A Phase II Study of Leucovorin, 5-FU and Docetaxel Combination Chemotherapy in Patients with Inoperable or Postoperative Relapsed Gastric Cancer
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Purpose: To estimate the effect and toxicity of bimonthly low-dose leucovorin (LV) and fluorouracil (5-FU) bolus plus continuous infusion(LV5FU2) with docetaxel combination chemotheraphy in patients with inoperable or postoperative relapsed gastric cancer. Materials and Methods: Total 27 patients are enrolled in this study. LV 20 mg/m² (bolus), 5FU 400 mg/m² (bolus), 5-FU 600 mg/m² (24-hour continuous infusion) on day 1, 2, 15, and 16, docetaxel 60 mg/m² (1-hour infusion) on day 15 every 4 weeks. Results: Total of 141 cycles were administered and response rate were 36.8% with 2 complete response (10.5%) and 5 partial response (26.3%) in 19 evaluable patients. The median response duration is 8.1 months (95% CI, 4.0∼12.1). The median progression-free survival time is 6.7 months (95% CI, 5.0∼8.5) and the median overall survival time is 11.9 months (95% CI, 4.8∼19.1). The grade 3-4 toxcity of neutropenia (24.8%) and anemia (11.3%), neutropenic fever (2.8%) is observed. The grade 1 toxcity of injection site reaction is observed all patients and the grade 1-2 toxcity of alopecia is observed 60%. Conclusions: LV5FU2 with docetaxel combination chemotheraphy is effective and tolerable in patients with inoperable or postoperative relapsed gastric cancer. (Cancer Res Treat. 2008;40:11-15)
Abstract
Purpose: To estimate the effect and toxicity of bimonthly low-dose leucovorin (LV) and fluorouracil (5-FU) bolus plus continuous infusion(LV5FU2) with docetaxel combination chemotheraphy in patients with inoperable or postoperative relapsed gastric cancer. Materials and Methods: Total 27 patients are enrolled in this study. LV 20 mg/m² (bolus), 5FU 400 mg/m² (bolus), 5-FU 600 mg/m² (24-hour continuous infusion) on day 1, 2, 15, and 16, docetaxel 60 mg/m² (1-hour infusion) on day 15 every 4 weeks. Results: Total of 141 cycles were administered and response rate were 36.8% with 2 complete response (10.5%) and 5 partial response (26.3%) in 19 evaluable patients. The median response duration is 8.1 months (95% CI, 4.0∼12.1). The median progression-free survival time is 6.7 months (95% CI, 5.0∼8.5) and the median overall survival time is 11.9 months (95% CI, 4.8∼19.1). The grade 3-4 toxcity of neutropenia (24.8%) and anemia (11.3%), neutropenic fever (2.8%) is observed. The grade 1 toxcity of injection site reaction is observed all patients and the grade 1-2 toxcity of alopecia is observed 60%. Conclusions: LV5FU2 with docetaxel combination chemotheraphy is effective and tolerable in patients with inoperable or postoperative relapsed gastric cancer. (Cancer Res Treat. 2008;40:11-15)
참고문헌 (20)
- Hai-Rim Shin, "2002 Annual Report of the Korea Central Cancer Registry: Based on Registered Data from 139 Hospitals", Cancer Research and Treatment, 36(2), pp.103~114 (2004), 대한암학회
- Dupont JB Jr, "Adenocarcinoma of the stomach: review of 1,497 cases", Cancer, 41, pp.941~7 (1978)
- Wagner AD, "Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data", J Clin Oncol, 24, pp.2903~9 (2006)
- Sobrero AF, "Fluorouracil in colorectal cancer--a tale of two drugs: implications for biochemical modulation", J Clin Oncol, 15, pp.368~81 (1997)
- Poon MA, "Biochemical modulation of fluorouracil: evidence of significant improvement of survival and quality of life in patients with advanced colorectal carcinoma", J Clin Oncol, 7, pp.1407~18 (1989)
- Bouche O., "Randomized multicenter phase II trial of a biweekly regimen of fluorouracil and leucovorin (LV5FU2), LV5FU2 plus cisplatin, or LV5FU2 plus irinotecan in patients with previously untreated metastatic gastric cancer: a Federation Francophone de Cancerologie Digestive Group Study-- FFCD 9803", J Clin Oncol, 22, pp.4319~28 (2004)
- Sobrero AF, "Synergism and lack of cross-resistance between short-term and continuous exposure to fluorouracil in human colon adenocarcinoma cells", J Natl Cancer Inst, 85, pp.1937~44 (1993)
- Ajani JA, "Phase II multi-institutional randomized trial of docetaxel plus cisplatin with or without fluorouracil in patients with untreated, advanced gastric, or gastroesophageal adenocarcinoma", J Clin Oncol, 23, pp.5660~7 (2005)
- Einzig AI, "Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: the Eastern Cooperative Oncology Group (ECOG) results of protocol E1293", Med Oncol, 13, pp.87~93 (1996)
- Ridwelski K., "Combination chemotherapy with docetaxel and cisplatin for locally advanced and metastatic gastric cancer", Ann Oncol, 12, pp.47~51 (2001)
- Sulkes A., "Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group", Br J Cancer, 70, pp.380~3 (1994)
- Therasse P., "New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada", J Natl Cancer Inst, 92, pp.205~16 (2000)
- Cunningham D., "ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of gastric cancer", Ann Oncol, 16, pp.122~3 (2005)
- Pye JK, "One-year survey of carcinoma of the oesophagus and stomach in Wales", Br J Surg, 88, pp.278~85 (2001)
- Cancer M-aGI, "Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. Meta-analysis Group In Cancer", J Clin Oncol, 16, pp.301~8 (1998)
- de Gramont A., "Randomized trial comparing monthly lowdose leucovorin and fluorouracil bolus with bimonthly highdose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study", J Clin Oncol, 15, pp.808~15 (1997)
- Jager E., "Weekly high-dose leucovorin versus low-dose leucovorin combined with fluorouracil in advanced colorectal cancer: results of a randomized multicenter trial. Study Group for Palliative Treatment of Metastatic Colorectal Cancer Study Protocol 1", J Clin Oncol, 14, pp.2274~9 (1996)
- Van Cutsem E., "Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group", J Clin Oncol, 24, pp.4991~7 (2006)
- Hoff PM, "Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study", J Clin Oncol, 19, pp.2282~92 (2001)
- Van Cutsem E., "Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study", J Clin Oncol, 19, pp.4097~106 (2001)