CRC: E3200 trial

Abbreviations

No EU-CTR

  • E3200 references
    2007-04-20
    Bruce J. Giantonio

    JCO

    Bevacizumab in Combination With Oxaliplatin, Fluorouracil, and Leucovorin (FOLFOX4) for Previously Treated Metastatic Colorectal Cancer
Investigated (inv)
Comparator (comp)

BEVA+FOLFOX4

FOLFOX4

286

291

Phase:

3

Randomisation:

Open label

Primary tumour:

CRC

Subtype (biomarker):

Any

Stage:

meta

Line of therapy:

L2

Primary
BEVA+FOLFOX4
FOLFOX4
HR
p
OS
12.9 mo
10.8 mo
0.75
0.0011
Secondaries
BEVA+FOLFOX4
FOLFOX4
HR
p
PFS
7.3 mo
4.7 mo
0.61
<0.0001
ORR
22.7%
8.6%
<0.0001
CR
1.7%
0.7%
PR
21.0%
7.9%
(all grades, %)
BEVA+FOLFOX4
FOLFOX4
p
Adverse event leading to treatment discontinuation
23.4
23.9
NA
Death from any cause within 60 days from start of therapy
5
4
NA
Any adverse event (gr.3)
49.5
36.1
NA
Neuropathy (gr.3)
16
8.8
0.011
Vomiting (gr.3)
8.7
2.8
0.001
Hypertension (gr.3)
5.2
1.4
0.008
Bleeding (gr.3)
3.1
0.4
0.011
Thromboembolism (gr.3)
3.1
1.1
0.62
Proteinuria (gr.3)
0.7
0.0
0.5
Cardiac ischemia (gr.3)
0.3
0.4
NA
  • Inclusion
  • Exclusion

- histologically confirmed colorectal cancer that was advanced or metastatic and measurable as defined by the Responsedc-returnEvaluation Criteria in Solid Tumors (RECIS T)dc-return- prior chemotherapy with irinotecan and a fluoropyrimidine for advanced disease was requireddc-return- a history of hypertension was allowed provided that blood pressure readings were maintained below 150/100 mmHg on a stable antihypertensive regimendc-return- baseline urinalysis demonstrating protein were required to have less than 500 mg of protein excreted over a 24-hour period

- previous use of oxaliplatin or bevacizumab was not permitteddc-return- a history of major surgery within 28 daysdc-return- radiotherapy within 14 daysdc-return- hypersensitivity to recombinant murine monoclonal antibodiesdc-return- a thrombotic or hemorrhagic event within 6 months of study entrydc-return- those patients requiring therapeutic anticoagulationdc-return- low-dose warfarin used for the maintenance of venous access devices was permitted, as was daily aspirin use of 325 mg or less

Characteristics
BEVA+FOLFOX4
FOLFOX4
Age & sex
Median agedc-comma yr (range)
62 (21-85)
60.8 (25-84)
Femaledc-comma %
39.5
39.2
ECOG Performance statusdc-comma %
0
48.9
51.2
1
46.9
43.0
2
4.2
5.8
Prior radiation therapy
Prior radiation therapydc-comma %
25.9
24.7
Disease sitedc-comma %
Liver
73.4
75.9
Lung
55.5
51.2
Ad-hoc:
no.pts inv.
no.pts comp.
BEVA+FOLFOX4
FOLFOX4
HR
p
  • OS
analisys of OS
BEVA+FOLFOX4
FOLFOX4
HR (95% CI)
analisys of
BEVA+FOLFOX4
FOLFOX4
HR (95% CI)