A randomised phase II study of two different schedules of pegylated liposomal doxorubicin in metastatic breast cancer (EORTC-10993).

One hundred and sixteen women with measurable metastatic breast cancer participated in a randomised phase II study of single agent liposomal pegylated doxorubicin (Caelyx) given either as a 60 mg/m2 every 6 weeks (ARM A) or 50 mg/m2 every 4 weeks (ARM B) schedule. Patients were over 65 years of age or, if younger, had refused or been unsuitable for standard anthracyclines. The aims of the study were to evaluate toxicity and dose delivery with the two schedules and obtain further information on the response rate of liposomal pegylated doxorubicin as a single agent in anthracycline nai ve advanced breast cancer.

3-year results of docetaxel-based sequential and combination regimens in the adjuvant therapy of node-positive breast cancer: a pilot study.

Background: Docetaxel has proven efficacy in metastatic breast cancer. In this pilot study, we explored the efficacy/feasibility of docetaxel-based sequential and combination regimens as adjuvant therapy of node-positive breast cancer.

Patients And Methods: From March 1996 till March 1998, four consecutive groups of patients with stages II and III breast cancer, aged < or = 70 years, received one of the following regimens: a) sequential Doxorubicin (A) --> Docetaxel (T) --> CMF (Cyclophosphamide+Methotrexate+5-Fluorouracil): A 75 mg/m q 3 wks x 3, followed by T100 mg/m2 q 3 wks x 3, followed by i.

An EORTC-IDBBC phase I study of gemcitabine and continuous infusion 5-fluorouracil in patients with metastatic breast cancer resistant to anthracyclines or pre-treated with both anthracyclines and taxanes.

The aim of this study was to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and potential activity of combined gemcitabine and continuous infusion 5-fluorouracil (5-FU) in metastatic breast cancer (MBC) patients that are resistant to anthracyclines or have been pretreated with both anthracyclines and taxanes. 15 patients with MBC were studied at three European Organization for Research and Treatment of Cancer centres. 13 patients had received both anthracylines and taxanes.

Regional differences in HIV testing among European patients with sexually transmitted diseases: trends in the history of HIV testing and knowledge of current serostatus.

Objectives: To determine trends in (1) HIV testing and knowledge of current serostatus and (2) clinic-visits of aware HIV-infected patients and (3) to determine associates of incident HIV infection among patients with sexually transmitted disease (STD) in 15 countries participating in a European Community anonymous HIV seroprevalence survey.

Methods: Demographics, STD diagnosis, self-reported history of HIV tests and current HIV test results were collected for patients diagnosed with one of 12 pre-selected STDs. Incident HIV infections were determined among patients who reported prior HIV-negative test results.

Effect of HIV-1 infection on tuberculosis and fertility in a large workforce in Kinshasa, Democratic Republic of the Congo.

To determine the effect of an HIV counseling service on the incidence of HIV and tuberculosis infection and on the fertility rate in a large workforce cohort of adult men and women from Kinshasa, Democratic Republic of Congo (formerly Zaire), we conducted a 2-year prospective longitudinal cohort study, two large Kinshasa businesses (a commercial bank and a textile factory). We determined baseline HIV-1 seroprevalence, HIV-1 and tuberculosis mortality/morbidity, and fertility rates during 24 months of follow-up on 8866 employees and 6411 wives of male employees. The baseline HIV-1 seroprevalence was 2.

Trends in HIV seroprevalence among patients with sexually transmitted diseases in 17 European sentinel networks, 1990-1996. European Study Group.

Objective: To monitor trends in HIV seroprevalence among sentinel populations of patients with new sexually transmitted disease episodes in 17 networks of 15 European countries.

Methods: Time trends were estimated by logistic regression for homo-/bisexual men, injecting drug users (IDU) and non-IDU heterosexuals. The networks were included as independent variables to account for different prevalence levels across Europe.

The Swiss Network of Dermatology Policlinics HIV prevalence study: rationale, characteristics and results (1990-1996).

The Swiss Network of Dermatology Policlinics (SNDP) has monitored the prevalence of HIV among patients treated for a sexually transmitted disease (STD) since January 1990. A questionnaire was sent to each policlinic in the network (Basel, Bern, Geneva, Lausanne, and two in Zurich) to collect information on their participation in this study and the characteristics of the network. The responses reveal that the six policlinics followed the HIV prevalence study protocol in a uniform manner and had similar logistical and organisational characteristics HIV prevalences in this population were high (1.

The HIV epidemic associated with injecting drug use in Europe: geographic and time trends.

Objectives: To evaluate the magnitude and trends of the HIV epidemic associated with injecting drug use in Europe.

Methods: AIDS cases associated with injecting drug users (IDU) diagnosed through 1995 were analysed, including IDU, homo-/bisexual IDU, heterosexual partners of IDU and children whose mothers were IDU. HIV seroprevalence studies among IDU were reviewed.

HIV status of female sex partners of men reactive to HIV-1, HIV-2 or both viruses in Abidjan, Côte d'Ivoire.

Objectives: To compare rates of serologic concordance in the female sex partners of men with HIV-1 and HIV-2 infections, and to determine the serologic status of sex partners of men who reacted serologically to both viruses.

Design: Cross-sectional study.

Setting: Infectious diseases service in a University Hospital in Abidjan, Côte d'Ivoire (West Africa).

High HIV-1 incidence in young women masked by stable overall seroprevalence among childbearing women in Kinshasa, Zaïre: estimating incidence from serial seroprevalence data.

Objective: To describe the dynamics of the HIV-1 epidemic in childbearing women in Kinshasa, Zaïre, by estimating incidence from serial seroprevalence studies.

Methods: In 1986 and 1989, 5937 and 4623 pregnant women, respectively, were screened for HIV-1 in Kinshasa. We estimated age-specific incidence from two seroprevalence surveys by using a birth-year cohort analysis and adjusting for differences in mortality and fertility between HIV-1-infected and uninfected women.

AIDS orphans in Kinshasa, Zaïre: incidence and socioeconomic consequences.

Objective: To determine the incidence, morbidity, mortality, and socioeconomic consequences of becoming an AIDS orphan (a child with an HIV-1-seropositive mother who has died) in Kinshasa, Zaïre.

Design: A longitudinal cohort study was undertaken between 1986 and 1990. Within this cohort, a nested case-control study of AIDS orphans was performed.

Retrospective study of maternal HIV-1 and HIV-2 infections and child survival in Abidjan, Côte d'Ivoire.

Objectives: To compare the effects of maternal HIV-1 and HIV-2 infections on outcome of pregnancy, infant mortality, and child survival, and to measure serological concordance between mothers and children.

Design: Retrospective cohort study with cross sectional study of concordance for HIV antibodies.

Setting: Hospital, tuberculosis clinic, and maternal and child health centre in Abidjan, Côte d'Ivoire, west Africa.

Excluding blood donors at high risk of HIV infection in a west African city.

Objective: To examine the potential impact of deferral of blood donors at high risk of HIV infection in a west African city where blood is screened for HIV antibodies but no other special measures are taken to protect the blood supply.

Design: Cross sectional study.

Setting: National Blood Transfusion Centre and Project RETRO-CI, an international collaborative AIDS research project, Abidjan, Côte d'Ivoire.

Impact of HIV counseling and testing among child-bearing women in Kinshasa, Zaïre.

Objective: To determine the impact of HIV counseling and testing among child-bearing women.

Study Setting: Mama Yemo Hospital in Kinshasa, Zaïre.

Participants And Interventions: After informed consent, 187 HIV-seropositive and 177 HIV-seronegative child-bearing women received pre- and post-test counseling for HIV infection.

Risk for perinatal HIV-1 transmission according to maternal immunologic, virologic, and placental factors.

Objective: To evaluate how maternal and obstetric factors interact to influence mother-to-child human immunodeficiency virus type 1 (HIV-1) transmission.

Design: Prospective, observational cohort study of children born to HIV-infected women to determine child's HIV infection status. The analysis then compared peripartum maternal, placental, and obstetric variables between HIV-1 transmitter and nontransmitter women.

Safety and immunogenicity of bacille Calmette-Guérin, diphtheria-tetanus-pertussis, and oral polio vaccines in newborn children in Zaire infected with human immunodeficiency virus type 1.

Objective: To determine the safety and immunogenicity of childhood vaccines in children with perinatally acquired human immunodeficiency virus type 1 (HIV-1) infection.

Design: Nonrandomized, prospective cohort study; 12-month follow-up period.

Setting: Obstetric wards and outpatient pediatric clinics at two large hospitals in Kinshasa, Zaire.

Non-ulcerative sexually transmitted diseases as risk factors for HIV-1 transmission in women: results from a cohort study.

Objectives: The heterosexual spread of HIV-1 is occurring at different rates in different parts of the world. The transmission probability of HIV-1 per sexual contact is low, but may be greatly enhanced by several cofactors. Sexually transmitted diseases (STD), especially genital ulcers, may be such factors.

Stability of human immunodeficiency virus type 1 antibodies in whole blood dried on filter paper and stored under various tropical conditions in Kinshasa, Zaire.

The use of whole-blood spots on filter paper for the detection of antibody to human immunodeficiency virus type 1 (HIV-1) was evaluated during a 20-week period under a variety of storage environments simulating the harsh tropical field conditions in Kinshasa, Zaire. During the first 6 weeks of storage, all replicates of high- and low-titer HIV-1-positive reference samples remained positive by enzyme immunoassay and Western blotting (immunoblotting), and all replicates of HIV-1-negative samples remained negative under all storage conditions. However, hot and humid storage conditions for up to 20 weeks caused a progressive decline in enzyme immunoassay optical density ratio values, which was particularly noticeable in samples with a low HIV-1 antibody titer.

Fertility rates in 238 HIV-1-seropositive women in Zaire followed for 3 years post-partum.

Birth-control use and fertility rates were prospectively determined in 238 HIV-1-seropositive and 315 HIV-1-seronegative women in Kinshasa, Zaire, during the 36-month period following the delivery of their last live-born child. No women delivered children during the first follow-up year. Birth-control utilization rates (percentage use during total observation time) and fertility rates (annual number of live births per 1000 women of child-bearing age) in the second year of follow-up were 19% (107.

Evidence from Zaire that breast-feeding by HIV-1-seropositive mothers is not a major route for perinatal HIV-1 transmission but does decrease morbidity.

Breast-feeding as a route of HIV-1 transmission during infancy but also as a protective measure against early childhood morbidity has been investigated prospectively in children born to HIV-1-seropositive mothers and control children born to age- and parity-matched HIV-1-seronegative women. The mothers of all study children had been enrolled antenatally at a maternity hospital in Kinshasa, Zaire, which served a relatively affluent group of women who sometimes chose not to breast-feed their infants. In 106 children born to HIV-1-seropositive women, the rate of HIV-1 transmission was 21% in 28 infants exclusively breast-fed, 19% in 68 infants both breast- and bottle-fed and 0% in 10 infants who were bottle-fed only (P = 0.