Capped-dose mitomycin C: a pooled safety analysis from three prospective clinical trials
- Nse NtukidemAffiliated withDepartment of Medicine, The Ohio State University
- , Carlos Arce-LaraAffiliated withDepartment of Medicine, The Ohio State University
- , Gregory A. OttersonAffiliated withDepartment of Medicine, The Ohio State University
- , Eric KrautAffiliated withDepartment of Medicine, The Ohio State University
- , Spero CatalandAffiliated withDepartment of Medicine, The Ohio State University
- , Tanios Bekaii-SaabAffiliated withDepartment of Medicine, The Ohio State UniversityDepartment of Pharmacology, The Ohio State University Email author
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Mitomycin C (MMC) up-regulates topoisomerase-I and thymidine phosphorylase making it ideal to combine with irinotecan or capecitabine. One of the most devastating toxicities MMC has been associated with is thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) in 4–15% of patients, especially when receiving cumulative doses higher than 60 mg/m2.
We conducted a pooled safety analysis of 140 patients enrolled in three prospective clinical trials at our institution from 2001 to 2008. MMC on all our studies was capped to a cumulative dose of 36 mg/m2 to limit toxicity while retaining efficacy. We reviewed our electronic medical records and clinical trial database for individual patient data on these studies with a specific intent to identify patients meeting criteria for TTP/HUS.
In combination with irinotecan or capecitabine, MMC was associated with manageable toxicities. We found no cases of MMC-associated TTP/HUS. There were no reported cardiac or pulmonary toxicities in our analysis. Most common grade 3/4 toxicities were diarrhea (19%), neutropenia (17%) and dehydration (12%) predominantly when MMC was combined with irinotecan.
In this large pooled analysis, we found MMC, when capped at a cumulative dose of 36 mg/m2, to be safe and tolerable in combination with capecitabine or irinotecan with no reportable cases of TTP/HUS.
KeywordsMitomycin C Thrombotic thrombocytopenic purpura HUS Dose
- Capped-dose mitomycin C: a pooled safety analysis from three prospective clinical trials
Cancer Chemotherapy and Pharmacology
Volume 65, Issue 2 , pp 319-324
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- Mitomycin C
- Thrombotic thrombocytopenic purpura
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- 1. Department of Medicine, The Ohio State University, B407 Starling Loving Hall, 320 West 10th Avenue, 43206, Columbus, OH, USA
- 2. Department of Pharmacology, The Ohio State University, Columbus, OH, USA