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Bolusvs. continuous hepatic arterial infusion of cisplatin plus intravenous 5-fluorouracil chemotherapy for unresectable colorectal metastases

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Diseases of the Colon & Rectum

Abstract

A multicenter, randomized Phase 2 study that compared patients, affected by colorectal liver metastases, who received intrahepatic arterial infusion with two different schedules of cisplatin, bolusvs. continuous infusion, and systemic 5-fluorouracil. PURPOSE: The aim of this study was to validate results of a previous Phase 2 trial on bolus cisplatin intrahepatic arterial infusion, which reported a 47 percent response rate and a 32 percent 4-year survival rate for Gennari's Stage 2 patients, with a high rate of neurologic, gastrointestinal, and hematologic toxicity. METHODS: One hundred nine patients were randomized in a Phase 2 study to receive cisplatin intrahepatic arterial infusion (24 mg/m2/day, 1→5, bolusvs. continuous infusion) and systemic intravenous 5-fluorouracil (250, 375, or 500 mg/m2/day, 1→5; escalating doses, respectively, at cycles I, II, III, and VI). To avoid neurotoxicity a maximum of six cycles was administered. RESULTS: Preliminary results for the 78 evaluable patients are similar to those of the previous study: response rate 46 percent and at a median follow-up of 16.5 months, the overall survival was 16.5 months, with 45 percent of the patients who received more than 3 cycles alive at 3 years. Toxicity, evaluable in 99 patients, showed a decreased incidence of neurotoxicity and a tolerable gastrointestinal and hematologic toxicity, lower in the cisplatin continuous infusion arm. CONCLUSION: This study clearly shows that cisplatin intrahepatic arterial infusion is able to provide a good palliative effect with a tolerable toxicity.

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Author information

Authors and Affiliations

  1. Medical Oncology, University of Rome, Policlinico Umberto I, 00161, Rome, Italy

    E. Cortesi M.D. & A. Padovani M.D.

  2. Regina Elena Cancer Institute, Italy

    L. Capussotti M.D., A. Callopoli M.D., D. Giannarelli Ph.D. & M. Cosimelli M.D.

  3. University of Genoa, Italy

    P. Di Tora M.D.

  4. Ospedale Civile, University of Palermo, Italy

    E. Mannella M.D. & V. Casaldi M.D.

  5. Iseo

    D. Civalleri M.D.

  6. Mauriziano Hospital, University of Padua, Italy

    G. B. Morandi M.D.

  7. Turin National Register of Implantable Systems (RNSI), Rome, Italy

    P. P. Da Pian M.D.

Authors
  1. E. Cortesi M.D.
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  2. L. Capussotti M.D.
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  3. P. Di Tora M.D.
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  4. E. Mannella M.D.
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  5. V. Casaldi M.D.
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  6. D. Civalleri M.D.
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  7. G. B. Morandi M.D.
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  8. P. P. Da Pian M.D.
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  9. A. Padovani M.D.
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  10. A. Callopoli M.D.
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  11. D. Giannarelli Ph.D.
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  12. M. Cosimelli M.D.
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Additional information

This study was supported in part by Pharmacia-Deltec, Italy.

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Cortesi, E., Capussotti, L., Di Tora, P. et al. Bolusvs. continuous hepatic arterial infusion of cisplatin plus intravenous 5-fluorouracil chemotherapy for unresectable colorectal metastases. Dis Colon Rectum 37 (Suppl 2), S138–S143 (1994). https://doi.org/10.1007/BF02048447

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  • DOI: https://doi.org/10.1007/BF02048447

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