Fluorouracil-alone versus high-dose folinic acid and fluorouracil in advanced colorectal cancer: A randomized trial of the Italian Oncology Group for Clinical Research (GOIRC)

F. Di Costanzo, R. Bartolucci, F. Calabresi, M. Sofra, M. Marzola, V. Belsanti, C. Boni, M. Bacchi

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Abstract

One hundred eighty-one patients with measurable recurrent or metastatic colorectal cancer, who had not received prior chemotherapy, were randomized in a prospective controlled trial to receive 5-fluorouracil (5FU), 13.5 mg/kg, for five days (arm A) or high-dose folinic acid [Cyanamid-Lederle, Italy] (FA), 200 mg/m2, for five days and 5FU, 400 mg/m2 for five days (arm B). The treatments were repeated every four weeks. One hundred fifty-five patients were evaluable for response. The two arms were balanced for all potential prognostic factors studied. The response rate (CR + PR) was 18% in the 5FU arm and 16% in the 5FU plus FA arm. Median duration of response was 56 weeks for 5FU alone and 42 weeks for the combination (p = 0.48). Median time to failure (TTF) was 20 weeks for arm A and 21 for arm B (p = 0.62). Median survival was 62 weeks on the 5FU arm and 53 weeks on the FA plus 5FU arm (p = 0.14). Dose intensity (DI) delivered was the same in both arms. Diarrhea and mucositis were the most frequent adverse reactions in arm B; 20% of the patients in arm A and 38% of those in arm B experienced diarrhea (p = 0.008). Mucositis occurred in 34% of patients in arm A and 42% in arm B (p = 0.04). In general nausea and vomiting were moderate. Hematological toxicity was more severe in patients treated with 5FU alone: 31% in arm A and 14% in arm B developed leukopenia (p = 0.015). In the combination arm one patient died due to gastrointestinal and hematological toxicity after the seventh cycle. This study indicates that, in advanced colorectal cancer, the combination of high-dose FA and 5FU is not superior to 5FU alone when utilized at standard high dose intensity.

Original languageEnglish
Pages (from-to)371-376
Number of pages6
JournalAnnals of Oncology
Volume3
Issue number5
Publication statusPublished - 1992

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Colorectal Cancer
Oncology
Randomized Trial
Medical Oncology
Leucovorin
Fatty Acids
Fluorouracil
Toxicity
Colorectal Neoplasms
Dose
Chemotherapy
Acids
Research
Prognostic Factors
Nausea
Vomiting
Mucositis
Diarrhea
Cycle
Colorectal cancer

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Statistics, Probability and Uncertainty
  • Applied Mathematics
  • Public Health, Environmental and Occupational Health
  • Neuropsychology and Physiological Psychology
  • Hematology

Cite this

Fluorouracil-alone versus high-dose folinic acid and fluorouracil in advanced colorectal cancer : A randomized trial of the Italian Oncology Group for Clinical Research (GOIRC). / Di Costanzo, F.; Bartolucci, R.; Calabresi, F.; Sofra, M.; Marzola, M.; Belsanti, V.; Boni, C.; Bacchi, M.

In: Annals of Oncology, Vol. 3, No. 5, 1992, p. 371-376.

Research output: Contribution to journalArticle

Di Costanzo, F, Bartolucci, R, Calabresi, F, Sofra, M, Marzola, M, Belsanti, V, Boni, C & Bacchi, M 1992, 'Fluorouracil-alone versus high-dose folinic acid and fluorouracil in advanced colorectal cancer: A randomized trial of the Italian Oncology Group for Clinical Research (GOIRC)', Annals of Oncology, vol. 3, no. 5, pp. 371-376.
Di Costanzo, F. ; Bartolucci, R. ; Calabresi, F. ; Sofra, M. ; Marzola, M. ; Belsanti, V. ; Boni, C. ; Bacchi, M. / Fluorouracil-alone versus high-dose folinic acid and fluorouracil in advanced colorectal cancer : A randomized trial of the Italian Oncology Group for Clinical Research (GOIRC). In: Annals of Oncology. 1992 ; Vol. 3, No. 5. pp. 371-376.
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title = "Fluorouracil-alone versus high-dose folinic acid and fluorouracil in advanced colorectal cancer: A randomized trial of the Italian Oncology Group for Clinical Research (GOIRC)",
abstract = "One hundred eighty-one patients with measurable recurrent or metastatic colorectal cancer, who had not received prior chemotherapy, were randomized in a prospective controlled trial to receive 5-fluorouracil (5FU), 13.5 mg/kg, for five days (arm A) or high-dose folinic acid [Cyanamid-Lederle, Italy] (FA), 200 mg/m2, for five days and 5FU, 400 mg/m2 for five days (arm B). The treatments were repeated every four weeks. One hundred fifty-five patients were evaluable for response. The two arms were balanced for all potential prognostic factors studied. The response rate (CR + PR) was 18{\%} in the 5FU arm and 16{\%} in the 5FU plus FA arm. Median duration of response was 56 weeks for 5FU alone and 42 weeks for the combination (p = 0.48). Median time to failure (TTF) was 20 weeks for arm A and 21 for arm B (p = 0.62). Median survival was 62 weeks on the 5FU arm and 53 weeks on the FA plus 5FU arm (p = 0.14). Dose intensity (DI) delivered was the same in both arms. Diarrhea and mucositis were the most frequent adverse reactions in arm B; 20{\%} of the patients in arm A and 38{\%} of those in arm B experienced diarrhea (p = 0.008). Mucositis occurred in 34{\%} of patients in arm A and 42{\%} in arm B (p = 0.04). In general nausea and vomiting were moderate. Hematological toxicity was more severe in patients treated with 5FU alone: 31{\%} in arm A and 14{\%} in arm B developed leukopenia (p = 0.015). In the combination arm one patient died due to gastrointestinal and hematological toxicity after the seventh cycle. This study indicates that, in advanced colorectal cancer, the combination of high-dose FA and 5FU is not superior to 5FU alone when utilized at standard high dose intensity.",
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T2 - A randomized trial of the Italian Oncology Group for Clinical Research (GOIRC)

AU - Di Costanzo, F.

AU - Bartolucci, R.

AU - Calabresi, F.

AU - Sofra, M.

AU - Marzola, M.

AU - Belsanti, V.

AU - Boni, C.

AU - Bacchi, M.

PY - 1992

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N2 - One hundred eighty-one patients with measurable recurrent or metastatic colorectal cancer, who had not received prior chemotherapy, were randomized in a prospective controlled trial to receive 5-fluorouracil (5FU), 13.5 mg/kg, for five days (arm A) or high-dose folinic acid [Cyanamid-Lederle, Italy] (FA), 200 mg/m2, for five days and 5FU, 400 mg/m2 for five days (arm B). The treatments were repeated every four weeks. One hundred fifty-five patients were evaluable for response. The two arms were balanced for all potential prognostic factors studied. The response rate (CR + PR) was 18% in the 5FU arm and 16% in the 5FU plus FA arm. Median duration of response was 56 weeks for 5FU alone and 42 weeks for the combination (p = 0.48). Median time to failure (TTF) was 20 weeks for arm A and 21 for arm B (p = 0.62). Median survival was 62 weeks on the 5FU arm and 53 weeks on the FA plus 5FU arm (p = 0.14). Dose intensity (DI) delivered was the same in both arms. Diarrhea and mucositis were the most frequent adverse reactions in arm B; 20% of the patients in arm A and 38% of those in arm B experienced diarrhea (p = 0.008). Mucositis occurred in 34% of patients in arm A and 42% in arm B (p = 0.04). In general nausea and vomiting were moderate. Hematological toxicity was more severe in patients treated with 5FU alone: 31% in arm A and 14% in arm B developed leukopenia (p = 0.015). In the combination arm one patient died due to gastrointestinal and hematological toxicity after the seventh cycle. This study indicates that, in advanced colorectal cancer, the combination of high-dose FA and 5FU is not superior to 5FU alone when utilized at standard high dose intensity.

AB - One hundred eighty-one patients with measurable recurrent or metastatic colorectal cancer, who had not received prior chemotherapy, were randomized in a prospective controlled trial to receive 5-fluorouracil (5FU), 13.5 mg/kg, for five days (arm A) or high-dose folinic acid [Cyanamid-Lederle, Italy] (FA), 200 mg/m2, for five days and 5FU, 400 mg/m2 for five days (arm B). The treatments were repeated every four weeks. One hundred fifty-five patients were evaluable for response. The two arms were balanced for all potential prognostic factors studied. The response rate (CR + PR) was 18% in the 5FU arm and 16% in the 5FU plus FA arm. Median duration of response was 56 weeks for 5FU alone and 42 weeks for the combination (p = 0.48). Median time to failure (TTF) was 20 weeks for arm A and 21 for arm B (p = 0.62). Median survival was 62 weeks on the 5FU arm and 53 weeks on the FA plus 5FU arm (p = 0.14). Dose intensity (DI) delivered was the same in both arms. Diarrhea and mucositis were the most frequent adverse reactions in arm B; 20% of the patients in arm A and 38% of those in arm B experienced diarrhea (p = 0.008). Mucositis occurred in 34% of patients in arm A and 42% in arm B (p = 0.04). In general nausea and vomiting were moderate. Hematological toxicity was more severe in patients treated with 5FU alone: 31% in arm A and 14% in arm B developed leukopenia (p = 0.015). In the combination arm one patient died due to gastrointestinal and hematological toxicity after the seventh cycle. This study indicates that, in advanced colorectal cancer, the combination of high-dose FA and 5FU is not superior to 5FU alone when utilized at standard high dose intensity.

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