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Phase III comparison of the treatment of advanced gastrointestinal cancer with bolus weekly 5‐FU vs. methyl‐CCNU plus bolus weekly 5‐FU. A southwest oncology group study
Author(s) -
Baker Laurence H.,
Talley Robert W.,
Matter Richard,
Lehane Daniel E.,
Ruffner B. W.,
Jones Stephen E.,
Morrison Francis S.,
Stephens Ronald L.,
Gehan Edmund A.,
Vaitkevicius Vainutis K.
Publication year - 1976
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(197607)38:1<1::aid-cncr2820380102>3.0.co;2-s
Subject(s) - medicine , bolus (digestion) , gastrointestinal cancer , fluorouracil , regimen , colorectal cancer , gastroenterology , gastrointestinal tract , phases of clinical research , cancer , chemotherapy
In a randomized and stratified study, 294 patients with advanced gastrointestinal cancer were treated either with 5‐fluorouracil (5‐FU) 400 mg/m 2 weekly intravenously (i.v.) or 5‐FU 400 mg/m 2 i.v. weekly plus methyl‐CCNU 175 mg/m 2 orally (p.o.) every 6 weeks. The response rate in colorectal cancer with 5‐FU was 9.5% while the two‐drug treatment produced a response of 31.8% ( p = .009). The response in all gastrointestinal cancers to 5‐FU was 10.6% as compared with 29.3% for the combination ( p = .012). All responses were partial. The two‐drug regimen is more effective and more toxic than weekly 5‐FU therapy.