ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of weekly paclitaxel combined with S-1 or fluorouracil in the first line treatment of advanced gastric carcinoma.</p><p><b>METHODS</b>Two hundred and forty patients with untreated advanced gastric carcinoma were randomized into two arms, patients in the experimental arm were given paclitaxel and S-1, while those in the control arm received paclitaxel and fluorouracil. The regimen of experimental arm was paclitaxel 60 mg/m(2) by intravenous infusion, day 1, 8, 15; S-1 80 - 120 mg/day given by oral administration, day 1 - 14. The regimen of control arm was fluorouracil 500 mg/m(2) by intravenous infusion continuously, day 1 - 5; CF 20 mg/m(2) by intravenous infusion, day 1 - 5. The regimens in both arms were repeated every 28 days. The efficacy and safety of both arms were assessed.</p><p><b>RESULTS</b>Two hundred and twenty-eight patients were analyzed in the full analysis set, and 192 patients were analyzed in per-protocol set (experimental arm 100 patients, control arm 92 patients). The overall response rates of experimental and control arms were 50.0% and 28.3% (P = 0.002), and the disease control rates were 82.0% and 70.7% (P = 0.064), respectively. The primary endpoints of experimental arm were non-inferior to that of the control arm. The secondary endpoint of experimental arm in terms of median progression free survival was significantly better than that of control arm (5 months versus 4 months, P = 0.006). The experimental arm had a higher incidence of grade III-IV bone marrow suppression than the control arm, but the incidence of fever in both arms was not significantly different.</p><p><b>CONCLUSIONS</b>Oral administration of S-1 is an alternative option of venous infusional fluorouracil. Weekly paclitaxel combined with S-1 is a safe regimen and has a promising efficacy.</p>
Subject(s)
Female , Humans , Male , Middle Aged , Adenocarcinoma , Drug Therapy , Pathology , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Carcinoma, Squamous Cell , Drug Therapy , Pathology , Diarrhea , Disease-Free Survival , Drug Combinations , Fluorouracil , Follow-Up Studies , Leukopenia , Neoplasm Staging , Oxonic Acid , Paclitaxel , Prospective Studies , Remission Induction , Stomach Neoplasms , Drug Therapy , Pathology , Survival Rate , TegafurABSTRACT
Objective To evaluate the efficacy of calcium(Ca)and magnesium(Mg)infusions in pre- vention of oxaliplatin-induced acute neurotoxicity.Methods Fourty-two patients with advanced colorectal carcinoma were eligible for the study:21 were assigned to the Ca/Mg ann and 21 to the control arm.The Ca/ Mg arm and the control arm were comparable for patients'characteristics.Chemotherapy regimen were al- most the same in both arms.Chemotherapy regimen consisted of oxaliplatin 130 mg/m~2 on day 1,given as a 3-hour infusion in 500 ml of 5% glucose,concurrent with rahitrexed 3 mg/m~2 as a 15-minute intravenous (Ⅳ)infusion or calcium folinate(CF)200 mg?m~(-2)?d~(-1),days 1～5,5-Fluorouracil(5-Fu)500 mg?m~(-2)?d~(-1),days 1～5.Therapy was repeated every 3 weeks.The treatment consisted of Ca gluconate and Mg sulfate,1 g each, delivered i.v.over 15 min just before the oxaliplatin infusion and repeated at the same dose after the comple- tion of the oxaliplatin infusion.A specific neurotoxicity scale was used for oxaliplatin-related neurotoxicity. Results Ten patients(47.62%)had acute neurotoxicity in the Ca/Mg arm compared with 19 patients (90.48%)in the control arm(P0.05).Conclusion Ca/Mg infusions seem to reduce incidence and intensity of oxaliplatin-induced acute neurotoxicity,and they do not reduce the clinical activity of oxaliplatin,but dosage and administration schedule could be optimized.