Dominique Rey

Adjuvant endocrine therapy with tamoxifen in young women with breast cancer: determinants of interruptions vary over time

BACKGROUND In premenopausal women with hormone receptor-positive breast cancer (BC), 5 years of tamoxifen is recommended. Little is known about reasons for interruption in this population. The aim was to estimate the incidence of tamoxifen interruption and its correlates among younger women. PATIENTS AND METHODS Using a prospective cohort Elippse 40 of women with BC aged ≤ 40 diagnosed between 2005 and 2008, we studied 196 women. Tamoxifen interruption was defined as two or more consecutive months without dispensed prescription of tamoxifen, based on pharmacy refill database. Two periods were studied: between tamoxifen initiation and 16 months after BC diagnosis, and between 16 and 28 months. RESULTS Among women treated with tamoxifen, 42% interrupted within the first 2 years of treatment. During the first period, treatment interruptions were associated with a lack of understandable information about endocrine treatment and insufficient social support. During the second period, another set of factors were associated with interruption: treatment side-effects, no longer fearing cancer relapse, lack of social support, no opportunity to ask questions at the time of diagnosis, and fewer treatment modalities. CONCLUSIONS Improving information and patient-provider relationship might prevent interruption. Particular attention should be paid to women with little social support.

Gender differences in risk behaviors among HIV+ persons with an IDU history. The link between partner characteristics and women's higher drug-sex risks. The Manif 2000 Study Group.

BACKGROUND AND OBJECTIVES Risk-taking behaviors differ among women and men injection drug users (IDU). GOAL To specify the nature of sexual and drug risk-taking among women IDU and ex-IDU and how it relates to partner characteristics. DESIGN A cross-sectional analysis of 324 HIV+ subjects enrolled into a prospective cohort study in Marseille, France. RESULTS Women, as compared with men, were considerably more likely to report nonuse of condoms with a main partner (31% versus 12%). They were more likely to shoot with a partner at last injection (39% versus 12%), but far less likely to sterilize used needles (4% versus 16%). Two thirds of both men and women reported consistent condom use with a seronegative partner, but only 47% of men and 23% of women reported the same with a seropositive partner. Among the women only, needle and syringe sharing was associated with consistent use of a condom. CONCLUSIONS Women reported behaviors which protect their partners from STD infection more frequently than behaviors which protect themselves. Greater attention must be paid to sexual risk-taking among HIV+ women.

Early discontinuation of tamoxifen intake in younger women with breast cancer: Is it time to rethink the way it is prescribed?

BACKGROUND Tamoxifen is the main recommended adjuvant hormonal treatment for premenopausal women with hormone-responsive early breast cancer. Little data is available on compliance and persistence to tamoxifen intake in younger women. METHODS Using the French National Health Insurance System database, we constituted a cohort of 288 women who were diagnosed with breast cancer and received at least one supply of tamoxifen for breast cancer between September 2005 and July 2011. Medical records and mailed questionnaires provided complementary sources of data. Time to treatment discontinuation and associated predictors were studied using techniques for censored data. RESULTS Among women who received a prescription of tamoxifen, 6.1% (16) did not fill any prescription. After 2 years of tamoxifen intake, 29.7% (95%confidence interval (CI) 24.1-36.4) had discontinued their treatment; after 3 years this percentage increased to 39.5% (95% CI 32.9-47.0). The risk of treatment discontinuation rose sharply during the 1st year of treatment and remained approximately constant in the second year. After multivariate adjustment, tamoxifen discontinuation increased significantly with low social support (Hazard Ratio (HR) = 2.1; 95%CI 1.2-3.4), and self-reporting of non-compliance behaviour (HR = 2.2; 95% CI 1.3-3.7). CONCLUSION The consequences of high treatment discontinuation rates in younger women with long potential life expectancy may be significant. There is an urgent need to acknowledge and tackle compliance issues in the field of oncology, unless we are willing to accept inefficient prescriptions of efficacious drugs.

Proposed recommendations for the management of HIV post-exposure prophylaxis after sexual, injecting drug or other exposures in Europe.

Post-exposure prophylaxis (PEP) is the standard of care for a healthcare worker (HCW) accidentally exposed to an HIV infected source person (occupational exposure), but this is not the case for non-occupational exposures. Very few national guidelines exist for the management of non-occupational exposures to HIV in Europe, contrarily to the occupational ones. The administration of non-occupational post-exposure prophylaxis (NONOPEP) for HIV may be justified by: a biological plausibility, the effectiveness of PEP in animal studies and occupational exposures in humans, efficacy in the prevention of mother to child HIV transmission, and cost effectiveness studies. These evidences, the similar risk of HIV transmission for certain non-occupational exposures to occupational ones, and the conflicting information about attitudes and practices among physicians on NONOPEP led to the proposal of these European recommendations. Participant members of the European project on HIV NONOPEP, funded by the European Commission, and acknowledged as experts in bloodborne pathogen transmission and prevention, met from December 2000 to December 2002 at three formal meetings and a two day workshop for a literature review on risk exposure assessment and the development of the European recommendations for the management of HIV NONOPEP. NONOPEP is recommended in unprotected receptive anal sex and needle or syringe exchange when the source person is known as HIV positive or from a population group with high HIV prevalence. Any combination of drugs available for HIV infected patients can be used as PEP and the simplest and least toxic regimens are to be preferred. PEP should be given within 72 hours from the time of exposure, starting as early as possible and lasting four weeks. All patients should receive medical evaluation including HIV antibody tests, drug toxicity monitoring and counseling periodically for at least 6 months after the exposure. NONOPEP seems to be a both feasible and frequent clinical practice in Europe. Recommendations for its management have been achieved by consensus, but some remain controversial, and they should be updated periodically. NONOPEP should never be considered as a primary prevention strategy and the final decision for prescription must be made on the basis of the patient-physician relationship. Finally, a surveillance system for these cases will be useful to monitor NONOPEP practices in Europe.

Physicians’ and patients’ adherence to antiretroviral prophylaxis after sexual exposure to HIV: results from South-Eastern France

Abstract French national guidelines for the management of HIV non-occupational post-exposure (nPEP) were issued in 1998 and updated in 2003. NPEP is available and free of charge in all emergency or AIDS care units of French hospitals. A regional survey was carried out to study physicians’ adherence to national guidelines, and determinants of adherence to nPEP follow-up in individuals sexually exposed to HIV. The survey was based on retrospective data collection of all consultations for nPEP made in the three AIDS information centers in South-Eastern France (January 2001–December 2002). Information included personal data, type of exposure, and treatment at the first visit after exposure and during follow-up. Exposures were classified into high risk (treatment highly recommended), moderate risk (treatment possibly recommended) and negligible risk (treatment never recommended) categories, according to the level of HIV risk of sexual transmission as indicated by the French national nPEP guidelines. Among the 910 sexual exposures, 56%, 37%, and 4% were classified as cases with high, moderate, and no risk respectively. NPEP was prescribed to 85% of cases. HIV risk of sexual exposure was significantly associated with nPEP receipt though more than half of the cases with negligible risk received nPEP. Independent characteristics associated with non-adherence to nPEP follow-up were younger age, being referred to hospital by a physician, sexual exposure with a casual partner or sexual assault, and “moderate risk” exposure. Better information should be provided to physicians prescribing nPEP to limit over-prescription while new strategies should be implemented to improve follow-up of individuals receiving nPEP, especially those who are younger or survivors of sexual assault.

The labour market, psychosocial outcomes and health conditions in cancer survivors: protocol for a nationwide longitudinal survey 2 and 5 years after cancer diagnosis (the VICAN survey)

Introduction Today, a growing need exists for greater research into cancer survivorship, focusing on different spheres of the day-to-day life of diagnosed patients. This article describes the design and implementation of VICAN (VIe après le CANcer), a national survey on French cancer survivors. Method and analysis The target population included patients aged 18–82, diagnosed with cancer between January and June 2010, and registered in one of the three main French Health Insurance Schemes. It was restricted to 12 tumour sites. Sampling was stratified using a non-proportional allocation, based on age at diagnosis (18–52 and 53–82) and tumour site. Data were collected from telephone interviews with patients 2 and 5 years after diagnosis, a medical survey completed by the physician who initiated cancer treatment, and information from the national medicoadministrative database on reimbursement data and hospital discharge records. First data collection, 2 years after diagnosis, occurred between March and December 2012. Second data collection, 5 years after diagnosis, will be conducted in 2015. Analyses will be conducted on various outcomes: quality of life, health status and psychosocial conditions, with a particular focus on the impact of cancer diagnosis on the labour market. The variety of measurements included in the survey will enable us to control a wide range of factors. Ethics and dissemination The methodology of the VICAN survey was approved by three national ethics commissions. Results of the study will be disseminated through national and international research conferences, and in articles published in international peer-reviewed journals.

Impact of HAART-related side effects on unsafe sexual behaviours in HIV-infected injecting drug users: 7-year follow up.

Objective: To investigate the impact of non-lipodystrophy HAART-related side effects on unprotected sexual behaviours among HIV-infected drug users. Designand participants: HAART-treated patients who reported having occasional partners during the follow-up period after HAART initiation were selected among patients of the MANIF 2000 cohort of HIV-infected drug users. Methods: Visits where patients reported unsafe sexual behaviours with occasional partners were compared to visits where they reported safe sexual behaviours using a logistic model based on Generalized Estimating Equations. Results: One-hundred and ninety-two HAART-treated patients reported occasional sexual partners at least once during follow-up, accounting for a total of 464 visits. Among these 192 patients, 134 (70%) declared at least once unsafe sexual behaviours with occasional partners. During follow-up, three or more HAART-related side effects were reported in 273 of the 464 visits. When comparing visits where patients reported unsafe sexual behaviours with occasional partners (n = 249) with those where they reported safe sexual behaviours (n = 215), experiencing three or more HAART-related side effects was significantly associated with unsafe sex after adjustment for cofactors such as injecting drug status, reporting more than two sexual partners and having sex more than once a week. Conclusions: Perceived side effects play a role in determining unsafe sexual behaviours. HIV prevention interventions must consider the negative impact of HAART-related side effects on sexual risk-taking behaviours. Drug maintenance programs contribute to sexual risk reduction among drug injecting patients.

Complementary or Alternative Medicine as Possible Determinant of Decreased Persistence to Aromatase Inhibitor Therapy among Older Women with Non-Metastatic Breast Cancer

Purpose Aromatase inhibitor therapy (AI) significantly improves survival in breast cancer patients. Little is known about adherence and persistence to aromatase inhibitors and about the causes of treatment discontinuation among older women. Methods We constituted a cohort of women over 65 receiving a first AI therapy for breast cancer between 2006 and 2008, and followed them until June 2011. Women were selected in the population-based French National Health Insurance databases, and data was collected on the basis of pharmacy refills, medical records and face-to-face interviews. Non-persistence to treatment was defined as the first treatment discontinuation lasting more than 3 consecutive months. Time to treatment discontinuation was studied using survival analysis techniques. Results Overall among the 382 selected women, non-persistence to treatment went from 8.7% (95%CI: 6.2–12.1) at 1 year, to 15.6% (95%CI: 12.2–19.8) at 2 years, 20.8% (95%CI: 16.7–25.6) at 3 years, and 24.7% (95%CI: 19.5–31.0) at 4 years. In the multivariate analysis on a sub-sample of 233 women with available data, women using complementary or alternative medicine (CAM) (HR = 3.2; 95%CI: 1.5–6.9) or suffering from comorbidities (HR = 2.2; 95%CI: 1.0–4.8) were more likely to discontinue their treatment, whereas women with polypharmacy (HR = 0.4; 95%CI: 0.2–0.91) were less likely to discontinue. In addition, 13% of the women with positive hormonal receptor status did not fill any prescription for anti-hormonal therapy. Conclusion AI therapy is discontinued prematurely in a substantial portion of older patients. Some patients may use CAM not as a complementary treatment, but as an alternative to conventional medicine. Improving patient-physician communication on the use of CAM may improve hormonal therapy adherence.

HIV screening for pregnant women in South Eastern France : evolution 1992-1994-1996

OBJECTIVES To assess the evolution of the HIV screening practices towards pregnant women between 1992 and 1996, in relation with the 1993 French mandatory obligation to offer prenatal HIV testing and recent therapeutic possibilities to reduce HIV vertical transmission. STUDY DESIGN Three successive surveys (January 1992, May 1994 and May 1996) about HIV screening policies among medical chiefs of all prenatal care and abortion departments of South Eastern France. Sixty-seven of the 74 departments concerned agreed to participate in the three surveys. RESULTS The proportion of departments practising routine prenatal HIV screening had not increased since 1992 (89%) but systematic womens consent is more often requested (65.5 vs. 38.2%, P < 0.01). In the context of abortion, HIV testing is more often routinely offered (38.1 vs. 16.4%, P < 0.05) but selective screening remains a frequent practice (29.1%). CONCLUSION Mandatory proposal of HIV testing to women who terminate could improve access to test but is not sufficient to guarantee adequate preventive counselling.

Awareness of non-occupational Hiv postexposure prophylaxis among French people living with Hiv: the need for better targeting

Background:Since 1998, French HIV prevention guidelines have recommended the use of HIV post-exposure prophylaxis (PEP) after unprotected sex with a HIV-positive partner who should be informed about this option. This study analysed factors associated with PEP awareness in a population of individuals living with HIV/AIDS (PLHAs). Methods:In 2003, a face-to-face survey was conducted among PLHAs selected from a random stratified sample of 102 French hospital departments delivering HIV care. Those who knew about PEP and those who did not were compared to identify factors related to PEP awareness in the sub-sample who reported that they had been sexually active in the prior 12 months. Results:Among the 2,280 sexually active PLHAs, the median age was 40 years. Women comprised 26% of the sample, 41% were homosexual men and 16% were immigrants. Thirty percent of individuals reported not being aware of the availability of PEP. After multiple adjustment, factors associated with lack of PEP awareness were a low educational level, unemployment, older age, and CD4 cell counts <200. In addition, homosexual men showed a higher level of PEP awareness compared with the other participants, especially when compared with immigrant heterosexual men and women. Individuals who reported having unprotected sex with a non-HIV-positive steady partner also independently showed lower levels of PEP awareness. Finally, reporting having casual partners was associated with better awareness. Conclusion:Awareness of PEP is insufficient among PLHAs, especially among immigrants. Programmes aimed at improving positive prevention among PLHAs are much needed and should be promoted.