Search

Non-small cell lung cancer (NSCLC) presents the greatest number of identified therapeutic targets, some of which have therapeutic utility. Currently, detecting EGFR, BRAF, KRAS and MET mutations, ALK, ROS1, NTRK and RET translocations, and PD-L1 expression in these patients is considered essential. The use of next-generation sequencing facilitates precise molecular diagnosis and allows the detection of other emerging mutations, such as the HER2 mutation and predictive biomarkers for immunotherapy responses. In this consensus, a group of experts in the diagnosis and treatment of NSCLC selected by the Spanish Society of Pathology and the Spanish Society of Medical Oncology have evaluated currently available information and propose a series of recommendations to optimize the detection and use of biomarkers in daily clinical practice.

Bone metastases are common in many advanced solid tumours, being breast, prostate, thyroid, lung, and renal cancer the most prevalent. Bone metastases can produce skeletal-related events (SREs), defined as pathological fracture, spinal cord compression, need of bone irradiation or need of bone surgery, and hypercalcaemia. Patients with bone metastases experience pain, functional impairment and have a negative impact on their quality of life. Several imaging techniques are available for diagnosis of this disease. Bone-targeted therapies include zoledronic acid, a potent biphosfonate, and denosumab, an anti-RANKL monoclonal antibody. Both reduce the risk and/or delay the development of SREs in several types of tumours. Radium 233, an alpha-particle emitter, increases overall survival in patients with bone metastases from resistant castration prostate cancer. Multidisciplinary approach is essential and bone surgery and radiotherapy should be integrated in the treatment of bone metastases when necessary. This SEOM Guideline reviews bone metastases pathogenesis, clinical presentations, lab tests, imaging techniques for diagnosis and response assessment, bone-targeted agents, and local therapies, as radiation and surgery, and establishes recommendations for the management of patients with metastases to bone.

In 2011, the Spanish Society of Medical Oncology and the Spanish Society of Pathology started a joint project to establish recommendations on biomarker testing in patients with advanced non-small-cell lung cancer based on the current evidence. Most of these recommendations are still valid, but new evidence requires some aspects to be updated. Specifically, the recommendation about which biomarkers to test in which patients is being amended, and the best way to manage tumour samples and minimum requirements for biomarker test material are defined. Suitable techniques for testing for epidermal growth factor receptor mutations and anaplastic lymphoma kinase rearrangement are also reviewed, and a consensus is reached on which situations warrant re-biopsy.

Lung cancer incidence is decreasing worldwide among men but rising among women due to recent changes in smoking patterns in both sexes. In Europe, the smoking epidemic has evolved different rates and times, and policy responses to it, vary substantially between countries. Differences in smoking prevalence are much more evident among European women reflecting the heterogeneity in cancer incidence rates. Other factors rather than smoking and linked to sex may increase women's susceptibility to lung cancer, such as genetic predisposition, exposure to sex hormones and molecular features, all of them linked to epidemiologic and clinical characteristics of lung cancer in women. However, biological bases of sex-specific differences are controversial and need further evaluation. This review focuses on the epidemiology and outcome concerning non-small cell lung cancer in women, with emphasis given to the Spanish population.

Patients with advanced non-small-cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) mutations can now have specific treatment based on the result of biomarker analysis and patients with rearrangements of the anaplastic lymphoma kinase (ALK) gene will probably soon be able to. This will give them better quality of life and progression-free survival than conventional chemotherapy. This consensus statement was conceived as a joint initiative of the Spanish Society of Medical Oncology (SEOM) and the Spanish Society of Pathology (SEAP), and makes diagnostic and treatment recommendations for advanced NSCLC patients based on the scientific evidence on biomarker use. It therefore provides an opportunity to improve healthcare efficiency and resource use, which will undoubtedly benefit these patients. Although this field is in continuous evolution, at present, with the available data, this panel of experts recommends that all patients with advanced NSCLC of non-squamous cell subtype, or non-smokers regardless of the histological subtype, should be tested for EGFR gene mutations within a maximum of 7 days from the pathological diagnosis. Involved laboratories must participate in external quality control programmes. In contrast, ALK gene rearrangements should only be tested in the context of a clinical trial, although the promising data obtained will certainly justify in the near future its routine testing in patients with no EGFR mutations. Lastly, routine testing for other molecular abnormalities is not considered necessary in the current clinical practice.

Gastroenteropancreatic neuroendocrine tumours (GEP NETs) represent a heterogenous family of tumours with growing incidence and challenging clinical management. Unlike other solid tumours, they have the ability to secrete different peptides and neuramines that cause distinct clinical syndromes. However, many are clinically silent until advanced disease. This guideline aims to provide practical recommendations for the diagnosis and treatment of GEP NETs. Most recent histological and staging classifications, as well as available therapeutic approaches, such as surgery, locoregional therapy, peptide receptor radionuclide therapy (PRRT) and hormonal or systemic therapy, are discussed in this manuscript, including some recent relevant achievements with novel targeted agents. Clinical presentation (with or without hormonal syndrome), histological tumour features (including proliferation index (Ki-67) and the presence or not of somatostatin receptors), tumour stage, and location of primary tumour and distant metastasis are all key issues that shall be taken into consideration to properly design and integrate the most adequate therapeutic strategy.

Oesophageal cancer is currently the eighth most common malignancy worldwide. The incidence varies enormously between geographic areas, with increased incidences (100/100,000) in Asia, and central and south Africa. The incidence of oesophageal cancer in Spain has been approximately 8/100,000 among men and 1/100,000 among women. Oesophageal cancers are histologically classifi ed as squamous cell carcinoma (SCC) or adenocarcinoma, both with different associated risk factors. While SCCs have become increasingly less common, the incidence of adenocarcinoma has risen steeply. In the SEOM Clinical Guidelines for Oesophageal Cancer we propose rules for adequate initial diagnosis and staging as well as treatment recommendations from early to advanced disease.

Although thyroid cancer represents less than 1% of malignant tumours, its increased incidence detected in recent years and the appearance and development of new drugs targeting specific molecular targets has attracted the attention of the doctors involved in this pathology, especially medical oncologists. For this reason it is important at this critical point, when treatment may be substantially changed, to establish and agree updated guidelines. These guidelines should incorporate the newly developed strategies that, although still preliminary in evidence level, will surely have an important role, especially in relapsed and refractory tumours, which are unsuitable for surgical or radio-iodine treatment. Particular histological and molecular features of these tumours must be taken into account in order to optimise therapeutic approaches.

Nowadays, treatment selection for most types of cancers is based on anatomical, histological and clinical criteria, which are defi ned by the selection criteria used in registration phase III trials. However, different cancers present distinct molecular features, so the current approach results in a lack of specificity of cancer therapy, which is associated with decreased efficacy and unnecessary toxicities and costs. Molecular diagnostics has proved able to predict the efficacy of selected targeted therapies. This allows the selection of specific treatments for different types of cancer, increasing their efficiency. Even though the number of treatments for solid tumours that can be selected based on molecular diagnostic tools is limited, much effort is being put into the identification of new biomarkers. This guideline reviews molecular diagnostic biomarkers that allow selection of specific therapies that have obtained regulatory approval as treatment of solid tumours.

While hepatocellular carcinoma (HCC) is a relatively common tumour with an annual incidence in the EU of 8 cases/100,000 inhabitants, bile tract carcinoma (BTC) is much less common, with an incidence of 4 cases per 100,000 inhabitants per year. In both cases, when planning treatment it is essential to perform accurate staging, evaluate hepatic functional reserve and performance status, and obtain the opinion of the patient. The only curative treatment is surgery. However, several interventional radiological techniques can help to achieve local disease control and the alleviation of symptoms. In addition, sorafenib (HCC) and chemotherapy (BTC) may contribute to prolong survival in patients with disseminated disease. Therefore, the therapeutic strategy should always be discussed and planned within a multidisciplinary tumour board.

The purpose of this article is to provide updated recommendations for the diagnosis and treatment of muscle- invasive and metastatic bladder cancer. The diagnosis of muscle-invasive bladder cancer is made by transurethral resection and following histopathologic evaluation. Invasive bladder cancer should be staged according to the UICC system. Patients with confirmed muscle-invasive bladder cancer should be staged by computed tomography scans of the chest, abdomen and pelvis. Radical cystectomy is the treatment of choice for both sexes and lymph node dissection should be an integral part of cystectomy. In muscle- invasive bladder cancer (cT2-4aN0M0) patients with good performance status (PS 0-1) and correct renal function, neoadjuvant chemotherapy should be recommended. Adjuvant chemotherapy is widely used in high-risk patients with pathologic stage T3 or T4 and/or positive nodes and within clinical trials. Multimodality bladder-preserving treatment in localised disease is currently regarded only as an alternative in selected, well informed and compliant patients for whom cystectomy is not considered for clinical or personal reasons. In metastatic disease, the first-line treatment for patients is cisplatin-containing combination chemotherapy. Recently, vinflunine has been approved in Europe for second-line treatment and is an option for second-line therapy in patients progressing to first-line platinum-based chemotherapy.

Nasopharyngeal carcinoma is an unusual tumour in Spain. It has differences in epidemiology, histology, clinical behaviour, treatment and prognosis from those of other head and neck neoplasms, which justifies separate analysis. It is a neoplasm with a high possibility of cure with a combined treatment if even it is diagnosed in an advanced locoregional stage (stage III or IV, without metastasis). The multidisciplinary team, bringing together all professionals who specialize in the diagnosis and treatment of these tumors make the decision to establish the best sequence of individualized diagnosis, staging and treatment for each patient. This guide gives recommendations for diagnosis, staging and treatment for nasopharyngeal carcinoma. The treatment recommendations are summarized as local disease, locally advance and recurrent and metastatic disease.

Hodgkin's lymphoma is a malignant disease with an incidence of 2.2 cases/100,000. The main goals of staging are to measure the extent of disease and associated prognostic factors. Distinct recommendations were produced for initial work-up, first-line therapy of early and advanced stage disease and treatment of relapsed or resistant patients.

Colorectal cancer is the third most common malignant neoplasm and the second cause of death by cancer in western countries. In this manuscript, the clinical guidelines of the Spanish Society of Medical Oncology (SEOM) for diagnosis and adjuvant treatment of colon cancer and rectal cancer are reported.

Colorectal cancer is the first cause of cancer diagnosis in Spain. Over half of the patients are diagnosed with or will eventually develop distant metastasis. The current manuscript aims to provide synthetic practical guidelines for the therapeutic approaches in advanced disease. Available systemic therapeutic options, and integration and sequencing of chemotherapy with surgical procedures are discussed. Extent of disease, treatment objective, tumor kras mutation status, as well as patient's functional and comorbid conditions shall be considered to properly design the most adequate therapeutic strategy.

The purpose of this article is to provide updated recommendations for the diagnosis and treatment of patients non-small-cell lung cancer (NSCLC). The staging system for lung cancer has recently been revised by the International Association for Study of Lung Cancer and patients with NSCLC shall now be staged according to the UICC system 7th edition. Recommendations for treatment were based on treatment strategies that improve overall survival. In functionally fit patients with stage I-II disease surgical resection is recommended. Four cycles of adjuvant cisplatin-based chemotherapy is recommended in patients with pathologic stage II-III. For patients with stage IIIA and non-bulky mediastinal lymph node survival was significantly improved with induction chemotherapy plus surgical resection. Patients with unresectable or bulky stage IIIA and those with stage IIIB, should be treated with platinum-based chemotherapy and thoracic radiotherapy. For patients with metastatic disease and performance status of 0 or 1, a platinum-based two-drug combination of cytotoxic drugs is recommended. Nonplatinum cytotoxic doublets are acceptable for patients with contraindications to platinum therapy. For elderly patients and those with performance status of 2, a single cytotoxic drug is sufficient. Stop first-line cytotoxic chemotherapy at disease progression or after four cycles in patients who are not responding to treatment. Stop two-drug cytotoxic chemotherapy at six cycles even in patients who are responding to therapy. The first-line use of gefitinib may be recommended for patients with known epidermal growth factor receptor (EGFR) mutation; for negative or unknown EGFR mutation status, cytotoxic chemotherapy is preferred. Bevacizumab is recommended with platinum-based chemotherapy, except for patients with certain clinical characteristics. Maintenance therapy with pemetrexed or erlotinib increases survival in patients who did not progress after 4 cycles of a platinum based chemotherapy. Docetaxel, erlotinib, gefitinib, or pemetrexed is recommended as second-line therapy. Erlotinib is recommended as third-line therapy for patients who have not received prior erlotinib or gefitinib. Data are insufficient to recommend the routine third-line use of cytotoxic drugs.

Diffuse large B-cell non-Hodgkin's lymphoma (LDCGB) is one of the best examples of chemotherapy curable malignant diseases. This "Oncoguía SEOM" summarizes the basic directions of staging and recommended treatment options. The staging study should be thorough and includes clinical, laboratory, diagnostic imaging and nuclear medicine. Treatment depends on patient characteristics and comorbidity and on disease extension and prognostic factors. In localized cases, chemoimmunotherapy (CHOP-R) of short duration, followed by involved-field irradiation is the preferred option. In advanced stages, the association of CHOP-like chemotherapy and Rituximab has been a major breakthrough in terms of cure rate. It is important do not forget the supportive treatment in these patients.

Treatment of anaemia is a very important aspect in the management of cancer patients. In order to carry out a consensus process about the use of erythropoietic stimulating agents (ESAs) in cancer patients, the Spanish Society of Medical Oncology (SEOM) elaborated a working group which coordinated a panel of medical oncology specialists. This working group has reviewed the main issues about the use of ESAs. In addition a consensus meeting was held in Madrid on 25 April 2007. The following conclusions were made: Since ESA treatment increases the haemoglobin (Hb) level and decreases the red blood cell (RBC) transfusion requirements, ESAs should be used within the approved indications in patients undergoing chemotherapy treatment, beginning at a Hb level below 11 g/dl and maintaining it around 12 g/dl, with iron supplements if necessary. Neither increasing the ESA dose in non-responders nor the use of ESAs in the treatment of chronic cancer-related anaemia is recommended.

Anal carcinoma is an uncommon disorder accounting for less than 2% of large bowel malignancies and 1-6% of anorectal tumours. Its incidence ranges between 0.5 and 1% per 100,000. Local staging should be done with MR imaging using an external pelvic phased-array coil. Treatment strategy should be optimally discussed in a multidisciplinary team. HIV-positive patients seem to achieve similar response rate and overall survival to HIV-negative patients but with increased toxicity and higher local recurrences. Combined modality treatment with irradiation and chemotherapy has resulted in complete response over 90% and local control over 85%. This guide gives recommendations for diagnosis, staging and treatment.

The poor prognosis of non-small-cell lung cancer (NSCLC) is changing thanks to the constant development of new treatments and the introduction of target therapies, even in stage IV disease. This patient had bone metastases when he was diagnosed. Maintenance treatment, a much discussed topic nowadays, achieved a dramatic complete response.

We have carefully read the letter ‘‘Comments to SEOM clinical guidelines for the treatment of thyroid cancer’’ sent on behalf of the Thyroid Cancer Committee from the Spanish Society of Endocrinology and Nutrition (SEEN). We greatly appreciate and welcome the interest shown by our colleagues in our guidelines [1] that, as the rest of the clinical SEOM guidelines in cancer, are specially focused on helping medical oncologists in management of different tumors from our field of expertise. All our guidelines are mainly designed in a brief, schematic and practical format, to be a useful clinical tool for the medical oncologist, which is a specialty focused on treatment. That is the reason why not every issue concerning each cancer subtype is covered. If this issue is not taken into account, these guidelines could be considered incomplete. We fully agree that thyroid cancer treatment should be performed necessarily in a multidisciplinary context. Since the development of our specialty, we think that medical oncologists’ contribution to multidisciplinary management of cancer has been crucial in Spain. That is the reason why we do not care leaving untouched topics. We are sure that no medical oncologist is going to work outside a multidisciplinary team, where undoubtedly all patients will be comprehensively evaluated. Regarding the first three critical considerations, we believe it is important to understand that our guide is aimed particularly, as we stated at the beginning of the article, to ‘‘incorporate the new developed strategies, that surely will have an important role especially in relapsed and refractory tumors, unsuitable for surgical or Radio-iodine treatment.’’ We would not claim our guidelines to be used as reference in the field of diagnosis or surgical treatment. These other issues have been widely covered by previous and more completes guidelines. We agree, obviously, that a radioactive iodide (RAI) thyroid scan should be performed in a suspected nodule prior to FNA to rule out a hyperfunctioning one, where surgery would not be necessary. We also agree that where we said ‘‘radiological signs of suspect’’, it would be more accurate to say ‘‘ultrasound signs of suspect’’. In relation to the third point, we agree that cytopathological interpretation of FNA samples in thyroid nodules is a critical issue, but it far exceeds the targets set in our guide. Considering the fourth comment about the indication of lobectomy in some unilateral tumors, we honestly believe that the critical consideration does not really sustain, since we clearly stated that thyroidectomy is the most common and recommended oncologic approach, and that lobectomy ‘‘can be considered’’ in exceptional cases (very low-risk patients). We also clearly pointed out that this issue is controversial. We do not think that we say anything different to what other guidelines say [2, 3]. Related to the last consideration about follow-up, we agree also that ultrasound plays a critical role in follow-up, J. Martinez Trufero (&) Servicio de Oncologia Medica, Hospital Universitario Miguel Servet, Zaragoza, Spain e-mail: jmtrufero@seom.org