International Scholarly Research Notices / 2012 / Article / Tab 3 / Clinical Study
Resection and Immunotherapy for Recurrent Grade III Glioma Table 3 Features of present and literature studies.
Immunotherapy Yung 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 publication Present study 1999 2003 2001 2008 2001 2003
2004 Study design Retrospective 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 Prospective Prospective multicentre phase II Single centre open label Study population AA + AOA + AOD AA+AOA AOD AOD + AOA HGG AOD + AOA AOD + AOA HGG
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patients39 (18 AA, 13 AOD, 8 AOA) 162 (AA = 111) 28 48 (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 events 2 or more 2 NS NS Max 3 NS NS Any Surgery at relapse All patients NA +§ NA NA +§ +§ NA 6 months PFS (%) AA = 37.5 AOD = 33.3 AA = 49 AOD = 29 51* AA = 50/AOD = 58 Responding = 44* 71°* 41* 12 months PFS (%) AA = 37.5 AOD = 25 AA = 24 AOD = 11 25* AA = 33/AOD = 42 Responding = 27* 40°* NA median PFS (m) AA = 4.45 AOD = 4 AA = 5.5 AOD = 8 NA AA = 6/AOD = 8 NA Total = 10.4* Responding = 13.2*
5.3* 6 months OS (%) AA = 94.2 AOD = 92.3 AA = 78 NA 77* AA = 86/AOD = 75 NA NA 75* 12 months OS (%) AA = 76.5 AOD = 77 AA = 56 NA 46* AA = 59/AOD = 71 NA NA NA median OS (m) AA = 20.5 AOD = 18.8 AA = 14.2 AOD = 12 10* AA = 14.6/AOD = 18 Responding = 7* Not yet reached* 12.3* Grade III-IV toxicity Hematological (%) No Lymphopenia: 6 Neutropenia: 2 Leukopenia: 2 Anemia: 1 Granulopenia and/or thrombocytopenia: 7.1 Thrombocytopenia: 6.4 18 Lymphopenia: 13.3 Granulopenia and/or thrombocytopenia: 25.6 25 Infection (%) No NA NA NA NA NA 2.6 NA Nausea/vomiting (%) no 12 10.7 NA NA 6.7 5.1 4 Hepatotoxicity (%) No NA NA NA NA 3.3 NA 1 Fatigue (%) No 6 NA 17 NA NA NA 4 Others No Edema (1%) Fever (2%) Convulsions (5%) Headache (5%) Dysphagia NA 2 deaths NA NA Allergy
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.