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Vol. 66, No. 2, 2004
Issue release date: May 2004
Oncology 2004;66:118–125
(DOI:10.1159/000077437)

Phase II Study of Cisplatin and 5-Fluorouracil (PF) and Mitomycin C, Vincristine, Cisplatin and 5-Fluorouracil (MVPF) in Patients with Metastatic Large Bowel Cancer: An Eastern Cooperative Oncology Group Study (EST 1285)

Pandya K.J. · Lefkopoulou M. · Petrelli N.J. · Vaughn D.J. · Smith T.J. · Harris J.E. · Haller D.G.
aUniversity of Rochester Cancer Center, Rochester, N.Y., bDana-Farber Cancer Institute, Boston, Mass., cRoswell Park Memorial Institute, Buffalo, N.Y., dUniversity of Pennsylvania Cancer Center, Philadelphia, Pa., eMorristown Memorial Hospital, Morristown, N.J., and fRush-Presbyterian-St. Luke’s Medical Center, Chicago, Ill., USA

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Abstract

Purpose: To compare the efficacy and the toxicity of cisplatin and 5-fluorouracil (PF) and mitomycin C, vincristine, cisplatin and 5-fluorouracil (MVPF) in patients with metastatic large bowel cancer. Patients and Methods: A total of 94 patients with no prior chemotherapy and measurable metastatic large bowel cancer were randomly assigned to one of the two treatment regimens. Eastern Cooperative Oncology Group (ECOG) criteria were used to evaluate response and toxicity. Results: Fifty patients were randomized to PF and 44 to MVPF. Toxicity was evaluable in all patients except one; response was evaluable in 40 and 31, with response rate of 13 and 42%, respectively. Intent-to-treat analysis showed a response rate of 12 and 32%, respectively (p = 0.076), where it was assumed that none of the ineligible or unevaluable patients responded. Median survival for all patients was 9 months, with no difference between PF and MVPF. ECOG Performance Status (0 vs. 1), weight loss (≤10 vs. >10%) and site of metastatic lesion had statistically significant impact on survival. MVPF was definitely more toxic than PF (p < 0.000005). Conclusion: Both treatment regimens showed clinical activity. The MVPF regimen resulted in more responses than PF, no improvement in survival, and more toxicity.



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References

  1. Davis HL: Chemotherapy of large bowel cancer. Cancer 1982;50:2638–2646.
  2. Ansfield F, Klotz J, Nealon T, et al: A phase III study comparing the clinical utility of four regimens of 5-fluorouracil. A preliminary report. Cancer 1977;39:34–40.
  3. Seifert P, Baker L, Reed M, et al: Comparison of continuously infused 5-fluorouracil with bolus injection in treatment of patients with colorectal adenocarcinoma. Cancer 1975;36:123–138.
  4. Crooke ST, Bradner WT: Mitomycin C: A review. Can Treat Rev 1976;3:121–139.
  5. Pouillart P, Huong MT, Burgerie E, et al: Sequential administration of two oncostatic drugs: Study of modalities for pharmacodynamic potentiation. Biomedicine 1974;21:471–479.
  6. Kovach JS, Moertel CG, Schutt AJ, et al: Phase II study of cis-diamminedichloroplatinum in advanced carcinoma of the large bowel. Can Chemother Rep 1973;57:357–359.
  7. Bergerat JP, Barlogie B, Drewinko B: Effects of cis-dichlorodiammine platinum (II) on human colon carcinoma cells in vitro. Can Research 1979;39:1334–1338.
  8. Woodman RJ, Sirica AE, Gang M: The enhanced therapeutic effect of cis-platinum (II) diaminodichloride against L1210 leukemia when combined with cyclophosphamide or several other antitumor agents. Chemotherapy 1973;18:169–183.
  9. Schabel FM Jr, Trader MW, Laster WR, et al: Cis-dichlorodiammineplatinum (II): Combination chemotherapy and cross-resistance studies with tumors of mice. Can Treat Rep 1979;63:1459–1473.
  10. Bergerat J-P, Green C, Drewinko B: Combination chemotherapy in vitro IV: Response of human colon carcinoma cells to combinations using cis-diamminedichloroplatinum. Can Biochem Biophys 1979;3:173–180.
  11. Moertel CG, O’Connell MJ, Ritts RE Jr, et al: A controlled evaluation of combined immunotherapy (MER-BCG) and chemotherapy for advanced colorectal cancer; in Ter WD, Windhurst D (eds): Immunotherapy of Cancer: Present Status of Trials of Man. New York, Raven Press, 1978:573–586.
  12. Shepard KV, Bitran JD, Sweet DL, et al: Treatment of metastatic colorectal carcinoma with cisplatinum (DDP) and 5-fluorouracil (5-FU). Proceed ASCO 1984;3:147.
  13. Einhorn LH, Williams DS, Loehrer PJ: Combination chemotherapy with platinum (P) plus 5-FU in metastatic colorectal carcinoma. Proceed ASCO 1984;3:133.
  14. Petrelli N, Madajewicz S, Rustum Y, et al: Combination chemotherapy of cisplatin and 5-fluorouracil for advanced colorectal carcinoma. Cancer Chemother Pharmacol 1989;23:57–60.
  15. Pandya KJ, Chang AYC, Asbury RF, et al: Combination chemotherapy for advanced colorectal cancer. A pilot study. Am J Clin Oncol 1986;9:31–34.
  16. Pandya KJ: Unpublished data.
  17. Oken MM, Creech RM, Tormey DC, et al: Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649–655.
  18. Mehta CR, Patel NR, Tsiatis AA: Exact significance testing for ordered categorical data. Biometrics 1984;40:819–825.
  19. Cox DR: The analysis of binary data. London: Methuen, 1970.
  20. Mantel N, Haenszel W: Statistical aspects of the analysis of data from retrospective studies of disease. J Nat Cancer Inst 1959;22:719–748.
  21. Cox DR: Regression models and life-tables. JR Statist Soc B 1972;34:187–220.
  22. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Statist Ass 1958;53:457–481.
  23. O’Connell MJ, Moertel CG, Kvols LK, et al: Clinical trial of cisplatin and intensive course 5-fluorouracil for the treatment of advanced colorectal cancer. Am J Clin Oncol 1986;9:192–195.
  24. Dy C, Gil A, Algarra SM, et al: Combination chemotherapy of cisplatin and 5-FU in advanced colorectal carcinoma. Cancer Treat Rep 1986;70:465–468.
  25. Whitehead RP, Fleming TR, Macdonald JS, et al: A phase II study of chemotherapy of metastatic colorectal carcinoma with 5-fluorouracil plus cisplatin. A Southwest Oncology Group Study. Invest New Drugs 1991;9:345–347.
  26. Loehrer PJ Sr, Turner S, Kubilis P, et al: A prospective randomized trial of fluorouracil versus fluorouracil plus cisplatin in the treatment of metastatic colorectal cancer: A Hoosier Oncology Group Trial. J Clin Oncol 1988;6:642–648.
  27. Labianca R, Pancera G, Cesana B, et al: Cisplatin + 5-fluorouracil versus 5-fluorouracil alone in advanced colorectal cancer: A randomized study. Eur J Cancer Clin Oncol 1988;24:1579–1581.
  28. Kemeny N, Israel K, Niedzwiecki D, et al: Randomized study of continuous infusion fluorouracil versus fluorouracil plus cisplatin in patients with metastatic colorectal cancer. J Clin Oncol 1990;8:313–318.
  29. Cantrell JR Jr, Hart RD, Taylor RF, et al: Pilot trial of prolonged continuous-infusion 5-fluorouracil and weekly cisplatin in advanced colorectal cancer. Cancer Treat Rep 1987;71:615–618.
  30. LoRusso P, Pazdur R, Redman BG, et al: Low-dose continuous infusion 5-fluorouracil and cisplatin: Phase II evaluation in advanced colorectal carcinoma. Am J Clin Oncol 1989;12:486–490.
  31. Hansen RM, Ryan L, Anderson T, et al: Phase III study of bolus versus infusion fluorouracil with or without cisplatin in advanced colorectal cancer. J Natl Cancer Inst 1996;88:668–674.
  32. Ross P, Norman A, Cunningham D, et al: A prospective randomized trial of protracted venous infusion 5-fluorouracil with or without mitomycin C in advanced colorectal cancer. Ann Oncol 1997;8:995–1001.
  33. Mothe G, Kidani Y, Segignchi M, et al: Oxalito-platinum or L-OHP, a third-generation platinum complex: An experimental and clinical appraisal and preliminary comparison with cis-platinum and carboplatinum. Biomed Pharmacother 1989;43:237–250.
  34. Garufi C, Brienza S, Bensmaine MA, et al: Addition of oxaliplatin (L-OHP) to chronomodulated (CM) 5-fluorouracil (5-FU) and folinic acid (FA) for reversal of acquired chemoresistance in patients with advanced colorectal cancer (ACC). Proc Am Soc Clin Oncol 1995;14:192 (abstr 446).
  35. Fink D, Nebel S, Aebi S, et al: The role of DNA mismatch repair in platinum drug resistance. Cancer Res 1996;56:4881–4886.
  36. Misset JL, Bleiberg H, Sutherland W, et al: Oxaliplatin clinical activity: A review. Crit Rev Oncology-Hematology 2000;35:75–93.


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