In an older population with metastatic colorectal cancer (mCRC), adding irinotecan to first-line infusional fluorouracil (5-FU)-based chemotherapy did not significantly improve either progression-free or overall survival, a new study published online ahead of print in the journal Annals of Oncology has shown.1

Although mCRC frequently occurs in older patients, there are limited data on the efficacy and tolerability of doublet chemotherapy with irinotecan in a geriatric population.

Therefore, researchers led by Thomas Aparicio, MD, PhD, at Université Paris 13 in France sought to assess the benefit of first-line chemotherapy intensification in older patients with mCRC.

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For the study, researchers enrolled 282 patients 75 years or older with previously untreated mCRC. Participants were randomly assigned 1:1:1:1 to receive classic LV5FU2 or simplified LV5FU2 alone or in combination with irinotecan (LV5FU2-irinotecan or FOLFIRI, respectively).

Results showed no significant difference in median progression-free survival between 5-FU-based chemotherapy  alone and  5-FU-based chemotherapy with irinotecan (HR=.84; 95% CI, 0.66–1.07; P=.15) or between classic LV5FU2 with or with irinotecan and simplified LV5FU2 with or without irinotecan (HR=.85; 95% CI, 0.67–1.09; P=.19).

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There was also no significant difference in median overall survival between 5-FU-based chemotherapy alone and 5-FU-based chemotherapy with irinotecan (HR=.96; 95% CI, 0.75–1.24); however, classic LV5FU2 was associated with an improved overall survival compared with simplified LV5FU2 (HR=.71; 95% CI, 0.55-0.92).

In regard to tolerability, 76.3% of patients in the irinotecan groups experienced grade 3 to 4 toxicities vs 52.2% of patients in the 2 groups that did not receive irinotecan.


  1. Aparicio T, Lavau-Denes S, Phelip JM, et al. Randomized phase III trial in elderly patients comparing LV5FU2 with or without irinotecan for first-line treatment of metastatic colorectal cancer [published online ahead of print October 20, 2015]. Ann Oncol. doi: 10.1093/annonc/mdv491.