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Ranpirnase Added to Doxorubicin Improves Survival in Pretreated Patients With Malignant Mesothelioma: Presented at ASCO
By Emma Hitt, PhD
ORLANDO, Fla -- June 2, 2009 -- Ranpirnase added to doxorubicin improves survival in pretreated patients with malignant mesothelioma, according to findings from a phase 3 trial presented here on June 1 at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO).
According to the researchers, a previous study has demonstrated that ranpirnase, a novel ribonuclease, resulted in a 1-year survival rate of 42% in a multicentre phase 2 trial in chemotherapy-naïve and pretreated patients.
Martin Reck, MD, Hospital Grosshansdorf, Hamburg, Germany, and colleagues compared the efficacy and safety of doxorubicin with or without ranpirnase. Patients (n = 413) had unresectable malignant mesothelioma and an Eastern Cooperative Oncology Group performance status of 0 to 1, and they were allowed to have up to 1 previous line of treatment. Mean age was approximately 62 years.
An intent-to-treat analysis found no significant difference in median overall survival. With doxorubicin plus ranpirnase, the median survival was 11.1 versus 10.7 months for doxorubicin plus placebo (hazard ratio [HR] = 1.02; 95% confidence interval [CI], 0.82-1.26).
However, in a preplanned analysis of 130 patients who had been pretreated with chemotherapy, a significant advantage in survival in favour of doxorubicin plus ranpirnase was noted, with a median survival of 10.5 months for ranpirnase versus 9 months for placebo (HR = 1.49; 95% CI, 1.02-2.17).
No adverse safety issues were observed with the addition of ranpirnase. The most common side effects were associated with doxorubicin and included nausea, fatigue, and alopecia. Other side effects included neutropenia, oedema, arthralgia, and peripheral neuropathy.
The researchers concluded that the treatment is safe and feasible and may result in a significant impact on survival compared with doxorubicin alone for pretreated patients.
"Further evaluation of ranpirnase in combination with pemetrexed and confirmation of second-line efficacy will be of interest," Dr. Reck said during the presentation.
[Presentation title: Randomized, Multicenter Phase III Study of Ranpirnase Plus Doxorubicin (DOX) Versus DOX in Patients With Unresectable Malignant Mesothelioma (MM). Abstract 7507]
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