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A Prospective Multi-institutional Trial

Chantal M. Giguère, MD; Nancy M. Bauman, MD; Yutaka Sato, MD; Diane K. Burke, RN, BSN; John H. Greinwald, MD; Seth Pransky, MD; Peggy Kelley, MD; Keith Georgeson, MD; Richard J. H. Smith, MD

Arch Otolaryngol Head Neck Surg. 2002;128:1137-1144.

Objective  To describe and to determine the robustness of our study evaluating the efficacy of OK-432 (Picibanil) as a therapeutic modality for lymphangiomas.

Design and Setting  Prospective, randomized trial and parallel-case series at 13 US tertiary care referral centers.

Subjects  Thirty patients diagnosed as having lymphangioma. Ages in 25 ranged from 6 months to 18 years. Twenty-nine had lesions located in the head-and-neck area.

Intervention  Every patient received a 4-dose injection series of OK-432 scheduled 6 to 8 weeks apart unless a contraindication existed or a complete response was observed before completion of all injections. A control group was observed for 6 months.

Outcome Measures  Successful outcome of therapy was defined as a complete or a substantial (>60%) reduction in lymphangioma size as determined by calculated lesion volumes on computed tomographic or magnetic resonance imaging scans.

Results  Overall, 19 (86%) of the 22 patients with predominantly macrocystic lymphangiomas had a successful outcome.

Conclusions  OK-432 should be efficacious in the treatment of lymphangiomas. Our study design is well structured to clearly define the role of this treatment agent.

From the Departments of Otolaryngology (Drs Giguère, Bauman, and Smith and Ms Burke) and Radiology (Dr Sato), The University of Iowa, Iowa City; the Departments of Otolaryngology, Children's Hospital, Cincinnati, Ohio (Dr Greinwald), Children's Association Medical Group, San Diego, Calif (Dr Pransky), and The Children's Hospital, Denver, Colo (Dr Kelley); and the Department of Pediatric Surgery, Children's Hospital of Alabama, Birmingham (Dr Georgeson).

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