Reviving Lonidamine and 6-Diazo-5-oxo-L-norleucine to Be Used in Combination for Metabolic Cancer Therapy

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; 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%	[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	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	Median OS 29.8 versus 32.2 months; TTP 9.9 versus 10.8 months, trend favoring LND arms,	[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.