Randomized controlled trial of adjuvant uracil-tegafur versus surgery alone for serosa-negative, locally advanced gastric cancer

British Journal of Surgery

Volumn 94, Issue 12, 2007, Pages 1468-1476

  Nakajima, T ^a   Kinoshita, T ^b   Nashimoto, A ^c   Sairenji, M ^d   Yamaguchi, T ^a   Sakamoto, J ^e   Fujiya, T ^f   Inada, T ^g   Sasako, M ^b   Ohashi, Y ^h  

^a CANCER INSTITUTE HOSPITAL   (Japan)

^b NATIONAL CANCER CENTER HOSPITAL   (Japan)

^c NIIGATA CANCER CENTER HOSPITAL   (Japan)

^d KANAGAWA CANCER CENTER   (Japan)

^e AICHI CANCER CENTER HOSPITAL   (Japan)

^f Miyagi Cancer Center   (Japan)

^g TOCHIGI CANCER CENTER   (Japan)

^h UNIVERSITY OF TOKYO   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

UFT;

ADJUVANT THERAPY; ADVANCED CANCER; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER CHEMOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; FOLLOW UP; GASTRECTOMY; HAZARD RATIO; HUMAN; HYPERBILIRUBINEMIA; INFECTION; KAPLAN MEIER METHOD; LYMPH NODE DISSECTION; NAUSEA AND VOMITING; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGNOSIS; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL; RASH; RECURRENCE RISK; SEROSA; SIDE EFFECT; STATISTICAL ANALYSIS; STOMACH CANCER; SURGICAL APPROACH;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; DISEASE-FREE SURVIVAL; FEMALE; GASTRECTOMY; HUMANS; LYMPH NODE EXCISION; LYMPHATIC METASTASIS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; STOMACH NEOPLASMS; TEGAFUR; URACIL;

EID: 37249028822     PISSN: 00071323     EISSN: 13652168     Source Type: Journal    
DOI: 10.1002/bjs.5996     Document Type: Article

References (44)

1. Hermans J, Bonenkamp JJ, Boon MC, Bunt AMG, Ohyama S, Sasako M et al. Adjuvant therapy after curative resection for gastric cancer: meta-analysis of randomized trials. J Clin Oncol 1993; 11: 1441-1447.
2. Hermans J, Bonenkamp JJ. In reply to the editor. J Clin Oncol 1994; 12: 879-880.
3. Nakajima T, Ohta K, Ishihara S, Ohyama S, Nishi M, Hamashima N. Evaluation of adjuvant chemotherapy in gastric cancer with meta-analysis. Gan To Kagaku Ryoho 1994; 21: 1800-1805.
4. Pignon J, Decreux M, Rougier P. Meta-analysis of adjuvant chemotherapy in gastric cancer: a critical reappraisal. J Clin Oncol 1994; 12: 877-878.
5. Earle C, Maroun J. Adjuvant chemotherapy after curative resection for gastric cancer in non-Asian patients: revisiting a meta-analysis of randomised trials. Eur J Cancer 1999; 35: 1059-1064.
6. Mari E, Floriani I, Tinassi A, Buda A, Belfiglio M, Valentini M et al. Efficacy of adjuvant chemotherapy after curative resection for gastric cancer: a meta-analysis of published randomized trials. A study of the GISCAD (Grappe Italiano per lo Studio dei Carcinomi dell'Apparato Digerente). Ann Oncol 2000; 11: 837-843.
7. Janunger K, Hafstrom L, Nygren P, Glimelius B. A systematic overview of chemotherapy effects in gastric cancer. Acta Oncol 2001; 40: 309-326.
8. Panzini I, Gianni L, Fattori P, Tassinari D, Imola M, Fabbri P et al. Adjuvant chemotherapy in gastric cancer: a meta-analysis of randomized trials and a comparison with preveious meta-analyses. Tumori 2002; 88: 21-27.
9. Nakajima T. Success of adjuvant chemotherapy trials for gastric cancer. In Multimodality Therapy for Gastric Cancer, Nakajima T, Yamaguchi T (eds). Springer: Tokyo, 1999; 3-6.
10. Nakajima T, Fukami A, Ohashi I, Kajitani T. Long-term follow-up study of gastric cancer patients treated with surgery and adjuvant chemotherapy with mitomycin C. Int J Clin Pharmacol 1978; 16: 209-216.
11. Nakajima T, Fukami A, Takagi K, Kajitani T. Adjuvant chemotherapy with mitomycin C, and with a multi-drug combination of mitomycin C, 5-fluorouracil and cytosine arabinoside after curative resection of gastric cancer. Jpn J Clin Oncol 1980; 10: 187-194.
12. Huguier PH, Destroyes JP, Baschet C, Le Henand F, Bernard PF. Gastric carcinoma treated by chemotherapy after resection: a controlled study. Am J Surg 1980; 139: 197-199.
13. Blake JR, Hardcastle JD, Wilson RG. Gastric cancer: a controlled trial of adjuvant chemotherapy following gastrectomy. Clin Oncol 1981; 7: 13-21.
14. Alcobendas F, Milla A, Estape J, Curto J, Pera C. Mitomycin C as adjuvant in resected gastric cancer. Ann Surg 1983; 198: 13-17.
15. Fielding JW, Fagg SL, Jones BG, Ellis D, Hockey MS, Minawa A et al. An interim report of a prospective, randomized, controlled study of adjuvant chemotherapy in operable gastric cancer: British Stomach Cancer Group. World J Surg 1983; 7: 390-399.
16. Nakajima T, Takahashi T, Takagi K, Kuno K, Kajitani T. Comparison of 5-fluorouracil with ftorafur in adjuvant chemotherapies with combined inductive and maintenance therapies for gastric cancer. J Clin Oncol 1984; 2: 1366-1371.
17. Allum WH, Hallissey MT, Ward LC, Hockey MS. A controlled prospective, randomised trial of adjuvant chemotherapy or radiotherapy in resectable gastric cancer: interim report. British Stomach Cancer Group. Br J Cancer 1989; 60: 739-744.
18. Allum WH, Hallissey MT, Kelley KA. Adjuvant chemotherapy in operable gastric cancer: 5 year follow-up of first British Stomach Cancer Group trial. Lancet 1989; 18: 571-574.
19. Krook JE, O'Connell MJ, Wieand HS, Beard RW Jr, Leigh JE, Kugler JW et al. A prospective, randomized evaluation of intensive-course 5-fluorouracil plus doxorubicin as surgical adjuvant chemotherapy for resected gastric cancer. Cancer 1991; 67: 2454-2458.
20. Nakajima T, Okabayashi K, Nakazato H, Imanaga T, Ohta K, Kinoshita T et al. Effect of MFC-based adjuvant chemo-therapy in gastric cancer with curative surgery. Jpn J Soc Cancer Ther 1994; 29: 654-662.
21. Lise M, Nitti D, Marchet A, Sahmoud T, Buyse M, Duez N et al. Final results of a phase III clinical trial of adjuvant chemotherapy with the modified fluorouracil, doxorubicin, and mitomycin regimen in resectable gastric cancer. J Clin Oncol 1995; 13: 2757-2763.
22. Macdonald J, Fleming T, Peterson R, Berenberg J, McClure S, Chapman R et al. Adjuvant chemotherapy with 5-FU, Adriamycin, and mitomycin-C (FAM) versus surgery alone for patients with locally advanced gastric adenocarcinoma: a Southwest Oncology Group study. Ann Surg Oncol 1995; 2: 488-494.
23. Crookes P, Leichman C, Leichman L, Tan M, Laine L, Stain S et al. Systemic chemotherapy for gastric carcinoma followed by postoperative intraperitoneal therapy: a final report. J Clin Oncol 1997; 79: 1767-1775.
24. Rosen H, Jatzko G, Repse S, Potrc S, Neudorfer H, Sandbichler P et al. Adjuvant intraperitoneal chemotherapy with carbon-adsorbed mitomycin in patients with gastric cancer: results of a randomized multicenter trial of the Austrian Working Group for Surgical Oncology. J Clin Oncol 1998; 16: 2733-2738.
25. Nakajima T, Nashimoto A, Kitamura M, Kito T, Iwanaga T, Okabayashi K et al. Adjuvant mitomycin and fluorouracil followed by oral uracil plus tegafur in serosa-negative gastric cancer: a randomized trial. Gastric Cancer Surgical Study Group. Lancet 1999; 354: 273-277.
26. Nashimoto A, Nakajima T, Furukawa H, Kitamura M, Kinoshita T, Yamamura Y et al. Randomized trial of adjuvant chemotherapy with mitomycin, fluorouracil, and cytosine arabinoside followed by oral fluorouracil in serosa-negative gastric cancer: Japan Clinical Oncology Group 9206-1. J Clin Oncol 2003; 21: 2282-2287.
27. Ota K, Taguchi T, Kimura K. Report on nationwide pooled data and cohort investigation in UFT phase II study. Cancer Chemother Pharmacol 1988; 22: 333-338.
28. Tobinai K, Kohno A, Shimada Y, Watanabe T, Tamura T, Takeyama K et al. Toxicity grading criteria of the Japan Clinical Oncology Group. The Clinical Trial Review Committee of the Japan Clinical Oncology Group. Jpn J Clin Oncol 1993; 23: 250-257.
29. Japanese Research Society for Gastric Cancer. Japanese Classification of Gastric Carcinoma. Kanehara: Tokyo, 1995.
30. Fielding JW. The value of a multidisciplinary approach in the management of gastric cancer. Recent Results Cancer Res 1988; 110: 57-64.
31. Sano T, Sasako M, Katai H, Maruyama K. Randomized controlled trials on adjuvant therapy for gastric cancer: Japanese experience. In Multimodality Therapy for Gastric Cancer, Nakajima T, Yamaguchi T (eds). Springer: Tokyo, 1999; 7-16.
32. Douglass HJ, Nava H, Smith J. Multimodality therapy for completely resected (RO) gastric cancer (excluding Japanese trials). In Multimodality Therapy for Gastric Cancer, Nakajima T, Yamaguchi T (eds). Springer: Tokyo, 1999; 17-26.
33. Kato H, Ichinose Y, Ohta M, Hata E, Tsubota N, Tada H et al. A randomized trial of adjuvant chemotherapy with uracil-tegafur for adenocarcinoma of the lung. N Engl J Med 2004; 350: 1713-1721.
34. Feliu J, Gonzalez Baron M, Espinosa E, Garcia Giron C, de la Gandara I, Espinosa J et al. Uracil and tegafur modulated with leucovorin. An effective regimen with low toxicity for the treatment of colorectal carcinoma in the elderly. Cancer 1997; 79: 1884-1889.
35. Carmichael J, Popiela T, Radstone D, Falks K, Borner M, Oza A et al. Randomized comparative study of tegafur/uracil and oral leucovorin versus parenteral fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2002; 20: 3617-3627.
36. Douillard JY, Hoff PM, Skillings JR, Eisenberg P, Davidson N, Harper P et al. Multicenter phase III study of uracil-tegafur and oral leucovorin versus fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2002; 20: 3605-3616.
37. Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN et al. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med 2001; 345: 725-730.
38. Akasu T, Moriya Y, Ohashi Y, Yoshida S, Shirao K, Kodaira S, for the National Surgical Adjuvant Study of Colorectal Cancer. Adjuvant chemotherapy with uracil-tegafur for pathological stage III rectal cancer after mesorectal excision with selective lateral pelvic lymphadenectomy: a multicenter randomized controlled trial. Jpn J Clin Oncol 2006; 36: 237-244.
39. Kerbel RS, Kamen BA. The anti-angiogenic basis of metronomic chemotherapy. Nat Rev Cancer 2004; 4: 423-436.
40. Koizumi W, Kurihara M, Nakano S, Hasegawa K. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. Oncology 2000; 58: 191-197.
41. Hundahl SA, Macdonald JS, Benedetti J, Fitzsimmons T, Southwest Oncology Group and the Gastric Intergroup. Surgical treatment variation in a prospective, randomized trial of chemoradiotherapy in gastric cancer: the effect of undertreatment. Ann Surg Oncol 2002; 9: 278-286.
42. Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I et al. Extended lymph-node dissection for gastric cancer. Dutch Gastric Cancer Group. N Engl J Med 1999; 340: 908-914.
43. Smith DD, Schwarz RR, Schwarz RE. Impact of total lymph node count on staging and survival after gastrectomy for gastric cancer: data from a large US-population database. J Clin Oncol 2005; 23: 7114-7124.
44. Peeters KC, Hundahl SA, Kranenbarg EK, Hartgrink H, van de Velde CJ. Low maruyama index surgery for gastric cancer: blinded reanalysis of the Dutch D1-D2 trial. World J Surg 2005; 12: 1576-1584.