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, Gemcitabine, Liposomal doxorubicin
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/