See editorial on pages 3229–31, this issue.
A multicenter, randomized, phase 2 clinical trial to evaluate the efficacy and safety of combination docetaxel and carboplatin and sequential therapy with docetaxel then carboplatin in patients with recurrent platinum-sensitive ovarian cancer†
Article first published online: 9 NOV 2011
Copyright © 2011 American Cancer Society
Volume 118, Issue 13, pages 3283–3293, 1 July 2012
How to Cite
Secord, A. A., Berchuck, A., Higgins, R. V., Nycum, L. R., Kohler, M. F., Puls, L. E., Holloway, R. W., Lewandowski, G. S., Valea, F. A. and Havrilesky, L. J. (2012), A multicenter, randomized, phase 2 clinical trial to evaluate the efficacy and safety of combination docetaxel and carboplatin and sequential therapy with docetaxel then carboplatin in patients with recurrent platinum-sensitive ovarian cancer. Cancer, 118: 3283–3293. doi: 10.1002/cncr.26610
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- Issue published online: 18 JUN 2012
- Article first published online: 9 NOV 2011
- Manuscript Accepted: 6 JUL 2011
- Manuscript Revised: 20 JUN 2011
- Manuscript Received: 1 APR 2011
- ovarian neoplasm;
- drug therapy;
The aim of this randomized clinical trial was to evaluate the efficacy and safety of combination (cDC) and sequential (sDC) weekly docetaxel and carboplatin in women with recurrent platinum-sensitive epithelial ovarian cancer (EOC).
Participants were randomized to either weekly docetaxel 30 mg/m2 on days 1 and 8 and carboplatin area under the curve (AUC) = 6 on day 1, every 3 weeks or docetaxel 30 mg/m2 on days 1 and 8, every 3 weeks for 6 cycles followed by carboplatin AUC = 6 on day 1, every 3 weeks for 6 cycles or until disease progression. The primary endpoint was measurable progression-free survival (PFS).
Between January 2004 and March 2007, 150 participants were enrolled. The response rate was 55.4% and 43.2% for those treated with cDC and sDC, respectively. The median PFS was 13.7 months (95% confidence interval [CI], 9.9-16.8) for cDC and 8.4 months (95% CI, 7.1-11.0) for sDC. On the basis of an exploratory analysis, patients treated with sDC were at a 62% increased risk of disease progression compared to those treated with cDC (hazard ratio = 1.62; 95% CI, 1.08-2.45; P = .02). The median overall survival time was similar in both groups (33.2 and 30.1 months, P = .2). The incidence of grade 2 or 3 neurotoxicity and grade 3 or 4 neutropenia was higher with cDC than with sDC (11.7% vs 8.5%; 36.8% vs 11.3%). The sDC group demonstrated significant improvements in the Functional Assessment for Cancer Therapy–Ovarian, Quality of Life Trial Outcome Index scores compared with the combination cohort (P = .013).
Both cDC and sDC regimens have activity in recurrent platinum-sensitive EOC with acceptable toxicity profiles. The cDC regimen may provide a PFS advantage over sDC. Cancer 2011. © 2011 American Cancer Society.