Phase III trials presented at the ESMO 2014 Congress report major advances in supportive care for cancer patients.
Therapies have been shown to reduce chemotherapy-induced nausea and vomiting, bleeding in patients with venous thromboembolism (VTE) and cancer anorexia-cachexia syndrome (CACS).
Nausea and Vomiting
Rolapitant was found to reduce nausea and vomiting in patients receiving cisplatin-based chemotherapy in a phase III trial. Such symptoms are often experience by patients on cisplatin and can cause dose reductions and treatment discontinuation.
The trial met its primary endpoint, with 72.7% of patients receiving rolapitant achieving complete response (defined as the patient having no emesis and not requiring any rescue medication) in the delayed phase (>24-120 hours post-chemotherapy) compared to 58.4% of those receiving placebo (p<0.001).
ESMO spokesperson Dr Roberto Labianca, director of the Cancer Center, Ospedale Giovanni XXIII, Bergamo, Italy, said: “In this well conducted large-scale clinical trial there was a clear advantage in patients receiving rolapitant when treated with highly emetogenic chemotherapy. It is remarkable that this effect was observed worldwide across different geographic regions. As the new drug is very selective and long-acting, and also well tolerated, it could be easily introduced in clinical practice in order to prevent both acute and delayed chemotherapy-induced nausea and vomiting.”
Bleeding and VTE
Oral rivaroxaban reduced the risk of bleeding in patients with cancer and acute VTE who participated in the EINSTEIN DVT and EINSTEIN PE phase III trials. Both studies compared rivaroxaban to standard treatment with enoxaparin/vitamin K antagonist (VKA) for the treatment of symptomatic VTE in patients with cancer. Anticoagulant therapy is indicated to prevent recurrent VTE but is associated with a high risk of major bleeding.
The study found that the incidence of recurrent VTE and of mortality was similar between the rivaroxaban and enoxaparin/VKA groups for patients with active cancer and a history of cancer. The risk of major bleeding significantly reduced with rivaroxaban in patients with active cancer, with a hazard ratio of 0.42 but was similar between treatments for patients with a history of cancer.
Dr Labianca commented, “Rivaroxaban is an oral drug, with the same antithrombotic effect as compared to the traditional drugs, but with a reduced risk of bleeding. This characteristic can be very important in clinical practice, allowing an easier and more convenient treatment of such a serious complication of cancer.”
Cancer Anorexia-Cachexia Syndrome
The phase III ROMANA 1 trial investigated the efficacy and safety of anamorelin HCI, a novel, selective ghrelin receptor agonist, for the treatment of CACS in patients with unresectabe advanced non-small cell lung cancer.
Dr Labianca said: “This is really an important advance, as the study emphasises the absolute need of establishing an approach of simultaneous palliative care in patients with advanced disease (such as NSCLC) treated with anti-tumour drugs and affected with serious symptoms like CACS.”
He concluded: “These studies demonstrate the research efforts directed toward improving the quality of life for patients with cancer and the significant advances that have been made to control some of the most severe repercussions of treatment.”