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Table 3 Phase I/II trials of neoadjuvant concurrent chemoradiation approaches with the addition of bevacizumab

From: Recent advances in (chemo-)radiation therapy for rectal cancer: a comprehensive review

Author

Year

Phase

Disease stage

n

RT dose

Conc. CHT

Adj. CHT

pCR rate (%)

Downst

Tox gr.3+

Postop. c

Crane [59]

2010

II

T3 N0-1

25

50.4

Cap + Bev

rec

32

84%7

4%

12%9

Willett [60]

2010

I/II

T3/4

32

50.4

5-FU ci + Bev

rec

16

n.r

n.r

n.r

Kourkourakis [61]

2010

II

T3 or N+

19

34 4

Cap + Bev + Ami

Cap

37

n.r

n.r

5%

Liang [62]

2011

II

T3/4 or N+

28

45

FOLFOX + Bev

n.s

25

n.r

n.r

n.r

Velenik [63]

2011

II

T3/4 or N+

61

50.4

Cap + Bev

Cap

13

74%7

n.r

10%9

Di Petrillo [64]

2012

II

T3/4 or N+

26

50.4

5-FU ci + Ox + Bev5

rec

20

n.r

76%

n.r

Gasparini [65]

2012

II

T3/4 or T2N+

43

50.4

Cap + Bev

5-FU/LV ± Bev

14

n.r

n.r

8%

Resch [66]

2012

II

T3

8

45

Cap + Bev

dis

25

n.r

50%8

25%

Kennecke [67]

2012

II

T3/4 or N2

42

50.4

Cap + Ox + Bev

n.s

18

n.r

n.r

11%9

Spigel [68]1

2012

II

T3/4 or N+

35

50.4

5-FU + Bev

FOLFOX + Bev

29

n.r

n.r

n.r

Landry [69]

2013

II

T3/4

53

50.4

Cap + Ox + Bev

FOLFOX + Bev

17

59%7

72%

6%9,10

Dellas [70]

2013

II

T3/43

70

50.4

Cap + Ox + Bev

Cap

17

n.r

11%

16%

Wang [71]

2014

II

T3/4 or N+

12

45

FOLFOX + Bev

n.s

33

n.r

25%

0%

Borg [72]2

2014

II

T3

45

45

5-FU ci + Bev

n.s

11

n.r

20%

20%

Garcia [73]

2015

II

T3/4

43

45

Cap + Bev

Cap or CAPOX11

8

78%7

n.r

n.r

Sadahiro [74]

2015

II

T3/4 or N+

52

45

S-1 + Bev

S-1

19

71%7

2%

29%

Salazar [75]

2015

II, rand

T3/4 or N+

90

45

Cap + Bev

n.s

16

73%7

16%

16%

     

45

Cap

 

11

78%7

13%

7%

Maeda [76]

2018

II

T3/4 or N+

25

50.4

Cap + Bev

Cap

16

n.r

0%

n.r

Yu [77]

2018

II

T3/4 or N+

45

50

Cap + Ox + Bev6

XELOX → Cap

40

n.r

20%

13%9

  1. n: number of patients, RT dose: radiation dose in Gy, conc. CHT: concurent chemotherapy, adj. CHT: adjuvant chemotherpy, pCR rate: percentage ofpatients with pathologic complete remission, downst.: percentage of patients with major downstaging defined according to study protocol (only listed if combined T and N downstaging was reported), tox gr. 3+: acute grade 3+ toxicity during chemoradiation (only listed if an overall percentage was reported), postop. c.: postoperative complications grade 3+ (only listed if an overall percentage was reported), rand.: randomized, 5-FU: 5-fluorouracil, ci: contineous infusion, Ox: Oxaliplatin, Bev: Bevacizumab, Cap: Capecitabine, Ami: amifostine, FOLFOX: combination regimen including 5-fluorouracil, leucovorin and oxaliplatin, XELOX: combination regimen including capecitabine and oxaliplatin, S-1: oral fluoropyrimidin prodrug, LV: leucovorine, CAPOX: combination regimen including Capecitabine and Oxaliplatin, rec.: recommended, dis.: at the discretion of the treating physician, n.s.: not specified, n.r.: not reported, 1: only data from preoperative chemoradiation arm included, 2: only data from study arm without induction chemotherapy included, 3: included 17% patients with M1, 4: in 10 fractions, 5: 1 cycle of FOLFOX + Bev as induction chemotherapy, 6: 1 cycle of XELOX + Bev as induction chemotherapy, 7: downstaging defined as reduction in pathological stage compared to clinical stage, 8: study terminated due to predefined toxicity criteria, 9: complications requiring surgical intervention, 10: late surgical complications of any grade in 47%, 11: Cap for ypN0, CAPOX or FOLFOX for ypN+ patients, bold style indicates significant difference