Cytoreductive Surgery Combined with Hyperthermic Intraperitoneal Chemotherapy with Oxaliplatin Increases the Risk of Postoperative Hemorrhagic Complications: Analysis of Predictive Factors.

BACKGROUND: Treatment of peritoneal carcinomatosis (PC) using cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is recommended as curative treatment for selected patients. Modalities of HIPEC remain heterogeneous and HIPEC using oxaliplatin (HIPEC-Ox) appears to increase the risk of postoperative hemorrhagic complications (HCs). OBJECTIVE: The aim of this study was to assess the risk of HCs after CRS combined with HIPEC-Ox versus other drugs, and to determine predictive factors for HCs after HIPEC-Ox. METHODS: Data from 701 patients included in the National French Registry who were treated with CRS and HIPEC at 24 centers between 1998 and 2007 were used to evaluate the incidence of HCs following HIPEC with or without oxaliplatin. Overall, 771 patients treated with HIPEC-Ox at five French specialty centers were then analyzed to determine factors associated with the occurrence of HCs. RESULTS: The overall incidence of HCs was 9.8 %. When used with HIPEC, oxaliplatin significantly and independently increased the rate of HCs (15.7 vs. 2.6 % for other drugs; p = 0.004, odds ratio 32.4). Among the 771 patients who underwent HIPEC-Ox, HCs occurred in 14.3 % of patients. The only independent risk factor for HCs was an extended PC with a Peritoneal Cancer Index (PCI) >12 (p = 0.040). CONCLUSION: HIPEC-Ox increases the risk of HCs compared with HIPEC with other drugs. The potential oncologic benefit of oxaliplatin and the risk of HCs should be considered in patients with PC who have a high PCI, as well as in at-risk patients.

Pathologic Response, When Increased by Longer Interval, Is a Marker but Not the Cause of Good Prognosis in Rectal Cancer: 17-year Follow-up of the Lyon R90-01 Randomized Trial.

PURPOSE: The Lyon R90-01 randomized trial investigated whether the interval between preoperative radiation therapy and surgery influenced rectal cancer outcome. Long-term results are reported here after a median follow-up of 17 years. METHODS AND MATERIALS: Between February 1991 and December 1995, 210 patients from 29 French centers were randomly assigned (ratio of 1:1) to groups that waited either 2 weeks (short interval [SI]) or 6 to 8 weeks (long interval [LI]) between neoadjuvant radiation therapy and surgery. The primary endpoint was sphincter-preserving surgery. RESULTS: LI group showed a better pathologic response (complete response or few residual cells) after radiation therapy than the SI group (26% vs 10.3%, P=.015). A better pathologic response was associated in multivariate analysis with significant improvement of overall survival (pT: P=.0293 and pN: P=.0048) but it was irrespective of the interval duration. The median follow-up was 17.2 years. The 5-, 10-, 15-, and 17-year overall survival rates were, respectively, 66.8%, 48.7%, 40.0%, and 34.0% for the SI group and, respectively, 67.1%, 53.5%, 41.9%, and 34.0% for the LI group. There were no significant differences between groups in terms of survival (P=.7656) or local recurrence rates (SI: 14.4% vs LI: 12.1%, respectively; P=.6202). Of 24 local disease recurrences, 20 (83%) occurred during the first 2 postoperative years, and all but one (96%) occurred during the first 5 postoperative years. The rate of second new malignancies was 9.4% (19 patients). CONCLUSIONS: The radiation-induced sterilization rate of the preoperative cancer specimen was a marker of good prognosis. The interval duration (the treatment being the same) although it is modifying the sterilization rate has no impact on survival. Radiation therapy did not postpone local recurrence, because the rate of local relapse after 5 years was low. Radiation-induced cancers after radiation therapy were unusual and should not influence treatment decisions in adults.

[Reluctance of patients with chronic kidney disease stage 3 to join education programs offered by a health network]. / Freins à la participation des patients en stade 3 de la maladie rénale chronique à l'éducation thérapeutique proposée en réseau de santé

INTRODUCTION: Therapeutic education helps patients to acquire the knowledge and ability to live with their disease. However, some patients are not willing to take part in a health education program. Identifying the barriers of their non-adherence would help us to determine accurately their effective educational needs and to adapt the program to deliver a better education for less-motivated patients. PATIENTS AND METHODS: An education program for chronic kidney disease stage 3 patients was implemented across a health network. The study is based on patient's participation during each step of the program. The reasons for non-participation were collected, via direct survey and cross-referencing with available medical records. RESULTS: From 80 eligible patients, and after medical approval, 66 patients received information about the program. Thirty-six patients elected to participate in program and 21 of them joined a therapeutic education group. We did not find any significant differences in the medical or social profile to determine the characteristics of non-participating patients. We found less program involvement however, with patients complying with biomedical follow-up but who do not benefit from complementary paramedical care. CONCLUSION: Nearly half of patients did not take part in the therapeutic education program, primarily those who did not benefit from a multidisciplinary team to manage their chronic disease. Therapeutic education remains a less known concept by patients, and requires an informative and encouraging exhortation from practitioners during casual medical care.

Impact of prior CKD management in a renal care network on early outcomes in incident dialysis patients: a prospective observational study.

BACKGROUND: Effective therapeutic strategies are available to prevent adverse outcomes in patients with chronic kidney disease (CKD) but their clinical results are hindered by unplanned implementation. Coordination of care emerges as a suitable way to improve patient outcomes. In this study, we evaluated the effect of planned and coordinated patient management within a dedicated renal care network comparatively to standard renal care delivered in nephrology departments of teaching hospitals. METHODS: This observational matched cohort study included 40 patients with CKD stage 4-5 in the network group as compared with a control group of 120 patients matched for age, sex and diabetic status. Main outcome was a composite endpoint of death from cardiovascular cause and cardiovascular events during the first year after dialysis initiation. RESULTS: There was no difference between the two groups neither for the primary outcome (40% vs 41%) nor for the occurrence of death from cardiovascular cause or cardiovascular events. Whereas the proportion of patients requiring at least one hospitalization was identical (83.3% vs 75%), network patients experienced less individual hospitalizations than control patients (2.3 ± 2.0 vs 1.6 ± 1.7) during the year before dialysis start. Patients of the network group had a slower renal function decline (7.7 ± 2.5 vs 4.9 ± 1.1 ml/min/1,73 m(2) per year; p=0.04). CONCLUSIONS: In this limited series of patients, we were unable to demonstrate a significant impact of the coordinated renal care provided in the network on early cardiovascular events in incident dialysis patients. However, during the predialysis period, there were less hospitalizations and a slower slope of renal function decrease.

Use of a collaborative database for epidemiological analyses and professional practice evaluation.

RATIONALE: In nephrology, the NEOERICA project assessed the feasibility of the diagnosis scheme based on a general practice database. This approach opened a new area where routinely collected data could be used for purposes other than patient management, such as epidemiological analysis and professional practice evaluation. In Lyon, the TIRCEL network is made up of a coordination team and an online database. In 2008, a total of 468 professionals participated and 983 patients were in the database corresponding to 4114 consultations and 9250 biological assessments. OBJECTIVE: To investigate the impact of a quality control process on the data from operational databases. METHODS: We set up a quality control process and we described the impact of this process on data. We also specifically investigated the role of measurement scales in error frequency and we studied the impact of data quality on variables which could be used for professional practice evaluation. RESULTS: Quality control allowed us to detect as inconsistent data 7.5% of tested data. This rate is linked to the parameters and varied from less than 1% (weight, diastolic blood pressure and urinary sodium) to more than 30% (serum iron and ferritin). Quality control led mainly to the validation of the identified data for 80.4%, a direct correction was realized for 12.9%, 5.6% by the lab and only 1.2% were set to missing. Average proteinuria was modified with the quality control process (2.09 g per 24 hours vs. 0.82 g per 24 hours); however, the median remained stable (0.21 g per 24 hours). CONCLUSION: Specialty databases such as TIRCEL could not be used for epidemiological research or for the extraction of indicators for professional practice evaluation without strict quality control or the set-up of data-entering limits and alarms.

Increased bone resorption is associated with higher mortality in community-dwelling men >or=50 years of age: the MINOS study.

Low BMD, high concentration of 17beta-estradiol (17betaE2), and decreased level of 25-hydroxycholecalciferol [25(OH)D] predict mortality. Our hypothesis is that high levels of biochemical bone turnover markers (BTMs) are independent predictors of mortality in home-dwelling men. In 781 men >or=50 yr of age followed up prospectively for 10 yr, we studied the association of BTMs with mortality after adjustment for confounders including BMD, major osteoporotic fractures, and concentrations of 17betaE2 and 25(OH)D. Men who died had lower BMD and higher BTM levels. In multivariate models, mortality was higher in men with low BMD (lowest quartile) at the total hip, whole body, and ultradistal radius (HR = 1.49-1.70, p < 0.05). After exclusion of the first 3 yr, higher levels (fourth quartile) of bone resorption markers (free and total deoxypyridinoline and urinary and serum type I collagen C-telopeptide) predicted mortality in multivariate models adjusted for age, BMI, smoking habits, alcohol intake, physical performance and activity, comorbidities, total hip BMD, major osteoporotic fractures, creatinine clearance, season, and concentrations of 17betaE2 and 25(OH)D (HR = 1.58-2.44, p < 0.05-0.001). In conclusion, in older community-dwelling men, increased bone resorption markers levels predicted mortality regardless of age and other confounders. Thus, in older men, high bone resorption may reflect poor current health status and poor aging.