A phase II prospective randomized controlled trial of weekly paclitaxel combined with S-1 or fluorouracil for advanced gastric carcinoma / 中华肿瘤杂志

<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>

A crossover control study of prophylactic treatment of chemotherapy-induced constipation by senna extract / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the prophylactic effects of senna extract 40 mg/kg on chemotherapy-induced constipation.</p><p><b>METHODS</b>Eighty-two patients suffering from constipation after chemotherapy were assigned to Group AB and Group BA. Group AB referred to patients who first took senna extract in the 1st chemotherapeutic course and the crude fiber diet in the 2nd chemotherapeutic course. But the sequence was just the opposite in Group BA. The effective rates of relieving chemotherapy-induced constipation by senna extract and by the crude fiber diet were observed. The differences of the digestive tract reaction and the hematotoxicity reaction were compared. The conditions of patients' abdominal pain and stool properties were observed after they took senna extract.</p><p><b>RESULTS</b>The effective rate of constipation by taking senna extract was 92.68% and that by the crude fiber diet was 10.93%, with statistical difference shown (P < 0.01). There was no statistic difference in adverse reaction rate such as decreased neutrophils over degree II, decreased hemoglobin, decreased platelet, nausea, vomit, etc. (P > 0.05). The occurrence rate of abdominal pain over degree II after taking senna was 8.54%. In the distribution of stool properties, the rate of loose stool was 35.53%.</p><p><b>CONCLUSION</b>Senna extract 40 mg/kg was effective and safe in treating chemotherapy-induced constipation.</p>

Comparison of the therapeutic effects of paclitaxel liposome-5-Fu versus paclitaxel-5-Fu on 67 patients with advanced gastric cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To explore the efficacy, time to disease progression (TTP), overall survival (OS) and toxicity of paclitaxel liposome versus paclitaxel combined with 5-fluorouracil (5-Fu) for patients with advanced gastric cancer.</p><p><b>METHODS</b>The therapeutic efficacy of chemotherapy with either of the two regimens for 67 cases of naïve advanced gastric cancer was analyzed. Among them, 31 patients in the paclitaxel liposome-5-Fu group received paclitaxel liposome 175 mg/m(2) d1, CF 200 mg/m(2) d1, 5-Fu 2.6 g/m(2) civ. 46 hours, 21 days as one cycle, and 34 patients in the paclitaxel-5-Fu group received paclitaxel 175 mg/m(2) d1, CF 200 mg/m(2) d1, 5-Fu 2.6 g/m(2) civ. 46 hours, 21 days as one cycle.</p><p><b>RESULTS</b>The objective response rate was 54.8% in the paclitaxel liposome group and 44.1% in the paclitaxel group (P = 0.388). The median time to progression was 5.10 months vs. 5.20 months (P = 0.266) and the median survival time was 10.07 months vs. 8.97 months (P = 0.186). The most frequent side-effects were nausea, vomit and hematological toxicities. The rates of grade III-IV nausea and vomit were 16.1% and 50.0% (P = 0.038), muscle and joint pain were 9.7% and 29.4% (P = 0.047).</p><p><b>CONCLUSION</b>Both regimens are effective in the treatment of advanced gastric cancer. However, less adverse effects occur in the paclitaxel liposome group.</p>