Cancer-related fatigue among long-term survivors of breast, cervical, and colorectal cancer: a French registry-based controlled study.

BACKGROUND: While several studies have documented fatigue during and after cancer treatment, long-term cancer survivor fatigue is underreported. In this study, we compare fatigue, quality of life (QoL), and anxiety between relapse-free cancer survivors 15 years after diagnosis and healthy controls. METHODS: Cancer survivors (CS) were randomly selected from three large population-based cancer registries (Bas-Rhin, Calvados, and Doubs, France). Cancer-free controls were randomly selected from electoral lists with stratification on age group, residence area, and gender. All participants completed self-reported fatigue (MFI), QoL (EORTC QLQ-C30), and anxiety (STAI) questionnaires. Univariable and multivariable logistic regression were used to study the association between fatigue and cancer status, in three cancer subgroups: breast cancer (BC), cervical cancer (CC), and colorectal cancer (CRC). RESULTS: Two hundred sixty-three CS and 688 controls (125/275, 45/153, 93/260 CS/controls for BC, CC, and CRC respectively) were included. The mean age was 66 years. In multivariable analyses, CS had higher general and mental fatigue than controls p = 0.04 and p = 0.02, respectively. No difference in QoL was observed between CS and controls. CS were more anxious than controls (p < 0.01). Anxiety was associated with general fatigue (p < 0.0001) and mental fatigue (p < 0.0001). CONCLUSION: Fifteen years after diagnosis, cancer survivors reported more general and mental fatigue compared with controls. Our results reinforce guidelines, identifying fatigue as a persistent symptom.

Cross-cultural adaptation and validation of the French version of the Expanded Prostate cancer Index Composite questionnaire for health-related quality of life in prostate cancer patients.

BACKGROUND: Health-related quality of life (HRQoL) has been positioned as one of the major endpoints in oncology. Thus, there is a need to validate cancer-site specific survey instruments. This study aimed to perform a transcultural adaptation of the 50-item Expanded Prostate cancer Index Composite (EPIC) questionnaire for HRQoL in prostate cancer patients and to validate the psychometric properties of the French-language version. METHODS: The EPIC questionnaire measures urinary, bowel, sexual and hormonal domains. The first step, corresponding to transcultural adaptation of the original English version of the EPIC was performed according to the back translation technique. The second step, comprising the validation of the psychometric properties of the EPIC questionnaire, was performed in patients under treatment for localized prostate cancer (treatment group) and in patients cured of prostate cancer (cured group). The EORTC QLQ-C30 and QLQ-PR25 prostate cancer module were also completed by patients to assess criterion validity. Two assessments were performed, i.e., before and at the end of treatment for the Treatment group, to assess sensitivity to change; and at 2 weeks' interval in the Cured group to assess test-retest reliability. Psychometric properties were explored according to classical test theory. RESULTS: The first step showed overall good acceptability and understanding of the questionnaire. In the second step, 215 patients were included from January 2012 to June 2014: 125 in the Treatment group, and 90 in the Cured group. All domains exhibited good internal consistency, except the bowel domain (Cronbach's α = 0.61). No floor effect was observed. Test-retest reliability assessed in the cured group was acceptable, expect for bowel function (intraclass coefficient = 0.68). Criterion validity was good for each domain and subscale. Construct validity was not demonstrated for the hormonal and bowel domains. Sensitivity to change was exhibited for 5/8 subscales and 2/4 summary scores for patients who experienced toxicities during treatment. CONCLUSIONS: The French EPIC questionnaire seems to have adequate psychometric properties, comparable to those exhibited by the original English-language version, except for the construct validity, which was not available in original version.

Impact of the occurrence of a response shift on the determination of the minimal important difference in a health-related quality of life score over time.

BACKGROUND: An important challenge of the longitudinal analysis of health-related quality of life (HRQOL) is the potential occurrence of a Response Shift (RS) effect. While the impact of RS effect on the longitudinal analysis of HRQOL has already been studied, few studies have been conducted on its impact on the determination of the Minimal Important Difference (MID). This study aims to investigate the impact of the RS effect on the determination of the MID over time for each scale of both EORTC QLQ-C30 and QLQ-BR23 questionnaires in breast cancer patients. METHODS: Patients with breast cancer completed the EORTC QLQ-C30 and the EORTC QLQ-BR23 questionnaires at baseline (time of diagnosis; T0), three months (T1) and six months after surgery (T2). Four hospitals and care centers participated in this study: cancer centers of Dijon and Nancy, the university hospitals of Reims and Strasbourg At T1 and T2, patients were asked to evaluate their HRQOL change during the last 3 months using the Jaeschke transition question. They were also asked to assess retrospectively their HRQOL level of three months ago. The occurrence of the RS effect was explored using the then-test method and its impact on the determination of the MID by using the Anchor-based method. RESULTS: Between February 2006 and February 2008, 381 patients were included of mean age 58 years old (SD = 11). For patients who reported a deterioration of their HRQOL level at each follow-up, an increase of RS effect has been detected between T1 and T2 in 13/15 dimensions of QLQ-C30 questionnaire, and 4/7 dimensions of QLQ-BR23 questionnaire. In contrast, a decrease of the RS effect was observed in 8/15 dimensions of QLQ-C30 questionnaire and in 5/7 dimensions of QLQ-BR23 questionnaire in case of improvement. At T2, the MID became ≥ 5 points when taking into account the RS effect in 10/15 dimensions of QLQ-C30 questionnaire and in 5/7 dimensions of QLQ-BR23 questionnaire. CONCLUSIONS: This study highlights that the RS effect increases over time in case of deterioration and decreases in case of improvement. Moreover, taking the RS into account produces a reliable and significant MID.

A longitudinal analysis of patient satisfaction with care and quality of life in ambulatory oncology based on the OUT-PATSAT35 questionnaire.

BACKGROUND: In the oncology setting, there has been increasing interest in evaluating treatment outcomes in terms of quality of life and patient satisfaction. The aim of our study was to investigate the determinants of patient satisfaction, especially the relationship between quality of life and satisfaction with care and their changes over time, in curative treatment of cancer outpatients. METHODS: Patients undergoing ambulatory chemotherapy or radiotherapy in two centers in France were invited to complete the OUT-PATSAT35, at the beginning of treatment, at the end of treatment, and three months after treatment. This questionnaire evaluates patients' perception of doctors and nurses, as well as other aspects of care organization and services. Additionally, for each patient, socio-demographic and clinical characteristics, and self-reported quality of life data (EORTC QLQ-C30) were collected. RESULTS: Of the 691 patients initially included, 561 answered the assessment at all three time points. By cross-sectional analysis, at the end of the treatment, patients who experienced a deterioration of their global health reported less satisfaction on most scales (p ≤ 0.001). Three months after treatment, the same patients had lower satisfaction scores only in the evaluation of doctors (p ≤ 0.002). Furthermore, longitudinal analysis showed a significant relationship between a deterioration in global health and a decrease in satisfaction with their doctor and, conversely, between an improvement in global health and an increase in satisfaction on the overall satisfaction scale. Global health at baseline was largely and significantly associated with all satisfaction scores measured at the following assessment time points (p < 0.0001). Younger age (<55 years), radiotherapy (versus chemotherapy) and head and neck cancer (versus other localizations) were clinical factors significantly associated with less satisfaction on most scales evaluating doctors. CONCLUSIONS: Pre-treatment self-evaluated global health was found to be the major determinant of patient satisfaction with care. The subsequent deterioration of global health, during and after treatment, emphasized the decrease in satisfaction scores, mainly in the evaluation of doctors. Early initiatives aimed at improving the delivery of care in patients with poor health status should lead to improved perception of the quality of care received.

Item response theory and factor analysis as a mean to characterize occurrence of response shift in a longitudinal quality of life study in breast cancer patients.

BACKGROUND: The occurrence of response shift (RS) in longitudinal health-related quality of life (HRQoL) studies, reflecting patient adaptation to disease, has already been demonstrated. Several methods have been developed to detect the three different types of response shift (RS), i.e. recalibration RS, 2) reprioritization RS, and 3) reconceptualization RS. We investigated two complementary methods that characterize the occurrence of RS: factor analysis, comprising Principal Component Analysis (PCA) and Multiple Correspondence Analysis (MCA), and a method of Item Response Theory (IRT). METHODS: Breast cancer patients (n = 381) completed the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires at baseline, immediately following surgery, and three and six months after surgery, according to the "then-test/post-test" design. Recalibration was explored using MCA and a model of IRT, called the Linear Logistic Model with Relaxed Assumptions (LLRA) using the then-test method. Principal Component Analysis (PCA) was used to explore reconceptualization and reprioritization. RESULTS: MCA highlighted the main profiles of recalibration: patients with high HRQoL level report a slightly worse HRQoL level retrospectively and vice versa. The LLRA model indicated a downward or upward recalibration for each dimension. At six months, the recalibration effect was statistically significant for 11/22 dimensions of the QLQ-C30 and BR23 according to the LLRA model (p ≤ 0.001). Regarding the QLQ-C30, PCA indicated a reprioritization of symptom scales and reconceptualization via an increased correlation between functional scales. CONCLUSIONS: Our findings demonstrate the usefulness of these analyses in characterizing the occurrence of RS. MCA and IRT model had convergent results with then-test method to characterize recalibration component of RS. PCA is an indirect method in investigating the reprioritization and reconceptualization components of RS.

Quality of life in long-term cervical cancer survivors: a population-based study.

OBJECTIVES: To assess long-term quality of life (QOL) in cervical cancer survivors (CCSs), 5, 10, and 15 years after diagnosis. METHODS: In a cross-sectional population-based study, CCSs diagnosed in 1990, 1995, or 2000 were randomly selected from 3 tumor registries in France. Healthy controls were randomly selected from electoral rolls, stratifying on age group and residence area. Five QOL questionnaires (SF-36, EORTC QLQ-C30, the cervical cancer-specific module (EORTC QLQ-CX24), the MFI fatigue questionnaire, the STAI for anxiety) and a life condition questionnaire were used. Analysis of variance was used to compare QOL scores of survivors by period of diagnosis (5, 10, and 15 years) with those of controls and according to treatment modality, adjusted for socio-demographic data. RESULTS: A total of 173 localized CCSs (42% treated with surgery alone and 58% with a combination of treatments) and 594 controls participated in the study. Compared with controls, CCSs expressed globally similar good QOL, except for impaired psychoemotional domains in 15-year survivors (p<0.01). Worsening of some symptoms was observed over time, 15-year survivors in particular reported significantly more lymphedema than 5-year (p=0.0009) and 10-year CCSs (p=0.002). Compared with CCSs treated by surgery alone, QOL of CCSs who received radiotherapy was significantly more affected in terms of cervical cancer specific problems, such as sexual dysfunction (p=0.002), voiding and abdominal symptoms (p=0.01), and lymphedema (p=0.01). CONCLUSIONS: Even after 15 years, QOL of CCSs is impacted in psychological domains, compared with healthy controls. Among CCSs, women treated by adjuvant radiotherapy expressed more physical sequelae.

The relationship between traits optimism and anxiety and health-related quality of life in patients hospitalized for chronic diseases: data from the SATISQOL study.

BACKGROUND: The impact of psychological factors is often taken into account in the evaluation of quality of life. However, the effect of optimism and trait anxiety remains controversial and they are rarely studied simultaneously. We aimed to study the effect of this factor on health-related quality of life (HRQOL) of patients after a hospitalization in relation with their chronic disease. METHODS: Using cross-sectional data from the SATISQOL cohort, we conducted a multicentric study, including patients hospitalized for an intervention in connection with their chronic disease. Six months after hospitalization, patients completed a generic HRQOL questionnaire (SF-36), and the STAI and LOT-R questionnaires to evaluate optimism and trait anxiety. We studied the effect of each trait on HRQOL separately, and simultaneously, taking account of their interaction in 3 models, using an ANOVA. RESULTS: In this study, 1529 patients were included in three participating hospitals and there existed wide diversity in the chronic diseases in our population. The HRQOL score increased for all dimensions of SF36 between 15,8 and 44,5 when the level of anxiety decreased (p < 0.0001) for the model 1, assessing the effect of anxiety on HRQOL and increased for all dimensions of SF36 between 3.1 and 12.7 with increasing level of optimism (< 0.0001) in the model 2 assessing the effect of optimism on HRQOL. In the model 3, assessing the effect of both anxiety and optimism on HRQOL, and their interaction, the HRQOL score for all dimensions of the SF36 increased when the level of anxiety decreased (p < 0.0001). It increased with increasing level of optimism (p < 0.006) in the model for all dimensions of SF36 except the Role Physical dimension. In this model, interaction between anxiety and optimism was significant for the Social Functioning dimension (p = 0.0021). CONCLUSIONS: Optimism and trait anxiety appeared to be significantly correlated with HRQOL. Furthermore, an interaction existed between the trait anxiety and optimism for some dimensions of SF36. Contrary to optimism, it seems essential to evaluate trait anxiety in future studies about HRQOL, since it could represent a confounding factor.

Health-related quality of life among long-term survivors of colorectal cancer: a population-based study.

BACKGROUND: The number of long-term colorectal cancer survivors is increasing. Cancer and its treatment can cause physical and psychological complications, but little is known about how it impacts quality of life (QOL) over the long term-5, 10, and 15 years after diagnosis. METHODS: Cancer survivors were randomly selected from three tumor registries in France, diagnosed in 1990 (±1 year), 1995 (±1 year), and 2000 (±1 year). Controls were randomly selected from electoral rolls, stratifying on gender, age group, and residence area. Participants completed two QOL questionnaires, a fatigue questionnaire, an anxiety questionnaire, and a life conditions questionnaire. An analysis of variance was used to compare QOL scores of cancer survivors by period of diagnosis (5, 10, and 15 years) with those of controls, adjusted for sociodemographic data and comorbidities. RESULTS: We included 344 colon cancer and 198 rectal cancer survivors and 1,181 controls. In a global analysis, survivors reported a statistically and clinically significant lower score in social functioning 5 years after diagnosis and higher scores in diarrhea symptoms 5 and 10 years after diagnosis. In subgroup analyses, rectal cancer affected QOL in the physical dimensions at 5 years and in the fatigue dimensions at 5 and 10 years. CONCLUSION: Survivors of colorectal cancer may experience the effects of cancer and its treatment up to 10 years after diagnosis, particularly for rectal cancer. Clinicians, psychologists, and social workers must pay special attention to rectal cancer survivors to improve overall management.

Time to deterioration in quality of life score as a modality of longitudinal analysis in patients with breast cancer.

PURPOSE: This prospective multicenter study explored different definitions of time to deterioration (TTD) in quality of life (QoL) scores, according to different cutoffs of the minimal clinically important difference (MCID) as a modality for longitudinal QoL assessment in breast cancer patients. METHODS: QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and BR-23 before surgery, after surgery, and 6 and 12 months later. The global health score, arm symptoms score (BRAS), and breast symptoms score were analyzed. For a given baseline score, QoL was considered to have deteriorated if this score decreased by ≥5 points at any time point after baseline. Analyses were repeated using an MCID of 10 points and taking the score after surgery as the reference score (to explore the occurrence of response shift). TTD was calculated using the Kaplan-Meier method and Cox regression was used to identify independent factors associated with TTD. RESULTS: Two hundred thirty-five patients underwent axillary lymph node dissection (ALND), 222 underwent sentinel lymph node biopsy (SLNB), and 61 underwent SLNB plus ALND. Patients who underwent SLNB had a significantly longer TTD for the BRAS dimension than those who underwent ALND. Cox multivariate analyses showed that treatment using SLNB and age >59 years were independently associated with longer TTD for the BRAS, whereas surgery elsewhere than at the Centre Georges François Leclerc was associated with a shorter TTD. CONCLUSION: Exploration of different definitions of TTD in QoL provides meaningful longitudinal QoL results for clinicians.

Long-term quality of life after breast cancer: a French registry-based controlled study.

Population-based studies on quality of life (QOL) of long-term breast cancer survivors are quite recent and insufficient attention has been paid to the effect of time since diagnosis. We compared long-term QOL of population-based breast cancer survivors 5, 10, and 15 years after diagnosis with that of healthy controls. Breast cancer survivors were randomly selected from three population-based cancer registries (Bas-Rhin, Calvados and Doubs, France) along with healthy controls, stratified for age and place of residence, randomly selected from electoral rolls. Participants completed five self-administered questionnaires: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Short Form-36 (SF-36), Spielberger State-Trait Anxiety Inventory (STAI), Multidimensional Fatigue Inventory (MFI) and a life conditions questionnaire. An analysis of variance was used to compare QOL scores of breast cancer survivors by period (5, 10, or 15 years) of diagnosis with those of controls, adjusted for sociodemographic data and comorbidities. Six hundred and fifty-two cases and 1,188 controls participated in the study. For many QOL scales, scores were significantly different between cancer survivors and controls. A clinically significant difference was evidenced for the fatigue scales, the SF36 physical functioning, role-physical, and role-emotional scales, with more favorable results for controls. Differences decreased with time and 15-year cancer survivors were generally not different from controls. Scores were particularly influenced by age and mean household income. More efforts should be made, specifically during the first 5 to 10 years after diagnosis, to help women with breast cancer to overcome their impairment in QOL.

Determinants of patient satisfaction in ambulatory oncology: a cross sectional study based on the OUT-PATSAT35 questionnaire.

BACKGROUND: The aim of this study was to identify factors associated with satisfaction with care in cancer patients undergoing ambulatory treatment. We investigated associations between patients' baseline clinical and socio-demographic characteristics, as well as self-reported quality of life, and satisfaction with care. METHODS: Patients undergoing ambulatory chemotherapy or radiotherapy in 2 centres in France were invited, at the beginning of their treatment, to complete the OUT-PATSAT35, a 35 item and 13 scale questionnaire evaluating perception of doctors, nurses and aspects of care organisation. Additionally, for each patient, socio-demographic variables, clinical characteristics and self-reported quality of life using the EORTC QLQ-C30 questionnaire were recorded. RESULTS: Among 692 patients included between January 2005 and December 2006, only 6 were non-responders. By multivariate analysis, poor perceived global health strongly predicted dissatisfaction with care (p < 0.0001). Patients treated by radiotherapy (vs patients treated by chemotherapy) reported lower levels of satisfaction with doctors' technical and interpersonal skills, information provided by caregivers, and waiting times. Patients with primary head and neck cancer (vs other localisations), and those living alone were less satisfied with information provided by doctors, and younger patients (< 55 years) were less satisfied with doctors' availability. CONCLUSIONS: A number of clinical of socio-demographic factors were significantly associated with different scales of the satisfaction questionnaire. However, the main determinant was the patient's global health status, underlining the importance of measuring and adjusting for self-perceived health status when evaluating satisfaction. Further analyses are currently ongoing to determine the responsiveness of the OUT-PATSAT35 questionnaire to changes over time.

Responsiveness of EORTC QLQ-C30, QLQ-CR38 and FACT-C quality of life questionnaires in patients with colorectal cancer.

BACKGROUND: The aim of this study was to compare the responsiveness of the European Organization for Research and Treatment (EORTC) quality of life questionnaires (QLQ-C30, QLQ-CR38) and the Functional Assessment of Cancer Therapy-colorectal version 4 questionnaire (FACT-C). METHOD: This prospective study included 127 patients with colorectal cancer: 71 undergoing chemotherapy and 56 radiation therapy. Responsiveness statistics included the Standardized Response Mean (SRM) and the Effect Size (ES). The patient's overall assessment of his/her change in state of health status was the reference criterion to evaluate the responsiveness of the QoL questionnaires. RESULTS: 34 patients perceived their health as stable and 17 as improved between the first and the fourth courses of chemotherapy. 21 patients perceived their health as stable and 22 as improved between before and the last week of radiotherapy.The responsiveness of the 3 questionnaires differed according to treatments. The EORTC QLQ-C30 questionnaire was more responsive in patients receiving chemotherapy, particulary functional scales (SRM > 0.55). The QLQ-CR38 and the FACT-C questionnaires provided little clinically relevant information during chemotherapy or radiotherapy. CONCLUSION: The EORTC QLQ-C30 questionnaire appears to be more responsive in patients receiving chemotherapy.

[Long-term occupational situation after cancer: A French registry-based study]. / Situation professionnelle à long terme après un cancer : étude réalisée à partir de registres de population.

INTRODUCTION: Few studies have explored the long-term occupational situation after cancer. The aim of our study were to study the employment status among long-term cancer survivors and to compare it to cancer-free controls from the general population at 5, 10 or 15 years after cancer diagnosis. METHODS: From data of a registry-based study, long-term survivors from breast,cervical and colorectal cancer, randomly selected from three tumor registries in France, were compared to cancer-free controls randomly selected from electoral lists. We selected active cancer survivors and cancer-free controls aged less than 60 at the time of the survey. We have studied the employment status of cases vs. controls and the factors associated with employment status. RESULTS: At 5, 10 or 15 years after diagnosis, we did not observe any significant difference in employment status between cases and controls. Among cases, 17% had lost their jobs. Older age, lower incomes, lower education, a short-term employment contract, the presence of co-morbidities, fatigue and a worse quality of life were associated with job loss. DISCUSSION: Although the employment status of the cases was comparable to that of the controls, efforts should be intensified to make it easier for patients diagnosed with cancer to return to work.

Feasibility of chemoradiotherapy for oesophageal cancer in elderly patients aged >or=75 years: a prospective, single-arm phase II study.

BACKGROUND: The number of elderly patients with oesophageal cancer is expected to increase with the aging of the population and the rapidly increasing incidence of adenocarcinoma. Surgical resection is standard treatment for patients with localized disease considered fit for operation. However, elderly patients with oesophageal cancer are rarely referred for surgery. The aim of this prospective, single-arm, phase II study was to evaluate the feasibility and efficacy (tumour response) of chemoradiotherapy in the treatment of elderly patients with localized oesophageal cancer. Secondary endpoints were progression-free survival (PFS) and quality of life (QOL). METHODS: The main study inclusion criteria were: patients aged >or=75 years; oesophageal cancer disease stage II-III; Charlson co-morbidity index score

Early changes in local hemostasis activation following percutaneous coronary intervention in stable angina patients: a comparison between drug-eluting and bare metal stents.

BACKGROUND: Early change in local intracoronary hemostasis following drug-eluting (DES) and bare metal stent (BMS) implantation has never been assessed in stable angina patients. METHODS: Markers of local platelet activation (soluble glycoprotein V [sGPV] and P-Selectin [CD62P]), coagulation activation (tissue factor [TF], prothrombin fragments 1 + 2 [F1 + 2] and activated factor VII [FVIIa]) and fibrinolysis markers (D-dimers [DD], fibrinogen [FIB], tissue plasminogen activator [t-PA], and plasminogen activator inhibitor type-1 complexes [PAI-1]) were determined in 20 patients with stable angina who underwent percutaneous coronary intervention (PCI). All patients were pretreated with clopidogrel, aspirin, and enoxaparin. Systematic balloon predilation was performed before DES (9 patients) and BMS (11 patients) implantation. All blood samples were drawn 10-20 mm distal to the lesion site. RESULTS: No significant changes in levels of platelet activation markers occurred during PCI. There was a transient significant increase in TF (14%; P = 0.004), in F1 + 2 (40%; P = 0.001), and FVIIa (31%; P = 0.007) following angioplasty. Similarly, a significant 43% increase was observed in DD levels following balloon predilation, associated with an increase of 46%, 60%, and 70% in FIB, t-PA and PAI-1 levels, respectively (all P < 0.0001). All these markers returned to baseline values after stent implantation. No difference was observed between DES and BMS. CONCLUSIONS: Early changes in local hemostasis activation following PCI, were related to balloon predilation. Neither DES nor BMS increased markers of platelet activation, coagulation, or fibrinolysis, under dual antiplatelet and anticoagulant pretreatment.

Radiochemotherapy of locally advanced anal canal carcinoma: prospective assessment of early impact on the quality of life (randomized trial ACCORD 03).

BACKGROUND AND PURPOSE: The aim of this study was to prospectively assess the quality of life (QOL) of patients treated by concomitant chemo radiation for locally advanced anal canal carcinoma. MATERIALS AND METHODS: We report on a subgroup of 119 patients enrolled in a 306-patient therapeutic intensification prospective trial (ACCORD 03). This trial evaluated the impact on colostomy-free survival of induction chemotherapy and/or high dose radiotherapy (factorial design 2 *2 treatment arms). QOL was assessed both before and 2 months after treatment using the EORTC QLQ-C30 questionnaire as well as a questionnaire relating to anal sphincter conservative treatment (AS-CT). RESULTS: Compared to pre-treatment scores, patients reported significant improvement in their emotional function (+8.4 points p=0.002), global health status (+5.9 points p=0.0007), as well as a decrease in insomnia (-13.8 points p<0.0001), constipation (-12.0 points p<0.0001), appetite loss (-10.3 points p<0.0001) and pain (-9.6 points p=0.0002). The AS-CT degree of satisfaction with intestinal functions score was increased (+11.2 points p<0.0001). CONCLUSION: This is the first prospective study comparing QOL of patients with advanced anal canal carcinoma, before and 2 months after conservative treatment. Two months after treatment, QOL was improved. Induction chemotherapy and/or high dose radiotherapy did not provide a negative impact on QOL.

Randomized clinical trial of post-operative radiotherapy versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement.

BACKGROUND AND PURPOSE: Post-operative radiotherapy is indicated for the treatment of head and neck cancers. In vitro, chemotherapy potentiates the cytotoxic effects of radiation. We report the results of a randomized trial testing post-operative radiotherapy alone versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement. MATERIALS AND METHODS: The study involved patients undergoing curative-intent surgery for head and neck cancers with histological evidence of lymph node involvement. Patients were randomly assigned to receive radiotherapy alone (54-72Gy, 30-40 fractions, 6-8 weeks) or identical treatment plus concomitant Carboplatin (50mg/m(2) administered by IV infusion twice weekly). RESULTS: Between February 1994 and June 2002, 144 patients were included. With a median follow-up of 106 months (95% confidence interval (CI) [92-119]), the 2-year rate of loco-regional control was 73% (95% CI: 0.61-0.84) in the combined treatment group and 68% (95% CI: 0.57-0.80) in the radiotherapy group (p=0.26). Overall survival did not differ significantly between groups (hazard ratio for death, 1.05; 95% CI: 0.69-1.60; p=0.81). CONCLUSIONS: Twice-weekly administration of carboplatin concomitant to post-operative radiotherapy did not improve local control or overall survival rates in this population of patients with node-positive head and neck cancers.

Rurality and survival differences in lung cancer: a large population-based multivariate analysis.

Several studies have suggested rural health disadvantages. In France, studies on rural-urban patterns of lung cancer survival have yielded conflicting results. The aim of this analysis was to determine whether rural residence was associated with poor survival in three French counties. The database consisted of all primary lung cancer cases diagnosed in 2000 and 2001 collected through the Doubs cancer registry. A degree of rurality, obtained from socio-demographic and farming parameters of the 1999 French census treated with factor analysis, was attributed to each patient according to his/her place of residence. Among the 802 patients, 21% resided in rural areas, 11% were semi-urban inhabitants and 68% were urban residents. Survival differed significantly between these three rurality categories (p=0.04), with 2-year survival rates of 18, 29 and 24%, respectively. Using a Cox model, rural areas were significantly correlated with poor survival as compared with semi-urban areas (OR=1.42; 95% confidence interval=1.06-1.90; p=0.02). There was no survival difference between semi-urban and urban patients (OR=1.18; 95% confidence interval=0.91-1.53; p=0.21). Patient and tumour characteristics, especially stage and staging procedures, as well as first line treatment, did not vary with the degree of rurality. In conclusion, rurality has to be considered as a strong prognostic factor. Several intricate factors might be hypothesized such as increasing time to diagnosis leading to heavier tumour burden, worse treatment compliance and socioeconomic status. Before practical interventions can be proposed, prospective studies are warranted with further definition of rural risk factors for decreased survival in rural lung cancer patients.

Early local intracoronary platelet activation after drug-eluting stent placement.

BACKGROUND: Early local platelet activation after coronary intervention identifies patients at increased risk of acute stent thrombosis (AST). However, early changes in platelet activation in coronary circulation following drug-eluting stent (DES) implantation have never been reported. METHODS: In a prospective study of 26 consecutive elective stable angina patients, platelet activation was analyzed by measuring soluble glycoprotein V (sGPV) and P-selectin (CD62P) before and after implantation of either DES or bare metal stent (BMS). All patients were pretreated with clopidogrel (300 mg loading dose) and aspirin (75 mg orally) the day before the procedure. Blood samples were drawn from the coronary ostium and 10 - 20 mm distal to the lesion site. RESULTS: Consistent with the lower baseline clinical risk, the levels of CD62P and sGPV were within normal reference range, both in the coronary ostium and distal to the lesion before percutaneous coronary intervention (PCI) procedure. The levels of CD62P and sGPV did not change significantly (CD62P: (31.1 +/- 9.86) ng/ml vs (29.5 +/- 9.02) ng/ml, P = 0.319 and sGPV: (52.4 +/- 13.5) ng/ml vs (51.8 +/- 11.7) ng/ml, P = 0.674, respectively) after stent implantation when compared with baseline. Changes in these platelet activation markers did not differ between stent types. CONCLUSIONS: Intracoronary local platelet activation does not occur in stable angina patients before and immediately following DES implantation when dual anti-platelet is administered.

Preoperative radiotherapy in elderly patients with rectal cancer.

PURPOSE: We performed a retrospective analysis in order to evaluate the compliance with preoperative radiotherapy in patients aged>or=70 with locally advanced resectable rectal cancer, and to evaluate the influence of comorbidities on treatment tolerance and oncological results. METHODS: From March 1984 to December 2000, 95 patients with T3-T4 N0 M0 rectal cancer received a preoperative radiotherapy in 2 radiotherapy departments. Nineteen patients received concomitant chemotherapy. RESULTS: All patients completed the radiation schedule. Six patients suffered grade 3 acute WHO toxicity. Surgical resection was performed in 87 patients. There were 3 post-operative deaths. Analysis of peri-operative complications showed thromboembolism (4.9%), ileus (9.8%) and diarrhoea (6.1%). After a median follow-up of 29 months, the 3- and 5-year overall survival rates were 65% and 49% respectively. In univariate analysis, a tumour located in the mid part of the rectum, a radiation dose less than 40 Gy, the absence of chemotherapy were significantly associated with a poor prognosis. There was a trend to a better survival for patients with a Charlson score of 0 (P=0.0584). In multivariate analysis, only initial WHO performance status was significant. CONCLUSIONS: Compliance with preoperative radiotherapy is good in elderly patients. Toxicity rates are similar to those described in randomised trials in which only younger patients were included. Initial WHO performance status