Table 4 Toxicity comparison of intermittent vs continuous dose schedule

From: Combination therapy: intermittent sorafenib with bevacizumab yields activity and decreased toxicity

 

DL 4, 5A, 5B ( N =17)

DL 1, 2 ( N =39)

 

Toxicity grade G2–4

No. of patients (%)

Diarrhoea

4/17 (24)

7/39 (20)

Fatigue

3/17 (18)

15/39 (38)

Fistula

1/17 (6)

2/39 (5)

Mucositisa

5/17 (29)

NA

Skin rashes

 HFSRb

8a/17 (47)

23/39 (59)

 Otherc

2

 

Hypertension

10/17 (59)

26/39 (67)

Perforation

1/17 (6)

1/39 (3)

Proteinuria

2/17 (12)

6/39 (15)

Thrombocytopaenia

0/17 (0)

2/39 (5)

Thrombosis

2/17 (12)

3/39 (8)

Transaminitis

4/17 (24)

13/39 (33)

  1. DLs=dose levels; HFSR=hand–foot skin reaction; NA=not applicable.
  2. aOne patient had mouth, tongue, throat, and anal mucositis.
  3. bAlthough the numbers are small, when the difference in HFSR is compared between those receiving intermittent and continuous sorafenib schedules using the χ2-test, P=0.08.
  4. cEar and perirectal desquamation and rashes (separate patient with HFSR).
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