Weekly levofolinic acid and 5-fluorouracil plus hydroxyurea in metastatic gastrointestinal adenocarcinomas

Nicolo' Gebbia, Calogero Cipolla, Vittorio Gebbia, Mario Latteri, Nicola Gebbia, Vittorio Gebbia, Buccellato, Comande, Curto, Valenza, Calogero Cipolla, Mario A. Latteri, Testa

Risultato della ricerca: Article

7 Citazioni (Scopus)

Abstract

There were 42 patients with advanced gastrointestinal carcinomas (GA) enrolled in the study. In the Phase I part of the study we identified the MTD of 5-fluorouracil (5FU) in combination with levofolinic acid 100 mg/m2 per week intravenously plus hydroxyurea 1 g/m2 per week given by mouth in 3 refracted doses starting 6 hours after 5FU was administered. This treatment was given weekly for 6 consecutive weeks followed by a 15-day rest period. We were not able to increase 5FU weekly dosage above 700 mg/m2 due to the occurrence of grade 3-4 gastrointestinal toxicity. Thus 5FU was employed at 600 mg/m2 per week for the Phase II part of the study. Among 20 evaluable patients with measurable metastatic colorectal cancer, 1 patient had CR of 6.0+months and 7 patients had PR with a mean duration of 6.2+months, for an overall response rate of 40%. Four patients (20%) showed stable disease, and 8 patients progressed. The mean survival of the whole group was 5+ months (range: 3.0-12.8). This treatment was very well tolerated by most patients, with grade 3 diarrhea in 10% of cases and grade 3 vomiting in 20% of patients. Hydroxyurea (HU), employed at this dosage, seems not to increase 5FU/FA-related toxicity. This regimen is quite active in the management of advanced colorectal carcinoma, and may be safely given on an outpatient basis. A Phase III randomized trial may be established if HU improves results achievable with the 5FU-FA combination.
Lingua originaleEnglish
pagine (da-a)485-489
Numero di pagine5
RivistaAMERICAN JOURNAL OF CLINICAL ONCOLOGY: CANCER CLINICAL TRIALS
Volume17
Stato di pubblicazionePublished - 1994

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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