Our purpose was to determine the response rate and median and overall survival of gemcitabine as monotherapy versus gemcitabine plus irinotecan in advanced or metastatic pancreatic cancer. Patients with histologically or cytologically confirmed adenocarcinoma who were chemotherapy and radiotherapy naive were enrolled. Patients were centrally randomised at a one-to-one ratio to receive either gemcitabine monotherapy (900 mg m À2 on days 1, 8 and 15 every 4 weeks (arm G), or gemcitabine (days 1 and 8) plus irinotecan (300 mg m À2 on day 8) (arm IG), repeated every 3 weeks. The total number of cycles administered was 255 in the IG arm and 245 in the G arm; the median number of cycles was 3. In all, 145 patients (71 in arm IG and 74 in arm G) were enrolled; 60 and 70 patients from arms IG and G, respectively, were evaluable. A complete clinical response was achieved in three (4.3%) arm G patients; nine (15%) patients in arm IG and four (5.7%) in arm G achieved a partial response. The overall response rate was: arm IG 15% and arm G 10% (95% CI 5.96 -24.04 and 95% CI 2.97 -17.03, respectively; P ¼ 0.387). The median time to tumour progression was 2.8 months and 2.9 months and median survival time was 6.4 and 6.5 months for the IG and G arms, respectively. One-year survival was 24.3% for the IG arm and 21.8% for the G arm. No statistically significant difference was observed comparing gemcitabine monotherapy versus gemcitabine plus irinotecan in the treatment of advanced pancreatic cancer, with respect to overall and 1-year survival.

This study was conducted to investigate the clinical utility of CEA, CA 19-9, and CA-50 in the diagnosis, monitoring, and prognosis of 62 gastric carcinoma patients having either adjuvant or palliative chemotherapy. Patients were divided in two groups: group A included patients treated on an adjuvant basis following a curative resection of gastric cancer, and group B included patients with residual disease post surgery or patients with inoperable tumor or generalized disease. Serum marker levels were measured in a prospective study just before the initiation of chemotherapy and before each course during chemotherapy. In group A, CEA was positive in 2/25 (8%) patients, CA 19-9 in 1/25 (4%), and CA-50 in 1/25 (4%). In group B the sensitivity of CEA was 48.6% (18/37 patients), of CA 19-9 64.9% (27/37 patients), and of CA-50 70.3% (26/37) patients. There was a significant correlation between the CA 19-9 and CA-50 levels in both groups. No correlation was found between the sensitivity or the absolute initial marker levels and the tumor's differentiation or extent of disease. In group A the only patient with initially elevated CA 19-9 and CA-50 values relapsed early while he was on adjuvant chemotherapy. It was also found that the rising final CA 19-9 and CA-50 values at the end of chemotherapy were correlated with an increased incidence of relapse, but not with the disease-free interval. In group B the initially low marker levels showed a trend to predict a favorable outcome of treatment. There was no statistically significant correlation between the marker titers before each course and response to chemotherapy. It is concluded that the comeasurement of CA 19-9 and CA-50, and to some degree of CEA, is justifiable for gastric cancer. The estimation of CA 19-9 and CA-50 may be useful for early detection of recurrence after curative surgery and adjuvant chemotherapy. In advanced or recurrent gastric cancer, the estimation of either CA 19-9 or CA-50 and CEA serum values may help in checking the prognosis, determining the efficacy of palliative treatment modalities, and recognizing recurrences.

A total of 76 patients with transitional cell carcinoma of the bladder were prospectively monitored with simultaneous serum value estimations of tumor polypeptide antigen (TPA), tumor-associated trypsin inhibitor (TATI), carcinoembryonic antigen (CEA), alpha-fetoprotein (AFP), beta-human chorionic gonadotropin (beta-HCG), prostatic specific antigen (PSA), squamous cell carcinoma antigen (SCC), and CA 19-9 in different stages and phases of their disease. In locally advanced disease positive values were noted for TATI in 22/28 patients (78.5%), for TPA in 17/28 (60.7%), for CA 19-9 in 10/28 (35.7%), for CEA 11/28 (39.2%), for beta-HCG in 3/28 (10.7%), for PSA in 6/28 (21.4%), for SCC in 6/28 (21.4%), and for AFP in 0/28. In metastatic disease elevated levels were observed for TATI in 43/48 patients (89.5%), for TPA in 41/48 (85.4%), for CA 19-9 in 19/48 (39.5%), for CEA in 20/48 (41.6%), for beta-HCG in 6/48 (12.5%), for PSA in 7/48 (14.5%), for SCC in 8/48 (16.6%), and for AFP in 1/48 (2.1%). In metastatic disease TATI and TPA values were significantly modified in patients with complete remission and TATI, TPA, and CA 19-9 in patients with partial remission and nonresponders. In T2-T4-N0M0 tumors, TPA, TATI, CA 19-9, and CEA were significantly increased in nonresponders. In patients with complete remission, a change in serum TATI, TPA, and CA 19-9 levels cannot be evidenced with the available numbers. The concurrent determination of TATI and TPA in T2-T4N0M0 tumors and TATI, TPA, and CA 19-9 in generalized disease could predict the response to chemotherapy. This study indicates that only the determination of TATI and TPA and in some degree the CA 19-9 is a potential tool for monitoring the efficacy of treatment.

No abstract