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1.
Eur Heart J Imaging Methods Pract ; 2(1): qyae005, 2024 Jan.
Article in English | MEDLINE | ID: mdl-39045196

ABSTRACT

Health problems in the Latin American and the Caribbean (LAC) region are highly concentrated on non-communicable diseases, being cardiovascular diseases (CVDs) and cancer the leading causes of death. Different countries of the region are at different stages of development in addressing CVDs and cancer. Opportunities for training and continuing education in cardio-oncology, as well as active cardio-oncology groups, are primarily limited to large academic institutions in major metropolitan areas. In addition, the development of advanced imaging modalities in LAC faces challenges such as the high cost of equipment, a lack of equipment maintenance and service, as well as insufficient specific training for both imaging specialists and referring clinicians. To contribute to the implementation of actionable strategies ensuring equitable access to care for all, international organizations, such as the International Atomic Energy Agency (IAEA), offer support for the regional development of health projects that address educational needs. In this context, a new IAEA regional cooperation project for LAC titled 'Strengthening of regional capacities on the use of Nuclear Medicine techniques in a Cardio-oncology multimodality approach in patients with cancer' will be developed during 2024-2025. The experience of some centres, as well as national experiences in certain countries of the region, that have been previously involved in other regional projects, can be leveraged for the benefit of the entire region. We present a proposed road map for cross-institutional/countries collaboration in the development of cardio-oncology in the LAC region, contributing to decreasing the barriers to the growth of the subspecialty.

2.
Paediatr Child Health ; 29(4): 224-230, 2024 Jul.
Article in English | MEDLINE | ID: mdl-39045479

ABSTRACT

Objectives: Access to early phase trials for children with relapsed, refractory or progressive (RRPD) cancer is limited in Canada. Patients and families face barriers to access trials, which are poorly understood. The aims of this study were to assess availability of early phase trials and examine the impact of distance from home to study centre on trial enrolment among paediatric oncology patients with RRPD. Methods: Oncology patients ≤18 years at diagnosis who later had RRPD were identified retrospectively via registry at the only quaternary paediatric oncology centre in British Columbia (BC). We determined if distance to home, as calculated using geocoding software, was predictive of trial offer or enrolment. Results: Between January 2015 and July 2021, 266 patients experienced 396 RRPD events. Seventy-five patients (28.2%) were eligible for an early phase trial at least once. At first eligible event, 61 patients (22.9%) were offered trial (median age 11.8 years; 69.0% male; 46.0% with CNS tumour) and thirty patients (11.3%) enrolled. Distance was not associated with odds of offer (OR 1.01, CI 0.98 to 1.05) or enrolment (OR 0.99, CI 0.95 to 1.03) on univariate or multivariable analysis adjusted for sex and disease (OR 0.93, CI 0.86 to 1.00). For offered patients, 2-year event-free survival (EFS) and overall survival (OS) were 39.1% (CI 28.0% to 54.8%) and 51.8% (CI 39.9% to 67.2%), respectively. EFS/OS did not differ with distance or enrolment, but varied by disease (EFS P = 0.002, OS P < 0.0001). Conclusions: Children in BC with cancer and RRPD have limited access to early phase trials. Distance was not predictive of enrolment, suggesting that families travel to access therapy.

3.
Qual Life Res ; 2024 Jul 24.
Article in English | MEDLINE | ID: mdl-39046616

ABSTRACT

PURPOSE: The Functional Assessment of Cancer Therapy item (FACT-GP5) has the potential to provide an understanding of global treatment tolerability from the patient perspective. Longitudinal evaluations of the FACT-GP5 and challenges posed by data missing-not-at-random (MNAR) have not been explored. Robustness of the FACT-GP5 to missing data assumptions and the responsiveness of the FACT-GP5 to key side-effects are evaluated. METHODS: In a randomized, double-blind study (NCT00065325), postmenopausal women (n = 618) with hormone receptor-positive (HR+), advanced breast cancer received either fulvestrant or exemestane and completed FACT measures monthly for seven months. Cumulative link mixed models (CLMM) were fit to evaluate: (1) the trajectory of the FACT-GP5 and (2) the responsiveness of the FACT-GP5 to CTCAE grade, Eastern Cooperative Oncology Group (ECOG) Performance Status scale, and key side-effects from the FACT. Sensitivity analyses of the missing-at-random (MAR) assumption were conducted. RESULTS: Odds of reporting worse side-effect bother increased over time. There were positive within-person relationships between level of side-effect bother (FACT-GP5) and severity of other FACT items, as well as ECOG performance status and Common Terminology Criteria for Adverse Events (CTCAE) grade. The number of missing FACT-GP5 assessments impacted the trajectory of the FACT-GP5 but did not impact the relationships between the FACT-GP5 and other items (except for nausea [FACT-GP2]). CONCLUSIONS: Results support the responsiveness of the FACT-GP5. Generally speaking, the responsiveness of the FACT-GP5 is robust to missing assessments. Missingness should be considered, however, when evaluating change over time of the FACT-GP5. TRIAL REGISTRATION: NCT00065325. TRIAL REGISTRATION YEAR: 2003.


Researchers have been exploring the use of a single question, FACT-GP5 ("I am bothered by side effects of treatment"), as a quick way to learn about drug tolerability from the patients' perspective. This study explores if this single question can capture changes in tolerability during treatment, and if the assessment is missed by patients, whether that impacts the interpretation of tolerability. In our study, we found that the FACT-GP5 can be used to understand how tolerability changes during treatment. Missing assessments of the FACT-GP5 are important to account for when interpreting results. The FACT-GP5 may be a useful question for capturing the patient experience of drug tolerability.

4.
J R Soc Interface ; 21(216): 20240099, 2024 Jul.
Article in English | MEDLINE | ID: mdl-39013418

ABSTRACT

Cancer incidence increases rapidly with age, typically as a polynomial. The somatic mutation theory explains this increase through the waiting time for enough mutations to build up to generate cells with the full set of traits needed to grow without control. However, lines of evidence ranging from tumour reversion and dormancy to the prevalence of presumed cancer mutations in non-cancerous tissues argue that this is not the whole story, and that cancer is also an ecological process, and that mutations only lead to cancer when the systems of control within and across cells have broken down. Aging thus has two effects: the build-up of mutations and the breakdown of control. This paper presents a mathematical modelling framework to unify these theories with novel approaches to model the mutation and diversification of cell lineages and of the breakdown of the layers of control both within and between cells. These models correctly predict the polynomial increase of cancer with age, show how germline defects in control accelerate cancer initiation, and compute how the positive feedback between cell replication, ecology and layers of control leads to a doubly exponential growth of cell populations.


Subject(s)
Neoplasms , Humans , Neoplasms/genetics , Neoplasms/metabolism , Models, Biological , Mutation , Models, Genetic
5.
BMC Med Educ ; 24(1): 767, 2024 Jul 16.
Article in English | MEDLINE | ID: mdl-39014422

ABSTRACT

BACKGROUND: Comprehensive cancer care requires effective collaboration by interprofessional healthcare teams. The need to develop educational initiatives to improve interprofessional collaboration is increasingly recognised. However, there is no agreement regarding the interprofessional competencies required for effective cancer care leading to much variation on the focus of research, planning and managing change. A scoping review was conducted to identify the current status of IPE in cancer care and to summarise the results of previous research in order to guide the development of interprofessional education in cancer care. METHODS: The JBI Scoping Review guidelines were used to guide the process of the review. A search of the available literature was conducted in CINAHL, MEDLINE (Ovid), PubMed, PsycInfo, Scopus databases from January 2012 to March 2023 to investigate IPE for health professional clinicians working in cancer care. RESULTS: Of the 825 initial references and 153 studies imported for screening, a total of 28 studies were included in the final review. From those studies, seven focused on the need for IPE and interprofessional competence for oncology healthcare professionals, four reviewed existing IPE programs and 17 described the development and evaluation of interprofessional education. Findings show variation and lack of concept definitions underpinning research in IPE in cancer care settings. Variation also exists in the range of research activities in IPE, most notably related to communication, teamwork and the development of interprofessional practice. The evaluation of impact of IPE is mainly focused on health care professionals' self-evaluation and general feedback. Impact on patient care was only evaluated in one study. CONCLUSIONS: Based on the results, interprofessional education research in the field of cancer care is limited in Europe. Thus, there is a significant increase in publications in the last five years. A more systematic focus on the theoretical framework and definition of concepts would be of value. Research and programme development should be based on a shared understanding on what constitutes the interprofessional competences and IPE. Programmes to develop interprofessional practice should be developed and implemented systematically with inclusion of validated assessment methods, and evaluated and improved regularly.


Subject(s)
Interprofessional Relations , Neoplasms , Patient Care Team , Humans , Neoplasms/therapy , Interprofessional Education , Medical Oncology/education , Health Personnel/education , Cooperative Behavior
6.
Implement Sci Commun ; 5(1): 76, 2024 Jul 17.
Article in English | MEDLINE | ID: mdl-39020422

ABSTRACT

BACKGROUND: Adolescents and Young Adult (AYA) cancer survivors are at risk for psychological distress due to their unique developmental and medical needs. Healthcare providers can leverage the convenience and appeal of technology to provide supportive care for this vulnerable population. Using evidence-based mindfulness-based mobile interventions as a case example, the goal of this study was to identify key patient-, provider-, and organization-level barriers and facilitators to supportive care and implementing digital health interventions in AYA survivorship care. METHODS: Twenty semi-structured interviews were conducted with stakeholders including AYA survivors (n = 10; between 18-29 years old) and clinical providers and administrators (n = 10). Interviews were transcribed and deductively mapped using the Consolidated Framework for Implementation Research (CFIR) and Theoretical Domains Framework (TDF) complementary frameworks. RESULTS: Results indicated that factors like cost and patients' needs and resources were prevalent among both survivors and providers. There were key differences between providers and AYA survivors. Providers' adoption and promotion of digital health interventions were influenced most strongly by contextual factors, including available resources (Inner Setting), culture (Outer Setting), and networks and communications (Outer Setting). On the other hand, survivors emphasized individual and intervention-related factors; they reported that social influence and knowledge influenced their adoption and use of digital health interventions, including meditation apps. CONCLUSIONS: These results identified barriers and facilitators to the adoption of supportive care digital health interventions from multiple stakeholders. Results can be used to guide the development of implementation strategies to improve the uptake of digital health interventions in survivorship care, ultimately improving the psychosocial well-being of AYA cancer survivors.

7.
Heliyon ; 10(12): e33052, 2024 Jun 30.
Article in English | MEDLINE | ID: mdl-39021957

ABSTRACT

The Food and Drug Administration (FDA) has approved vorinostat, also called Zolinza®, for its effectiveness in fighting cancer. This drug is a suberoyl-anilide hydroxamic acid belonging to the class of histone deacetylase inhibitors (HDACis). Its HDAC inhibitory potential allows it to accumulate acetylated histones. This, in turn, can restore normal gene expression in cancer cells and activate multiple signaling pathways. Experiments have proven that vorinostat induces histone acetylation and cytotoxicity in many cancer cell lines, increases the level of p21 cell cycle proteins, and enhances pro-apoptotic factors while decreasing anti-apoptotic factors. Additionally, it regulates the immune response by up-regulating programmed death-ligand 1 (PD-L1) and interferon gamma receptor 1 (IFN-γR1) expression, and can impact proteasome and/or aggresome degradation, endoplasmic reticulum function, cell cycle arrest, apoptosis, tumor microenvironment remodeling, and angiogenesis inhibition. In this study, we sought to elucidate the precise molecular mechanism by which Vorinostat inhibits HDACs. A deeper understanding of these mechanisms could improve our understanding of cancer cell abnormalities and provide new therapeutic possibilities for cancer treatment.

8.
Cureus ; 16(6): e62530, 2024 Jun.
Article in English | MEDLINE | ID: mdl-39022461

ABSTRACT

Metastasis of cervical cancer to the heart is rare. Cervical carcinoma typically spreads to the lungs, liver, bones, and lymph nodes via hematogenous, lymphatic, transvenous, or direct extension. Cardiac metastasis from cervical carcinoma is uncommon and portends a dismal prognosis, with mean survival under six months post-diagnosis. A high index of suspicion and multimodal imaging is imperative for prompt diagnosis and improved outcomes in these patients. Here, we report a rare case where a 41-year-old African American female with stage IIIB cervical squamous cell carcinoma (SCC) presented with exertional dyspnea and chest pain concerning pulmonary embolism (PE). Computed tomography angiography showed no PE but revealed a right ventricular (RV) mass and diffuse pulmonary nodules. Echocardiography suggested an RV tumor versus a thrombus. Cardiac magnetic resonance imaging demonstrated a large RV infiltrative mass favoring metastasis over thrombus. A biopsy of one of the pulmonary nodules confirmed metastatic SCC. Despite treatment, the prognosis was poor.

9.
Cureus ; 16(6): e62488, 2024 Jun.
Article in English | MEDLINE | ID: mdl-39022485

ABSTRACT

BACKGROUND: Mohs micrographic surgery is a specialized tissue-sparing technique used to treat skin cancers. OBJECTIVE: By understanding the attributes that make a research paper one of the top 100 cited papers on Mohs surgery, we hope to illuminate seminal research in this field. METHODS AND MATERIALS: The global literature about Mohs surgery published between 1900 and 2023 was searched on the Web of Science. Publication data for all results meeting the search criteria were exported and analyzed. RESULTS: In total, 4,961 publications with 81,405 citations were identified. Dermatologic Surgery was the most cited journal, with 1,073 publications. Papers from the top 100 most cited that were published in the year 2000 or prior had an average of 22.1 citations in the first five years after publication, whereas papers published after 2001 had an average of 56.0 citations in the first five years. CONCLUSION: Analysis of the most cited papers on Mohs surgery demonstrates the influential role of the Dermatological Surgery journal in advancing the field. Noteworthy studies addressing cost, safety, and efficacy have received substantial citations, reflecting their significance within the literature. A trend toward more citation in the first five years after publication over time was identified.

10.
Support Care Cancer ; 32(8): 526, 2024 Jul 18.
Article in English | MEDLINE | ID: mdl-39023806

ABSTRACT

PURPOSE: Live-remote exercise interventions, supervised by exercise professionals in a home-based setting, could potentially enhance exercise accessibility for cancer survivors, yet research on their perspectives is limited. This study explored cancer survivors' experience of exercise within the context of a live-remote exercise intervention, to understand factors influencing exercise engagement. METHODS: Four online focus groups with, in total, 22 breast, prostate, and colorectal cancer survivors were conducted between March and June 2023. These individuals had participated in a 12-week live-remote exercise intervention. The semi-structured discussions were transcribed verbatim and analysed using reflexive thematic analysis with an abductive approach. The Capability, Opportunity, Motivation model of Behaviour (COM-B) served as a supportive framework. RESULTS: Nine themes were identified and mapped onto COM-B domains (capability, opportunity, motivation). Factors influencing cancer survivors' exercise engagement included exercise readiness following cancer treatment, bringing exercise closer, in capable hands, peer support through shared experience, life factors as hurdles or support, exercise as an integral component of cancer treatment, caring for myself and others after me, the positive impact of exercise exceeding expectations, and getting into the habit. CONCLUSIONS: Identifying factors shaping exercise engagement, these findings emphasise live-remote's potential benefit in overcoming barriers and fostering participation. Supervised by professionals, it offered psychosocial and exercise support, facilitating the integration of exercise into daily life. IMPLICATIONS FOR CANCER SURVIVORS: Elucidating key factors for exercise engagement within a live-remote context is essential for developing and implementing live-remote exercise interventions to ensure accessible, integrated exercise for optimal post-treatment well-being for cancer survivors.


Subject(s)
Cancer Survivors , Exercise Therapy , Focus Groups , Motivation , Humans , Cancer Survivors/psychology , Female , Male , Middle Aged , Aged , Exercise Therapy/methods , Exercise/psychology , Exercise/physiology , Neoplasms/therapy , Neoplasms/psychology , Breast Neoplasms/therapy , Breast Neoplasms/psychology , Adult , Colorectal Neoplasms/therapy , Colorectal Neoplasms/psychology , Qualitative Research , Prostatic Neoplasms/psychology , Prostatic Neoplasms/therapy
11.
BMC Cancer ; 24(1): 852, 2024 Jul 18.
Article in English | MEDLINE | ID: mdl-39026174

ABSTRACT

BACKGROUND: Providing appropriate specialized treatment to the right patient at the right time is considered necessary in cancer management. Targeted therapy tailored to the genetic changes of each breast cancer patient is a desirable feature of precision oncology, which can not only reduce disease progression but also potentially increase patient survival. The use of artificial intelligence alongside precision oncology can help physicians by identifying and selecting more effective treatment factors for patients. METHOD: A systematic review was conducted using the PubMed, Embase, Scopus, and Web of Science databases in September 2023. We performed the search strategy with keywords, namely: Breast Cancer, Artificial intelligence, and precision Oncology along with their synonyms in the article titles. Descriptive, qualitative, review, and non-English studies were excluded. The quality assessment of the articles and evaluation of bias were determined based on the SJR journal and JBI indices, as well as the PRISMA2020 guideline. RESULTS: Forty-six studies were selected that focused on personalized breast cancer management using artificial intelligence models. Seventeen studies using various deep learning methods achieved a satisfactory outcome in predicting treatment response and prognosis, contributing to personalized breast cancer management. Two studies utilizing neural networks and clustering provided acceptable indicators for predicting patient survival and categorizing breast tumors. One study employed transfer learning to predict treatment response. Twenty-six studies utilizing machine-learning methods demonstrated that these techniques can improve breast cancer classification, screening, diagnosis, and prognosis. The most frequent modeling techniques used were NB, SVM, RF, XGBoost, and Reinforcement Learning. The average area under the curve (AUC) for the models was 0.91. Moreover, the average values for accuracy, sensitivity, specificity, and precision were reported to be in the range of 90-96% for the models. CONCLUSION: Artificial intelligence has proven to be effective in assisting physicians and researchers in managing breast cancer treatment by uncovering hidden patterns in complex omics and genetic data. Intelligent processing of omics data through protein and gene pattern classification and the utilization of deep neural patterns has the potential to significantly transform the field of complex disease management.


Subject(s)
Artificial Intelligence , Breast Neoplasms , Precision Medicine , Humans , Breast Neoplasms/therapy , Breast Neoplasms/genetics , Precision Medicine/methods , Female , Prognosis , Machine Learning , Neural Networks, Computer
12.
Med Res Arch ; 12(1)2024 Jan.
Article in English | MEDLINE | ID: mdl-39026931

ABSTRACT

Pediatric cancer consists of a diverse group of rare diseases. Due to limited patient populations, standard randomized and controlled trials are often infeasible. As a result, single-arm trials are common in pediatric oncology and the use of external controls is often desirable or necessary to help generate actionable evidence and contextualize trial results. In this paper, we illustrate unique features in pediatric oncology clinical trials and describe their impact on the use of external controls. Various types of relevant external control data sources are described in terms of their utility and drawbacks. Statistical methodologies and design implications with external control are discussed. Two recent case studies using external controls to support pediatric oncology drug development are described in detail.

13.
Pediatr Blood Cancer ; : e31206, 2024 Jul 19.
Article in English | MEDLINE | ID: mdl-39030929

ABSTRACT

Central venous access through tunneled central venous catheters (CVCs) are one of the cornerstones of modern oncologic practice in pediatric patients since CVCs provide a reliable access route for the administration of chemotherapy. Establishing best practices for CVC management in children with cancer is essential to optimize care. This article reviews current best practices, including types of devices, their placement, complications, and long-term outcomes. Additionally, nutrition status and nutritional support are also very important determinants of outcomes and care in pediatric surgical oncology patients. We review current nutritional assessment, support, access for enteral and parenteral nutrition delivery, and their complications, mainly from a surgical perspective. Overall, access surgery, whether for CVCs, or for enteral access can be challenging, and best practice guidelines supported by current though limited evidence are necessary to minimize complications and optimize outcomes.

14.
J Pediatr Nurs ; 2024 Jul 16.
Article in English | MEDLINE | ID: mdl-39025711

ABSTRACT

PROBLEM: The terminal phase of childhood cancer poses profound physical and mental challenges for children, simultaneously influencing parents and rendering them particularly susceptible to psychosocial issues. ELIGIBILITY CRITERIA: This review included studies exploring the experiences of either: (1) paediatric terminal oncology patients aged under 18 years, (2) parents with a child facing terminal cancer undergoing palliative care, or (3) parents with a child who had undergone palliative care and died. English language, qualitative journal studies or grey literature of any care settings, geographical locations and publication years were included. Studies exploring the experiences of (1) paediatric terminal oncology not receiving palliative care from qualified healthcare professionals, and (3) non-biological parents or non-parental family members, were excluded. SAMPLE: A total of 22 studies were included, published between January 2000 and December 2023. Seventy-two children (aged between 5 and 18 years old) and 236 parents (aged between 24 and 57 years old) participated across all studies. Palliative care settings mostly comprised oncology centres, hospitals and homes. RESULTS: Two themes were identified from the 22 included studies: (1) Navigating rough waters and enduring hardships, and (2) Preparing for end-of-life amidst the looming threat of death. CONCLUSIONS: This review underscored the importance of integrating palliative childhood cancer care in a holistic, age-specific, family-centred, person-centred and timely manner. IMPLICATIONS: Paediatric oncology nurses should attend to physical and psychosocial needs of children and parents, fostering familial and social ties while recognising cultural and spiritual needs. Future research could recruit participants of varying ages, genders, and cultures.

15.
Article in English | MEDLINE | ID: mdl-39025746

ABSTRACT

INTRODUCTION: Radiomics offers the potential to predict oncological outcomes from pre-operative imaging in order to identify 'high risk' patients at increased risk of recurrence. The application of radiomics in predicting disease recurrence provides tailoring of therapeutic strategies. We aim to comprehensively assess the existing literature regarding the current role of radiomics as a predictor of disease recurrence in gastric cancer. METHODS: A systematic search was conducted in Medline, EMBASE, and Web of Science databases. Inclusion criteria encompassed retrospective and prospective studies investigating the use of radiomics to predict post-operative recurrence in ovarian cancer. Study quality was assessed using the QUADAS-2 and Radiomics Quality Score tools. RESULTS: Nine studies met the inclusion criteria, involving a total of 6,662 participants. Radiomic-based nomograms demonstrated consistent performance in predicting disease recurrence, as evidenced by satisfactory area under the receiver operating characteristic curve values (AUC range 0.72 - 1). The pooled AUCs calculated using the inverse-variance method for both the training and validation datasets were 0.819 and 0.789 respectively CONCLUSION: Our review provides good evidence supporting the role of radiomics as a predictor of post-operative disease recurrence in gastric cancer. Included studies noted good performance in predicting their primary outcome. Radiomics may enhance personalised medicine by tailoring treatment decision based on predicted prognosis.

16.
BMJ Case Rep ; 17(7)2024 Jul 18.
Article in English | MEDLINE | ID: mdl-39025796

ABSTRACT

Anal squamous cell carcinoma, typically associated with human papillomavirus infection, remains a rare malignancy. This article outlines a case of local recurrence in a male patient with a history of HIV and hepatitis C virus infection, previously treated with chemoradiotherapy. Extensive tumour involvement called for total pelvic exenteration extended to anterior osteomuscular compartment and genitalia. The surgical approach involved multidisciplinary collaboration and detailed preoperative planning using three-dimensional reconstruction. Key surgical considerations comprised the following: achieving tumour-free margins (R0 resection), extensive osteotomies and intricate pelvic floor reconstruction with prosthetic mesh and flap reconstruction. The procedure successfully yielded an R0 resection, maintaining adequate lower limb functionality. Our case report underscores the benefits of pelvic exenteration in locally advanced or recurrent pelvic tumours, invariably following careful patient selection and exhaustive preoperative studies.


Subject(s)
Anus Neoplasms , Carcinoma, Squamous Cell , Chemoradiotherapy , Neoplasm Recurrence, Local , Pelvic Bones , Pelvic Exenteration , Plastic Surgery Procedures , Surgical Flaps , Humans , Male , Anus Neoplasms/therapy , Anus Neoplasms/surgery , Carcinoma, Squamous Cell/therapy , Carcinoma, Squamous Cell/surgery , Neoplasm Recurrence, Local/surgery , Chemoradiotherapy/methods , Pelvic Bones/surgery , Plastic Surgery Procedures/methods , Middle Aged
18.
J Biopharm Stat ; : 1-22, 2024 Jul 19.
Article in English | MEDLINE | ID: mdl-39028254

ABSTRACT

Dose selection and optimization in early phase of oncology drug development serves as the foundation for the success of late phases drug development. Bivariate Bayesian logistic regression model (BLRM) is a widely utilized model-based algorithm that has been shown to improve the accuracy for identifying recommended phase 2 dose (RP2D) based on dose-limiting-toxicity (DLT) over traditional method such as 3 + 3. However, it remains a challenge to optimize dose selection that strikes a proper balance between safety and efficacy in escalation and expansion phase of phase I trials. In this paper, we first use a phase I clinical trial to demonstrate how the variability of drug exposure related to pharmacokinetic (PK) parameters among trial participants may add to the difficulties of identifying optimal dose. We use simulation to show that concurrently or retrospectively fitting BLRM model for dose/toxicity data from escalation phase with dose-independent PK parameters as covariate lead to improved accuracy of identifying dose level at which DLT rate is within a prespecified toxicity interval. Furthermore, we proposed both model- and rule-based methods to modify dose at patient level in expansion cohorts based on their PK/exposure parameters. Simulation studies show this approach leads to higher likelihood for a dose level with a manageable toxicity and desirable efficacy margin to be advanced to late phase pipeline after being screened at expansion phase of phase I trial.

19.
Int J Palliat Nurs ; 30(7): 370-378, 2024 Jul 02.
Article in English | MEDLINE | ID: mdl-39028315

ABSTRACT

BACKGROUND: Caring for patients with advanced cancer is complex and challenging, requiring varied expertise, including symptom management, communication skills, care coordination and emotional resilience. Within existing literature, the lived experiences of oncology nurses are poorly articulated in countries with a lower income where formal palliative care (PC) is absent. AIM: To explore the lived experiences of Gazan oncology nurses who provide care to patients with advanced cancer in healthcare systems, without formal palliative care infrastructure. METHODS: A phenomenological approach was adopted. Semi-structured interviews were conducted between January and April 2022, in the Turkish Palestinian Friendship Hospital. Thematic analysis used the themes (corporeality, relationality, spatiality and temporality) to facilitate reflection on the meaning of participants' lived experiences. RESULTS: Interviews were undertaken with 16 oncology nurses. The experience of the 'erosion of nurses' work when coping with anxious attachments to patients and families' was the overarching theme in nurses' views, characterised by five sub-themes: (1) inadequacy of PC training and resources, (2) serving humanity, (3) pride in their profession, (4) existential distress and the coping strategies used by nurses, and (5) reported stress and anxiety when caring for seriously ill patients and their families. CONCLUSIONS: The study sheds light on the challenges and powerful emotions experienced by oncology nurses who care for patients with advanced cancer, yet lack the necessary PC training and institutional resources. The findings indicate an urgent need for PC training for nurses within the Gazan healthcare system and other lower-income settings. Assessing nurses' emotions and relationships with patients and family caregivers is imperative to enable optimum care for patients with cancer and to foster resilience among their nurses.


Subject(s)
Neoplasms , Oncology Nursing , Humans , Neoplasms/nursing , Adult , Female , Male , Middle Aged , Palliative Care , Qualitative Research , Adaptation, Psychological , Turkey , Interviews as Topic
20.
Jpn J Clin Oncol ; 2024 Jul 18.
Article in English | MEDLINE | ID: mdl-39023439

ABSTRACT

BACKGROUND: The prognosis of gynecological malignancies has improved with the recent advent of molecularly targeted drugs and immune checkpoint inhibitors. However, these drugs are expensive and contribute to the increasing costs of medical care. METHODS: The Japanese Clinical Oncology Group (JCOG) Health Economics Committee conducted a questionnaire survey of JCOG-affiliated facilities from July 2021 to June 2022 to assess the prevalence of high-cost regimens. RESULTS: A total of 57 affiliated facilities were surveyed regarding standard regimens for advanced ovarian and cervical cancers for gynecological malignancies. Responses were obtained from 39 facilities (68.4%) regarding ovarian cancer and 37 (64.9%) concerning cervical cancer, with respective case counts of 854 and 163. For ovarian cancer, 505 of 854 patients (59.1%) were treated with regimens that included PARP inhibitors, costing >500 000 Japanese yen monthly, while 111 patients (13.0%) received treatments that included bevacizumab, with costs exceeding 200 000 Japanese yen monthly. These costs are ~20 and ~10 times higher than those of the conventional regimens, respectively. For cervical cancer, 79 patients (48.4%) were treated with bevacizumab regimens costing >200 000 Japanese yen per month, ~10 times the cost of conventional treatments. CONCLUSIONS: In this survey, >70% of patients with ovarian cancer were treated with regimens that included poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors or bevacizumab; ~50% of patients with cervical cancer were treated with regimens containing bevacizumab. These treatments were ~10 and ~20 times more expensive than conventional regimens, respectively. These findings can inform future health economics studies, particularly in assessing cost-effectiveness and related matters.

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