Table 4.
Comparison of dose-dense temozolomide trials: patients’ characteristic
| Study (enrolment) |
NOP | Country | Study design | Inclusion | Med age | KPS | Pretreatment | MTAD | Other | Current treatment | |||
| SRG | RT | TMZ | Regimen | NOC | |||||||||
| Brandes et al153 | 33 | Italy | Phase II Prospective cohort uncontrolled |
Recurrent/progressive GBM in chemo-naïve patients with KPS ≥60 in SCC; 45% of met-MGMT | 57 | 90% (60–100) | 100% | 100% | 0% | N/A | R1: 100%: met 45.5%; re-op. 3% | 75 mg/m2/day qd X21/28 d | 153 ccls: mean 4.6, med 3 (1–15)* |
| Strik155
(2005–2007) |
18 | Germany | Recurrent/progressive GBM, KPS ≥50 in SCC: 1st relapse: 78%, 2nd relapse: 22% | 54.8 | 60% (50–100) | 100% | 100% | 100% (≥1 adj TMZ ccls) | 7.5 m† | R1/2: 77.8/22.2%; met. 46.2%; re-op. 33.3% | 100 mg/m2/day qd X21/28 d | 154 ccls, mean 7.3, med 5 (2–18)* | |
| Abacioglu156
(2006–2008) |
16 | Turkey | Recurrent/progressive GBM, KPS ≥70 in SCC | 50 | 80% (50–100) | 100% | 100% | 100% (med 6 ccls) | 13 (6–105)* | med 2 (1–8)* | |||
| Berrocal157 | 47 | Spain | Recurrent/progressive HGG with KPS ≥60 in SCC; WHO IV GBM 57%, WHO III 43% | 50 | (70%–80%) ECOG 1 | 81% | 100% | 100% (med 6 ccls) | 14 m (6–126)* | 85 mg/m2/day qd X21/28 d | med 2 (1–13)* | ||
| Norden154 | 55 | USA | Recurrent/progressive GBM with KPS ≥60 in SCC, standard (Stupp) pretreatment with ≥2 adjuvant cycles) | 57 | 90% (60–100) | 100% | 100% | 100% (≥2 adj TMZ ccls) (med six ccls (12–16)) | N/A | R1: 100%; R/P: 48%/52%, met. 65% | 100 mg/m2/day qd X21/28 d×12 ccls or until PD | N/A | |
| Sahinbas23
(2000–2005) |
54 | Germany | Retrospective cohort uncontrolled | Recurrent/progressive GBM, KPS ≥40 | 49.8 | 60% (40–100)‡ | 93% | 93% | 87% | 9.5 m (5.9–10.7)§ | 100 mg/m2/day qd X21/28 d+mEHT | 84 ccls, mean 1.6±0.1, med 1 (1–5)* | |
*Range.
†Corrected data (the originally reported survival in months is derived from weeks by division to 4 (eg, 32.8 weeks=8.2 months), which overprices survival for 9%).
‡Estimated.
§95% CI.
ccls, cycles; GBM, glioblastoma multiforme; ECOG, Eastern Cooperative Oncology Group; HGG, high-grade glioma; KPS, Karnofsky performance score; met, methylated MGMT promoter gene; MGMT, O6-methylguanine DNA methyltransferase; MTAD, median time after diagnosis; NOC, number of cycles;
SCC, stable clinical condition; qd, daily; N/A, not available; PD, progressive disease; R/P, relapse/progression; R1, first relapse/progression; R1/2, first/second relapse; re-op, re-operation; TMZ, temozolomide.