Martin et al Lancet Oncol 2007
Vinorelbine+Gemcitabine (anthras & taxanes pre-treated)
•
Phase III RCT: vinorelbine
30
/gemcitabine
1200
vs vinorelbine
30
d1,8 q21d
•
Locally recurrent and MBC pre-treated with anthras and taxanes (N=252)
•
1L (21 and 15% pts per arm)
•
Primary endpoint: PFS (secondary: RR, OS, DoR, toxicity)
•
Patients with MBC assigned GV had better PFS compared with those assigned VNB alone but did
not translate into a difference in OS. Although toxicity was manageable, pts in the combined
group had more haematological toxic effects
•
Grade 3 or 4 neutropenia 61% GV vs 44% V*
•
Febrile neutropenia 11% GV vs 6% V (NS)
•
Incidences of grade 3 or 4 non-haematological toxic
effects were similar
