Clinical determinants of survival in patients with 5-fluorouracil-based treatment for metastatic colorectal cancer: results of a multivariate analysis of 3825 patients.

BACKGROUND: Patients with metastatic colorectal cancer are usually offered systemic chemotherapy as palliative treatment. A multivariate analysis was performed in order to identify predictors and their constellation that allow a valid prediction of the outcome in patients treated with 5-fluorouracil (5-FU)-based therapy. PATIENTS AND METHODS: A total of 3825 patients treated with 5-FU within 19 prospective randomised and three phase II trials were separated into learning (n = 2549) and validation (n = 1276) samples. Data were analysed by tree analysis using the recursive partition and amalgamation method (RECPAM). A predictor could only enter the RECPAM analysis if the number of patients with missing values was < 33.3% within a node, and the minimal node size was set to 50 patients. Twenty-three potential predictors were grouped into subsets of laboratory variables (11 parameters), tumour-related variables (seven parameters) and clinical variables (five parameters). In the first step, tree analysis was performed separately for each predictor subset. The selected prognostic parameters of the resulting partial models (the 'winners') were entered into the general model. The classification rule from the data of the learning set was applied to the independent validation set. RESULTS: Winners of the subgroup analysis for laboratory variables were: platelets > or = 400 x 10(9)/l, alkaline phosphatase > or = 300 U/l, white blood cell (WBC) count > or = 10 x 10(9)/l and haemoglobin < 11 x 10(9)/l, and all predicted a worse outcome. Negative predictors within the subgroup of tumour parameters were: number of tumour sites more than one or more than two, presence of liver metastases or peritoneal carcinomatosis, which predicted a worse outcome. Furthermore, presence of lung metastases, a primary rectal cancer and presence of lymph node metastases all predicted a better outcome in the multivariate setting. Among the clinical parameters only performance status of ECOG 0 or 1 predicted better outcome. In the final regression tree, three risk groups could be identified: low risk group (n = 1111) with a median survival of 15 months for patients with ECOG 0/1 and only one tumour site; intermediate risk group (n = 904) with a median survival of 10.7 months for patients with ECOG 0/1 and more than one tumour site and alkaline phosphatase < 300 U/l or patients with ECOG > 1, WBC count < 10 x 10(9)/l and only one tumour site; high risk group (n = 534) with a median survival of 6.1 months for patients with ECOG 0/1 and more than one tumour site and alkaline phosphatase of > or = 300 U/l or patients with ECOG > 1 and more than one tumour site or WBC count > 10 x 10(9)/l. The median survival times for the good, intermediate and high risk groups in the validation sample were 14.7, 10.5 and 6.4 months, respectively. CONCLUSIONS: Patients can be divided into at least three risk groups depending on the four baseline clinical parameters: performance status, WBC count, alkaline phosphatase and number of metastatic sites. Any molecular or biological marker should be validated against these clinical parameters and decisions for more or less intensive treatments may be studied separately in these three risk groups. Also, clinical trials should be stratified according to the three risk groups.     

Psychological distress across the course of care: a case study from implantable cardioverter defibrillator to cardiac transplantation evaluation

The psychological distress of cardiac patients can complicate treatment or the recovery process. This case study presents a 47-year-old male recipient of an implantable cardioverter defibrillator who experienced multiple, consecutive shocks and subsequently developed anxiety and depressive difficulties. Psychological treatment to diminish these symptoms was employed. Despite declining cardiac function, the patient made significant progress in managing this negative affect. Subsequently, he was evaluated for cardiac transplant, and this treatment progress became critical evidence of his psychosocial suitability for transplant.     

Computer graphics for digitally formatted images

The increasing use of digitally formatted imaging systems requires high-quality interactive gray-scale computer raster graphics systems for the management, display, and analog film recording of digital image and alphanumeric information. These systems are a combination of computer hardware and software and implement a set of graphics protocols. This paper describes a set of interactive graphics protocols that has been developed for clinical use.     

Mapping the quality of life and unmet needs of urban women with metastatic breast cancer

Enhancing quality of life and reducing the unmet needs of women are central to the successful management of advanced breast cancer. The objective of this study was to investigate the quality of life and support and information needs of urban women with advanced breast cancer. This study was conducted at four large urban hospitals in Melbourne, Australia. A consecutive sample of 105 women with advanced breast cancer completed a questionnaire that contained the European Organization of Research and Treatment of Cancer Quality of Life Q-C30 and the Supportive Care Needs Survey. Between one quarter and a third of the women reported difficulties with their physical, role and social functioning, and a little over a quarter of the women reported poor global health status. Fatigue was a problem for most women. The highest unmet needs were in the psychological and health information domains. Almost no differences in unmet needs were detected when comparing different demographic and disease characteristics of women. Health care providers should routinely monitor the quality of life and needs of women with advanced breast cancer to ensure that appropriate treatment, information or supportive services are made available.     

Preoperative factors and models predicting mortality in liver transplantation

We analyzed preoperative factors related to postoperative mortality after liver transplantation among a cohort of 268 consecutive liver transplant patients over 6 years. We studied the impact of 10 recipient variables, 14 donor features, and three operative aspects. We also studied the correlation with death and survival using various predictive scores (Child, Cordoba Score, MELD, and UCLA). Univariate analysis showed that the factors with a significant association with postoperative mortality were the use of noradrenaline in the donor, total ischemia time (>12 hours), and transplant indication (hepatitis C virus versus the rest). Multivariate analysis of mortality showed the impact of female donor sex, recipients over >60 years, recipient albumin less than 2.8, and total graft ischemia time more than 12 hours. Univariate analysis of 1-year survival showed a statistically significant relation with D/R gender similarity, as well as donor GOT (>170) and GPT (>140) values. Multivariate analysis of 1-year survival showed donor GOT (>170) and donor/recipient gender similarity to be significant. Concerning the prediction models, Child-Pugh (AB versus C) best determined postoperative mortality (P < .006), MELD was predictive of 1-year survival (P < .03). The most important variables related to postoperative mortality were total ischemia time over 12 hours, recipient albumin less than 2.8, and age above 60 years. The variable with most impact on 1-year survival was the degree of graft hepatocyte lesion as determined by GOT. The Child-Pugh system is still the best indicator of postoperative mortality, although MELD may also be a good predictor of survival.     

Pancreas islet transplantation in patients with type 1 diabetes mellitus after kidney transplantation

Diabetic patients with end-stage renal disease have a high mortality rate. A combined kidney-pancreas transplant is associated with greater life expectancy. Pancreas islet transplantation is an alternative involving a lower degree of morbidity. We present two patients, of 41 and 37 years of age, with a long history of diabetes mellitus (C-peptide negative), both with a previous kidney transplant, who had been treated with 22 and 28 U of insulin/d, respectively. Both patients had frequent episodes of unawareness hypoglycemia. Pancreatic islets were infused to a total of 7809 and 19,180 IE/kg, respectively. Basal posttransplant C peptide levels were 2.9 and 1.3 ng/mL. After the implant, one patient required occasional doses of insulin, and the other patient more than 50% reduced dose. After the first implant neither patient had any episodes of unawareness hypoglycemia. HbA1c at 4 months were 6.2% and 6.9%. There were no transplant-related complications.