Prognostic factors for long-term overall survival (OS) for patients (pts) undergoing first-line treatment for metastatic colorectal cancer (mCRC) with chemotherapy (CT) plus bevacizumab (bev): Findings from a large observational study.
590 Background: Bev+CT has been shown to improve OS vs. CT alone in phase III and IV mCRC studies. However, as only a subset of pts experience OS >30 months (m), clinical factors may help to identify pt groups with the largest potential benefit. Methods: This large observational study included pts receiving bev with various first-line CT regimens in Germany from 2005–2009, with predefined assessment of OS, progression free survival (PFS), toxicity and 22 baseline variables, including pt characteristics, pre-treatment duration/procedures, blood parameters, tumour characteristics. Pts with long-term OS (defined as OS >30m) were compared to those with OS <30m. Surviving pts with observations <30m were defined as ‘censored’. Association between variables and OS was explored by univariate analyses and then multivariate analysis (logistic regression) to find independent variables for long-term OS. Results: 392 (22%) out of 1777 eligible pts had OS >30m (195 events, median OS 46.8m), 717 pts (40%) had OS <30m (median OS 14.3m), and 688 (38%) pts were censored. Median PFS was 17.7m (329 events) for pts with OS >30m, 7.7m for pts with OS <30m, and 11.8m (313 events) for censored pts. In the univariate analysis, nine variables were associated with OS >30m: age (continuous variable; p=0.0008), ECOG PS (0 vs. 1–4; p=0.0025), WBC <8.0/nL (p=0.013), CEA <20ng/mL(p<0.0001), single metastatic site (p<0.0001), initial pT4 vs. others (p<0.0001), pN0 vs. pN1/2 (p=0.0002), initial M0 vs. M1 (p=0.0021), grading G1/2 vs. G3/4 (p<0.0001). Independent variables for pts with OS <30m were found in the multivariate analysis. Conclusions: In general, the prognostic factors identifying long-term survivors in the CT only era are confirmed in this large cohort with bev treatment. However, the predominant role of grading and CEA level are remarkable. [Table: see text]