians had lower educational attainment, socioeconomic status, and less knowledge of cholera than Dominicans (adjusted odds ratio [aOR] = 0.66; 95% confidence interval [95%CI] = 0.55-0.81). Access to improved drinking water was low for both groups, but particularly low among rural Haitians (aOR = 0.21; 95%CI: 0.04-1.01). No differences were found in access to sanitation after adjusting for sociodemographic confounders (aOR = 1.00; 95%CI: 0.57-1.76)., Conclusions: Urban/rural geography and socioeconomic status play a larger role in cholera risk factor prevalence than nationality, indicating that Haitians' perceived vulnerability to cholera is confounded by contextual factors. Understanding the social dynamics that lead to cholera risk can inform control strategies, leading to better targeting and the possibility of eliminating cholera from the island.

Objective: Many Haitian migrants live and work as undocumented laborers in the Dominican Republic. This study examines the legacy of anti-Haitian discrimination in the Dominican Republic and association of discrimination with mental health among Haitian migrants., Design: This study used mixed methods to generate hypotheses for associations between discrimination and mental health of Haitian migrants in the Dominican Republic. In-depth interviews were conducted with 21 Haitian and 18 Dominican community members and clinicians. One hundred and twenty-seven Haitian migrants participated in a pilot cross-sectional community survey. Instruments included culturally adapted Kreyòl versions of the Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) and a locally developed function impairment scale., Results: Haitian migrants described humiliation (imilyasyon) as a reason for mental distress and barrier to health care. Dominicans reported that discrimination (discriminación) was not a current social problem and attributed negative social interactions to sociocultural, behavioral, and biological differences between Dominicans and Haitians. These qualitative findings were supported in the quantitative analyses. Perceived discrimination was significantly associated with depression severity and functional impairment. Perceived mistreatment by Dominicans was associated with a 6.6-point increase in BDI score (90% confidence interval [CI]: 3.29, 9.9). Knowing someone who was interrogated or deported was associated with a 3.4-point increase in BAI score (90% CI: 0.22, 6.64)., Conclusion: Both qualitative and quantitative methods suggest that perceived discrimination and the experience of humiliation contribute to Haitian migrant mental ill-health and limit access to health care. Future research should evaluate these associations and identify intervention pathways for both improved treatment access and reduction of discrimination-related health risk factors.

A rich Haitian ethnopsychology has been described, detailing concepts of personhood, explanatory models of illness, and links between mind and body. However, little research has engaged explicitly with mental illness, and that which does focuses on the Kreyòl term fou (madness), a term that psychiatrists associate with schizophrenia and other psychoses. More work is needed to characterize potential forms of mild-to-moderate mental illness. Idioms of distress provide a promising avenue for exploring common mental disorders. Working in Haiti's Central Plateau, we aimed to identify idioms of distress that represent cultural syndromes. We used ethnographic and epidemiologic methods to explore the idiom of distress reflechi twòp (thinking too much). This syndrome is characterized by troubled rumination at the intersection of sadness, severe mental disorder, suicide, and social and structural hardship. Persons with "thinking too much" have greater scores on the Beck Depression Inventory and Beck Anxiety Inventory. "Thinking too much" is associated with 8 times greater odds of suicidal ideation. Untreated "thinking too much" is sometimes perceived to lead to psychosis. Recognizing and understanding "thinking too much" may allow early clinical recognition and interventions to reduce long-term psychosocial suffering in Haiti's Central Plateau.

The lack of culturally appropriate mental health assessment instruments is a major barrier to screening and evaluating efficacy of interventions. Simple translation of questionnaires produces misleading and inaccurate conclusions. Multiple alternate approaches have been proposed, and this study compared two approaches tested in rural Haiti. First, an established transcultural translation process was used to develop Haitian Kreyòl versions of the Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI). This entailed focus group discussions evaluating comprehensibility, acceptability, relevance, and completeness. Second, qualitative data collection was employed to develop new instruments: the Kreyòl Distress Idioms (KDI) and Kreyòl Function Assessment (KFA) scales. For the BDI and BAI, some items were found to be nonequivalent due to lack of specificity, interpersonal interpretation, or conceptual nonequivalence. For all screening tools, items were adjusted if they were difficult to endorse or severely stigmatizing, represented somatic experiences of physical illness, or were difficult to understand. After the qualitative development phases, the BDI and BAI were piloted with 31 and 27 adults, respectively, and achieved good reliability. Without these efforts to develop appropriate tools, attempts at screening would have captured a combination of atypical suffering, everyday phenomena, and potential psychotic symptoms. Ultimately, a combination of transculturally adapted and locally developed instruments appropriately identified those in need of care through accounting for locally salient symptoms of distress and their negative sequelae.

Vodou as an explanatory framework for illness has been considered an impediment to biomedical psychiatric treatment in rural Haiti by some scholars and Haitian professionals. According to this perspective, attribution of mental illness to supernatural possession drives individuals to seek care from houngan-s (Vodou priests) and other folk practitioners, rather than physicians, psychologists, or psychiatrists. This study investigates whether explanatory models of mental illness invoking supernatural causation result in care-seeking from folk practitioners and resistance to biomedical treatment. The study comprised 31 semi-structured interviews with community leaders, traditional healers, religious leaders, and biomedical providers, 10 focus group discussions with community members, community health workers, health promoters, community leaders, and church members; and four in-depth case studies of individuals exhibiting mental illness symptoms conducted in Haiti's Central Plateau. Respondents invoked multiple explanatory models for mental illness and expressed willingness to receive treatment from both traditional and biomedical practitioners. Folk practitioners expressed a desire to collaborate with biomedical providers and often referred patients to hospitals. At the same time, respondents perceived the biomedical system as largely ineffective for treating mental health problems. Explanatory models rooted in Vodou ethnopsychology were not primary barriers to pursuing psychiatric treatment. Rather, structural factors including scarcity of treatment resources and lack of psychiatric training among health practitioners created the greatest impediments to biomedical care for mental health concerns in rural Haiti.

Haiti's 2010 earthquake mobilized mental health and psychosocial interventions from across the globe. However, failure to understand how psychological distress is communicated between lay persons and health workers in rural clinics, where most Haitians access care, has been a major limitation in providing mental health services. The goal of this study was to map idioms of distress onto Haitian ethnopsychologies in a way that promotes improved communication between lay persons and clinicians in rural Haiti. In Haiti's Central Plateau, an ethnographic study was conducted in May and June 2010, utilizing participant observation in rural clinics, 31 key informant interviews, 11 focus groups, and four case studies. Key informants included biomedical practitioners, traditional healers, community leaders, and municipal and religious figures. Deductive and inductive themes were coded using content analysis (inter-rater reliability > 0.70). Forty-four terms for psychological distress were identified. Head (tèt) or heart (kè) terms comprise 55% of all qualitative text segments coded for idioms of distress. Twenty-eight of 142 observed patient-clinician contacts involved persons presenting with tèt terms, while 29 of the 142 contacts were presentations with kè terms. Thus, 40% of chief complaints were conveyed in either head or heart terms. Interpretations of these terms differed between lay and clinical groups. Lay respondents had broad and heterogeneous interpretations, whereas clinicians focused on biomedical concepts and excluded discussion of mental health concerns. This paper outlines preliminary evidence regarding the psychosocial dimensions of tèt and kè-based idioms of distress and calls for further exploration. Holistic approaches to mental healthcare in Haiti's Central Plateau should incorporate local ethnopsychological frameworks alongside biomedical models of healthcare., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Objective: The objective of the study was to confirm that concurrent cisplatin (CT) with radiation therapy (RT) is associated with improved long-term progression-free survival (PFS) and overall survival (OS), compared with RT alone in stage IB bulky carcinoma of the cervix, when both groups' therapy is followed by hysterectomy., Study Design: Three hundred seventy-four patients entered this trial. There were 369 evaluable patients; 186 were randomly allocated to receive RT alone and 183 to receive CT plus RT. Radiation dosage was 45 Gray (Gy) in 20 fractions followed by low dose-rate intracavitary application(s) of 30 Gy to point A. Chemotherapy consisted of intravenous cisplatin 40 mg/m2 every week for up to 6 weekly cycles. Total extrafascial hysterectomy followed the completion of RT by 6-8 weeks., Results: Preliminary results have been published, at which time there were 292 censored observations, and median duration of follow-up was only 36 months. Patient and tumor characteristics were well balanced between the regimens. The median patient age was 41.5 years; 81% had squamous tumors; 59% were white. Median follow-up is now 101 months. The relative risk for progression was 0.61 favoring CT plus RT (95% confidence interval [CI] 0.43 to 0.85, P < .004). At 72 months, 71% of patients receiving CT plus RT were predicted to be alive and disease free when adjusting for age and tumor size, compared with 60% of those receiving RT alone. The adjusted death hazard ratio was 0.63 (95% CI 0.43 to 0.91, P < .015) favoring CT plus RT. At 72 months, 78% of CT plus RT patients were predicted to be alive, compared with 64% of RT patients. An increased rate of early hematologic and gastrointestinal toxicity was seen with CT plus RT. There was no detectable difference in the frequency of late adverse events., Conclusion: Concurrent weekly cisplatin with RT significantly improves long-term PFS and OS when compared with RT alone. Serious late effects were not increased. The inclusion of hysterectomy has been discontinued on the basis of another trial. Pending further trials, weekly cisplatin with radiation is the standard against which other regimens should be compared.

Background: Despite their low risk for recurrence, many women with endometrial adenocarcinoma receive postoperative radiation therapy (RT). This study was developed to determine if adjunctive external beam irradiation lowers the risk of recurrence and death in women with endometrial cancer International Federation of Gynaecology and Obstetrics (FIGO) stages IB, IC, and II (occult disease)., Methods: Four hundred forty-eight consenting patients with "intermediate risk" endometrial adenocarcinoma were randomized after surgery to either no additional therapy (NAT) or whole pelvic radiation therapy (RT). They were followed to determine toxicity, date and location of recurrence, and overall survival. A high intermediate risk (HIR) subgroup of patients was defined as those with (1) moderate to poorly differentiated tumor, presence of lymphovascular invasion, and outer third myometrial invasion; (2) age 50 or greater with any two risk factors listed above; or (3) age of at least 70 with any risk factor listed above. All other eligible participants were considered to be in a low intermediate risk (LIR) subgroup., Results: Three hundred ninety-two women met all eligibility requirements (202 NAT, 190 RT). Median follow-up was 69 months. In the entire study population, there were 44 recurrences and 66 deaths (32 disease or treatment-related deaths), and the estimated 2-year cumulative incidence of recurrence (CIR) was 12% in the NAT arm and 3% in the RT arm (relative hazard (RH): 0.42; P=0.007). The treatment difference was particularly evident among the HIR subgroup (2-year CIR in NAT versus RT: 26% versus 6%; RH=0.42). Overall, radiation had a substantial impact on pelvic and vaginal recurrences (18 in NAT and 3 in RT). The estimated 4-year survival was 86% in the NAT arm and 92% for the RT arm, not significantly different (RH: 0.86; P=0.557)., Conclusions: Adjunctive RT in early stage intermediate risk endometrial carcinoma decreases the risk of recurrence, but should be limited to patients whose risk factors fit a high intermediate risk definition.

Objective: To evaluate, in a randomized clinical trial, the role of adjuvant hysterectomy after standardized radiation in improving progression-free survival and survival for patients with "bulky" stage IB cervical cancer., Methods: A total of 256 eligible patients with exophytic or "barrel" shaped tumors measuring > or = 4 cm were randomized to either external and intracavitary irradiation (RT, N = 124) or attenuated irradiation followed by extrafascial hysterectomy (RT + HYST, N = 132). Twenty-five percent of patients had tumors with a maximum diameter of > or =7 cm., Result: Tumor size was the most pronounced prognostic factor followed by performance status 2 and age at diagnosis. Hysterectomy did not increase the frequency of reported grade 3 and 4 adverse effects (both groups, 10%). The majority of these adverse effects were from the gastrointestinal or genitourinary tracts exclusively. There was a lower cumulative incidence of local relapse in the RT + HYST group (at 5 years, 27% vs. 14%). There were no statistical differences in outcomes between regimens except for the adjusted comparison of progression-free survival, although all indicated a lower risk in the adjuvant hysterectomy regimen (unadjusted relative risk [URR] of progression, 0.77, P = 0.07; URR of death, P = 0.26, both one tail)., Conclusion: Overall, there was no clinically important benefit with the use of extrafascial hysterectomy. However, there is good evidence to suggest that patients with 4-, 5-, and 6-cm tumors may have benefitted from extrafascial hysterectomy (URR of progression; 0.58; URR of death, 0.60).

Several large, prospectively randomized clinical trials run by multi-institutional cooperative groups have established that the best treatment for advanced cancer of the cervix is primary radiotherapy with concurrent, cisplatin-based chemotherapy. In fact, patients with earlier stage cervix cancer with poor prognostic indicators (large, bulky tumors, positive pelvic lymph nodes, or unexpected parametrial disease at the time of surgery) also show a survival benefit with this approach. Adequate radiation dosing (both external beam and intracavitary) is essential. The additional benefit of periaortic lymph node irradiation is debated, but generally accepted, for patients with locally advanced disease or pelvic lymph node involvement.

Background: Bulky stage IB cervical cancers have a poorer prognosis than smaller stage I cervical cancers. For the Gynecologic Oncology Group, we conducted a trial to determine whether weekly infusions of cisplatin during radiotherapy improve progression-free and overall survival among patients with bulky stage IB cervical cancer., Methods: Women with bulky stage IB cervical cancers (tumor, > or =4 cm in diameter) were randomly assigned to receive radiotherapy alone or in combination with cisplatin (40 mg per square meter of body-surface area once a week for up to six doses; maximal weekly dose, 70 mg), followed in all patients by adjuvant hysterectomy. Women with evidence of lymphadenopathy on computed tomographic scanning or lymphangiography were ineligible unless histologic analysis showed that there was no lymph-node involvement. The cumulative dose of external pelvic and intracavitary radiation was 75 Gy to point A (cervical parametrium) and 55 Gy to point B (pelvic wall). Cisplatin was given during external radiotherapy, and adjuvant hysterectomy was performed three to six weeks later., Results: The relative risks of progression of disease and death among the 183 women assigned to receive radiotherapy and chemotherapy with cisplatin, as compared with the 186 women assigned to receive radiotherapy alone, were 0.51 (95 percent confidence interval, 0.34 to 0.75) and 0.54 (95 percent confidence interval, 0.34 to 0.86), respectively. The rates of both progression-free survival (P<0.001) and overall survival (P=0.008) were significantly higher in the combined-therapy group at four years. In the combined-therapy group there were higher frequencies of transient grade 3 (moderate) and grade 4 (severe) adverse hematologic effects (21 percent, vs. 2 percent in the radiotherapy group) and adverse gastrointestinal effects (14 percent vs. 5 percent)., Conclusions: Adding weekly infusions of cisplatin to pelvic radiotherapy followed by hysterectomy significantly reduced the risk of disease recurrence and death in women with bulky stage IB cervical cancers.

We examined whether the cell proliferation index by MIB-1, HER-2/neu gene amplification, Gleason grade, and pretreatment level of serum prostate specific antigen (PSA) correlated with postradiation recurrence (PRR) in patients with prostatic adenocarcinoma. Formalin-fixed, paraffin-embedded tissue sections from 42 pretreated cases of prostatic adenocarcinoma (38 needle biopsy and 4 transurethral resection specimens) were immunostained for MIB-1 (MMI, Ventana Medical Systems, Tucson, Ariz). HER-2/neu gene amplification was analyzed by fluorescence in situ hybridization using the Oncor unique sequence probe (Oncor, Gaithersburg, Md). The cell proliferation index by MIB-1 was determined by labeling index; levels of HER-2/neu were analyzed semiquantitatively. Twenty-three of 42 patients (55%) were considered to have PRR on the basis of consecutive elevations of serum levels of PSA to greater than 1.5 ng/mL after completion of treatment (mean follow-up time, 33.4 months). The cell proliferation index correlated with PRR on both univariate and multivariate analyses. Of the 23 tumors that showed PRR, 18 (78%) revealed a high cell proliferation index, compared with 6 of 19 cases (32%) that showed no PRR. Twelve of 23 cases of prostatic adenocarcinoma (52%) in the recurrent group showed HER-2/neu gene amplification, compared with 5 of 19 (26%) in the nonrecurrent group; these findings reached near significance on univariate analysis. Pretreatment levels of serum PSA also reached significance on multivariate analysis. In this preliminary study, the cell proliferation index by MIB-1 reached independent significance in predicting PRR in patients with prostatic adenocarcinoma, whereas HER-2/neu amplification by fluorescence in situ hybridization reached near significance.

Purpose: Long-term follow-up data of a randomized trial that compared hydroxyurea and the hypoxic-cell radiosensitizer to misonidazole as adjuncts to standard radiation therapy in locally advanced carcinoma of the cervix are reported., Patients and Methods: Three hundred eight women were entered, and all 294 eligible patients are assessable as randomized. Eighty-one percent of patients have been monitored for 5 years or to death., Results: There was an advantage for hydroxyurea in progression-free interval and survival (P = .05 and P = .066, respectively). There was no significant difference in the distribution of sites of failure between the regimens. For the 39% of patients with stages III to IVA disease, the advantage in progression-free interval for hydroxyurea was significant (47.8% v 33.6%). More leukopenia occurred on the hydroxyurea regimen than on the misonidazole regimen., Conclusion: In summary, these data provide stronger evidence than our previous analysis that hydroxyurea is superior to misonidazole as an adjunct to radiation therapy. For patients with locally advanced carcinoma of the cervix, hydroxyurea continues to be the adjunct of choice with radiation.

Between 1977 and 1985, the Gynecologic Oncology Group (GOG) conducted three clinical trials in locally advanced carcinoma of the cervix, clinical Stages I to IVA as classified by the International Federation of Gynecology and Obstetrics (FIGO). All 626 patients had primary carcinoma of the cervix and underwent operative assessment of the para-aortic (PA) lymph nodes. Patients received standardized external radiation therapy to the pelvis or to the pelvis and PA lymph nodes followed by one or two brachytherapy applications. To date, no statistically significant differences in progression-free interval (PFI) or survival time have been identified between the randomization treatment arms on any of these studies. Basic similarities among these studies led us to pool these data to identify patient characteristics and tumor characteristics associated with an increased risk of treatment failure. Multi-variate analysis showed patient age, performance status (PS), PA lymph node status, tumor size, and pelvic node status to be significantly associated with PFI. When modeling for survival, all these factors and clinical stage and bilateral extension were significant.

The incidence of para-aortic node metastasis in cancer of the cervix ranges from 5%to 50% in clinical Stages i-iv. Extended field irradiation is being administered more frequently because of high incidence of extrapelvic disease. The cancer of the cervix material at Walter Reed General Hospital has been analyzed as to site and time of failure to determine who might have benefited from extended field irradiation. Of patients who fail, the majority will have uncontrolled pelvic disease regardless of other involvement. Diagnostic procedures including staging laparotomy are unable to predict pelvic failure or the presence of occult distant disease in lung and bone. The maximum number of patients who could benefit from pari-aortic irradiation is lessthan 3% of a total series. It is concluded that the salvage of patients with para-aortic metastasis will be small, but for those few long-term survivors, the benefit will be great.

Thirty-four patients wih infiltrative bladder carcinoma, Stage B2C or higher were treated with immunotherapy and irradiation. Seventeen patients are alive, and 17 have succumbed to their disease. Eight patients underwent cystectomy after immunotherapy and irradiation; 6 of 8 are alive and well at the present time. The technique of immunotherapy is outlined. New methodology for sequential CT scans and scheduled bladder biopsies is mentioned. The 17 patients have survived twelve to sixty-nine months after immunotherapy and irradiation. Downstaging is demonstrated based on sequential CT scans of the bony pelvis and histologic biopsy. The biopsies reveal eosinophilia and multinucleated giant cells, a specific response to immunotherapy. A prospective randomized study will be initiated.

Computed tomography (CT) was utilized as part of the surgical-pathologic-radiologic evaluation of 21 patients who were treated for bladder carcinoma with attenuated irradiation and immunotherapy. Fifteen patients had moderately infiltrative (Stage B2-C or less) disease, and it was found that a routine high resolution CT technique using a modern fast scanner delineated the tumor in most cases. More accurate assessment of tumor response to therapy and evaluation of tumor progression were facilitated using a gas insufflation technique combined with intravenous contrast fusion. This was followed in selected cases by quantitative measurements of CT attenuation values using a recently introduced CT software program. Using this program, individual pixel values were obtained in selected areas and evaluation of the resulting numerical data and pixel histograms aided in the differentiation of tumor tissue from adjacent bladder wall and mapped out areas of tumor necrosis. Our preliminary observations suggest that quantitative CT studies incorporating assessment of printouts of attenuation values of adjacent pixels within a region of interest will improve the delineation of smaller (B1/B2) lesions and will aid objective characterization of tumor tissue during and following therapy.

The use of 3 dose assessment systems is compared. The Manchester approach which measures a dose to Point A and Point B; the Paris approach using rads and mgh; and Ellis's NSD approach appear to have equal value in predicting probability of pelvic control and the likelihood of complication over the dose range employed at this hospital. Control increases with higher dose schemes, but complications appear to be influenced by other variables not accounted for in the 3 systems.

Heterotopic ossification is a complication of total hip arthroplasty in 14 to 30% of patients. Significant functional impairment will occur in up to 28% of patients with ectopic bone. The high risk group includes those with preexisting heterotopic bone in either hip, those suffering from hypertrophic osteoarthritis or ankylosing spondylitis and patients who have had multiple procedures on the hip. Fifty-eight patients (67 hips) were irradiated after surgical removal of ectopic bone (53 hips) or received radiation prophylaxis of heterotopic ossification (14 hips). Ninety-five percent of patients had either no bone visible or insignificant amounts of ectopic bone visible on postoperative hip X-rays. Only 5% of patients showed significant persistence of ectopic bone. Postoperative hip function was dramatically improved compared to preoperative function in all patients treated. The importance of early commencement of irradiation is emphasized.