Capped-dose mitomycin C: A pooled safety analysis from three prospective clinical trials

Nse Ntukidem, Carlos Arce-Lara, Gregory A. Otterson, Eric Kraut, Spero Cataland, Tanios Bekaii-Saab

Research output: Contribution to journalArticlepeer-review

4 Scopus citations


Background: 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/m 2. Methods: 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/m 2 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. Results: 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. Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)319-324
Number of pages6
JournalCancer chemotherapy and pharmacology
Issue number2
StatePublished - Jan 2010


  • Dose
  • HUS
  • Mitomycin C
  • Thrombotic thrombocytopenic purpura

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)


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