NSABP C-08: trial | Bending the Curve: Trial by Trial

NSABP C-08

Phase III trial assessing bevacizumab in stages II and III carcinoma of the colon: results of NSABP protocol C-08

Population

2,672 analysed patients with stage II or III colon cancer (ClinicalTrials.gov enrolment 2710).

Design

Randomised phase III trial in stage II or III colon cancer comparing mFOLFOX6 every 2 weeks for 26 weeks with the same regimen plus bevacizumab 5 mg/kg every 2 weeks for 52 weeks. Primary endpoint disease-free survival.

Primary endpoint

DFS

Arms

mFOLFOX6 (control): mFOLFOX6 every 2 weeks for 26 weeks
mFOLFOX6 plus bevacizumab (experimental): mFOLFOX6 plus bevacizumab 5 mg/kg every 2 weeks for 52 weeks

People

Allegra CJ

DFSHR 0.89 (95% CI 0.76–1.04)Δ 36-month DFS+1.9 pointsDFSHR 0.61 (95% CI 0.48–0.78)DFSHR 1.22 (95% CI 0.98–1.52)

Show the numbers

Results reported for NSABP C-08
Endpoint	Analysis	mFOLFOX6 plus bevacizumab	mFOLFOX6	Effect
DFSAnalysed patients with stage II or III disease (2,672); analysis population not labelled in the abstract	primarymedian follow-up 35.6 monthsAllegra 2011	77.4% at 3 y	75.5% at 3 y	HR 0.89 (95% CI 0.76–1.04)P=0.15Point estimates of 3-year DFS. By stage, 3-year DFS was 87.4 percent versus 84.7 percent in stage II and 74.2 percent versus 72.4 percent in stage III (experimental versus control).
DFSExploratory landmark analysis before 15 months	exploratoryAllegra 2011	—	—	HR 0.61 (95% CI 0.48–0.78)P<0.001Time-by-treatment interaction P < .0001. The authors interpret the transient effect as a biologic effect during bevacizumab exposure.
DFSExploratory landmark analysis after 15 months	exploratoryAllegra 2011	—	—	HR 1.22 (95% CI 0.98–1.52)P=0.076

Results reported for NSABP C-08
Endpoint	Analysis	mFOLFOX6 plus bevacizumab	mFOLFOX6	Effect
DFSAnalysed patients with stage II or III disease (2,672); analysis population not labelled in the abstract	primarymedian follow-up 35.6 monthsAllegra 2011	77.4% at 3 y	75.5% at 3 y	HR 0.89 (95% CI 0.76–1.04)P=0.15Point estimates of 3-year DFS. By stage, 3-year DFS was 87.4 percent versus 84.7 percent in stage II and 74.2 percent versus 72.4 percent in stage III (experimental versus control).
DFSExploratory landmark analysis before 15 months	exploratoryAllegra 2011	—	—	HR 0.61 (95% CI 0.48–0.78)P<0.001Time-by-treatment interaction P < .0001. The authors interpret the transient effect as a biologic effect during bevacizumab exposure.
DFSExploratory landmark analysis after 15 months	exploratoryAllegra 2011	—	—	HR 1.22 (95% CI 0.98–1.52)P=0.076

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
DFS	0.89	0.76–1.04
DFS	0.61	0.48–0.78
DFS	1.22	0.98–1.52

Appears in

2010 Adjuvant bevacizumab and cetuximab trials in colon cancer

Sources

Allegra CJ, Yothers G, O'Connell MJ, Sharif S, Petrelli NJ, Colangelo LH, et al. Phase III trial assessing bevacizumab in stages II and III carcinoma of the colon: results of NSABP protocol C-08. J Clin Oncol. 2011;29(1):11-6.
PubMed DOI