Epicure: a European epidemiological study of patients with an advanced or metastatic Urothelial Carcinoma (UC) having progressed to a platinum-based chemotherapy.

BACKGROUND: Platinum-based systemic chemotherapy is considered the backbone for management of advanced urothelial carcinomas. However there is a lack of real world data on the use of such chemotherapy regimens, on patient profiles and on management after treatment failure. METHODS: Fifty-one randomly selected physicians from 4 European countries registered 218 consecutive patients in progression or relapse following a first platinum-based chemotherapy. Patient characteristics, tumor history and treatment regimens, as well as the considerations of physicians on the management of urothelial carcinoma were recorded. RESULTS: A systemic platinum-based regimen had been administered as the initial chemotherapy in 216 patients: 15 in the neoadjuvant setting, 61 in adjuvant therapy conditions, 137 in first-line advanced setting and 3 in other conditions. Of these patients, 76 (35 %) were initially considered as cisplatin-unfit, mainly because of renal impairment (52 patients). After platinum failure, renal impairment was observed in 44 % of patients, ECOG Performance Status ≥ 2 in 17 %, hemoglobinemia < 10 g/dL in 16 %, hepatic metastases in 13 %. 80 % of these patients received further anticancer therapy. Immediately after failure of adjuvant/neoadjuvant chemotherapy, most subsequent anticancer treatments were chemotherapy doublets (35/58), whereas after therapy failure in the advanced setting most patients receiving further anticancer drugs were treated with a single agent (80/114). After first progression to chemotherapy, treatment decisions were mainly driven by Performance Status and prior response to chemotherapy (>30 % patients). The most frequent all-settings second anticancer therapy regimen was vinflunine (70 % of single-agent and 42 % of all subsequent treatments), the main reasons evoked by physicians (>1 out of 4) being survival benefit, safety and phase III evidence. CONCLUSION: In this daily practice experience, a majority of patients with urothelial carcinoma previously treated with a platinum-based therapy received a second chemotherapy regimen, most often a single agent after an initial chemotherapy in the advanced setting and preferably a cytotoxic combination after a neoadjuvant or adjuvant chemotherapy. Performance Status and prior response to chemotherapy were the main drivers of further treatment decisions.

Prognostic time dependence of deletions affecting codons 557 and/or 558 of KIT gene for relapse-free survival (RFS) in localized GIST: a Spanish Group for Sarcoma Research (GEIS) Study.

BACKGROUND: To assess whether deletions involving codons 557 and/or 558 (critical deletions) of exon 11 of KIT are relevant in the prognosis of relapse-free survival (RFS) in gastrointestinal stromal tumor (GIST) patients with a long follow-up. PATIENTS AND METHODS: A univariate and multivariate analysis for RFS were carried out on 162 localized GIST patients over the entire follow-up period and over the intervals 0-4 years and >4 years. Factors assessed among others were Fletcher/National Institutes of Health and Miettinen-Lasota/Armed Forces Institute of Pathology (M-L/AFIP) risk categories, critical deletions and non-deletion-type mutation (NDTM) within exon 11 of KIT. RESULTS: Multivariate analyses revealed that M-L/AFIP [relative risk (RR) 11.45, confidence interval (CI) 4.40-29.76, for the high-risk subgroup and RR 5.97, CI 2.09-17.06, for the intermediate subgroup] and critical deletions (RR 3.05, CI 1.59-5.85) were independent prognostic factors for RFS for the first 4 years and for the entire follow-up period. Beyond 4 years, the high-risk M-L/AFIP subgroup (RR 8.12, CI 1.48-44.4) and NDTM (RR 6.42, CI 1.17-35.12) were independent prognostic factors for RFS. The median follow-up was 84 months. CONCLUSION: Critical deletions represent a time-dependent prognostic factor limited to the first 4 years after surgery, which could help identify a subset with higher and earlier risk for relapse in GIST patients.

SEOM clinical guideline for treatment of kidney cancer (2019).

In this article, we review de state of the art on the management of renal cell carcinoma (RCC) and provide recommendations on diagnosis and treatment. Recent advances in molecular biology have allowed the subclassification of renal tumours into different histologic variants and may help to identify future prognostic and predictive factors. For patients with localized disease, surgery is the treatment of choice with nephron-sparing surgery recommended when feasible. No adjuvant therapy has demonstrated a clear benefit in overall survival. Considering the whole population of patients with advanced disease, the combination of axitinib with either pembrolizumab or avelumab increase response rate and progression-free survival, compared to sunitinib, but a longer overall survival has only been demonstrated so far with the pembrolizumab combo. For patients with IMDC intermediate and poor prognosis, nephrectomy should not be considered mandatory. In this subpopulation, the combination of ipilimumab and nivolumab has also demonstrated a superior response rate and overall survival vs. sunitinib. In patients progressing to one or two antiangiogenic tyrosine-kinase inhibitors, both nivolumab and cabozantinib in monotherapy have shown benefit in overall survival compared to everolimus. Although no clear sequence can be recommended, medical oncologists and patients should be aware of the recent advances and new strategies that improve survival and quality of life in patients with metastatic RCC.

The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation study for Spanish patients.

OBJECTIVES: The EORTC Quality of Life (QL) Group has developed a questionnaire, the EORTC QLQ-PR25, for evaluating QL in prostate cancer. The aim of this study is to assess the psychometric properties of the EORTC QLQPR25 when applied to a sample of Spanish patients. MATERIALS AND METHODS: One hundred and thirty-seven prostate cancer patients with localised disease who started radiotherapy with radical intention combined with or without hormonotherapy prospectively completed the EORTC QLQ-C30 and EORTC QLQ-PR25 questionnaires three times: on the first and last day of radiotherapy and in the follow-up period. Psychometric evaluation of the questionnaires' structure, reliability and validity was conducted. RESULTS: Multitrait scaling analysis showed that many of the item-scale correlation coefficients met the standards of convergent and discriminant validity. Exceptions appeared mainly in the scales for bowel symptoms and for hormonal- treatment-related symptoms. Cronbach's coefficients of the scales were good (0.72-0.86) for the urinary symptoms and sexual function scales but they were lower (<0.70) for the bowel and hormonal treatment scales. Most scales of the EORTC QLQ-PR25 had low to moderate intercorrelations. Correlations between the scales of the QLQ-C30 and the module were generally low. Group comparison analyses showed better QL in patients with higher Performance Status. Changes in QL appeared throughout the measurements. These were in line with the treatment process. CONCLUSIONS: The EORTC QLQ-PR25 was a reliable and valid instrument when applied to a sample of Spanish prostate cancer patients. These results are in line with those of the EORTC validation study.

Correction to: SEOM Clinical Guideline for treatment of muscle-invasive and metastatic urothelial bladder cancer (2016).

Due to a technical issue, the family name of the author.

SEOM clinical guideline for treatment of muscle-invasive and metastatic urothelial bladder cancer (2018).

The goal of this article is to provide recommendations about the management of muscle-invasive (MIBC) and metastatic bladder cancer. New molecular subtypes of MIBC are associated with specific clinical-pathological characteristics. Radical cystectomy and lymph node dissection are the gold standard for treatment and neoadjuvant chemotherapy with a cisplatin-based combination should be recommended in fit patients. The role of adjuvant chemotherapy in MIBC remains controversial; its use must be considered in patients with high-risk who are able to tolerate a cisplatin-based regimen, and have not received neoadjuvant chemotherapy. Bladder-preserving approaches are reasonable alternatives to cystectomy in selected patients for whom cystectomy is not contemplated either for clinical or personal reasons. Cisplatin-based combination chemotherapy is the standard first-line protocol for metastatic disease. In the case of unfit patients, carboplatin-gemcitabine should be considered the preferred first-line chemotherapy treatment option, while pembrolizumab and atezolizumab can be contemplated for individuals with high PD-L1 expression. In cases of progression after platinum-based therapy, PD-1/PD-L1 inhibitors are standard alternatives. Vinflunine is another option when anti-PD-1/PD-L1 therapy is not possible. There are no data from randomized clinical trials regarding moving on to immuno-oncology agents.

The Medical Oncology resident mentor: situation and workload.

PURPOSE: The Spanish Society for Medical Oncology (SEOM, for its acronym in Spanish) and the National Commission for the Specialty of Medical Oncology seek to highlight the important workload and unrecognized dedication entailed in working as a Medical Oncology (MO) resident mentor, as well as its relevance for the quality of teaching units and the future of the specialty. MATERIALS AND METHODS: The current situation and opinion regarding the activity of MO resident mentors was analyzed by reviewing the standing national and autonomic community regulations and via an online survey targeting mentors, residents, and physicians who are not MO mentors. The project was supervised by a specially designated group that agreed on a proposal containing recommendations for improvement. RESULTS: Of the MO mentors, 90% stated that they did not have enough time to perform their mentoring duties. An estimated 172 h/year on average was dedicated to mentoring, which represents 10.1% of the total time. MO mentors dedicate an average of 6.9 h/month to these duties outside their workday. Forty-five percent of the mentors feel that their role is scantly recognized, if at all. CONCLUSIONS: The study reveals the substantial dedication and growing complexity of MO resident mentoring. A series of recommendations are issued to improve the conditions in which it is carried out, including the design of systems that adapt to the professional activity in those departments that have time set aside for mentoring tasks.

[Orbital metastases of breast cancer]. / Metástasis orbitarias del cáncer de mama.

Orbital metastases are a defined subgroup within ocular affection secondary to the distant spread of breast cancer. We review the published experience on the incidence of orbit extension from this type of tumour, with reference made to our experience as medical oncologists, together with the most common clinical features and the relevant aspects for imaging and histopathological diagnoses. The therapy for orbital metastases from breast cancer is included within the systemic therapy required by the distant spread of the disease, with some clinical benefits obtained from hormone therapy, chemotherapy and monoclonal antibodies. Palliative radiation and surgery may also play an important role in providing care to these patients. Although there are some published cases with long-term survival, the prognosis for these patients is poor, and new advances in knowledge and therapy are needed for this complication due to breast cancer.

SEOM clinical guidelines in gestational trophoblastic disease (2017).

Gestational trophoblastic disease (GTD) is a rare but curable disease. Recent improvements in diagnosis and molecular biology have resulted in changes in staging and treatment. These guidelines provide evidence-based recommendation on how to manage GTD.

SEOM Clinical Guideline for treatment of muscle-invasive and metastatic urothelial bladder cancer (2016).

The goal of this article is to provide recommendations for the diagnosis and treatment of muscle-invasive and metastatic bladder cancer. The diagnosis of muscle-invasive bladder cancer is made by pathologic evaluation after transurethral resection. Recently, a molecular classification has been proposed. Staging of muscle-invasive bladder cancer must be done by computed tomography scans of the chest, abdomen and pelvis and classified on the basis of UICC system. Radical cystectomy and lymph node dissection are the treatment of choice. In muscle-invasive bladder cancer, neoadjuvant chemotherapy should be recommended in patients with good performance status and no renal function impairment. Although there is insufficient evidence for use of adjuvant chemotherapy, its use must be considered when neoadjuvant therapy had not been administered in high-risk patients. Multimodality bladder-preserving treatment in localized disease is an alternative in selected and compliant patients for whom cystectomy is not considered for clinical or personal reasons. In metastatic disease, the first-line treatment for patients must be based on cisplatin-containing combination. Vinflunine is the only drug approved for use in second line in Europe. Recently, immunotherapy treatment has demonstrated activity in this setting.

SEOM Clinical Guideline in ovarian cancer (2016).

Despite remarkable advances in the knowledge of molecular biology and treatment, ovarian cancer (OC) is the first cause of death due to gynecological cancer and the fifth cause of death for cancer in women in Spain. The aim of this guideline is to summarize the current evidence and to give evidence-based recommendations for clinical practice.

[Oncologic treatment of oto-neuro-ophthalmological metastases and their complications]. / Tratamiento oncológico de las metástasis otoneuroftalmológicas y sus complicaciones.

INTRODUCTION: Cerebral metastases and the sequelae of their treatment are the major cause of neurological symptoms in patients with cancer. OBJECTIVE: In this article we review the oto-neuro-ophthalmological complications of the treatment of metastases with radiotherapy and/or chemotherapy. DEVELOPMENT: When speaking of the iatrogenic diseases caused by radiotherapy treatment of metastases, it is important to emphasize that the major complications of this form of treatment are seen in the long term, in general, months or years later. When dealing with incurable diseases, such as most metastatic cancers, the benefit/risk balance of each therapeutic option has to be taken into account. Thus we have a population of patients with symptoms secondary to metastatic involvement, and with an overall life expectancy which may be measured in months. The oto-neuro-ophthalmological toxicity of the chemotherapy may present as an infrequent and unexpected complication or as a usual, expected secondary effect of the drug used. A large variety of drugs are used for the systemic control of cancer (cystostatic drugs, hormones and modifiers of the biological response) which, in one way or another, may cause neurological signs. CONCLUSION: The increasingly frequent use of high dose chemotherapy and of the combined use of chemotherapy and radiotherapy mean that these types of toxicity have become common clinical syndromes in current oncological practices.

[Emergency treatment of urological complications in cancer patients]. / Manejo urgente de las complicaciones urológicas en el paciente tumoral.

Patients affected by neoplastic diseases frequently come for consultation to the emergency services of our hospitals. A large part of these consultations occur due to complications of an urological type, whatever the origin of the tumour that the patient presents. The pathology can be secondary to the neoplasy or to the means used in its treatment, although they are often complications that appear independently of the course of the disease. We offer an outline of the most frequent causes of emergency consultation due to urological problems in the patient affected by neoplastic diseases, whether they are in the urogential apparatus or not. We comment especially on the initial study and treatment by the emergency doctor or by the oncologist.

[Treatment of emesis induced by chemotherapy]. / Tratamiento de la emesis inducida por quimioterapia.

Respiratory emergencies in a patient with cancer can have their origin in pathologies of the airway, of the pulmonary parenchyma or the large vessels. The cause can be the tumour itself or concomitant complications. Obstruction of the airway should be initially evaluated with endoscopic procedures. Surgery is rarely possible in serious situations. The endobronchial placement of stents or radioactive isotopes (brachytherapy), tumoural ablation by laser or photodynamic therapy can quickly alleviate the symptoms and re-establish the air flow. Treatment of haemoptysis depends on the cause that is provoking it and on its quantity. Bronchoscopy continues to be the front line procedure in the majority of cases; it provides diagnostic information and can interrupt bleeding through washes with ice-cold serum, endobronchial plugging or topical injections of adrenaline or thrombin. External radiotherapy continues to be an extraordinarily useful procedure in treating haemoptysis caused by tumours and in carefully selected situations of endobronchial therapy with laser or brachytherapy, and bronchial arterial embolisation can provide a great palliative effect. Respiratory emergencies due to pulmonary parenchyma disease in the oncology patient can have a tumoural, iatrogenic or infectious cause. Early recognition of each of these will determine the administration of a specific treatment and the possibilities of success.

SEOM clinical guidelines for the treatment of renal cell carcinoma.

The purpose of this article was to provide updated recommendations for the diagnosis and treatment of renal cell carcinoma. Pathological confirmation is mandatory before treatment with ablative or focal therapies before any type of systemic therapy. Renal cell cancer should be staged according to the TNM classification system. A laparoscopic nephron-sparing surgery should be the approach for tumors <4 cm if technically feasible. Otherwise, radical (or partial in selected cases) nephrectomy is the treatment of choice, with lymph node dissection only performed in patients with clinically detected lymph node involvement. Some retrospective evidence for a cytoreductive nephrectomy in the postimmunotherapy era suggests a benefit in patients with good or intermediate risk or for patients with a symptomatic primary lesion. Adjuvant treatment with chemotherapy or with targeted agents is not recommended and studies are ongoing today. Patients with metastatic disease should be staged by computed tomography scans of the chest, abdomen and pelvis. The efficacy of sunitinib, bevacizumab plus interferon-α, and pazopanib is well established in patients with good and intermediate risk as well for temsirolimus in poor-risk patients. These four agents are considered standard of care in first-line treatment. Sorafenib, axitinib and everolimus are standard of care in second line in different settings based on their benefit in PFS. Besides some benefit described for IL-2 in highly selected patients in first line, there is a promising and emerging role for the new immunotherapeutic approaches in metastatic renal cell carcinoma.