Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial.

BACKGROUND: OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD) over PLD alone in relapsed ovarian cancer. The optimal management of patients with partially platinum-sensitive relapse [6-12 months platinum-free interval (PFI)] is unclear. PATIENTS AND METHODS: within OVA-301, we therefore now report on the outcomes for the 214 cases in this subgroup. RESULTS: Trabectedin/PLD resulted in a 35% risk reduction of disease progression (DP) or death [hazard ratio (HR) = 0.65, 95% confidence interval (CI), 0.45-0.92; P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months). The safety of trabectedin/PLD in this subset mimicked that of the overall population. Similar proportions of patients received subsequent therapy in each arm (76% versus 77%), although patients in the trabectedin/PLD arm had a slightly lower proportion of further platinum (49% versus 55%). Importantly, patients in the trabectedin/PLD arm survived significantly longer after subsequent platinum (HR = 0.63; P = 0.0357; median 13.3 versus 9.8 months). CONCLUSION: This hypothesis-generating analysis demonstrates that superior benefits with trabectedin/PLD in terms of PFS and survival in the overall population appear particularly enhanced in patients with partially sensitive disease (PFI 6-12 months).

Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval.

BACKGROUND: OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD; CentoCor Ortho Biotech Products L.P., Raritan, NJ, USA). over single-agent PLD in 672 patients with relapsed ovarian cancer, particularly in the partially platinum-sensitive subgroup [platinum-free interval (PFI) of 6-12 months]. This superiority has been suggested to be due to the differential impact of subsequent (platinum) therapy. PATIENTS AND METHODS: a detailed analysis of subsequent therapies and survival outcomes in the overall population and in the subsets according to platinum sensitivity was therefore conducted. RESULTS: similar proportions of patients received subsequent therapy in each arm (76% versus 77%), including further platinum-based regimens (49% versus 55%). Patients in the trabectedin/PLD arm received subsequent chemotherapy at a later time (median delay 2.5 months versus PLD arm). Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357). CONCLUSION: the superiority of trabectedin/PLD over single-agent PLD in OVA-301 cannot be explained by differences in the extent or nature of subsequent therapies administered to these patients. On the other hand, these exploratory analyses support the hypothesis that the enhanced survival benefits in the partially platinum-sensitive subset might be due to an extended PFI leading to longer survival with subsequent platinum.

[Clinical implications of undesirable consequences of antineoplastic drug interactions]. / Znaczenie kliniczne niepozadanych nastpstw interakcji leków przeciwnowotworowych.

The fundamental objective of treating patients with tumor disease is to destroy the largest possible number of neoplastic cells, simultaneously minimizing toxicogenic after--effects. Currently there are approximately 60 drugs that are used in treatment of various types of tumors. They are chemical compounds varying in respect of both their origin and action. Most of them are substances which damage the DNA of a neoplastic cell. With chemotherapy the most important issue is to administer to patients the maximum amount of medicine in the shortest intervals possible. Nevertheless, we must first of all bear in mind that there exist undesirable drug interactions which may radically alter a chemical treatment objective. It is a commonly known fact that reducing doses of medicine involves the failure of chemical treatment. The failure of a chemical treatment may also be connected with a decrease in anti-neoplastic activity or with an increase in toxicity of anti-neoplastic drugs. A number of most clinically important unfavourable interactions between commonly applied drugs and cytostatics are presented in this article. It is crucial issue to become acquainted with all the undesirable interactions in applying chemotherapy, since the lack of knowledge in this area may result in mishandling the chance of recovery.

[Evaluation of the efficacy of anti-emetic therapy with ondansetron injected intravenously at a daily dose of 8mg (analysis of material)]. / Ocena skutecznosci leczenia przeciwwymiotnego ondansetronem podawanym dozylnie w dawce dobowej 8 mg (analiza materialu).

The one of the most unpleasant undesirable symptoms of chemotherapy are nausea and vomiting. Authors evaluated and efficacy of ondansetron in anti-emetic therapy in 217 patients. In they opinion is very effective and improves a quality of life.