Skip to main content

Table 4 Phase I/II trials of neoadjuvant concurrent chemoradiation approaches with the addition of EGFR-pathway targeting agents

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

Author

Year

Phase

KRAS

Disease stage

n

RT dose

Conc. CHT

Adj. CHT

pCR rate (%)

downst

tox gr.3+

postop. c

Machiels [78]

2007

I/II

n.s

T3/4 or N+

40

45

Cap + Cet

dis

5

38%7

n.r

13%

Roedel [79]

2008

I/II

n.s

T3/4 or N+ 

60

50.4

Cap + Ox + Cet

n.s

9

n.r

n.r

11%9

Valentini [80]

2008

I/II

n.s

T3 or T2N+

41

50.4

5-FU ci + Gef

5-FU/LV11

27

73%8

41%

0%

Bertolini [81]

2009

II

n.s

T3/4

40

50–50.4

5-FU ci + Cet3

n.s

8

45%8

n.r

n.r

Horisberger [82]

2009

II

n.s

T3/4 or N+

50

50.4

Cap + Iri + Cet

n.s

8

n.r

n.r

n.r

Velenik [83]

2010

II

n.s

T3/4 or N+

37

45

Cap + Cet4

Cap

8

73%7

n.r

5%9

Kim [84]

2011

II

n.s

T3/4 or N+

40

50.4

Cap + Iri + Cet

5-FU/LV

23

n.r

18%

5%

Pinto [85]

2011

II

n.s

T3N+ or T4

60

50.4

5-FU ci + Ox + Pan

FOLFOX + Pan

21

58%7

n.r

n.r

Sun [86]

2012

II

n.s

T3/4 or N+

63

45

Cap + Cet

dis

13

78%7

n.r

n.r

Kim [87]

2012

Pooled

wt

T3/4 or N+

62

50.4

Cap + Iri

5-FU/LV

21

44%8

n.r

n.r

       

Cap + Iri + Cet

5-FU/LV

28

56%8

n.r

n.r

Dewdney [88]

2012

II, rand

n.s

T3c/T41

165

50.4

Cap5

CAPOX

15

n.r

n.r

n.r

Expert-C

     

50.4

Cap + Cet6

CAPOX + Cet

18

n.r

n.r

n.r

Helbling [89]

2013

II, rand

wt

T3/4 or N+

40

45

Cap + Pan

rec

10

n.r

n.r

18%10

SAKK 41/07

    

28

45

Cap

 

18

n.r

n.r

15%10

Eisterer [90]

2014

II

n.s

T3/4

31

45

Cap + Cet

n.s

0

n.r

n.r

n.r

Mardjuadi [91]

2015

II

wt

T3/4 or N+

19

45

Pan

n.s

0

n.r

n.r

n.r

Jin [92]

2015

II

n.s

T3/4 or N+

23

50.4

Cap + Nim3

CAPOX

19

n.r

n.r

n.r

Bazarbashi [93]

2016

II

n.s

T3/4 or N+

15

50.4

Cap + Cet

5-FU/LV or Cap

13

n.r

n.r

n.r

Gollins [94]

2017

II

n.s

MRF+ or dis.2

82

45

Cap + Iri + Cet

dis

17

49%7

59%

n.r

Pinto [95]

2018

II

wt

T3 or T2N+ 

98

50.4

Pan

FOLFOX

11

46%7

n.r

n.r

  1. KRAS: KRAS status of included patients, n: number of patients, RT dose: radiation dose in Gray, conc. CHT: concurrent chemotherapy, adj. CHT: adjuvant chemotherapy, pCR rate: percentage of patients with complete pathologic remission, downst.: percentage of patients with major downstaging 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, n.s.: not specified, wt: wild type, MRF: mesorectal fascia, dis.: distal tumors, Cap: Capecitabine, Cet: Cetuximab, Ox: Oxaliplatin, 5-FU: 5-fluorouracil, ci: contineous infusion, Gef: gefitinib, Iri: Irinotecan, Pan: Panitumumab, Nim: Nimotizumab, CAPOX: combination regimen including capecitabine and oxaliplatin, dis: at the discretion of the treating physician, LV: leucovorine, FOLFOX: combination regimen including 5-FU, leucovorine and oxaliplatin, rec. recommended, bold style indicates significant difference, 1: or threatened mesorectal fascia (< 1 mm) or EVSI or tumor at levator level, 2: MRF+ defined as tumor < 1 mm of mesorectal fascia or involved fascia, 3: 3 times cetuximab mono as induction, 4: 2 weeks capecitabine mono as induction, 5: 4 cycles CAPOX as induction, 6: 4 cycles CAPOX + Cetuximab as induction, 7: downstaging defined as reduction of pathological stage versus clinical stage, 8: downstaging defined as yp stage 0–1, 9: re-operation rate, 10: rate of surgical interventions, 11: if ypN+
Back to article page

Radiation Oncology

ISSN: 1748-717X

Contact us