Multi-center Phase II Trial of Weekly Paclitaxel Plus Cisplatin Combination Chemotherapy in Patients with Advanced Gastric and Gastro-esophageal Cancer

Q. Sun, C. Liu, H. Zhong, B. Zhong, H. Xu, W. Shen, D. Wang
2009 Japanese Journal of Clinical Oncology  
Objective: This study is performed to evaluate the response rate, time to progression and safety of the combination chemotherapy with weekly paclitaxel plus cisplatin in advanced gastric and gastro-esophageal cancer. Methods: The paclitaxel 100 mg/m 2 was administered through a 1 h intravenous infusion on Days 1 and 8. The cisplatin 30 mg/m 2 was also administered along with a program of forced diuresis that included at least 2000 ml of fluids after the paclitaxel infusion over 30 min on Days 1
more » ... and 8. The chemotherapy was given every 21 days and continued until disease progression, patient refusal or an unacceptable toxicity up to nine cycles. Results: Forty-seven (95.9%) of the 49 patients were assessable for response. Two cases of complete response and 19 cases of partial response were confirmed, giving an overall response rate of 42.9% (95% CI, 29.0 -56.8%). The median time to progression and overall survival for all patients were 5.9 months (95% CI, 1.6 -9.1 months) and 11.2 months (95% CI, 6.1 -21.3 months). The most severe hematologic adverse event was neutropenia, which occurred with a Grade 3 intensity in 17.0% and Grade 4 in 4.3%. Grade 3 vomiting, peripheral neuropathy and elevated transaminase were observed in 4.3%, 4.3% and 2.1% of patients. Conclusions: Combination of weekly paclitaxel plus cisplatin is an active regimen with excellent tolerability as a first-line treatment of advanced gastric and gastro-esophageal cancer.
doi:10.1093/jjco/hyp008 pmid:19264768 fatcat:t7dqpmxaxjgbzfek742g7igfu4