Outcomes of patient education in adult oncologic patients receiving oral anticancer agents: a systematic review protocol.

BACKGROUND: A large variety of oral anticancer agents have become available and while at first glance these therapies appear to provide only benefits, patients have expressed their need for educational interventions and raised safety issues. Although both patients and providers have recognized patient education's importance, and an interplay with safety has been acknowledged, no systematic reviews of the literature that summarize all of the current evidence related to patient education's outcomes for patients who receive oral anticancer agents have been performed to date. Accordingly, this systematic review will attempt to fill the gap in the literature as well as to map (1) contents, (2) methodologies, (3) settings, (4) timing/duration, and (5) healthcare professionals involved. METHODS: This protocol is being reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic review will be performed. Studies that targeted eligible adult patients (≥ 18 years old) in hospital, outpatient, and home settings, and reported patient education's outcomes for those taking oral anticancer agents will be included. Searches will be conducted in PubMed/MEDLINE, CINAHL, Embase, and Scopus, and gray literature will be also sought. Two researchers will screen the search results independently and blindly in two phases: (1) title/abstract screening and (2) full-text screening using the Rayyan AI platform. An electronic data extraction form will be implemented and piloted, and then, two trained data extractors will extract the data cooperatively. Thereafter, a quality appraisal will be conducted using the Critical Appraisal Tools from The Joanna Briggs Institute. The results will be analyzed, grouped, clustered into categories, and discussed until a consensus is reached. Emerging evidence will be synthesized narratively and reported in accordance with the synthesis without meta-analysis guidelines. DISCUSSION: The systematic review's results will be relevant to (1) policymakers and management at an institutional level, and (2) for clinical practice, in an evidence-based paradigm, potentially leading to a quality improvement with respect to safety and patient satisfaction. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022341797.

Pharmacovigilance in oncology.

Background Side effects of cancer therapy are one of the most important issues faced by cancer patients during their illness. Pharmacovigilance, namely the science and activities aimed at monitoring the safety of drugs, is particularly important in oncology, due to the intrinsic biologic toxicity of antineoplastic agents, their narrow therapeutic windows, and the high doses and rigid timing of treatment regimens. Aim of the review To identify the main issues in carrying out an effective pharmacovigilance activity in oncology. Method We searched PubMed for articles about pharmacovigilance in relation to chemotherapy, radiotherapy and targeted therapy for cancer, using MeSH terms and text words. We also searched Embase, CINAHL, Scopus, Micromedex, the Cochrane Library, two pharmacovigilance databases and the gray literature for articles published in 2012-2018. Overall, 137 articles were considered potentially relevant and were critically appraised independently by two authors, leading to the inclusion of 44 relevant studies, guidelines and reviews. Another 10 important research reports were included in the review. Results Eight critical issues of pharmacovigilance in oncology were identified. These issues pertain to: terminology; range of side effects; targeted therapy and immunotherapy; chemoradiotherapy; generic drugs and biosimilars; drug interactions, pharmacogenetics and polypharmacy; special patient categories; and under-reporting of ADRs. Conclusion The importance of pharmacovigilance in oncology must be highlighted with every effort, to improve safety and offer cancer patients every possible help to improve their quality of life during such a critical period of their lives.

Immune checkpoint inhibitors and response analysis: a tough challenge. A case report.

BACKGROUND: Treatment of metastatic NSCLC patients with immune-checkpoint medicine is intriguing for the potential efficacy; however it may be difficult to evaluate the clinical response due to the lack of reliable immune-monitoring markers up to now and the possibility of radiological pseudo-progression. CASE PRESENTATION: Herein we report the case of a patient ex-smoker with adenocarcinoma of the lung, stage IV for liver metastases, in progression after cisplatin-based chemotherapy and treated with antiPD-L1 (MPDL3802-Roche Genentech) e.v. every 3 weeks in a clinical trial. Treatment with antiPD-L1 was well tolerated and CT scan after 6 weeks of treatment showed stabilization of mediastinal lymph nodes, while progression of liver metastases; liver progression only was confirmed by further CT-scans. Patient was asymptomatic and it was unclear if we faced a pseudo-progression in the liver or a real progression. Data about his PDL1 expression were not available because the patient was in a clinical trial. Eventually a biopsy of the liver metastasis confirmed that there was a massive neoplastic invasion with tumor infiltrating lymphocytes <5 %. We stopped anti-PD-L1 therapy due to progression. CONCLUSION: Evaluation of response may be difficult with immune checkpoint inhibitors, in particular radiologic images may be a matter of debate; eventually we performed a biopsy to study tumor infiltrating lymphocytes to decide whether it was pseudo-progression or real progression.

Patient-Centered Cancer Care Programs in Italy: Benchmarking Global Patient Education Initiatives.

In Italy, educational programs for cancer patients are currently provided by the national government, scientific societies, and patient advocate organizations. Several gaps limit their effectiveness, including the lack of coordinated efforts, poor involvement of patient feedback in the planning of programs, as well as a lack of resources on innovative cancer-related topics. This process is parallel to a strong shift in the attitude of patients towards health in general and taking charge of their own health conditions in particular. The National Cancer Institute in the USA and the Organization of European Cancer Institutes encourage comprehensive cancer centers in providing educational programs conceived to overcome these gaps. The goal of this paper is to identify and describe the key elements necessary to develop a global patient education program and provide recommendations for strategies with practical examples for implementation in the daily activities of cancer institutes. A multidisciplinary committee was established for patient education, including patient representatives as equal partners, to define, implement, verify, and evaluate the fundamental steps for establishing a comprehensive education program. Six essential topics were identified for the program: appropriate communication of cancer epidemiology, clinical trial information, new therapeutic technologies, support in the use of medicines, psycho-oncological interventions, age-personalized approaches, and training programs for healthcare providers. Integration of these topics along with patient feedback is the key to a successful model for educational programs. An integrated educational program can transform a comprehensive cancer center to an institution that provides research and care for and with patients.

Activity of crizotinib over choroidal metastases in non-small-cell lung cancer (NSCLC)-ALK rearranged: a case report.

BACKGROUND: Adenocarcinoma of the lung with EML4-ALK translocation is a rare subtype of Non Small-Cell Lung Cancer (NSCLC) that has recently shown to benefit from treatment with crizotinib. Despite the concerns about the efficacy of crizotinib over cerebral metastases, some reports have described its activity, although always after local treatment with radiotherapy. Recently it has been reported activity of crizotinib over choroidal metastases, again after radiotherapy. CASE PRESENTATION: Herein we report a case of activity of crizotinib over choroidal metastases not previously treated with radiotherapy. CONCLUSION: We suggest crizotinib may be active over choroidal metastases in a patient harboring ALK translocation with no need of radiotherapy.

Assessing cancer-related fatigue: the psychometric properties of the Revised Piper Fatigue Scale in Italian cancer inpatients.

GOALS OF WORK: Fatigue is the most distressing untreated symptom for many cancer patients, and its measurement is of great topical interest. The aim of the present study was to assess psychometric properties of Revised Piper Fatigue Scale (PFS-r) in Italian cancer patients. PATIENTS AND METHODS: From January to June 2007, 115 histologically confirmed cancer inpatients (age >or=18 years; Eastern Cooperative Oncology Group [ECOG] performance status or=0.97) for all subscales. Exploratory factor analysis revealed three dimensions instead of four in the US questionnaire; 68.2% of the common variance was explained. Internal consistency was satisfactory (Cronbach's alpha >0.80) as was the test-retest reliability. Good correlations between PFS-r subscale and POMS subscales confirmed criterion validity. CONCLUSIONS: The psychometric properties of the Italian version of PFS-r, as evaluated in cancer patients ongoing chemotherapy, were satisfactory. We suggest the possible implementation of the Italian PFS-r in the assessment of fatigue particularly when it has been more fully validated on a wider range of cancer patients.