Activity and toxicity of oxaliplatin and bolus fluorouracil plus leucovorin in pretreated colorectal cancer patients: A phase II study

Virginia Ferraresi, M. A. Giampaolo, A. Gabriele, G. Mansueto, A. Buccilli, D. Giannarelli, M. Ciccarese, T. Gamucci

Research output: Contribution to journalArticle

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Abstract

The aim of the current study was to evaluate the activity and toxicity of a combination of oxaliplatin with bolus fluorouracil and leucovorin in colorectal cancer (CRC) patients pretreated for advanced disease with various schedules including continuous fluorouracil infusion. Thirty consecutive patients with pretreated advanced CRC received oxaliplatin 130 mg/m2 by 2-h infusion d1, leucovorin 100 mg/m2 by 1-h infusion followed by fluorouracil 425 mg/m2 i.v. bolus from day 1 to 3 every 3 weeks for a maximum of 6 cycles. The best overall response rate in an intent-to-treat analysis was 13% (2 complete responses and 2 partial responses) (95% CI, 1.2-25.5%) and 37% of patients obtained stable disease with a tumor growth control rate of 50% (95% CI, 32.1-67.9%). The median progression-free survival was 4.0 months (95% CI, 1.4-6.5 months) and median overall survival was 12.0 months (95% CI, 9.9-14.1 months). The independent prognostic factors for improved overall survival were a good performance status and a response/stabilization of disease to chemotherapy. Severe neutropenia was quite common (43.3% of patients and 14.4% of cycles), although complicated by fever only in one case (3.3% of patients). There was one toxic death. In conclusion, the study combination showed an interesting rate of tumor growth control in a cohort of patients previously treated for advanced disease with various schedules including continuous fluorouracil infusion.

Original languageEnglish
Pages (from-to)187-196
Number of pages10
JournalJournal of Experimental and Clinical Cancer Research
Volume24
Issue number2
Publication statusPublished - Jun 2005

Fingerprint

oxaliplatin
Leucovorin
Fluorouracil
Colorectal Neoplasms
Appointments and Schedules
Survival
Poisons
Growth
Neutropenia
Disease-Free Survival
Neoplasms
Fever

Keywords

  • Advanced colorectal cancer
  • Bolus 5-fluorouracil
  • Chemotherapy
  • Oxaliplatin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Activity and toxicity of oxaliplatin and bolus fluorouracil plus leucovorin in pretreated colorectal cancer patients : A phase II study. / Ferraresi, Virginia; Giampaolo, M. A.; Gabriele, A.; Mansueto, G.; Buccilli, A.; Giannarelli, D.; Ciccarese, M.; Gamucci, T.

In: Journal of Experimental and Clinical Cancer Research, Vol. 24, No. 2, 06.2005, p. 187-196.

Research output: Contribution to journalArticle

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abstract = "The aim of the current study was to evaluate the activity and toxicity of a combination of oxaliplatin with bolus fluorouracil and leucovorin in colorectal cancer (CRC) patients pretreated for advanced disease with various schedules including continuous fluorouracil infusion. Thirty consecutive patients with pretreated advanced CRC received oxaliplatin 130 mg/m2 by 2-h infusion d1, leucovorin 100 mg/m2 by 1-h infusion followed by fluorouracil 425 mg/m2 i.v. bolus from day 1 to 3 every 3 weeks for a maximum of 6 cycles. The best overall response rate in an intent-to-treat analysis was 13{\%} (2 complete responses and 2 partial responses) (95{\%} CI, 1.2-25.5{\%}) and 37{\%} of patients obtained stable disease with a tumor growth control rate of 50{\%} (95{\%} CI, 32.1-67.9{\%}). The median progression-free survival was 4.0 months (95{\%} CI, 1.4-6.5 months) and median overall survival was 12.0 months (95{\%} CI, 9.9-14.1 months). The independent prognostic factors for improved overall survival were a good performance status and a response/stabilization of disease to chemotherapy. Severe neutropenia was quite common (43.3{\%} of patients and 14.4{\%} of cycles), although complicated by fever only in one case (3.3{\%} of patients). There was one toxic death. In conclusion, the study combination showed an interesting rate of tumor growth control in a cohort of patients previously treated for advanced disease with various schedules including continuous fluorouracil infusion.",
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