Gliadel wafer implantation combined with standard radiotherapy and concurrent followed by adjuvant temozolomide for treatment of newly diagnosed high-grade glioma: a systematic literature review

Table 4 Grade 3 and 4 adverse events reported in nine trials of Gliadel wafers combined with standard radiotherapy and concurrent followed by adjuvant temozolomide for treatment of newly diagnosed high-grade glioma

Clinical trial	Number	CE	HA	IH	II	ND	S	LE	F	GI	MY	SK	TE	Total, n
Aoki et al. [27]^a	24	2				5	1	2	1		4			15
Bock et al. [28]	44	7	11		6	8	7				1		6	46
Burri et al. [29]	46	1	2	7	3		3	3			18		2	39
Duntze et al. [30]^b	92		3	2	5	12					7			29
Miglierini et al. [33]	24				3						3			6
Noel et al. [34]	28										4			4
Pan et al. [35]	21				1	1								2
Pavlov et al. [36]	61			2		3					1			6
Salvati et al. [37]	32		2											0
Total, n	372	10	16	11	18	29	11	5	1	1	38	1	8	147
Total, %		2.7 %	4.3 %	3.0 %	4.8 %	7.8 %	3.0 %	1.3 %	0.3 %	0.3 %	10.2 %	0.2 %	2.15 %	39.5 %

CE cerebral edema, HA healing abnormalities (including CSF leak and hydrocephalus), IH intracranial hypertension, II intracranial infections (including abscess, cerebritis, hydrocephitis, and meningitis), ND neurological deficit (including aphasia, change of mental status, epilepsy, and hemiparesis), S seizures, LE elevated liver enzymes, F fatigue (including fever), GI gastrointestinal disorders (including nausea, vomiting, and constipation), MY myelosuppression (including anemia, lymphopenia, leukocytopenia, neutropenia, and thrombocytopenia), SK skin and subcutaneous disorders, TE thromboembolic events (including deep vein thrombosis and pulmonary embolism)
^aIncludes 16 patients treated for newly diagnosed high-grade glioma and 8 patients treated for recurrent high-grade glioma
^bIncludes all 92 patients treated with Gliadel wafers, of whom 65 received Gliadel plus RT/TMZ

ISSN: 1477-7819