Polyadenylic-polyuridylic acid as an adjuvant in resectable colorectal carcinoma: a 6 1/2 year follow-up analysis of a multicentric double blind randomized trial.
In a double blind study, patients with operable carcinoma of the colon and the upper rectum, who have undergone a macroscopically complete resection of their tumor, were randomized to receive either (i) polyadenylic-polyuridylic acid (AU), one i.v. injection of 60 mg (in 50 ml of solution) once a week for 6 weeks, or (ii) a placebo (P) one i.v. injection of 50 ml of a saline solution with the same schedule. From January 1983 to December 1986, 288 patients were enrolled: 145 in AU group and 143 in P group. The main clinical and pathological characteristics were equally distributed throughout the two groups. There was a significant difference (P < 0.02) in the overall survival (OS) between the two groups, in favor of the P group. The 5-year OS rate was 68% (SD = 4%) in the AU group versus 81% (SD = 3%) in the P group. Thus, AU as a single adjuvant, appears to be ineffective and therefore has no indication in the treatment of colorectal carcinoma.
Lacour
J
J
Institut Gustave-Roussy, Villejuif, France.
Laplanche
A
A
Malafosse
M
M
Gallot
D
D
Julien
M
M
Rotman
N
N
Guivarc'h
M
M
Roullet-Audy
J C
JC
Lasser
P
P
Hautefeuille
P
P
D000368:Aged; D017024:Chemotherapy, Adjuvant; D016009:Chi-Square Distribution; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000601:surgery; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011063:Poly A-U / Q000627:therapeutic use*; D012044:Regression Analysis; D016019:Survival Analysis
D011063:Poly A-U