Phase 3 randomised study of canfosfamide (Telcyta®, TLK286) versus pegylated liposomal doxorubicin or topotecan as third-line therapy in patients with platinum-refractory or -resistant ovarian cancer
Vergote I et al. - Canfosfamide HCl (CAN; a glutathione analogue prodrug that is activated by glutathione S-transferase P1-1 and induces apoptosis) was well tolerated in pts with platinum-refractory or -resistant ovarian cancer (OC). Methods- Pts with platinum-refractory or -resistant OC who had progressed on second-line therapy with pegylated liposomal doxorubicin (PLD) or topotecan (TOPO), were randomized to:
- CAN 1000 mg/m2 IV q 3 weeks or
- Either PLD 50 mg/m2 IV q 4 wks or TOPO 1.5 mg/m2 IV d1-5 q 3 wks
Results- 461 pts were randomised after stratification for ECOG performance status, prior therapy, and bulky (>5 cm) disease
- Groups were well balanced
- In the control arm 58% and 42% were treated with PLD and TOPO, respectively
- CAN was well tolerated with the most common grade 3-4 toxicities of 5% anaemia, 4% neutropaenia (no febrile neutropaenia), 4% thrombocytopaenia, and 7% vomiting
- PFS and OS were higher in the control arm
- In a subgroup analysis PFS and OS were higher with PLD than with TOPO
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