The impact of dose intensity on the efficacy of gemcitabine plus carboplatin (GC) therapy for recurrent platinum-sensitive ovarian cancer (PSOC): A retrospective analysis of AGO-OVAR 2.5.

Abstract

5088 Background: The gemcitabine plus carboplatin combination (GC) is known to provide a clinical advantage compared to single-agent C for patients (pts) with recurrent PSOC. Dose reductions and delays for toxicity are common during standard GC therapy. To evaluate the potential impact of G and C dose adjustments on clinical outcomes in pts with PSOC, we retrospectively analyzed dose intensity (DI) data from the phase III trial AGO-OVAR 2.5. METHODS Data analyses were performed for 175 GC-treated pts. G and C weekly DIs were calculated as the mean dose of drug received divided by the planned weekly dose for each pt through each cycle of treatment. Progression-free survival (PFS) and response rate (RR) were compared across G DI groups for pts who received 6 cycles using the log-rank test and Fisher's exact test, respectively To reduce the bias of time dependence, we examined subsequent PFS after cycle 2 stratified by G DI within the first 2 cycles (in pts who received >2 cycles). RESULTS A total of 99 pts (56.6%) completed 6 cycles. The mean weekly G DI ranged from 89.5% at cycle 1 to 73.0% at cycle 6; the mean weekly C DI ranged from 99.5% at cycle 1 to 91.5% at cycle 6. Results for pts receiving either 6 cycles or >2 cycles are shown in the table. There were no significant differences across G DI groups for either PFS (P=0.199) or RR (P=0.537) for pts receiving 6 cycles or for subsequent PFS (P=0.249) when pts were grouped by G DI within the first 2 cycles. Comparisons of G and C DI based on the numbers of cycles completed (up to 8) also showed no significant differences in PFS or RR. CONCLUSIONS Differences in DI of both G and C for pts receiving from 2 to 8 cycles of standard GC chemotherapy had no impact on either PFS or RR in the AGO-OVAR 2.5 trial. Protocol-specified dose adjustments do not appear to impact the efficacy of GC therapy for pts with PSOC. [Table: see text].

Cite this paper

@article{Kurzeder2011TheIO, title={The impact of dose intensity on the efficacy of gemcitabine plus carboplatin (GC) therapy for recurrent platinum-sensitive ovarian cancer (PSOC): A retrospective analysis of AGO-OVAR 2.5.}, author={Christian Kurzeder and L Zhao and Elizabeth Eisenhauer and Ignace Vergote and Andreas du Bois and Datchen Fritz Tai and Yanping Wang and John F. Gill and Hal W. Hirte and Barbara Richter and Lars Christian Hanker and Jared Bentley and Ulf Wagner and Marie Andr{\'e}e Plante and Rainer Kimmig and Jacobus Pfisterer}, journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology}, year={2011}, volume={29 15_suppl}, pages={5088} }