Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer

Trial ID # NCT00326456; MITO-2
Phase III
Drug Class Chemotherapy
Drug Name Carboplatin, Liposomal doxorubicin, Paclitaxel
Alternate Drug Names Paraplatin, Novoplatinum, Doxil, Dox-SL, Evacet, LipoDox, liposomal doxorubicin, Pegylated Liposomal Doxorubicin Hydrochloride, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL
Drugs in Trial Carboplatin, Liposomal doxorubicin, Paclitaxel
Eligible Participant

Newly diagnosed stage IC-IV ovarian cancer

Patients Enrolled

820

Therapy Setting

First-line

Study Design

Open-Label, Randomized

Endpoints

PFS, OS, evaluated per RECIST

Efficacy

CarboPt+Pac vs CarboPt+PLD:

PFS: 16.8 vs 19.0 months, HR: 0.95 (0.81-1.13, p=0.58)
OS: 53.2 vs 61.6 months, HR: 0.89 (0.72-1.12, p=0.32)

Clinically Significant Adverse Events

CarboPt+Pac vs CarboPt+PLD:

Grade 3-4 AE: anemia (3 vs 10%), thrombocytopenia (7 vs 16%)
All grades: Hair loss (63 vs 14%), diarrhea (12 vs 6%) neuropathy (47 vs 15%) skin toxicity (6 vs 21%), stomatitis (9 vs 18%)

Conclusion

No significant PFS or OS difference when paclitaxel or liposomal doxorubicin is added to carboplatin, but different toxicity profiles

Reference

Pignata S et al. Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: the MITO-2 randomized phase III trial. J Clin Oncol (2011) 29(27):3628-35
https://www.ncbi.nlm.nih.gov/pubmed/21844495