A phase II randomized controlled study of pegylated liposomal doxorubicin and carboplatin vs. gemcitabine and carboplatin for platinum-sensitive recurrent ovarian cancer (GOTIC003/intergroup study)

Trial ID #	GOTIC003; Intergroup study
Phase	II
Drug Class	Chemotherapy
Drug Name	Carboplatin
Alternate Drug Names	Paraplatin, Novoplatinum
Drugs in Trial	Carboplatin, Liposomal doxorubicin, Gemcitabine
Eligible Participant	Platinum sensitive ovarian cancer at first recurrence
Patients Enrolled	100
Therapy Setting	Recurrence
Endpoints	ORR, PFS, evaluated per RECIST
Efficacy	CarboPt+PLD (n=49) vs CarboPt+Gem (n=51): ORR: 57.1 vs 56.4% PFS: 12.0 vs 9.8 months; HR: 0.69 (0.46-1.05)
Clinically Significant Adverse Events	CarboPt+PLD (n=49) vs CarboPt+Gem (n=51): Serious AE: Grade 3-4 AE: no difference
Conclusion	Carboplatin with liposomal doxorubicin or gemcitabine are comparable; however, the liposomal doxorubicin combo has a more favorable risk-benefit profile than that of the gemcitabine combo
Reference	Fujiwara H et al. A phase II randomized controlled study of pegylated liposomal doxorubicin and carboplatin vs. gemcitabine and carboplatin for platinum-sensitive recurrent ovarian cancer (GOTIC003/intergroup study). Int J Clin Oncol (2019) 24(10):1284-1291 https://pubmed.ncbi.nlm.nih.gov/31127479/