The SEOM was founded in 1980, 2 years after the specialty of Medical Oncology was established in Spain [15
]. 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 [16
]. 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 [3
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 [3
]. 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.
- It is not true that oral anticancer drugs are less toxic. Although the toxicity profiles of the newer molecularly targeted drugs are less focused on blood cells than those of the traditional chemotherapeutics, they are not, in any sense, insignificant (). This class of drugs retains the potential for severe and possibly lethal adverse events, whose diagnosis and treatment cannot be properly handled by untrained physicians who do not work in a multidisciplinary environment. Thus, any antitumor therapy, whether administered orally or i.v., whether cytostatic or molecularly targeted, requires safe and careful handling by an experienced specialist and preferably one who has been formally trained in their use.
Table 2. Main toxic effects of oral anticancer drugs 
- The evaluation of the clinical response according to universally accepted criteria is key to anticancer drug administration [17, 18]. Only the training programs in Medical Oncology specifically include this expertise [3, 5]. Furthermore, in some malignancies, such as gastrointestinal stromal tumors, the response criteria used are specifically tailored for a single disease . Physicians, if unfamiliar with the subtleties of oncology practice, may keep administering a drug as long as the patient seems to be tolerating it well, hence confusing ‘clinical appearance’ with ‘clinical response’. In oncology, the term ‘clinical benefit’ means objective response or disease stability in the absence of limiting toxicity . This concept implies carrying out regular and objective evaluations of the tumor's response to therapy.
- A physician untrained in cancer therapy who decides to prescribe an oral anticancer drug may often administer it as monotherapy because he may feel uncomfortable using the whole range of anticancer agents. Based on wider experience, a medical oncologist will choose the best treatment, either as monotherapy or in combination with other oral or i.v. antitumor drugs, depending on the patient's situation and the existence of published evidence which supports their use.
- Often, an untrained physician will be familiarized with the use of one oral agent only. For this reason, treatment options offered to a patient may be in these cases just two: either to be treated with that single drug or to be not treated at all. At the heart of a multidisciplinary team that includes a medical oncologist, many treatment options are available. Oral therapy is usually one among several possibilities. The alternatives range from various types of surgeries, radiotherapy, combinations of a variety of chemotherapeutics and biological agents, participation in clinical trials, or referral to an oncology palliative care team. In this era of individualized medicine, cancer treatment in inexperienced hands implies a clear limitation in the chances of tailoring treatments according to the individualized needs of a patient.
- Oncology teams have acquired a particular medical culture founded upon the use of protocols. Not only are anticancer drugs given according to specific and detailed written protocols but also the administration of complementary therapies, such as antiemetics, bone marrow growth factors, pain management, palliative care, information for the patient and relatives, genetic counseling services, or data inclusion in cooperative databases, is covered by strict procedural guidelines. Outside the area of Medical Oncology, an inexperienced physician often works alone or in small groups, and hence a patient may suffer from inadequate treatment and support.
- We know that anticancer drugs do not benefit all patients in the same way, and many efforts are oriented to the development of biomarkers that make cancer therapy more cost-effective. In a context of finite budgets, it is important that the prescription of these drugs is done by trained specialists that are proficient in treatment selection. Specific policy measures at the European and National levels should conduct strict reimbursement policies that take into account the prescribing physicians' specialty.
- Lastly, in everyday oncology practice, medical therapy and clinical research are so closely linked that it is almost unthinkable to consider them apart. The inclusion of patients in large cooperative clinical trials not only constitutes the best treatment option for many patients but is also a key element in the development of cancer therapy. The sponsors of clinical trials are often either large research cooperative groups or multinational pharmaceutical companies. In these studies, only those professionals who are integrated into solid multidisciplinary teams; who have the infrastructure, the knowledge, the experience, and the motivation necessary to achieve a high recruitment volume; and who demonstrate an impeccable adherence to the complex research protocols are invited to participate. For patients, being treated outside the oncological expertise may result in missing the opportunity to be included in a clinical trial. For clinical research itself, this may translate into a decrease in the number of patients recruited in clinical trials and in a difficulty in controlling selection bias.