Japanese Journal of Clinical Oncology Advance Access published online on March 4, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp008
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© The Author (2009). Published by Oxford University Press. All rights reserved
Multi-center Phase II Trial of Weekly Paclitaxel Plus Cisplatin Combination Chemotherapy in Patients with Advanced Gastric and Gastro-esophageal Cancer
1 Department of Medical Oncology, Wuxi 2nd Hospital, Nanjing Medical University
2 Department of Medical Oncology, Wuxi People Hospital, Nanjing Medical University, Nanjing
3 Department of Medical Oncology, Zhejiang Cancer Hospital, Zhejiang Traditional Chinese Medicine University, Zhejiang
4 School of Public Health, Peking University, Peking
5 Department of Medical Oncology, The First People of Kunshan Hospital, Medical School of Jiangsu University, Jiangsu
6 AmMed Cancer Center, Shanghai Ruijin Hospital, Medical School of Shanghai Jiaotong University, Shanghai, People's Republic of China
For reprints and all correspondence: Daoyuan Wang, AmMed Cancer Center, Shanghai Ruijin Hospital, Medical School of Shanghai Jiaotong University, No. 197, Rui Jin Er Lu, Shanghai 200025, People's Republic of China. E-mail: ghealth2008{at}gmail.com
Received November 21, 2008; accepted January 12, 2009
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/m2 was administered through a 1 h intravenous infusion on Days 1 and 8. The cisplatin 30 mg/m2 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 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.
Key Words: advanced gastric cancer • advanced gastro-esophageal cancer • paclitaxel • cisplatin • weekly