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PubMed1996

The combination of cisplatin, doxorubicin, and mitomycin (PAM) compared with the FAM regimen in treating advanced gastric carcinoma. A phase II randomized trial of the Italian Oncology Group for Clinical Research.

BACKGROUND: In a randomized Phase II study, the authors evaluated the activity and toxicity of the new cisplatin, doxorubicin, and mitomycin C (PAM) combination, that includes cisplatin (P) instead of 5-fluorouracil as in the 5-fluorouracil, doxorubicin, and mitomycin C (FAM) combination, in patients with advanced gastric carcinoma. FAM was utilized as a control treatment arm. METHODS: Fifty eligible patients were assigned to the FAM (5-fluorouracil 600 mg/m2 intravenous (i.v.) on Days 1, 8, 29, 36; doxorubicin 30 mg/m2 i.v. on Days 1 and 29; mitomycin C 10 mg/m2 i.v. on Day 1; every 8 weeks) and 52 to the PAM combination (cisplatin 60 mg/m2 i.v. on Days 1 and 29; doxorubicin 30 mg/m2 i.v. on Days 1 and 29; mitomycin C 10 mg/m2 i.v. on Day 1; every 8 weeks). All eligible patients were included in the evaluation of response, toxicity and survival. RESULTS: The PAM combination complete response (CR) rate was 8%, and the CR plus partial response (PR) rate was 21% (95% confidence interval [CI] from 10% to 32%). The median time to progression, duration of response, and duration of survival were 15, 26, and 29 weeks, respectively. The FAM combination CR rate was 2% and the CR plus PR rate was 26% (95% CI from 14% to 38%). The median time to progression, duration of response, and duration of survival were 17, 27, and 23 weeks, respectively. Hematologic and nonhematologic toxicity were mild with both regimens. CONCLUSIONS: This study shows that this new combination, that does not include 5-fluorouracil, is active in patients with advanced gastric carcinoma. Since treatment with 5-fluorouracil alone is still considered the standard according to some authors, the PAM combination may be included among the sequential clinical options before or after treatment with 5-fluorouracil alone.

Adult↗
PubMed1978

5FU infusion with mitomycin-C versus 5 FU infusion with methyl-CCNU in the treatment of advanced colon cancer: a Southwest Oncology Group Study.

The Southwest Oncology Group (SWOG) in a randomized trial evaluated 5FU infusions in combination with either Mitomycin-C or Methyl-CCNU in patients with disseminated large bowel cancer. A response rate of 18% was noted on the 5FU-Mitomycin limb as compared to 16% on the Methyl-CCNU arm (p = .39). Median survival for all treated patients was 43 weeks on both arms. Myelosuppression was found to be more significant on the Mitomycin-C arm. Regression analysis demonstrated that performance status, sex, and primary site were significant pretreatment characteristics for predicting survival. The response rates associated with this burdensome method of 5FU administration in combination with either Mitomycin-C or Methyl-CCNU appear to offer little advantage over bolus 5FU alone.

Adenocarcinoma↗
PubMed1980

Percutaneous hepatic arterial infusion (HAI) of mitomycin C and floxuridine (FUDR): an effective treatment for metastatic colorectal carcinoma in the liver.

The response rate of metastatic colorectal carcinoma confined to the liver to HAI of FUDR alone is at the range of 50% and to mitomycin C by hepatic arterial infusion (HAI) at the range of 35%. Mitomycin C was added to FUDR by continuous infusion and given by HAI to 12 patients with colorectal cancer confined to the liver. Catheters were placed subselectively in the hepatic artery, and infusion continued for five to six days when the catheter was removed. Cycles were repeated every 30 days. Chemotherapy consisted of mitomycin C 15 mg/m2 administered on day 1 followed by FUDR 100 mg/m2 by continuous infusion daily for five days. Response to treatment was evaluated by serial determinations of plasma CEA and by imaging techniques consisting of a computerized tomography, sonography, and radionuclide scanning of liver as well as by angiography. In 2 patients, complete remission was achieved; in 4 patients a 75% and in another 4 patients a 50% decrease in liver metastasis was observed, while 2 patients had stable disease. Thus, a response rate of 83% with a median duration of six to seven months was achieved. The median survival of the these patients was 16 months. Eight of the 12 patients have failed previous, i.v. 5-FU containing regimens. Complications related to 45 treatment cycles were the following: catheter displacement in 11.1%, an intimal tear, usually in the hepatic artery in 4.4%, gastric ulcerations in 5.4%, and septicemia in 2.7% of the cycles. In addition, aneurysmal dilation of the hepatic artery occurred in 4 patients (8.8% of the treatment cycles), all of whom continued treatment. Chemotherapy-related complications included primarily thrombocytopenia and stomatitis. Mitomycin C + FUDR by hepatic arterial infusion is an effective treatment for colorectal carcinoma metastatic to the liver. The high response rate justifies the adjuvant treatment of Dukes class C colon cancer patients with this treatment.

Adult↗
PubMed1982

Veno-occlusive disease of the liver after high-dose mitomycin C therapy and autologous bone marrow transplantation.

Twenty-nine patients with refractory malignancies underwent intensive therapy with mitomycin C (60, 75, or 90 mg/m2 IV) and autologous marrow transplantation. Six patients developed the clinical syndrome of hepatic veno-occlusive disease (VOD) characterized by progressive abnormalities in liver function, abdominal pain, and ascites 15-70 days after mitomycin C therapy. Postmortem material was available in 16 patients, including four patients who had the clinical syndrome. VOD of the central and sublobular hepatic veins was noted in these four patients. VOD was discovered incidentally at autopsy in one of 12 patients without antemortem clinical evidence of disease. Two patients with abnormalities of liver function but without ascites or right upper quadrant pain had no evidence of VOD at autopsy. Although not statistically significant, there was a greater incidence of VOD with increasing doses of mitomycin C. When bone marrow toxicity of mitomycin C was overcome by autologous bone marrow transplantation, the development of VOD appeared to be the limiting factor in dose escalation.

Adult↗
PubMedDate not supplied

Effect of mitomycin-C on the bioavailability of the radiopharmaceutical (99m)technetium-phytic acid in mice: a model to evaluate the toxicological effect of a chemical drug.

The many desirable characteristics of technetium-99m ((99m)Tc) have stimulated the development of labelling techniques for different molecular and cellular structures. It is generally accepted that a variety of factors can alter the biodistribution of radiopharmaceuticals and one such factor is drug therapy. Because patients on chemotherapeutic treatment receive a radiopharmaceutical in a nuclear medicine procedure, we have studied in Balb/c mice the effect of mitomycin-C on the biodistribution of the radiopharmaceutical (99m)Tc-phytic acid ((99m)Tc-PHY) used in hepatic scintigraphy. Mitomycin-C is an antineoplastic agent obtained from Streptomyces caesptosus and is used on the treatment of disseminated adenocarcinoma of the stomach or pancreas. Three doses of mitomycin-C were administered via the ocular plexus into Balb/c mice. One hour after the last dose, (99m)Tc-PHY was administered and the animals were sacrificed. The organs were isolated, the radioactivity was determined in a well counter and the percentages of radioactivity in the organs were calculated. The results have shown that the percentage radioactivity has been increased in stomach, spleen, lung, thyroid and bone, decreased in pancreas and thymus and not altered in ovary, uterus, kidney, heart, liver and brain. The changes in the distribution of (99m)Tc-PHY may be the result of metabolic processes and/or therapeutic actions produced by the administration of mitomycin-C.

Animals↗
PubMed1994

Dose intensity of mitomycin C in adjuvant cancer chemotherapy for patients with gastric cancer.

Using a cohort of macroscopic curative resections of gastric cancer at stages II, III, and IV, a randomized controlled trial was performed to elucidate the dose efficacy of intensive adjuvant cancer chemotherapy with mitomycin C. Between June 1983 and December 1986, 336 patients with gastric cancer from 31 institutes were enrolled in the study. The cohort was stratified randomly by the telephone method into two arms. Group A received 20 mg and 10 mg of mitomycin C per body intravenously (IV) on postoperative days 0 and 1, respectively, and then tegafur at 600 mg/body daily perorally (PO) from postoperative week 2 for 1 year. Group B also received 0.2 mg of mitomycin C per kg IV at 3, 6, 9, and 12 months after surgery. The background factors in groups A and B were essentially identical, and the adverse effects were tolerable in both groups. The total administered doses of mitomycin C were significantly higher in group B than in group A, according to the protocol. Although no significant differences were observed in the actuarial overall survival rates between groups A and B at stages II, III, and IV, favorable survival was observed in group B, which received histologically absolute curative resection. This dose-intensive adjuvant cancer chemotherapy would be useful for gastric cancer patients treated by histologically curative surgery.

Chemotherapy, Adjuvant↗
PubMed1978

Mitomycin-C alone and in combination with infused 5-fluorouracil to the treatment of disseminated gastrointestinal carcinomas.

One hundred and thirty-two previously untreated patients with metastatic adenocarcinoma of the gastrointestinal (GI) tract were randomized to receive either a 120-hr infusion of 5-fluorouracil (5FU) with mitomycin-C or mitomycin-C alone. Superiority of the combination treatment was demonstrated with remissions in 30 out of 82 (37%) patients versus 9 out of 50 (18%) with the single drug treatment (P = 0.02). The median survial with 5FU--mitomycin-C was 29 weeks, as opposed to 20 weeks with mitomycin-C alone (P = 0.03). The combination produced significantly more severe myelotoxicity than the single drug, and jaundiced patients experienced more myelosuppression than non-jaundiced patients with both treatments.

Adenocarcinoma↗
PubMed1978

Mitotic chiasmata and other quadriradials in mitomycin C-treated Bloom's syndrome lymphocytes.

Mitotic chiasmata and other quadriradials (QRs) were studied by Q-banding in mitomycin C-treated and untreated lymphocytes from two sibs with Bloom's syndrome. The frequency of chiasmata was very significantly increased by the mitomycin treatment in cells from both sibs. Chiasmata occurred throughout the chromosomes, but were favored in Q-dark regions, particularly at borders between dark and light regions (Kuhn, 1976). No significant difference was found in the distribution of chiasmata among chromosome regions in treated and untreated material. This differs from the reported action of mitomycin C on cultured lymphocytes of normal persons, where chiasmata are concentrated at secondary constrictions and centromeres. Adjacent counterparts to mitotic chiasmata, and chromatid translocations between non-homologous chromosomes, also occurred in the treated material, but with a much lower frequency than mitotic chiasmata. This again differs from the effects of mitomycin C on lymphocytes of normal persons, where chiasmata account for 20% or less of total QRs.

Abnormalities, Multiple↗
PubMed1993

Pharmacokinetics of BW12C and mitomycin C, given in combination in a phase 1 study in patients with advanced gastrointestinal cancer.

The effect of combining the oxygen-transport-modifying drug BW12C with mitomycin C was investigated in a phase 1 study of 26 patients with advanced gastrointestinal cancer. The dose of BW12C was increased from 20 mg/kg to 60 mg/kg. Dose-limiting toxicity of vomiting was experienced at doses greater than 50 mg/kg. This corresponded to whole blood levels > or = 700 micrograms/ml and to > 50% haemoglobin modification. Whole blood concentrations of BW12C and modification of the haemoglobin oxygen saturation curve were linearly dependent on dose. BW12C whole blood pharmacokinetics were best described by a one-compartment model and were clearly dose-dependent. The half-life increased from 2.1 h at a dose of 20 mg/kg to 7.2 h at a dose of 60 mg/kg. The AUC increased in a similar non-linear fashion with increasing dose. Mitomycin C was given at a fixed dose of 20 mg/m2 at the end of the BW12C infusion. Mitomycin C plasma pharmacokinetics fitted a two-compartment model, giving a mean beta half-life of 50 +/- 7 min and AUC of 1.1 +/- 0.08 micrograms/ml h, and were unaffected by the combined treatment. There was no evidence of increased mitomycin C toxicity.

Benzaldehydes↗
PubMed1995

Mitomycin C and menadione for the treatment of lung cancer: a phase II trial.

A phase II trial of menadione [2.5 gm/m2 as a continuous intravenous (i.v.) infusion over 48 hours] followed by mitomycin C (10-20 mg/m2 i.v. bolus) administered every 4 to 6 weeks was performed in 23 patients with advanced lung cancer. Menadione, a vitamin K analog which lowers intracellular pools of reduced glutathione (GSH), was combined with mitomycin C in an attempt to overcome thiol-mediated resistance to alkylating agent chemotherapy. The median age of patients entered on this trial was 62 years; performance status ranged from 60-90%. Two of the 23 patients (9%; 95% confidence interval, 1% to 28%) had objective responses lasting 3.5 months and 13 months respectively, while 4 additional patients developed short unconfirmed responses (lacking follow-up response data to estimate response duration). Median survival for all patients was 5.5 months. Treatment with mitomycin C and menadione was well tolerated except for hematologic toxicity and cardiac events of unclear relationship to the study drugs. Thirty-one percent of treatment courses were complicated by grade 3 or 4 hematologic toxicity including one episode of hemolytic anemia. One patient developed interstitial pneumonitis. Two patients developed a decrease in left ventricular ejection fraction: one patient remained asymptomatic, but the other patient developed congestive heart failure. Although only 9% of patients had confirmed objective responses, 28% (5 of 18) of the patients with non-small cell lung cancer demonstrated biological activity (tumor regression fulfilling the criteria for objective response on a single occasion but 3 patients lacking a follow-up measurement to document response duration) to this combination of mitomycin C and menadione. We conclude that further studies of chemomodulation in non-small cell lung cancer are appropriate.

Adult↗
PubMed1992

Mitomycine, suterelysis and hypotony.

In 35 patients 37 trabeculectomies (TE) were performed using mitomycin as a fibrosisinhibitor. Mitomycin (0.5 mg/ml) was applied to the sclera (under the scleral flap) and conjunctiva in the area of the projected TE during 5 minutes using a small sponge. The indications for operation were: visual field progression in 15 eyes, too high IOP in 13 eyes and severe visual field defects (central island and/or centro coecal visual field defects) in 9 eyes. Six patients had Normal Pressure Glaucoma, 17 Primary Open Angle Glaucoma and 12 had other forms of glaucoma. There were 22 first TE's and 15 re-operations. The scleral flap was sutured with 5 to 8 10/0 nylon sutures. The system of a large number of sutures and subsequent suturelysis was our routine management for reducing complications after TE. This report deals with the postoperative period of the first three months. Suturelysis in combination with mitomycine caused an unexpected high number of postoperative hypotonies (IOP < = 6 mmHg with reduced visual acuity and/or retinal folds or large persistent choroidal detachment and shallow anterior chamber) In the 27 eyes who had suturelysis performed, 7 developed a hypotony. The hypotony may develop as late as three weeks postoperative after suturelysis!. Two eyes developed a hypotony without suturelysis. Seven patients needed resuturing of the scleral flap. The use of mitomycine to enhance filtration after TE may cause serious hypotonies if the scleral flap is not securely closed and if suturelysis is used too early or too extensively.

Adult↗
PubMed1992

Intraoperative and post operative treatment with 5-fluorouracil and mitomycin-c: long term effects in vivo on subconjunctival and scleral fibroblasts.

Rabbits undergoing full thickness glaucoma filtering surgery were exposed to one of 4 treatments. Group 1 received intraoperative distilled water, group 2 received intraoperative mitomycin-c 0.2 mg/ml for 5 minutes, group 3 received 5 post operative injections of 5-Fluorouracil (5-FU) 5 mg in 0.1 ml, and group 4 received intraoperative 5-FU 50 mg/ml followed by 5 post operative injections of 5-FU. 30 days after the operation tissue biopsies were taken from the subconjunctival and scleral tissue at the treated area and 90 and 180 degrees from the treated area. The biopsies were then placed in tissue culture media and the outgrowths quantitated. The fibroblast outgrowths from all areas did not differ significantly from each other except for the outgrowths from the areas directly treated with mitomycin 0.2 mg/ml which were significantly smaller. In addition then cells were morphologically abnormal although there were foci of normal cells which appeared to be growing from localised areas in the tissue biopsies. The outgrowths from the areas 90 and 180 degrees from the treated area were normal. Intraoperative treatments with mitomycin-c result in long term inhibition of fibroblast proliferation limited to the treated area, when compared with intraoperative and postoperative treatment with 5-FU. Failure of filtration surgery in eyes treated with intraoperative mitomycin may in part be due to unaffected cells reproliferating.

Animals↗
PubMed2002

Safety monitoring of the coliseum technique for heated intraoperative intraperitoneal chemotherapy with mitomycin C.

BACKGROUND: Treatment of carcinomatosis may involve the use of heated intraperitoneal chemotherapy; the cytotoxic solution is administered in the operating room with the abdomen open so that manual distribution results in uniform treatment. The potential risk of this procedure to the operating room personnel has not been previously investigated. METHODS: Mitomycin C was perfused through the peritoneal cavity, which was partially covered by a plastic sheet. Large volumes of air were suctioned from 5 and 35 cm above the abdominal skin edge. Urine from the surgeon and from the perfusionist were assayed. Sterile gloves worn in the operating room for manipulating the viscera during treatment were assayed for their permeability to mitomycin C. All samples were analyzed by high-performance liquid chromatography. RESULTS: Analysis of samples of operating room air and urine from 10 procedures showed no detectable levels of mitomycin C. Six tests of three different types of gloves showed a 10-fold range of mitomycin C penetration. The least permeable gloves leaked a mean of 3.8 parts per million over 90 minutes. CONCLUSIONS: No detectable safety hazard to the surgeon or other operating room personnel was demonstrated.

Air Pollutants↗
PubMedDate not supplied

Effects of mitomycin C on the rat retina.

To evaluate the retinal toxicity of mitomycin C injection in the rat eye, we conducted an electroretinographic study and a histopathologic study. Three different concentrations of mitomycin C (0.2, 0.3 and 0.4 mg/ml) were injected into either the vitreous cavity or the anterior chamber of the experimental eyes. A full-field electroretinogram was recorded before injection and 2, 4 and 7 days after injection. The retinas of all eyes were examined by light and electron microscopy. We found no evidence of electroretinographic and histologic changes 2 and 7 days after injection of 0.4 mg/ml of mitomycin C into the anterior chamber. However, profound electroretinographic changes did follow injection of the drug into the vitreous. These were absent with the 0.2-mg/ml solution at 7 days, mild with the 0.3-mg/ml solution at 7 days and profound with the 0.4-mg/ml solution as early as 2 days. Intravitreal injection of 0.4 mg/ml, however, showed selective degeneration of Müller cell process at day 2, retinal pigment epithelium changes at day 4 and irregular arrangement of the outer nuclear layer and photoreceptors at day 7. Intravitreal injection of mitomycin C in a concentration comparable to the one used clinically could cause retinal disorders, both functionally and histologically.

Animals↗
PubMed1977

Ultrastructural investigation of the effect of mitomycin C on the rat exocrine pancreas.

In order to clarify the pathophysiology of digestive disorders which are caused with anticancer agents, Mitomycin C was intravenously administrated to rats and the ultrastructure of the pancreas was studied. The alteration of acinar cells after under 4 daily administrations of 1.0 mg/Kg of Mitomycin C was not remarkable and in an early stage returned to normal structure. In above 8 daily administrations of 1.0 mg/Kg of Mitomycin C, however, pronounced degeneration of acinar cells was induced and acinar cells did not recover to the previous level, but die within one month. The ultrastructural changes induced by Mitomycin C were mainly aggregation of chromatin in the nuclei, tubularly dilatation of the rough endoplasmic reticulum, and swelling of the mitochondria. It was surmised that the biosynthesis and supply of protein such as digestive enzymes were not amply carried on; hence, the ehcmotherapy could give rise to severe digestion disorders. It appeared necessary to further study the dosage and dosage schedule of the anticancer agents, along with the necessity for taking ample care of patients presenting such disorders.

Animals↗
PubMed2006

Smac/DIABLO promotes mitomycin C-induced apoptosis of bladder cancer T24 cells.

The enhancing effects of Smac gene on the mitomycin C-induced apoptosis of the bladder cancer cell line T24 were investigated. The Smac gene was transfected into bladder cancer cell line T24 under the induction of liposome. The intrinsic Smac level was detected by using immunohistochemistry and RT-PCR. The in vitro cellular growth activities were assayed by MTT colorimetry. Apoptosis was assayed by the flow cytometry. The results showed that as compared with the control cells, the apoptosis rate of T24 cells induced by mitomycin C was enhanced by transfected Smac gene. Flow cytometry revealed that, the apoptosis rate was 18.84% and 33.52%, and 10.72% and 26.24% respectively in blank and transfected cells treated with 0.05 or 0.005 mg/mL mitomycin C (P < 0.05). It was concluded that Smac could enhance the apoptosis of T24 by mitomycin C, which could provide a useful experimental evidence for bladder cancer therapy.

Apoptosis↗
PubMedDate not supplied

Pharmacokinetics of mitomycin C in patients after bolus injection and chemobolisation of the hepatic artery with Spherex starch particles.

The pharmacokinetics of mitomycin C after chemobolisation of the common hepatic artery by micronized Spherex starch particles (mean particle size 30 microns) were investigated in 5 cancer patients. Bolus injection and simultaneous occlusion of the artery lead to a significantly lower systemic circulation of mitomycin C in the blood vessel system than after bolus injection without chemobolisation. The plasma concentration-time curves showed lower values in the alpha-phase in the presence of Spherex (co = 743 ng/ml) than without starch particles (co = 987 ng/ml). Accordingly, the AUC values were significantly lower too (AUC = 28.6 micrograms/ml.h with Spherex and 39.7 micrograms/ml.h without Spherex), thus leading to a lower systemic bioavailability of the drug and a higher local bioavailability in the tumor region. Elimination of mitomycin from the central compartment was similar for both administrations (t1/2 = 27 min with Spherex and 28 min without Spherex) and showed the characteristic profile of the substance. The clinical picture showed a milder toxicity with a certain loss of side effects. These results indicate a significant and desirable change in the pharmacokinetics of mitomycin C during the distribution phase into the tissue of patients.

Aged↗
PubMed2005

[Systemic corticoid application in combination with topical mitomycin or dexamethasone. Inhibition of wound healing after tympanic membrane perforation].

BACKGROUND: The purpose of this study was to determine whether systemic glucocorticoid application, in combination with topical mitomycin or dexamethasone, prolongs the patency of a tympanic membrane perforation. METHOD: Bilateral myringotomies were performed on 24 rats. The 48 ears were separated into eight groups. Treatment with combined systemic and topical dexamethasone or mitomycin differed between these groups. After the first 2 weeks, the animals were checked weekly for a total of 12 weeks. RESULTS: A combination of systemic and topical dexamethasone delayed tympanic membrane closure after myringotomy. Perforation size increased in all tympanic membranes treated with mitomycin plus systemic dexamethasone. CONCLUSION: Topical mitomycin plus systemic glucocorticoid may lead to a massive malfunction of tympanic membrane healing.

Administration, Topical↗