[Response to OK-432 (picibanil) in cancer patients and change of immunological parameters for the administration of OK-432 (picibanil)].
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Adult↗
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Sclerotherapy of cervical cysts with Picibanil (OK-432).
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.
Adolescent↗
Sclerotherapy with picibanil (OK-432) for congenital lymphatic malformation in the head and neck.
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.
Child↗
[Intracerebral picibanil injection in the rat neurogenic tumor--its histopathological changes].
Penicillin-free-Picibanil was injected into the brain of Wistar/Fibiger strain rat to investigate the histological changes. Its effect on the growth of rat schwannoma inoculated in the brain was also examined histologically. Picibanil caused the most prominent but focal lymphoreticular cell reaction around the injected site in the brain 24 to 48 hours after injection. The cells infiltrating from the blood vessels were neutrophils, monocytes, lymphocyte-like cells, histiocyte-like cells and unidentified cells. This lympho-reticular cell reaction gradually subsided in the next 4 to 5 days. Neutrophils and monocytes (macrophages)stayed till the later phase. Two weeks later, the lesion was minimal with only mild glial changes. Picibanil was however, considered to exert at the site of injection neurotoxic and glia-toxic activity at a concentration of 0.1 KE/10 microliters. The rat schwannoma (T1) cells, when inoculated without any treatment, showed vivid growth in the brain and no lympho-reticular cell reaction was observed. When the T1 tumor cells, suspended in the Picibanil solution, were inoculated into the brain, no lymph-reticular cell reaction was observed 7 and 14 days after inoculation. However, when the rat was pretreated with Picibanil into the brain 7 days before inoculation, only a mild lymphoreticular cell reaction was observed around the T1 cells till 7 days after inoculation. Accordingly, Picibanil was considered to induce nonspecific immunological in the rat brain even around the glioma.
Animals↗
Treatment of lymphangiomas in children: an update of Picibanil (OK-432) sclerotherapy.
Picibanil (OK-432) is a sclerosing agent derived from a low-virulence strain of Streptococcus pyogenes that induces regression of macrocystic lymphangiomas. This report describes a prospective, nonrandomized trial to evaluate the efficacy of Picibanil in the treatment of 13 affected children ranging in age from 1 to 94 months. On average, 4.1 fluoroscopically guided intracystic injections were performed per child, with an average total dose of 0.56 mg of Picibanil. As judged by physical examination and radiographic studies, 5 children (42%) showed a complete or substantial response, and 2 children (16%) showed an intermediate response. No response was seen in 5 children (42%), 2 of whom had massive craniofacial lymphangioma. Factors that contribute to failure with Picibanil sclerotherapy are the presence of a significant microcystic component to the lesion, massive craniofacial involvement, and previous surgical resection. Macrocystic lymphangiomas of the infratemporal fossa or cervical area have the best response to therapy.
Adolescent↗
Effect of streptococcal preparation (picibanil) on the postoperative rise in serum alanine aminotransferase activity in patients with urogenital cancer.
The effect of Picibanil, a streptococcal agent, on the development of liver injury after operations for urogenital cancer was studied retrospectively in the light of serum alanine aminotransferase (ALT) activity. The series comprised 32 cases receiving Picibanil and 33 controls with otherwise comparable clinical backgrounds. Picibanil reduced the incidence of postoperative ALT rise over 50 U/l within 6 weeks but increased it thereafter. The increase in ALT activity after 6 weeks was relatively small and was seen more often in patients given blood transfusions. It was interpreted as retardation and suppression of ALT rise and as being related to the induction of interferon or to immunopotentiation. Other antihepatotoxic effects of Picibanil, due to its antioxidant activity, for example, may also account for the prevention of the early postoperative rise in ALT activity.
Adult↗
[Combination (RaHPP) of radiotherapy, hyperthermia and chemotherapy (peplomycin and picibanil) for bladder cancer].
Four patients with urinary bladder carcinoma were treated by combination therapy which consisted of hyperthermia vesical irrigation of two anticancer drugs (peplomycin and picibanil), intravesical instillation of those drugs and radiation. Following the therapeutic method we planned, 40 mg of peplomycin and 10 KE of picibanil in 1,500 ml of sterile distilled water was irrigated at 42 to 43 degrees C into the bladder for 3 hours; 40 mg of peplomycin and 10 KE of picibanil in 40 ml of sterile distilled water was instilled into the bladder; and, the focus was irradiated with 60Co to a focal dose of 200 rad 30 minutes later. This pattern of treatment was repeated once a week, 3 to 5 times in total. On the days this pattern was not taken, 5 KE of picibanil in 20 ml of sterile distilled water was instilled into the bladder cavity. Complete response was observed in one patient and partial response in 3 patients. The side effect was temporary irritable bladder symptom.
Aged↗
Effect of Picibanil (OK-432) on the scavenging effect of free radicals produced during liver regeneration in the rat.
We administered a biological response modifier Picibanil (OK-432), attenuated Streptococcus pyogenes, via the dorsal vein of the penis after 70% hepatectomy in rats, and clarified the scavenging effect of Picibanil on free radicals generated in the regenerating liver. A group of 5 rats was intravenously administered with 25 KE/kg of OK-432 after hepatectomy, while the control group was given saline after hepatectomy. Serum levels of aspartate aminotransferase and alanine aminotransferase and the value of thiobarbituric acid-reactive substances in serum and hepatic tissue after hepatectomy were serially measured, and these values were significantly lower in Picibanil treated animals than in control animals. Free radical production in the regenerating liver was also measured by electron spin resonance spectrometry, and OK-432 injection significantly reduced free radical production. These results suggested that OK-432 reduced hepatocellular damage in regenerating liver by inhibiting lipid peroxidation.
Alanine Transaminase↗
Effects of streptolysin O, picibanil (OK 432) and interferon alpha 2A on cytochrome P-450-dependent monooxygenases and arylamine N-acetyltransferase in rat liver.
Streptolysin O, a thiol-activated exotoxin from group A beta-haemolytic streptococci, caused a dose-dependent depression of aniline hydroxylase, aminopyrine N-demethylase and ethylmorphine N-demethylase activities when added into the hepatic microsomal mixtures from male rats at concentrations 0.02-0.4 HU/mL in vitro. The activities of 7-ethoxycoumarin O-deethylase, 7-ethylresorufin O-deethylase and 7-pentylresorufin O-depentylase were not altered with the used concentrations of the toxin. Specific antibody against haemolytic action of streptolysin O added to incubation mixtures in vitro was not able to protect streptolysin-sensitive monooxygenases from the inhibition. The addition of streptolysin O (0.01-0.8 HU/mL) into the cytosol-containing medium did not significantly influence the activity of procainamide N-acetyltransferase. Immunomodulators picibanil (OK 432) and human recombinant interferon alpha 2A which are known to suppress oxidative metabolism in vivo in humans and animals, were without effect either on the cytochrome P-450-dependent monooxygenases or on the N-acetyltransferase activity when administered in vitro at the doses real in their clinical application (0.001-0.1 KE/mL of picibanil and 10-500 U/mL of alpha-interferon).
Animals↗
Cell regulatory and immunorestorative activity of picibanil (OK432).
Picibanil (OK432), a pharmaceutical preparation of a low virulent Su strain of Streptococcus pyogenes, possesses cell regulatory activity particularly in its ability to augment natural killer (NK) cell activity and to activate macrophages to exert a tumoricidal effect both in vitro and in vivo. It is effective in retarding and/or inhibiting the growth of three different tumors: MBL-2 lymphoma, M109 alveolar adenocarcinoma, and B16 melanoma. The antitumor effect is mediated through regulation of NK cells and macrophages, possibly by its ability to stimulate the production and secretion of interferon and interleukin 1 and 2. It is a very effective adjuvant for tumor cell vaccines that elicit cytotoxic T-cell responses. Following cytoreductive chemotherapy (Cytoxan) Picibanil treatment leads to an earlier reconstitution of both bone marrow cellularity and differentiation to granulocyte-macrophage colonies.
Animals↗
[Thermotherapy for cancer of the urinary bladder in combination with tegafur suppository and picibanil--concentrations of tegafur in the serum and tissues in bladder carcinoma].
Thermotherapy combined with tegafur (FT-207) and Picibanil was performed in 13 patients with cancer of the urinary bladder. The thermotherapy was performed using a closed circulation type of thermotherapeutic apparatus manufactured for this experiment, by way of a 3-way catheter. The flow rate of the perfusate was 150 ml/min at a constant temperature of 43 degrees C. The temperature was monitored at the inlet and outlet catheter of the urethral meatus. The thermotherapy was performed for a 6-hour period once a week. A tegafur 3000-mg suppository was given 2 hours before the thermotherapy, and Picibanil was added to the perfusate at the time of thermotherapy. No anesthesia was used. Complete disappearance of the tumor was observed in 1 case. The concentrations of tegafur in the serum, tumor and bladder wall were measured simultaneously. The levels obtained at two hours after rectal administration of the tegafur 3000-mg suppository were 19.420 mcg/ml for FT-207 and 0.025 mcg/ml for 5-FU in the serum, 13.170 mcg/g for FT-207 and 0.140 mcg/g for 5-FU in the bladder tumor, and 20.447 mcg/g for FT-207 and 0.252 mcg/g for 5-FU in the bladder wall. Eruption was observed in 1 case. No other side effects were noted.
Adult↗
Enhanced production of human interferon-gamma by the use of a combination of inducers--phytohemagglutinin, picibanil and tumor promoting agent.
Phytohemagglutinin (PHA), picibanil (OK432) and tumor promoting agent (TPA) were tested in various combinations for optimal induction of human interferon-gamma (HuIFN-gamma). It was found that the use of a mixture of all 3 inducers resulted in IFN production 2-3 times higher than either PHA (10 micrograms/ml) in combination with TPA (5 ng/ml) or picibanil (10 micrograms/ml) alone. The IFN was produced by T lymphocytes and could be neutralized by specific IFN-gamma antiserum. It was pH 2.0 labile and species specific.
Biological Products↗
[Combination chemotherapy with neocarzinostatin(NCS), HCFU and picibanil(NHO therapy) for advanced carcinoma of the digestive system--a comparative study with NF, and NFO therapy].
We have previously reported the clinical effects of NF therapy (NCS + 5-FU) and NFO therapy (NCS + 5-FU + Picibanil) on patients with advanced carcinoma of the digestive organs. In the present study, (NHO therapy (NCS + HCFU + Picibanil) performed in 41 patients and 30 patients were evaluated for its clinical effects. In comparison with NHO, NF and NFO, partial regression (tumor regression exceeding 50%) was noted in 5 of 30 patients (16.7%) on NHO, which was superior to 7.4% on NF, but slightly inferior to 18.8% on NFO. However, six and twelve month survival rate and 50% survival month on NHO therapy were 31.6%, 10.5% and 4.6 months, respectively and they were superior to those of NF and NFO therapy. Though the incidence of the adverse effects by NHO was almost identical with that of NFO and not more frequent than that of NF therapy. Urinary frequency, hot sensation and urgency due to HCFU administration were observed approximately in 10% on NFO therapy. In the three modalities the advantageous clinical effects on patients with hepatic carcinoma irrespective of primary or metastatic were observed.
Adult↗
[Thermotherapy for cancer of the urinary bladder in combination with tegafur and picibanil--with special reference to the serum bladder and bladder cancer tissue concentrations of tegafur in a perfusion fluid].
Thermotherapy combined with Tegafur and Picibanil was performed in 32 patients with cancer of the urinary bladder. The thermotherapy was performed with a closed circulation type of thermotherapeutic apparatus manufactured for trial, using a 3-way catheter. The flow quantity of the perfusate was 150 ml/min at a constant temperature of 43 degrees C. The temperature was monitored at the inlet and outlet catheter at the urethral meatus. The thermotherapy was performed for 6 hours once a week. Tegafur and Picibanil were added to the perfusate at the time of thermotherapy. No anesthesia was used. Complete disappearance of tumor occurred in 9 cases. The concentration of Tegafur in the serum, tumor and bladder wall was simultaneously measured. The serum levels after two hours of thermotherapy with 16 gm of dissolved Tegafur showed that FT-207 was 28.837 mcg/ml and 5-FU, 0.028 mcg/ml. After 4 hours the FT-207 was 36.464 mcg/ml and 5-FU, 0.040 mcg/ml. By the 6th hour FT-207 was 39.430 mcg/ml and 5-FU, 0.049 mcg/ml. After 24 hours FT-207 was 11.242 mcg/ml and 5-FU, 0.013 mcg/ml in the serum, while FT-207 was 8.205 mcg/g and 5-FU, 0.274 mcg/g in the bladder tumor, and FT-207 was 17.029 mcg/g and 5-FU, 0.157 mcg/g in the bladder wall. Nausea was observed in 1 case in which a large quantity of Tegafur was absorbed. No other side effects were noted.
Aged↗
Treatment of lymphangiomas with OK-432 (Picibanil) sclerotherapy: a prospective multi-institutional trial.
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.
Adolescent↗
In vivo administration of picibanil (OK-432) prior to tumor harvest leads to an enhancement of tumor-infiltrating lymphocyte (TIL) cytotoxicity.
TILs can be isolated and expanded in vitro in the presence of RIL-2. The resulting cells are highly cytotoxic in vitro and in vivo against a variety of tumor targets. Although most of the TILs bear T cell antigens on their cell surface, recent evidence suggests that natural killer (NK) cells may be part of the overall population of infiltrating cells. Based upon this evidence, we have evaluated the effects of Picibanil (OK-432), a well-known inducer of NK cell and T cell cytotoxicity, on TILs. OK-432 was administered intravenously at a dose of 100 micrograms, previously determined to be optimal for NK stimulation, to tumor-bearing animals. Two days later, control and experimental animals had their tumors harvested and processed in order to grow their TILs in vitro in complete medium containing RIL-2 at a final concentration of 1,000 U/ml. The following observations were made: 1) a greater than 300% increase in overall TIL number compared to controls on day 10 of culture returning to normal by day 30; 2) a marked increase in the percent of cells expressing cytotoxic and differentiation antigens in the experimental group compared to controls, such increase seen mostly from day 7 to day 10; 3) a marked increase in the cytotoxic activity of the experimental TILs against an NK-sensitive tumor target, the YAC-1 lymphoma, throughout the period of growth of the TILs (3-4 times controls) and to a lesser extent against an NK-resistant tumor target. These findings may have potential application, in immunotherapeutic trials against human tumors and may help to understand the reasons for the effectiveness of OK-432 in vivo against selected murine tumors.
Adenocarcinoma↗
Effect of picibanil (OK432) on neutrophil-mediated antitumor activity: implication of monocyte-derived neutrophil-activating factors.
Picibanil (OK432), an extract from streptococci, has been widely utilized to treat malignant ascites and pleural effusions. The antitumor mechanism is believed to include complement-mediated neutrophil activation. Employing a flow-cytometric analysis of actin polymerization as an indicator of cell activation as well as a tumor proliferation assay, we have found that monocyte-derived neutrophil-activating factors were involved in OK432-induced neutrophil activation as well as antitumor activity. OK432-stimulated (0.1 KE/ml; 0.01 mg/ml) monocyte supernatants (OKMS) induced neutrophil actin polymerization and chemotaxis. OKMS were responsible for neutrophil-mediated inhibition of human leukemic (CEM) cell proliferation and stimulated neutrophils to produce superoxide in the presence of CEM leukemic cells at an effector/target ratio higher than 20/1. In contrast, OK432 alone, OK432-stimulated lymphocyte supernatants, or OK432-stimulated neutrophil supernatants had no effect on neutrophil activation or suppression of tumor cell proliferation. OK432 in combination with mononuclear cells also had no effect on the inhibition of CEM cell proliferation. Pretreatment of OKMS at 56 degrees C for 30 min did not affect its ability to activate neutrophils, implying that complement activation is not responsible for the neutrophil activation. Supernatants from OK432-stimulated mononuclear cells, as determined by enzyme-linked immunosorbent assays and radioimmunoassays, contained high levels of interleukin-8 (IL-8; 1567 +/- 145 pg/ml) and tumor necrosis factor (TNF alpha; 2105 +/- 152 pg/ml), low levels of leukotriene B4 (800 +/- 45 pg/ml) and IL-1 beta (180 +/- 22 pg/ml), but interferon gamma was not detectable. IL-1 beta, IL-8, and TNF alpha transcripts, undetectable in untreated monocytes, increased significantly after 30-60 min exposure to OK432. These results suggest that neutrophil-activating factors from monocytes or resident macrophages may play an important role in the OK432-induced neutrophil activation and antitumor activity.
Adult↗
OK-432 (Picibanil) therapy for lymphangiomas in children.
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.
Adolescent↗