AFSOS-SFRO-SFH-SFNEP-SFCE-GFRP guidelines on radio-induced nausea and vomiting.

INTRODUCTION: The prevalence of radiation-induced nausea and vomiting varies between 40% and 80%. They have many consequences on treatment and comorbidities. This work thus aimed to define clinical practice guidelines for the management of radiation-induced nausea and vomiting. METHODS: XXXXX, XXXX, XXX, XXXXX, XXXX and XXXX compiled a working group who draft these recommendations. RESULTS: The assessment of the emetogenic risk found two main predictive factors: 1) the irradiated anatomical location, 2) an associated concomitant chemotherapy. In the case of exclusive radiotherapy, primary antiemetic prophylaxis depends on the emetogenic risk (the irradiated anatomical location). In the case of concomitant chemotherapy, the emetogenic risk is generally higher and the primary antiemetic prophylaxis corresponds to that of chemotherapy-induced nausea and vomiting. In cases where symptoms persist, remedial treatments are poorly codified. CONCLUSION: Radiation-induced nausea and vomiting remains underdiagnosed and undertreated, its rapid detection and treatment are essential to reinstate good clinical practice.

[Patients' satisfaction and waiting time in oncology day care centers in Champagne-Ardenne]. / Programme d'évaluation de l'administration des chimiothérapies en hôpital de jour en Champagne-Ardenne (PEACH) : satisfaction et délais d'attente des patients.

AIM: Quality of life of patients suffering from cancer may be influenced by the way healthcare is organized and by patient experiences. Nowadays, chemotherapy is often provided in day care centers. This study aimed to assess patient waiting time and satisfaction in oncology day care centers in Champagne-Ardenne, France. METHODS: This cross-sectional survey involved all patients receiving ambulatory chemotherapy during a one-week period in day care centers of Champagne-Ardenne public and private healthcare institutions participating in the study. Sociodemographic, medical and outpatient data were collected. Patient satisfaction was measured using the Out-Patsat35 questionnaire. RESULTS: Eleven (out of 16) oncology day care centers and 441 patients participated in the study. Most of the patients were women (n=252, 57.1%) and the mean age was 61±12 years. The mean satisfaction score was 82±14 (out of 100) and the mean waiting time between the assigned appointment time and administration of chemotherapy was 97±60 min. CONCLUSION: This study has shown that waiting times are important. However, patients are satisfied with the healthcare organization, especially regarding nursing support. Early preparation of chemotherapy could improve these parameters.

Tokuhashi score and other prognostic factors in 260 patients with surgery for vertebral metastases.

BACKGROUND: Metastatic disease of the spine is an increasingly common public health problem. Surgery should be an integral component of the overall cancer treatment plan and, importantly, must neither delay not jeopardize any of the other components. The prognosis governs the choice of the surgical strategy. Tokuhashi et al. developed a prognostic score in 1990, then revised it in 2000 and 2005. Here, our objective was to evaluate the performance of the Tokuhashi score in a cohort of 260 patients and to look for other variables that might improve preoperative outcome prediction. MATERIAL AND METHOD: We retrospectively established a single-centre cohort of 260 patients who underwent spinal metastasis surgery between 1998 and 2008. For each patient, the following data were collected prospectively: socio-demographic features, history of the malignancy, variables needed to determine the Tokuhashi score, and treatments used. SAS 9.0 software was chosen for the statistical analysis. Variables were described as mean ± SD, overall survival was estimated using the Kaplan-Meier method, and survivals in subgroups were compared by the log-rank test. To assess agreement between survival predicted by the Tokuhashi score and observed survival, we computed Cohen's kappa and interpreted the results according to Landis and Koch. RESULTS: There were 143 females and 117 males with a mean age of 59 years and overall median survival of 10 months. Median observed survivals in the three Tokuhashi score categories (< 6, 6-12, and > 12 months predicted survival) were 5, 10, and 36 months, respectively. These survival times differed significantly (P < 0.0001). Cohen's kappa indicated moderate agreement between predicted and observed survivals. Other factors associated with significant survival differences were time from cancer diagnosis to metastasis diagnosis (synchronous, < 2 years, 2-5 years, or > 5 years; P < 0.0001) and age (< 70 years or ≥ 70 years, P = 0.0053). CONCLUSION: Our cohort study supports the validity and reproducibility of the Tokuhashi score. Our finding that shorter time to metastasis diagnosis and age ≥ 70 years were also significantly associated with survival in our population invites further efforts to improve and update the Tokuhashi score.

Impact of geriatric risk factors on pegylated liposomal doxorubicin tolerance and efficacy in elderly metastatic breast cancer patients: final results of the DOGMES multicentre GINECO trial.

BACKGROUND: Metastatic breast cancer chemotherapy in the elderly is considered effective in carefully selected patients, but there is little data regarding its effect in vulnerable patients. METHODS: We evaluated tumour response (primary endpoint), feasibility and outcomes after six courses of an adapted dose of pegylated liposomal doxorubicin (PLD) (40 mg/m(2) every 28 days) as first-line chemotherapy for hormone-resistant MBC. RESULTS: Of 60 patients >70 years (median 77 years), 15% had performance status ≥2 and 73% had visceral metastases. Geriatric assessment included: ≥2 comorbidities, 42%; ≥1 deficiency in Activities of Daily Living (ADL), 10% and Instrumental ADL (IADL), 82%; living in residential homes, 12%; albumin <35 g/L, 17%; body mass index (BMI) <21, 20%; depression, 17%; and lymphocytes ≤1 × 10(3)/mm(3), 27%. Complete response, partial response and stable disease were observed in 5%, 15% and 60%, respectively, but only 48% completed six cycles. Treatment discontinuations were mostly due to disease progression (18%) and non-haematological (NH) toxicities (22%). Eight patients died during treatment (three possibly related to PLD), and 15 had unplanned hospital admissions. Exploratory analyses to identify geriatric covariates associated with treatment outcomes revealed severe haematological toxicities significantly correlated with lymphocytes ≤1 × 10(3)/mm(3). NH toxicities correlated with age ≥80 years and living in residential homes. Progression-free survival (median 6.1 months) decreased with age, deficiency in IADL, cardiac dysfunction and living in residential homes. Overall survival (median 15.7 months) also decreased with living in residential homes. CONCLUSION: Despite manageable haematological toxicities and expected response rates, PLD feasibility was poor in unselected elderly patients.

[Comparison between PET(-FDG) and computed tomography in the staging of lung cancer. Consequences for operability in 94 patients]. / Comparaison entre TEP(-FDG) et scanner dans le bilan d'extension du cancer bronchopulmonaire, conséquences pour l'opérabilité chez 94 patients.

INTRODUCTION: Lung cancer, a major application of FDG/PET-CT, has recently been introduced in daily practice in France. The authors retrospectively studied its impact on the management of this disease. METHODS: The results of PET-CT and conventional assessment (brain imaging, chest and abdominal CT and possibly bone scintigraphy) were compared in 94 patients, referred for the staging of non-small cell lung cancer, or the assessment of a solitary lung lesion. The impact of thoracic lymph node involvement on the operability of patients was studied in 44 patients. RESULTS: PET-CT revealed metastases in 20% of the patients without metastases found by conventional imaging and modified the stage of the disease in 28% of the cases. It changed the indication of surgical treatment in 19% of the cases and led to induction chemotherapy in two patients. In addition, two synchronous cancers were discovered. Regarding lymph node involvement, PET-CT remains of diagnostic value regardless of the scanner results. CONCLUSION: The impact of PET-CT in assessing non-small cell lung cancer was confirmed in the authors' practice. Its interest and the consequences in some patients misclassified with conventional assessment have been demonstrated.

Derivation and validation of a mortality-risk index from a cohort of frail elderly patients hospitalised in medical wards via emergencies: the SAFES study.

To identify predictive factors for 2-year mortality in frail elderly patients after acute hospitalisation, and from these to derive and validate a Mortality Risk Index (MRI). A prospective cohort of elderly patients was set up in nine teaching hospitals. This cohort was randomly split up into a derivation cohort (DC) of 870 subjects and a validation cohort (VC) of 436 subjects. Data obtained from a Comprehensive Geriatric Assessment were used in a Cox model to predict 2-year mortality and to identify risk groups for mortality. A ROC analysis was performed to explore the validity of the MRI. Five factors were identified and weighted using hazard ratios to construct the MRI: age 85 or over (1 point), dependence for the ADL (1 point), delirium (2 points), malnutrition risk (2 points), and co-morbidity level (2 points for medium level, 3 points for high level). Three risk groups were identified according to the MRI. Mortality rates increased significantly across risk groups in both cohorts. In the DC, mortality rates were: 20.8% in the low-risk group, 49.6% in the medium-risk group, and 62.1% in the high-risk group. In the VC, mortality rates were respectively 21.7, 48.5, and 65.4%. The area under the ROC curve for overall score was statistically the same in the DC (0.72) as in the VC (0.71). The proposed MRI appears as a simple and easy-to-use tool developed from relevant geriatric variables. Its accuracy is good and the validation procedure gives a good stability of results.

Predicting early mortality among elderly patients hospitalised in medical wards via emergency department: the SAFES cohort study.

OBJECTIVES: The aim of the study was, by early identification of deleterious prognostic factors that are open to remediation, to be in a position to assign elderly patients to different mortality risk groups to improve management. DESIGN: Prospective multicentre cohort. SETTING: Nine French teaching hospitals. PARTICIPANTS: One thousand three hundred and six (1 306) patients aged 75 and over, hospitalised after having passed through Emergency Department (ED). MEASUREMENTS: Patients were assessed using Comprehensive Geriatric Assessment (CGA) tools. A Cox survival analysis was performed to identify prognostic variables for six-week mortality. Receiver Operating Characteristics analysis was used to study the discriminant power of the model. A mortality risk score is proposed to define three risk groups for six-week mortality. RESULTS: Crude mortality rate after a six week follow-up was 10.6% (n=135). Prognostic factors identified were: malnutrition risk (HR=2.1; 95% CI: 1.1-3.8; p=.02), delirium (HR=1.7; 95% CI: 1.2-2.5; p=.006), and dependency: moderate dependency (HR=4.9; 95% CI: 1.5-16.5; p=.01) or severe dependency (HR=10.3; 95% CI: 3.2-33.1; p < .001). The discriminant power of the model was good: the c-statistic representing the area under the curve was 0.71 (95% IC: 0.67 - 0.75; p < .001). The six-week mortality rate increased significantly (p < .001) across the three risk groups: 1.1% (n=269; 95% CI=0.5-1.7) in the lowest risk group, 11.1% (n=854; 95% CI=9.4-12.9) in the intermediate risk group, and 22.4% (n=125; 95% CI=20.1-24.7) in the highest risk group. CONCLUSIONS: A simple score has been calculated (using only three variables from the CGA) and a practical schedule proposed to characterise patients according to the degree of mortality risk. Each of these three variables (malnutrition risk, delirium, and dependency) identified as independent prognostic factors can lead to a targeted therapeutic option to prevent early mortality.

[Diagnostic modalities of visceral metastases during follow-up of patients with stage I-II melanoma]. / Malades suivis pour mélanome de stade I-II: modalités diagnostiques des métastases viscérales.

INTRODUCTION: Although not recommended in France at the consensus conference of 1994, routine monitoring of patients with stage I melanoma using imaging techniques is commonly carried out. The aim of this retrospective regional study was to define methods for diagnosing transition to the metastatic stage of melanoma. PATIENTS AND METHODS: This was a retrospective study based on questionnaires among dermatologists in the Champagne-Ardenne and southern Aisne regions of France. For each patient with stage IV melanoma between 1987 and 2002, data were collected concerning the primary melanoma (date of diagnosis, clinical picture, histopathologic features), stage of melanoma prior to diagnosis of metastatic melanoma and characteristics of the metastases (date, number, type, site and modern discovery: clinical signs or routine imaging). RESULTS: One hundred and eight patients (63 men and 45 women; mean age: 59 years) were included in the study. The predominant site of the primary melanoma was the trunk for men (n=31) and the lower limbs for women (n=16) and the mean Breslow index was 4.31 mm (SD=4.22), with histologic ulceration being present in 40% of cases. The mean time to transition to stage IV after discovery of the primary tumour was 2.8 years (SD=2.95). The modes of discovery of metastases comprised clinical examination (functional signs or physical examination) in 58 cases and routine imaging in 50 cases, with no significant differences based on whether patients were initially in stage I-II or in stage III. DISCUSSION: This study shows that over half of patients progressing to stage IV melanoma had a suspicious sign or clinical symptom, once again highlighting the importance of clinical monitoring. In contrast, many organ metastases, particularly pulmonary, were discovered by routine imaging examinations carried out as part of patient follow-up, although this is not currently recommended practice in France. CONCLUSION: The role of powerful imaging examinations such as scans, with constantly improving resolution, still remains to be defined in the follow-up of patients with stage I-II melanoma, and further prospective studies are thus required.

Health status in patients with Alzheimer's disease: an investigation of inter-rater agreement.

OBJECTIVE: The purpose of the present study was to examine the level of agreement between health status ratings provided by patients with Alzheimer's disease and by their proxies. BACKGROUND: Because proxy-completed responses are often necessary in assessing health outcomes for the elderly, it is necessary to determine the feasibility and potential limitations of using proxies as a patient substitutes. METHODS: To assess the potential utility of proxy responses on health status when subjects present a cognitive impairment, this study compared the responses of 70 subjects with Alzheimer's disease and those of their family and/or care provider proxy using the SF-36. Agreement between proxies and patients was measured by intraclass correlation coefficients (ICCs). RESULTS: The proportion of exact agreement between patients and proxies on the 36 items ranged from 3.3 to 41.7%. Results reveal poor to moderate agreement between patient and proxy reports. Proxy reliability varied according to the relationship of the proxy to the index subject. Agreement decreased significantly with increasing severity of dementia and with increasing severity of Physical status (Katz ADL). Agreement was better for measures of functions that are directly observable and relatively poor for more subjective measures. CONCLUSIONS: Our results confirm the importance of the information source used for patient health status.

[Postoperative radiotherapy in N0 laryngeal cancer]. / Radiothérapie postopératoire des cancers laryngés classés N0.

PURPOSE: A retrospective study to re-assess the indications for postoperative radiation therapy in squamous cell carcinoma of the larynx staged N0 after gross resection. PATIENTS AND METHODS: Between January 1975 and December 2000, 166 patients with squamous cell carcinoma of the larynx were treated by total laryngectomy with or without neck dissection. Surgery was completed by external radiotherapy delivering 45 to 65 Gy to the tumour bed and 45 to 50 Gy to cervical lymphatic chains. Minimal follow-up was 36 months and median follow-up was 98 months. RESULTS: The rate of nodal recurrence was 6% (median time for relapse was 9 months). The survival rates at 1, 2, 3 and 5 years were 93.5, 84, 80 and 69% respectively, with a 8 year 3 month median survival. The univariate analysis showed 4 parameters, which significantly increased the risk of local recurrence: the medical necessity for immediate tracheotomy, the subglottic involvement, the involvement of the whole larynx and the presence of lymphatic embols in the neck dissection. There was no statistically significant difference between the patients with or without a neck dissection. Fifty-nine secondary cancers were observed, 15 of them occurring in the head and neck area. The late complications consisted of cervical subcutaneous fibrosis (7%), oesophageal stricture (4%), oeso-tracheal fistula (l%), hypothyroidism (3%), bone necrosis (1%). CONCLUSION: Prophylactic cervical radiotherapy in laryngeal cancers resulted in 6% cervical node recurrence rate. This value may represent the maximal rate to accept if one would favour new therapeutic strategies based on restricted indications for radiotherapy.

[Pharmacodynamic interest of ceftazidime continuous infusion vs intermittent bolus administration in patients with severe nosocomial pneumonia]. / Intérêt pharmacodynamique de la perfusion continue vs l'administration intermittente de ceftazidime dans les pneumonies nosocomiales sévères.

GOAL OF THE STUDY: It is well known today that the main determinant of beta-lactam antibiotics efficacy is the duration of the time that concentrations remain in excess of the minimum inhibitory concentration (MIC) of susceptible organism over the course of therapy. This prospective study aimed to evaluate the efficacy, in term of pharmacodynamic profile, of continuous infusion versus intermittent administration of ceftazidime in intensive care unit patients with severe nosocomial pneumonia. PATIENTS AND METHODS: 16 patients under mechanical ventilation with nosocomial pneumonia were randomised to receive either 60 mg/kg/day ceftazidime by constant rate infusion following a 20 mg/kg loading dose (Group A) or 20 mg/kg every 8 hour by intravenous bolus injection (Group B). In both groups, serial blood samples were collected during 48 hours (12 and 18 samples in Group A and B, respectively) after the start of drug administration. Plasma concentrations of ceftazidime were measured by high performance liquid chromatography. Based on our local bacteriological conditions, the pharmacodynamic profile of ceftazidime was assessed as the duration of time the plasma concentration remained above a desired target concentration of 20 mg/l for each regimen. RESULTS: The mean time (expressed as a percentage) for which plasma ceftazidime concentrations were above 20 mg/l was 100% for the continuous infusion group (Group A) and 56+/-33% for the intermittent administration group (Group B). CONCLUSION: These findings show that ceftazidime administered by continuous infusion in critically ill patients under mechanical ventilation with nosocomial pneumonia appears to substantially improve the pharmacodynamic profile of this beta-lactam compared to the intermittent regimen.

[Pertrochanteric fractures: a randomized prospective study comparing dynamic screw plate and intramedullary fixation]. / Comparaison vis-plaque dynamique et ostéosynthèse intra-médullaire antérograde dans les fractures pertrochantériennes: une étude prospective randomisée.

PURPOSE OF THE STUDY: The objective of this study was to compare the dynamic hip screw (Synthes) and intramedullary fixation (Targon PF, Aesculap) for the treatment of pertrochanteric fractures in terms of stability, complications and cost effectiveness. MATERIAL AND METHODS: This prospective randomized study included 60 patients hospitalized in an emergency setting for pertrochanteric fractures between December 2003 and June 2004. All surgeons in our unit participated in the study. Two fixation systems were used: the Targon proximal femoral nail (Aesculap) and the screw-plate dynamic hip screw (Synthes). We noted: patient status (ASA classification), operative data (type of implant, duration), postoperative data (blood loss, radiographic findings, early complications), and outcome (Harris score, time to walking, mortality). All patients were assessed three months after surgery. The series included 60 patients, 14 men (23%) and 46 women (77%). The Targon PF nail was used for 34 patients and the DHS for 26. In the intramedullary fixation group mean age was 81 years (SD = 12.8, range 23-96); it was 82 years (SD 9.8, range 47-97) in the screw-plate group. The AO classification was: intramedullary fixation 31A1 (n = 11), 31A2 (n = 20), 31A3 (n = 3); screw-plate 31A1 (n = 14), 31A2 (n = 11), 31A3 (n = 1). Thirty-one fractures were stable, 29 unstable. Unstable fractures were treated with the Targon PF nail (n = 18) and the DHS screw-plate (n = 11). Stable fractures were treated with the Targon PF nail (n = 15) and the DHS screw-plate (n = 15). RESULTS: Mean operative time was 35 minutes for intramedullary nailing and 42 mintues for screw-plate fixation. Mean blood loss was 410 ml for intramedullary nailing and 325 ml for screw-plate fixation (p = 0.07). Mean hospital stay was the same (11 days) in both groups. At three months, mechanical complications involved migration of the cervical screw outside the femoral head for three Targon PF fixations and for two DHS fixations. Screw migration was favored by fracture instability and presence of osteoporosis. There were two deaths in the intramedullary nailing group and one in the screw-plate group. Time to walking was 20 days on average in the intramedullary nailing group and 25 days in the screw-plate group. The mean Harris hip score was 60 in the intramedullary group and 59 in the screw-plate group. DISCUSSION AND CONCLUSION: Data in the literature report an advantage for intramedullary nailing, particularly a mechanical advantage, for the treatment of pertrochanteric fractures. Our findings show that good results are obtained with the screw-plate fixation using the DHS with less blood loss and at a lower cost.