Japanese Journal of Clinical Oncology Advance Access originally published online on December 6, 2005
Japanese Journal of Clinical Oncology 2005 35(12):720-726; doi:10.1093/jjco/hyi198
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© 2005 Foundation for Promotion of Cancer Research
Phase II Trial of Low-dose Paclitaxel and Cisplatin in Patients with Advanced Gastric Cancer
1 Department of Internal Medicine, 2 Cancer Research Institute, Seoul National University College of Medicine, 3 Department of Internal Medicine, Seoul National University Hospital, Seoul, 4 Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam and 5 Department of Internal Medicine, Seoul Municipal Boramae Hospital, Seoul, Republic of Korea
For reprints and all correspondence: Seock-Ah Im, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 28 Yongon-Dong, Chongno-Gu, Seoul 110-744, Republic of Korea. E-mail: moisa{at}snu.ac.kr
Received July 27, 2005; accepted October 10, 2005
Background: Paclitaxel has shown promising activity in gastric cancer and has synergism with cisplatin. This study was performed to evaluate the efficacy and toxicity of low-dose paclitaxel (145 mg/m2) plus cisplatin chemotherapy in metastatic or relapsed gastric cancer.
Methods: Chemotherapy-naïve patients with metastatic or relapsed gastric cancer were enrolled. Paclitaxel 145 mg/m2 was administered intravenously over 3 h, followed by cisplatin 60 mg/m2 on Day 1 every 3 weeks in the outpatient setting.
Results: Of 39 patients enrolled, 17 (44%) had partial responses. Twelve (31%) had stable disease and eight (21%) progressive disease. Two patients (5%) were not evaluable because of early drop-out. The median time to progression was 4.7 months and the median overall survival was 12.1 months. The most common hematologic toxicity was anemia (41%). Grade 3/4 neutropenia and thrombocytopenia developed in 14 and 3%, respectively. The most common non-hematologic toxicities were peripheral neuropathy (43%) and emesis (43%). Grade 3/4 non-hematologic toxicities included emesis (11%), peripheral neuropathy (3%), diarrhea (3%) and hepatotoxicity (3%).
Conclusions: Low-dose paclitaxel and cisplatin chemotherapy was active and well-tolerated in chemotherapy-naïve gastric cancer patients. This regimen seems to have comparable efficacy to previously reported higher-dose paclitaxel plus cisplatin-containing regimens and fewer toxicities.
Key Words: chemotherapy • cisplatin • gastric cancer • paclitaxel
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