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PubMed1992

Mitomycin C + high-dose medroxyprogesterone versus cyclophosphamide+doxorubicin plus fluorouracil as first-line treatment for metastatic breast cancer.

A pilot study was undertaken to compare mitomycin C plus oral high-dose medroxyprogesterone acetate (MMPA) to cyclophosphamide+doxorubicin+ fluorouracil (CAF). Thirty-four women were randomized at first relapse to receive MMPA or CAF. Patients were balanced with respect to age, performance status, hormone receptor status, prior adjuvant treatment, site of metastases, and number of metastatic sites. On MMPA 9/18 objective responses occurred and on CAF 12/18. Median time to treatment failure was 5.7 months on MMPA and 7.6 months on CAF; median survival on MMPA was 22.5 months and on CAF 16.7 months. Although there were more objective responses on CAF, this was not statistically significantly different, and CAF was associated with significantly more hemopoietic toxicity. It is concluded that mitomycin C should be further studied in front-line regimens for patients with metastatic breast cancer.

Adult↗
PubMedDate not supplied

A randomized trial comparing adjuvant fluorouracil, epirubicin, and mitomycin with no treatment in operable gastric cancer.

Combination chemotherapy (CT) has, in some groups of patients with gastric cancer (GC), who are at a high risk for relapse, resulted in a small but measurable improvement in palliation and patient survival not reaching statistical significance and therefore remaining applicable in an investigational setting. Based on the above data, we studied adjuvant CT with FEM (5-fluorouracil (5-FU), epirubicin, mitomycin C) in a randomized study of patients with completely resected stage III GC and patients with stages T1-3 with a low histologic grade. CT was started 2-3 weeks after surgery. From August 1988 until February 1994, 84 patients with completely resected tumors and lymph nodes were randomized to either group A (FEM) or group B (no treatment). Patients were eligible for randomization if they had a Karnofsky score > 60, no postoperative evidence of residual tumor, and normal cardiac, hepatic and renal functions. Forty-two patients were randomized to each group, with no significant differences regarding: age distribution, group A 53 years (41-65), group B 57 years (35-66); sex, group A 32/10, group B 25/17 (men/women); site of primary tumor, group A 22/20, group B 25/17 (pylorus/antrum); histologic grade, group A 0/19/23, group B 0/25/17 (grades I/II/III); lymph node metastases, group A 30, group B 32, and surgical procedure, group A 33/9/6, group B 35/7/9 (total gastrectomy/partial gastrectomy/splenectomy). Group A received 5-FU 600 mg/m2/day i.v. on days 1, 8, 29 and 36, epirubicin 45 mg/m2/day i.v. on days 1 and 29, and mitomycin C 10 mg/m2 i.v. on day 1. The schedule was repeated every 56 days for 3 cycles. Group B received no treatment odd was only subjected to the regular follow-up. At the last follow-up at 66 months, 27/42 patients in group A (64%) had relapsed or died, compared to 34/42 patients in group B (81%). The differences in the relapse and the disease-free and the overall survival rates were not statistically significant. Only the subgroup of patients with histologic grade III tumors receiving adjuvant FEM demonstrated a trend towards improved survival (p = 0.085). Main therapy-related toxicities for the treatment group were grade I-II anemia, neutropenia, and throbocytopenia in 16, 45, and 22% of patients, respectively, and grade I-II nausea and vomiting in 29% of patients. Based on the present findings and those of previous studies, even if one considers the difference reaching statistical significance in the latter for histologic grade III tumors, it becomes evident that with current therapeutic modalities adjuvant therapy has no established role in the management of resectable GC. Studies of new-generation regimens, such as FAMTX (5-FU, Adriamycin and methotrexate) as well as ELF (etoposide, Leucoverin, and 5-FU), should be conducted in the adjuvant therapy setting with a nontherapy control group, in order to clarify the issue of adjuvant CT in resectable GC.

Adult↗
PubMed1992

Three cases of allergic dermatitis due to intravesical mitomycin C.

Irritant contact dermatitis has frequently been described in association with mitomycin instillation into the bladder. Three cases of allergic contact dermatitis in which patch tests demonstrated a type IV hypersensitivity reaction are reported. Patients showing skin reaction during mitomycin C vesical instillation should be patch tested to make a decision whether the drug might be continued (toxic reaction) or discontinued (allergic reaction).

Administration, Intravesical↗
PubMed1993

Corneoscleral ulceration and corneal perforation after pterygium excision and topical mitomycin C therapy.

A 78-year-old woman complained of ocular pain in the right eye. Thirty-three months before, the patient had a pterygium excised and mitomycin C, 0.04%, was instilled 3 times a day postoperatively for 10 days in the right eye. The same surgery was performed and the same drug was used for a course of 5 days in the left eye. Corneoscleral ulceration and corneal performation occurred in the right eye. The lesions were successfully treated with a lamellar patch graft with reserved corneosclera. We believe that it may not be safe to instill 0.04% mitomycin C 3 times a day postoperatively for 10 days.

Administration, Topical↗
PubMed1997

Is mitomycin effective in preventing muscle migration after hang-back recession in a rabbit model?

To investigate the effect of intraoperative mitomycin C (MMC) application on muscle insertion migration after adjustable surgery, hang-back recession was bilaterally performed for 4 mm on the inferior rectus muscle in 30 rabbits. The scleral wound of the insertion site of one eye of each pair was treated with a sponge soaked with a solution cotaining mitomycin at a concentration of either 0.4 or 1.0 mg/ml for 5 min. As a control, the contralateral eye was treated with a distilled-water-soaked sponge. Three, 6 and 12 weeks later, the distance from the anterior border of the reattached muscle to the original insertion was measured with in vivo and microscopic examination. Anterior migration of the muscle insertion was observed in both the MMC-treated and control eye. The measurement by the in vivo and histologic examinations revealed that MMC treatment did not significantly reduce the anterior migration relative to the control eye. Analysis of the time course in the MMC-treated eye revealed a significant increase during the observation period in anterior migration as measured by the histologic examination (p = 0.0267 for the 0.4 mg/ml group and p = 0.0408 for the 1.0 mg/ml group). Exposure to MMC has no significant inhibitory effect on the muscle migration compared to that in the control eyes.

Animals↗
PubMed1983

Mitomycin instillation to prevent recurrence of superficial bladder carcinoma. Results of a controlled, prospective study in 58 patients.

In a prospective randomized study, 58 patients with superficial bladder carcinoma received, after transurethral resection (TUR), either no further therapy (30 patients) or mitomycin at 20 mg/20 ml instilled every 2 weeks for the first year and every 4 weeks for the second year starting 3-4 weeks after TUR (28 patients). Bladder tumors recurred in only 2 patients in the treatment group; 15 patients in the control group had recurrences, with increases in grade in 4 patients and in stage in 6 patients. 3 patients in the control group developed metastases, including 1 who died of his tumor; there were no tumor-related deaths in the mitomycin group.

Clinical Trials as Topic↗
PubMedDate not supplied

Concurrent 5-fluorouracil, mitomycin C and radiation with or without brachytherapy in recurrent cervical cancer: a scoring system to predict clinical response and outcome.

AIMS AND PURPOSE: This is a prospective, phase II study aimed to evaluate the effect of concurrent 5-fluorouracil, mitomycin C, and radiation with or without brachytherapy on the clinical outcome of a series of recurrent cervical cancer patients and to determine the prognostic impact of a subset of factors. METHODS: Thirty-three patients with locally recurrent, non-metastatic cervical cancer received external beam radiation (4-week split course: 23.4 + 23.4 Gy) plus two courses of concomitant chemotherapy (5-fluorouracil, 96-h continuous infusion, days 1-4, 1 g/m2/day; mitomycin C, 10 mg/m2, bolus i.v., day 1). Twelve patients with vaginal recurrence (36.4%) underwent endocavitary low-dose rate brachytherapy boost (20-25 Gy); 11 patients with lateral pelvic recurrence (33.3%) received external beam radiation boost (14-20 Gy). RESULTS: Fourteen complete responses (42.4%), 7 partial responses (21.2%), 5 disease stabilizations (15.1%) and 7 progressions (21.2%) were obtained. After a median follow-up of 34 months (range, 6-127), overall actuarial 3-year survival, progression-free survival and local progression-free survival were 59.7%, 48.1% and 51.7%, respectively. Patients with vaginal recurrence of less than 4 cm and negative lymph nodes proved to respond best to the treatment. Two patients (6.1%) experienced hematologic grade 3 toxicity. One patient had grade 3 intestinal toxicity (3.0%). No patient had major skin or urological acute toxicity. Severe late toxicity was infrequent. Three patients had prolonged leukopenia (9.0%). Four patients showed severe vaginal stenosis (12.1%). A clinical score of 0 to 1 was assigned to each patient on the basis of the absence (score = 0) or presence (score = 1) of any of the following prognostic factors: time between surgery and recurrence shorter than 12 months, pelvic wall site of recurrence, positive lymph nodes, hemoglobin < 11 g/dL. Using this system, it was clear that patients with a low total score had a significantly better outcome (clinical remission, 51% of patients with a score < or = 2 vs 12% of patients with a score > 2, P = 0.06), local control of the disease (65% vs 20% after 3 years, P = 0.001,) and overall survival (75% vs 30% after 3 years, P = 0.032). CONCLUSIONS: Our data suggest that this combined modality therapy was relatively well tolerated and resulted in reasonable local control and survival. The scoring system proved to be helpful to identify patients with the greatest chance of benefiting from the treatment. Further studies are probably needed to salvage the other patients, whose prognosis remains severe.

Adult↗
PubMedDate not supplied

Chemotherapy with mitomycin C and capecitabine in patients with advanced colorectal cancer pretreated with irinotecan and oxaliplatin.

AIMS AND BACKGROUND: To assess the activity and tolerability of the combination of mitomycin C and capecitabine in patients with metastatic colorectal cancer after failure of irinotecan and oxaliplatin-containing regimens. METHODS: We retrospectively reviewed 28 patients with pretreated advanced colorectal cancer who had been treated with mitomycin C, 6 mg/m2 on day 1, and capecitabine, 1900 mg/m2 on days 1-14, every 3 weeks. Tumor assessment was performed every 3 cycles, toxicity assessed at each cycle. RESULTS: Main patient characteristics were median age, 61 years (range, 35-73); male/female ratio, 16/12; single metastatic site involvement, 5/28 (18%); > or =3 metastatic sites, 10/28 (36%). Ninety-six courses of therapy were given (median number, 3; range, 1-9). Twenty-six patients were assessable for response, and all were assessable for toxicity. There was 1 partial response (4%) and 12 had stable disease (43%). Median time to progression was 2 months (range, 1-9) and median overall survival was 6 months (range, 1-29+), with a 1-year overall survival rate of 25%. The regimen was very well tolerated without significant hematological toxicity. CONCLUSIONS: Our results are disappointing. Despite the good safety profile, they do not support further investigation or the routine use of this regimen in this setting.

Adult↗
PubMed1993

Mitomycin C, 5fluorouracil and folinic acid in combination with alpha 2b interferon for advanced colorectal cancer.

AIMS AND BACKGROUND: This study was conducted to investigate the activity and toxicity of 5fluorouracil folinic acid+mitomycin C combined with alpha 2b interferon in advanced colorectal cancer based upon recent studies suggesting a possible biochemical modulation of 5fluorouracil by interferon. PATIENTS AND METHODS: Between June 1990 and April 1991 25 previously untreated patients with advanced colorectal carcinoma were treated with mitomycin C 10 mg/m2 iv bolus on day 1, 5fluorouracil 375 mg/m2 on days 1 to 4 and folinic acid 200 mg/m2 on days 1 to 4 every 4 weeks, combined with alpha 2b interferon 3 million U day continuously. RESPONSE: Of the 25 patients entered into the study, 20 were evaluable for response as 5 patients withdrew due to toxicity (grade 3-4 thrombocytopenia in 4 cases and fatigue in 1). No complete response was recorded, 6 patients had partial remission (30%; 95% confidence interval, 10% to 50%), 4 experienced no change and 10 showed progressive disease. The toxicity of this regimen was significant, particularly myelosuppression. CONCLUSIONS: This combination showed a significant toxicity and low response rate compared with other 5fluorouracil based regimens in advanced colorectal cancer.

Aged↗
PubMedDate not supplied

Randomized comparison of goserelin acetate versus mitomycin C plus goserelin acetate in previously untreated prostate cancer patients with bone metastases.

In a prospective trial conducted by the Gruppo Onco Urologico Piemontese, newly diagnosed prostate cancer patients with bone metastases were randomized to receive goserelin (3.6 mg subcutaneously every 4 weeks) or goserelin plus mitomycin at 14 mg/m2 i.v. every 6 weeks. Treatment was planned to be continued until progression. The study was interrupted because of inadequate accrual rate when 63 patients had been recruited. A long-term follow-up (median, 47 months), performed to counterbalance the limited number of patients included, revealed no difference in time to progression and overall survival between the study treatments. However, 56.5% of assessable patients allocated to the chemotherapy arm presented a > or =90% reduction of prostate-specific antigen levels compared with 36.3% in the goserelin group, and previously elevated levels normalized in 73.9% versus 45.4%. Non-progressing patients received 5-7 cycles of mitomycin C with acceptable toxicity, but the cytotoxic treatment was interrupted early in all cases within the first year due to cumulative myelotoxicity. In conclusion, the results, although inconclusive, fail to support a clear advantage in terms of cost/benefit of chemotherapy plus hormone therapy over hormone treatment alone in advanced prostate cancer with bone involvement.

Aged↗
PubMedDate not supplied

Intrahepatic chemotherapy with floxuridine, leucovorin and dexamethasone in continuous infusion and mitomycin-C bolus in unresectable hepatic metastases from colorectal cancer: a phase II study.

BACKGROUND: Intrahepatic continuous infusion FUDR induces a 50% response rate in patients with hepatic metastases from colorectal cancer. Lower rates have been observed in pretreated patients. The combination of floxuridine plus leucovorin has obtained over 70% responses, with high hepatic toxicity. The use of dexamethasone can decrease hepatic toxicity. A randomized study reported an increase in response rate and a decrease in hepatic toxicity in a group of patients treated with floxuridine plus dexamethasone compared to a group receiving only floxuridine. Moreover, the combination of mitomycin C, carmustine and floxuridine is also effective in pretreated patients. METHODS: On such premises, since July 1993 we have treated 39 patients affected by unresectable hepatic metastases from colon carcinoma (26 patients) and rectal carcinoma (13 patients) with the combination continuous infusion of floxuridine (0.20 mg/kg per day) + leucovorin (7.5 mg/m2/day) + dexamethasone (20 mg on days 1 to 14) and bolus mitomycin C (10 mg/m2 on day 1) via the hepatic artery. Cycles were administered every four weeks. There were as 28 males and 11 females, with a median age of 64 years (range, 39-75) and a median PS = 0. Twenty-two patients were pretreated with systemic chemotherapy including 5-fluorouracil plus leucovorin. Total number of cycles was 189, with a median of 6 cycles per patient (range, 1-12). RESULTS: Of 39 patients 37 were assessable for response (2 patients were not assessable because they stopped chemotherapy for occlusion of the catheter after the first cycle). There were 3 complete responses (1 in a naive patient and 2 in pretreated patients), 16 partial responses (11 in pretreated patients and 5 in chemonaive patients), 4 minor responses, 4 stable disease and 10 progressive disease. The overall response rate was 51.3% (95 Cl, 51.3-86.7%). Median time to progression was 6 months (range, 1-34+). Overall survival was 18 months (range, 1-34+). Of 39 patients, 36 were assessable for toxicity (WHO) (3 patients died after the first cycle for progression of disease): diarrhea and nausea-vomiting grade 3-4 occurred respectively in 15 (41%) and 3 patients (8%); hepatic toxicity was mild. CONCLUSIONS: The treatment we used showed an elevated activity in liver metastases from colorectal cancer even in patients pretreated and resistant to systemic chemotherapy, although toxicity grade 3-4 diarrhea occurred in approximately 40% of the patients.

Adult↗
PubMed1986

Vinblastine-associated pulmonary toxicity in patients receiving combination therapy with mitomycin and cisplatin.

Two of 33 patients entered in a local pilot study of mitomycin, vinblastine, and cisplatin for non-small cell lung cancer developed vinblastine-associated pulmonary toxicity. As with other reports of vinca alkaloid-related pulmonary toxicity, the regimen included mitomycin. Based on these cases and others previously reported, the incidence of abrupt pulmonary toxicity following vinca alkaloid administration as part of mitomycin/vinca alkaloid combination appears to be three to six percent. Suggestions for management are given.

Adenocarcinoma↗
PubMedDate not supplied

Results of the application of intraoperative mitomycin C in dacryocystorhinostomy.

PURPOSE: Dacryocystorhinostomy (DCR) is widely accepted as the procedure of choice for surgical correction of lacrimal drainage system obstruction distal to common canaliculus in adulthood. The success rate of DCR has been reported to be from 63% to 99%. DCR failure has been attributed to membranous occlusion of the rhinostomy site caused by soft tissue scarring. More recently, use of mitomycin C (MMC) has been described in lacrimal drainage surgery. The beneficial effect of MMC as a surgical adjunct is thought to be related to its potent inhibition of fibroblast proliferation. METHODS: To improve the success rate of DCR, the authors used MMC as an adjunct to surgery in 130 patients with nasolacrimal duct obstruction undergoing lacrimal surgery. They were assigned randomly into a MMC DCR group and a regular DCR group (control group). RESULTS: The mean age of the MMC group was 40+/-15 years and that of the control group was 42+/-16 years. The standard surgical techniques of an external DCR were used in all patients of both groups. Patients were followed for 6 months. The authors evaluated the patients with subjective symptoms (improvement in tearing) and objective findings such as the height of tear meniscus, fluorescein dye test, and patency at the time of irrigation. There was no significant difference in the age between the two groups (p=1.00). Six patients in the mitomycin group were symptomatic after 6 months' follow-up; probe and irrigation showed non-patency of lacrimal system. The success rate in the MMC group was therefore 90.5% (59/65), and in the conventional group it was 92.4% (60/65). No significant difference between the two groups was present (p=0.75). CONCLUSIONS: The authors conclude that the use of intraoperative MMC in DCR surgery does not change the success rate of this procedure.

Adult↗
PubMedDate not supplied

Morphometric study of wound healing in a model of filtering surgery with mitomycin-C.

BACKGROUND: Failure of filtering surgery may be related to excessive wound healing in the surgical area. This effect diminishes with the use of antimetabolic agents. Mitomycin-C (MMC) has proved to be the most effective drug to reduce myofibroblastic proliferation in experimental in vivo and in vitro models. To our knowledge, the objective changes induced by mitomycin-C in the size of wound healing areas have not been investigated. METHODS: Filtering surgery was performed on both eyes of 40 pigmented rabbits. Preoperatively one of the eyes received MMC (0.5 mg/ml), and the fellow eye received balance salt solution as placebo. Animals were killed on days 6, 15, 30 and 58. Microscopic healing areas were measured by digital procedures. The areas of target and fellow control eyes were compared by the Wilcoxon test. RESULTS: This study showed significant differences (p < 0.05) between treated and untreated groups, the healing are a gradually becoming smaller. CONCLUSIONS: Objective methods to quantify the microscopic effects of MMC can be useful to improve our knowledge about the action on this antimetabolite and to enable us to adjust more accurately the timing and dosage when applying the drug in glaucoma filtering surgery.

Animals↗
PubMedDate not supplied

Scleromalacia following trabeculectomy with intraoperative mitomycin C.

PURPOSE: To report the development of scleromalacia in pediatric age as a complication of trabeculectomy with the adjunctive use of intra-operative mitomycin C. PATIENTS: Reported are 2 patients who developed scleromalacia following trabeculectomy combined with intra-operative 0.4 mg/ml mitomycin C application for 5 minutes for refractory glaucoma in aphakic bullous keratopathy and penetrating keratoplasty. RESULTS: Scleromalacia localised in the surgical area developed in 2 young patients. Scleromalacia remained stable in both patients after 6 and 24 months follow-ups. CONCLUSIONS: It is suggested that this procedure be done more selectively, especially in young patients, with a shorter application time and using a lower concentration.

Chemotherapy, Adjuvant↗
PubMed1997

Chemotherapy of non small cell lung cancer. A prospectively randomized study of cisplatin-etoposide versus cisplatin-mitomycin-vinblastine.

Based on preclinical studies showing synergism between cisplatin and etoposide, we randomized patients with non small cell lung cancer (NSCLC) to receive either the above combination (cisplatin 100 mg/m2 day 1, etoposide 130 mg/m2 days 1-3) or the combination of cisplatin-mitomycin-c and vinca drugs (MVP) (cisplatin 100 mg/m2, vinblastine 6 mg/m2, mitomycin 10 mg/m2 day 1), a regimen with a steady response rate. Partial responses were achieved in 12/44 (27%) of the cisplatin-etoposide group and in 11/43 (26%) of the MVR group. No difference in median survival could be demonstrated between the two groups (36 weeks versus 38 weeks). Myelotoxicity and alopecia were more severe in the cisplatin-etoposide group. Compared to international experience both regimens exhibited a relatively low response rate. It seems that for NSCLC new agents are required.

Aged↗
PubMed1998

5-Fluorouracil, high-dose folinic acid and mitomycin C combination chemotherapy in previously treated patients with advanced colorectal carcinoma.

The aim of this study was to evaluate the efficacy and tolerance of second-line continuous 5-fluorouracil (5FU) chemotherapy combined with folinic acid and mitomycin C in patients with advanced colorectal cancer who progressed on first-line chemotherapy. From June 1992 to April 1994, 24 consecutive patients, median age 59.7 years (range 41-73), performance status (PS) 0 to 2, were treated as second-line chemotherapy with mitomycin C, 7 mg/m2 every 4 weeks, folinic acid 200 mg/m2/day as a 2 h infusion followed by 400 mg/m2 of 5FU bolus and 600 mg/m2 continuous 5FU infusion for 22 h on days 1 and 2 and every 14 days; 19 patients did not respond to folinic acid and 5FU bolus regimen (in 2 patients, this was associated with pirarubicin in a continuous hepatic artery infusion) and 3 did not respond to irinotecan; 2 patients had disease progression during adjuvant chemotherapy with folinic acid and 5FU bolus. Tumor response was assessed every 12 weeks. One patient died before evaluation and 1 was lost to follow-up after 3 cycles; 7/24 patients had an objective response (29.2%, 95% confidence interval (CI): 11.0-47.4) including 2 complete responses; 7 additional patients had stable disease or minor response. Mean duration of response was 7.5 months. Median survival was 10 months and survival at 1 year was 39.4% (95% CI: 4-59.4). One patient who had a disease progression under irinotecan presented an objective response. No iatrogenic deaths occurred, nor was any grade 3 or 4 myelotoxicity seen. No hand-foot syndrome nor any cardiotoxicity arose but 2 grade II alopecia were seen. Digestive toxicities were the most frequent but with only 4 grade III toxicities (1 vomiting, 1 mucositis and 2 diarrhea) and no grade IV. With nearly 30% objective response and acceptable toxicity this treatment seems to offer a good alternative in the treatment of advanced colorectal cancers after the failure of first-line chemotherapy.

Adult↗
PubMed2001

Nitrotriazole AK-2123 enhances mitomycin C activity in mice bearing multidrug-resistant tumors.

The often observed cross resistance of multidrug-resistant (MDR) tumors to mitomycin C (MMC) is surprising, as these tumors are, as a rule, sensitive to alkylating drugs, and the mechanism of MMC activity is connected to alkylation of DNA. This study shows that nitrotriazole AK-2123 significantly enhances the sensitivity of MDR-strains of P388 mouse leukemia (developed and characterized by authors previously) to mitomycin C. The modulating effect is dependent on the initial sensitivity of resistant tumors to MMC which is correlated with the existence or absence of sorcin (cytosole Ca2+-binding protein) gene coamplification in MDR-amplicon. In agreement with authors' previous data about AK-2123 influence on active Ca2+-transport, it is supposed that the modulatory effect of radiosensitizer is at least partially dependent on this capacity. AK-2123 has no own antitumor effect on investigated tumors and cannot modify the sensitivity of the parent tumor P388 to MMC.

Animals↗