Treatment of lymphangiomas with OK-432 (Picibanil) sclerotherapy: a prospective multi-institutional trial.

Abstract

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.

• Authors: Chantal M Giguère, Nancy M Bauman, Yutaka Sato, Diane K Burke, John H Greinwald, Seth Pransky, Peggy Kelley, Keith Georgeson, Richard J H Smith
• Journal: Archives of otolaryngology--head & neck surgery (Arch Otolaryngol Head Neck Surg) Vol. 128 Issue 10 Pg. 1137-44 (Oct 2002) ISSN: 0886-4470 [Print] United States
• PMID: 12365884 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, Non-P.H.S.)

Chemical References

• Antineoplastic Agents
• Picibanil

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Child
• Child, Preschool
• Female
• Head and Neck Neoplasms (diagnostic imaging, pathology, therapy)
• Humans
• Infant
• Lymphangioma (diagnostic imaging, pathology, therapy)
• Magnetic Resonance Imaging
• Male
• Middle Aged
• Picibanil (administration & dosage, adverse effects, therapeutic use)
• Prospective Studies
• Sclerotherapy (adverse effects)
• Tomography, X-Ray Computed
• Treatment Outcome