Adding olaratumab to liposomal doxorubicin does not result in significant improvements in progression-free survival (PFS) or overall survival (OS) in platinum-resistant or platinum-refractory ovarian cancer, results from a phase II study suggest.
The open label study randomised patients with platinum-refractory or platinum-resistant advanced ovarian cancer 1:1 to receive liposomal doxorubicin (40 mg/m2 IV) every four weeks with or without olaratumab (20 mg/kg IV) every two weeks. A total of 123 patients were treated (62 olaratumab+liposomal doxorubicin; 61 liposomal doxorubicin).
Median PFS was 4.2 months for olaratumab+liposomal doxorubicin and 4.0 months for liposomal doxorubicin (stratified HR 1.043; 95% CI 0.698-1.558; P=.837). Median OS was 16.6 months and 16.2 months, respectively (HR 1.098; 95% CI 0.71-1.71).
In the platinum-refractory subgroup, median PFS was 5.5 months (95% CI 1.6-9.2) and 3.7 months (95% CI 1.9-9.2) with olaratumab+liposomal doxorubicin (n=15) and liposomal doxorubicin (n=16), respectively (HR 0.85; 95% CI 0.38-1.91).
Overall, 59.7 per cent of olaratumab+liposomal doxorubicin patients and 65.6 per cent of liposomal doxorubicin patients reported grade ≥3 adverse events. The most common treatment-emergent adverse events (all grades) were fatigue-related (61%), nausea (57%) and constipation (52%) with olaratumab+liposomal doxorubicin, and nausea (64%), fatigue-related (62%) and mucositis (46%) with doxorubicin alone.
The findings are published in BMC Cancer.