Table 1 Incidence of hypertension in pivotal phase 3 bevacizumab clinical trials in gynaecological cancers

From: Expert recommendations on the management of hypertension in patients with ovarian and cervical cancer receiving bevacizumab in the UK

 

GOG-21833

ICON736

ROSiA35

OCEANS32,40

GOG-21334

AURELIA37

GOG-24038,39

Indication

1L OC

1L OC

1L OC

Recurrent OC

Recurrent OC

Recurrent platinum-resistant OC

Recurrent, persistent or metastatic CC

Study design

Double-blind, Ph 3 RCT

Open-label, Ph 3 RCT

Single-arm, open-label, Ph 3b trial

Double-blind, Ph 3 RCT

Open-label, Ph 3 RCT

Open-label, Ph 3 RCT

Open-label, Ph 3 RCT

Assigned to bevacizumab, n

Initiation: 625 Throughout: 623

764

1 021

242

337

179

227

Bevacizumab given with

Paclitaxel/carboplatin

Paclitaxel/carboplatin

Paclitaxel/carboplatin

Gemcitabine/cisplatin

Paclitaxel/carboplatin

Single-agent chemotherapy

Cisplatin/paclitaxel or topotecan/paclitaxel

Median no. bevacizumab cycles (range)a

Initiation: 12 (0–22) Throughout: 14 (0–21)

17 (IQR 12–18)b

23 (1–61)

12 (1–43)

16 (1–111)

6 (1–24)

7 (0–36)

Baseline hypertension, n (%)

NR

NR

336 (32.9)

96 (39.7)

NR

NR

NR

Incidence of hypertension, n (%)

 All grades

NR

193 (25.9)

558 (54.7)

104 (42.1)

135 (40.9)

NR

NR

 Grade ≥2

100 (16.5)/139 (22.9)

NR

NR

NR

NR

36 (20.1)

55 (25.0)

 Grade ≥3

NR

46 (6.2)

252 (24.7)c

42 (17.0)

39 (11.8)

13 (7.3)

NR

 Leading to discontinuation

NR

NR

30 (2.9)

10 (3.6)

NR

NR

NR

  1. 1L first-line, CC cervical cancer, IQR interquartile range, NR not reported, OC ovarian cancer, RCT randomised controlled trial
  2. aUnless otherwise indicated. bFor women in the bevacizumab group who started chemotherapy >4 weeks after surgery. cIncludes six (0.6%) patients who experienced grade 4 hypertension
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