Japanese Journal of Clinical Oncology Advance Access originally published online on August 22, 2006
Japanese Journal of Clinical Oncology 2006 36(9):570-577; doi:10.1093/jjco/hyl082
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© 2006 Foundation for Promotion of Cancer Research
Randomized Phase II Study of Immunomodulator Z-100 in Patients with Stage IIIB Cervical Cancer with Radiation Therapy
1 Kinki University, 2 Department of Biostatistics/Epidemiology and Preventive Health Sciences, University of Tokyo, Tokyo, 3 Saiseikai Suita Hospital, Suita, Osaka, 4 Department of Obstetrics and Gynecology, Osaka City University, Osaka, 5 Bell-land General Hospital, Sakai, Osaka, 6 Department of Quantum Medical Technology, Kanazawa University, Kanazawa, 7 Department of Radiologic Technology, Tokushima University School of Health Science, Tokushima, 8 Department of Radiology and Radiation Oncology, Gunma University Hospital, Maebashi, 9 Department of Gynecology and Obstetrics, Kyoto University, Kyoto, 10 Department of Radiology, Hakujikai Memorial Hospital, Tokyo, 11 Toki Municipal Hospital, Toki, Gifu, 12 Medical Scanning Shibuya, Tokyo and 13 Department of Obstetrics and Gynecology, Kawasaki Medical School, Kurashiki, Okayama, Japan
For reprints and all correspondence: Keiichi Fujiwara, Gynecologic Oncology, Department of Obstetrics and Gynecology, Saitama Medical University, 38 Morohongo, Moroyama, Iruma, Saitama 350-0495, Japan. E-mail: fujiwara{at}med.kawasaki-m.ac.jp
Received March 9, 2006; accepted June 8, 2006
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 µg 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 µg group, 84.6% (33/39) in the 20 µg group and 94.3% (33/35) in the 40 µg group (P = 0.006). However, the survival was not significantly different.
Conclusions: The optimal dose of Z-100 was determined to be 40 µg 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.
Key Words: immunomodulator • cervical cancer • radiotherapy • Z-100 • SSM