Randomized phase II trial of OK-432 in patients with malignant pleural effusion due to non-small cell lung cancer.

Published on Mar 1, 2006in Anticancer Research1.994
Kazuo Kasahara28
Estimated H-index: 28
(Kanazawa University),
Kazuhiro Shibata1
Estimated H-index: 1
+ 14 AuthorsShinji Nakao59
Estimated H-index: 59
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
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