Randomized phase III Study of 5-fluorouracil plus high dose folinic acid versus 5-fluorouracil plus folinic acid plus methyl-lomustine for patients with advanced colorectal cancer

✍ Scribed by Dennie V. Jones; Roger J. Winn; Barry W. Brown; Lawrence B. Levy; Reginald P. Pugh; James L. Wade III; Howard M. Gross; Kelly B. Pendergrass; Bernard Levin; James L. Abbruzzese

• Publisher: John Wiley and Sons
• Year: 1995
• Tongue: English
• Weight: 501 KB
• Volume: 76
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/1097-0142(19951115)76:10<1709::aid-cncr2820761006>3.0.co;2-5

✦ Synopsis

Background. Metastatic colorectal cancer is generally incurable. The most active regimen available, 5-fluorouracil(5-FU) and folinic acid (Leucovorin), produces response rates of approximately 25% to 30%. Methyl-lomustine is a nitrosourea with modest activity against colorectal cancer. A randomized trial was undertaken to evaluate the impact the addition of methyl-lomustine would have on response, duration of survival, and survival rates in patients with advanced colorectal cancer.

Methods. The methyl-lomustine/5-FU/Leucovorin (MFL) regimen consisted of methyl-lomustine (110 mg/ m2), administered on Day 1 of each 8-week cycle with six weekly boluses of 5-FU (600 mg/m2), and Leucovorin (500 mg/mz). The FL treatment arm consisted of the administration of 5-FU and Leucovorin as described above. Patients were evaluated for response and toxicity after each 8-week cycle.