Phase II study of irinotecan plus leucovorin and bolus 5-fluorouracil as first- or second-line chemotherapy in patients with advanced gastric or esophageal-gastric junction adenocarcinoma

Journal of Chemotherapy

Volumn 19, Issue 6, 2007, Pages 724-730

  Koutras, A K ^a   Gerolymos, M K ^a   Kontogeorgou, E ^a   Iconomou, G ^a   Vourli, G ^a   Tsiata, E ^a   Makatsoris, T ^a   Chrysanthopoulos, C ^a   Kalofonos, H P ^a  

^a UNIVERSITY OF PATRAS   (Greece)

Author keywords

5 fluorouracil; Advanced gastric cancer; Chemotherapy; Irinotecan

Indexed keywords

FLUOROURACIL; FOLINIC ACID; IRINOTECAN;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; CANCER GROWTH; CANCER SURVIVAL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DIARRHEA; DRUG ACTIVITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ESOPHAGEAL ADENOCARCINOMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HUMAN; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; STOMACH ADENOCARCINOMA; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

EID: 38949124736     PISSN: 1120009X     EISSN: None     Source Type: Journal    
DOI: 10.1179/joc.2007.19.6.724     Document Type: Article

References (36)

1. Kelley JR, Duggan JM. Gastric cancer epidemiology and risk factors. J Clin Epidemiol 2003; 56: 1-9.
2. Pyrhonen S, Kuitunen T, Nyandoto P et al. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer 1995; 71: 587-591.
3. Murad A, Santiago F, Petroianu A et al. Modified therapy with 5-fluorouracil, doxorubicin and methotrexate in advanced gastric cancer. Cancer 1993; 72: 37-41.
4. Glimelius B, Ekstrom K, Hoffman K et al. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol 1997; 8: 163-168.
5. Kelsen D, Atiq O, Saltz L et al. FAMTX versus etoposide, doxorubicin and cisplatin: a random assignment trial in gastric cancer. J Clin Oncol 1992; 10: 541-548.
6. Wils J, Klein H, Wagener D et al. Sequential high-dose methotrexate and fluorouracil combined with doxorubicin - a step ahead in the treatment of advanced gastric cancer: a trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. J Clin Oncol 1991; 9: 827-831.
7. Vanhoefer U, Rougier P, Wilke H et al. 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. J Clin Oncol 2000; 18: 2648-2657.
8. Webb A, Cunningham D, Scarffe J et al. Randomised trial comparing epirubicin, cisplatin and fluorouracil versus fluorouracil, doxorubicn and methotrexate in advanced oesophagogastric cancer. J Clin Oncol 1997; 15: 261-267.
9. Ross P, Nicolson M, Cunningham D et al. Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5FU) with epirubicin, cisplatin and PVI 5FU in advanced oesophagogastric cancer. J Clin Oncol 2002; 20: 1996-2004.
10. Saltz LB, Cox JV, Blanke C et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer: Irinotecan Study Group. N Engl J Med 2000; 343: 905-914.
11. Douillard JY, Cunningham D, Roth AD et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: A multicentre randomised trial. Lancet 2000; 355: 1041-1047.
12. Kohne CH, Catane R, Klein B et al. Irinotecan is active in chemonaive patients with metastatic gastric cancer: A phase II multicentric trial. Br J Cancer 2003; 89: 997-1001.
13. Lin-Shin L, Hecht J. A phase II trial of irinotecan in patients with advanced adenocarcinoma of the gastroesophageal (GE) junction. Proc Am Soc Clin Oncol 2000; 19: 289a.
14. Hecht J, Parson M, Lee R. A phase II trial of irinotecan (CPT-11) in patients with adenocarcinoma of the esophagus and gastric cardia. Proc Am Soc Clin Oncol 1999; 18: 287a.
15. Futatsuki K, Wakui A, Nakao I et al. Late phase II study of irinotecan hydrochloride (CPT-11) in advanced gastric cancer: CPT-11 Gastrointestinal Cancer Study Group. Gan To Kagaku Ryoho 1994; 21: 1033-1038.
16. Ohtsu A, Shimada Y, Shirao K et al. Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205). J Clin Oncol 2003; 21: 54-59.
17. Kim NK, Park YS, Heo DS et al. A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer 1993; 71: 3813-3818.
18. Coombes RC, Chilvers CE, Amadori D et al. Randomised trial of epirubicin versus fluorouracil in advanced gastric cancer: An International Collaborative Cancer Group (ICCG) study. Ann Oncol 1994; 5: 33-36.
19. Johnson PW, Thompson PI, Seymour MT et al. A less toxic regimen of 5-fluorouracil and high-dose folinic acid for advanced gastrointestinal adenocarcinomas. Br J Cancer 1991; 64: 603-605.
20. Louvet C, de Gramont A, Demuynck B et al. High-dose folinic acid, 5-fluorouracil bolus and continuous infusion in poor-prognosis patients with advanced measurable gastric cancer. Ann Oncol 1991; 2: 229-230.
21. Rubin J, Gallagher JG, Schroeder G et al. Phase II trials of 5-fluorouracil and leucovorin in patients with metastatic gastric or pancreatic carcinoma. Cancer 1996; 78: 1888-1891.
22. Machover D, Goldschmidt E, Chollet P et al. Treatment of advanced colorectal and gastric adenocarcinomas with 5-fluorouracil and high-dose folinic acid. J Clin Oncol 1986; 4: 685-696.
23. Blanke CD, Haller DG, Benson AB et al. A phase II study of irinotecan with 5-fluorouracil and leucovorin in patients with previously untreated gastric adenocarcinoma. Ann Oncol 2001; 12: 1575-1580.
24. Assersohn L, Brown G, Cunningham D et al. Phase II study of irinotecan and 5-fluorouracil/leucovorin in patients with primary refractory or relapsed advanced oesophageal and gastric carcinoma. Ann Oncol 2004; 15: 64-69.
25. Findlay MPN, Ackland S, Gebski V et al. Phase II study of irinotecan, leucovorin and 5FU (ILF) in advanced gastric cancer. Proc Am Soc Clin Oncol 2001; 20: 165a.
26. Wagner AD, Grothe W, Haerting J et al. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol 2006; 24: 2903-2909.
27. Bouché O, Raoul JL, Bonnetain F et al. 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 Fédération Francophone de Cancérologie Digestive Group study-FFCD 9803. J Clin Oncol 2004; 22: 4319-4328.
28. Moehler M, Eimermacher A, Siebler J et al. Randomized phase II evaluation of irinotecan plus high-dose 5-fluorouracil and leucovorin (ILF) versus 5-fluorouracil, leucovorin, and etoposide (ELF) in untreated metastatic gastric cancer. Br J Cancer 2005; 92: 2122-2128.
29. Dank M, Zaluski J, Valvere V et al. Randomized phase III trial of irinotecan (CPT 11) + 5- FU/folinic acid (FA) vs CDDP + 5-FU in first line advanced gastric cancer patients. J Clin Oncol 2005; 23: 308s (suppl 16, abstr 4003).
30. Kalofonos HP, Skarlos D, Bafaloukos D et al. A phase II study with CPT-11 plus leucovorin and bolus IV 5-fluorouracil in patients with advanced colorectal carcinoma. Cancer Invest. 2003; 21: 855-862.
31. Kalofonos HP, Aravantinos G, Kosmidis P et al. Irinotecan or oxaliplatin combined with leucovorin and 5-fluorouracil as first-line treatment in advanced colorectal cancer: a multicenter, randomized, phase II study. Ann Oncol 2005; 16: 869-877.
32. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate response to treatment in solid tumors. J Natl Cancer Inst. 2000; 92: 205-216.
33. Roth AD. Multimodality management of metastatic gastric and esophageal cancer. ASCO Educational Book 2004:199-204.
34. Pozzo C, Barone C, Szanto J et al. Irinotecan in combination with 5-fluorouracil and folinic acid or with cisplatin in patients with advanced gastric or esophageal-gastric junction adenocarcinoma: results of a randomized phase II study. Ann Oncol 2004; 15: 1773-1781.
35. Fazio N, Zampino G, Nolè F et al. Irinotecan combined with infusional 5-fluorouracil and folinic acid (folfiri) in patients with metastatic gastric cancer resistant to cisplatin-containing chemotherapy. Proc Am Soc Clin Oncol 2004; 22: 4146.
36. Kim ST, Kang WK, Kang JH et al. Salvage chemotherapy with irinotecan, 5-fluorouracil and leucovorin for taxane-and cisplatin-refractory, metastatic gastric cancer. Br J Cancer 2005; 92: 1850-1854.