Neoadjuvant bevacizumab and irinotecan versus bevacizumab and temozolomide followed by concomitant chemoradiotherapy in newly diagnosed glioblastoma multiforme: A randomized phase II study

Figures & data

Figure 1. The study was composed of a neoadjuvant phase, a concomitant phase and an adjuvant phase (each of eight weeks) as shown. Patients in both treatment arms began radiotherapy at the start of the concomitant phase.

Table I. Patient characteristics.

	Bev-Tem (n = 32)	Bev-Iri (n = 31)
Median age (range)	62 (30–73)	59 (36–77)
ECOG performance status
0	13	20
1	17	10
2	2	1
Male/Female	21/11	18/13
Surgical resection/biopsy only	30/2	28/3
Median MMSE (range)	28 (9–30)	28 (4–30)
Median prednisolone dose in mg (25–75 percentile)	25 (10–50)	25 (12–50)

Data on baseline prednisolone dose were missing in 5 patients on the Bev-Iri arm and mini-mental state examination (MMSE) score data were missing in 8 patients on the Bev-Iri arm and 3 patients on the Bev-Tem arm.

Table II. Response after neoadjuvant chemotherapy.

Response	Bev-Tem	Bev-Iri
CR	0	0
PR	10	6
mPR	11	7
SD	6	7
PD	4	6
NE	1	5

At the time of blinded review, 3 patients in the Bev-Iri arm did not have contrast enhancing tumor at baseline and 2 had to poor quality of MR scan to allow meaningful evaluation of radiological response while 1 patient in the Bev-Tem arm did not have contrast enhancing tumor at baseline. These 6 patients were all clinical non-PD and continued as planned with the chemoradiotherapy phase.

Table III. Non-hematological toxicity from neoadjuvant treatment.

	Bev-Tem		Bev-Iri
	I/II	III/IV	I/II	III/IV
Nausea	12	0	13	0
Emesis	8	0	3	0
Diarrhea	6	0	8	0
Thrombosis	0	0	0	1
Alopecia	0	0	7	0
Hypertension	12	3	10	0
Fatigue	22	2	23	0

Table IV. Hematological toxicity from neoadjuvant treatment.

	Bev-Tem		Bev-Iri
	I/II	III/IV	I/II	III/IV
Granulocytopenia	0	3	0	1
Lymphocytopenia	1	2	2	2
Thrombocytopenia	4	3	0	0