The initial change in tumor size predicts response and survival in patients with metastatic colorectal cancer treated with combination chemotherapy

Ann Oncol. 2012 Apr;23(4):948-54. doi: 10.1093/annonc/mdr350. Epub 2011 Aug 10.


Background: To determine whether the change in tumor diameters at the first follow-up computed tomography (CT) examination after baseline examination (first change) correlates with outcome in patients with metastatic colorectal cancer (mCRC) treated with combination chemotherapy.

Patients and methods: The first change was analyzed in a multicenter randomized phase III trial (Nordic VI, N = 567) comparing first-line irinotecan with either bolus or infused 5-fluorouracil. Cox proportional hazards multiple regression model and Kaplan-Meier survival analyses after correction for guarantee-time bias were carried out to evaluate correlations between first change, objective response according to RECIST 1.0, progression-free survival (PFS), and overall survival (OS).

Results: The hazard ratios for PFS and OS decreased along with first change. A decrease between 10% and <30%, albeit RECIST does not regard this as a partial response, was a positive prognostic factor for PFS and OS. Patients who had new lesions or unequivocal progression of nonmeasurable lesions had a worse prognosis than those with only an increase in size of >20%.

Conclusions: The change in tumor size at the first follow-up CT is strongly prognostic for PFS and OS in mCRC.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Camptothecin / administration & dosage
  • Camptothecin / analogs & derivatives
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / mortality
  • Colorectal Neoplasms / pathology*
  • Disease-Free Survival
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Irinotecan
  • Kaplan-Meier Estimate
  • Leucovorin / administration & dosage
  • Liver Neoplasms / drug therapy
  • Liver Neoplasms / mortality
  • Liver Neoplasms / secondary*
  • Lung Neoplasms / drug therapy
  • Lung Neoplasms / mortality
  • Lung Neoplasms / secondary*
  • Lymphatic Metastasis
  • Male
  • Middle Aged
  • Proportional Hazards Models
  • Treatment Outcome
  • Tumor Burden / drug effects*


  • Irinotecan
  • Leucovorin
  • Fluorouracil
  • Camptothecin