Table 2.
Summary of phase II clinical studies with lonidamine.
| Number of studies | # pts | Tumor type | Treatment | Overall response rate (ORR) | Observations | References |
|---|---|---|---|---|---|---|
| 4 | 51 | Breast | LND + epi: | 21% | Metastatic disease | [36–39] |
| 24 29 22 |
LND + epi; LND + epi + cis LND + epi + cis |
57% 73% 81.8% |
Mean response duration 12.4, 7.0, and 9.8 months in the first three trials, respectively | |||
|
| ||||||
| 3 | 25 54 31 |
Lung | LND alone; LND + cis + gem + vnr; LND + cis + epi |
24%, 37% 41.4% |
Advanced or metastatic disease Mean response duration 13.7, 4.5, and 8.5 months |
[40–42] |
|
| ||||||
| 4 | 35 27 9 26 |
Ovarian | LND + cis + pac LND + cis LND + cis LND + epi |
80% 37% 44% 33.3% |
LND + cis + pac, untreated pts. PFS 28.5 months The other 3 studies in pretreated patients |
[43–46] |
|
| ||||||
| 3 | 40 | Head and neck | LND + RT | CR 65% | Untreated | [47–49] |
| 89 | LND + mtx versus mtx + pla | ORR 26.3 versus 18.2% | Advanced/recurrent | |||
| 96 | LND + RT versus RT + pla | CR 66 versus 65% | Untreated 5-year DFS 40 versus 19%, p < 0.03 | |||
LND: lonidamine; epi: epirubicin; cis: cisplatin; gem: gemcitabine; vnr; vinorelbine; pac: paclitaxel; RT: radiation; mtx: methotrexate; pla: placebo; CR: complete response; PFS: progression-free survival; DFS: disease-free survival.