Bevacizumab plus irinotecan in the treatment patients with progressive recurrent malignant brain tumours

Figures & data

Table I.  Baseline patient demographic and clinical characteristics (N = 52)

Median age, years (range)	46 (26–67)
Gender
Male	34
Female	18
WHO performance status
0	20
1	21
2	11
Histological diagnosis
Grade IV glioma (glioblastoma multiforme)	27
Grade III anaplastic astrocytoma	13
Grade III anaplastic oligodendroglioma	5
Grade III ependymoma	1
Grade III haemangiopericytoma	1
Malignant prolactinoma	1
Grade brain-stem glioma	3
Grade IV medulloblastoma	1
Concomitant medication
EIAED	18
Non-EAIAD	15
No AEDs	19
Median time from primary diagnosis to enrolment, months (range)
All patients	37 (5–183)
Grade IV glioma	16 (4–118)
Grade III glioma	47 (9–137)
No. of interventions before enrolment
2	2
3	17
4	17
5	10
6	5
7	1
No. of responders (CR + PR) to previous chemotherapy
All patients	8
Grade IV glioma	0
Grade III glioma	6
Others	2

Abbreviations: AED, antiepileptic drug; CR, complete response; EIAED, enzyme-inducing antiepileptic drug; non-EIAED, non-enzyme-inducing antiepileptic drug; PR, partial response.

Table II.  Reasons for patient discontinuation from the study and duration of study treatment

Reason for treatment discontinuation	Patients (no.)	Duration on study medication (months)
Disease progression
Glioblastoma multiforme	12	2–12
Anaplastic Astrocytoma	7	2–14
Anaplastic oligodendroglioma	3	2–10
Other	2	2–6
Adverse events
Grade 3 CNS haemorrhage	1	3
Grade 5 diarrhoea	1	1
Grade 3 intestinal perforation	1	4.5
Grade 3 cardiac arrhythmia	1	1
Toxicity and consent withdrawal	3	1–3

Table III.  Change in steroid dose, WHO performance status and clinical symptoms according to best radiological response in evaluable patients (N = 47).

	No. of patients (% improved or unchanged)
	CR + PR (n = 13)		SD (n = 29)		PD (n = 5)
Steroid dose
Decreased	6	} 100%	14	} 96%	1	} 60%
Unchanged	4		8		2
Increased	0		1		2
NR*	3		6		0
WHO performance status
Improved	2	} 80%	0	} 59%	0	} 33%
Unchanged	6		13		1
Worsened	2		9		2
NR*	3		7		2
Clinical symptoms†
Improved	8	} 91%	13	} 81%	0	} 0%
Unchanged	2		8		0
Worsened	1		5		5
NR*	2		3		0

*Data not recorded (not included in percent determination).

†Includes neurological symptoms, fatigue and/or mobility.

Abbreviations: CR, complete response; NR, not recorded; PD, progressive disease; PR, partial response; SD, stable disease.