Table 2.
Status | Vintafolide + PLD arm
|
PLD alone arm
|
|||||||
---|---|---|---|---|---|---|---|---|---|
No. of Patients | Total Events | Median PFS (months) | No. of Patients | Total Events | Median PFS (months) | HR | 95% CI | P-value | |
mITT | 100 | 62 | 5.0 | 49 | 33 | 2.7 | 0.626 | 0.409–0.959 | 0.031 |
FR 10%–100% | 48 | 30 | 5.7 | 26 | 19 | 1.7 | 0.547 | 0.304–0.983 | 0.041 |
FR 100% | 23 | 15 | 5.5 | 15 | 13 | 1.5 | 0.381 | 0.172–0.845 | 0.013 |
FR 10%–90% | 25 | 15 | 5.7 | 11 | 6 | 7.0 | 0.873 | 0.334–2.277 | 0.790 |
FR 0% | 13 | 8 | 3.8 | 7 | 2 | 5.4 | 1.806 | 0.369–8.833 | 0.468 |
Note: Reprinted with permission. © 2013 American Society of Clinical Oncology. All rights reserved. Naumann RW, Coleman RL, Burger RA, et al. PRECEDENT: a randomized Phase II trial comparing vintafolide (EC145) and pegylated liposomal doxorubicin (PLD) in combination versus PLD alone in patients with platinum-resistant ovarian cancer. J Clin Oncol. 2013;31(35):4400–4406.74
Abbreviations: FR, folate receptor; HR, hazard ratio; CI, confidence interval; mITT, intent-to-treat population of patients with measurable disease; PFS, progression-free survival; PLD, PEGylated liposomal doxorubicin.