Folinic acid + 5-fluorouracil (5-FU) versus equidose 5-FU in advanced colorectal cancer. Phase III study of 'GISCAD' (Italian Group for the study of digestive tract cancer)

R. Labianca, G. Pancera, E. Aitini, S. Barni, A. Beretta, G. D. Beretta, B. Cesana, G. Comella, L. Cozzaglio, M. Cristoni, P. Spagnolli, L. Frontini, O. Gottardi, G. Martignoni, R. Scapaticci, F. Smerieri, M. Vinci, A. Zadro, A. Zaniboni, G. Luporini

Research output: Contribution to journalArticle

Abstract

In a multicentre Phase III trial, 182 patients were randomized to either folinic acid (FA) (200 mg/sqm i.v. x 5 days) + 5-fluorouracil (5-FU) (400 mg/sqm i.v. in 15' x 5 days) every 4 weeks (Arm A), or to 5-FU alone at the same dosage (Arm B). Response rates were 20.6% (Arm A) and 10% (Arm B) with a significant (p = 0.046) advantage for FA + 5-FU. Median time to progression (6 and 6 months) and overall survival (11.5 and 11 months) were similar in the 2 groups of patients, while neither treatment was effective in reducing pain or improving performance status. Univariate analysis showed that no prognostic factors other than treatment influenced response, although survival was affected by the number and site of metastases, performance status, and the presence and degree of pain. Toxicity was acceptable and lower in comparison with other Phase II-III trials, with no significant difference between the 2 arms. However, in individual patients, grade 3-4 side effects (mainly stomatitis and diarrhoea) were observed, particularly in patients receiving FA: this led to interruption of the treatment in 7 cases. The superiority, in terms of objective response, of FA + 5-FU over 5-FU alone would seem to justify a large-scale evaluation of this combination in the adjuvant setting. Further improvements in relation to advanced disease (i.e., modifications to the schedule and/or introduction of other modulators) are warranted.

Original languageEnglish
Pages (from-to)673-679
Number of pages7
JournalAnnals of Oncology
Volume2
Issue number9
Publication statusPublished - 1991

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Colorectal Cancer
Leucovorin
Fluorouracil
Gastrointestinal Tract
Colorectal Neoplasms
Cancer
Pain
Acids
Prognostic Factors
Neoplasms
Metastasis
Modulator
Toxicity
Progression
Justify
Univariate
Schedule
Stomatitis
Survival
Modulators

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

Folinic acid + 5-fluorouracil (5-FU) versus equidose 5-FU in advanced colorectal cancer. Phase III study of 'GISCAD' (Italian Group for the study of digestive tract cancer). / Labianca, R.; Pancera, G.; Aitini, E.; Barni, S.; Beretta, A.; Beretta, G. D.; Cesana, B.; Comella, G.; Cozzaglio, L.; Cristoni, M.; Spagnolli, P.; Frontini, L.; Gottardi, O.; Martignoni, G.; Scapaticci, R.; Smerieri, F.; Vinci, M.; Zadro, A.; Zaniboni, A.; Luporini, G.

In: Annals of Oncology, Vol. 2, No. 9, 1991, p. 673-679.

Research output: Contribution to journalArticle

Labianca, R, Pancera, G, Aitini, E, Barni, S, Beretta, A, Beretta, GD, Cesana, B, Comella, G, Cozzaglio, L, Cristoni, M, Spagnolli, P, Frontini, L, Gottardi, O, Martignoni, G, Scapaticci, R, Smerieri, F, Vinci, M, Zadro, A, Zaniboni, A & Luporini, G 1991, 'Folinic acid + 5-fluorouracil (5-FU) versus equidose 5-FU in advanced colorectal cancer. Phase III study of 'GISCAD' (Italian Group for the study of digestive tract cancer)', Annals of Oncology, vol. 2, no. 9, pp. 673-679.
Labianca, R. ; Pancera, G. ; Aitini, E. ; Barni, S. ; Beretta, A. ; Beretta, G. D. ; Cesana, B. ; Comella, G. ; Cozzaglio, L. ; Cristoni, M. ; Spagnolli, P. ; Frontini, L. ; Gottardi, O. ; Martignoni, G. ; Scapaticci, R. ; Smerieri, F. ; Vinci, M. ; Zadro, A. ; Zaniboni, A. ; Luporini, G. / Folinic acid + 5-fluorouracil (5-FU) versus equidose 5-FU in advanced colorectal cancer. Phase III study of 'GISCAD' (Italian Group for the study of digestive tract cancer). In: Annals of Oncology. 1991 ; Vol. 2, No. 9. pp. 673-679.
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T1 - Folinic acid + 5-fluorouracil (5-FU) versus equidose 5-FU in advanced colorectal cancer. Phase III study of 'GISCAD' (Italian Group for the study of digestive tract cancer)

AU - Labianca, R.

AU - Pancera, G.

AU - Aitini, E.

AU - Barni, S.

AU - Beretta, A.

AU - Beretta, G. D.

AU - Cesana, B.

AU - Comella, G.

AU - Cozzaglio, L.

AU - Cristoni, M.

AU - Spagnolli, P.

AU - Frontini, L.

AU - Gottardi, O.

AU - Martignoni, G.

AU - Scapaticci, R.

AU - Smerieri, F.

AU - Vinci, M.

AU - Zadro, A.

AU - Zaniboni, A.

AU - Luporini, G.

PY - 1991

Y1 - 1991

N2 - In a multicentre Phase III trial, 182 patients were randomized to either folinic acid (FA) (200 mg/sqm i.v. x 5 days) + 5-fluorouracil (5-FU) (400 mg/sqm i.v. in 15' x 5 days) every 4 weeks (Arm A), or to 5-FU alone at the same dosage (Arm B). Response rates were 20.6% (Arm A) and 10% (Arm B) with a significant (p = 0.046) advantage for FA + 5-FU. Median time to progression (6 and 6 months) and overall survival (11.5 and 11 months) were similar in the 2 groups of patients, while neither treatment was effective in reducing pain or improving performance status. Univariate analysis showed that no prognostic factors other than treatment influenced response, although survival was affected by the number and site of metastases, performance status, and the presence and degree of pain. Toxicity was acceptable and lower in comparison with other Phase II-III trials, with no significant difference between the 2 arms. However, in individual patients, grade 3-4 side effects (mainly stomatitis and diarrhoea) were observed, particularly in patients receiving FA: this led to interruption of the treatment in 7 cases. The superiority, in terms of objective response, of FA + 5-FU over 5-FU alone would seem to justify a large-scale evaluation of this combination in the adjuvant setting. Further improvements in relation to advanced disease (i.e., modifications to the schedule and/or introduction of other modulators) are warranted.

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