Health-related quality of life outcomes of docetaxel/carboplatin combination therapy vs. sequential therapy with docetaxel then carboplatin in patients with relapsed, platinum-sensitive ovarian cancer: Results from a randomized clinical trial
Article
Pokrzywinski, Robin, Secord, Angeles Alvarez, Havrilesky, Laura J., Puls, Larry E., Holloway, Robert W., Lewandowski, George S., Higgins, Robert V., Nycum, Lawrence R., Kohler, Matthew F., Revicki, Dennis A.
abstract
Objectives. A phase II clinical trial compared docetaxel in combination with carboplatin to sequential single agent docetaxel followed by carboplatin for treatment of recurrent platinum-sensitive ovarian, peritoneal, or tuba! cancer. This manuscript reports prospectively collected health-related quality of life (HRQL). Methods. Participants were randomized to either weekly docetaxel 30 mg/m(2)/days 1 and 8 and carboplatin AUC 6/day 1 every 3 weeks (cDC) or docetaxel 30 mg/m(2)/days 1 and 8, repeated every 3 weeks for 6 cycles followed by carboplatin AUC 6/day 1 every 3 weeks for 6 cycles or until disease progression (sDC). The primary HRQL endpoint was the trial outcome index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, and was assessed as an intent-to-treat analysis. The secondary HRQL endpoints included the FACT-O total score, the FACT-General, and several domain scores of the FACT-O instrument (physical wellbeing (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and the ovarian cancer specific (OCS) module). The FACT-O was administered at randomization, prior to each of 6 cycles of treatment, and at study endpoint. Results. One hundred forty-eight participants were randomized to each group. Sequential docetaxel followed by carboplatin (sDC) was associated with significant improvements in the FACT-O TOI (p = 0.013). FACT-O total score (p = 0.033), and OCS (p = 0.029) compared to the combination docetaxel and carboplatin group (cDC). Conclusions. Sequential single agent docetaxel followed by carboplatin is associated with improved HRQL when compared to cDC The improved progression-free survival observed with cDC should be weighed against lower quality of life during treatment. (C) 2011 Elsevier Inc. All rights reserved.