Nonmelanoma skin cancer is the most common malignant tumor in the fair skin population, with each year several millions of diagnosed cases. Their most common risk factors are fair skin, a history of ...excessive ultraviolet light exposure, chronic inflammatory skin conditions, exposure to radiation, and contact with arsenic. Certain drugs can also be associated with a higher risk of nonmelanoma skin cancer. These include hydroxyurea, which acts as a metabolic inhibitor of ribonucleotide reductase and a potent nonalkylating myelosuppressive agent. It is used for the treatment of various myeloproliferative disorders, including chronic myeloid leukemia, polycythemia vera, and essential thrombocytopenia. Several publications describe an increased occurrence of skin manifestations following hydroxyurea treatment. A growing body of evidence indicates a possible role of hydroxyurea in skin cancer progression. In this review article, we summarize some relevant observations about the association of hydroxyurea and skin cancer, and we describe our own clinical experiences to provide up to date recommendations about the care of patients on hydroxyurea therapy.
Carbapenem-resistant Klebsiella pneumoniae (CRKP) spread and infections in patients with haematological malignancies are a serious concern especially in endemic areas. Treatment failures and delay in ...appropriate therapy for CRKP infections are frequent and the mortality rate associated with CRKP bacteremia in neutropenic haematological patients is reported about 60%.
Haematological patients harboring CRKP hospitalized between February 2012 and May 2013 in an Italian Teaching hospital were examined. Conditions favouring CRKP spread in a haematological unit, risk factors for bacteremia in CRKP-carriers and for CRKP bacteremia-related death were evaluated in this observational retrospective study.
CRKP was isolated in 22 patients, 14 (64%) had bacteremia. Control measures implementation, particularly the weekly rectal screening for CRKP performed in all hospitalized patients and contact precautions for CRKP-carriers and newly admitted patients until proved CRKP-negative, reduced significantly the CRKP spread (14 new carriers identified of 131 screened patients vs 5 of 242 after the intervention, p = 0.001). Fifty-eight percent of carriers developed CRKP bacteremia, and acute myeloid leukemia (AML) resulted independently associated with the bacteremia occurrence (p = 0.02). CRKP bacteremias developed mainly during neutropenia (86%) and in CRKP-carriers (79%). CRKP bacteremias were breakthrough in 10 cases (71%). Ten of 14 patient with CRKP bacteremias died (71%) and all had AML. The 70% of fatal bacteremias occurred in patients not yet recognized as CRKP-carriers and 80% were breakthrough. Initial adequate antibiotic therapy resulted the only independent factor able to protect against death (p = 0.02).
The identification of CRKP-carriers is confirmed critical to prevent CRKP spread. AML patients colonized by CRKP resulted at high risk of CRKP-bacteremia and poor outcome and the adequacy of the initial antibiotic therapy may be effective to improve survival. To limit the increase of resistance, the extensive use of antibiotics active against CRKP should be avoided, but in the setting of high CRKP pressure and high-risk CRKP-colonized haematological patients, timely empiric antibiotic combinations active against CRKP could be suggested as treatment of febrile neutropenia.
Organ dysfunctions and medical complications, such as renal failure, liver impairment, coagulation disorders, cardiovascular and respiratory illnesses, may hamper an adequate pain management in ...haematological patients.
To summarize current knowledge on pain management in hematological patients presenting major organ dysfunctions and comorbidity. We also attempted to provide recommendations to optimize analgesia and to minimize side effects in the setting of medically compromised and frail haematological patients.
A systematic search of the literature, using relevant key words, was conducted in PubMed.
Pain in hematological patients is a common symptom and is often multi-factorial. Most pharmacotherapeutic measures, including causal therapies, analgesics and adjuvant agents routinely applied in pain management, may also be used in the setting of clinical frailty and medical comorbidities; however, comprehensive clinical and functional patient's evaluations and a careful consideration of expected benefits and potential adverse events are required.
The prevention of oral mucositis (OM) in the management of hematological malignancies continues to represent an unmet clinical need. Addressing this issue has major clinical implications as OM can ...also greatly impair patient's quality of life.
To review currently available measures and investigational agents to prevent OM in hematological patients.
we searched for OM and related issues using Medline; the abstract books of the most important hematological and oncological meetings were also reviewed.
Many agents targeting different mechanisms of mucosal damage have been applied in order to prevent OM; most of them have failed or its efficacy has not been fully demonstrated. Palifermin is the first pharmaceutical/biological agent approved for the prevention of OM; its use is currently restricted to patients who have received radiotherapy-containing conditioning regimens prior to autologous hematopoietic stem cell transplantation. No clear benefit by this agent has been demonstrated outside of this specific setting and its application should be limited to clinical trials. Other interventions, such as other growth factors and non mitogenic measures are under investigation or in development and their application in the hematological setting is expected in the short term.
Background Although efficacy and safety data on chimeric antigenic receptor (CAR) T-cell therapy for patients aggressive B-cell lymphomas are being accumulated, there is limited research on ...health-related quality of life (HRQoL) and symptom burden of these patients. Additionally, the few HRQoL data available mainly stems from selected patients enrolled in clinical trial settings. Objective The primary objective of this study was to compare HRQoL of patients with relapsed/refractory aggressive B-cell lymphomas just before receiving CAR T-cell infusion in real-life, with that of their peers in the general population. Secondary objectives were to describe the prevalence of disease-specific symptoms and worries, and to investigate the relationships between symptom burden and HRQoL and functional outcomes. Methods: Baseline data from an ongoing prospective observational study by the Italian GIMEMA Group were analyzed. Inclusion criteria were: adult patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed by indolent lymphoma and mantle cell lymphoma, scheduled to receive CAR T-cell therapy. HRQoL was assessed with the EORTC QLQ-C30 and its recently validated module for patients with high-grade non-Hodgkin lymphoma (EORTC QLQ-NHL-HG29). Multivariable linear regression analyses were performed to estimate the overall mean difference in the QLQ-C30 scores between patients and the general population, adjusting for age, sex and comorbidity. Evidence-based guidelines for interpretation of the QLQ-C30 were used to determine clinically meaningful differences between groups. The prevalence of patients who reported symptoms and worries on the QLQ-NHL-HG29 was based on the number of patients who answered, “a little,” “quite a bit,” or “very much” on a given item. This was assessed overall and by age groups. For descriptive purposes, we divided the sample by the median age, deriving two subgroups: younger (with a median age of 50 years; IQR: 41 - 56) and older patients (with a median age of 65 years; IQR: 63 - 71). Mean scores of functional and global QoL scales of the EORTC QLQ-C30 were analyzed by severity of symptom burden. Patients were categorized as having high or low symptom burden based on the median score of the validated symptom burden scale of the QLQ-NHL-HG29 questionnaire. Results Overall, 65 patients enrolled across 9 centers were analyzed. Median age at study entry was 61 years (IQR, 50-65) and 21 (32%) were women. Median time since diagnosis was 2 years (IQR, 1-4). Eighteen patients (28%) had already received autologous hematopoietic stem cell transplantation (auto-HSCT) before study inclusion. Median number of previous lines of therapy was 2 (IQR: 2-3), and eleven patients (18%) reported at least 1 comorbidity. Patients reported statistically and clinically meaningful worse scores across several domains, compared with their peers in the general population. The top three largest statistically and clinically meaningful differences with regard to functional scales were observed for role functioning (Δ=26.8, p<.001), social functioning (Δ=17.6, p<.001) and the global QoL scale (Δ=14.3, p<.001). With regard to symptoms, the two largest statistically and clinically meaningful worse symptoms, compared to the general population, were observed for fatigue (Δ=14.2, P<.001), dyspnea (Δ=10.9, p=.003) and financial difficulty (Δ=10.6, p=.001). Prevalence of symptoms and worries was high with more than 50% of patients reporting 14 different symptoms and worries. Younger patients tended to report a higher prevalence in regard to specific worries. The top ten most prevalent symptoms and worries by the QLQ-NHL-HG29, overall and by age groups, are reported in Table 1. Patients with a greater symptom burden had a clinically meaningful worse global QoL, and worse physical, role, social, and cognitive functioning compared to those with a lower symptom burden (Figure 1). Conclusion: Using a validated disease-specific measure for high-grade non-Hodgkin lymphoma, we observed that just before CAR T-cell therapy in real-life, patients report substantial HRQoL impairments and a high prevalence of symptoms and worries. Our findings also suggest to pay special attention to patients with a greater symptom burden, being a vulnerable group with important HRQoL and functional impairments.
Background Digital health tools are increasingly being used in oncology practice to better monitor patients' health status. They may include electronic-patient-reported outcome (ePRO) monitoring ...systems, with automated alerts triggered to the physician depending on specific conditions (e.g., when patients report clinically relevant problems). Although implementation of these tools in real-life practice may offer valuable benefits, it is important to assess their usability and utility from the users' standpoint. Objective The aim of this study was to evaluate the patients' perception of usability and utility of a digital health tool for ePRO monitoring of patients with hematologic malignancies in real-life practice. Methods In December 2020, the GIMEMA Group developed a digital health platform for adult patients with hematologic malignancies (GIMEMA-ALLIANCE platform) with the goal of facilitating patient-centered care. The platform was open to enrollment until December 2022 and involved 26 hospitals. After providing written informed consent, patients received a personal password to access the secure patient portal and complete ePRO questionnaires assessing health-related quality of life (HRQoL) and symptoms (EORTC QLQ-C30 and selected items from the EORTC Item Library). Real-time graphical presentation of PRO results is displayed for both patients and physicians. The platform allows hematologists to receive real-time alerts in the presence of clinically important problems and symptoms. For the purpose of this study, a dedicated section in the patient portal was developed to evaluate the usability and utility of the platform. In this section, patients had the possibility to complete the System Usability Scale (SUS). The SUS is a 10-item widely used questionnaire to evaluate users' perceived system satisfaction. Its score ranges from 0 to 100 and a score ≥70 is considered a threshold for an acceptable usability. Analyses were performed overall and by age group category, based on the median age of the patient population. Patients also completed an ad-hoc survey consisting of 6 items covering aspects on the utility of the platform, for example in favoring shared decision-making or improving the communication with the treating hematologist. Only patients who have completed the ePRO questionnaires at least twice, i.e. those who had the possibility to sufficiently test its functionalities, were considered eligible for completing the survey on usability and utility of the platform. Results Out of the 362 eligible patients, a total of 161 (44%) completed the survey. No difference in age and sex was found between patients who completed or not the survey. The median age of patients who completed the survey was 59 years (IQR: 51 - 67) and 53 (34%) were women. The most prevalent diagnosis was multiple myeloma (n=40, 25%). At the time of survey completion, 69% of the patients were receiving a treatment for their disease. The mean SUS score of the overall population was 80.8 (SD 15.5) and the majority of patients (n=131, 81%) gave a rating ≥70 (the prespecified threshold for the acceptable usability). The mean SUS score for the younger and the older groups was 80.5 (SD 14.9) and 81.4 (SD 16), respectively. Eighty-eight percent of patients agreed or strongly agreed that the platform was easy to use, 83% felt very confident in using the platform, and 72% found the various functionalities offered by the platform well integrated (Figure 1). Positive feedbacks on the utility of the platform were also collected. For example, 71% of patients considered the ePRO questionnaires useful for their health conditions and 63% would recommend its use to other patients. However, amongst the patients who had visits at the clinic (n=127), only 39% reported that their doctor discussed ePRO results with them, and this may explain the lower agreement for some items (Figure 2). For example, 38% of the patients strongly agreed/agreed that the platform helped them to improve the communication with their doctor, while 44% neither agreed or disagreed and 18% strongly disagreed/disagreed. Conclusion This study showed a good usability and utility of the GIMEMA-ALLIANCE platform from the patients' perspective, and this was true for younger and older patients. Future areas of improvement should include actions to facilitate physicians in discussing ePRO results during the clinical encounter with their patients.
Background: The aim of this study was to assess the phenomenon of episodic breathlessness in advanced cancer patients followed by palliative care services at home.
Methods: A consecutive sample of ...patients with advanced cancer, admitted to home care for a period of six months, was surveyed. The presence of background breathlessness and episodic breathlessness, their intensity, and drugs used for their treatment were collected. Factors inducing episodic breathlessness, and its influence on daily activities were investigated.
Results: Three hundred forty-seven advanced cancer patients admitted to home palliative care were surveyed. The prevalence of breathlessness was 35.3%. The mean intensity of breathlessness was 3.8 (SD 1.96), out of a maximum score of 10 for worst imaginable. Sixty patients (49.2%) were receiving drugs for background breathlessness. In the multivariate analysis the risk of breathlessness increased with cardiovascular disease, chronic obstructive pulmonary disease, and lung cancer while it decreased in patients with a better performance status. The prevalence of episodic breathlessness in patients with background breathlessness was 79.5% and its mean intensity was 7.1 (SD 1.5, range 2-10). The mean duration of episodic breathlessness was 28.6 minutes (SD 47.1, range 1-300 minutes). Forty-three patients (44.3%) were receiving one or more drugs as needed. The majority of episodic breathlessness events were triggered by activity. Episodic breathlessness was interfering with daily activities in 65 patients (67%). Episodic breathlessness wasn't associated with any variable taken into consideration.
Conclusion: This study showed that episodic breathlessness frequently occurs in advanced cancer patients admitted to home care, is severe in intensity, is triggered in most cases by activity, and is characterized by a short duration which requires rapid measures.
Background
There is now great interest in using digital health tools to monitor patients' health status in real-world practice. Such tools often include electronic-patient-reported outcome (ePRO) ...systems in which symptoms questions are included into online interfaces for patient self-reporting, with real-time alerts triggered to the treating physician if severe symptoms or problems are reported. However, there is little information about the clinical utility and user perceptions of these systems, and this is particularly true in the area of hematology.
Objectives
This study investigates physicians' perceptions of usability and clinical utility of using remote ePROs in routine practice of patients with hematologic malignancies and explored implications in the delivery of patient care.
Patients and Methods
Remote ePROs are being gathered since December 2020 by the ALLIANCE Digital Health Platform, whose details of the development process have been previously described (Efficace F. et al., JMIR Res Protoc. 2021 Jun 1;10:e25271). Adult patients diagnosed with any hematologic malignancy are eligible to enter the platform, after having provided written informed consent. Aspects related to health-related quality of life (HRQoL), symptoms and medication adherence are assessed via validated PRO measures. The platform allows for real-time graphical presentation to physicians of individual patient symptoms and HRQoL outcomes. Based on a pre-defined algorithm, which includes the presence of clinically important problems and symptoms, the platform triggers automated alerts to the treating haematologists and medical staff. The definition of clinically important problems and symptoms is based on previously defined evidence-based thresholds (Giesinger J. et al., J Clin Epidemiol. 2020 Feb;118:1-8). We asked treating haematologists a feedback about their experience in using the platform, by an ad hoc web-survey consisting of 27 items covering several domains, including: usability and benefits, current use, evaluation of patient health-status, symptoms and adverse events, as well as physician-patient communication. We summarized characteristics of enrolled patients and treating haematologists by proportions, mean, median and range. We also used logistic regression analysis to check the possible association of characteristics of haematologists with survey results.
Results
Of the 201 patients invited to participate between December 2020 and June 2021 (cut-off date for current analysis), 180 (90%) accepted to enter the ALLIANCE platform, currently activated in 19 centers. The median age of patients was 57 years (range 21-91) and 58% were males. The majority were diagnosed with chronic myeloid leukemia (n=32, 18%) and multiple myeloma (n=31, 17%) and were in stable disease (n=89, 49%). Twenty-three hematologists (44% males) with a median age of 42 years (range 31-63) and an average 17 years (range 5-34) of experience in clinical practice, completed the survey. The majority of physicians (78%) accessed the platform at least once per month (of whom 39% at least once per week), regardless the alerts sent by the system about patients' clinically relevant problems. The frequency of access on a regular basis was also independent of physician sex (p=0.393) and years of experience in clinical practice (p=0.404). Overall, 57% of hematologists discussed often or very often ePROs with their patients, while 83% and 61% deemed this information helpful to better identify symptomatic adverse events (AEs) of grade 1-2 or of grade 3-4, respectively (see figure). Also, 87% and 91% of hematologists found ePROs useful to improve physician-patient communication and the accuracy of documentation of symptomatic AEs (regardless of severity), respectively. Physicians' responses to selected items of the survey are reported in the figure.
Conclusions:
Current findings support the clinical utility, from the perspective of the treating physician, of integrating ePROs into routine cancer care of patients with hematologic malignancies.
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Efficace: Takeda: Consultancy; Janssen: Consultancy; Abbvie: Consultancy, Other: Grants (to Institution); Amgen: Consultancy, Other: Grants (to Institution). Breccia: Bristol Myers Squibb/Celgene: Honoraria; Pfizer: Honoraria; Abbvie: Honoraria; Incyte: Honoraria; Novartis: Honoraria. Fazio: Janseen: Honoraria. Petrucci: Karyopharm: Honoraria, Other: Advisory Board; GSK: Honoraria, Other: Advisory Board; Amgen: Honoraria, Other: Advisory Board; Takeda: Honoraria, Other: Advisory Board; BMS: Honoraria, Other: Advisory Board; Janssen-Cilag: Honoraria, Other: Advisory Board; Celgene: Honoraria, Other: Advisory Board. Rigacci: Merck: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accomodations, Expenses; Gilead Science: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Menarini: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Tafuri: Roche: Research Funding; Celgene: Research Funding; Novartis: Research Funding. Siragusa: Novartis, CSL, Behring, Amgen, Novonoridsk, SOBI, Bayer: Consultancy, Honoraria, Speakers Bureau. Patriarca: Incyte: Honoraria; Takeda: Honoraria; Novartis: Honoraria; Amgen: Honoraria; Pfizer: Honoraria; Argenix: Honoraria. Luppi: Abbvie: Honoraria; Novartis: Honoraria; Sanofi: Honoraria; MSD: Honoraria; Gilead Science: Honoraria, Other: Travel grant; Daiichi-Sankyo: Honoraria; Jazz Pharma: Honoraria. Vignetti: Novartis: Honoraria; Incyte: Honoraria; Amgen: Consultancy, Honoraria.
Long-term survival of relapsed/refractory acute myeloid leukemia (AML) remains a major problem, particularly in patients not eligible for transplantation.We hereby evaluated the feasibility and ...efficacy of adding Gemtuzumab Ozogamicin to salvage chemotherapy (Ara-C, Idarubicine, Peg-Filgrastim) in relapsed/refractory AML. The main endpoints were: the rate of complete remissions (CR) and the proportion of patients capable of undergoing a stem cell transplant.Fourty-two patients were enrolled. The overall CR rate was 76% and no induction deaths were reported. In 56% of patients, a transplant procedure could be performed. The treatment schedule proved feasible and well tolerated, providing a high CR rate and a useful bridge to transplant.
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