title: Clinical effect of sizofiran combined with irradiation in cervical cancer patients: a randomized controlled study. Cooperative Study Group on SPG for Gynecological Cancer.
abstract: To evaluate the clinical effect of a biological response modifier (BRM), sizofiran (SPG), combined with irradiation, a randomized controlled study was performed in patients with stage II or III cervical cancer involving the collaboration of 52 institutes throughout Japan. Patients were randomly allocated to the control group (radiotherapy only) and the SPG group (radiotherapy + SPG). SPG was given intramuscularly, 40 mg once and 20 mg twice, a week concomitantly with radiotherapy. A total 315 patients were enrolled for the study but 23 were excluded from analysis. Of the remaining 292 patients, 121 were of stage II (43 controls and 78 SPG) and 171 of stage III (49 controls and 122 SPG). The results were as follows. (1) The complete response (CR) rate among stage II patients was higher in the SPG group (91.0%) than in the control group (79.1%); also the CR rate among stage III patients was significantly higher in the SPG group (77.9%) than in the control group (61.2%). (2) The SPG group showed a significantly rapid recovery from the decreased lymphocyte counts due to radiotherapy (P less than 0.05). (3) Side effects, probably associated with SPG administration, were observed in 11 cases (5.2%).
authors.affiliation: Department of Obstetrics and Gynecology, Kinki University School of Medicine, Osaka.
authors.forename: K
authors.initials: K
authors.lastname: Noda
authors.forename: S
authors.initials: S
authors.lastname: Takeuchi
authors.forename: A
authors.initials: A
authors.lastname: Yajima
authors.forename: K
authors.initials: K
authors.lastname: Akiya
authors.forename: T
authors.initials: T
authors.lastname: Kasamatsu
authors.forename: Y
authors.initials: Y
authors.lastname: Tomoda
authors.forename: M
authors.initials: M
authors.lastname: Ozawa
authors.forename: K
authors.initials: K
authors.lastname: Sekiba
authors.forename: H
authors.initials: H
authors.lastname: Sugimori
authors.forename: S
authors.initials: S
authors.lastname: Hashimoto
mesh_terms: D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D012566:Sizofiran / Q000627:therapeutic use*; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy
chemical_list: D012566:Sizofiran