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Cancer Chemotherapy and Pharmacology

Published in:

01-01-2010 | Original Article

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

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

Published in: Cancer Chemotherapy and Pharmacology | Issue 2/2010

Abstract

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/m².

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/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.

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.

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Title: Capped-dose mitomycin C: a pooled safety analysis from three prospective clinical trials
Authors: Nse Ntukidem
Carlos Arce-Lara
Gregory A. Otterson
Eric Kraut
Spero Cataland
Tanios Bekaii-Saab
Publication date: 01-01-2010
Publisher: Springer-Verlag
Published in: Cancer Chemotherapy and Pharmacology / Issue 2/2010
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-009-1036-3

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Abstract

Background

Methods

Results

Conclusions

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