How is best supportive care provided in clinical trials for patients with advanced cancer? A review of registered protocols of clinical trials.

Background: In 2012, 11 standards describing best supportive care (bsc) in clinical trials in advanced cancer were defined through consensus statements. The consensus included 15 key components. Our objective was to analyze whether clinical trials that involved patients with advanced cancer and that included bsc in at least 1 arm met the standards and contained the key components. Methods: We reviewed clinical trials registered in ClinicalTrials.gov, the isrctn (International Standard Randomised Controlled Trial Number) registry, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform for 2012-2018. We selected only phase iii studies in patients with advanced cancer that included bsc in at least 1 arm. We describe the characteristics of the trials, together with the definition and components of bsc. We analyzed how the trials met the standards and adopted the key components of bsc. Results: Of 193 trials retrieved, only 64 met the inclusion criteria; 36 of those trials (56%) had no definition of bsc. Less than 7% of the trials included even 3 of the 8 bsc standards that were defined to be included in the design of trials. Furthermore, trials mentioned only 5 of the 15 key components that the consensus defined to be fundamental, with symptom management appearing in 22% of trials and the other 4 components appearing in less than 8%. Summary: Most clinical trials registered during 2012-2018 that involved patients with cancer and an arm with bsc did not define the bsc concept. Hence, the design of those trials does not meet the consensus recommendations.

Heart metastases and superior vena cava syndrome.

Superior vena cava syndrome (SVCS) may be due to a tumour infiltrating the right atrium. We present two patients with SVCS. The first one was secondary to solitary atrial metastases of rectal adenocarcinoma and benefited from palliative chemotherapy. The second patient had a disseminated large cell B-cell lymphoma with rapid clinical complete response, but she eventually died after relapse.

[Gastrointestinal stromal tumors (GISTs): clinical aspects]. / Tumores de la estroma gastroinestinal (GIST): aspectos clínicos.

INTRODUCTION: Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors in the gastrointestinal tract. One of their features is the expression of the c-KIT/CD117 receptor. AIMS AND METHODS: We will focus on describing the symptoms, clinical studies prior to diagnosis, histologic and immunohistochemical characteristics, as well as the progression of disease in a group of patients. RESULTS: Seventeen cases were diagnosed between December 1999 and April 2005. Mean age of patients was 64.5 (+/-11.9); 47% were women. Tumor location was as follows: 52.9% in the jejunum or ileum, 29.4% were gastric, 11.7% were in the duodenum, and 5.8% were located in the mesentery. Tumor size was 6.0 cm on average (+/-5.0); 47% were asymptomatic, and to a lesser degree caused abdominal pain or digestive bleeding; 94.1% of tumors expressed CD117. Most of them were discovered while performing a laparotomy or ultrasound scan; 94.1% of tumors were removed; 35.2% (6 out of 17) of patients suffering from GIST met consensus criteria for aggressive behavior. Over 25.6 months (+/-22.5) metastasis or tumor relapse occurred in 23.5% (4 out of 17) of patients--those with more frequent high-risk criteria, symptomatic and bigger tumors, and tumors not expressing CD117. The three patients with tumor relapse were prescribed imatinib mesylate. Three patients died because of the tumor, and four from other causes unrelated to GIST. CONCLUSIONS: GIST was diagnosed in around 12 cases per million a year. Its diagnosis was usually an incidental finding during a medical evaluation, and tumors were malignant in nearly one fourth of cases. We can predict its outcome depending on different aspects.

Intestinal bleeding in disseminated non-small cell lung cancer.

A case of gastrointestinal bleeding in a 40 year old male with NSCLC is presented. Usual diagnostic tools did not reveal the cause of bleeding and a laparotomy was necessary to localise and treat the haemorrhage. Intestinal metastases have been described in 11% of lung cancer but they rarely produce symptoms. However, intestinal metastases may produce gastrointestinal perforation, obstruction and very occasionally bleeding. In fact, the present report is the second case published of gastrointestinal bleeding from lung cancer metastases. In most cases prognosis is poor for these patients with a medium survival of a few weeks. Surgery may palliate selected patients but there is no evidence that chemotherapy is beneficial.

[The follow-up of the cancer patient: how and when?]. / Seguimiento del paciente oncológico: cómo y cuándo?

The medical resources devoted to cancer patient follow-up are growing. However, intensive follow-up is not translated to any significant improvement survival in a majority of patients. A few neoplasias have an effective salvage therapy, and are worth having strict follow-up to diagnose earlier the recurrence. In many tumours, as breast cancer, an early diagnosis of recurrence does not imply an improvement on survival. Tumoral markers are able to detect the presence of tumour cells even before being clinically apparent and are routinely used in the follow-up of tumours; however, they do not seem to improve survival. The cost-benefit relation of multiple revision in cancer patients apparently cured is debated. No general consensus is achieved to define the best tests to follow-up cancer patients. The trend is to minimize the diagnostic tests and to recommend a clinical follow-up with anamnesis and physical exploration.

[Syndrome of recommended patient]. / El síndrome del recomendado.

"Syndrome of recommended patient" is manifested as the presence of numerous unexpected and unusual complications in patients that the treating physician is trying to give a better assistance. Even assuming that a few complications may appear by chance, there are several factors from daily clinical practice that facilitate the presence of such a syndrome, and some of them can be corrected in order to reduce its incidence. All of them come from the change on daily clinical practice on these patients, as if they do not fit for the attention provided for other people. These factors favouring the presence of this syndrome come from: patients' attitude, inefficient use of health resources, absence of an adequate register of clinical data and change in usual clinical practice on interpretation of diagnostic tests as well as in the indication of treatment of these patients. The best way to prevent this "syndrome of recommended patient" is to maintain, even within these patients, an attitude based on solid clinical knowledge and to follow up the same clinical rules accepted for other patients.

[Dose intensity of chemotherapy in small-cell lung carcinoma. Review of comparative studies]. / Intensidad de dosis de quimioterapia en carcinoma microcítico de pulmón. Revisión de estudios comparativos.

Chemotherapy improves survival and achieves an impressive response rate, and, eventually, a percentage of long-term survivors in small-cell lung cancer. A possible way to a further improvement of these therapeutic outcomes is increasing chemotherapy dose-intensity. However, randomised comparative trials only show a slight improvement of results, with small clinical relevance. Prophylactic use of colony-stimulating factors decrease the incidence of neutropenia and neutropenic fever in comparative studies when an exceedingly myelotoxic chemotherapy regimen is used. And they also permit a little increase in chemotherapy dose-intensity without significant antineoplastic effect and almost no impact in overall survival. Nowadays, the administration of higher doses of chemotherapy in small-cell lung cancer still remains investigational in oncology.

[Colony stimulating factors in chemotherapy induced neutropenic fever]. / Factores estimulantes de colonias en neutropenia febril inducida por quimioterapia.

We review the randomized trials published so far comparing the use of colony-stimulating factors (both G-CSF and GM-CSF) as adjunctive care in chemotherapy-induced neutropenic fever. With this treatment a slight one day reduction in duration of neutropenia under 500 neutrophils per mm3 is observed; this effect seems to be more important in prolonged neutropenias. The number of days with fever remain unchanged. No clear benefit expressed as clinical and quality of life improvement or economical saving is proved. According to these results, and as previous recommendation about the use of colony-stimulating factors pointed out, the indications for administration of such cytokines in neutropenic fever are restrictive and its use could be acceptable only in patients with poor prognostic factors.

[Chemotherapy and palliation in patients with advanced cancer]. / Quimioterapia y paliación en enfermos con cáncer avanzado.

Chemotherapy shows antitumoral activity in several advanced cancers. However, toxicity is frequent and may even overwhelm the clinical benefit of antineoplastic activity. To recommend such a treatment, we need to know the sensibility of cancer to therapy, its toxic effects and the clinical benefit we are looking for, expressed as: symptoms relief or delay in its presentation, improvement in quality of life, increase in overall survival and reduction in tumor volume. We need also to evaluate the performance status and functional status of each patient, its prognosis, the severity of symptoms and its interest to receive any antitumor treatment. According to these parameters we can individualize each therapy to select those patients whose expected benefit from this palliative chemotherapy is higher.

[How is an instrument for measuring health to be validated?]. / ¿Cómo validar un instrumento de medida de la salud?

It is increasingly necessary to have a measuring instrument available in the health field that can be used in clinical practice and research. In order to guarantee the quality of their measurements it is essential that the instruments should be subjected to a process of validation. This process consists in adapting the instrument culturally to the setting where its psychometric characteristics are to be administered and checked, such as: reliability, validity, sensitivity and feasibility. There are measuring instruments from the health field available in other languages but that have not been validated into Spanish. Besides, the methodology for validating an instrument is little understood by the health professionals, which explains the indiscriminate use of instruments that have only been adapted or validated in a way that is not very consistent. The aim of this review is to bring up to date the process of validating an instrument for measuring health, and what it involves, in a practical way. The accessibility of evaluation instruments that have been culturally adapted and validated in different languages will facilitate the comparison of results obtained with the same instrument and the development international studies in different cultures.

[Asthenia in advanced cancer and the use of psychostimulants]. / Astenia en cáncer avanzado y uso de psicoestimulantes.

Asthenia is the most frequent symptom in patients with advanced cancer and is probably what most affects the quality of life of oncology patients since it interferes in their physical and social activity. Treatment in the majority of cases is symptomatic. There is growing interest in the use of psychostimulants for treating asthenia. Methylphenidate and modafinil are two psychostimulants that have already been tested in controlled studies on asthenia of the patient with advanced cancer; they have proved to be efficient, particularly in patients in very advanced stages who are very tired.