Abstract
e20522 Background: A randomized, multicenter phase 3 trial of PLD+D showed a significant improvement in the primary endpoint of time to progression (TTP) compared with D alone but with increased Grade 3/4 hand-foot syndrome (HFS: 24% vs. 0%) and mucositis/stomatitis (M/S: 12% vs. 1%) in patients (pts) with advanced breast cancer (BC). (Sparano JA et al. SABCS 2008. #80) This analysis evaluated HRQOL in these pts. Methods: Pts were randomized to D 75 mg/m2 (N=373) or PLD 30 mg/m2 + D 60 mg/m2 (N=378) on Day 1 every 21 days until progression or unacceptable toxicity. HRQOL was assessed using the Functional Assessment of Cancer Therapy - Breast (FACT-B) at baseline and at every cycle during treatment. FACT-B has 4 primary domains: physical, social/family, emotional, and functional, plus a BC-specific subscale. The primary analysis was a t-test comparison of change in the trial outcome index (TOI) from baseline to the last evaluation. TOI combined physical/functional domain scores with BC-specific scores. Other FACT-B endpoints analyzed included FACT-B total score and individual subscales. Also, % pts meeting an established minimally important difference (MID) of HRQOL improvement in TOI was assessed. Results: Median number of cycles was 6 for both arms. TOI was available for 97.9% of all scheduled assessments for both treatment groups. At baseline, mean FACT-B and TOI scores were similar for PLD+D vs D arms (94.2±18.6 vs 95.3±18.7 and 59.7±13.8 vs 60.2±13.4, respectively); other FACT-B domains were also similar. PLD+D vs D arms showed similar mean change from baseline to last evaluation in TOI (-4.6±12.2 vs -6.0±12.4; P=0.13). Other FACT-B subscales showed 1–2 point differences across domains over time. Likewise, % pts reaching MID was similar across arms. Pts in both arms experienced similar FACT-B declines as disease progressed. Conclusions: Despite increased HFS and M/S with PLD+D vs D alone, HRQOL was comparable for both arms. [Table: see text]
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.
