Irinotecan in first line therapy of elderly and non-elderly patients with metastatic colorectal cancer: Meta-analysis of four trials investigating 5-FU and irinotecan

3578 Background: Irinotecan has been shown to improve response rate and progression free survival in three randomized studies. In a recent metaanalysis showed that elderly patients have a similar benefit from 5-FU containing palliative treatment as younger patients (Folprecht 2004). Methods: We performed a metaanalysis of three randomized trials investigating 5-FU/FA/irinotecan vs. 5-FU/FA (Saltz 2000, Douillard 2000, Köhne 2005 [EORTC 40986]), and one phase II trial with 5-FU/irinotecan (Sastre 2005) to explore the efficacy and toxicity in elderly (≥70 years) and non-elderly (< 70 years) patients. Only data from randomized trials were used to compare the treatment arms 5-FU/FA plus irinotecan (IFL, FOLFIRI or Irinotecan/AIO) vs. 5-FU/FA (Mayo clinic regimen, LV5FU2 or AIO). Results: In total, 303 patients ≥70 y. and 1181 patients < 70 y were analyzed. Overall response rate was 39.5% in elderly and 33.1% in non-elderly patients (p=.055). Progression free survival was 6.7 (5.6–7.8) and 5.7 (5.2–6.1) months in elderly and younger patients (p=.12), respectively, overall survival 15.9 (13.6–18.3) vs. 15.4 (14.3–16.5) months (p=.9). Neutropenia gr. 3/4 and stomatitis gr. 3/4 was found to be more frequent in elderly patients. No differences were found in the other toxicities. Conclusion: The analysis confirms that neutropenia and stomatitis is moderately increased in elderly patients. However elderly patients benefit from treatment with irinotecan/5-FU in a similar way as younger patients do, and (fit) elderly should be offered the irinotecan-containing therapy in the same way as younger patients. [Table: see text] No significant financial relationships to disclose.