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Annals of Oncology 15:559-567, 2004
© 2004 European Society for Medical Oncology

Original Paper

Phase I/II trial of irinotecan plus high-dose 5-fluorouracil (TTD regimen) as first-line chemotherapy in advanced colorectal cancer

Received 2 October 2003; revised 15 December 2003; accepted 22 December 2003

Background:

We conducted a phase I/II study of weekly irinotecan [30 min intravenous (i.v.) infusion] combined with 5-fluorouracil (5-FU 3 g/m2 weekly 48 h i.v. infusion, TTD regimen) as first-line chemotherapy for patients with advanced colorectal cancer (CRC).

Patients and methods:

The maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) in the treatment of gastrointestinal solid tumors (in phase I), and the antitumor activity and toxicity of the recommended phase I dose (in phase II) were determined.

Results:

Diarrhea was the DLT, and irinotecan 80 mg/m2 plus 5-FU 3 g/m2 was the recommended phase I dose. In phase II, the confirmed response rate was 44% [95% confidence interval (CI) 29% to 59%] and the median overall survival was 23.8 months. However, grade 3/4 diarrhea affected 59% of patients and led to withdrawal of three patients. A second cohort of patients studied using the same schedule but with a reduced 5-FU starting dose of 2.25 g/m2 showed improved tolerance (the incidence of grade 4 diarrhea decreased from 28% to 11% and overall grade 3/4 diarrhea to 56%, with no patient withdrawals) but the confirmed response rate was 28% (95% CI 14% to 45%) and median overall survival was 17.2 months.

Conclusions:

We found weekly irinotecan 80 mg/m2 plus TTD regimen (5-FU 2.25 g/m2 given as 48-h i.v. infusion) to be a feasible and active combined chemotherapy for the first-line treatment of advanced colorectal cancer.

E. Aranda1,*, A. Carrato2, A. Cervantes3, J. Sastre4, M. A. Gómez1, A. Abad5, B. Masutti6, F. Ribera7, E. Marcuello8, L. Pronk9, M. Balcells10 and E. Díaz-Rubio4

1 Hospital Universitario Reina Sofía, Córdoba; 2 Hospital General Universitario, Elche; 3 Hospital Clínico Universitario, Valencia; 4 Hospital Clínico San Carlos, Madrid; 5 Hospital Universitario Germans Trias i Pujol, Badalona; 6 Hospital General, Alicante; 7 Hospital Marqués de Valdecilla, Santander; 8 Hospital de la Santa Creu i Sant Pau, Barcelona; 9 Aventis Pharma, Madrid; 10 Prasfarma-Grupo Almirall Prodesfarma, Barcelona, Spain

Key words: antitumoral, colorectal cancer, 5-FU, irinotecan, toxicity, TTD regimen


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E. Aranda, M. Valladares, M. Martinez-Villacampa, M. Benavides, A. Gomez, B. Massutti, E. Marcuello, M. Constenla, J. C. Camara, A. Carrato, et al.
Randomized study of weekly irinotecan plus high-dose 5-fluorouracil (FUIRI) versus biweekly irinotecan plus 5-fluorouracil/leucovorin (FOLFIRI) as first-line chemotherapy for patients with metastatic colorectal cancer: a Spanish Cooperative Group for the Treatment of Digestive Tumors Study
Ann. Onc., February 1, 2009; 20(2): 251 - 257.
[Abstract] [Full Text] [PDF]


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