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Clinical trials for advanced gastrointestinal cancers in Japan

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Abstract

No standard chemotherapy regimen for the treatment of advanced gastrointestinal cancer exists. However, 5-fluorouracil (5-FU) is being used more frequently as a key component of combination therapy regimens for this disease, and including cisplatin (CDDP) in combination therapy regimens produces significant tumor shrinkage. Although oral formulations of 5-FU are widely used in Japan, their clinical activity and toxicity have not been thoroughly evaluated. In 1992, the Japan Clinical Oncology Group initiated a phase III study in which the survival rates of patients treated with 5-FU 800 mg/m2/day for 5 days by continuous infusion (5-FUci), 5-FUci with CDDP 20 mg/ m2/day for 5 days by infusion, or oral uracil/Ftorafur 375 mg/m2/day with weekly MMC 5 mg/m2 iv were compared. This study was closed with 280 patients accrued in 1997, and final analysis was made in early 1998. Irinotecan and paclitaxel are new drugs with activity against gastric cancer. Combination chemotherapy consisting of irinotecan with CDDP has also been evaluated. For treatment of metastatic colorectal cancer, the only active drug previously available in Japan was 5-FU, although 5-FU + leucovorin is the international standard regimen. Irinotecan is now approved in Japan, Europe, and the USA and is the most effective drug for 5-FU-refractory patients. The optimal irinotecan and 5-FU combination regimen is being extensively examined but further trials aimed at accumulating basic data are warranted.

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References

  1. Ajani JA, Fairweather J, Dumas P, Pazdur R, Mansfield PF (1997) A phase II study of Taxol in patients with advanced untreated gastric carcinoma. Proc Am Soc Clin Oncol 16:263a (abstract 933)

    Google Scholar 

  2. Boku N, Ohtsu A, Shimada Y, Shirao K, Seki S, Saito H, Sakata Y, Hyodo I (1997) Phase II study of a combination of CDDP and CPT- 11 in metastatic gastric cancer: CPT-11 Study Group for Gastric Cancer. Proc Am Soc Clin Oncol 16:264a (abstract 936)

    Google Scholar 

  3. Cocconi G, Bella M, Zironi S, Algeri R, DiCostanzo F, DeLisi V, Luppi G, Mazzocchi B, Rodino G, Soldani M, Gilli G, Finardi C (1994) Fluorouracil, doxorubicin, and mitomycin combination versus PELF chemotherapy in advanced gastric cancer: a prospective randomized trial of the Italian Oncology Group for Clinical Research. J Clin Oncol 12:2687

    PubMed  CAS  Google Scholar 

  4. Cullinan SA, Moertel CG, Wieand H, et al (1994) Controlled evaluation of three drug combination regimen versus fluorouracil alone in the therapy of advanced gastric cancer. J Clin Oncol 12:412

    PubMed  CAS  Google Scholar 

  5. Kakizoe T (ed) (1997) Cancer Statistics in Japan-1997. Tokyo: Foundation for Promotion of Cancer Research

    Google Scholar 

  6. Kambe M, Wakui A, Nakao I, Futasuki K, Sakata Y, Yoshino M, Shimada Y, Taguchi T, the CPT-11 Gastrointestinal Cancer Study Group (1993) A late phase II study of irinotecan (CPT-11) in patients with advanced gastric cancer. Proc Am Soc Clin Oncol 12:198 (abstract 584)

    Google Scholar 

  7. Kelsen D, Atig O, Saltz L, Niedzwiecki D, Ginn D, Chapman D, Heelan R, Lightdale C, Vinciguerra V, Brennan M (1992) FAMTX versus etoposide, doxorubicin and cisplatin: a randomized trial in gastric cancer. J Clin Oncol 10:541

    PubMed  CAS  Google Scholar 

  8. Kim NK, Park YS, Heo DS, Suh C, Kim SY, Park KC, Kang YK, Shin DB, Kim HT, Kim HJ, Kang WK, Suh CI, Bang YJ (1993) 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 71:3813

    Article  PubMed  CAS  Google Scholar 

  9. Koizumi W, Kurihara M, Sasai T, Yoshida S, Morise K, Imamura A, Akazawa S, Betsuyaku T, Ohkubo S, Takahashi H, Akiya T, Hamada T, Kiyohashi A (1993) A phase II study of combination therapy with 5′-deoxy-5-fluorouridine and cisplatin in the treatment of advanced gastric cancer with primary foci. Cancer 72:658

    Article  PubMed  CAS  Google Scholar 

  10. Kurihara M, Izumi T, Yoshida S, Ohkubo T, Suga S, Kiyohashi A, Yaosaka T, Takahashi H, Ito T, Sasai T, Akiya T, Akazawa S, Betsuyaku T, Taguchi S (1991) A cooperative randomized study on tegafur plus mitomycin C versus combined tegafur and uracil plus mitomycin C in the treatment of advanced gastric cancer. Jpn J Cancer Res 82:613

    PubMed  CAS  Google Scholar 

  11. Masuda N, Fukuoka M, Takada M, Kusonoki Y, Negoro S, Matsui K, Kudoh S, Takafuji N, Nakagawa K, Kishimoto S (1992) CPT-11 in combination with cisplatin for advanced non-small-cell lung cancer. J Clin Oncol 11:1775

    Google Scholar 

  12. Masuda N, Fukuoka M, Kudoh S, Kusonoki Y, Matsui K, Takafuji N, Nakagawa K, Tamanoi M, Nitta T, Hirashima T, Negoro S, Takada M (1993) Phase I and pharmacologic study of irinotecan in combination with cisplatin for advanced lung cancer. Br J Cancer 68:77

    Google Scholar 

  13. Ohtsu A, Shimada Y, Saito H, Seki S, Morise K, Kurihara M (1994) Phase II study of protracted infusional 5-fluorouracil combined with cisplatin for advanced gastric cancer: Report from the Japan Clinical Oncology Group (JCOG). Eur J Cancer 30A:2091

    Article  PubMed  CAS  Google Scholar 

  14. Ohtsu A, Boku N, Tamura F, Muro K, Shimada Y Saigenji K, Akazawa S, Kitajima M, Kanamaru R, Taguchi T (1998) An early phase II study of three-hour infusional paclitaxel for advanced gastric cancer. Am J Clin Oncol (in press)

  15. Pazdur R, Lassere Y, Rhodes V, Ajani JA, Sugarman SM, Patt YZ, Jones DV, Markowitz AB, Abbruzzese JL, Bready B, Levin B (1994) Phase II trial of uracil and tegafur plus oral leucovorin: an effective oral regimen in the treatment of metastatic colorectal cancer. J Clin Oncol 12:2296

    PubMed  CAS  Google Scholar 

  16. Shimada Y, Sasaki Y, Sugano K, Shirao K, Kondo H, Yokota T, Saito D, Tamura T, Ohe Y, Shinkai T, Eguchi K, Saijo N, Shintani S (1993) Combination phase I study of CPT-11 (irinotecan) combined with continuous infusion of 5-fluorouracil (5-FU) in metastatic colorectal cancer. Proc Am Soc Clin Oncol 12:196 (abstract 575)

    Google Scholar 

  17. Shimada Y, Yoshino M, Wakui A, Nakao I, Futasuki K, Sakata Y Kambe M, Taguchi T, the CPT-11 Gastrointestinal Cancer Study Group (1993) Phase II study of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer. J Clin Oncol 11:909

    PubMed  CAS  Google Scholar 

  18. Shirao K, Shimada Y Kondo H, Saito D, Yamao T, Ono H, Yokoyama T, Fukuda H, Oka M, Watanabe Y Ohtsu A, Boku N, Fujii T, Oda Y, Muro K, Yoshida S (1997) Phase I-II study of irinotecan hydrochloride combined with cisplatin in patients with advanced gastric cancer. J Clin Oncol 15:921

    PubMed  CAS  Google Scholar 

  19. Wilke H, Wils J, Rougier Ph, Lacave A, Cutsem EV, Vanhoefer U, Sahmoud T, Curran D, Marinus A (1995) Preliminary analysis of a randomized phase III trial of FAMTX versus ELF versus Cisplatin/ FU in advanced gastric cancer (GC). A trial of the EORTC Gastrointestinal Tract Cancer Cooperative Group and the AIO (Arbeitsgemeinschaft Internistische Onkologie). Proc Am Soc Clin Oncol 14:206 (abstract 500)

    Google Scholar 

  20. Wils JA, Klein HO, Wagener DJTh, Bleiberg H, Reis H, Korsten F, Conroy Th, Fickers M, Leyvraz S, Buyse M, Duez N, for the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group (1991) 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 9:827

    PubMed  CAS  Google Scholar 

  21. Yamao T, Shimada Y Shirao K, Kondo H, Matsumura Y Sugano K, Saito D, Ohtsu A, Boku N, Yoshida S, Sasaki Y, Ono K (1996) Phase I study of CPT-11 combined with sequential 5FU in metastatic colorectal cancer (CRC). Proc Am Soc Clin Oncol 15:481 (abstract 1527)

    Google Scholar 

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Authors and Affiliations

  1. Department of Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, 104-0045, Tokyo, Japan

    Yasuhiro Shimada

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  1. Yasuhiro Shimada
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Work presented at the 13th Bristol-Myers Squibb Nagoya International Cancer Treatment Symposium, “Strategic Cross Talk between Major Oncology Groups/Clinical Pharmacology in Cancer Chemotherapy”, 17–18 October 1997, Nagoya, Japan

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Shimada, Y. Clinical trials for advanced gastrointestinal cancers in Japan. Cancer Chemother Pharmacol 42 (Suppl 1), S80–S84 (1998). https://doi.org/10.1007/s002800051085

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