A multicenter phase II study of "adjuvant" irinotecan following resection of colorectal hepatic metastases

Helen J. Mackay, Kevin Billingsley, Steven Gallinger, Scott Berry, Andrew Smith, Raymond Yeung, Gregory R. Pond, Marina Croitoru, Paul E. Swanson, Smitha Krishnamurthi, Lillian L. Siu

Research output: Contribution to journalArticlepeer-review

19 Scopus citations


Objectives: This study evaluates the efficacy and toxicity of single-agent irinotecan following hepatectomy for metachronous colorectal metastases, and examines the predictive value of p27 and p53 expression and of microsatellite instability (MSI) status. Methods: Twenty-nine patients, previously treated with 5-fluorouracil, with operable hepatic colorectal metastases underwent hepatectomy and received adjuvant irinotecan (thrice weekly) for 6 planned cycles. Metastases were examined for p53 and p27 expression by immunohistochemistry and for MSI using mono- and dinucleotide markers. Results: The starting dose of irinotecan was 350 mg/m2 (in 3 patients), 300 mg/m2 (n = 14), and 250 mg/m2 (n = 12). Four patients failed to complete 6 cycles (2 progressive disease and 2 toxicity). Grade ≥3 toxicity was experienced in 8% of cycles (13 of 165). The estimated median relapse-free survival (RFS) was 45.2 months. RFS at 18 months was estimated to be 59% (95% confidence interval [CI], 43-80), 2-year overall survival (OS) was 85% (95% CI, 72-99.8), and the median follow-up was 27.9 months. Six patients (21%) have died; median OS has not been reached. In univariate analyses, p27 and MSI status were not predictive for RFS while p53 approached statistical significance (P = 0.051). Duration of chemotherapy was the only significant predictive factor (P = 0.006). Conclusion: The tolerability of this regimen after major liver resection supports further evaluation of irinotecan-based adjuvant chemotherapy in this group of patients.

Original languageEnglish (US)
Pages (from-to)547-554
Number of pages8
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number6
StatePublished - Dec 2005
Externally publishedYes


  • Chemotherapy
  • Hepatic colorectal metastases
  • Irinotecan (CPT-11)
  • Liver resection
  • Microsatellite instability
  • p27
  • p53

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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