Journal article
A prospective randomized trial of 5-fluorouracil versus 5-fluorouracil and high-dose leucovorin versus 5-fluorouracil and methotrexate in previously untreated patients with advanced colorectal carcinoma
Journal of clinical oncology, Vol.5(10), pp.1559-1565
10/01/1987
DOI: 10.1200/JCO.1987.5.10.1559
PMID: 2443619
Abstract
Seventy-four previously untreated patients with metastatic colorectal adenocarcinoma were prospectively randomized into one of three treatment regimens: (1) 5-fluorouracil (5-FU) 450 mg/m2 as an intravenous (IV) bolus daily for five days or toxicity, then 200 mg/m2 IV bolus every other day for six doses; (2) methotrexate (MTX) 50 mg/m2 in normal saline by IV infusion over four hours followed by an IV bolus of 5-FU 600 mg/m2. This was administered weekly for 4 weeks and then every 2 weeks. (3) Leucovorin 500 mg/m2 in a two-hour IV infusion of normal saline with 5-FU 600 mg/m2 as an IV bolus one hour after the Leucovorin began every week for 6 weeks. The combined complete and partial response rates in the three regimens were 11%, 5%, and 48%, respectively (P = .0009). The median duration of response in the 5-FU and Leucovorin regimen was 10 months. There was no statistically significant difference between the treatment regimens with respect to survival time (P = .6). Toxicity in the 5-FU and Leucovorin regimen was predominantly diarrhea (13 of 30 patients, 40%). In this regimen, eight of 13 patients (52%) who developed diarrhea not only required a dose reduction of 5-FU, but also hospitalization for IV hydration. The predominant toxicity in the 5-FU alone regimen and the 5-FU and MTX regimen was leukopenia. One drug-related death occurred in each regimen.
Details
- Title: Subtitle
- A prospective randomized trial of 5-fluorouracil versus 5-fluorouracil and high-dose leucovorin versus 5-fluorouracil and methotrexate in previously untreated patients with advanced colorectal carcinoma
- Creators
- Nicholas Petrelli - Roswell Park Cancer InstituteLemuel HerreraYoucef RustumPatricia BurkePatrick CreavenJaroslav StulcLawrence J EmrichArnold Mittelman
- Resource Type
- Journal article
- Publication Details
- Journal of clinical oncology, Vol.5(10), pp.1559-1565
- DOI
- 10.1200/JCO.1987.5.10.1559
- PMID
- 2443619
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 10/01/1987
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359662702771
Metrics
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