Meeting Abstract | 2011 ASCO Annual Meeting I


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.

Patients receiving 
 6 cycles 
Patients receiving 
 >2 cycles 
Mean DI of G by quartile N RR 
 P Median PFS 
 P N Median PFS 
DI <25th percentile 25 64% 0.537 11.5 0.199 39 9.1 0.249
25th percentile ≤ DI< median 24 50% 8.9 39 8.4
Median ≤ DI <75thpercentile 25 64% 10.0 40 6.4
DI ≥75thpercentile 25 48% 7.6 40 7.7

© 2011 by American Society of Clinical Oncology


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DOI: 10.1200/jco.2011.29.15_suppl.5088 Journal of Clinical Oncology 29, no. 15_suppl (May 20, 2011) 5088-5088.

Published online May 20, 2011.

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