SEOM clinical guidelines in advanced and recurrent breast cancer (2018)

Although the metastasic breast cancer is still an incurable disease, recent advances have increased significantly the time to progression and the overall survival. However, too much information has been produced in the last 2 years, so a well-based guideline is a valuable document in treatment decision making. The SEOM guidelines are intended to make evidence-based recommendations on how to manage patients with advanced and recurrent breast cancer to achieve the best patient outcomes based on a rational use of the currently available therapies. To assign a level of certainty and a grade of recommendation the United States Preventive Services Task Force guidelines methodology was selected as reference

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2018 consensus statement by the Spanish Society of Pathology and the Spanish Society of Medical Oncology on the diagnosis and treatment of cancer of unknown primary

Cancer of unknown primary (CUP) is defined as a heterogeneous group of tumours that present with metastasis, and in which attempts to identify the original site have failed. They differ from other primary tumours in their biological features and how they spread, which means that they can be considered a separate entity. There are several hypotheses regarding their origin, but the most plausible explanation for their aggressiveness and chemoresistance seems to involve chromosomal instability. Depending on the type of study done, CUP can account for 2-9% of all cancer patients, mostly 60-75 years old. This article reviews the main clinical, pathological, and molecular studies conducted to analyse and determine the origin of CUP. The main strategies for patient management and treatment, by both clinicians and pathologists, are also addressed

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Nuevos avances de tratamiento inmunobiológico en el melanoma avanzado / Advances in the Immunobiological Therapies for Advanced Melanoma

El melanoma irresecable localmente avanzado y metastásico es una situación clínica asociada a una elevada tasa de morbimortalidad. En los últimos años, sin embargo, han acontecido notables avances en el ámbito del tratamiento sistémico de esta enfermedad, con la irrupción de la terapia dirigida con inhibidores tirosincinasa que actúan bloqueando la vía de las MAPKinasas, y de la moderna inmunoterapia con anticuerpos monoclonales inmunomoduladores. En la presente revisión se realiza una actualización sobre los datos disponibles con los nuevos inmunoterápicos, así como un repaso del desarrollo clínico que ha permitido la aprobación para su uso en la práctica clínica habitual (AU)

Metastatic or locally advanced unresectable melanoma carries a high morbidity and mortality. However, notable advances have been made in recent years in the systemic treatment of this disease, with the appearance of targeted therapy using tyrosine kinase inhibitors that block the mitogen activated protein kinase pathway, and of modern immunotherapy with immune-modulating monoclonal antibodies. In this paper, we provide an update of available data on new immune therapies and we review the clinical development that led to their approval for use in routine clinical practice (AU)

Safety of vemurafenib in patients with BRAFV600 mutated metastatic melanoma: the Spanish experience

Objectives. Vemurafenib tolerability was assessed in a large, open-label, multicentre study in patients with BRAFV600 mutated advanced melanoma. We investigated safety, tolerability and efficacy of vemurafenib in Spanish patients participating in that study. Methods. Patients with previously treated or treatment-naive, unresectable stage IIIC or stage IV, BRAFV600 mutation-positive melanoma received vemurafenib 960 mg twice daily until disease progression, unacceptable toxicity, withdrawal of consent or death. The primary endpoint was safety; secondary endpoints included overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). Results. 301 Spanish patients were included, 70 % with M1c disease, 22 % with brain metastases and 51 % with prior systemic therapy for metastatic disease. Most frequent adverse events included fatigue (48 %), arthralgia (45 %), rash (41 %), photosensitivity (34 %) and skin neoplasms (21 %). Grade 3/4 adverse events occurred in 156 patients (52 %), including cutaneous squamous cell carcinoma (including keratoacanthoma; 16 %), fatigue (6 %) and arthralgia (5 %). The ORR was 28 % (95 % CI 23-34 %). Responses occurred in patients with brain metastases (18 %), elevated baseline lactate dehydrogenase (19 %) and poor performance status (15 %), and elderly patients (22 %). Median PFS was 5.8 (95 % CI 5.0-6.4) months; median OS was 10.5 (95 % CI 9.5-13.5) months. Conclusion. Our results for Spanish patients in the vemurafenib safety study indicate similar efficacy and a comparable safety profile in Spanish patients with no new safety signals compared with the overall population. Clinical benefit was demonstrated in poor-prognosis patients and in those with favourable baseline characteristics, suggesting that poor-prognosis patients may also benefit from vemurafenib treatment (AU)

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Clinical use of ipilimumab for metastatic melanoma in Spain: towards a more consistent approach

Introduction: Ipilimumab has been approved in patients with advanced melanoma by different regulatory bodies worldwide, but its use in clinical practice is not fully consistent among oncologists. We have surveyed a representative sample of Spanish medical oncologists on issues related to the use of ipilimumab. Materials and methods: The survey was based on the Delphi method, where experts respond anonymously to two rounds of a questionnaire. Questionnaire consisted of 42 statements divided among the following eight categories: Pathology and Diagnosis; Patterns of Response; Parameters affecting Treatment Selection; Patient Profile; Sequencing of Treatment; Definition of Long-Term Survivors; Quality of Life; Concept of Immuno-oncology. The experts were asked to rate each statement on a scale of 1-9, where 1 meant 'completely disagree' and 9 meant 'completely agree'. Results: Thirty-three oncologists responded to both rounds of the survey (62.3 % of total surveyed). On issues related to pathology and diagnosis, patterns of response, and immuno-oncology, the specialists reached a high level of consensus. There was also a high level of agreement, albeit without consensus on assessment of BRAF mutations before deciding on treatment with ipilimumab. However, there was a lower level of agreement on sequencing treatment with BRAF inhibitors and ipilimumab, on predictive factors, on the use of corticosteroids, and on patient quality of life. Conclusions: The disparity in many of these topics suggests that oncologists need more information on certain aspects of ipilimumab treatment. We need to define generally accepted algorithms of treatment, especially with regard to issues that were shown to be controversial or unclear (AU)

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SEOM clinical guidelines in metastatic breast cancer 2015

Metastatic breast cancer is essentially an incurable disease. However, recent advances have resulted in a significant improvement of overall survival. The SEOM guidelines are intended to make evidence-based recommendations on how to manage patients with metastatic breast cancer to achieve the best patient outcomes based on a rational use of the currently available therapies. To assign a level of certainty and a grade of recommendation the United States Preventive Services Task Force guidelines methodology was selected as reference (AU)

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SEOM clinical guidelines for the treatment of Hodgkin’s lymphoma

Hodgkin lymphoma (HL) is an uncommon B cell lymphoid malignancy representing approximately 10-15 % of all lymphomas. HL is composed of two distinct disease entities; the more commonly diagnosed classical HL and the rare nodular lymphocyte-predominant HL. An accurate assessment of the stage of disease and prognostic factors that identify patients at low or high risk for recurrence are used to optimize therapy. Patients with early stage disease are treated with combined modality strategies using abbreviated courses of combination chemotherapy followed by involved-field radiation therapy, while those with advanced stage disease receive a longer course of chemotherapy often without radiation therapy. High-dose chemotherapy (HDCT) followed by an autologous stem cell transplant (ASCT) is the standard of care for most patients who relapse following initial therapy. Brentuximab vedotin should be considered for patients who fail HDCT with ASCT (AU)

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SEOM clinical guidelines for the treatment of follicular non-Hodgkin’s lymphoma

Follicular non-Hodgkin's lymphoma (FL) is a nodal B lymphoid malignancy that originates from the germinal center of a lymph node. FL is the second most frequent lymphoma subtype. The course of the disease is usually characterised by a typically indolent clinical course, with a median survival rate of 8-10 years, although most patients relapse after treatment. Diagnosis should always be based on a surgical specimen like an excisional node lymph biopsy. The first-line treatment of FL will depend of extension disease, tumour burden, patient symptoms, performance status and also patient decision. The addition of rituximab to conventional chemotherapy has improved ORR, PFS and OS. As first line in patients that need treatment, a combination of chemotherapy with rituximab induction followed by 2 years of rituximab maintenance is the best option. High-dose chemotherapy with autologous stem-cell transplantation in first line has not shown improvement and is not recommended as first-line therapy. Before any treatment decision in relapsed patients, a repeat biopsy is mandatory to rule out a transformation into large cell aggressive lymphoma. Standard treatment is controversial, depends on the efficacy of prior treatment, duration of the time-to-relapse, patient’s age and histological findings at relapse (AU)

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Adjuvant regimens with trastuzumab administered for small HER2-positive breast cancer in routine clinical practice

Purpose. Trastuzumab has proven to improve the prognosis of HER2-positive breast cancer, but the information available about its administration for small tumors is still limited. Therefore, we assessed the use of adjuvant regimens with trastuzumab for the treatment of small HER2-positive breast cancer in routine clinical practice. Methods. This observational study was conducted in patients with HER2-positive breast adenocarcinoma ≤1.5 cm who received trastuzumab-based adjuvant treatment in clinical practice. Clinical/histopathological data were retrieved from patients’ medical charts. Results. A total of 101 evaluable patients were enrolled (median age [range], 56.7 [49.0–64.8] years; ECOG 0, 98.0 %; ductal carcinoma, 88.1 %; lymph nodes N0, 79.2 %). Only five (5.0 %) patients received neoadjuvant treatment, while all patients underwent tumor surgery. Adjuvant trastuzumab was administered at a mean (±SD) dose of 5.9 ± 1.5 mg/kg/cycle, and mostly in a three-weekly schedule (89 [89.0 %] patients). The most frequent adjuvant therapy used with trastuzumab was chemotherapy (87 [86.1 %] patients), followed by radiotherapy (63 [62.4 %] patients) and hormone therapy (52 [51.5 %] patients). Chemotherapy regimens mainly included doxorubicin, cyclophosphamide and paclitaxel/docetaxel (n = 30), docetaxel and cyclophosphamide (n = 15), docetaxel and carboplatin (n = 13). Hormone therapy mainly included letrozole (n = 17) and tamoxifen (n = 17). Nine (8.9 %) patients reported trastuzumab-related adverse events; only one allergic reaction reached grade 3 toxicity. Conclusion. This study shows that trastuzumab-based adjuvant treatment of small HER2-positive breast cancer is mostly based on chemotherapy—mainly paclitaxel/docetaxel. Adjuvant administration of trastuzumab for small HER2-positive breast cancer seems to be similar to that used for larger tumors (AU)

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Clinical guideline SEOM: cancer of unknown primary site

Cancer of unknown primary site is a histologically confirmed cancer which is manifested in advanced stage, with no identifiable primary site after the use of standard diagnostic procedures. Patients are initially placed into one of categories based upon the examination of the initial biopsy: adenocarcinoma, squamous cell carcinoma, neuroendocrine carcinoma and poorly differentiated carcinoma. Appropriate patient management requires an understanding of several clinicopathologic features that help to identify several subsets of patients with more responsive tumors (AU)

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Primary intracranial malignant peripheral nerve sheath tumour responding to chemotherapy

Malignant peripheral nerve sheath tumours (MPNST) are a rare variety of soft tissue sarcomas (STS) arising from major peripheral nerve branches and typically located in the lower extremity, chest wall or the retroperitoneum. It is a biologically aggressive neoplasm for which the treatment of choice is surgery, but usually requires a multimodality approach, having been generally labelled as chemoresistant. We present a case of MPNST located intracranially with a good response to chemotherapy (AU)

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Role of transforming growth factor beta in cancer microenvironment

Transforming growth factor Beta (TGF-Beta) family members are polypeptidic cytokines with pleiotropic physiological properties. In relation to cancer, TGF-Beta exerts a dual tumour-suppressive and oncogenic effect, which is largely dependent on microenvironment stimuli. After activation of TGF-Beta signalling, two pathways can be activated: the canonical one through the mammalian Smad family or the non-canonical one activating, among others, the cellular mitogen-activated protein kinase (MAPK) signalling downstream, which interacts with Smad signalling. During tumorigenesis, cells of many cancer types often lose their response to the tumour-suppressive effects of TGF-Beta, which, in turn, has the opposite effect, acting as an autocrine tumour-promoting factor. In this review, we summarise the current knowledge about this intriguing cytokine, with special emphasis on its immunosuppressive actions (AU)

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Obstrucción intestinal maligna, sintomatología depresiva y solicitud de «eutanasia» / No disponible

Los síntomas de difícil control constituyen un elemento de estrés para pacientes, familiares y profesionales, y a veces generan la solicitud de «eutanasia». En algunos casos ese término se utiliza para solicitar prácticas que no son eutanasia, como el rechazo de tratamientos fútiles, limitación de esfuerzo terapéutico, o sedación paliativa. En todos estos casos una correcta evaluación y tratamiento de los síntomas, centrada en cada paciente, el cuidado de la esfera psicosocial, la comunicación de calidad y una intervención interdisciplinar pueden aliviar el sufrimiento. Presentamos un caso en el que describe la intervención de un Equipo de Cuidados Paliativos ante una oclusión intestinal y una situación de sufrimiento psicoemocional refractario, que motivó una solicitud de «eutanasia». La valoración detallada de los problemas, la reflexión crítica, la cooperación de los profesionales y la intervención progresiva facilitaron la toma de decisiones. El objetivo de esta nota clínica es analizar la intervención del Equipo de Cuidados Paliativos de Medicina Interna, coordinada con el Servicio de Oncología Médica y otros (AU)

Refractory symptoms lead to stressful situations for patients, caregivers, and the medical staff. Most requests for euthanasia arise from these situations in palliative care teams. The most important tools to deal with suffering include: correct assessment and treatment, psychosocial approach, communications skills, and multiprofessional interventions. We report a case describing a palliative care team intervention for a patient suffering forma highly symptomatic malignant bowel obstruction and psycho-spiritual suffering. This was the cause to request euthanasia. An accurate assessment of each problem, a critical, reflective and cooperative approach, and a progressive intervention helped in decision making. The aim of this case report is to analyze the intervention of a palliative care team in an internal medicine department, in coordination with a medical oncology department (AU)

Beneficio Clínico: beneficio ¿para quién? / Clinical benefit: whom does it benefit?

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