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Anticancer Research 2004OK-432 (Picibanil), a streptococcal preparation with potent biological response modifying activities, was approved in Japan as an anticancer agent in 1975. In the... (Review)
Review
OK-432 (Picibanil), a streptococcal preparation with potent biological response modifying activities, was approved in Japan as an anticancer agent in 1975. In the ensuing 30 years, since then, a significant amount of data, including clinical as well as experimental studies, has been accumulated. OK-432 has been reported to induce various cytokines, activate immunological cells and thus augment anticancer immunity. Recently, the interrelation between innate immunity and adaptive immunity has become clear and it was reported that OK-432 acts, at least in part, via Toll-like receptor (TLR) 4-MD2 signaling pathway. In addition, dendritic cells (DCs) are considered to play a pivotal role in immunological response and it is reported that OK-432 induced maturation of DCs both in vitro and in vivo. These results suggest that OK-432 is a useful adjuvant in DC-based anticancer immunotherapy. Clinical studies of DC therapy with OK-432 are under way.
Topics: Animals; Antineoplastic Agents; Dendritic Cells; Humans; Immunotherapy, Adoptive; Picibanil
PubMed: 15515424
DOI: No ID Found -
European Archives of... May 2002Lymphangiomas are benign, soft tumors that most often affect the head and neck area, usually causing marked cosmetic and functional problems. Treatment options include... (Review)
Review
Lymphangiomas are benign, soft tumors that most often affect the head and neck area, usually causing marked cosmetic and functional problems. Treatment options include surgery and a large number of different sclerotherapy agents. Surgical treatment is challenging because of the need for complete excision. The risk of damage to surrounding structures or poor cosmetic results is high. Various sclerotherapy agents have been shown to have minimal effects on lymphangiomas. Their use has been associated with severe systemic, local and cosmetic side effects. OK-432 (Picibanil) is a new and promising form of sclerotherapy. An intracystic injection of OK-432 produces a local inflammatory reaction, which leads to resolution of the lesion. We have treated 11 pediatric lymphangioma patients with OK-432 with excellent results: complete regression in six, marked regression in four and no response in one case. Local swelling should be anticipated, especially when treating lesions near the upper airway. We found OK-432 injections to be safe and effective as a first line of treatment for lymphangiomas.
Topics: Adolescent; Antineoplastic Agents; Child; Child, Preschool; Female; Head and Neck Neoplasms; Humans; Infant; Lymphangioma; Male; Picibanil; Radiography
PubMed: 12107533
DOI: 10.1007/s00405-001-0438-6 -
The Journal of Craniofacial Surgery Jul 2009Lymphatic malformations (LM) are benign structural defects that can cause serious complications because of their size and location. Traditionally, surgical removal was... (Review)
Review
INTRODUCTION
Lymphatic malformations (LM) are benign structural defects that can cause serious complications because of their size and location. Traditionally, surgical removal was the first treatment modality, but this could be associated with many complications and risks. Since Ogita introduced OK-432 (picibanil) in 1987 as a treatment method, this sclerosant has become popular. This paper is a review of the trials published so far on this topic.
PATIENTS AND METHODS
A literature search of English trials with 5 or more patients in it with LM who had never been treated before was done. The paper had to use the microcystic-macrocystic classification and have a mean follow-up of more than a year to be included in this review. Results were classified as "excellent" when the lesions show a regression of more than 90%, "good" when regression is more than 50%, and "poor" when shrinkage is less than 50% (this also includes no response at all).
RESULTS
Twenty-seven percent of microcystic LMs show an excellent result; 33%, a good result; and 40%, a poor result. Of the macrocystic LMs, 88% have excellent results. Recurrence rates vary from 5% to 8%. The adverse effects are mostly mild.
DISCUSSION
Most trials have a short follow-up; therefore, there are uncertainties when it comes to cure and regression. Mostly, the adverse effects of OK-432 are trivial and disappear after a week, but the need for a temporary tracheostomy has been described. Screening for allergic reactions to penicilline is needed, with the risk of anaphylactic shock in mind. It is difficult to compare the different techniques used by the authors, and none of the trials included in this study are randomized controlled trials; most are retrospective and were so-called level 4 studies.
CONCLUSIONS
This review demonstrates that OK-432 is an effective way to treat LM. Because of a possible risk of airway obstruction, treatment should always take place in specialized treatment facilities. Macrocystic lesions show a better response to OK-432 treatment than microcystic lesions. Serious complications with OK-432 are infrequent, and this type of sclerotherapy seems to have no influence on future surgery. We therefore suggest the use of OK-432 as an effective first-line treatment of LMs.
Topics: Cysts; Humans; Lymphatic Abnormalities; Picibanil; Sclerosing Solutions; Sclerotherapy
PubMed: 19553857
DOI: 10.1097/SCS.0b013e3181abb249 -
International Journal of Pediatric... Sep 2008Although surgery is the first choice of therapy for plunging ranula, it is associated with technical difficulties, morbidity and recurrence. Plunging ranula may be also... (Review)
Review
OBJECTIVE
Although surgery is the first choice of therapy for plunging ranula, it is associated with technical difficulties, morbidity and recurrence. Plunging ranula may be also primarily treated with nonsurgical sclerotherapy, but there is little experience in pediatric patients. We, therefore, assessed the efficacy of OK-432 sclerotherapy for pediatric plunging ranula.
METHODS
Nine children with plunging ranula were prospectively treated with intracystic injections of OK-432. At the outpatient clinic, the ranula was punctured in the neck and aspirated mucus was replaced with 0.1-0.2mg OK-432 solution. The size of the ranula was compared before and after sclerotherapy.
RESULTS
Total or nearly total shrinkage was observed in 6 of 9 patients; marked reduction (>50% of original size) in 2; and partial reduction (<50% of original size) in 1. At a mean follow-up of 26 months after last sclerotherapy, recurrence was observed in only 1 patient; this patient showed complete response after reinjection of OK-432 solution. No significant complications were observed, with only fever and mild local pain observed in 4 patients for 2-4 days after treatment.
CONCLUSIONS
OK-432 sclerotherapy is safe and effective in the treatment of pediatric plunging ranula. Sclerotherapy may become a primary treatment modality prior to surgery.
Topics: Adolescent; Antineoplastic Agents; Child; Child, Preschool; Female; Humans; Male; Picibanil; Prospective Studies; Punctures; Ranula; Sclerotherapy
PubMed: 18617276
DOI: 10.1016/j.ijporl.2008.06.003 -
The Journal of Laryngology and Otology Nov 2008We report an adult case of cystic lymphangioma treated with OK-432 (Picibanil). (Review)
Review
OBJECTIVE
We report an adult case of cystic lymphangioma treated with OK-432 (Picibanil).
METHOD
A case report and review of the literature concerning the use of OK-432 to treat cystic lymphangioma is presented.
RESULTS
A 31-year-old woman developed a cystic lymphangioma four weeks post-partum. This was treated initially by aspiration, for diagnostic purposes. Investigation suggested that surgery would be challenging. A review of the literature demonstrated success with OK-432 in the treatment of this condition, although primarily in the paediatric population. This patient was successfully treated thus, and at the time of writing remained symptom free. A suggested management plan is outlined.
CONCLUSION
Treatment with OK-432 is useful in the management of cystic lymphangiomas in adults and should be considered as first line treatment.
Topics: Adult; Antineoplastic Agents; Female; Head and Neck Neoplasms; Humans; Injections; Lymphangioma, Cystic; Picibanil; Tomography, X-Ray Computed; Treatment Outcome
PubMed: 18430261
DOI: 10.1017/S0022215107001132 -
Casopis Lekaru Ceskych May 1983
Topics: Adenocarcinoma; Biological Products; Female; Humans; Melanoma; Ovarian Neoplasms; Picibanil
PubMed: 6850738
DOI: No ID Found -
European Archives of... Apr 2007The effectiveness of intralesional sclerotherapy of lymphangiomas and ranulas with OK-432 (Picibanil) has been proved in several clinical studies. The aim of our study...
The effectiveness of intralesional sclerotherapy of lymphangiomas and ranulas with OK-432 (Picibanil) has been proved in several clinical studies. The aim of our study was to review the effectiveness of sclerotherapy of benign cervical cysts with Picibanil as an alternative method to surgical excision. Between March 2002 and March 2006, a prospective observational study was carried out to assess the effects of Picibanil on cervical cysts. Between 2002 and 2006 we treated 14 patients having cervical cysts through intralesional application of Picibanil with a dose of 0.01 mg/ml. So far we used Picibanil with 13 patients achieving a high success rate. In eight cases we observed, both clinically and ultrasonographically, a nearly complete regression, and a complete regression of the cysts in three cases. In two cases the cysts atrophied. In these cases only residual findings could be observed. In one case we extirpated the remaining cyst. If there is no clear reaction of the cyst to the treatment, an excision is indicated 6 weeks after the injections to gain meaningful histological examination. No significant complication after sclerotherapy with Picibanil was observed. According to our results the application of OK-432 (Picibanil) is a safe and effective primary method for sclerotherapy of benign cervical cysts which can replace surgical extirpation in special cases. However, the risk of malign diseases has to be excluded before the commencement of the Picibanil treatment.
Topics: Adolescent; Antineoplastic Agents; Child, Preschool; Cysts; Female; Humans; Injections; Lymphangioma, Cystic; Lymphocele; Magnetic Resonance Imaging; Male; Middle Aged; Neck; Picibanil; Sclerotherapy
PubMed: 17082941
DOI: 10.1007/s00405-006-0201-0 -
Lymphatic Research and Biology 2004Lymphatic malformations are rare forms of vascular anomalies. They are most frequently diagnosed at birth and most often occur in the head and neck area. Their treatment... (Review)
Review
Lymphatic malformations are rare forms of vascular anomalies. They are most frequently diagnosed at birth and most often occur in the head and neck area. Their treatment continues to be challenging, and treatment methods continue to evolve. In this article, the embryology of the lymphatic system is reviewed, and the classification of lymphatic malformations and their natural history and treatment are discussed.
Topics: Humans; Lymphatic Vessels; Picibanil; Sclerotherapy
PubMed: 15609924
DOI: 10.1089/1539685041690436 -
The Laryngoscope Aug 2001Congenital lymphatic malformations of the head and neck (LMHN) present special challenges to the otolaryngologist-head and neck surgeon. Recently, a number of...
HYPOTHESIS/OBJECTIVES
Congenital lymphatic malformations of the head and neck (LMHN) present special challenges to the otolaryngologist-head and neck surgeon. Recently, a number of sclerotherapy trials have shown promising results. In this study, we present our experiences with picibanil (OK-432) sclerotherapy for this lesion.
STUDY DESIGN
Retrospectively review.
METHODS
We retrospectively reviewed 21 patients who have undergone sclerotherapy with picibanil for LMHN.
RESULTS
Satisfactory response with complete or nearly complete shrinkage of the lesions was observed in 15 cases after repeated sclerotherapy (average, two times). We did not observe any significant morbidity or complications in the patients treated with picibanil. Reduction in size of the mass was achieved in weeks to months. Some of the patients who had not had any other previous treatment showed remarkable reductions in size even after the first therapy. When we used picibanil sclerotherapy as a primary treatment for the LMHN, most of our patients showed satisfactory results regardless of the size or location of the lesions.
CONCLUSION
Given with our experience and the reports that failure of picibanil sclerotherapy does not hinder subsequent surgical salvage procedures, we recommend trying picibanil sclerotherapy as a primary treatment for the LMHN and performing surgical excision as a secondary modality if the response to the sclerotherapy is not satisfactory.
Topics: Child; Child, Preschool; Female; Head; Humans; Infant; Injections, Intralesional; Lymphatic System; Male; Middle Aged; Neck; Picibanil; Retrospective Studies; Sclerosing Solutions; Sclerotherapy
PubMed: 11568580
DOI: 10.1097/00005537-200108000-00020 -
Cardiovascular and Interventional... 2003To determine the efficacy of OK-432 sclerotherapy in the treatment of lymphangiomas.
PURPOSE
To determine the efficacy of OK-432 sclerotherapy in the treatment of lymphangiomas.
METHODS
The treatment was begun for 14 patients with lymphangioma. The age range of the patients at the time of the first injection was from 10 months to 42 years. Eleven of the lesions involved the head and neck region, two the thorax and one was localized in the extremity. Prior to treatment all patients were investigated with either magnetic resonance imaging, computed tomography, ultrasound or a combination of these modalities. The injections were performed with ultrasound and/or fluoroscopic guidance. Eight patients received OK-432 as first-line treatment; five were treated after surgery and one after medical therapy. On average, 2.2 intracystic injections were performed per patient. Nine of the lesions were macrocystic and five were mixed lesions.
RESULTS
Eleven patients showed complete or marked response to the OK-432 sclerotherapy, two patients had moderate shrinkage of their lesions and only one patient showed no response to therapy. Macrocystic lesions showed the best response to therapy. Those patients who received OK-432 as first-line treatment showed complete or marked response.
CONCLUSION
It was found that treatment of lymphangiomas with OK-432 was safe and effective.
Topics: Adolescent; Adult; Antineoplastic Agents; Child; Child, Preschool; Female; Humans; Infant; Lymphangioma; Male; Picibanil; Sclerotherapy; Treatment Outcome
PubMed: 12491020
DOI: 10.1007/s00270-002-1980-3