Clinical Study

Resection and Immunotherapy for Recurrent Grade III Glioma

Table 3

Features of present and literature studies.

ImmunotherapyYung et al. [14] van den Bent et al. [12]Chinot et al. [10]Balmaceda et al. [8]van den Bent et al. [11]van den Bent et al. [12]Chang et al. [9]
Year of publicationPresent study199920032001200820012003 2004

Study designRetrospective
single centre
Prospective
multicentre
phase II
open label
Prospective
multicentre
phase II
open label
Prospective
single centre
phase II
open label
Prospective
Multicentre
Phase II
Open arm
ProspectiveProspective
multicentre
phase II
Single centre
open label

Study populationAA + AOA + AODAA+AOAAODAOD + AOAHGGAOD + AOAAOD + AOAHGG

𝑛 patients39 (18 AA, 13 AOD,
8 AOA)
162 (AA = 111)2848 (AOD = 39)120 (AA = 28,
AOD = 24)
30 (AOD = 22)39 (AOD = 24)213 (AA = 53, AOA = 17)

TMZ protocol/150–200 mg/m²
5 d/28 d
until 2 y/progression
150 mg/m²
5 d/28 d
6 cycles
150–200 mg/m²
5 d/28 d
until 2 y/progression
1 × 200 mg/m²
9 × 90 mg/m²
repeat every 28 d
until 20 m/progression
150–200 mg/m²
5 d/28 d
12 cycles
200 mg/m²
5 d/28 d
12 cycles
150–200 mg/m²
5 d/28 d
until 1 y/progression

N events2 or more2NSNSMax 3NSNSAny

Surgery at relapseAll patientsNA+§NANA+§+§NA

6 months PFS (%)AA = 37.5
AOD = 33.3
AA = 49AOD = 2951*AA = 50/AOD = 58Responding = 44*71°*41*

12 months PFS (%)AA = 37.5
AOD = 25
AA = 24AOD = 1125*AA = 33/AOD = 42Responding = 27*40°* NA

median PFS (m)AA = 4.45
AOD = 4
AA = 5.5AOD = 8NAAA = 6/AOD = 8NATotal = 10.4* Responding = 13.2* 5.3*

6 months OS (%)AA = 94.2
AOD = 92.3
AA = 78NA77*AA = 86/AOD = 75NANA75*

12 months OS (%)AA = 76.5
AOD = 77
AA = 56NA46*AA = 59/AOD = 71NANA NA

median OS (m)AA = 20.5
AOD = 18.8
AA = 14.2AOD = 1210*AA = 14.6/AOD = 18Responding = 7*Not yet reached*12.3*

Grade III-IV toxicity

Hematological (%)NoLymphopenia: 6
Neutropenia: 2
Leukopenia: 2
Anemia: 1
Granulopenia and/or thrombocytopenia: 7.1Thrombocytopenia: 6.418Lymphopenia: 13.3Granulopenia and/or thrombocytopenia: 25.625

Infection (%)NoNANANANANA2.6NA

Nausea/vomiting (%)no1210.7NANA6.75.14

Hepatotoxicity (%)NoNANANANA3.3NA1

Fatigue (%)No6NA17NANANA4

OthersNoEdema (1%)
Fever (2%)
Convulsions (5%)
Headache (5%)
DysphagiaNA2 deathsNANAAllergy

AA: anaplastic astrocytoma; AOD: anaplastic oligodendroglioma; AOA: anaplastic oligoastrocytoma; NS: nonspecified; NA: not available; PFS: progression-free survival; OS: overall survival;
*: no subgroup details; °: not clarified whether results are from total or responding group; §: % patients that underwent surgery and % of total resection not available.