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   (n=99)					Patients receiving   >2 cycles   (n=158)
Mean DI of G by quartile	N	RR	P	Median PFS   (months)	P	N	Median PFS   (months)	P
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 <75th   percentile	25	64%		10.0		40	6.4
DI ≥75th   percentile	25	48%		7.6		40	7.7

Gynecologic Cancer

Article Tools

OPTIONS & TOOLS

COMPANION ARTICLES

ARTICLE CITATION

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

OPTIONS & TOOLS

COMPANION ARTICLES

ARTICLE CITATION

Quick Links

Content

Journal Information

Resources

Submit Your Manuscript

Subscribe to this Journal

ASCO Family of Sites

Journals

Publications

Education

Other Sites