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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.

Publication ,  Journal Article
Alvarez Secord, A; Berchuck, A; Higgins, RV; Nycum, LR; Kohler, MF; Puls, LE; Holloway, RW; Lewandowski, GS; Valea, FA; Havrilesky, LJ
Published in: Cancer
July 1, 2012

BACKGROUND: 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). METHODS: Participants were randomized to either weekly docetaxel 30 mg/m(2) on days 1 and 8 and carboplatin area under the curve (AUC) = 6 on day 1, every 3 weeks or docetaxel 30 mg/m(2) 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). RESULTS: 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). CONCLUSIONS: 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.

Duke Scholars

Published In

Cancer

DOI

EISSN

1097-0142

Publication Date

July 1, 2012

Volume

118

Issue

13

Start / End Page

3283 / 3293

Location

United States

Related Subject Headings

  • Taxoids
  • Recurrence
  • Quality of Life
  • Platinum
  • Ovarian Neoplasms
  • Oncology & Carcinogenesis
  • Middle Aged
  • Humans
  • Female
  • Drug Administration Schedule
 

Citation

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Alvarez Secord, A., Berchuck, A., Higgins, R. V., Nycum, L. R., Kohler, M. F., Puls, L. E., … 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(13), 3283–3293. https://doi.org/10.1002/cncr.26610
Alvarez Secord, Angeles, Andrew Berchuck, Robert V. Higgins, Lawrence R. Nycum, Matthew F. Kohler, Larry E. Puls, Robert W. Holloway, George S. Lewandowski, Fidel A. Valea, and Laura J. Havrilesky. “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, no. 13 (July 1, 2012): 3283–93. https://doi.org/10.1002/cncr.26610.
Alvarez Secord A, Berchuck A, Higgins RV, Nycum LR, Kohler MF, Puls LE, Holloway RW, Lewandowski GS, Valea FA, Havrilesky LJ. 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. 2012 Jul 1;118(13):3283–3293.
Journal cover image

Published In

Cancer

DOI

EISSN

1097-0142

Publication Date

July 1, 2012

Volume

118

Issue

13

Start / End Page

3283 / 3293

Location

United States

Related Subject Headings

  • Taxoids
  • Recurrence
  • Quality of Life
  • Platinum
  • Ovarian Neoplasms
  • Oncology & Carcinogenesis
  • Middle Aged
  • Humans
  • Female
  • Drug Administration Schedule