AVANT

[63]

Adjuvant bevacizumab in stage II/III resected CRC in combination with FOLFOX-6 [3451 evaluable, 2861 (83%) stage III]

Initial enrollment (3451):

•  FOLFOX-4 (1151/955 stage III) vs. FOLFOX-4/B (1155/960 stage III) vs. XELOX/B (1145/952 stage III)

Randomized multi-center open-label phase III trial of FOLFOX-4 vs. FOLFOX-4/B vs. XELOX/B in resected stage II/III CRC Primary: DFS (stage III patients)

FOLFOX-4, FOLFOX-4/B and XELOX/B as above

Not applicable

Analysis:

•  DFS: HR 1.17 (FOLFOX-4 vs. FOLFOX-4/B) (non- significant)

•  DFS: HR 1.07 (FOLFOX-4 vs. XELOX/B) (non- significant)

•  OS: HR 1.27 (FOLFOX-4 vs. FOLFOX-4/B) (significant)

•  OS: HR 1.15 (FOLFOX-4 vs. XELOX/B) (non- significant)

FIRE-3

[31]

Seeabove

AVAGAST

[64]

1st line metastaticgastriccarcinoma in combination with cisplatin/capecitabine (774 evaluable)

Initial enrollment (774):

•  CX (387) vs. CX/B (387)

Randomized international multi-center placebo- controlled phase III trial of cisplatin/ capecitabine (CX) +/− bevacizumab Primary: OS Secondary: PFS, RR

Cisplatin/ capecitabine (CX) as above Bevacizumab: IV bevacizumab 7.5 mg/m² q3 weekly

Analysis (CX vs. CX/B):

•  RR: 37.4% vs. 46.0% (significant)

Analysis (CX vs. CX/B):

•  Median PFS: 5.3 mths vs 6.7 mths (significant)

•  Median OS: 10.1 mths vs. 12.1 mths (non- significant)

AVATAR

[65]

1st line metastaticgastriccarcinoma in combination with cisplatin/capecitabine in Asian patients (202 evaluable)

Initial enrollment (202):

•  CX (102) vs. CX/B (100)

Randomized multi-center placebo- controlled phase III trial of cisplatin/ capecitabine (CX) +/− bevacizumab Primary: OS Secondary: PFS, RR

Cisplatin/ capecitabine as above Bevacizumab as above

Analysis (CX vs. CX/B):

•  RR (PR/CR): 33.7% vs. 40.7%

•  DCR (PR/CR/SD): 72.1% vs. 75.3%

Analysis (CX vs. CX/B):

•  Median PFS: 6.0 mths vs 6.3 mths

•  Median OS: 11.4 mths vs. 10.5 mths

CALGB 80303 [66]

1st line metastaticpancreaticcarcinoma in combination with gemcitabine (535 evaluable)

Initial enrollment (535):

•  G (256) vs. G/B (279)

Randomized multi-center placebo- controlled phase III trial of gemcitabine (G) +/− bevacizumab Primary: OS Secondary: PFS, RR

Gemcitabine (G vs. CX/B):

IV gemcitabine 1000 mg/m² D1, 8 and 15 q4weekly Bevacizumab: IV bevacizumab 10 mg/m² D1 and 15 q4weekly

Analysis (G vs. G/B):

•  RR (PR/CR): 10% vs. 13%

Analysis (G vs. G/B):

•  Median PFS: 3.8 mths vs 2.9 mths

•  Median OS: 5.9 mths vs. 5.8 mths