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[Clinical study on the effect of adjuvant immunochemotherapy using OK-432 and 5-FU in pharyngeal and laryngeal cancers].

Abstract
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.
AuthorsK Yajin, Y Harada, N Tagashira, M Suzuki, K Hirakawa, K Sera, M Nakata, S Takebayashi, H Okazaki, T Yashiki
JournalGan to kagaku ryoho. Cancer & chemotherapy (Gan To Kagaku Ryoho) Vol. 15 Issue 6 Pg. 1921-7 (Jun 1988) ISSN: 0385-0684 [Print] Japan
PMID3289502 (Publication Type: Clinical Trial, English Abstract, Journal Article, Randomized Controlled Trial)
Chemical References
  • Biological Products
  • Picibanil
  • Fluorouracil
Topics
  • Administration, Oral
  • Aged
  • Biological Products (administration & dosage)
  • Clinical Trials as Topic
  • Drug Administration Schedule
  • Female
  • Fluorouracil (administration & dosage)
  • Humans
  • Laryngeal Neoplasms (immunology, mortality, therapy)
  • Male
  • Middle Aged
  • Pharyngeal Neoplasms (immunology, mortality, therapy)
  • Picibanil (administration & dosage)
  • Random Allocation

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