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Phase II trial of low-dose paclitaxel and cisplatin in patients with advanced gastric cancer

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Lee, Keun-Wook; Im, Seock Ah; Yun, Tak; Song, Eun Kee; Na, Im Il; Shin, Hyunchoon; Choi, In Sil; Oh, Do Youn; Kim, Jee Hyun; Kim, Dong Wan; Kim, Tae You; Lee, Jong Seok; Heo, Dae Seog; Bang, Yung-Jue; Kim, Noe Kyeong

Issue Date
Oxford University Press
Japanese Journal of Clinical Oncology, Vol.35 No.12, pp.720-726
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/m(2)) plus cisplatin chemotherapy in metastatic or relapsed gastric cancer. Methods: Chemotherapy-naive patients with metastatic or relapsed gastric cancer were enrolled. Paclitaxel 145 mg/m(2) was administered intravenously over 3 h, followed by cisplatin 60 mg/m(2) 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-naive gastric cancer patients. This regimen seems to have comparable efficacy to previously reported higher-dose paclitaxel plus cisplatin-containing regimens and fewer toxicities.
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  • Department of Medicine
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