A Pilot Study of Cisplatin, Irinotecan, Leucovorin and 5-fluorouracil (PILF) Combination Chemotherapy for Advanced Gastric Cancer
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Purpose: Irinotecan, in combination with leucovorin/ 5-fluorouracil (FU) or with cisplatin, is known to be active for treating advanced gastric cancer (AGC). This pilot study evaluated a novel three-drug combination of irinotecan, leucovorin/FU and cisplatin as a first-line treatment of AGC. The primary endpoint was to assess the feasibility in anticipation of conducting a larger phase II study. Materials and Methods: Chemotherapy-naive AGC patients received irinotecan 150 mg/m2 on day 1, and leucovorin 200 mg/m2 and a 22-h infusion of FU 1000 mg/m2 on days 1 and 2. Cisplatin 30 mg/m2 was administered on day 2. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity. Results: Of the 17 eligible patients, two patients had an ECOG performance status of 2 and their median age was 48 years (range: 31 to 69). A total of 117 chemotherapy cycles were delivered (median: 6, range: 1 to 12). The causes of treatment discontinuation were disease progression in 9 patients (53%), refusal (35%) and toxicity (12%). Although grade 3 or 4 neutropenia (41% of patients) was the major toxicity that required dose adjustments, only one episode of febrile neutropenia occurred. Grade 3 or 4 nausea and vomiting, diarrhea and fatigue were observed in 35%, 35% and 29% of patients, respectively. None of the patients died of toxicity during treatment. Of the 16 patients who were evaluable for response, 7 (44%) experienced a partial response. Conclusion: This novel multi-drug combination was tolerated well in patients with AGC. Based on the encouraging efficacy and tolerability, a randomized phase II study is ongoing in this disease setting. (Cancer Res Treat. 2006;38:121-125)
Abstract
Purpose: Irinotecan, in combination with leucovorin/ 5-fluorouracil (FU) or with cisplatin, is known to be active for treating advanced gastric cancer (AGC). This pilot study evaluated a novel three-drug combination of irinotecan, leucovorin/FU and cisplatin as a first-line treatment of AGC. The primary endpoint was to assess the feasibility in anticipation of conducting a larger phase II study. Materials and Methods: Chemotherapy-naive AGC patients received irinotecan 150 mg/m2 on day 1, and leucovorin 200 mg/m2 and a 22-h infusion of FU 1000 mg/m2 on days 1 and 2. Cisplatin 30 mg/m2 was administered on day 2. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity. Results: Of the 17 eligible patients, two patients had an ECOG performance status of 2 and their median age was 48 years (range: 31 to 69). A total of 117 chemotherapy cycles were delivered (median: 6, range: 1 to 12). The causes of treatment discontinuation were disease progression in 9 patients (53%), refusal (35%) and toxicity (12%). Although grade 3 or 4 neutropenia (41% of patients) was the major toxicity that required dose adjustments, only one episode of febrile neutropenia occurred. Grade 3 or 4 nausea and vomiting, diarrhea and fatigue were observed in 35%, 35% and 29% of patients, respectively. None of the patients died of toxicity during treatment. Of the 16 patients who were evaluable for response, 7 (44%) experienced a partial response. Conclusion: This novel multi-drug combination was tolerated well in patients with AGC. Based on the encouraging efficacy and tolerability, a randomized phase II study is ongoing in this disease setting. (Cancer Res Treat. 2006;38:121-125)
참고문헌 (20)
- "Annual report of the Korean central cancer registry program 2000", 34, pp.77~83 (2002)
- "Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer", 71, pp.587~591 (1995)
- "Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer", 8, pp.163~168 (1997)
- "Controlled evaluation of three drug combination regimens versus fluorouracil alone for the therapy of advanced gastric cancer", 12, pp.412~416 (1994), North Central Cancer Treatment Group
- "Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer", 21, pp.54~59 (2003), The Japan Clinical Oncology Group Study (JCOG 9205)
- "Disparities in gastric cancer chemotherapy between the East and West", 24, pp.2188~2196 (2006)
- "Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer", 15, pp.261~267 (1997)
- "Final results of a randomized comtrolled phase III trial (TAX 325) comparing docetaxel (T) combined with cisplatin (C) and 5-fluorouracil (F) to CF in patients with metastatic gastric adenocarcinoma (MGC)", 23, pp.308~ (2005)
- "Irinotecan is active in chemonaive patients with metastatic gastric cancer", 89, pp.997~1001 (2003)
- "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", 22, pp.4319~4328 (2004)
- "CPT-11 plus cisplatin in patients with advanced, untreated gastric or gastroesophageal junction carcinoma", 94, pp.641~646 (2002)
- "Irinotecan in combination with 5-fluorouracil and folinic acid or with cisplatin in patients with advanced gastric or esophageal-gastric junction adenocarcinoma", 15, pp.1773~1781 (2004)
- "Phase I", II study with weekly infusional high-dose 5-fluorouracil, irinotecan in combination with biweekly cisplatin as first-line chemotherapy for metastatic gastric carcinoma, 2003[DOI]
- "Fluorouracil, leucovorin, irinotecan, and cisplatin (FLIP) in chemotherapy naive metastatic gastric carcinoma", iri(tecan), pp.~79 (2006)
- "One-sample multiple testing procedure for phase II clinical trials", pp.143~51 (1982)
- "Second-line chemotherapy with mitomycin C and S-1 in patients with advanced gastric cancer", 24 (2006)
- "CPT-11 in gastrointestinal cancer", 35, pp.371~379 (1999)
- "Salvage chemotherapy with irinotecan, 5-fluorouracil and leucovorin for taxane- and cisplatin-refractory, metastatic gastric cancer", 92, pp.1850~1854 (2005)
- "Randomized phase III study of high-dose fluorouracil given as a weekly 24-hour infusion with or without leucovorin versus bolus fluorouracil plus leucovorin in advanced colorectal cancer", 21, pp.3721~3728 (2003)
- "A prospective randomized study comparing high- and low-dose leucovorin combined with same-dose 5-fluorouracil in advanced colorectal cancer", 21, pp.233~236 (1998)