Purpose: To assess the efficacy and safety of S-1, a novel oral fluoropyrimidine derivative, we conducted a multicenter late phase II study in patients with advanced gastric cancer. Patients and Methods: Fifty-one patients who had received no previous chemotherapy were enrolled. Fifty patients were eligible for efficacy and safety analyses. The overall response was evaluated for the 43 patients who had metastatic lesions. S-1 was administered orally after breakfast and dinner for 28 days, followed by a 14-day break. The dosages were assigned according to the patients’ body surface area (BSA): BSA <1.25 m2, 40 mg; 1.25–1.5 m2, 50 mg, and BSA ≥1.5 m2, 60 mg, twice daily. Results: The overall response to treatment was evaluated as partial response in 19 of the 43 patients (44%; 95% confidence interval 30–59%). The median survival time in all patients was 207 days with 1- and 2-year survival rates of 36.0 and 14.0%, respectively. Grade 3 adverse reactions included decreased hemoglobin values in 2 patients, leukopenia, neutropenia and diarrhea in 1 patient each. No other grade 4 or unexpected adverse reactions were seen. Conclusions: S-1 is effective against advanced gastric cancer. This oral treatment is suitable for outpatients because of its mild toxicity. Further therapeutic benefits are likely to be obtained by combining S-1 with other chemotherapeutic agents.
We cannot deny that, with the recent rise in the recovery rate of cancers, the significance of mortality statistics in studying the geographical distribution of cancer has been reduced, but seeing that in many part of the world, however, no survey on cancer morbidity has been carried out to date, we believe, the significance has not yet been lost altogether. We applied to the central statis tical administrations of many countries and have been kindly supplied with data on the mortality for cancer. In this report, we will write on the ageadjusted death rates for cancer for the two years of 1954 and 1955 and on the geographical correlation among them.
Method of StudyWe have been furnished with the statistical data on the population and the mortality for cancers in some specified sites by the central statistical adminis trations of 23 countries and calculated the age-adjusted death rates. The countries from which we were furnished the data were as follows :
Aim:To assess the validity of the measurement of pepsinogen I and II as a screening test for gastric cancer and pre-malignant lesions, namely low-grade dysplasia, both in the general population and in selected groups of patients.
Methods:A meta-analysis of sensitivity and specificity results from individual papers on the use of the pepsinogen test. An intrinsic cut-off effect was assumed and a random effect model was used for pooling.Results: Forty-two data sets were included: 27 (64%) population-based screening studies (n=296,553) and 15 (36%) sets of selected individuals (n=4385). Homogenous sensitivity and diagnostic odds ratio (DOR) estimates were found in studies using both pepsinogen I levels and pepsinogen I/II ratio calculations. Pooled pairs of sensitivity and false positive rates (FPr) for pepsinogen I ≤70; pepsinogen I/II ratio ≤3, pepsinogen I ≤50; pepsinogen I/II ratio ≤3, and pepsinogen I ≤30; pepsinogen I/II ratio ≤2, were sensitivity 77%/FPr 27%, sensitivity 68%/FPr 31%, and sensitivity 52%/FPr 84%, respectively. Positive predictive values (PPV) varied between 0.77% and 1.25%, and negative predictive values (NPV) varied between 99.08% and 99.90%. In selected groups, pooling was only possible when considering pepsinogen I ≤70; pepsinogen I/II ratio ≤3: giving sensitivity 57%, specificity 80%, PPV 15% and NPV 83%. As for the diagnosis of dysplasia, studies considering pepsinogen I <50; pepsinogen I/II ratio <3 obtained sensitivity 65% and specificity ranging from 74%-85%, both with NPV >95%.
Conclusion:Pepsinogen test definition should include pepsinogen I/II ratio as consistency was obtained, both in population based studies and in selected groups for those studies that used pepsinogen I serum levels together with pepsinogen I/II ratio for screening for gastric cancer in highincidence regions other than Japan. Further studies of this test in the management of high-risk patients seem to be worthwhile.
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