Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: A trial of the European organization for research and treatment of cancer gastrointestinal tract cancer cooperative group

被引:448
作者
Vanhoefer, U
Rougier, P
Wilke, H
Ducreux, MP
Lacave, AJ
Van Cutsem, E
Planker, M
Dos Santos, JG
Piedbois, P
Paillot, B
Bodenstein, H
Schmoll, HJ
Bleiberg, H
Nordlinger, B
Couvreur, ML
Baron, B
Wils, JA
机构
[1] Univ Essen Gesamthsch, W German Canc Ctr, Dept Internal Med Canc Res, D-45122 Essen, Germany
[2] Klinikum Krefeld, Krefeld, Germany
[3] Klinikum Minden, Minden, Germany
[4] Univ Halle Wittenberg, Clin Hematol & Oncol, Halle, Germany
[5] Hop Ambroise Pare, Paris, France
[6] Inst Gustave Roussy, Villejuif, France
[7] Hop Henri Mondor, F-94010 Creteil, France
[8] CHU Rouen, Rouen, France
[9] Hosp Gen Asturias, Med Oncol Serv, E-33006 Oviedo, Spain
[10] Univ Hosp Gasthuisberg, Dept Internal Med, B-3000 Louvain, Belgium
[11] Inst Jules Bordet, B-1000 Brussels, Belgium
[12] European Org Res Treatment Canc, Ctr Data, Brussels, Belgium
[13] Inst Portuges Oncol, Porto, Portugal
[14] St Laurentius Hosp, Roermond, Netherlands
关键词
D O I
10.1200/JCO.2000.18.14.2648
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: To compare the efficacy and tolerability of etoposide, leucovorin, and bolus fluorouracil (ELF) or infusional fluorouracil plus cisplatin (FUP) with that of the reference protocol of fluorouracil, doxorubicin, and methotrexate (FAMTX) in advanced gastric cancer. Patients and Methods: A total of 399 patients with advanced adenocarcinoma of the stomach were randomized and analyzed for toxicity, tumor response, and progression-free and overall survival. Only reviewed and confirmed responses were considered. The analysis of remission was based on assessable patients with documented measurable lesions. The intent-to-treat principle, log-rank test, and Cox regression model were used for the statistical analysis of time-to-event end points. Results: The overall response rate for 245 eligible patients with measurable disease was 9% with ELF, 20% with FUP, and 12% with FAMTX, with no significant differences. One hundred twelve patients were eligible for efficacy in assessable, nonmeasurable disease. No change was observed in 66% of patients treated with ELF, 56% with FUP, and 55% with FAMTX. Two patients achieved a complete tumor regression tone each for ELF and FAMTX). With a median follow-vp time of 4.5 years, the median survival times were 7.2 months with ELF, 7.2 months with FUP, and 6.7 months with FAMTX, respectively, with no significant differences. Nonhematologic and hematalagic toxicities of ELF, FUP, and FAMTX were acceptable, with neutropenia being the major toxicity for all three regimens. Seven treatment-related deaths occurred (two with FUP and five with FAMTX). Conclusion: All three investigated regimens demonstrate modest clinical efficacy and should not be regarded as standard treatment for advanced gastric cancer. New strategies should be considered to achieve a better clinical efficacy in the treatment of advanced gastric cancer. (C) 2000 by American Society of Clinical Oncology.
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收藏
页码:2648 / 2657
页数:10
相关论文
共 43 条
[1]   IMPROVING SURVIVAL IN GASTRIC-CANCER - REVIEW OF 5-YEAR SURVIVAL RATES IN ENGLISH-LANGUAGE PUBLICATIONS FROM 1970 [J].
AKOH, JA ;
MACINTYRE, IMC .
BRITISH JOURNAL OF SURGERY, 1992, 79 (04) :293-299
[2]   A phase II trial of etoposide, leucovorin and 5-fluorouracil (ELF) in patients with advanced gastric cancer [J].
Au, E ;
Koo, WH ;
Tan, EH ;
Ang, PT .
JOURNAL OF CHEMOTHERAPY, 1996, 8 (04) :300-303
[3]  
BARTOLUCCI AA, 1984, CANCER CLIN TRIALS, P337
[4]   Phase II study of the modified regimen of etoposide, leucovorin and 5-fluorouracil for patients with advanced gastric cancer [J].
Chiou, TJ ;
Tung, SL ;
Hsieh, RK ;
Wang, WS ;
Yen, CC ;
Fan, FS ;
Liu, JH ;
Chen, PM .
JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 1998, 28 (05) :318-322
[5]  
COX DR, 1972, J R STAT SOC B, V34, P187
[6]  
DIBARTOLOMEO M, 1995, ONCOLOGY, V52, P41
[7]   GASTRIC-CARCINOMA - A 10-YEAR REVIEW [J].
DIEHL, JT ;
HERMANN, RE ;
COOPERMAN, AM ;
HOERR, SO .
ANNALS OF SURGERY, 1983, 198 (01) :9-12
[8]  
DUPONT JB, 1978, CANCER-AM CANCER SOC, V41, P941, DOI 10.1002/1097-0142(197803)41:3<941::AID-CNCR2820410323>3.0.CO
[9]  
2-M
[10]  
Feliu J, 1996, CANCER-AM CANCER SOC, V78, P211, DOI 10.1002/(SICI)1097-0142(19960715)78:2<211::AID-CNCR4>3.0.CO