Liposomal Doxorubicin HCI Tested In Women With Recurrent Disease.(Doxil R tested as ovarian cancer treatment)

2001 AUG 23 - (NewsRx Network) -- A recent study compared Doxil R (liposomal doxorubicin HCI) with topotecan, another common treatment for recurrent ovarian cancer.

The report was published in the July 2001 issue of The Journal of Clinical Oncology. The randomized, multicenter study, evaluating 474 patients at 104 research centers in the United States and Europe, was one of the largest conducted among women suffering from ovarian cancer. The report provided the results of a Phase III clinical trial comparing Doxil and topotecan. Further studies will be required to establish the clinical benefit of Doxil.

The objective of the study was to compare the efficacy and safety of Doxil versus topotecan in patients with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy. The primary endpoint of the study was to determine time to progression. The results of the study showed that median time to progression (overall progression-free survival) for Doxil was 16.1 weeks and 17.0 weeks for topotecan (p=0.095). Overall response rates for Doxil and topotecan were 19.7% and 17.0%, respectively (p=0.390).

Doxil-treated patients survived an average of 60 weeks and topotecan-treated patients survived an average of 56.7 weeks. Doxil is indicated to treat metastatic ovarian cancer in women whose disease is refractory to paclitaxel- and platinum-based chemotherapy. This indication is based on objective tumor response rates.

No results are available from controlled trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in disease-related symptoms or increased survival. Refractory ovarian cancer is defined as disease that has progressed during treatment or within six months after completing treatment.

As prospectively planned and outlined in the protocol's study analysis, the researchers conducted a subset analysis and found that Doxil-treated patients who were still responsive to platinum-based chemotherapy showed statistically significant increases in the length of survival time compared with topotecan-treated patients (2.1 years vs. 1.4 years, p=0.008). Platinum-sensitive patients demonstrated a significant improvement in progression-free survival (p=0.037) with Doxil, 28.9 weeks vs. 23.3 weeks. Response rates of 28.4% (Doxil) and 28.8% (topotecan) were not statistically different (p=0.964).

The platinum-refractory subgroup demonstrated a non-statistically significant survival trend in favor of topotecan (p=0.733). Response rates and times to progression in this subgroup were not statistically different between the two treatment arms. These results suggest another trial is ...