BackgroundImmune checkpoint inhibitors (CIs) have revolutionized treatment of advanced melanoma, leading to an emerging population of long-term survivors. Survivors’ quality of life (QOL) and symptom burden are poorly understood. We set out to evaluate symptom burden and QOL in patients with advanced melanoma alive more than 1 year after initiating CI therapy.MethodsCross-sectional surveys, accompanied by chart review of patients with advanced melanoma treated with CIs at Memorial Sloan Kettering Cancer Center, completed therapy, and were alive >1 year after treatment initiation. Surveys were administered between February and August 2018. Surveys included: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, EuroQOL, items from Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events and Fatigue Severity Scale.ResultsWe included 90 patients. The most common CI regimens were ipilimumab plus nivolumab (53%) and pembrolizumab (41%); most patients (71%) were not treated in clinical trials. Median time from CI therapy initiation was 40 months and from last dose was 28 months. Fatigue was reported by 28%, with higher fatigue scores in women than men; 12% reported difficulty sleeping. Aching joints (17%) and muscles (12%) were fairly common. Level of functioning was generally high. Overall QOL was excellent though 40% reported ‘some or moderate’ problems with anxiety/depression and 31% with pain/discomfort.ConclusionsAfter CI therapy, long-surviving advanced melanoma patients commonly report fatigue but otherwise have moderate symptom burden and good QOL. Ensuring appropriate symptom management will optimize clinical outcomes for these patients.
Objective To identify all known ties between the medical product industry and the healthcare ecosystem. Design Scoping review. Methods From initial literature searches and expert input, a map was created to show the network of medical product industry ties across parties and activities in the healthcare ecosystem. Through a scoping review, the ties were then verified, cataloged, and characterized, with data abstracted on types of industry ties (financial, non-financial), applicable policies for conflict of interests, and publicly available data sources. Main outcome measures Presence and types of medical product industry ties to activities and parties, presence of policies for conflict of interests, and publicly available data. Results A map derived through synthesis of 538 articles from 37 countries shows an extensive network of medical product industry ties to activities and parties in the healthcare ecosystem. Key activities include research, healthcare education, guideline development, formulary selection, and clinical care. Parties include non-profit entities, the healthcare profession, the market supply chain, and government. The medical product industry has direct ties to all parties and some activities through multiple pathways; direct ties extend through interrelationships among parties and activities. The most frequently identified parties were within the healthcare profession, with individual professionals described in 422 (78%) of the included studies. More than half (303, 56%) of the publications documented medical product industry ties to research, with clinical care (156, 29%), health professional education (145, 27%), guideline development (33, 6%), and formulary selection (8, 1%) appearing less often. Policies for conflict of interests exist for some financial and a few non-financial ties; publicly available data sources seldom describe or quantify these ties. Conclusions An extensive network of medical product industry ties to activities and parties exists in the healthcare ecosystem. Policies for conflict of interests and publicly available data are lacking, suggesting that enhanced oversight and transparency are needed to protect patient care from commercial influence and to ensure public trust.
When recurrence is suspected, clinicians should include biopsy of the distal apex, areas surrounding the urethra, and seminal vesicles. This information will help tailor successful salvage treatments.
Introduction: The addition of targeted prostate biopsy to systemic biopsy impacts patient experience. We examined patient-reported pain, discomfort, anxiety, and tolerability among men undergoing magnetic resonance imaging (MRI)-targeted prostate biopsy in addition to transrectal ultrasound-guided systematic biopsy compared to those undergoing systematic biopsy alone. Methods: All patients underwent transrectal systematic 14-core biopsies. Patients with regions of interest on MRI underwent additional targeted biopsies. All patients received equivalent periprostatic nerve block. Four single-item, standard 11-point numerical rating scales evaluating pain, discomfort, anxiety, and tolerability were completed immediately after biopsy. Differences in means were compared using t-tests. Correlation between rated domains was tested using Spearman’s correlation coefficient. Results: Of 273 consecutive patients, 195 (71%) underwent targeted biopsy and 188 (69%) had undergone prior biopsy. In all men, the median score for pain and tolerability was 3, while the median score for discomfort and anxiety was 4. Pain was rated at 7 or above by 15% of patients. Moderate correlation between pain, discomfort, anxiety, and tolerability of repeat biopsy was observed (Spearman’s p between 0.48 and 0.76). Compared to patients undergoing systematic biopsy alone, men who received both targeted and systematic biopsies reported higher anxiety scores (difference 1.2; 95% confidence interval [CI] 0.4–2.0; p=0.004) and discomfort (difference 1.0; 95% CI 0.3–1.7; p<0.001). Conclusions: Patients undergoing targeted and systematic biopsies report more discomfort and anxiety than patients undergoing systematic biopsies alone. Absolute differences are small, and patients are willing to undergo repeat biopsy if advised. Interventions to reduce biopsy-related anxiety are needed.
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