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British Journal of Cancer (2006) 95, 159-163.
doi:10.1038/sj.bjc.6603225 Published online 27 June 2006
An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer
Y Chao1,2,3,14, C P Li3,4,14, T Y Chao5, W C Su6, R K Hsieh7, M F Wu8, K H Yeh9,10,11, W Y Kao5, L T Chen12,13 and A L Cheng9,10
1Cancer Center, Taipei Veterans General Hospital, Taipei, Taiwan
2Central Clinic Hospital, Taipei, Taiwan
3National Yang-Ming University School of Medicine, Taipei, Taiwan
4Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
5Division of Hematology and Oncology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan
6Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan
7Division of Hematology and Oncology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
8Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan
9Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan
10Cancer Research Center, National Taiwan University College of Medicine, Taipei, Taiwan
11Division of Oncology and Hematology, Department of Internal Medicine, Far Eastern Memorial Hospital, Taipei, Taiwan
12Institute of Cancer Research, National Health Research Institutes, Taipei, Taiwan
13Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
Correspondence to: Dr LT Chen, Institute of Cancer Research, National Health Research Institutes, Taipei Veterans General Hospital, Ward 191, No. 201, Sec. 2, Shih-Pai Road, Taipei 112, Taiwan. E-mail: leochen@nhri.org.tw or AL Cheng, Department of Internal Medicine and Department of Oncology, National Taiwan University Hospital, No. 2, Chung-Shan S Rd, Taipei 100, Taiwan. E-mail: andrew@ha.mc.ntu.edu.tw
14These authors contributed equally to this work.
Received 6 February 2006; revised 17 May 2006; accepted 19 May 2006; published online 27 June 2006
The aim of the study was to evaluate the response rate and safety of weekly paclitaxel (TaxolÒ) combination chemotherapy with UFT (tegafur, an oral 5-fluorouracil prodrug, and uracil at a 1 : 4 molar ratio) and leucovorin (LV) in patients with advanced gastric cancer. Patients with histologically confirmed, locally advanced or recurrent/metastatic gastric cancer were studied. Paclitaxel 1-h infusion at a dose of 100 mg m-2 on days 1 and 8 and oral UFT 300 mg m-2 day-1 plus LV 90 mg day-1 were given starting from day 1 for 14 days, followed by a 7-day period without treatment. Treatment was repeated every 21 days. From February 2003 to October 2004, 55 patients were enrolled. The median age was 62 years (range: 32-82). Among the 48 patients evaluated for tumour response, two achieved a complete response and 22 a partial response, with an overall response rate of 50% (95% confidence interval: 35-65%). All 55 patients were evaluated for survival and toxicities. Median time to progression and overall survival were 4.4 and 9.8 months, respectively. Major grade 3-4 toxicities were neutropenia in 25 patients (45%) and diarrhoea in eight patients (15%). Although treatment was discontinued owing to treatment-related toxicities in nine patients (16%), there was no treatment-related mortality. Weekly paclitaxel plus oral UFT/LV is effective, convenient, and well tolerated in treating patients with advanced gastric cancer.
Keywords: paclitaxel; UFT; leucovorin; gastric cancer
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| Print ISSN: 0007-0920 | Online ISSN: 1532-1827 | © 2006 Cancer Research UK | ||
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