Table 2.
Irinotecan monotherapy studies for malignant glioma
| Study | n | Patient Characteristics | Irinotecan Treatment | Response Rate | Results |
|---|---|---|---|---|---|
| Friedman et al., 199921 | 60 | ≥ 3 wks after resection; ≥ 6 wks after RT or CT; ≤1 prior chemotherapy regimen; ≥ 29 on EIAEDs | 125 mg/m2 weekly for 4/6 wks | 15% (95% CI, 6%–24%) | Median TTP, 12 wks (range, 6–68 wks) |
| Buckner et al., 200346 | 64 | ≥ 8 wks after RT; 44 on EIAEDs |
Trial A (n = 32): 125 mg/m2 or 100 mg/m2 with prior nitrosourea for 4/6 wks
Trial B (n = 32): 300 mg/m2 or 250 mg/m2 with prior nitrosourea q3wks |
Trial A (30 evaluable): 7%
Trial B: 13%; 10% overall |
|
| Raymond et al., 200347 | 52 | Chemotherapy-naive; Group A (n = 25): inoperable or incompletely resected RT-naive GBM
Group B (n = 27): relapsed after RT; most (n = 40) on anticonvulsant therapy |
Group A: 3 cycles of 350 mg/m2 q21d;
Group B: ≤6 cycles |
2.2% ORR (95% CI, 0.2%–6.5%); 46 evaluable |
Group A (n = 22): median TTP, 9 wks (range, 3.6–53.1; 95% CI, 8.1–22.4)
Group B (n= 24): median TTP 14.4 wks (range, 5.5–36.8; 95% CI 9.0–21.1) |
| Chamber- lain, 200248 | 40 | Previously treated with surgery, RT, and ≥ 1 CT w/alkylating agent but no iri; 25/40 on EIAEDs | 400 mg/m2 with 500 mg/m2 3 wks later | None | Median OS, 4 mos (range, 3–8 mos) |
| Turner et al., 200249 | 22 | Pediatric, variety of recurrent tumors (n = 18), or newly diagnosed GBM (n = 4) | 125 mg/m2 weekly for 4/6 wks | 4/9 w/GBM or AA (44% [95% CI, 11%–82%]) | 2 recurrent GBM: CR, 9 and >48 mos; 1 newly diagnosed GBM: PR, 18 mos; 1 recurrent AA: PR, 11 mos |
| Cloughesy et al., 200250 | 14 | ≥ 4 wks prior RT or CT; ≥ 10 d prior surgical resection; no iri or topo; 13 on EIAEDs | 300 mg/m2 q3wks for 2 cycles, then increased to 350 mg/m2 if tolerated | 14% (95% CI, 2%–43%) | Median TTP, 6 wks; median survival, 24 wks |
| Cloughesy et al., 200351 | 35 | ≥ 4 wks prior RT or CT; ≥ 10 d prior surgical resection; no previous iri or topo; 29 on EIAEDs | 350–400 mg/m2 q3wks, increasing q cycle by 100 mg/m2 w/EIAEDs or 50 mg/m2 wo/EIAEDs | 9% | Median TTP, 2.1 mos; median OS, 8.5 mos |
| Batchelor et al., 200452 | 18 | Prior RT; 16 prior CT; 12 on EIAEDs | 411 mg/m2 weekly for 4/6 wks w EIAEDs, or 117 mg/m2 w/o EIAEDs | 6% CR | Median PFS, 7.3 mos; median OS, 10.4 mos |
| Gilbert et al., 200353 | 40 | ≥ 3 m prior RT; ≥ 3 wks prior CT, except ≥ 6 wks prior CENU; 31 on EIAEDs | 125 mg/m2 q4wks w/escalation based on modified continual reassessment | 4 on EIAEDs showed OR | Median OS, 7.4 mos |
| Prados et al., 200454 | 48 | ≤2 prior CT regimens; all on EIAEDs | 350 mg/m2 q3wks escalated by 50 mg/m2 to 800 mg/m2 | None (42 pts evaluable) | Median PFS, 6 wks |
| Prados et al., 200655 | 51 | ≤1 prior CT regimen; 29 on EIAEDs | 350 mg/m2 q3wks wo/EIAEDs; 750 mg/m2 w/EIAEDs | 5.8% PR; 17 SD | 6-mo PFS, 17.6% |
AA = anaplastic astrocytoma; CENU = chloroethylnitrosourea regimen; CR = complete response; CT = chemotherapy; EIAED = enzyme-inducing antiepileptic drug; GBM = glioblastoma; iri = irinotecan; ORR = overall response rate; OS = overall survival; PR = partial response; PFS = progression-free survival; SD = stable disease; RT = radiotherapy; topo = topotecan; TTP = time to progression.