E3200: efficacy(The capacity for beneficial change (or therapeutic effect) of a given intervention) of Avastin plus FOLFOX-4 in second-line mCRC

E3200 was a phase III trial of Avastin in combination with FOLFOX-4 in previously treated (irinotecan-based regimen) patients with mCRC.¹

Patients were randomised(How subjects are assigned to a treatment arm in a study. The treatment a subject receives is determined by chance alone) to one of three treatment arms until PD

• Avastin 10mg/kg alone every 2 weeks.
• FOLFOX-4.
• FOLFOX-4 plus Avastin 10mg/kg every 2 weeks.

The Avastin-alone arm was closed to further enrolment based on a review of early results by the ECOG data monitoring committee. Randomisation to the remaining two treatment arms continued.

The addition of Avastin to FOLFOX4 resulted in a statistically significant(Pertaining to an event that is unlikely to have occurred by chance) increase in OS(The time from trial entry to death from any cause) and in PFS(The time from trial entry to disease progression or death from any cause).

Primary endpoint

• OS.

Secondary endpoints

• PFS.
• Response rate.
• Safety.

E3200: effect of Avastin on OS

Median OS was significantly increased in the Avastin plus FOLFOX4 combination therapy arm compared with FOLFOX4 alone (12.9 vs 10.8 months; HR(An estimate of relative risk of an event occurring)=0.75; p=0.0011).¹

E3200: effect of Avastin on PFS

Median PFS was significantly increased when Avastin was combined with FOLFOX4 (7.3 vs 4.7 months; HR=0.61; p<0.0001).¹

E3200: effect of Avastin on ORR(The proportion of patients with defined tumour shrinkage; generally the sum of partial responses plus complete responses)

ORR, measured using the RECIST criteria(A set of published rules that define when cancer patients improve (‘respond’), stay the same (‘stabilise’), or worsen (‘progression’) during treatments), was 22.7% in the Avastin plus FOLFOX4 arm, 8.6% in the FOLFOX4-alone arm and 3.3% in the Avastin monotherapy(Treatment of a condition by means of a single drug) arm.¹