Return to work and psychosocial trajectories after breast cancer: a longitudinal and sequential approach.

PURPOSE: We aimed to describe the psychosocial adjustments according to return to work (RTW) trajectories in breast cancer survivors (BCS) using a sequential and temporal approach. METHODS: We used BCS data included from February 2015 to April 2016 in the Longitudinal Study on Behavioural, Economic and Sociological Changes after Cancer (ELCCA) cohort. RTW trajectories were identified using the sequence analysis method followed by a clustering. Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale and the EORTC quality of life questionnaire was used at inclusion and all follow-up visits to assess Health-Related Quality of Life (HRQoL). RESULTS: Fifty-two BCS were included in the study among whom four clusters of RTW trajectories were identified and labeled: slow RTW (N = 10), quick RTW (N = 27), partial RTW (N = 8), and part-time work (N = 7). Quick and slow RTW clusters showed slightly lower baseline mean levels of anxiety and higher levels of HRQoL. In the 4 years following diagnosis, BCS in the quick RTW cluster tended to report higher HRQoL in terms of functioning and less symptoms of pain and fatigue while those in the partial RTW cluster showed a lower HRQoL on almost all dimensions. All clusters showed an increase in pain and fatigue symptoms until 6 months followed by a tendency to recover baseline levels. CONCLUSIONS: The results of this study suggest that BCS who return to full-time work (slow and quick RTW patterns) recover better than patients who return to part-time work (partial and part-time RTW patterns).

Unsupervised item response theory models for assessing sample heterogeneity in patient-reported outcomes measures.

PURPOSE: Unsupervised item-response theory (IRT) models such as polytomous IRT based on recursive partitioning (IRTrees) and mixture IRT (MixIRT) models can be used to assess differential item functioning (DIF) in patient-reported outcome measures (PROMs) when the covariates associated with DIF are unknown a priori. This study examines the consistency of results for IRTrees and MixIRT models. METHODS: Data were from 4478 individuals in the Alberta Provincial Project on Outcome Assessment in Coronary Heart Disease registry who received cardiac angiography in Alberta, Canada, and completed the Hospital Anxiety and Depression Scale (HADS) depression subscale items. The partial credit model (PCM) based on recursive partitioning (PCTree) and mixture PCM (MixPCM) were used to identify covariates associated with differential response patterns to HADS depression subscale items. Model covariates included demographic and clinical characteristics. RESULTS: The median (interquartile range) age was 64.5(15.7) years, and 3522(78.5%) patients were male. The PCTree identified 4 terminal nodes (subgroups) defined by smoking status, age, and body mass index. A 3-class PCM fits the data well. The MixPCM latent classes were defined by age, disease indication, smoking status, comorbid diabetes, congestive heart failure, and chronic obstructive pulmonary disease. CONCLUSION: PCTree and MixPCM were not consistent in detecting covariates associated with differential interpretations of PROM items. Future research will use computer simulations to assess these models' Type I error and statistical power for identifying covariates associated with DIF.

Posttraumatic growth inventory: challenges with its validation among French cancer patients.

BACKGROUND: The Posttraumatic growth inventory (PTGI) aims to assess the positive psychological changes that individuals can perceive after a traumatic life event such as a cancer diagnosis. Several French translations of the PTGI have been proposed, but comprehensive data on their psychometric properties are lacking. This study aimed to provide a more complete assessment of the psychometric properties of one of the most used PTGI translations in early-stage breast cancer and melanoma patients. METHODS: A sample of 379 patients completed the PTGI two years after their cancer diagnosis. A confirmatory analysis was first performed to determine whether the initial five-factor structure of the PTGI was adequate for this French version. As issues were identified in the translation and in the questionnaire structure, we performed an exploratory analysis to determine the most suitable structure for this questionnaire. Validity and reliability of the evidenced structured were then assessed. RESULTS: The exploratory analysis evidenced a four-factor structure close to the initial structure: four of the five initial domains were recovered, and items from the unrecovered domain were split into the other domains. This new structure showed good internal consistency and acceptable validity. CONCLUSIONS: This study highlights that the process of translation and cross-cultural validation of questionnaires is crucial to obtain valid and reliable psychometric instruments. We advise French psycho-oncology researchers and psychotherapists to (i) use the revised translation of Lelorain et al. (2010) proposed in this manuscript and (ii) use the four scores newly evidenced with a grouping of two response categories.

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force.

AIMS: Proxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations. METHODS: We systematically searched Medline, PsycINFO, PsycTESTS, CINAHL and EMBASE from database inception to February 2018. Search terms included a combination of terms for quality of life and health outcomes, proxy-reporters, and health condition terms. The data extracted included clinical context, the name of the proxy measure(s) used and other descriptive data. We determined whether the measures were developed specifically for proxy use or were existing measures adapted for proxy use. RESULTS: The database search identified 17,677 possible articles, from which 14,098 abstracts were reviewed. Of these, 11,763 were excluded and 2335 articles were reviewed in full, with 880 included for data extraction. The most common clinical settings were dementia (30%), geriatrics (15%) and cancer (13%). A majority of articles (51%) were paired studies with proxy and patient responses for the same person on the same measure. Most paired studies (77%) were concordance studies comparing patient and proxy responses on these measures. DISCUSSION: Most published research using proxies has focused on proxy-patient concordance. Relatively few measures used in research with proxies were specifically developed for proxy use. Future work is needed to examine the performance of measures specifically developed for proxies. SYSTEMATIC REVIEW REGISTRATION: PROSPERO No. CRD42018103179.

Longitudinal associations between coping strategies, locus of control and health-related quality of life in patients with breast cancer or melanoma.

PURPOSE: A diagnosis of breast cancer or melanoma is a traumatic life event that patients have to face. However, their locus-of-control (LOC) beliefs and coping strategies as well as the associations with health-related quality of life (HRQoL) changes over time are still not well known and rarely compared by cancer site. METHODS: The objective of this longitudinal study was to assess the association of LOC (Cancer Locus-of-Control Scale) and coping (Brief Cope) changes, with change in HRQoL (EORTC QLQ-C30) over time in newly diagnosed breast cancer and melanoma patients at 1, 6, 12, and 24 month post-diagnosis. Mixed models were used to compare LOC and coping longitudinal changes as well as their associations with HRQoL changes in early-stage breast cancer and melanoma patients. RESULTS: Overall, 215 breast cancer and 78 melanoma patients participated in the study. At baseline, HRQoL levels were often higher for breast cancer compared to melanoma patients. For breast cancer and melanoma patients, negative coping strategies and perceived control over the course of illness were negatively and positively associated with HRQoL changes, respectively. For breast cancer patients only, emotional coping and internal causal attribution were negatively associated with HRQoL changes. For both cancer sites, living with a partner correlated with worse HRQoL. CONCLUSIONS: Understanding coping strategies and LOC beliefs used by patients soon after their cancer diagnosis and over the course of illness can help identifying psychological and supportive care to modify maladaptive thoughts and beliefs and promote more adaptive behaviors to ultimately improve patients' well-being and HRQoL.

How to Investigate the Effects of Groups on Changes in Longitudinal Patient-Reported Outcomes and Response Shift Using Rasch Models.

In order to investigate patients' experience of healthcare, repeated assessments of patient-reported outcomes (PRO) are increasingly performed in observational studies and clinical trials. Changes in PRO can however be difficult to interpret in longitudinal settings as patients' perception of the concept being measured may change over time, leading to response shift (longitudinal measurement non-invariance) and possibly to erroneous interpretation of the observed changes in PRO. Several statistical methods for response shift analysis have been proposed, but they usually assume that response shift occurs in the same way in all individuals within the sample regardless of their characteristics. Many studies aim at comparing the longitudinal change of PRO into two groups of patients (treatment arm, different pathologies, …). The group variable could have an effect on PRO change but also on response shift effect and the perception of the questionnaire at baseline. In this paper, we propose to enhance the ROSALI algorithm based on Rasch Measurement Theory for the analysis of longitudinal PRO data to simultaneously investigate the effects of group on item functioning at the first measurement occasion, on response shift and on changes in PRO over time. ROSALI is subsequently applied to a longitudinal dataset on change in emotional functioning in patients with breast cancer or melanoma during the year following diagnosis. The use of ROSALI provides new insights in the analysis of longitudinal PRO data.

A comparison of posttraumatic growth changes in breast cancer and melanoma.

OBJECTIVE: This article presents a comparison of the changes of Posttraumatic Growth (PTG) in breast cancer and melanoma patients over a 2-year follow-up period and investigates the associations between coping strategies, anxiety, depression, emotional functioning, and PTG over time. METHOD: Seventy-eight early stage melanoma patients from Nantes University Hospital and 215 breast cancer patients from Nantes Cancerology Institute completed self-administered questionnaires collecting sociodemographic and medical information and assessing health-related quality of life, coping strategies, anxiety and depression within 1 month of diagnosis and 6, 12, and 24 months after the diagnosis. PTG was assessed at 6, 12, and 24 months postdiagnosis. RESULTS: We found that PTG increased over time for both cancers, but that breast cancer and melanoma patients did not experience the same magnitude of changes in PTG depending on time and on depression. While we did not find any relationship between anxiety, emotional functioning, negative coping and PTG; positive and emotional coping were positively associated with PTG changes for both cancers. Substance use was negatively related to PTG at 2 years postdiagnosis for melanoma and breast cancer. CONCLUSIONS: Our findings reveal that PTG increases over time for both cancers. In addition, it provides relevant information about the coping strategies that are associated with the experience of positive changes. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

A mini-review of quality of life as an outcome in prostate cancer trials: patient-centered approaches are needed to propose appropriate treatments on behalf of patients.

BACKGROUND: Patients with prostate cancer (PC) may be ready to make trade-offs between their quantity and their quality of life. For instance, elderly patients may prefer the absence of treatment if it is associated with a low-risk of disease progression, compared to treatments aiming at preventing disease progression but with a substantial deterioration of their Health-Related Quality of Life (HRQoL). Therefore, it seems relevant to compare the treatments by considering both survival and HRQoL. In this mini-review, the aim was to question whether the potential trade-offs between survival and HRQoL are considered in high impact factor journals. METHODS: The study was conducted from the PubMed database for recent papers published between May 01, 2013, and May 01, 2015. We also restricted our search to nine medical journals with 2013 impact factor > 15. RESULTS: Among the 30 selected studies, only six collected individual HRQoL as a secondary endpoint by using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. In four studies, the time to HRQoL change was analyzed, but its definitions varied. In two studies, the mean changes in HRQoL between the baseline and the 12- or 16-week follow-up were analyzed. None of the six studies reported in a single endpoint both the quantity and the quality of life. CONCLUSIONS: Our mini-review, which only focused on recent publications in journals with high-impact, suggests moving PC clinical research towards patient-centered outcomes-based studies. This may help physicians to propose the most appropriate treatment on behalf of patients. We recommend the use of indicators such as Quality-Adjusted Life-Years (QALYs) as principal endpoint in future clinical trials.

Identifying patterns of adaptation in breast cancer patients with cancer-related fatigue using response shift analyses at subgroup level.

Fatigue is the most prevalent symptom in breast cancer. It might be perceived differently among patients over time as a consequence of the differing patients' adaptation and psychological adjustment to their cancer experience which can be related to response shift (RS). RS analyses can provide important insights on patients' adaptation to cancer but it is usually assumed that RS occurs in the same way in all individuals which is unrealistic. This study aimed to identify patients' subgroups in which different RS effects on self-reported fatigue could occur over time using a combination of methods for manifest and latent variables. The FATSEIN study comprised 466 breast cancer patients followed over a 2-year period. Fatigue was measured with the Multidimensional Fatigue Inventory questionnaire (MFI-20) during 10 visits. A novel combination of Mixed Models, Growth Mixture Modeling, and Structural Equation Modeling was used to assess the occurrence of RS in fatigue changes to identify subgroups displaying different RS patterns over time. An increase in fatigue was evidenced over the 8-month follow-up, followed by a decrease between the 8- and 24-month. Four latent classes of patients were identified. Different RS patterns were detected in all latent classes between the inclusion and 8 months (last cycle of chemotherapy). No RS was evidenced between 8- and 24-month. Several RS effects were evidenced in different groups of patients. Women seemed to adapt differently to their treatment and breast cancer experience possibly indicating differing needs for medical/psychological support.

A multi-faceted strategy to reduce ventilation-associated mortality in brain-injured patients. The BI-VILI project: a nationwide quality improvement project.

PURPOSE: We assessed outcomes in brain-injured patients after implementation of a multi-faceted approach to reduce respiratory complications in intensive care units. METHODS: Prospective nationwide before-after trial. Consecutive adults with acute brain injury requiring mechanical ventilation for ≥24 h in 20 French intensive care units (ICUs) were included. The management of invasive ventilation in brain-injured patients admitted between 1 July 2013 and 31 October 2013 (4 months) was monitored and analysed. After the baseline period (1 November 2013-31 December 2013), ventilator settings and decision to extubate were selected as targets to hasten weaning from invasive ventilation. During the intervention period, low tidal volume (≤7 ml/kg), moderate positive end-expiratory pressure (PEEP, 6-8 cm H2O) and an early extubation protocol were recommended. The primary endpoint was the number of days free of invasive ventilation at day 90. Comparisons were performed between the two periods and between the compliant and non-compliant groups. RESULTS: A total of 744 patients from 20 ICUs were included (391 pre-intervention; 353 intervention). No difference in the number of invasive ventilation-free days at day 90 was observed between the two periods [71 (0-80) vs. 67 (0-80) days; P = 0.746]. Compliance with the complete set of recommendations increased from 8 (2%) to 52 (15%) patients after the intervention (P < 0.001). At day 90, the number of invasive ventilation-free days was higher in the 60 (8%) patients whose care complied with recommendations than in the 684 (92%) patients whose care deviated from recommendations [77 (66-82) and 71 (0-80) days, respectively; P = 0.03]. The mortality rate was 10% in the compliant group and 26% in the non-compliant group (P = 0.023). Both multivariate analysis [hazard ratio (HR) 1.78, 95% confidence interval (95% CI) 1.41-2.26; P < 0.001] and propensity score-adjusted analysis (HR 2.25, 95% CI 1.56-3.26, P < 0.001) revealed that compliance was an independent factor associated with the reduction in the duration of mechanical ventilation. CONCLUSIONS: Adherence to recommendations for low tidal volume, moderate PEEP and early extubation seemed to increase the number of ventilator-free days in brain-injured patients, but inconsistent adoption limited their impact. Trail registration number: NCT01885507.

Does the relationship between health-related quality of life and subjective well-being change over time? An exploratory study among breast cancer patients.

It has been suggested recently that measures of Subjective Well-Being (SWB) instead of preferences could be employed to determine relative weights for the dimensions of health-related quality of life (HRQol) with the aim of developing health utility indexes for economic evaluation purposes. In this context, this paper addresses the possibility of reprioritization response shift in SWB. It examines whether the association between dimensions of HRQol and SWB changes over time in chronically ill patients. 215 women newly diagnosed for breast cancer in a French hospital between 2010 and 2012 completed the Satisfaction with Life Scale (SWLS) and the EORTC QLQ-C30 HRQol questionnaires over a two-year period. We estimated hierarchical random coefficients models for the repeated SWLS measures while allowing for time-varying parameters for the scales of the QLQ-C30 to test for reprioritization. Our findings suggest that women adapt to breast cancer by giving greater weight over time to the social dimension of HRQol. This possibility of reprioritization response shift should be considered in researches trying to develop SWB-based health utility values to inform the allocation of resources in health care.

Sustained quality of life improvement after intracoronary injection of autologous bone marrow cells in the setting of acute myocardial infarction: results from the BONAMI trial.

PURPOSE: Cardiac cell therapy is a promising treatment for acute myocardial infarction (AMI), leading to cardiac function improvement. However, whether it translates into quality of life (QoL) improvement is unclear. We hypothesized that administration of bone marrow cells (BMC) to patients with AMI improves QoL. METHODS: In the multicenter BONAMI trial (NCT00200707), patients with reperfused AMI and decreased myocardial viability were randomized to intracoronary autologous BMC infusion (n = 52) or state-of-the-art therapy (n = 49). QoL data, derived from the Minnesota Living with Heart Failure questionnaire (MLHFQ), were obtained 1, 3, and 12 months after AMI and analyzed using a Rasch-family model. RESULTS: Using this model, QoL improved over time in the BMC group (p = 0.025) but not in the control group. Furthermore, the BMC-group patients displayed a better QoL than the control-group patients at 3 and 12 months post-AMI (p = 0.034 and p = 0.003, respectively). These findings were not detected when analyzing MLHFQ data using a standard method. Cardiac function, myocardial viability, mortality, and number of major adverse cardiac events did not differ between treatment groups. CONCLUSION: Our results suggest that BMC therapy can improve QoL, stressing the need for confirmation trials and for systematic QoL assessment in cardiac cell therapy trials .

Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years--The PreKit-QoL study protocol.

BACKGROUND: Treatment of end stage renal disease has an impact on patients' physical and psychological health, including quality of life (QoL). Nowadays, it is known that reducing the dialysis period has many advantages regarding QoL and medical outcomes. Although preemptive transplantation is the preferred strategy to prevent patients undergoing dialysis, its psychological impact is unknown. Moreover, transplantation can be experienced in a completely different manner among patients who were on dialysis and those who still had a functioning kidney at the time of surgery. Longitudinal data are often collected to allow analyzing the evolution of patients' QoL over time using questionnaires. Such data are often difficult to interpret due to the patients' changing standards, values, or conceptualization of what the questionnaire is intended to measure (e.g. QoL). This phenomenon is referred to as response shift and is often linked to the way the patients might adapt or cope with their disease experience. Whether response shift is experienced in a different way among patients who were on dialysis and those who still had a functioning kidney at time of surgery is unknown and will be studied in the PreKit-QoL study (trial registration number: NCT02154815). Understanding the psychological impact of pre-emptive transplantation is an important issue since it can be associated with long-term patient and graft survival. METHODS/DESIGN: Adult patients with a pre-emptive transplantation (n = 130) will be prospectively included along with a control group of patients with a pre-transplant dialysis period < 36 months (n = 260). Only first and single kidney transplantation will be considered. Endpoints include: comparison of change between groups in QoL, anxiety and depressive disorders, perceived stress, taking into account response shift. These criteria will be evaluated every 6 months prior to surgery, at hospital discharge, at three and six months, one and two years after transplantation. DISCUSSION: The PreKit-QoL study assesses and compares the evolution of QoL and other psychological criteria in preemptive and dialyzed patients taking patients' adaptation into account through response shift analyses. Our study might help to conceive specific, adapted educational programs and psychological support to prevent a possible premature loss of the kidney as a consequence of non-compliance in patients that may be insufficiently prepared for transplantation. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02154815 , registered on May 28, 2014.

Overall performance of Oort's procedure for response shift detection at item level: a pilot simulation study.

OBJECTIVE: This simulation study was designed to provide data on the performance of Oort's procedure (OP) for response shift (RS) detection (regarding type I error, power, and overall performance), according to sample characteristics, at item level. A specific objective was to assess the impact of using different information criteria (IC), as alternatives to the LRT (likelihood-ratio test), for global assessment of RS occurrence. METHODS: Responses to five binary items at two times of measurement were simulated. Thirty-six combinations of sample characteristics [sample size (n), "true change," correlations between the two latent variables and presence/absence of uniform recalibration RS (ur)] were considered. A thousand datasets were generated for each combination. RS detection was performed on each dataset following OP. Type I error and power of the global assessment of RS occurrence, as well as overall performance of the OP, were assessed. RESULTS: The estimated type I error was close to 5 % for the LRT and lower than 5 % for the IC. The estimated power was higher for the LRT as compared to the AIC, which was the highest among the other IC. For the LRT, the estimated power for n = 100 and for the combination of n = 200 and ur = 1 item was below 80 %. Otherwise, for other combinations of sample characteristics, the estimated power was above 90 %. CONCLUSION: For the LRT, higher values of power were estimated compared to IC with appropriate values of type I error. These results were consistent with Oort's proposal to use the LRT as the criterion to assess global RS occurrence.

Method variation in the impact of missing data on response shift detection.

PURPOSE: Missing data due to attrition or item non-response can result in biased estimates and loss of power in longitudinal quality-of-life (QOL) research. The impact of missing data on response shift (RS) detection is relatively unknown. This overview article synthesizes the findings of three methods tested in this special section regarding the impact of missing data patterns on RS detection in incomplete longitudinal data. METHODS: The RS detection methods investigated include: (1) Relative importance analysis to detect reprioritization RS in stroke caregivers; (2) Oort's structural equation modeling (SEM) to detect recalibration, reprioritization, and reconceptualization RS in cancer patients; and (3) Rasch-based item-response theory-based (IRT) models as compared to SEM models to detect recalibration and reprioritization RS in hospitalized chronic disease patients. Each method dealt with missing data differently, either with imputation (1), attrition-based multi-group analysis (2), or probabilistic analysis that is robust to missingness due to the specific objectivity property (3). RESULTS: Relative importance analyses were sensitive to the type and amount of missing data and imputation method, with multiple imputation showing the largest RS effects. The attrition-based multi-group SEM revealed differential effects of both the changes in health-related QOL and the occurrence of response shift by attrition stratum, and enabled a more complete interpretation of findings. The IRT RS algorithm found evidence of small recalibration and reprioritization effects in General Health, whereas SEM mostly evidenced small recalibration effects. These differences may be due to differences between the two methods in handling of missing data. CONCLUSIONS: Missing data imputation techniques result in different conclusions about the presence of reprioritization RS using the relative importance method, while the attrition-based SEM approach highlighted different recalibration and reprioritization RS effects by attrition group. The IRT analyses detected more recalibration and reprioritization RS effects than SEM, presumably due to IRT's robustness to missing data. Future research should apply simulation techniques in order to make conclusive statements about the impacts of missing data according to the type and amount of RS.

Statistical challenges of quality of life and cancer: new avenues for future research.

Statistical modeling conference on the quality of life measurements of the French National Platform of Quality of Life and Cancer Faculty of Science in Luminy, Marseille, France, 12-13 September 2013 The French National Platform of Quality of Life and Cancer and the statistical team of the Mathematical Institute of Luminy undertook a successful first conference addressing the statistical challenges of measuring the quality of life in the field of oncology. More than 15 presentations were made over a 2-day period by the Faculty of Sciences in Luminy. The conference managed to assemble participants from different disciplines, such as mathematics and statistics, public health, epidemiology and psychology, to debate the key statistical and methodological issues of quality of life measurement and analysis. Three main topics were covered in this conference: the treatment of missing data, the development of item banking and computerised adaptive testing and the detection/understanding of response shift.

Source contributions of lead in residential floor dust and within-home variability of dust lead loading.

Evidence of the impact of exposure to low levels of lead on children's health is increasing. Residential floor dust is the assumed origin of lead exposure by young children. In this study, we estimate the contribution of different lead sources to household interior floor dust contamination. We also estimate the within-home variability of interior floor dust lead loadings. A multilevel model was developed based on data collected in a French survey in 2008-2009 (484 housing units, 1834 rooms). Missing data were handled by multiple imputation using chained equations. The intra-home correlation between interior floor Log dust lead loadings was approximately 0.6. Dust lead from the landing of an apartment, mostly originating outside the building, was the major contributor to interior floor dust lead. Secondary contributors included the lead-based paint on exterior railings, track-in of the exterior soil of the children's play area into the dwelling, smoking inside the home, demolition of nearby old buildings and sites of pollution in the vicinity. Interior lead-based paint contaminated interior floor dust only in old and non-renovated dwellings. To reduce interior floor dust lead levels in the general population of dwellings, common areas should be maintained, and track-in from the outside should be limited as much as possible.

Predictive factors of survival after thalidomide therapy in advanced multiple myeloma: long-term follow-up of a prospective multicenter nonrandomized phase II study in 120 patients.

UNLABELLED: Thalidomide monotherapy has demonstrated consistent results in the treatment of advanced multiple myeloma. We report a 9-year follow-up of a French multicenter nonrandomized phase II study that evaluated the effect of oral thalidomide in 120 patients with advanced multiple myeloma. Independent predictors of survival were response to last therapy, performance status, serum ß(2)-microglobulin level, platelet count, and response at day 60 of treatment. BACKGROUND: Thalidomide monotherapy has demonstrated consistent results in the treatment of advanced multiple myeloma. PATIENTS AND METHODS: We report the 9-year follow-up of a French multicenter, nonrandomized, phase II study that evaluated the effect of oral thalidomide in advanced multiple myeloma. Thalidomide was started at 200 mg/d and increased to 400 mg/d at day 15. RESULTS: One hundred twenty patients were enrolled in 2 months at 33 centers. The overall response rate was 31.7% (38/120) on day 60. Overall survival rates were 47.5% (95% confidence interval [CI], 38.6-56.4), 25.0% (95% CI, 17.3-32.7), 11.7% (95% CI, 5.9-17.4), and 7.5% (95% CI, 2.8-12.2) at 1, 3, 6, and 9 years, respectively. Independent predictors of short survival at 1, 3, 6, and 9 years were multiple myeloma refractory to last therapy, performance status ≥ 2, serum ß(2)-microglobulin level ≥ 3.5 mg/L, platelet count < 152 × 10(9)/L, and nonresponse at day 60 (Cox proportional hazards regression model). CONCLUSION: Our study identified 5 independent unfavorable prognostic factors associated with short survival. These prognostic factors were very robust, allowing the prediction of patient survival not only during the first year but also during 3, 6, and even 9 years after the beginning of treatment.

Quality of life and coping of women treated for breast cancer and their caregiver. What are the interactions?

This longitudinal study analyzed the interactions between the quality of life and the coping strategies of 100 patients treated for breast cancer and their caregivers. Data were collected after diagnosis, at the end of treatment, and 6 months after treatment with the Quality of Life Questionnaire-C30 (QLQ-C30), Duke Health Profile and Ways of Coping Checklist for both patients and caregivers. The theoretical model was tested using a typology of patients and mixed model analyses. The quality of life of patients changed over time and no cluster effect was found. The influence of the sociodemographic characteristics, coping strategies (patients and caregivers) and the quality of life of caregivers on patient's quality of life were different according to the quality of life dimensions considered. To understand the adaptation of patients to their disease, it is therefore essential to look at whether the caregiver is capable of playing a supporting role.

Investigation of the impact of HLA-DPB1 matching status in 10/10 HLA matched unrelated hematopoietic stem cell transplantation: results of a French single center study.

The impact of HLA-DPB1 mismatches after unrelated hematopoietic stem cell transplantation (HSCT) remains controversial. We retrospectively analyzed the impact of permissive/non-permissive HLA-DPB1 mismatches on the outcome of 141 patients who underwent 10/10 HLA allelic-matched unrelated HSCT. Each pair was classified according to the 3 (TCE3) and 4-group (TCE4) algorithm based on DPB1 alleles immunogenicity. Outcome analysis revealed that TCE3 and TCE4 non-permissive HLA-DPB1 disparities were not associated with worsened overall survival, relapse risk neither risk of acute GvHD. Overall, this single center retrospective study does not confirm the adverse prognostic of non-permissive HLA-DPB1 mismatches.