Table 3.
Phase III clinical studies with lonidamine in metastatic breast cancer.
| Patients accrued | Treatment | Response % | Observations | References |
|---|---|---|---|---|
| 265 | LND versus LND + FAC | ORR (%) 42.3 versus 66.3 | Median PFS 6 versus 9 months p < 0.0001 Multicentric study |
[50] |
|
| ||||
| 181 | dox to all, then randomized to dox + LND versus dox | ORR (%) 50 versus 38 | Response in liver metastases 68 versus 33% p = 0.03 |
[51] |
|
| ||||
| 326 | FEC/EM versus FEC/EM + LND | CR 10.8% versus 20.4% | No differences in PFS or OS | [52] |
|
| ||||
| 207 | LND + epi versus epi | ORR (%) 60 versus 39 p < 0.01 |
Higher response in liver metastases with LND + epi. No differences in PFS or OS |
[53] |
|
| ||||
| 371 | epi versus epi + cis versus epi + LND versus epi + cis + LND | ORR (%) 54 no LND arms versus 62.9 LND arms p = 0.08 |
Median OS 29.8 versus 32.2 months TTP 9.9 versus 10.8 months, trend favoring LND arms, p = NS |
[54] |
FAC: 5-fluorouracil-doxorubicin-cyclophosphamide; dox: doxorubicin; FEC: 5-fluorouracil-epirubicin-cyclophosphamide; EM: epirubicin-mitomycin; cis: cisplatin; ORR: overall response rate; PFS: progression-free survival; OS: overall survival; TTP: time to progression.