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PubMed2005

Phase II study of 5-fluorouracil, doxorubicin, and mitomycin C for metastatic small bowel adenocarcinoma.

BACKGROUND: Small bowel adenocarcinoma is a rare gastrointestinal malignancy that is treated primarily with surgery. Even with optimal resection, however, survival is poor and recurrences are common. Response rates to palliative combination chemotherapy are low, and the median duration of survival for metastatic disease is less than 1 year. This study aimed to document the response rate and survival time for patients with advanced small bowel adenocarcinoma who were not surgically curable and were treated with a regimen of 5-fluorouracil (5-FU), mitomycin C (Mutamycin; Bristol-Myers Squibb; Princeton, NJ), and doxorubicin (Adriamycin; Bedford Laboratories; Bedford, OH), the FAM regimen. METHODS: This multi-institutional study was performed by the Eastern Cooperative Oncology Group (ECOG). Between November, 1983 and December, 1985, 39 patients with advanced or recurrent disease were enrolled. Chemotherapy was given as follows: 5-FU, 600 mg/m(2) on days 1, 8, 29 and 36; mitomycin C, 10 mg/m(2) on day 1; and doxorubicin, 30 mg/m(2) on days 1 and 29. Eligibility criteria included an ECOG performance status score of 0-2, measurable disease, and adequate baseline organ function. Prior chemotherapy was allowed. Response was measured by examination and imaging techniques. Survival time and time to progression were evaluated by the method of Kaplan and Meier, and these outcomes were stratified by clinical and laboratory covariates. RESULTS: Of the 39 evaluated patients, 38 were eligible and 36 were evaluable for response. Grade 3-5 toxicities were experienced by a total of 26 patients (20 grade 3, 5 grade 4, 1 grade 5). The most common adverse events were neutropenia and vomiting. Responses were seen in a total of seven patients (2 complete responses, 5 partial responses), for a response rate of 18.4% (95% confidence interval of 7.8%-34.4%). The median survival time was 8 months. CONCLUSIONS: The FAM regimen was active and tolerable for patients with advanced small bowel adenocarcinoma; however, the results were no better than those seen with other chemotherapy combinations.

Adenocarcinoma↗

PubMed2006

Mitomycin: clinical applications in ophthalmic practice.

Mitomycin (mitomycin C; MMC) is an antibiotic isolated from Streptomyces caespitosus. The drug is a bioreductive alkylating agent that undergoes metabolic reductive activation, and has various oxygen tension-dependent cytotoxic effects on cells, including the cross-linking of DNA. It is widely used systemically for the treatment of malignancies, and has gained popularity as topical adjunctive therapy in ocular and adnexal surgery over the past 2 decades. In ophthalmic medicine, it is principally used to inhibit the wound healing response and reduce scarring of surgically fashioned ostia. Hence, it has been used as adjunctive therapy in various ocular surgeries, such as glaucoma filtering surgeries, dacryocystorhinostomy, corneal refractive surgery and surgeries for ocular cicatrisation. In addition, it has been used as an adjunct in the surgical management of pterygia, ocular surface squamous neoplasia, primary acquired melanosis with atypia and conjunctival melanoma. In many of these surgeries and ophthalmic pathologies, MMC showed a significant beneficial effect.

Antibiotics, Antineoplastic↗

PubMed2001

Hemolytic uremic syndrome with intracranial hemorrhage following mitomycin C administration.

A 50-year-old woman treated for breast cancer with mitomycin C developed severe hypertension, followed by deep coma 3 days later. Computed tomography of the brain showed frontoparietal intracranial hemorrhage accompanied by subarachnoid hemorrhage. The patient was diagnosed additionally with hemolytic uremic syndrome (HUS) based on hemolytic anemia with schistocytosis, thrombocytopenia, and acute renal failure. The patient underwent hemodialysis and plasmapheresis with no improvement. We present the pathologic findings of the general vessels, which has been reported rarely. This case represents the first reported intracranial hemorrhage in HUS following mitomycin C administration. We emphasize the need to control blood pressure in patients with HUS.

Alkylating Agents↗

PubMedDate not supplied

Topical application of mitomycin-C in endoscopic dacryocystorhinostomy.

Endoscopic dacryocystorhinostomy (DCR) is a well-established alternative to external DCR for treatment of obstruction of the lacrimal pathway and has a success rate of up to 95% in primary cases. Despite the benefits of using an endoscopic approach, including enhanced intranasal access to the lacrimal drainage system, there still exists a significant failure rate, particularly in revision procedures. As these failures are mainly due to obstructive postoperative adhesions, intraoperative adjuncts that prevent or minimize scarring should enhance the success rate. Endoscopic DCR was performed with intraoperative topical application of mitomycin-C, an antimetabolite often used in ophthalmologic procedures to reduce scarring and formation of adhesions following surgery. The procedure was successful in 7 of 8 instances, with a follow-up of 3 to 27 months. In one procedure, obstruction recurred 10 weeks after surgery. We feel that the results of this small series are encouraging and that further studies are warranted to determine the effectiveness of mitomycin-C as an adjunct to endoscopic DCR.

Administration, Topical↗

PubMedDate not supplied

The role of mitomycin C in surgery of the frontonasal recess: a prospective open pilot study.

BACKGROUND: Mitomycin C (MMC) inhibits fibroblast proliferation. The objective of this study was to determine the efficacy of MMC in reducing frontal ostium stenosis after endoscopic sinus surgery. METHODS: A prospective open pilot study was conducted in 28 patients who had undergone one or more previous surgical interventions for frontal sinusitis. MMC solution was applied to the frontal ostial region via an endoscopic or combined endoscopic and external approach. Patency of the frontal ostium was evaluated endoscopically during regular follow-up. If restenosis was observed further, endoscopic application of MMC was undertaken. RESULTS: There were 17 men and 11 women (mean age, 51.7 years; range, 26-86 years). Mean number of applications was 1.5 (range, 1:3). Mean follow-up was 19 months (range, 6-32 months). Patency rate was 86%. CONCLUSION: Mitomycin appears to have an important role in reducing postoperative scarring, which may obviate the need for repeated and more extensive surgery.

Adult↗

PubMed1980

Mitomycin C in advanced gallbladder carcinoma.

Seven patients with advanced gallbladder carcinoma were given intraarterial infusions of 10 to 15 mg mitomycin C with 10 to 24 days' interval, 3 received intravenous infusion (10 mg/m2) with median 3 weeks' interval. Stationary disease was obtained in 4 patients, progressive disease in 4, and treatment failures in 2. The median survival after mitomycin C treatment was 4 months (range 1-23 +). Irreversible thrombocytopenia occurred in 2 patients and a severe gastrointestinal bleeding episode in one.

Aged↗

PubMed1980

Short-term intra-arterial mitomycin C in hepatic metastases.

Short-term intra-arterial Mitomycin C treatment of hepatic metastases from various malignancies was performed in 24 evaluable patients. An objective regression was obtained in 12 patients. The median survival of responders was 11 months compared with 3 months in nonresponders. No complication of the technical procedure occurred and the treatment was well tolerated. The only side effect of clinical importance was thrombocytopenia, which occurred at a median dose of 45 mg of Mitomycin C.

Adult↗

PubMed1991

Continuous infusion 5-fluorouracil with bolus adriamycin and mitomycin and low-dose cisplatin (FAMP) in the treatment of metastatic gastric carcinoma: an evaluation of efficacy and toxicity.

A pilot study was performed to evaluate the feasibility of administering prolonged continuous infusion 5-fluorouracil with multiple bolus chemotherapeutic agents. Twelve patients with advanced measurable gastric carcinoma were treated with a combination chemotherapy program of continuous infusion 5-fluorouracil, bolus Adriamycin, mitomycin C, and low-dose cisplatin (FAMP). Responses were observed in 5 patients (2 complete and 3 partial). Observed toxicities included leukopenia, thrombocytopenia, mucositis, and hand-foot syndrome. Although the FAMP regimen has activity in advanced gastric carcinoma, the number of patients evaluated was small and significant improvement over currently available regimens could not be demonstrated. Evaluation of toxicities indicates that bolus administration of multiple agents (specifically, Adriamycin, mitomycin C, and cisplatin) can be used in conjunction with continuously infused 5-fluorouracil without excessive toxicity.

Adult↗

PubMed1993

Effects of mitomycin-C and etoposide in cell culture and in nude mice: the role of G-CSF mutein.

The combination of mitomycin-C and etoposide showed synergistic cell kill effects in vitro against HEp-2 laryngeal squamous carcinoma cells both in monolayer and in multicellular tumor spheroid systems. This combination was also synergistic in inhibiting HEp-2 tumors growing in nude mice. One course of this combination produced no complete regression of this tumor. When these two agents were combined with recombinant human granulocyte colony-stimulating factor (G-CSF) mutein, the doses of the drugs could be escalated approximately 1.5-fold higher than the doses that were tolerated without G-CSF support. With this modest dose intensification, apparent cure was observed. High-dose mitomycin-C plus etoposide with G-CSF support may be useful for the treatment of patients with inoperable squamous cell carcinoma of the head and neck.

Animals↗

PubMed1993

Incorporation and release of chemically intact mitomycin C from albumin microspheres: a high performance liquid chromatography evaluation.

Preparation of mitomycin C-loaded human serum albumin (HSA) microspheres using a new technique that avoids the use of heat denaturation, which is known chemically to degrade incorporated drug, is described. This method is based on cross-linking of protein by glutaraldehyde (2.2%) during emulsification (W/O) at room temperature. The resultant particles have a mean (s.d.) diameter of 16.9 (0.34) microns (50% weight average), contain mean (s.d.) 1.15 (0.05%) mitomycin C (MMC) (w/w, n = 17) and maintain sustained release of drug over 20 h. High performance liquid chromatography (HPLC) with diode array detection was used to study the chemical integrity of the drug. Two classes of decomposition products were evaluated: chemical degradation products and drug/nucleophile covalent adducts. The HPLC separation was validated by a number of standards of proposed degradation products. To examine incorporated drug, a complete microsphere system was solubilized with 0.4% trypsin for 24 h, while to examine released drug, microspheres were immobilized on a flow-through glass wool column and fractions were collected. No evidence of significant chemical degradation or covalent coupling to protein was detected in microsphere digests. Two candidate decomposition products, representing approximately 10% of drug released from microspheres (assuming similar molar extinction coefficients to MMC), were identified in column fractions. One of these products appeared to be a covalent adduct, the other possibly an isomeric form of intact MMC. Thus, MMC is predominantly incorporated into and released (90%) chemically intact from HSA microspheres prepared by the technique described.

Chromatography, High Pressure Liquid↗

PubMed2003

Effects of viscoelastic material on the corneal endothelial cells in trabeculectomy with adjunctive mitomycin-C.

We evaluated the change of corneal endothelium after trabeculectomy with mitomycin-C soaking (0.2 mg/ml, 2.4 +/- 1.2 minutes) and the effect of viscoelastic material in reducing this change. In randomly selected cases, 0.05 ml of sodium hyaluronate(Healon) was injected into anterior chamber (Healon group, n = 20), and same amount of balanced salt solution was injected in the other eyes (Control, n = 18) at the beginning of surgery. There were no differences in clinical variables and specular microscopy result between 2 groups before surgery. After surgery, the change of endothelial cells were significantly reduced in Healon group (cell density; -2.5 +/- 1.6%, variability of cell area; 5.8 +/- 2.5%, and percentage of hexagonal cell; -2.2 +/- 0.7%) compared to control group (-7.7 +/- 6.0%, 8.9 +/- 4.4%, and -4.8 +/- 3.5% respectively, p < 0.01). In trabeculectomy with mitomycin-C, the damage to the corneal endothelium was reduced significantly by injecting the viscoelastic material without significant complication.

Adjuvants, Immunologic↗

PubMedDate not supplied

Cisplatin, mitomycin-C, 5-fluorouracil and leucovorin combination chemotherapy (l-FCM) in locally advanced unresectable or metastatic gastric carcinoma: a phase-II study.

Despite relevant progress, the impact of chemotherapy on advanced gastric cancer patients' survival is still unsatisfactory. Thus, the key objective of our efforts should be palliation of the symptoms and the maintenance of an adequate quality of life. In this phase-II study, we evaluated toxicity and efficacy of the combination of cisplatin, fluorofolates and mitomycin C. Thirty-one advanced gastric cancer patients received cisplatin (15 mg/m2) and 5-fluorouracil (350 mg/m2), both for 5 consecutive days every 4 weeks; 5-fluorouracil infusion was preceded by a rapid i.v. injection of 100 mg/m2 leucovorin, while mitomycin-C (10 mg/m2) was administered on day 1 of odd cycles. Cycles were repeated every 4 weeks until disease progression. We recorded 16 objective responses (51.6%, 95% confidence interval: 42.63-60.57); furthermore, such a response rate was coupled with a moderate degree of toxicity and an extremely good tolerance. In particular, alopecia, a frequent and distressing side-effect in patients, especially women, in our series occurred only in two patients. This treatment appears to be an active and tolerable therapeutic option for patients with advanced gastric carcinoma.

Adult↗

PubMedDate not supplied

Laser epithelial keratomileusis with mitomycin C: indications and limits.

PURPOSE: To assess the advantages and safety of using mitomycin C (MMC) with laser epithelial keratomileusis (LASEK) by measuring high order aberrations of the cornea. METHODS: We analyzed the results of 86 eyes that had LASEK plus a brushstroke of MMC 0.01%. Another group of 100 eyes had LASEK only (control group). Mean follow-up was 312 days for the MMC group and 774 days for the control group. A Nidek EC-5000 laser was used in all eyes. We measured mean refractive error, best spectacle-corrected visual acuity (BSCVA), haze, and high order aberrations before and at 1 month and nearly 1 year after LASEK. RESULTS: Mean baseline spherical equivalent refraction was -6.80 +/- 3.00 D for the MMC group and -6.00 +/- 3.10 D for the control group (P=.34). In eyes with low myopia (-1.20 to -10.80 D), a single ablation zone of 6 mm with a transition zone of 8 mm was used, and in the higher myopia group (-5.60 to -15.50 D), smoothing and a cross sphere procedure (+0.75 D) were used. Mean spherical equivalent refraction after LASEK for low myopia in the MMC group at last examination (mean follow-up 312 days) was +0.50 +/- 0.93, and 0 +/- 0.34 D for the control group. Mean spherical equivalent refraction after LASEK for high myopia in the MMC group at last examination (mean follow-up 312 days) was +0.50 +/- 1.03 D, and +0.40 +/- 0.78 D for the control group. Mean haze in the low myopia MMC group was 0.06 and in the control group, 0.11; in the high myopia MMC group it was 0.1, and in the control group, 0.27 (all differences P<.05). No differences between baseline and postoperative BSCVA were noted. Early and late overcorrection were noted in the MMC group. Increased high order aberrations were evident at 1 month and 1 year in the MMC groups. CONCLUSIONS: The use of mitomycin C 0.01% with LASEK significantly decreased subepithelial haze. However, refractive outcome was less predictable. High order aberrations increased after LASEK with MMC. Additional studies with longer follow-up are necessary to evaluate long-term effects, and ideal MMC concentration and exposure time.

Antibiotics, Antineoplastic↗

PubMed2006

Comparison of laser epithelial keratomileusis with and without the use of mitomycin C.

PURPOSE: To analyze the results of prophylactic intraoperative use of mitomycin C (MMC) in laser epithelial keratomileusis (LASEK). METHODS: A retrospective analysis of 30 LASEK cases that received MMC 0.02% intraoperatively (MMC group) was performed and compared to the results obtained in 28 LASEK cases not receiving MMC (no MMC group). Mitomycin C was placed in contact with the ablation zone for 75 seconds with an imbibed microsponge. Both groups received postoperative fluorometholone for 3 months. Preoperative spherical equivalent refraction was -5.72 +/- 2.82 diopters (D) in the MMC group and -5.81 +/- 2.74 D in the no MMC group. Best spectacle-corrected visual acuity was 0.88 +/- 0.12 in the MMC group and 0.88 +/- 0.13 in the no MMC group. RESULTS: Spherical equivalent refraction at 6 months postoperatively was +0.11 +/- 0.13 D in the MMC group and +0.09 +/- 0.37 D in the no MMC group. Best spectacle-corrected visual acuity was 0.90 +/- 0.13 in the MMC group and 0.88 +/- 0.13 in the no MMC group. Uncorrected visual acuity (UCVA) > or = 20/40 was obtained in 93.3% of cases in the MMC group and in 89.3% of cases in the no MMC group; UCVA > or = 20/25 was achieved in 76.6% of cases in the MMC group and in 71.4% of cases in the no MMC group. Haze incidence for the MMC group was: trace: 0%, Grades I: 0%, II: 0%, III 0%, IV: 0%, and for the no MMC group: trace: 17.9%, Grades I: 3.6%, II: 0%, III: 0%, IV: 0%. A statistically significant difference (P<.001) was noted in haze intensity between the MMC group and no MMC group. CONCLUSIONS: Prophylactic use of intraoperative MMC in LASEK significantly decreases haze incidence.

Adult↗

PubMed2005

Mitomycin, ifosfamide, cisplatin for non-small cell lung cancer: an implementation study.

BACKGROUND: The MIP regimen (mitomycin, ifosfamide, cisplatin) demonstrated its effectiveness as first-line chemotherapy in phase II and III trials in NSCLC. We aimed to determine whether these results could be confirmed in a hospital population. METHODS: Between 1987 and 2004, 204 patients with NSCLC received MIP in our institution. Patients treated in and off trials received the same combination of cisplatin (50 mg/m2), ifosfamide (3 g/m2) and mitomycin C (6 mg/m2) every three weeks and were staged and followed in a similar way. RESULTS: Response rates for patients treated in or outside trials were 36.8% and 40.7%, respectively. After multiple logistic regressions, the only statistically significant factor predicting objective response was stage. The median survival time was 54.6 and 43.7 weeks respectively for patients treated in and outside trials. In multivariate analysis, four factors were statistically significantly associated with better survival: good performance status (p = 0.003), normal LDH value (p < 0.001), early stage (p = 0.01) and active smoking (p = 0.03). CONCLUSION: Participation in a clinical trial was not associated with a significant difference in efficacy. This implementation study thus confirms the activity of the MIP regimen when used in the routine management of patients with NSCLC.

Adult↗

PubMed2000

Results of intra-operative 0.5mg/ml mitomycin C with 20mg depo steroid in the treatment of primary pterygium.

OBJECTIVE: The effectiveness of intra-operative mitomycin C on the recurrence rate of pterygium in patients undergoing primary pterygium excision was assessed. METHOD: 51 consecutive primary pterygia of 46 patients were excised between April and December 1998. 0.5 mg/ml mitomycin C was applied on bare sclera for one minute and 20 mg depot steroid injected subconjunctivally. Post operatively patients were placed on Gutt Dexamethasone 0.1% with antazoline and chloramphenicol 1.0%. RESULTS: Follow up ranged from four to 14 months. There was no recurrence of pterygium. Side effects of treatment included: delayed wound healing, avascularised sclera and pyogenic granuloma. CONCLUSION: This study suggests that intraoperative application of 0.5 mg/ml mitomyin C with 20 mg depot steroid following primary pterygium excision is effective and safe in preventing recurrence.

Adult↗

PubMed1992

Combination chemotherapy with cisplatin, vindesine and mitomycin-C for advanced, inoperable non-small-cell lung cancer.

OBJECTIVES: To assess the activity of chemotherapy with cisplatin, vindesine and mitomycin-C (PVM) in advanced non-small-cell lung cancer (NSCLC) and to test the feasibility of preemptive therapy with PVM. DESIGN AND SETTING: A phase II clinical trial of PVM in patients with NSCLC treated at the Royal Prince Alfred Hospital between June 1987 and July 1990. PATIENTS: Forty-one patients with advanced, inoperable or recurrent NSCLC--22 women, 19 men, with a median age of 51 years. Thirteen patients had been treated previously with radiotherapy and/or surgery; 18 had extrathoracic metastases. Four patients previously deemed inoperable were treated preemptively with PVM before proceeding to radical surgery. INTERVENTIONS: Cisplatin 100 mg/m2, vindesine 5 mg and mitomycin-C 8 mg/m2, all given intravenously on Day 1, with vigorous hydration and antiemetic therapy. Cycles were repeated every four weeks. MAIN OUTCOME MEASURES: Objective tumour response to treatment, patient survival time, time to treatment failure, and treatment toxicity. RESULTS: There was one complete tumour response to PVM and 15 partial responses; 14 patients had stable disease and nine had progressive disease--yielding an objective response rate (complete plus partial responses) of 39% (16/41; 95% confidence interval [CI], 24%-56%). Responses were documented in all histological subgroups, in both locally advanced and disseminated disease, and in recurrent disease. Median survival of the group was six months (95% CI, 5-10 months; range, 0.5-19+ months), and is unchanged by exclusion of the four patients treated before surgery. Seven of the 41 patients (17%) survived 12 months or longer. Median time to treatment failure in patients who had an objective response was six months (95% CI, 5-10 months). Grade 3 or 4 nausea and vomiting occurred in 21 patients (51%). Haematological, renal and neurological toxicity were not major problems; there were no deaths from treatment toxicity. CONCLUSION: PVM is an active regimen in advanced NSCLC and can produce durable remissions. The potential palliative effects of PVM in incurable disease must be weighed against the risk of subjective toxicity.

Adult↗

PubMed1993

Synthesis and structure-activity relationships of new dimeric mitomycin derivatives; 7-N,7'-N'-bis(omega-thioalkyl)dimitomycins.

The reaction between mitomycin A (1) and cysteamine afforded 7-N,7'-N'-bis(2-thioethyl)dimitomycin C (7), 7-N-[2-[(2-aminoethyl)dithio]ethyl]mitomycin C (8), and 7-methoxy mitosenes (10, 11). The structures of 7 and 8 were elucidated on the basis of spectroscopy and reactions between 1 and 8, and 1 and cystamine. The observation of the time course for the reaction revealed the mechanism of the formation of 7 and 8. The rapid oxidation of cysteamine by the quinone of 1 gave cystamine, which was trapped by 1 to give 8, and 8 was additionally reacted with 1 to give 7. Since 7 showed significant antitumor activities, related 7-N,7'-N'-bis(omega-thioalkyl)dimitomycins were synthesized. They also showed remarkable antitumor activities against HeLa-S3 in vitro, sarcoma 180 (sc-ip), leukemia P388 (ip-ip) in vivo. In these evaluations, compound 7 demonstrated unique potency.

Animals↗