Prospective study evaluating the radiosensitizing effect of reduced doses of temozolomide in the treatment of Egyptian patients with glioblastoma multiforme

Figures & data

Table 1 Patient characteristics

Variables	Arm I		Arm II		P-value
	n	%	n	%
Age
Mean (SD)	47.4 (±9.7)		48.3 (±8.4)		0.096
<50 years	20	66.7	14	46.7
>50 years	10	33.3	16	53.3
Sex
Male	24	80	10	33.3	0.005
Female	6	20	20	66.7
KPS
70%	10	33.3	14	46.7	0.16
80%	12	40	10	33.3	0.39
90%	8	26.7	6	20	0.76
Clinical presentation
Headache	30	100	30	100	1
Vomiting	16	53.3	16	53.3	1
Blurring of vision	12	40	16	53.3	0.12
Seizure	0	0	2	6.7	0.52
Motor disturbance	12	40	22	73.3	0.007
Sensory disturbance	6	20	4	13.3	0.39
Surgical procedure
Biopsy	12	40	10	33.3	0.39
Subtotal resection	18	60	20	66.6

Abbreviations: SD, standard deviation; KPS, Karnofsky Performance Status.

Table 2 Tumor characteristics

Variables	Arm I		Arm II		P-value
	n	%	n	%
Tumor site
Frontal	6	20	6	20	1
Parietal	8	26	12	40	0.41
Temporoparietal	6	20	6	20	1
Parieto-occipital	6	20	6	20	1
Occipital	4	13.3	0	0	0.112
Tumor side
Right	16	53.3	14	46.7	0.79
Left	14	46.7	16	53.3
Pretreatment volume (cc)
Mean (SD)	42 (±30.7)		46.4 (±53.8)		0.78
Postsurgical volume (cc)
Mean (SD)	29.2 (±32.5)		33.6 (±55.2)		0.79

Abbreviation: SD, Standard deviation.

Table 3 Details of grade 1–2 toxicity

	Total (60) n (%)	Arm I (30) n (%)	Arm II (30) n (%)	P-value
Malaise	28 (46.7)	14 (46.7)	14 (46.7)	1
Alopecia (grade 2)	12 (20%)	8 (26.7%)	4 (13.3)	0.33
Nausea	6 (10%)	2 (6.7%)	4 (13.3)	0.67
Convulsions	4 (6.7)	4 (13.3)	0	0.113
Decreased consciousness level	2 (3.3)	2 (6.7)	0	1
Headache	2 (3.3)	2 (6.7)	0	1
Tingling	2 (3.3)	2 (6.7)	0	1

Table 4 Initial posttreatment response

Response	Total (60) n (%)	Arm I (30) n (%)	Arm II (30) n (%)	P-value
Complete remission	6 (10)	4 (13.3)	2 (6.7)	0.67
Partial remission	16 (26.7)	8 (26.7)	8 (26.7)	1
Stationary disease	36 (60)	16 (53.3)	20 (66)	0.42
Disease progression	2 (3.3)	2 (6.7)	0	0.49

Figure 1 Kaplan–Meier curve for progression-free survival of the whole group of patients.

Figure 2 Kaplan–Meier curves for progression free survival according to the treatment group.

Table 5 Progression-free survival (PFS) according to different variables in univariate and multivariate analyses

Variable	Group	n	Median PFS in months (95% CI)	P-value
				Univariate	Multivariate
Age (years)	<50	34	9.8 (7.3–12.2)	0.42	NA
	≥50	26	11.8 (9.6–14)
Sex	Female	26	9.7 (5.5–13.9)	0.026	0.006
	Male	34	12 (6.7–17.3)
Presurgery volume (cc)	<30	24	11.8 (8.8–14.9)	0.067	0.1
	30 to <50	22	9.8 (6.8–12.7)
	≥50	14	7.6 (1.7–13.5)
Surgery extent	Near total	14	9.7 (4.3–15.2)	0.249	NA
	Subtotal	24	10.6 (6.4–14.9)
	Biopsy	22	11.8 (9.1–14.6)
Postsurgery residual volume (cc)	≤10	18	13.5 (10.9–16.1)	0.043	0.016
	>10	42	8.8 (7–10.7)
KPS	≤80	46	9.7 (6.6–12.9)	0.09	0.02
	>80	14	13.5 (9.2–17.8)
Posttreatment (radio/chemotherapy) volume	≤10	26	13.4 (8.8–18.1)	0.056	0.054
	>10	34	8.7 (6.6–10.9)
Treatment arm	I	30	8.8 (5.9–11.7)	0.571	NA
	II	30	11.5 (8.9–14.2)
Response to treatment	Yes	20	10.6 (8.5–12.8)	0.98	NA
	No	40	9.8 (5.8–13.7)

Abbreviations: CI, confidence interval; NA, not applicable (multivariate [Cox regression] analysis included variables with a P-value ≤0.2 in univariate analysis); KPS, Karnofsky Performance Status.

Figure 3 Kaplan–Meier overall survival curve for the whole group of patients.

Table 6 Overall survival (OS) according to different variables in univariate and multivariate analysis

Variable	Group	n	Median OS in months (95% CI)	P-value
				Univariate	Multivariate
Age (years)	<50	34	14.1 (11.8–16.5)	0.56	NA
	≥50	26	15.2 (13.3–17.2)
Sex	Female	26	13.4 (7.3–19.5)	0.038	0.018
	Male	34	15.3 (13.2–17.4)
Presurgery volume (cc)	<30	24	15.3 (13.6–17)	0.035	0.032
	30 to <50	22	13 (10.2–15.8)
	≥50	14	12.2 (4.3–20.1)
Surgery extent	Near total	14	15.2 (12.8–17.7)	0.18	0.057
	Subtotal	24	13.4 (10.1–16.7)
	Biopsy	22	14.1 (12.3–16)
Postsurgery residual volume (cc)	≤10	18	15.3 (14.1–16.5)	0.029	0.008
	>10	42	13 (10.3–15.6)
KPS	≤80	46	13.4 (10.9–15.9)	0.073	0.01
	>80	14	17.2 (12.3–22.2)
Posttreatment (radio/chemotherapy) volume	≤10	26	15.3 (13.8–16.8)	0.03	0.031
	>10	34	13 (9.5–16.5)
Treatment arm	I	30	12.3 (7.7–16.9)	0.83	NA
	II	30	14.3 (14–14.7)
Response to treatment	No	40	14.3 (12.3–16.4)	0.89	NA
	Yes	20	14.3 (11.7–16.8)

Abbreviations: CI, confidence interval; NA, not applicable (multivariate [Cox regression] analysis included variables with a P-value ≤0.2 in univariate analysis); KPS, Karnofsky Performance Status.