PD-0010 - Clinical outcomes with first-line bevacizumab and chemotherapy for patients with metastatic colorectal cancer and a history of diabetes: results fro...

Date 27 June 2014
Event World GI 2014
Session Poster discussion session II – Tumor burden and biomarkers
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Cancer in Special Situations
Presenter Johanna C. Bendell
Citation Annals of Oncology (2014) 25 (suppl_2): ii5-ii13. 10.1093/annonc/mdu164
Authors Y. Mun1, S. Fish1, A. Cohn2
  • 1Genentech, Inc., San Francisco/US
  • 2Rocky Mountain Cancer Center, Denver/US



Patients with metastatic colorectal cancer (mCRC) who have a history of diabetes have lower rates of overall survival (OS) compared with those without preexisting diabetes (Zanders et al, Diabetes Metab 2014). Patients with diabetes are more likely to have other comorbidities at the time of diagnosis of mCRC and may have a greater risk for experiencing certain adverse events (AEs) associated with anticancer treatment. This analysis compared effectiveness and safety outcomes for patients with and without a history of diabetes receiving first-line chemotherapy with bevacizumab in the ARIES observational cohort study (OCS).


The ARIES study was a prospective OCS that enrolled patients receiving bevacizumab with chemotherapy for first-line mCRC. There were no protocol-specified treatments or assessments; the dose and schedule of bevacizumab and the choice of chemotherapy were at the discretion of the treating physician. Analyses were conducted in patients grouped according to history of diabetes requiring drug therapy at baseline, and included comparisons of progression-free survival (PFS), OS, and safety. PFS and OS were assessed using the Kaplan-Meier method; hazard ratios (HRs) and 95% confidence intervals (CIs) were generated using a Cox proportional hazards model.


A total of 1550 patients with first-line mCRC were enrolled; 245 patients (15.8%) had a history of diabetes requiring drug therapy at baseline. Median age was 64 years (range, 35–86) in the diabetes group compared with 61 years (range, 18–92) in the no-diabetes group. The race of patients in the diabetes group was 71% white, 22% black, and 7% other, compared with 83% white, 11% black, and 6% other in the no-diabetes group. Never smokers comprised 44% and 51% of the diabetes and no-diabetes groups, respectively. History of hypertension (81% vs 41%) and history of hypercholesterolemia (51% vs 17%) were each higher in the diabetes group. Most patients received first-line FOLFOX or FOLFIRI. In the diabetes group, 57% and 22% patients received FOLFOX and FOLFIRI, respectively, compared with 64% and 14% of patients in the no-diabetes group. PFS and OS results are shown in the Table. More patients in the diabetes group experienced a protocol-specified AE or serious AE (see Table). The incidence of ATEs, venous thromboembolic events (VTEs), and post-operative wound bleeding or healing AEs following a post-baseline surgery were all higher in the diabetes group compared with the no-diabetes group. Analyses of dose intensity and concomitant medications are ongoing.


Evidence from the ARIES OCS suggests that patients receiving bevacizumab with a history of diabetes are more likely to have comorbities than patients without diabetes and should be monitored carefully for AEs. However, the similar OS outcomes observed between the diabetes and no-diabetes groups in this less selected patient population suggest that patients should not be excluded from receiving first-line chemotherapy with bevacizumab on the basis of diabetes history alone.