Investigational New Drugs

, Volume 22, Issue 1, pp 91–97 | Cite as

Gemcitabine and Cisplatin for Patients with Metastatic or Recurrent Esophageal Carcinoma: A Southwest Oncology Group Study

  • Susan G. Urba
  • Kari Chansky
  • Peter J. vanVeldhuizen
  • Robert E. Pluenneke
  • Jacqueline K. Benedetti
  • John S. Macdonald
  • James L. Abbruzzese


Purpose: Experimental data, both in vivo and in vitro, suggest that the combination of gemcitabine and cisplatin acts synergistically. Within the Southwest Oncology Group, we designed a Phase II trial to test this chemotherapy combination for patients with esophageal cancer. Experimental design: Patients with metastatic or recurrent esophageal cancer were treated with gemcitabine 1000 mg/m2 on days 1, 8, and 15, and cisplatin 100 mg/m2 on day 15. Cycles were repeated every 28 days. The statistical endpoint was overall survival. Results: Sixty-four eligible patients were accrued from 37 institutions. Twenty-six percent of patients had prior chemotherapy. The treatment was generally well-tolerated, with the most common toxicity being neutropenia in 31% of patients. All 64 patients have died. Survival at 3 months was 81%, and at 1 year was 20%. Median survival was 7.3 months. Conclusions: This regimen is tolerable palliative option for patients with metastatic esophageal cancer.

esophageal cancer chemotherapy gemcitabine cisplatin 


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  1. 1.
    Panettiere FJ, Leichman LP, Tilchen E, Chen TT: Chemotherapy for advanced epidermoid carcinoma of the esophagus with single-agent cisplatin: Final report on a Southwest Oncology Group study. Cancer Treat Rep 68: 1023–1024, 1984Google Scholar
  2. 2.
    Ezdinli EZ, Gelber R, Desai DV, Falkson G, Moertel CG, Han RG: Chemotherapy of advanced esophageal carcinoma: Eastern Cooperative Oncology Group Experience. Cancer 46: 2149–2153, 1980Google Scholar
  3. 3.
    Ajani JA, Ilson DH, Daugherty K, Pazdur R, Lynch PM, Kelsen DP: Activity of taxol in patients with squamous cell carcinoma and adenocarcinoma of the esophagus. J Natl Cancer Inst 86: 1086–1091, 1994Google Scholar
  4. 4.
    Coia L: The use of Mitomycin-C in esophageal cancer. Oncol (snsuppl) 50: 53–62, 1993Google Scholar
  5. 5.
    Kambe M, Wakui A, Nakao I, Futatsuki K, Sakata Y, Yoshino M, Shimada Y, Taguchi T: A late phase II study of irinotecan (CPT-11) in patients with advanced gastric cancers. Proc Am Soc Clin Oncol 12: 584, 1993Google Scholar
  6. 6.
    Heath EI, Urba S, Marshall J, Piantadosi S, Forastiere AA: Phase II trial of docetaxel chemotherapy in patients with incurable adenocarcinoma of the esophagus. Invest New Drugs 20: 95–99, 2002Google Scholar
  7. 7.
    Ilson DH, Saltz L, Enzinger P, Huang Y, Kornblith A, Gollub M, O'Reilly E, Schwartz G, DeGroff J, Gonzalez G, Kelsen D: Phase II trial of weekly irinotecan plus cisplatin in advanced esophageal cancer. J Clin Oncol 17: 3270–3275, 1999Google Scholar
  8. 8.
    Macdonald JS, Jacobsen JL, Ketchel SJ, Weiss G, Taylor S, Mills G, Kuebler JP, Rivkin S, Conrad M: A phase II trial of topotecan in esophageal cancer: A Southwest Oncology Group study (SWOG 9339). Invest New Drugs 18: 199–202, 2000.Google Scholar
  9. 9.
    Hertel LW, Boder GB, Kroin JS, Rinzel SM, Poore GA, Todd GC, Grindey GB: Evaluation of the antitumor activity of gemcitabine (2′,2′-difluoro-2′-deoxycytidine). Can Res 50(14): 4417–4422, 1990Google Scholar
  10. 10.
    Peters GJ, Bergman AM, Ruiz van Haperen VWT, Veerman G, Kuiper CM, Braakhuis BJ: Interaction between cisplatin and gemcitabine in vitro and in vivo. Semin Oncol 22supp 11 72–79, 1995Google Scholar
  11. 11.
    Bergman A, Ruiz van Haperen VWT, Weerman G, Kuiper CM, Peters GJ: Synergistic interaction between cisplatin and gemcitabine in vitro. Clin Can Res 2: 521–530, 1996Google Scholar
  12. 12.
    Abbruzzese JL, Frost P: Studies on the mechanism of the synergistic interaction between 2′deoxy-5-azacytidine and cisplatin. Can Chem Pharm 30: 31–36, 1992Google Scholar
  13. 13.
    Bleiberg H, Conroy T, Paillot B, Lacave AJ, Blijham G, Jacob JH, Bedenne L, Namer M, De Besi P, Gay F, Collette L, Sahmoud T: Randomized phase II study of cisplatin and 5-fluorouracil versus cisplatin alone in advanced squamous cell esophageal cancer. Eur J Cancer 33: 1216–1220, 1997Google Scholar
  14. 14.
    van der Gaast, Kok TC, Kerkhofs L, Siersema PD, Tilanus HW, Splinter TA: Phase I study of a biweekly schedule of a fixed dose of cisplatin with increasing doses of paclitaxel in patients with advanced esophageal cancer. B J Cancer 80: 1052–1057, 1999Google Scholar
  15. 15.
    van der Gaast A, Polee M, Kok TC, Splinter TAW: Phase I study with weekly cisplatin and increasing doses of paclitaxel in patients with esophageal cancer. Proc Am Soc Clin Oncol 18:1162, 1999Google Scholar
  16. 16.
    Ilson DH, Ajani J, Bhalla, Forastiere A, Huang Y, Patel P, Martin L, Donegan J, Pazdur R, Reed C, Kelsen DP: Phase II trial of paclitaxel, fluorouracil, and cisplatin in patients with advanced carcinoma of the esophagus. J Clin Oncol 16: 1826–1834, 1998Google Scholar
  17. 17.
    Ilson DH, Forastiere A, Arquette M, Costa F, Heelan R, Huang Y, Kelsen D: A phase II trial of paclitaxel and cisplatin in patients with advanced carcinoma of the esophagus. Cancer J 6: 316–323, 2000Google Scholar
  18. 18.
    Sandler AB, Kindler HL, Einhorn LH, Mitchell E, Masters G, Kraut M, Nicol S, Raghavan D: Phase II trial of gemcitabine in patients with previously untreated metastatic cancer of the esophagus or gastroesophageal junction. Ann Oncol 11: 1161–1164, 2000Google Scholar
  19. 19.
    Pipp M, Mulkerin D, Warren D, Hotckis W, Berlin J, Thomas JP: A phase II trial of gemcitabine and 5-fluorouracil in advanced esophageal cancer. Proc Am Soc Clin Oncol 20: 630, 2001Google Scholar
  20. 20.
    Fleming DR, Glisson SD, Bhupalam L, Michelson GD, Goldsmith GH, LaRocca RV: Phase I study of paclitaxel and day 1/day 8 gemcitabine in patients with solid malignancies. Am J Clin Oncol 23: 349–352, 2000Google Scholar
  21. 21.
    Kroep JR, Peters GJ, van Moorsel CJ, Catik A, Vermorken JB, Pinedo HM, van Groeningen CJ: Gemcitabine-cisplatin: A schedule finding study. Ann Oncol 10: 1503–1510, 1999Google Scholar

Copyright information

© Kluwer Academic Publishers 2004

Authors and Affiliations

  • Susan G. Urba
    • 1
  • Kari Chansky
    • 2
  • Peter J. vanVeldhuizen
    • 3
  • Robert E. Pluenneke
    • 4
  • Jacqueline K. Benedetti
    • 2
  • John S. Macdonald
    • 5
  • James L. Abbruzzese
    • 6
  1. 1.University of Michigan Medical CenterAnn ArborU.S.A.
  2. 2.Southwest Oncology Group Statistical CenterSeattleU.S.A
  3. 3.University of Kansas Medical CenterKansas City
  4. 4.Kansas City Community Clinical Oncology ProgramKansas City
  5. 5.St Vincent's Comprehensive Cancer CenterNew YorkU.S.A
  6. 6.MD Anderson Cancer CenterHoustonU.S.A

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