title: Randomized phase II trial of OK-432 in patients with malignant pleural effusion due to non-small cell lung cancer.
abstract: To determine the optimum dose of OK-432 for intrathoracic administration, a multicenter randomized phase II trial was conducted in patients with malignant pleural effusion due to non-small cell lung cancer. Patients with histologically- or cytologically-proven malignant pleural effusions were randomized to arm A (10 Klinische Einheit (KE) of OK-432) or arm B (1 KE of OK-432). OK-432 was injected intrapleurally over 30 min on days 1 and 3 and the chest tube was clamped for 6 h. If control was inadequate on day 8, 10 KE was administered on days 8 and 10 in each treatment arm. Forty patients were enrolled and 38 patients were eligible (19 in arm A and 19 in arm B). The effusion control rate on day 8 was 79% in arm A and 53% in arm B, while control rates on day 28 were 74% and 84%, respectively. The median drainage time after administration was significantly shorter in arm A (4.0 +/- 1.2 days) than in arm B (7.0 +/- 1.7 days). The total drainage volume was also significantly less in arm A than in arm B. No grade 4 toxicities or treatment-related deaths were observed in either treatment arm. Intrathoracic injection of OK-432 is a feasible treatment for malignant pleural effusion. Although the malignant pleural effusion control rate was equivalent in each treatment arm, faster control and less drainage were achieved in arm A. A dose of OK-432 10 KE/body is, therefore, recommended for further trial.
authors.affiliation: Respiratory Medicine, Kanazawa University Hospital, 13-1, Takara-machi, Kanazawa, Ishikawa, 920-8641, Japan. kasa1237@med3.m.kanazawa-u.ac.jp
authors.forename: Kazuo
authors.initials: K
authors.lastname: Kasahara
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Shibata
authors.forename: Hiromoto
authors.initials: H
authors.lastname: Shintani
authors.forename: Kei-Ichi
authors.initials: K
authors.lastname: Iwasa
authors.forename: Takashi
authors.initials: T
authors.lastname: Sone
authors.forename: Hideharu
authors.initials: H
authors.lastname: Kimura
authors.forename: Kouichi
authors.initials: K
authors.lastname: Nobata
authors.forename: Tatsuki
authors.initials: T
authors.lastname: Hirose
authors.forename: Yuzo
authors.initials: Y
authors.lastname: Yoshimi
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katayama
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Ishiura
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kita
authors.forename: Koichi
authors.initials: K
authors.lastname: Nishi
authors.forename: Yasuto
authors.initials: Y
authors.lastname: Nakatsumi
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Ryoma
authors.forename: Masaki
authors.initials: M
authors.lastname: Fujimura
authors.forename: Shinji
authors.initials: S
authors.lastname: Nakao
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004322:Drainage / Q000379:methods; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010844:Picibanil / Q000009:adverse effects / Q000627:therapeutic use*; D016066:Pleural Effusion, Malignant / Q000188:drug therapy* / Q000473:pathology / Q000628:therapy
chemical_list: D000970:Antineoplastic Agents; D010844:Picibanil