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Table 2 Characteristics of randomized studies evaluating bevacizumab plus chemotherapy in patients with mCRC in first line chemotherapy

From: Efficacy and safety of bevacizumab plus chemotherapy compared to chemotherapy alone in previously untreated advanced or metastatic colorectal cancer: a systematic review and meta-analysis

Study

n

Type of study

Patients

Comparison

Primary endpoint

Regimens containing irinotecan with/without bevacizumab

 Hurwitz 2004/2005 [14, 42] (AVF 2107)

813

Randomized, multicenter, phase III

mCRC, ECOG PS 0–1, ≥ 18 years

IFL/Bev (5 mg/kg)

OS

IFL/placebo

 Guan 2011 [24] (ARTIST)

203

Randomized, multicenter, phase III

mCRC, ECOG PS 0–1, ≥ 18 years

IFL/Bev (5 mg/kg)

PFS and PFS rate in 6 months

IFL

 Stathopoulos 2010 [44]

222

Randomized, phase III

mCRC, ECOG PS 0–2, ≥ 18 years

IFL/Bev (7.5 mg/kg)

OS

IFL

Regimens containing oxaliplatin with/without bevacizumab

 Saltz/Cassidy 2008/2011 [45, 46] (NO16966)

1400

Randomized, multicenter, phase III

mCRC, ECOG PS 0–1, ≥ 18 years

XELOX or FOLFOX/Bev (5 mg/kg or 7.5 mg/kg)

PFS

XELOX or FOLFOX/placebo

Regimens containing oxaliplatin or irinotecan with/without bevacizumab

 Passardi 2013/2015 [21, 23] (ITACA)b

370

Randomized, multicenter, phase III

mCRC, ECOG PS 0–2, ≥ 18 years

FOLFOX or FOLFIRI/Bev (5 mg/kg)

PFS

FOLFOX or FOLFIRI

Regimens containing only 5-FU with/without bevacizumab

 Kabinnavar 2003 [47]

104

Randomized, multicenter, phase III

mCRC, ECOG PS 0–1, ≥ 18 years

5-FU/LV

TTP and ORR

5-FU/LV/Bev (5 mg/kg)

5-FU/LV/Bev (10 mg/kg)

 Kabinnavar 2005 [48]

209

Randomized, multicenter, phase III

mCRC, ECOG PS 1–2, ≥ 65 years

5-FU/LV/Bev (5 mg/kg)

OS

5-FU/LV/placebo

Regimens containing only capecitabine with/without bevacizumab

 Tebutt 2010 [40] (MAX)

313a

Randomized, multicenter, phase III

mCRC, ECOG PS 0–2, ≥ 18 years

Capecitabine/Bev (7.5 mg/kg)

PFS

Capecitabine

 Cunningham 2013 [22] (AVEX)

280

Randomized, multicenter, phase III

mCRC, ECOG PS 0–2, ≥ 70 years

Capecitabine/Bev (7.5 mg/kg)

PFS

Capecitabine

Chemotherapy protocols:

 Hurwitz 2004/2005 [14, 42] - (AVF 2107)

 IFL/Placebo: 5-FU: 500 mg/m2, bolus + LV: 20 mg/m2, during 2 h + irinotecan: 125 mg/m2, once/week for 4 weeks every 6 weeks.

 IFL/Bev: same chemotherapy regimen + bevacizumab: 5 mg/kg intravenously every 15 days until progression.

Guan 2011 [24] - (ARTIST)

 IFL/Placebo: 5-FU: 500 mg/m2 + LV: 20 mg/m2 (infusion: 6–8 h) + irinotecan: 125 mg/m2, once/week for 4 weeks every 6 weeks.

 IFL/Bev: same chemotherapy regimen + bevacizumab: 5 mg/kg intravenously every 15 days until progression.

Stathopoulos 2010 [44]

 IFL: 5-FU: 500 mg/m2 + LV: 200 mg/m2 + irinotecan: 135 mg/m2, in Day 1 (D1) every 3 weeks.

 IFL/Bev: same chemotherapy regimen + bevacizumab: 7.5 mg/kg intravenously every 3 weeks until progression.

Saltz/Cassidy 2008/2011 [45, 46] - (NO16966)

 FOLFOX/placebo: LV: 200 mg/m2/day intravenously in 2 h + 5-FU: 400 mg/m2/day in bolus, followed by 600 mg/m2/day in 22 h in Days 1 and 2 + oxaliplatin: 85 mg/m2, in 2 h, in D1;

 FOLFOX/Bev: same chemotherapy regimen + bevacizumab: 5 mg/kg, Day 1; every 15 days;

 XELOX/placebo: capecitabine: 1000 mg/m2 orally, twice/day, for 14 days + oxaliplatin: 130 mg/m2 intravenously in D1;

 XELOX/Bev: same chemotherapy regimen + bevacizumab: 7.5 mg/kg in D1; every 21 days, until progression.

Passardi 2013/2015 [21, 23] - (ITACA)

 FOLFOX: LV: 100 mg/m2/day intravenously D1 and D2 + 5-FU: 400 mg/m2/day in bolus D1 and D2, followed by 600 mg/m2 in 22 h in Days 1 and 2 + oxaliplatin: 85 mg/m2, in 2 h, in D1;

 FOLFIRI: LV: 100 mg/m2/day intravenously D1 and D2 + 5-FU: 400 mg/m2/day in bolus D1 and D2, followed by 600 mg/m2 in 22 h in Days 1 and 2 + irinotecan 180 mg/m2, in D1;

 FOLFOX or FOLFIRI/Bev: same chemotherapy regimen + bevacizumab: 5 mg/kg, Day 1; every 15 day;

Kabinnavar 2003 [47]

 5-FU/LV: 5-FU: 500 mg/m2/LV: 500 mg/m2, weekly for 6 weeks every 8 weeks.

 5-FU/LV/Bev (5 mg/kg): same chemotherapy regimen + bevacizumab: 5 mg/kg, Day 1, every 15 day;

 5-FU/LV/Bev (10 mg/kg): same chemotherapy regimen + bevacizumab: 10 mg/kg, Day 1, every 15 day;

Kabinnavar 2005 [48]

 5-FU/LV: 5-FU: 500 mg/m2/LV: 500 mg/m2, weekly for 6 weeks every 8 weeks + placebo every 15 day.

 5-FU/LV/Bev (5 mg/kg): same chemotherapy regimen + bevacizumab: 5 mg/kg, Day 1, every 15 day;

Tebutt 2010 [40] (MAX)a

 Capecitabine: 1000–1250 mg/m2 orally, twice/day, for 14 days;

 Capecitabine/Bev: same chemotherapy regimen + bevacizumab: 7.5 mg/kg D1; every 21 days, until progression.

Cunningham 2013 [22] - (AVEX)

 Capecitabine: 1000 mg/m2 orally, twice/day, for 14 days;

 Capecitabine/Bev: same chemotherapy regimen + bevacizumab: 7.5 mg/kg D1; every 21 days, until progression.

  1. Abbreviations: mCRC metastatic colorectal cancer, Bev bevacizumab, IFL fluorouracil/leucovorin + irinotecan, 5-FU fluorouracil, LV leucovorin, OS overall survival, PFS progression-free survival, FOLFOX bolus and infusional fluorouracil/leucovorin + oxaliplatin, XELOX oxaliplatin + capecitabine, ECOG Eastern Cooperative Oncology Group, PS performance status, TTP time to progression, ORR overall response rate
  2. aExcluded patients with mitomycin; bFOLFOX4 was used in 60 % of the patients and FOLFIRI in 40 %
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