Mitomycin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin (see WARNINGS and ADVERSE REACTIONS Sections).
Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure, has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs; however, most cases occur at doses ≥ 60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome.
The incidence of the syndrome has not been defined.
Mitomycin (also known as mitomycin-C) is an antibiotic isolated from the broth of Streptomyces caespitosus which has been shown to have antitumor activity. The compound is heat stable, has a high melting point, and is freely soluble in organic solvents. Mitomycin for Injection is a sterile dry mixture of mitomycin and mannitol, which, when reconstituted with Sterile Water for Injection, provides a solution for intravenous administration. Each vial contains either mitomycin 5 mg and mannitol 10 mg, or mitomycin 20 mg and mannitol 40 mg, or mitomycin 40 mg and mannitol 80 mg.
Mitomycin (MITOMYCIN) is indicated for the following:
Mitomycin for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.
Published Studies Related to Mitomycin
Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial. [2011.09]
BACKGROUND: The clinical effect of intravesical instillation of chemotherapy immediately after transurethral resection of bladder tumours (TURBT) has recently been questioned, despite its recommendation in guidelines. Our aim was to compare TURBT alone with immediate post-TURBT intravesical passive diffusion (PD) of mitomycin and immediate pre-TURBT intravesical electromotive drug administration (EMDA) of mitomycin in non-muscle invasive bladder cancer... INTERPRETATION: Intravesical EMDA mitomycin before TURBT is feasible and safe; moreover, it reduces recurrence rates and enhances the disease-free interval compared with intravesical PD mitomycin after TURBT and TURBT alone. FUNDING: None. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Preoperative radiotherapy with capecitabine and mitomycin C in locally advanced rectal carcinoma. [2011.09]
PURPOSE: To evaluate the efficacy and safety of preoperative radiotherapy with capecitabine and mitomycin C in patients with locally advanced rectal cancer... CONCLUSION: Preoperative chemoradiation with capecitabine and mitomycin C appeared to be effective with low toxicity in patients with locally advanced rectal cancer.
Impact of KRAS and BRAF Gene Mutation Status on Outcomes From the Phase III AGITG MAX Trial of Capecitabine Alone or in Combination With Bevacizumab and Mitomycin in Advanced Colorectal Cancer. [2011.07.01]
PURPOSE: Mutations affecting the KRAS gene are established predictive markers of outcome with anti-epithelial growth factor receptor (EGFR) antibodies in advanced colorectal cancer (CRC). The relevance of these markers for anti-vascular endothelial growth factor (VEGF) therapy is controversial. This analysis was performed to assess the predictive and prognostic impact of KRAS and BRAF gene mutation status in patients receiving capecitabine with bevacizumab (CG) or capecitabine without bevacizumab in the phase III AGITG MAX (Australasian Gastrointestinal Trials Group MAX) study... CONCLUSION: KRAS gene mutation status was neither prognostic for OS nor predictive of bevacizumab outcome in patients with advanced CRC. BRAF gene mutation status was prognostic for OS but was not predictive of outcome with bevacizumab.
Pegylated liposomal doxorubicin, 5-fluorouracil and cisplatin versus mitomycin-C, 5-fluorouracil and cisplatin for advanced gastric cancer: a randomized phase II trial. [2011.07]
PURPOSE: Clinical data suggested that a regimen incorporating doxorubicin to 5-fluorouracil (5-FU) and cisplatin may be more effective but probably quite toxic for advanced gastric cancer patients. With the aim to maintain efficacy while reducing toxicity, we compared the activity and safety of a combination of 5-FU, cisplatin and pegylated liposomal doxorubicin with a combination of 5-FU, cisplatin and mitomycin-C... CONCLUSIONS: A combination of pegylated liposomal doxorubicin, cisplatin and 5-FU can be safely administered in gastric cancer patients with a promising efficacy profile.
Wavefront-guided epithelial laser in situ keratomileusis with mitomycin-C for myopia and myopic astigmatism: flap-on versus flap-off technique. [2011.06]
PURPOSE: To compare the postoperative pain, visual recovery, and outcomes of flap-on and flap-off epithelial laser in situ keratomileusis (epi-LASIK) with mitomycin-C (MMC). SETTING: Asian Eye Institute, Makati, Philippines. DESIGN: Case-control study... CONCLUSIONS: Wavefront-guided epi-LASIK with MMC was effective, safe, and predictable in treating myopia and myopic astigmatism. Eyes that had flap-off epi-LASIK had less pain and faster visual recovery. Visual results, refractive outcomes, contrast sensitivity, and HOAs were comparable between groups. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned. Copyright (c) 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.
Clinical Trials Related to Mitomycin
Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae [Recruiting]
This study evaluates whether Mitomycin C is an effective alternative to septal splints in
the treatment of nasal synechiae.
Veliparib With or Without Mitomycin C in Treating Patients With Metastatic, Unresectable, or Recurrent Solid Tumors [Recruiting]
ABT-888 (veliparib) may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as mitomycin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving ABT-888 together with mitomycin may kill more tumor cells. This phase I
trial is studying the side effects and best dose of ABT-888 when given with or without
mitomycin in treating patients with metastatic, unresectable, or recurrent solid tumors
Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix [Recruiting]
This randomized phase II trial is studying the side effects and how well giving oxaliplatin
or mitomycin C directly into the abdomen after surgery works in treating patients with
tumors of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C,
work in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Heating a chemotherapy solution and infusing it directly into
the abdomen may kill more tumor cells. Giving these treatments after surgery may kill any
tumor cells that remain after surgery.
Recurrent Pterygium Surgery With Mitomycin C Application Using Limbal Conjunctival Versus Amniotic Membrane [Recruiting]
The purpose of this trial is to compare two techniques for the treatment of recurrent
pterygium: intraoperative mitomycin C plus limbal conjunctival autograft transplantation
versus intraoperative mitomycin C plus amniotic membrane graft transplantation.
Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Primary Colorectal Tumors or Tumors of the Appendix [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and mytomycin C, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Heating a chemotherapy solution and infusing it directly into the
abdomen may kill more tumor cells. Giving these treatments after surgery may kill any tumor
cells that remain after surgery.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving
oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating
patients with primary colorectal tumors or tumors of the appendix.
Reports of Suspected Mitomycin Side Effects
OFF Label USE (40),
Incorrect Route of Drug Administration (24),
Hepatic Failure (20),
Hepatic Cirrhosis (10),
Interstitial Lung Disease (5),
Nausea (5), more >>
Page last updated: 2011-12-09