Laboratory variables to stratify metastatic colorectal cancer patients.
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Biomedical subjects
Publications and source records attributed to J Watine.
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OBJECTIVE: To identify, through a review of the literature, the laboratory variables that would allow a more accurate stratification of unresected non small-cell lung cancer patients who participate in clinical trials. METHOD: Systematic review, without meta-analysis, following the recommendations of the International Federation of Clinical Chemistry and Laboratory Medicine, and taking into account the Consolidated Standards of Reporting Trials statement. RESULTS: Of 1106 publications retrieved, we were able to include only fourteen studies in our review. Available evidence would support the use of several laboratory variables as prognostic covariables to stratify non resected non small-cell lung cancer patients in clinical trials, but blood haemoglobin would be the only one that could be recommended on a routine basis, and only in patients treated with radiotherapy (three studies out of three). The possible consequences in terms of therapeutic decision of haemoglobin measurements remain however to be clarified. CONCLUSION: Until better designed studies are published, a number of arguments would support the pre-treatment measurements of the following variables in patients participating in clinical trials: blood haemoglobin, white blood cell count with differential, serum LDH, albumin, calcium, and NSE. Further studies would also be necessary to support the addition to this list, of other tumour markers (including Cyfra 21-1), and/or measurements during or after treatment.
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PURPOSE: We attempted to answer the question of whether serum levels of carcinoembryonic antigen provide prognostic information, in terms of survival, in patients resected for colorectal liver metastases, independently of that provided by other commonly used radioclinical and pathologic factors. METHOD: We performed a systematic review, without meta-analysis, of the biomedical literature using the methodology recommended by the Committee on Evidence-Based Laboratory Medicine of the International Federation of Clinical Chemistry and Laboratory Medicine. RESULTS: Despite the absence of sufficient details about the methods used to measure serum carcinoembryonic antigen in the 14 studies reviewed, strong arguments exist to include preoperative carcinoembryonic antigen measurements in future trials on the subject. In particular, preoperative carcinoembryonic antigen was found to be significant in the two studies with the greatest number of patients having a preoperative carcinoembryonic antigen assay, in the four studies with the most recent series of patients, in the study in which preoperative carcinoembryonic antigen was used as a continuous variable, and in the study in which preoperative carcinoembryonic antigen was used in terms of doubling time. Postoperative carcinoembryonic antigen was found to have a prognostic significance in the only two studies that evaluated this variable. CONCLUSION: Taking into account the possible reasons for disagreements regarding carcinoembryonic antigen prognostic value between the 14 studies reviewed, we propose some recommendations to improve the reproducibility and the quality of future studies in this field. In particular, we stress the need for a higher degree of multidisciplinary collaboration in clinical trials.
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OBJECTIVE: To search for laboratory variables having independent prognostic signification in patients with unresected colorectal liver metastases. METHODS: We have systematically reviewed the biomedical literature using the methodology recommended by the Committee on Evidence-Based Laboratory Medicine of the International Federation of Clinical Chemistry and Laboratory Medicine, and taking into account the Consolidated Standards of Reporting Trials Statement. RESULTS: Of 644 publications retrieved, the application of strict exclusion and inclusion criteria allowed us to include only eight studies in our systematic review. The main laboratory variables evaluated in these eight studies were serum carcino-embryonic antigen, alkaline phosphatase, albumin, bilirubin, and plasma prothrombin time. None of these variables were unanimously found to have an independent prognostic significance. A meta-analysis was not possible, mainly because of heterogeneity within the primary studies and these contradictory results. CONCLUSIONS: Current evidence would not support the routine use of laboratory variables as independent prognostic variables in patients with unresected colorectal liver metastases. Taking into account the inadequate quality of the published studies, this negative conclusion might be provisory only. Until better designed studies are published, a number of arguments would support to recommend pre-treatment measurement of serum carcino-embryonic antigen and alkaline phosphatase in patients participating in clinical trials.
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We have systematically reviewed the biomedical literature to try to establish whether laboratory variables might give any additional prognostic information in non-small-cell lung cancer (NSCLC) patients independently of the usual radioclinical parameters. In each study, we acknowledged the independent prognostic value of a biological fluid variable if it had been demonstrated through a multivariate statistical analysis in which at least the following had been included: patient's weight loss, age, gender, performance status, histology, stage and extent of the disease. The clearest conclusion that can be derived from the 42 studies we reviewed is that it remains to be clearly demonstrated whether or not the "new" tests (tumour markers, p53 antibodies, etc.) are superior to the "old" tests (serum LDH, calcium, albumin or other proteins, blood cell counts, etc.), even though a number of studies did suggest that serum cyfra 21-1 has a pre-therapeutic prognostic significance in NSCLC. From the four studies in which the same powerful statistical methodologies were used (i.e. Cox models in association with RECPAM analysis), it could be derived that serum calcium and perhaps the blood neutrophil and lymphocyte counts might have independent pre-therapeutic prognostic significance in advanced NSCLC. Further studies are needed to demonstrate whether repeated measurements during therapeutic follow-up can bring any independent prognostic information. Provided that both laboratory and statistical expertise is clearly guaranteed in future primary studies published in this particular biomedical field, it might perhaps become possible to propose laboratory variables as additional prognostic parameters in NSCLC.
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