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Cancer treatment involves the participation of multiple medical specialties and, as our knowledge of the disease increases, this fact becomes even more apparent . The degree of multidisciplinarity is determined by several factors, which include the severity and type of disease, the increasing diversity in the available pharmacological and non-pharmacological therapies, and the range of specialists involved in cancer therapy, such as medical oncologists, radiotherapists, gynecologists, gastroenterologists, urologists, surgeons, and pneumologists, among others. Across Europe, the situation of cancer care can be variable due to the diversity of health systems, differences in drug reimbursement, and the degree of establishment of Medical Oncology as a medical specialty in the European Union states .
Within this multidisciplinary approach, each of the specialties involved in cancer treatment has a specific role, and according to an international panel of experts, the medical oncologist is the physician who plans global cancer treatment, administers systemic anticancer therapies to the patient, and takes care of the general well-being of the patient .
Oral anticancer drugs have been available since the early days of cancer treatment, although their use had been limited due to, among other reasons, their sometimes unpredictable oral bioavailability, and i.v. agents were preferred. This approach has changed in recent years as a number of cytotoxic drugs such as capecitabine, vinorelbine, or topotecan have become available as oral agents for the treatment of a large variety of tumors like colon, breast, gastric, ovarian, or lung cancer (Table 1). More importantly, the introduction of therapies directed against specific molecular targets has steered the use of oral drugs into the heart of daily oncology practice. Indeed, almost half of the targeted molecules approved for the treatment of cancer in the European Union since the year 2000 are exclusively available as oral formulation (Table 1) [5–8]. Furthermore, the proportion of oral antitumor agents being developed today far exceeds three-quarters of all the cancer therapies that are currently under development . Additionally, some oral anticancer treatments are perceived by most patients as a valuable way to cope with their diseases without many side-effects, visits to the clinic, or venipunctures . Hence, it is hardly surprising that some cancer patients may prefer the use of oral to i.v. chemotherapy, even at the expense of sacrificing part of the clinical efficacy [11, 12].
Along with the growing numbers of oral drugs available for the treatment of cancer, we have observed with great concern that some of these drugs have been moving out of the use by the oncology experts and into that of other physicians that are less familiar with comprehensive cancer treatment. In Spain, we estimate that this practice represents, depending on a particular oral anticancer drug, from ~5% to >20%. This is very likely to eventually pose a risk to cancer patients. The use of oral cancer treatments by physicians unfamiliar with routine oncology practice is worrisome because it compromises the excellence of oncological practice and may result in a deterioration of the medical care received by cancer patients.
Therefore, the Spanish Society of Medical Oncology (SEOM) wishes to state its point of view on this subject to the medical community, with the objective to open a debate, as has been done in the past with other oncology-related subjects as the off-label use of drugs in oncology or the cancer care in the elderly population [13, 14].
The SEOM was founded in 1980, 2 years after the specialty of Medical Oncology was established in Spain . In Spain, the Ministries of Health and Education determine the requirements, the duration, and, above all, the contents of the training programs for each of the medical and surgical specialties, including Medical Oncology . The Spanish training program of Medical Oncology includes all cancer-related issues, namely the molecular biology, epidemiology, diagnostic procedures, the anticancer drugs, and the methodology to be followed in the various types of clinical trials based on the guidelines for Good Clinical Practice. Additionally, Medical Oncology is the only specialty in Spain that covers specifically the pharmacological treatment of cancer using drugs administered i.v., orally, or by any other route. The Spanish Medical Oncology training program has much in common with standards setup jointly by the European Society for Medical Oncology and the American Society of Clinical Oncology .
In our opinion, Medical Oncology specialists are presently the best-trained professionals to plan and administer systemic anticancer therapies throughout all European countries in which this medical specialty exits . In addition to Medical Oncology specialists, there are some physicians in Europe who may be empowered to treat cancer patients. Thus, in some European countries, there are supraspecialists within gynecology, gastroenterology, urology, or pneumology that may have the necessary training to qualify them to treat with drugs certain cancer types, although not all. Also, we must take into account those individual cases of physicians who, although not having formal oncology training, have acquired supervised or unsupervised experience during years of practice.
Why are professionals who are not fully trained or experienced in the pharmacotherapy of cancer prescribing oral antineoplastics? There are several reasons explaining this, among which is the belief that oral anticancer drugs have a lower toxicity, and hence their delivery does not require specific skills or knowledge, or that the administration outside of a day hospital facilitates the outpatient prescription of these agents. Furthermore, the possibility of using novel molecular-targeted drugs may be tempting from a professional point of view because of using ‘modern’ drugs. This is especially true in the field of cancer therapy, which has led the pharmacological molecular revolution that we are witnessing nowadays. In addition, there is a clear marketing pressure applied by pharmaceutical companies to non-oncology specialists for the use of their latest generation drugs.
Several solid reasons support our warning that the administration of oral anticancer drugs outside the scope of trained oncologists should be considered unsuitable and potentially dangerous.
SEOM has observed that untrained physicians outside the Medical Oncology specialty field are prescribing oral anticancer drugs to patients with cancer. This practice is sometimes based on false assumptions about the easiness of administration or the toxic effects profile of the newer oral anticancer drugs. Cancer therapy implies a global responsibility that goes beyond the prescription of a single drug; it is a commitment that encompasses many aspects of the medical care that is offered to a patient and reaches the society as a whole. The responsibility of safe and effective delivery can only be guaranteed within the heart of multidisciplinary teams who have undergone thorough training in all aspects of comprehensive cancer care and who are governed by strict protocols, have wide therapeutic experience, and are either led or coordinated by medical oncologists. We believe that the prescription of anticancer drugs by physicians who are not oncology experts may compromise the current standards of safety and efficacy in the medical care offered to cancer patients and the high quality of cancer research. SEOM wishes to alert our European Medical Oncology colleagues, the European national health care providers, the international oncology community as a whole, and the general public about this situation and to encourage awareness among health care providers. SEOM believes that regulatory measures to deal with this problem should be undertaken both locally and nationally.
The SEOM acknowledges the support for this project of unrestricted grants from Pfizer, Spain; Pierre Fabre Medicament, Spain; GlaxoSmithKline, Spain; Bayer HealthCare, Spain; and Novartis Farmacéutica, Spain.
Editorial assistance for the development of the manuscript was provided by Beatriz Gil-Alberdi from HealthCo (Madrid, Spain). The members of the SEOM Executive Committee 2007–2009 are RC, EA, AL, MM, ARL, JS, JA, AG-M, DI, ML, CAR, and JMT. LP-A, RR, EA, JT, MM, AG-M, JRG, JB, and JB represent the Spanish cancer research groups (a full list can be obtained at http://www.seom.org/seomcms/index.php?option=com_content&task=section&id=16&Itemid=272).