Treatment of cancer with oral drugs: a position statement by the Spanish Society of Medical Oncology (SEOM)
Cancer treatment involves the participation of multiple medical specialties and, as our knowledge of the disease increases, this fact becomes even more apparent [1]. 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 [2]. 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 [3].
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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)
[58]. Furthermore, the proportion of oral antitumor agents
being developed today far exceeds three-quarters of all the
cancer therapies that are currently under development [9].
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 [10]. 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].
the issue
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
offlabel use of drugs in oncology or the cancer care in the elderly
population [13, 14].
the position statement
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
cancerrelated 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
EMEA approval date Indications
Capecitabine February 2001 Da (...truncated)