Efficacy
From the Italian study, after a median follow up time of 39 weeks, no statistical difference in time to progression (TTP) was shown between the gemcitabine (16 weeks) and PLD (20 weeks) arms. There is a trend towards better OS in the PLD arm (56 weeks) compared to the gemcitabine arm (51 weeks), with a borderline significance p-value of 0.048. The authors felt low numbers and scarcity of post-treatment data did not allow firm conclusions to be drawn.r
There was no statistically significant difference in the rate of overall response according to treatment arms (p=0.66).
Quality of life data was collected in 79% of patients- it was similar in both arms at baseline, but statistically better in the PLD arm compared to gemcitabine in post-baseline assessments.
Kaplan-Meier curves of (A) Time to progression (TTP), and (B) Overall survivalr
P values were calculated using the log-rank test; PLD = peglylated liposomal doxorubicin, GEM = gemcitabine
© Journal of Clinical Oncology 2008
Platinum Resistant Disease
After a median follow up time of 29.2 months, the median PFS times were 3.6 months in the gemcitabine arm, and 3.1 months in the PLD arm thus not being statistically significant (p=0.870). Similarly, the OS were not statistically different; and the overall response rates were similar.r
Kaplan-Meier curves of (A) Progression-free survival, and (B) Overall survivalr
PLD = peglylated liposomal doxorubicin,
© Journal of Clinical Oncology 2007