Abstract
5565 Background: Both D and G have demonstrated single-agent activity in OC and PC. The purpose of this study was to prospectively evaluate the efficacy and toxicity for patients (pts) with relapsed platinum-sensitive (Plat-S) and platinum-resistant (Plat-R) OC or PC treated with combination weekly D and G. Methods: Eligibility criteria included women recurrent or refractory to first line platinum based therapy, a performance status of 2 or better, and adequate renal and hepatic function. Only one prior regimen (including maintenance therapy) was allowed. D (40 mg/m2) and G (800 mg/m2) were administered on days 1 and 8 of a 21 day cycle until progression. Best response was defined by RECIST criteria. Granulocyte stimulating factor prophylaxis was not allowed. There were 2 separate 2-stage designs used, one for each stratum: Plat-R and Plat-S, separately for a total planned sample of 62 pts. The primary endpoint was overall response rate (ORR). This study was approved by each center's institutional review board. Results: Thirty pts were enrolled prior to terminating accrual due to lagging enrollment. The median age was 57.5 years (range 41–80). One pt was diagnosed with PC; the remaining 29 had OC. Twenty-seven (90%) pts were response evaluable. The ORR was 59% (90% confidence interval: 0.44 - 0.73). Six pts (22%) achieved a complete response (CR), 10 pts (37%) achieved a partial response (PR) and one pt (4%) had stable disease. Progressive disease was noted in 10 pts (37%). Plat-S pts (n = 16) had a 69% ORR (CR = 31%, PR = 38%) and Plat-R pts (n = 11) had an ORR of 45% (CR = 9%, PR = 36%). Median overall survival was 12.7 months (Plat-S = 14.2 mos. and Plat-R = 6.7 mos.). Toxicity data were evaluable for 29 (97%) pts. Twelve pts (41%) experienced grade 3 or 4 neutropenia; two of these pts also had documented infections. Three pts had grade 3 anemia and 6 (21%) had grade 3 thrombocytopenia. Dose reductions were uncommon (n = 2, 7%). Twelve pts (41%) were hospitalized at least once during treatment. Conclusions: Weekly D and G combination therapy demonstrates significant activity and moderate toxicity in both Plat-S and Plat-R disease. This non-platinum combination deserves further evaluation and may be considered in pts with Plat-S and Plat-R OC and PC. No significant financial relationships to disclose.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
