[Clinical study on the effect of adjuvant immunochemotherapy using OK-432 and 5-FU in pharyngeal and laryngeal cancers].
A randomized controlled trial was carried out on 38 pharyngeal and 59 laryngeal previously untreated cancers to evaluate the effects of adjuvant immunochemotherapy using 5-FU with and without OK-432. After each fundamental therapy, 5-FU was given orally at a dose of 200-300 mg/day for more than a year. OK-432 was intracutaneously administered at a dose of 5KE once a week for more than a year. Three-year survival rates and disease-free intervals were estimated for the two groups. In cases of pharyngeal cancer, the 3-year survival rate was 58% in both groups and the disease-free interval rates for up to 3 years after the fundamental therapy was 49% in the OK-432 + 5-FU group and 52% in the 5-FU group. These results showed no statistically significant difference. In laryngeal cancers, the 3-year survival rate was 96% in the OK-432 + 5-FU group and 82% in the 5-FU group. These results also showed no statistically significant difference. The disease-free interval rates were 87% in the OK-432 + 5-FU group and 64% in the 5-FU group, revealing a statistically significant difference (p less than 0.1). This suggests that OK-432 is more effective in producing a higher survival rate in cases of laryngeal cancer.
Yajin
K
K
Dept. of Otolaryngology, School of Medicine, Hiroshima University.
Harada
Y
Y
Tagashira
N
N
Suzuki
M
M
Hirakawa
K
K
Sera
K
K
Nakata
M
M
Takebayashi
S
S
Okazaki
H
H
Yashiki
T
T
D000284:Administration, Oral; D000368:Aged; D001688:Biological Products / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D007822:Laryngeal Neoplasms / Q000276:immunology / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010610:Pharyngeal Neoplasms / Q000276:immunology / Q000401:mortality / Q000628:therapy*; D010844:Picibanil / Q000008:administration & dosage*; D011897:Random Allocation
D001688:Biological Products; D010844:Picibanil; D005472:Fluorouracil