The Cleopatra study reports improvement in median survival of almost 16 months in patients with HER2-positive metastatic breast cancer
The consequent clinical recommendation from now on is to administer the combination of the Pertuzumab, Trastuzumab and Docetaxel trio of drugs for the treatment of patients with HER2-positive metastatic breast cancer
Barcelona, 23 February 2015. – A Phase III, international, multicenter study led by the Vall d’Hebron Institute of Oncology (VHIO) has reported the best survival results in the history of metastatic breast cancer. Published recently in the New England Journal of Medicine (NEJM), the clinical trial combined three drugs for the treatment of patients with HER2-positive metastatic breast cancer — Pertuzumab, Trastuzumab and Docetaxel, resulting in an improvement in median survival of almost 16 months compared to the previous standard treatment of the Trastuzumab and Docetaxel (or paclitaxel) duo.
The results, which had already in-part been advanced as breaking-data during the most prestigious international scientific meetings in order to help advance the field as quickly as possible, have already provided the basis for a new clinical protocol and approach in the first line of treatment of HER2-positive metastatic breast cancer, which is one of the most aggressive tumor types.
“Reporting 16 months´survival improvement is unprecedented, and if we also factor in that we are dealing with metastatic disease, these results are enormously positive”, explains Javier Cortés, Principal Investigator of VHIO´s Breast Cancer and Melanoma Group, and head of the study. He continues, “These are the best ever results in breast cancer history, and some of the most promising from a solid tumor”.
From selective anti-HER2 treatments to Pertuzumab salvage therapy
More than 300,000 women are diagnosed with breast cancer in Europe every year. Approximately one in three women will present metastasis over time and the cancer will spread. Metastatic breast cancer is an advanced stage of the disease, and occurs when the cancer extends outside the breast to other parts of the body (lungs, bones, etc.). HER2-positive breast cancer has the HER2 protein in larger quantities on the surface of the tumor cells (overexpression) and patients with this tumor type benefit from HER2-targeted (anti-HER2) therapies. Nowadays, detection of this protein is carried out routinely since this overexpression can be treated with specific anti-HER2 antibodies.
Today´s anti-HER2 therapeutic weaponry represents one of the major advances in breast cancer treatment. Trastuzumab was one of the first anti-HER2 therapies and represented a revolution in the treatment of HER2-positive tumors. Although undeniably marking a tremendous milestone in expanding therapeutic options for these patients and a decisive turning point in the treatment of breast cancer, the need to further develop these therapies to become even more effective and further increase the survival of these patients, especially those with metastatic cancer, remained the focus of determined research efforts.
It was during such attempts to increase the therapeutic arsenal against these tumors that Pertuzumab was also proposed as a likely contender. This was not then the case. After years of studies, Pertuzumab did not deliver on objectives, results were discouraging as a monotherapy, and it seemed that this therapy would not prove useful in the battle against HER2-positivie breast cancer patients. That was until the Cleopatra study arrived.
The José Baselga and Javier Cortés tandem had previously demonstrated the usefulness of Pertuzumab in combination with other agents, and these results were the basis for this Phase III study. According to Cortés, “This advancement is possible thanks to the collective and titanic work of many. We are increasingly making anti-cancer therapies more precise and tailoring strategies to the specificities of each individual tumor. Undoubtedly we are making important progress towards a point in time when we will be able to talk about cancer as a chronic and/or curable disease.”
An unprecedented study, a protocol to follow
The data that were presented during the 2014 Congress of the European Society for Medical Oncology (ESMO), 26-30 September (Madrid, Spain), have since been through all the scientific validation processes, and it is of little surprise that such progressive results have now been published in the New England Journal of Medicine. This journal, which has one of the highest impact factors in biomedicine, is the top journal in clinical practice and generally marks the most widely recommended standard clinical protocols to be followed by the entire medical community.
These results, explains Cortés, are of great clinical significance and provide fresh hope for patients. “Never before have we had a study that improves survival in patients with advanced-stage HER2-positive breast cancer by 16 months. Generally, the Phase III studies we conduct in metastatic cancer achieve improvements in median survival of 3 or 4 months, and we are taking gradual steps forward. An improvement in survival of 16 months is like moving 5 years forward in research overnight, and directly for the benefit of the patients,” he says. “Right now, without a doubt, the recommendation is to administer this trio of drugs in the treatment of patients with HER2-positive metastatic breast cancer.”