Content validation of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (NFLymSI-18) in indolent B-cell non-Hodgkin's lymphoma.

BACKGROUND: The NFLymSI-18 is a patient-reported outcome measure comprised of the highest priority symptoms, emotional concerns, treatment side effects, and other concerns identified by lymphoma patients and oncologists. This study assessed the content validity of the NFLymSI-18 for patients with indolent B-cell non-Hodgkin's lymphoma (iNHL), with a focus on the Disease-Related Symptoms Physical (DRS-P) subscale. METHODS: Patients with a confirmed iNHL diagnosis who had received one or more lines of treatment were recruited during clinic visits. Patients described their symptoms, treatment side effects, and emotional concerns related to iNHL in a semi-structured interview. Qualitative data were analyzed using NVivo10. RESULTS: Data saturation was obtained by the 18th interview. Most participants (67%) had follicular lymphoma. 28% of participants had marginal zone lymphoma, and one participant had lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia. Mean age of the 18 participants was 67 years. 56% of the sample was male. Most participants (67%) had a college or advanced degree. When asked to describe their iNHL symptoms, patients most often discussed swelling (n = 14), fatigue (n = 11), and pain (n = 8). The following symptoms were mentioned by three patients each: anxiety, appetite loss, rash, sleep disruption, trouble breathing, and malaise. Mapping of NFLymSI-18 content to these concerns showed the instrument includes all those most frequently mentioned symptoms. CONCLUSIONS: This study supports the content validity of the NFLymSI-18, including its DRS-P Subscale, for patients with iNHL. The instrument shows strong validity for the most referenced symptoms of swelling, fatigue, and pain. The diversity of additional symptoms reported by patients is consistent with the heterogeneous symptomology of iNHL.

Obstacles to Biosimilar Acceptance and Uptake in Oncology: A Review.

Importance: Biosimilar drugs provide cost-effective yet clinically indistinguishable replications of target drugs. During initial development, this class of biologic medicines was expected to revolutionize pharmaceutical markets; however, following US Food and Drug Administration approval of the first biosimilar drug in 2015, the commercialization of biosimilars has been limited. The lack of biosimilar use may be especially salient in oncology, given that biosimilar distribution in this particularly high-cost area of medicine would bring savings on the order of many billions of dollars. Observations: While researchers have focused on salient economic barriers to biosimilar uptake in the US, the present review provides insight regarding noneconomic barriers. This review discusses psychological, attitudinal, and educational factors among both health care professionals and payers in the US that may play a role in slowing biosimilar uptake. More specifically, these factors include a lack of health care professional education, concerns of safety and efficacy, and overly complex product naming systems. Conclusions and Relevance: The pathway to biosimilar use has been obstructed by economic elements as well as attitudinal and psychological factors. For biosimilar drugs to achieve their potential in decreasing treatment costs and thus increasing patient access, it will be essential for both economic and noneconomic factors to be identified and systematically addressed.

A qualitative evaluation of factors influencing Tumor Treating fields (TTFields) therapy decision making among brain tumor patients and physicians.

BACKGROUND: Tumor Treating Fields (TTFields) Therapy is an FDA-approved therapy in the first line and recurrent setting for glioblastoma. Despite Phase 3 evidence showing improved survival with TTFields, it is not uniformly utilized. We aimed to examine patient and clinician views of TTFields and factors shaping utilization of TTFields through a unique research partnership with medical neuro oncology and medical social sciences. METHODS: Adult glioblastoma patients who were offered TTFields at a tertiary care academic hospital were invited to participate in a semi-structured interview about their decision to use or not use TTFields. Clinicians who prescribe TTFields were invited to participate in a semi-structured interview about TTFields. RESULTS: Interviews were completed with 40 patients with a mean age of 53 years; 92.5% were white and 60% were male. Participants who decided against TTFields stated that head shaving, appearing sick, and inconvenience of wearing/carrying the device most influenced their decision. The most influential factors for use of TTFields were the efficacy of the device and their clinician's opinion. Clinicians (N = 9) stated that TTFields was a good option for glioblastoma patients, but some noted that their patients should consider the burdens and benefits of TTFields as it may not be the desired choice for all patients. CONCLUSIONS: This is the first study to examine patient decision making for TTFields. Findings suggest that clinician support and efficacy data are among the key decision-making factors. Properly understanding the path to patients' decision making is crucial in optimizing the use of TTFields and other therapeutic decisions for glioblastoma patients.

Mucocele em mucosa de lábio inferior / Mucocele of the lower lip mucosa

Mucocele, também conhecido como fenômeno de extravasamento de muco é um pseudocisto de etiologia traumática onde há o rompimentodo ducto de uma glândula salivar menor. Clinicamente pode ser observada como uma tumefação ou bolha, flácida à palpação, assintomática, com a superfície lisa e tamanho variado e com coloração igual a da mucosa adjacente ou azulada, dependendo da sua profundidade no tecido. O paciente geralmente relata uma bolha que se rompe e retorna a encher liberando um líquido de gosto salgado. Sua maior incidência é no gênero feminino (25,4%), entre 8 e 14 anos de idade, sendo o sítio mais comum a mucosa do lábio inferior. No presente trabalho iremos ilustrar um caso clínico de mucocele realizado na Faculdade de Odontologia da Universidade Federal de Pelotas, no estado do Rio Grande do Sul, em um paciente com 23 anos do gênero masculino, leucoderma, o qual apresentava uma lesão situada na mucosa do lábio inferior do lado direito, próxima ao fundo de sulco, medindo, aproximadamente, 0,6cm com coloração semelhante à mucosa adjacente normal. O tratamento realizado foi a excisão cirúrgica do mucocele e das glândulas acessóriasenvolvidas na região da lesão. O laudo histopatológico confirmou o diagnóstico clínico de mucocele.

Mucocele, also known as mucous extravasation phenomenon, is a pseudocyst of traumatic etiology, in which a minor salivary gland ductruptures. Clinically it can be observed as a tumefaction or bubble; it is flaccid on palpation, asymptomatic, with a smooth surface and variable size, and with coloring equal to that of the adjacent mucosa, or bluish, depending on its depth in the tissue. The patient generally reports a bubble that has burst and fills up again, releasing a salty tasting liquid. There is greater incidence in women (25.4%), between the ages of 8 and 14 years, the commonest site being the mucosa of the lower lip. In the present study, the authors will present a clinical case of mucocele seen at the School of Dentistry at the Federal University of Pelotas, in the State of Rio Grande do Sul, Brazil, in a patient, a 23-year-old leukoderma man, who presented a lesion situated in the mucosa of the lower lip on the right side, close to the bottom of the fold, measuring approximately 0.6 cm, with coloring similar to the adjacent normal mucosa. The treatment performed was surgical excision of the mucocele and the accessory glands involved in the region of the lesion. The histopathologic report confirmed the clinicaldiagnosis of mucocele.