Randomized phase II study of immunomodulator Z-100 in patients with stage IIIB cervical cancer with radiation therapy.
OBJECTIVE
To find the optimal dose of immunomodulator Z-100 in patients with stage IIIB squamous cell carcinoma of the cervix in combination with radiation therapy.


METHODS
The patients were randomly assigned to the dosage levels of 2, 20 or 40 mug of Z-100. Z-100 was subcutaneously injected twice a week during radiotherapy and once in two weeks during the maintenance period. The response rate after radiotherapy was evaluated, and the optimal clinical dosage was then determined. Safety of Z-100 was evaluated during the radiation therapy and maintenance therapy. Survival was also evaluated.


RESULTS
A total of 116 patients were entered. The adverse reactions were not dose-dependent and no serious toxicities were observed. The response rates were 72.2% (26/36) in the 2 microg group, 84.6% (33/39) in the 20 microg group and 94.3% (33/35) in the 40 microg group (P = 0.006). However, the survival was not significantly different.


CONCLUSIONS
The optimal dose of Z-100 was determined to be 40 mug in combination with radiation therapy for stage IIIB cervical cancer. However, impact of Z-100 on survival must be determined by the placebo controlled randomized trial, because survival benefit was not observed in this small population study.
Noda
Kiichiro
K
Kinki University, Japan.
Ohashi
Yasuo
Y
Okada
Hiroji
H
Ogita
Sachio
S
Ozaki
Masami
M
Kikuchi
Yuzo
Y
Takegawa
Yoshihiro
Y
Niibe
Hideo
H
Fujii
Shingo
S
Horiuchi
Junichi
J
Morita
Kozo
K
Hashimoto
Shozo
S
Fujiwara
Keiichi
K
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001918:Brachytherapy; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008055:Lipids / Q000008:administration & dosage* / Q000009:adverse effects; D008351:Mannans / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D012042:Registries / Q000706:statistics & numerical data; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
D000970:Antineoplastic Agents; D008055:Lipids; D008351:Mannans; C031208:specific substance maruyama