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PubMed1994

Lack of activity of 5-fluorouracil plus mitomycin-C as salvage therapy in cisplatin-resistant epithelial ovarian cancer: results of a phase II trial.

Twenty-five patients with progressive, cisplatin-resistant epithelial ovarian cancer received 5-Fluorouracil (5-FU) 500 mg/m2 days one through three and Mitomycin-C 10 mg/m2 every 28 days in a phase II trial. Myelotoxicity manifested as thrombocytopenia resulted in dose reduction, delay of therapy, or discontinuation of treatment in 24% of patients. Only two patients (8%) demonstrated a partial response to therapy. Neither response was durable. The majority of patients (76%) demonstrated progression of disease following a single course of therapy. As utilized in this trial, the combination of 5-FU and Mitomycin-C is not an active salvage regimen for patients with cisplatin-resistant, progressive epithelial ovarian cancer.

Adult↗
PubMed1994

Mitomycin C as adjunctive therapy with glaucoma implant surgery.

Twenty-one eyes of 21 patients with refractory glaucoma underwent glaucoma surgery involving placement of a modified Molteno implant and intraoperative application of mitomycin C. Sixteen eyes (76.2%) had an intraocular pressure (IOP) of 21 mm Hg or less after a mean follow up of 9.4 +/- 6.4 months; additional medication was needed in six eyes. Major complications included early flat anterior chamber (42.9%), implant plate erosion (9.5%), tube erosion (4.8%), late hypotony (4.8%), tube-corneal touch (4.8%), and phthisis bulbi after choroidal hemorrhage (4.8%). Only one patient had a high IOP due to decreased filtration through the implant. These results suggest that glaucoma implant surgery with the adjunctive use of mitomycin C may be useful in eyes with refractory glaucoma.

Adult↗
PubMed1994

Randomized phase 2 evaluation of preoperative radiation therapy and preoperative chemotherapy with mitomycin, vinblastine, and cisplatin in patients with technically unresectable stage IIIA and IIIB non-small cell cancer of the lung. LCSG 881.

Between June 1988 and January 1980, 67 patients with pathologic stage III non-small cell lung cancer were randomized to receive either preoperative mitomycin, vinblastine, and cisplatin (MVP) chemotherapy (cisplatin 120 mg/m2, and mitomycin, 8 mg/m2 day 1 + 29, and vinblastine, 4.5 mg/m2 on day 1, 15, 22, and 29 and 2.0 mg/m2 day 8), or preoperative radiotherapy (44 Gy in 22 fractions to the primary tumor and mediastinum). The purpose of this study was to identify a treatment approach that showed sufficient effectiveness and acceptable toxicity to warrant testing by prospective randomized trial against "standard" nonsurgical treatment. All patients had surgical staging of the mediastinum and had either unresectable N2 disease or T4 disease with proximal extension of disease along the pulmonary artery. Response to preoperative therapy was evaluated 8 weeks after beginning treatment and patients with complete or partial radiographic response were to undergo surgical exploration and resection if possible. Fifty-seven patients were eligible and evaluable for response. Of the 67 total patients, 3 were unavailable for follow-up, 4 were ineligible, 1 was canceled, and 2 refused all treatment after having been randomized. Of the eligible and evaluable patients, 49 had stage IIIA and 8 had stage IIIB disease. Randomization was to MVP in 26 cases and to radiotherapy (XRT) in 31. Radiographic response to treatment was virtually identical for the two approaches, with 29 of the 57 evaluable patients achieving objective responses. In patients achieving radiographic response, 24 underwent surgical exploration and 20 underwent resection, of which 18 were complete. The mediastinum was free of tumor in seven patients but only two pathologic complete responses were seen (one each to XRT and MVP). In addition, ten nonresponders underwent surgery; seven underwent resection. Median survival for the entire group is 12 months, with a 27% actuarial survival at 4 years. Two patients died of treatment toxicity during preoperative therapy. Overall toxicity included 2 preoperative toxic deaths and 6 postoperative deaths in 34 patients who underwent surgical exploration (3 each with XRT and MVP) due to adult respiratory distress syndrome (3), myocardial infarction (1), pulmonary edema (1), and esophageal fistula (1), for an overall death rate 8 of 57 (14%) and a perioperative death rate in surgically explored patients of 6/34 (18%). These preoperative regimens, in the population studied herein, were of modest efficacy and substantial toxicity.(ABSTRACT TRUNCATED AT 400 WORDS)

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1976

Enhancing effect of a modified yeast mannan on antitumor activity of mitomycin-C.

A synthetic stearolymannan phosphate designated as SMP-Fr. I-d, consisting of three components, fatty acid, polysaccharide, and phosphate, enhanced the therapeutic effect of Mitomycin-C in mice implanted with 1 x 10(7) cells of Ehrlich carcinoma ascites form. Namely, 50% of the mice survived more than 60 days when ineffective doses of 0.5 mg/kg of Mitomycin-C and 50 mg/kg of SMP-Fr. I-d were administered intraperitoneally once daily for 7 days. SMP-Fr. I-d was found to be virtually non-toxic even in a dose of 1,000 mg/kg intraperitoneally in mice.

Animals↗
PubMed1993

[A pilot study of induction chemotherapy with cisplatin, mitomycin C and vindesine for stage III N2 non-small cell lung cancer].

PURPOSE: The postoperative survival of patients with preoperatively identified stage III N2 non-small cell cancer (NSCLC) is poor. A pilot study of induction chemotherapy consisting of cisplatin, mitomycin C and vindesine (CMV) was undertaken in an attempt to improve the curative potential of surgery in this group of patients. PATIENTS AND METHODS: Thirty-two patients with stage III N2a NSCLC received two cycles of CMV, (80 mg/m2 cisplatin i.v. on day 1, 8 mg/m2 mitomycin C i.v. on day 1, and 3 mg/m2 vindesine i.v. on day 1 and 8, every 4 weeks) preoperatively. The responding patients received a further two courses of CMV after surgery. RESULTS: The response rate was 63% (20 PR). All patients underwent operation including radical mediastinal node dissection. Twenty-six resections were curative and six were absolute non-curative. The toxicity was generally mild, but there were two hospital deaths, due to bronchopleural fistula and postoperative pneumonia. Sixteen patients have shown recurrent disease up to now. When the recurrence patterns were classified by clinical response, 11 responding patients were disease-free (9-84 months), but all non-responding patients had recurrent diseases. The median survival of curatively resected patients with pathological N2 was 39 months with a 5-year survival of 29%. CONCLUSIONS: This induction chemotherapy was well tolerated and revealed a high response rate. The current survival is obviously improved compared with the historical control, indicating that subsequent phase III clinical trials are urgently needed.

Adult↗
PubMed1994

Multicentre randomised study of adjuvant chemotherapy with mitomycin C and tegafur or tegafur-uracil in gastric cancer.

OBJECTIVE: To compare therapeutic results and five year survival after two regimens of adjuvant chemotherapy after resections for gastric cancer. DESIGN: Prospective randomised multicentre trial. SETTINGS: 21 departments of surgery. SUBJECTS: 243 patients with stage II, III, or IV gastric cancer. INTERVENTIONS: All patients received an intravenous bolus of mitomycin C 20 mg on the day of operation, and 10 mg on the first postoperative day. They were then randomised to receive either tegafur 600 mg or tegafur-uracil 600 mg orally daily beginning two weeks after operation and continuing for two years. Patients with histological confirmed stage IV disease also received mitomycin C 10 mg every three months starting one month after operation. MAIN OUTCOME MEASURES: Survival and side effects. RESULTS: 13 patients (5%) were withdrawn from the study, leaving 230 for analysis. There were no serious side effects and both drugs were safe when given continuously for two years. There were no significant differences in 5 year survival (though patients who were given tegafur-uracil tended to live longer), except when patients who had histological curative resections were compared with and those with poorly differentiated adenocarcinoma (p = 0.04).

Adult↗
PubMed1994

[Initial experience with the use of mitomycin C in anti-glaucoma filtering surgery].

The authors report on their initial experience with the use of peroperative administration of mitomycin C (0.5 mg/ml for a period of 5 mins.) in complicated cases of glaucoma. In 14 eyes of 15 with a mean observation period of 8 months compensation of the intraocular pressure was achieved. In one eye 5 months after a filtering operation transplantation of the cornea was performed with secondary implantation of the posterior-chamber intraocular lens, decompensation of the intraocular pressure was treated 11 months after the filtering operation by cyclocryotherapy. Mitomycin C is a promising substance which improves substantially the prognosis of complicated cases of glaucoma.

Adult↗
PubMed1993

The use of mitomycin in pterygium surgery.

We report on the use of mitomycin drops after the surgical removal of pterygiums in 70 patients. Our results justify the use of mitomycin as a standard postoperative procedure in preference to other treatments.

Combined Modality Therapy↗
PubMed1993

Incrusted cystitis after intravesical mitomycin C treatment.

Bladder wall calcification is a rare complication of intravesical therapy of superficial bladder cancer with Mitomycin C. A review of the literature revealed 2 other cases. We report a new case and discuss the pathogenic mechanism of this consequence of the intravesical treatment with Mitomycin C.

Administration, Intravesical↗
PubMed1993

[Efficacy of FEM (5-fluorouracil, epirubicin, mitomycin C) therapy for resected advanced gastric cancer. Ehime Gastric Cancer Study Meeting].

Between April 1990 and March 1991, postoperative adjuvant chemotherapy for resected gastric cancer employing 5-fluorouracil, epirubicin and mitomycin C (FEM) was performed. Forty-two patients subjected to the therapy were considered to have positive serosal invasion and underwent curative operation. FEM therapy consisted of intraoperative intraperitoneal administration of mitomycin C (0.3-0.4 mg/kg) combined with 8 cycles of intravenous bolus injection of epirubicin (20 mg/body) every 2-3 weeks which was started 2 weeks after the operation. Daily oral administration of 5-fluorouracil (150-200 mg/body) was started 2 weeks after the operation and continued for more than 6 months. Thirty-four of the 42 cases were assessable. Major adverse effects were nausea, vomiting, and general fatigue. There were no cardiovascular symptoms. The cumulative two-year survival rate was 74.2%, and follow-up was still under way at this writing.

Aged↗
PubMed1993

[Four long-surviving cases of gastric cancer with peritoneal dissemination treated by intraperitoneal administration of mitomycin C adsorbed on activated carbon particles].

A new dosage format (MMC-CH) of mitomycin C, which is composed of mitomycin C on activated carbon particles, was efficacious for prevention of peritoneal recurrence of gastric cancer. However, it had no such excellent therapeutic effect on the survival of patients with peritoneal dissemination. Out of 50 patients with peritoneal dissemination of gastric cancer treated by intraperitoneal administration of MMC-CH, 4 patients have survived for long periods of time (39-80 months). However, all of the other 50 patients, who did not receive intraperitoneally administered MMC-CH, died of peritoneal carcinomatosis within two years.

Adenocarcinoma↗
PubMedDate not supplied

Early hematological toxicity of adjuvant perioperative intraportal and intravenous chemotherapy with fluorouracil, mitomycin and heparin in colorectal cancer. Swiss Group for Clinical Cancer Research.

BACKGROUND: From 1987 to 1993 the Swiss Group for Clinical Cancer Research (SAKK) performed a randomized phase III adjuvant trial in patients with colorectal adenocarcinoma with the objective of comparing intraportal versus intravenous perioperative chemotherapy. PATIENTS AND METHODS: Patients younger than 75 years had a curative en bloc resection of their cancer and were then randomized into three arms: 1. adjuvant perioperative portal liver infusion with fluorouracil, mitomycin and heparin, 2. adjuvant subclavian intravenous infusion with the same regimen and 3. no adjuvant treatment. The hematological toxicity was evaluated by hemoglobin determination and leucocyte and thrombocyte counting before and during ten days after surgery. RESULTS: Hemoglobin showed a median decrease of 22% in the control group. This decrease is aggravated significantly by 3% through the chemotherapy. Leucocytes showed a median decrease of 7% in the control group. Perioperative chemotherapy caused a significantly higher median drop; 23% when given into the liver through the portal vein and 34% when given systemically through a subclavian catheter. Thrombocytes revealed a median decrease of 25% in the control group. Chemotherapy was not associated with a significant additional drop. CONCLUSIONS: Adjuvant perioperative chemotherapy with fluorouracil, mitomycin and Heparin as given in this study is associated with a significant mild drop in hemoglobin and leucocytes during the first 10 postoperative days. If drug dose increases are planned in future trials the addition of hematopoietic growth factors might be considered.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1995

Mitomycin-C concentration in human ocular aqueous humor after topical administration during trabeculectomy.

UNLABELLED: The concentration of the antitumor antibiotic mitomycin (CAS 50-07-7, mitomycin C, MMC), used in ophthalmic surgery for its antiproliferative effects, was measured in the aqueous humor of 7 glaucoma patients undergoing trabeculectomy. Sponges soaked with MMC-solution (100 microliters of MMC-solution 0.2 mg/ml: 20 micrograms) were applied intraoperatively on the scleral flap for 5 min. 100 to 200 microliters of aqueous humor were drawn with a needle 10 min following the end of topical MMC-treatment. Samples were assayed for MMC using a reverse-phase HPLC-system with ultraviolet detection (C18-column, elution: phosphate buffer (0.01 mol/l, pH: 6.5): methanol, v:v = 70:30, 365 nm). Swabs were extracted in phosphate-buffer (0.1 mol/l, pH: 7.0) before HPLC-analysis. External calibration was used for MMC quantitation. Quantitation limit was 10 ng/ml. In all aqueous humor samples MMC-concentration was below 10 ng/ml. MMC in the swabs amounted to 37% of the MMC amount applied. CONCLUSION: After intraoperative topical application, the MMC concentration in the aqueous humor of patients is very low. The substantial loss of MMC from the swabs used for the topical MMC-treatment suggests 1. rapid systemic absorption of MMC and/or 2. a loss through irrigation of the operative field following topical MMC-application.

Administration, Topical↗
PubMed1996

[Mitomycin C for the treatment of superficial tumors of the bladder (Tis-Ta-T1) with one or more risk factors. Argentinian Cooperative Group of Oncourology (GCAO)].

OBJECTIVES: To determine the efficacy and toxicity of intravesical mitomycin C in superficial bladder tumors (Tis Ta T1) completely resected with one or more risk factors. (Protocol U. 01/90). METHODS: The patients received six instillations weekly of 40 mg mitomycin C within 15 days post-TUR of a superficial bladder tumor with one or more risk factors: histological grade 3, tumor size more than 3 cm and/or multicentric lesion. The patients were evaluated by cystoscopy every three months for the first two years and every six months thereafter. Toxicity was evaluated according to Miller's score. Tumor recurrence, disease-free interval and survival were analyzed. RESULTS: 126 patients were entered into the study; of these, 110 were evaluable. At 18 months mean follow-up (range 6-36 months), 77 patients (70%) remain disease-free; the mean time to recurrence was 13.8 months. There were no differences between patients with one, two or three risk factors or those who received or did not receive previous treatments. The patients tolerated the treatment well; there were no dropouts or systemic toxicity. CONCLUSIONS: 1. At 18 months mean follow-up, 77 of 110 patients (70%) remain disease-free; 2. The mean time to recurrence was 13.8 months; 3. Local toxicity was minimal; 4. There were no dropouts due to toxicity; 5. Systemic toxicity was not observed.

Adult↗
PubMed1996

Regression of rubeosis iridis after trabeculectomy combined with mitomycin-C.

The authors report two cases in which severe rubeosis iridis regressed after trabeculectomy with intraoperative application of mitomycin-C. Several days after the operation, the vessels were no longer perfused. Only white, empty, "ghost" vessels were visible. This phenomenon was observed in one case with well-controlled intraocular pressure (IOP) after surgery, as well as in a case in which IOP rose again to high preoperative values. The authors conclude that the regression of the rubeosis may be caused by a local, intraocular pharmacologic side effect of mitomycin-C, not by the drop in IOP alone.

Aged↗
PubMed1996

Epidermoid anal cancer: results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. UKCCCR Anal Cancer Trial Working Party. UK Co-ordinating Committee on Cancer Research.

BACKGROUND: Non-surgical management of anal cancer by radiotherapy alone or combined with chemotherapy has, in uncontrolled studies, yielded similar local tumour control and survival rates to surgery. However, whether the addition of chemotherapy improves outcome without adding to morbidity is not known. Our trial was designed to compare combined modality therapy (CMT) with radiotherapy alone in patients with epidermoid anal cancer. METHODS: From 856 patients considered for entry to our multicentre trial, 585 patients were randomised to receive initially either 45 Gy radiotherapy in twenty or twenty-five fractions over 4-5 weeks (290 patients) or the same regimen of radiotherapy combined with 5-fluorouracil (1000 mg/m2 for 4 days or 750 mg/m2 for 5 days) by continuous infusion during the first and the final weeks of radiotherapy and mitomycin (12 mg/m2) on day 1 of the first course (295 patients). We assessed clinical response 6 weeks after initial treatment: good responders were recommended for boost radiotherapy and poor responders for salvage surgery. The main endpoint was local-failure rate (> or = 6 weeks after initial treatment); secondary endpoints were overall and cause-specific survival. Analysis was by intention-to-treat. FINDINGS: In the radiotherapy and CMT arms, respectively, five and three were ineligible, and six and nine died 6 weeks after initial treatment. After a median follow-up of 42 months (interquartile range 28-62), 164 of 279 (59%) radiotherapy patients had a local failure compared with 101 of 283 (36%) CMT patients. This gave a 46% reduction in the risk of local failure in the patients receiving CMT (relative risk 0.54, 95% CI 0.42-0.69, p < 0.0001). The risk of death from anal cancer was also reduced in the CMT arm (0.71, 0.53-0.95, p = 0.02). There was no overall survival advantage (0.86, 0.67-1.11, p = 0.25). Early morbidity was significantly more frequent in the CMT arm (p = 0.03), but late morbidity occurred at similar rates. INTERPRETATION: Our trial shows that the standard treatment for most patients with epidermoid anal cancer should be a combination of radiotherapy and infused 5-fluorouracil and mitomycin, with surgery reserved for those who fall on this regimen.

Adult↗
PubMed1996

Bleb rupture following filtering surgery with mitomycin-C: clinicopathologic correlations.

A 91-year-old woman with a complete rupture of her mitomycin-C filtration bleb associated with eye rubbing while crying was examined. An 18mm soft contact lens was placed preoperatively to re-form the anterior chamber and the patient underwent a conjunctival advancement. Histopathology of the free conjunctival specimen revealed a stratified squamous epithelium with marked attentuation of the subepithelial tissue in the area treated with mitomycin-C. Bleb rupture may be associated with minimal physical trauma following guarded filtration surgery. Successful visual rehabilitation is possible with conjunctival advancement, yet long-term survival of the bleb is poor.

Aged↗
PubMed1996

[Results of a prospective study of chemoprophylaxis with alternating mitomycin-C and BCG: complete response and recurrence and progression index].

OBJECTIVES: The high incidence of recurrence in superficial urothelial cancer warrants the use of chemoprophylaxis; however, the results achieved to date have been unsatisfactory. The present study investigated the possibility of reducing the incidence of recurrence of superficial urothelial cancer post-TUR and disease progression. METHODS/RESULTS: 99 patients were treated with monthly instillations of mitomycin-C and BCG alternately for one year, which commenced three weeks following TUR. The incidence of recurrence and progression were 15.3% and 5.10%, respectively. Treatment was well-tolerated and there were minimum side effects. CONCLUSIONS: Chemoprophylaxis with alternating mitomycin-C and BCG therapy in patients with superficial urothelial cancer achieves good results. It is well-tolerated and few side effects were observed.

Adjuvants, Immunologic↗