Let me first frame the system and environment under which he and most myeloma specialists in Europe operate. First, it is a National Health Care system and has some advantages and disadvantages. The key advantage is that all people obtain the same level of service. The negatives are that some of the newer drugs which have been approved by the FDA take much longer to be approved by the similar EMA (European Medicines Agency).
On June 29, 2006, lenalidomide received U.S. Food and Drug Administration (FDA) clearance for use in combination with dexamethasone in patients with multiple myeloma who have received at least one prior therapy.
On 23 April 2009, The National Institute for Health and Clinical Excellence (NICE) issued a Final Appraisal Determination (FAD) approving lenalidomide, in combination with dexamethasone, as an option to treat patients who suffer from multiple myeloma who have received two or more prior therapies in England and Wales.
Some of the major points which I took away from his broadcast were as follows:
- The myeloma effort is an international effort and we all learn from each other, and international collaboration is essential to its success.
- Message number one for the audience is an important and critical message. Because myeloma is such a rare and complex disease patients should find a myeloma specialist who sees more than 100 myeloma patients per year. Anything less, you may have a great doctor but they lack the necessary experience to adequately treat myeloma.
- Europe is moving towards more specialties where doctors will handle only one of the hematologic diseases like myeloma, leukemia, or lymphoma.
- Although the Allo transplant is used 7 times as often in Europe, it is not the standard of care for newly diagnosed. It is used in the context of clinical trials, and then only in young patients and those with early relapse. The allo transplant has 10 to 15% death rate in the first 100 days, and studies show no difference in outcomes between the allo and the auto. We hope for a graft vs. myeloma effect which is good, but could also have graft vs. host impact which is bad. So for the individual patient it is like Russian Roulette.
- Auto Transplant is used more in up-front treatment in Europe, whereas the US seems to be reluctant. Two trials clearly indicate the use of auto transplant at diagnosis provides improved response duration, and overall survival. Auto transplants must be delivered at diagnosis, and Dr. Palumbo utilizes tandem transplants.
- Fifty percent of patients who collect stem cells do not use them. Co-morbidity causes 15% of this 50%, a rural location not close to a transplant center 15%, and the doctor's choice to transplant or not 20% of patients.
- Patients and doctors in USA see the FDA as slow and ponderous, however the EMA (European Medicines Association) is far less effective, as can witnessed by the slow new drug approval. Europe does however have a more homogenous treatment approach where the drugs, transplants, and visits are free to the patient. The EMA determines that the drugs are effective and safe, and then each country decides whether to approve it for use.
- Dr. Palumbo changes the treatment options by using a scale of Fit, Unfit, and Frail. Some items which would dictate a modified approach would be a patient over 65 with co-morbidities, patients over the age of 80 where 81 is unfit, patients who have limited mobility, and those with compromised cognitive function may not allow the patient to take treatments as scheduled.
- In Europe recruitment for clinical trials may be easier for a few reasons. In a public health care system salaries are unchanged by treatment decisions, and patients have more faith the doctors will do the right thing. In the US there is more of a do- it- yourself mindset, where in Europe care is delegated to others, or as Dr. Palumbo called it the "BIG PA PA". He believes Europe is beginning to shift to be more like the US.
- Dr. Palumbo believes maintenance should be ongoing as long as there are no adverse reactions. The RD (Response Duration) is shown to be 1 to 1 1/2 years longer, whereas the OS (overall survival) advantage is small.
- Dr. Palumbo believes the groundbreaking work is being conducted in the area of mono clonal antibodies. He believes these will be game changers.
- He is of the opinion that there is no effective treatment as yet for high risk disease. For both high risk and low risk patients he will use VTD and two stem cell transplants and maintenance. He would use VRD-PACE, but this combination is not reimbursed. Because the current cure rate is between 15 to 25%, he spends more time on control rather than cure.
- He believes in early treatment of smoldering myeloma, with a monoclonal antibody added to VRD, and the advantages outweigh the possibility of the development of more aggressive clones.
Dr. Palumbo has proven he and his team can do more with less, and we thank him for his service to the myeloma patient community. A brief bio of Dr. Palumbo follows:
He received his medical degree from the University of Torino - Italy; served his residency in internal medicine and held a fellowship in hematology/oncology at the University of Torino.
Before his current position as Chief of the Myeloma Unit of the Department of Oncology, Division of Hematology, University of Torino, Dr. Palumbo was Research Associate at the Wistar Institute, University of Pennsylvania. He specialized in hematology malignancies and medical oncology and has clinical and research interest in plasma cell dyscrasia.
He is a member of Board of Directors of the International Myeloma Society (IMS), of the Advisory Board of the International Myeloma Foundation (IMF) and president of the European Myeloma Network Trial Group (EMNTG).
Dr. Palumbo is also leading several multidisciplinary projects on the molecular biology and the pathogenesis of multiple myeloma, and on the development of biological markers to predict clinical outcome. He is the principal investigator of many national and international trials investigating the role of new drugs and second-generation novel agents for the treatment of young and elderly patients with multiple myeloma, both at diagnosis and at relapse. The results achieved by his team and him contributed to prolong survival of patients and to improve their quality of life.
In Recognition of Significant Contributions to Myeloma Research and Patient Care International Myeloma Foundation Honors Dr. Antonio Palumbo with 2014 Robert A. Kyle Lifetime Achievement Award
In addition to membership in numerous professional organisations, Dr. Palumbo has authored more than 100 publications in peer reviewed journals as well numerous abstract and several textbooks chapters. His current research focuses on the pathogenesis and treatment of multiple myeloma.
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