Perception of PrEP-related stigma in PrEP users: Results from the ANRS-PREVENIR cohort.

INTRODUCTION: Since the advent of HIV pre-exposure prophylaxis (PrEP), stigma has been shown to be a major barrier to its uptake and adherence. It is therefore essential to define the proportion of users who consider that PrEP can negatively impact their image and the factors associated with this perception. METHOD: We performed a multivariable logistic regression on data from the 2567 participants in the ANRS-PREVENIR study who answered the outcome question. RESULTS: Almost one-third of the sample (comprising mostly cisgender men who have sex with men [94.3%]) considered that taking PrEP could give others a negative image of them. Younger participants (adjusted odds ratio [aOR] 0.98; 95% confidence interval [CI] 0.97-0.99) and more psychologically vulnerable participants (i.e., lower self-esteem score [aOR 0.98; 95% CI 0.96-0.99] and higher depression score [aOR 1.02; 95% CI 1.00-1.03]) were also more likely to have this perception. In contrast, participants encouraged to take PrEP by their main partner (aOR 0.67; 95% CI 0.51-0.88) and friends (aOR 0.79; 95% CI 0.66-0.95), and those who protected themselves more because they had knowledge of their most recent sexual partner's HIV status (aOR 0.83; 95% CI 0.69-0.99) and systematic use of PrEP and/or condoms during intercourse in the previous 3 months (aOR 0.80; 95% CI 0.67-0.96) were less likely to have this perception. DISCUSSION: Given the strong interrelation between stigmatization (real or perceived), risky behaviours and adherence, our results emphasize the need for HIV prevention campaigns to promote a positive image of PrEP users. They also show that stigmatization and its effects need to be fully considered to improve HIV prevention offers to current and potential PrEP users who are most likely to be psychologically vulnerable.

Cost-effectiveness of adjuvant docetaxel for node-positive breast cancer patients: results of the PACS 01 economic study.

BACKGROUND: Using data from the PACS 01 randomized trial, we evaluated the cost-effectiveness of anthracyclines plus docetaxel (Taxotere; FEC-D) versus anthracyclines alone (FEC100) in patients with node-positive breast cancer. PATIENTS AND METHODS: Costs and outcomes were assessed in 1996 patients and the incremental cost-effectiveness ratios (ICERs) were estimated, using quality-adjusted life years (QALYs) as outcome. To deal with uncertainty due to sampling fluctuations, confidence regions around the ICERs were calculated and cost-effectiveness acceptability curves were drawn up. Sensitivity analyses were also carried out to assess the robustness of conclusions. RESULTS: The mean cost of treatment was 33% higher with strategy FEC-D, but this difference decreased to 18% at a 5-year horizon. The ICER of FEC-D versus FEC100 was estimated to be 9665euro per QALY gained (95% confidence interval euro2372-euro55 515). The estimated probability that FEC-D was cost-effective reached >96% for a threshold of euro50 000 per QALY gained. If the price of taxane decreased slightly, the ICER would reach some very reasonable levels and this strategy would therefore be much more cost-effective. CONCLUSION: The sequential use of FEC100 followed by docetaxel appears to be a cost-effective alternative, even when uncertainty is taken into account.

Modulations of dose intensity of doxorubicin and cyclophosphamide in association with G-CSF and peripheral blood stem cells in adjuvant chemotherapy for breast cancer: comparative evaluation of completion and safety of three intensive regimens.

The aim of this study was to evaluate and to compare in terms of toxicity the modulations of dose intensity of cyclophosphamide and doxorubicin in adjuvant chemotherapy for high-risk breast cancer. Four cycles of sequential high-dose chemotherapy with doxorubicin and cyclophosphamide (AC), supported with G-CSF and peripheral blood stem cells (PBSC) were administered to 81 women. Three successive cohorts were studied: doxorubicin (75 mg/m(2)) + cyclophosphamide (3000 mg/m(2)) every 21 days (group 1), doxorubicin (75 mg/m(2)) + cyclophosphamide (3000 mg/m(2)) every 15 days (group 2), and doxorubicin (75 mg/m(2)) + cyclophosphamide (6000 mg/m(2)) every 21 days (group 3). Seventy-five patients received four cycles of treatment with a total of 310 cycles administered. The received dose intensity of doxorubicin was higher in group 2 and that of cyclophosphamide was lower in group 1 than in the other two groups. Hematological and extra-hematological toxicities, as well as the number and duration of hospitalizations for toxicity, were significantly higher in group 3. We conclude that the group 3 regimen is associated with toxicities comparable to autologous transplantation. Increasing dose intensity of doxorubicin and cyclophosphamide is feasible in an outpatient setting and safe in groups 1 and 2 with the support of hematopoietic factor and PBSC.

Benefits of granulocyte-colony-stimulating factor after stem cell transfusion in intensive sequential chemotherapy for breast cancer.

The aim of this study was to evaluate the clinical and economic benefit of filgrastim given with intensive sequential chemotherapy. Women with poor-prognosis breast cancer received four cycles of high-dose cyclophosphamide (3 g/m2) and doxorubicin (75 mg/m2), followed by filgrastim 5 microg/kg/dy, stem cell collection after the cycle 1, and stem cell infusion after cycle 3 and cycle 4. The first cohort received filgrastim after the fourth cycle but the second cohort did not.Thirty three patients were included in the first cohort and 13 in the second. The results indicate that the duration of grade IV neutropenia was shorter in the group given filgrastim as was the median time to recover an absolute neutrophil count (ANC) > 1.0 x 10(9)/L. The rate and duration of the rehospitalizations were higher in the group not receiving filgrastim. We found that costs such as drugs and hospitalizations were significantly higher (p = 0.032 and p = 0.049) in the non-filgrastim-treated group. Using ANC > 1.0 x 10(9)/L as an intermediary efficiency criterion it was more cost effective to give filgrastim. It can be concluded from this study that filgrastim can decrease the duration of grade IV neutropenia in patients receiving intensive sequential chemotherapy. This, in turn, reduces the cost of hospitalization. However, in our study, this reduction of neutropenia did not have any impact on further therapy.

[Choice and disclosure of preferences, towards sharing the therapeutic decision in cancerology: from economic theory to medical practice]. / Choix et révélation des préférences, vers le partage de la décision thérapeutique en cancérologie: de la théorie économique à la pratique médicale.

Today, as it is often difficult to demonstrate the superiority of a new molecule or a therapeutic strategy in term of plain efficacy on disease, the incitement is strong to provide some complementary argument of assessment, we are assisting to the emergence of a new concept: shared therapeutic decision making. Is the application of this concept--with make the paternalistic model questionnable--adapted to all cases? What are the different levels of participation that could be envisaged? Are there favourable methods for this participations? This shared decision making--direct (patients' choice between treatment options) or indirect (integration of elicited preferences in the decision process)--if it has to be efficient, must surround with care: to define its application limitation, to protect itself of manipulation. It shall require to consider information transmission difficulties, to establish some elicitation preference method. Some technical, such as time trade off, standard gamble or willingness to pay, supported by economic theory of expected utility, permit to help eliciting patients' preferences and to structure the therapeutic choice. Some empirical study of preference elicitation shall permit to get clear the complexity of trade off between the different choice element that could enter in the acceptability of the treatment for patients.

[Women's preferences for early discharge after conservative breast surgery: feasibility, patient profile and satisfaction]. / Préférences des femmes pour une réduction de l'hospitalisation après chirurgie conservatrice pour tumeur mammaire: faisabilité, profil et satisfaction des patientes.

PURPOSE: Ours aims were to assess the feasibility of short stay after conservative breast surgery when giving the choice to women, to identify women characteristics associated to short (less than 48 hours) or conventional stay and to confront satisfaction and anxiety of the two groups. METHODS: Women were able to choice the length of stay immediately after surgery. Afterwards they completed a questionnaire measuring pain, anxiety and satisfaction. Clinical data concerning surgery were also collected. RESULTS: The hospital stay was short for 114 women (75.5%) and conventional for 37 women (24.5%). Length of stay was related to education level (P = 0,021), general health status (ASA score) (P = 0,003), breast pain (P = 0,001), the number of wound drains (P = 0,005), cancer (P = 0,001) and satisfaction about hospitalisation (P = 0,022). Post-surgical morbidity was similar between groups, except prolonged axillary drainage more frequent in conventional stay group. CONCLUSION: Women often chose a short stay after breast conservative surgery. This procedure is feasible routinely without heavy complication. Women preference for a short stay is real and could be improved by a better organisation, which ensure the continuity of care between hospital and home, with satisfaction assessment.

[Breast reconstruction after mastectomy for breast cancer: which reconstructive surgical procedure should be retained?]. / Reconstructions mammaires après mastectomie pour cancer du sein: quelles indications retenir?

Post-mastectomy breast reconstruction represents a surgical option that may improve psychosocial outcome without modifying patients' survival. Psychosocial impact of used surgical technique and moment of realization of breast reconstruction remains unclear. However, complications are negatively related to patients' satisfaction. There is no guideline for BR indications. Therefore, a review of clinical and cosmetic outcomes of different breast reconstruction modalities was necessary. It permitted to propose a shared decision-making algorithm for the choice of moment and technique of BR according to the presence of radiotherapy that appears to be the main risk factor of clinical outcome of breast reconstruction. It also disclosed some limits in information reliability about clinical outcome of particular associations of breast reconstruction and radiotherapy. Proportion of women pursuing breast reconstruction, and particularly immediate breast reconstruction, is rising. Clinical surveys assessing relation between radiotherapy and clinical and psychosocial outcome of breast reconstruction are urgently expected.

Quality of life of breast cancer patients receiving high-dose-intensity chemotherapy: impact of length of cycles.

This study was designed to measure treatment side-effects and quality of life (QL) of 47 nonmetastatic breast cancer patients subjected to a dose-intensity increase while receiving a sequential high dose chemotherapy (doxorubicin+cyclophosphamide - 4 cycles). The dose-intensity increase was obtained by shortening the length of cycles from 21 to 14 days. Treatment side-effects were self-assessed in terms of frequency and associated distress in cycles 1 and 3 by using a specific side-effect self-report questionnaire (19 items). Multidimensional QL measurement was performed at inclusion and before the start of cycles 2 and 4, by using the EORTC QLQ-C30. Pain was evaluated by patients on a visual analogue scale at the same times as QL evaluation. Patients' self-ratings indicated that the total number of symptoms, the number of symptoms rated by patients as quite or very distressing, and symptom frequency were comparable whatever the length of cycle. Overall, although underestimating most patients' symptoms, physicians' reports provided similar results. However, analysis of multidimensional QL showed that, in comparison to standard administration of 4 cycles of 21 days, there was a more significant deterioration of the QLQ-C30 global QL score ( P=0.01) at the second cycle of chemotherapy and of the physical functioning score ( P=0.02) at the fourth cycle when the cycle length was reduced. This study, although limited by a small patient cohort, has shown that shortening cycles to increase dose intensity had relatively few consequences on adverse treatment effects but a highly negative impact on patients' quality of life.

Patient participation in medical decision-making: a French study in adjuvant radio-chemotherapy for early breast cancer.

BACKGROUND: Shared decision-making is increasingly advocated as an ideal model. However, very few studies have tested the feasibility of giving patients the opportunity to participate in the choice of treatment. PATIENTS AND METHODS: Women, with non-metastatic breast cancer, eligible for non-intensified adjuvant chemotherapy attending our hospital were proposed two administrations of chemotherapy and radiotherapy: a sequential and a concomitant one. Two patient-questionnaires were used to elicit motivations for their choice and their degree of comfort with the process of decision-making and one questionnaire to test physicians' ability to predict patients' choice. RESULTS: Participation rate in the study was 75.3% (n = 64). Majority (64%) of patients chose the concomitant treatment. Multivariate analysis revealed that patients with a lower level of education, who discussed the choice with social circle, and who most feared side-effects were more likely to choose the sequential treatment. Physicians were able to predict patients' choice in 66% of cases. 89% of patients declared that they were fully satisfied with having participated in the choice of treatment and 79% supported shared decision-making. CONCLUSIONS: Results are in favour of promoting active participation of cancer-patients in medical decision-making. The adequate degree of such participation remains however to be elicited and tested for therapeutic choices implying more difficult trade-offs between quantity and quality of life.

Determinants of patients' choice of reconstruction with mastectomy for primary breast cancer.

BACKGROUND: The aim of the study was to measure women's decisions about breast reconstruction (BR) after mastectomy and to assess the factors contributing to their decisions, in a context involving shared decision-making and maximum patient autonomy. METHODS: Women who were about to undergo mastectomy for primary breast cancer were systematically offered choices concerning BR and time of reconstruction (intervention always covered by the French National Insurance System). Self-administered questionnaires were used prior to the operation. RESULTS: Among the 181 respondents, 81% opted for BR and 19% for mastectomy alone. In comparison with those who chose mastectomy alone, those opting for BR more frequently recognized the importance of discussing these matters with the surgeon and their partner (adjusted odds ratio [OR(adj)] = 13.45 and 3.59, respectively; P <.05) and realized that their body image was important (OR(adj) = 10.55, P <.01); fears about surgery prevented some of the women from opting for BR (OR(adj) = 0.688, P <.05). Among the women opting for BR, 83% chose immediate breast reconstruction (IBR) and 17% chose delayed breast reconstruction (DBR). The preference for IBR was mainly attributable to the fact that these women had benefited more frequently from doctor-patient discussions (OR(adj) = 3.49, P <.05) but was also attributable to the patients' physical and functional characteristics: they were in a poorer state of health (P <.05). The surgeons predicted their patients' preferences fairly accurately. CONCLUSIONS: In a context of maximum autonomy, the great majority of the women chose IBR. The patients' choices were explained mainly by their psychosocial characteristics. The indication for BR should be properly discussed between patients and surgeons before mastectomy.