Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer.

BACKGROUND: Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube ("ovarian") cancer is widely practiced but has not been evaluated in phase 3 investigation. METHODS: We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival. RESULTS: A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P = 0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery. CONCLUSIONS: In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone. (Funded by the National Cancer Institute and others; GOG-0213 ClinicalTrials.gov number, NCT00565851.).

Establishing a small animal model for evaluating protective immunity against mumps virus.

Although mumps vaccines have been used for several decades, protective immune correlates have not been defined. Recently, mumps outbreaks have occurred in vaccinated populations. To better understand the causes of the outbreaks and to develop means to control outbreaks in mumps vaccine immunized populations, defining protective immune correlates will be critical. Unfortunately, no small animal model for assessing mumps immunity exists. In this study, we evaluated use of type I interferon (IFN) alpha/beta receptor knockout mice (IFN-α/ßR-/-) for such a model. We found these mice to be susceptible to mumps virus administered intranasally and intracranially. Passive transfer of purified IgG from immunized mice protected naïve mice from mumps virus infection, confirming the role of antibody in protection and demonstrating the potential for this model to evaluate mumps immunity.

Perceived financial need and sexual risk behavior among urban, minority patients following sexually transmitted infection diagnosis.

BACKGROUND: Previous studies have shown that racial/ethnic and gender disparities in human immunodeficiency virus (HIV)/sexually transmitted infections (STI) may be due in part to factors such as poverty and income-inequality. Little has been published in the HIV/STI literature on the effect of the perception of having unmet basic needs on sexual risk behavior. METHODS: Data on perceived financial need and sexual risk were collected as part of a behavioral intervention aimed at promoting STI partner notification and reducing sexual behavior among minority patients presenting for care at 1 of 2 STI treatment centers in Brooklyn, NY, between January 2002 and December 2004. Data from 528 participants collected at the 6-month follow-up visit were used for the current study. RESULTS: Forty-three percent of participants were categorized as having unmet needs. Those with unmet needs were more likely to report unprotected anal or vaginal sex (unprotected anal or vaginal intercourse [UAVI]; 62%) versus those who had met needs (53%). This association was significant (adjusted odds ratio=1.28; 95% confidence interval=1.04-1.53), after controlling for age, sex, site of recruitment, intervention group membership, and country of origin. Stratified analyses indicated that, in the group that did not receive the intervention, there was a statistically significant interaction between sex and basic needs such that women with unmet needs were more likely to report any UAVI (78%) than those with met needs (54%) (adjusted odds ratio=1.18; 95% confidence interval=1.07-1.24). No such relationship was detected for men in this sample. CONCLUSIONS: The significant association between perceived unmet needs and UAVI appears to be particularly relevant for women. These findings provide preliminary evidence that HIV/STI intervention components that seek to directly deal with issues of reduction in partner conflict might be beneficial to women with high perceived unmet basic needs, and for whom a potential dissolution of a relationship may represent a further loss in ability to meet basic needs.

A randomized controlled trial for reducing risks for sexually transmitted infections through enhanced patient-based partner notification.

OBJECTIVES: We sought to assess the effectiveness of approaches targeting improved sexually transmitted infection (STI) sexual partner notification through patient referral. METHODS: From January 2002 through December 2004, 600 patients with Neisseria gonorrhoeae or Chlamydia trachomatis were recruited from STI clinics and randomly assigned to either a standard-of-care group or a group that was counseled at the time of diagnosis and given additional follow-up contact. Participants completed an interview at baseline, 1 month, and 6 months and were checked at 6 months for gonorrhea or chlamydial infection via nucleic acid amplification testing of urine. RESULTS: Program participants were more likely to report sexual partner notification at 1 month (86% control, 92% intervention; adjusted odds ratio [AOR] = 1.8; 95% confidence interval [CI] = 1.02, 3.0) and were more likely to report no unprotected sexual intercourse at 6 months (38% control, 48% intervention; AOR = 1.5; 95% CI = 1.1, 2.1). Gonorrhea or chlamydial infection was detected in 6% of intervention and 11% of control participants at follow-up (AOR = 2.2; 95% CI = 1.1, 4.1), with greatest benefits seen among men (for gender interaction, P = .03). CONCLUSIONS: This patient-based sexual partner notification program can help reduce risks for subsequent STIs among urban, minority patients presenting for care at STI clinics.

Human immunodeficiency virus partner elicitation and notification in new york city: public health does it better.

BACKGROUND: Partner notification (PN) is an effective strategy to identify undiagnosed human immunodeficiency virus (HIV) infections and to likely reduce HIV transmission. Whereas published literature has documented the benefits of provider referral for HIV PN, determination of the optimal provider--health department staff or community clinician--has not been previously studied. This study examined whether PN conducted by New York City (NYC) Disease Intervention Specialists (DIS) is more successful than PN conducted by community clinicians. METHODS: PN results overall and by index case-patient characteristics were compared for new HIV cases diagnosed in public sexually transmitted disease (STD) clinics versus those diagnosed in non-STD facilities. RESULTS: In NYC in 2004, 206 new HIV cases were diagnosed in STD clinics and 3460 in non-STD facilities. STD DIS personnel elicited 4 times as many partners per case diagnosed (0.87 vs. 0.22, P <0.01). Index case-patient characteristics differed between STD clinics and non-STD facilities, but STD DIS elicited more partners within all demographic and risk subgroups. Excluding partners previously HIV+, the proportion of partners notified was 70.9% for partners elicited by STD DIS and 48.3% for partners elicited by community clinicians (P <0.01). Among tested partners with previously unknown or negative status, the proportion of new HIV diagnoses was similar between those elicited by DIS and community clinicians (27.0% vs. 22.2%, P = 0.56). CONCLUSIONS: NYC STD DIS appear to be more effective than community clinicians at both partner elicitation and notification. NYC has stationed DIS at large healthcare facilities to assist community clinicians with the PN process.

Long-term persistence of mumps antibody after receipt of 2 measles-mumps-rubella (MMR) vaccinations and antibody response after a third MMR vaccination among a university population.

BACKGROUND: High attack rates among vaccinated young adults reported during the 2006 mumps outbreak in the United States heightened concerns regarding mumps vaccine failure. METHODS: Serum specimens from university students and staff were tested for mumps immunoglobulin (Ig) G by enzyme immunoassay (EIA). A subset of participants vaccinated for < or =5 years and > or =15 years were tested by neutralizing antibody (NA) assay. Persons seronegative by EIA were offered a third dose of measles-mumps-rubella vaccine (MMR3), and serum specimens were obtained 7-10 days and 2-3 months after its administration. RESULTS: Overall, 94% (95% confidence interval [CI], 91%-96%) of the 440 participants were seropositive. No differences existed in seropositivity rates by sex, age, age at receipt of the second dose of MMR vaccine (MMR2), or time since receipt of MMR2 (P = .568). The geometric mean titer (GMT) of NA among persons vaccinated with MMR2 during the previous 1-5 years was 97 (95% CI, 64-148), whereas, among those vaccinated > or =15 years before blood collection, the GMT was 58 (95% CI, 44-76) (P = .065). After MMR3, 82% (14/17) and 91% (10/11) seroconverted in 7-10 days and 2-3 months, respectively. CONCLUSIONS: Lower levels of NA observed among persons who received MMR2 > or =15 years ago demonstrates antibody decay over time. MMR3 vaccination of most seronegative persons marked the capacity to mount an anamnestic response.

HIV and sexually transmitted infection risk behaviors and beliefs among Black West Indian immigrants and US-born Blacks.

OBJECTIVES: We compared Black West Indian immigrants' and US-born Blacks' sexual and drug-use risk behaviors and their beliefs related to using condoms and informing partners of sexually transmitted infections (STIs) to identify possible differences in risk. METHODS: We drew data from the baseline assessment of a clinic-based intervention designed to increase partner STI notification. RESULTS: Black West Indian men were less likely than were US-born Black men to report nonregular partners. There were no differences in condom use. US-born Black women were more likely than were Black West Indian women to be extremely confident that they could convince their regular partners to use condoms (odds ratio [OR] = 2.40; 95% confidence interval [CI] = 1.21, 4.76), whereas there were no differences between Black West Indian and US-born Black men on this measure (interaction P = .06). US-born Black women were more likely than were Black West Indian women to be extremely confident in their ability to discuss STI screening with their regular partners (OR = 1.89; 95% CI = 1.03, 3.47). CONCLUSIONS: Black West Indian women's lower levels of confidence that they can discuss STI screening with their regular partners and convince these partners to use condoms may increase their infection risk. Gender-sensitive interventions are warranted for Black West Indian immigrants, especially women.

Substance abuse intervention services in public STD clinics: a pilot experience.

Past research reported a gap in substance abuse treatment for patients in sexually transmitted disease (STD) clinics. Studies in New York City indicate that approximately 20% of patients with STD show symptoms of alcohol and substance abuse, but only 1% have ever received treatment services. This article reports findings from a pilot project that implemented early intervention service procedures in an STD clinic in New York City. Services implemented included screening for substance use problems, brief interventions, and referral for treatment. Four main issues were explored in this pilot study: the feasibility of implementing early intervention services in an STD clinic; the extent to which patients would accept such interventions; the extent to which STD staff would be ready to integrate substance abuse services into their primary care protocols; and the likelihood of sustaining such services in an STD environment. Results and recommendations are provided and discussed.

A case-control study of syphilis among men who have sex with men in New York City: association With HIV infection.

OBJECTIVE: The objective of this study was to determine factors associated with syphilis among men who report sex with other men in New York City. DESIGN, SETTING AND STUDY SUBJECTS: We conducted a case-control study among 88 men who reported sex with men in the previous year, 18 to 55 years old and diagnosed with primary or secondary syphilis during 2001; and 176 control subjects frequently matched by age and type of health provider. RESULTS: HIV prevalence among syphilis cases was 48% compared with 15% among control subjects (P <0.001). Variables associated with syphilis in a multivariate model were HIV infection (odds ratio [OR], 7.3; 95% confidence interval [CI], 3.5-15.4), income >$30,000 per year (OR, 2.7; CI, 1.4-5.2), and barebacking (OR, 2.6; CI, 1.4-4.8). The median time since HIV diagnosis for HIV-positive was 6 years for cases and 7 years for control subjects (P = 0.70). Among HIV-infected participants, syphilis cases were more likely than control subjects to report being on antiretroviral therapy (69% vs. 44%, P = 0.05) and to report having undetectable viral load (58% vs. 24%, P = 0.02). CONCLUSION: HIV infection was strongly associated with syphilis in this study. High-risk behavior reported by both cases and control subjects indicates the potential for increased HIV transmission.