Beschreibung:
<jats:p><b><i>Background:</i></b> Evidence for <i>TP53 </i>mutations as biomarker in colorectal cancer (CRC) is conflicting. <b><i>Methods:</i></b> We assessed<i> TP53</i> mutations in 51 patients with advanced CRC enrolled into a phase II, randomised trial of first-line tegafur-uracil (UFT)/leucovorin (LV) plus irinotecan (n = 23) versus UFT/LV plus oxaliplatin (n = 28). <b><i>Results:</i></b> Non-functional <i>TP53</i> mutations were found in 35% of patients. The response rate was not significantly different according to <i>TP53 </i>status. Progression-free and overall survival were longer in patients with <i>TP53</i> mutations compared to those with wild-type <i>TP53</i> (9 vs. 6.5 months, p = 0.0504, and 39.2 vs. 19.6 months, p = 0.0055, respectively). On multivariable analysis, <i>TP53</i> mutation was independently associated with a decreased risk of death (hazard ratio 0.329, 95% CI 0.159-0.679; p = 0.0026). Treatment arm did not interact with <i>TP53</i> in influencing outcomes. <b><i>Conclusion:</i></b><i>TP53</i> was not predictive of benefit from first-line irinotecan- or oxaliplatin-based chemotherapy. <i>TP53 </i>mutations may possibly be associated with a more indolent course of CRC after the diagnosis of metastatic disease.</jats:p>