Table 1.
Trials employing TMZ for the treatment of GBM and other tumors.
| Phase | Tumor Type | Number Patients Enrolled | Treatment Including TMZ |
OS
(Months) |
PFS (Months) | Response n (%) | Refs. (NCT) |
|---|---|---|---|---|---|---|---|
| I-II | GBM | 59 | RT+TMZ+TSC | NR | 3.3 | NR | [115] (NCT01465347) |
| III | GBM | 695 | TMZ+TTFields | 20.5 | 7.1 | NR | [116] (NCT00916409) |
| TMZ | 15.6 | 4 | NR | ||||
| III | GBM | 637 | RT+TMZ+BEV | 15.7 | 10.7 | NR | [117] |
| RT+TMZ+Placebo | 16.1 | 7.3 | NR | ||||
| III | GBM | 921 | TMZ+RT+BEV | 16.8 | 10.6 | NR | [118] |
| TMZ+RT+Placebo | 16.7 | 6.2 | NR | ||||
| I/II | GBM | 21 | TMZ+Sativex | 18.3 | NR | NR | [122] (NCT01812603) |
| TMZ+Placebo | 12.3 | NR | NR | ||||
| I-II | NETs | 35 | Lutetium-177-octreotate+Capecitabine+TMZ | NR | 31 | ORR: 56%; CR: 5 (15%); PR: 13 (38%); SD: 13 (38%) | [123] |
| III | NSCLC | 126 | WBRT+SRS+TMZ | 6.3 | 4.6 | NR | [128] |
| II | NSCLC | 45 | TMZ | 27.1 | 11.7 | NR | [129] |
| II | NSCLC | 60 | WBRT+TMZ+Pemetrexed | 16.9 | 19.3 | ORR: 12 (75%); CR: 6 (21.4%); PR: 15 (53.6%); SD: 4 (14.3%) | [130] (NCT02284490) |
| II | Breast cancer | 284 | Veliparib+TMZ | 19.1 | 7.4 | ORR: 28.6%; CR: 1.4%; PR: 27.1% | [135] (NCT01506609) |
| I | mCRPC | 26 | Veliparib+TMZ | 39.6 (weeks) |
9 (weeks) |
NR | [136] (NCT01085422) |
| II | Aerodigestive tract cancer and CRC | 86 | TMZ | 6.7 | 2.8 | ORR: 5.8%; PR: 5 (6%); SD: 39 (45%) | [139] (NCT00423150) |
| II | SCLC | 64 | TMZ | 5.8 | 1.6 | ORR: 20%; CR: 1; PR: 12; SD: 6 (9%) | [138] |
| I | Rectal cancer | 22 | RT+Capecitabine+TMZ | NR | NR | CR: 7 (31.8%) | [143] (NCT01781403) |
| II | CRC | 41 | TMZ | 5.1 | 1.9 | ORR: 4 (10%); CR: 0; PR: 4 (10%); SD: 9 (22%) | [144] |
| II | CRC | 29 | TMZ | 6.2 | 2.6 | ORR: 3.4%; PR: 1 (3.4%); SD: 13 | [145] |
| II | CRC | 32 | TMZ | 8.4 | 1.8 | ORR: 4 (12%); CR: 0; PR: 4 (12%); SD: 6 (19%) | [146] |
| II | AML and MDS | 45 | TMZ | 6.7 | NR (in entire group) | ORR: 53%; CR: 36% | [151] |
| I | AML | 48 | Veliparib+TMZ | 5.3 | NR (in entire group) | CR: 8 (16.6%) | [152] (NCT01139970) |
AML: acute myeloid leukemia; BEV: bevacizumab; CR: complete response; CRC: metastatic colorectal; GBM: glioblastoma; mCRPC: metastatic castration-resistant prostate cancer; MDS: myelodysplastic syndrome; NETs: neuroendocrine tumors; NR: no reported; NSCLC: non-small cell lung cancer; ORR: overall response rate; OS: overall survival; PFS: progression-free survival; PR: partial response; RT: radiotherapy; SCLC: small cell lung cancer; SD: stable disease; SRS: stereotactic radiosurgery; TMZ: temozolomide; TSC: trans sodium crocetinate; TTFields: tumor-treating fields; WBRT: brain radiation therapy.