BackgroundPersistent alopecia (PA) after docetaxel has been recently described. The aim of our study is to establish the incidence and characteristics of PA following adjuvant docetaxel for breast cancer (BC) and to test the ability of scalp cooling in prevention.Patients and methodsBC patients receiving adjuvant chemotherapy followed or not by endocrine therapy (and a control group receiving only endocrine therapy) were interviewed in a single institution at 1.5 to 5 years following primary diagnosis searching for PA. A confirmatory prevalence study was later performed in other two institutions. Finally, a prevention study using prophylactic scalp cooling (PSC) with ELASTO-GEL hypothermia caps in patients receiving adjuvant docetaxel was performed.ResultsIn the initial prevalence study (492 patients), minor forms of PA (grade 1) were recorded with all chemotherapy regimens and aromatase inhibitors. Patients receiving docetaxel regimens at cumulative dose (CD) ≥ 400 mmg/m2 presented a significantly higher prevalence of grades 1 PA (33–52%) and 2 PA (5–12%). Prevalence of grade 2 PA with docetaxel CD ≥ 400 mmg/m2 was confirmed in two other institutions. Overall, grade 2 PA was seen in 10.06% (95% CI 7.36–13.61) of 358 patients with docetaxel regimens reaching CD ≥ 400 mmg/m2, but not in patients with lower docetaxel CD, other chemotherapy regimens, or endocrine therapy alone. In prevention trial, no grade 2 PA occurred among 116 patients receiving adjuvant docetaxel (≥ 400 mmg/m2) and PSC followed-up after a 96 months median time. PSC was well tolerated. No scalp relapses were seen among 30 patients (22% of all inclusions) having disease relapse.ConclusionAdjuvant treatment with docetaxel (CD ≥ 400 mmg/m2) is associated with a significant rate of grade 2 PA, leading to wearing a wig, in around 10% of patients. This toxicity was completely prevented with scalp cooling. Clinical Trial Reference: NCT00515762.Electronic supplementary materialThe online version of this article (10.1007/s10549-018-4855-2) contains supplementary material, which is available to authorized users.

Um número significativo de pessoas adultas tem um acesso venoso periférico difícil, o que leva a múltiplas tentativas de punção e ao esgotamento da rede venosa. A escala Venous International Assessment (VIA) é considerada a nível internacional como um instrumento fiável que classifica as vias de acesso venoso periférico das pessoas e determina o risco de complicações associadas. Objetivos: Traduzir, adaptar culturalmente e validar a Escala VIA para português europeu. Metodologia: Estudo da tradução, adaptação cultural, e avaliação das propriedades psicométricas da escala VIA em amostra não probabilística de 100 pessoas doentes a precisar de cateterização venosa periférica. Resultados: A versão em português europeu da escala VIA (EARV) revelou valores moderados de fiabilidade inter-observadores (k = 0,490; p < 0,0005). As validades do critério e do constructo da EARV foram avaliadas através de análise preditiva, convergente e correlacional, com magnitudes moderadas a grandes e significância estatística. Conclusão: A EARV é um instrumento fiável e válido que pode ajudar os profissionais de saúde portugueses na determinação e categorização de acessos venosos periféricos difíceis. Contudo, recomenda-se a realização de mais estudos para testar a aplicabilidade transversal desta escala.

The VIA scale is a simple, easy and practical method for classification of the peripheral venous system in terms of vascular access. The practical application of our VIA scale significantly increases the quality of life of patients by increasing the chances of successful venipuncture and cannulation and thus reducing the risk of extravasation and material costs, allowing both an economical and a safe venous assessment tool.

Background Studies evaluating the effects of the COVID-19 pandemic on public healthcare systems are limited, particularly in cancer management. As no such studies have been carried out in Spain, our objective is to describe and quantify the impact of the COVID-19 pandemic on cancer patients in Spanish hospitals during the first wave of the pandemic. Materials and methods This retrospective, multicenter, nationwide study collected information from hospital departments treating oncology patients. An electronic questionnaire comparing outcomes and management of oncohematological patients for the March-June 2019 and March-June 2020 periods was used. Results Information from 78 departments (36 tertiary hospitals) was analyzed. Forty-four departments implemented adapted protocols during March 2020. Most of these ( n = 38/44; 86.4%) carried out COVID-19 triage, while 26 of 44 (59.1%) carried out onsite polymerase chain reaction tests for clinically suspected cases. A shift from in-person to telephone visits was observed in 43 of 44 (97.7%) departments. Comparing the March-June 2019 and March-June 2020 periods, the number of new patients decreased by 20.8% (from 160.2 to 126.4). Decreases were also seen in the mean number of total (2858.2 versus 1686.1) and cancer (465.5 versus 367.2) biopsies, as well as the mean number of bone marrow biopsies (30.5 versus 18.6). Concerning the number of patients visiting specific cancer care departments, a decrease from 2019 to 2020 was seen for mean number of chemotherapy treatments (712.7 versus 643.8) and radiation therapy (2169.9 versus 2139.9). Finally, a reduction from 2019 to 2020 of 12.9% (from 8.6 to 7.4) in the mean number of patients included in clinical trials was noted. Conclusions This study provides the first comprehensive data concerning the impact of COVID-19 on cancer care in Spain. The pandemic caused a 20.8% decrease in newly diagnosed patients, which may impact future outcomes. Measures must be taken to ensure cancer management receives priority in times of healthcare emergencies.

Purpose Cancer patients require implantation of venous access devices to meet their personalized therapeutic needs, which are often complex due to the nature of the medication and the disease status. Therefore, it is essential to have standardized protocols that guarantee the best results in health and patient safety. Methods To learn about the availability of protocols and aspects related to safety in clinical practice and to detect possible opportunities for improvement, a survey has been conducted in various Spanish hospitals, in addition to a review of the evidence regarding the various devices available and complications associated with the administration of chemotherapy. Results As a result of both analyses, the Foundation for Excellence and Quality in Oncology (ECO), the Spanish Society of Medical Oncology (SEOM), and the Spanish Society of Oncology Nursing (SEEO) have developed a catheter selection algorithm based on patient characteristics and treatment to facilitate the clinical decision-making process, as well as some recommendations aimed at ensuring patient safety and rational use of available resources. Conclusions In conclusion, both the venous access catheter selection algorithm and the proposed recommendations aim to respond to the needs revealed in clinical practice and to become an integrable tool in electronic prescription systems to offer homogeneous criteria for action in cancer patients that require venous access, optimizing the use of available health resources with the highest safety and quality of life for the patient.

IMPORTANCE Persistent chemotherapy-induced alopecia (pCIA) has been recently described in patients with breast cancer and in its most severe form occurs in up to 10% of these patients. Genetic risk factors associated with pCIA have not been adequately explored.OBJECTIVE To identify genetic variants associated with pCIA. DESIGN, SETTING, AND PARTICIPANTSIn this genetic association study, 215 women with breast cancer treated with docetaxel-based chemotherapy with a follow-up of 1.5 to 10 years after the end of the treatment were recruited retrospectively through 3 hospital oncology units across Spain between 2005 and 2018. Severe pCIA was defined as lack of scalp hair recovery (Common Terminology Criteria for Adverse Events, version 3.0, grade 2) 18 months or more after the end of treatment. Patients with grade 2 pCIA were selected as cases, and those with no sign of residual alopecia 12 months after the end of docetaxel treatment were selected as controls. A genome-wide association study in a discovery phase was conducted, and logistic regression was used to identify variants associated with the risk to develop this adverse effect. The validity of the association was addressed through a replication phase. EXPOSURES Docetaxel-based chemotherapy.MAIN OUTCOMES AND MEASURES Genotypes of single-nucleotide variants associated with pCIA. RESULTSIn total, 215 women with breast cancer (median age, 51.6 years; interquartile range, 44-60 years) were recruited (173 patients for the discovery phase and 42 patients for the replication phase). In the discovery phase, ABCB1 genetic variants were associated with risk to develop pCIA. In particular, single-nucleotide variation rs1202179, a regulatory variant located in an enhancer element that interacts with the ABCB1 promoter, was associated with the occurrence of pCIA. This finding was validated in the replication cohort (combined odds ratio, 4.05; 95% CI, ). This variant is associated with ABCB1 mRNA expression, and the risk allele was associated with decreased ABCB1 expression levels (P = 1.64 × 10 −20 ).CONCLUSIONS AND RELEVANCE This is the first study, to our knowledge, that identifies an association between a regulatory variant in the ABCB1 gene and the occurrence of pCIA in patients with breast cancer who were treated with docetaxel-based therapies. This finding suggests an important insight into the biological mechanisms underlying pCIA and opens the opportunity to explore personalized treatment of these patients.

Background. The approved capecitabine regimen as monotherapy in metastatic breast cancer (MBC) is 1,250 mg/m 2 twice daily for 2 weeks on and 1 week off (Cint). Dose modifications are often required because of severe hand-foot syndrome (HFS). We tested a continuous regimen with a lower daily dose but a similar cumulative dose in an attempt to reduce the severity of adverse events (AEs) while maintaining efficacy. Methods. We randomized 195 patients with HER-2/neunegative MBC to capecitabine 800 mg/m 2 twice daily throughout the 21-day cycle (Ccont) or to Cint to assess noninferiority in the percentage of patients free of progression at 1 year. Secondary endpoints included efficacy and safety. Associations between polymorphisms in capecitabine metabolismrelated genes and drug response were assessed. Results. The percentage of patients free of progression at 1 year was 27.3% with Cint versus 25.3% with Ccont (difference of 22.0%; 95% confidence interval: 215.5% to 11.5%, exceeding the 15% deemed noninferior). Differences regarding other efficacy variables were also not found. Grade 3-4 HFS was the most frequent AE (41.1% in Cint vs. 42.3% in Ccont). Grade 3-4 neutropenia, thrombocytopenia, diarrhea, and stomatitis were more frequent with Cint. A 59 untranslated region polymorphism in the carboxylesterase 2 gene was associated

Background Patients with cancer can experience bone metastases and/or cancer treatment-induced bone loss (CTIBL), and the resulting bone complications place burdens on patients and healthcare provision. Management of bone complications is becoming increasingly important as cancer survival rates improve. Advances in specialist oncology nursing practice benefit patients through better management of their bone health, which may improve quality of life and survival. Methods An anonymised online quantitative survey asked specialist oncology nurses about factors affecting their provision of support in the management of bone metastases and CTIBL. Results Of 283 participants, most stated that they worked in Europe, and 69.3% had at least 8 years of experience in oncology. The most common areas of specialisation were medical oncology, breast cancer and/or palliative care (20.8-50.9%). Awareness of bone loss prevention measures varied (from 34.3% for alcohol intake to 77.4% for adequate calcium intake), and awareness of hip fracture risk factors varied (from 28.6% for rheumatoid arthritis to 74.6% for age > 65 years). Approximately one-third reported a high level of confidence in managing bone metastases (39.9%) and CTIBL (33.2%). International or institution guidelines were used by approximately 50% of participants. Common barriers to better specialist care and treatment were reported to be lack of training, funding, knowledge or professional development. Conclusion This work is the first quantitative analysis of reports from specialist oncology nurses about the management of bone metastases and CTIBL. It indicates the need for new nursing education initiatives with a focus on bone health management. Keywords Bone. Cancer. Neoplasm metastasis. Nursing education. Bone drug effects Background Up to three-quarters of patients with advanced prostate or breast cancer develop bone metastases, and bone metastases are also common in patients with other solid tumours (e.g. lung and kidney cancers) [11-13]. Bone lesions are present in approximately 90% of patients with multiple myeloma [14]. Bone metastases and bone lesions are associated with lifealtering morbidity due to skeletal-related events (SREs), such as pathologic fractures, the need for radiotherapy or surgery to the bone, and spinal cord compression [13, 21, 26, 31], and with reduced overall survival [13, 18, 34]. There is a negative association between SREs and survival (e.g. in men with metastatic castration-resistant prostate cancer: mortality hazard ratio 1.67; 95% confidence interval 1.22-2.30; p = 0.001) [19]. Bone is also affected by many cancer treatments, which can induce bone loss (cancer treatment-induced bone loss [CTIBL]). CTIBL is associated with increased fracture risk and increased SRE burden in patients with advanced cancer Electronic supplementary material The online version of this article (