Does KRAS Testing in Metastatic Colorectal Cancer Impact Overall Survival A Comparative Effectiveness Study in a Population-Based SampleReport as inadecuate




Does KRAS Testing in Metastatic Colorectal Cancer Impact Overall Survival A Comparative Effectiveness Study in a Population-Based Sample - Download this document for free, or read online. Document in PDF available to download.

Purpose

Epidermal growth factor receptor EGFR inhibitors are approved for treating metastatic colorectal cancer CRC; KRAS mutation testing is recommended prior to treatment. We conducted a non-inferiority analysis to examine whether KRAS testing has impacted survival in CRC patients.

Patients and Methods

We included 1186 metastatic CRC cases from seven health plans. A cutpoint of July, 2008, was used to define two KRAS testing time period groups: -pre-testing- n = 760 cases and -post-testing- n = 426 cases. Overall survival OS was estimated, and the difference in median OS between the groups was calculated. The lower bound of the one-sided 95% confidence interval CI for the difference in survival was used to test the null hypothesis of post-testing inferiority. Multivariable Cox regression models were constructed to adjust for covariates.

Results

The median unadjusted OS was 15.4 months 95% CI: 14.0–17.5 and 12.8 months 95% CI: 10.0–15.2 in the pre- and post-testing groups, respectively. The OS difference was −2.6 months with one-sided 95% lower confidence bound of −5.13 months, which was less than the non-inferiority margin −5.0 months, unadjusted p = 0.06, leading to a failure to reject inferiority of OS in the post-testing period. In contrast, in the adjusted analysis, OS non-inferiority was identified in the post-testing period p = 0.001. Sensitivity analyses using cutpoints before and after July, 2008, also met the criteria for non-inferiority.

Conclusion

Implementation of KRAS testing did not influence CRC OS. Our data support the use of KRAS testing to guide administration of EGFR inhibitors for treatment of metastatic CRC without diminished OS.



Author: Heather Spencer Feigelson , Chan Zeng, Pamala A. Pawloski, Adedayo A. Onitilo, C. Sue Richards, Monique A. Johnson, Tia L. Kauffm

Source: http://plos.srce.hr/



DOWNLOAD PDF




Related documents