1554 Adverse events (AEs) from systemic treatment of cancer (STC) and patient-reported quality of life (QoL). Comparison to general population (GPOP)

Abstract Introduction Palliative care aims to improve quality of life through optimal symptom control and pain management. Cannabis-based medicinal products (CBMPs) have a proven role in the treatment of chemotherapy-induced nausea and vomiting. However, there is a paucity of high-quality evidence with regards to the optimal therapeutic regimen, safety, and effectiveness of CBMPs in palliative care, as existing clinical trials are limited by methodological heterogeneity. The aim of this study is to summarise the outcomes of the initial subgroup of patients from the UK Medical Cannabis Registry who were prescribed CBMPs for a primary indication of palliative care, cancer pain and chemotherapy-induced nausea and vomiting, including effects on health-related quality of life and clinical safety. Methods A case series from the UK Medical Cannabis Registry of patients, who were receiving CBMPs for the indication of palliative care was undertaken. The primary outcome consisted of changes in patient-reported outcome measures including EQ-5D-5L, General Anxiety Disorder-7 (GAD-7), Single-Item Sleep Quality Scale (SQS), Pain Visual Analog Scale (VAS) and the Australia-Modified Karnofsky Performance Scale at 1 and 3 months compared to baseline. Secondary outcomes included the incidence and characteristics of adverse events. Statistical significance was defined by p-value< 0.050. Results Sixteen patients were included in the analysis, with a mean age of 63.25 years. Patients were predominantly prescribed CBMPs for cancer-related palliative care (n = 15, 94%). The median initial CBD and THC daily doses were 32.0 mg (Range: 20.0–384.0 mg) and 1.3 mg (Range: 1.0–16.0 mg) respectively. Improvements in patient reported health outcomes were observed according to SQS, EQ-5D-5L mobility, pain and discomfort, and anxiety and depression subdomains, EQ-5D-5L index, EQ-VAS and Pain VAS validated scales at both 1-month and 3-months, however, the changes were not statistically significant. Three adverse events (18.75%) were reported, all of which were either mild or moderate in severity. Conclusion This small study provides an exploratory analysis of the role of CBMPs in palliative care in the first cohort of patients since CBMPs legalisation in the UK. CBMPs were tolerated with few adverse events, all of which were mild or moderate and resolved spontaneously. Further long-term safety and efficacy studies involving larger cohorts are needed to establish CBMPs role in palliative care, including comparisons with standard treatments.

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Simultaneous assessment of targeted anticancer therapy-associated mucocutaneous adverse events.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e20669 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e20669-e20669

Author(s):

Christine Bettine Boers-Doets ◽

Hans Gelderblom ◽

Joel Brian Epstein ◽

Mario E. Lacouture ◽

Ad A Kaptein

Keyword(s):

Quality Of Life ◽

Targeted Therapy ◽

Adverse Events ◽

Assessment Tool ◽

Symptom Burden ◽

Specific Patient ◽

Study Protocols ◽

Patient Reported ◽

Meta Analyses

e20669 Background: Mucocutaneous adverse events (mcAEs), including papulopustular rash, xerosis, pruritus, paronychia, hand-foot skin reaction, edema, taste alterations, oral pain and ulceration, hair-, periungual-, and ocular changes occur in the majority of patients during targeted anticancer therapies. Different mcAEs can be present with a variable symptom burden and affect upon patients’ quality of life. Use of standardized targeted therapy specific tools allows comparison of outcomes from different studies and in meta-analyses, advancing patient care and improving outcomes. A mcAE specific assessment tool about symptom burden is currently not available. A questionnaire which assesses both targeted therapy specific patient reported outcomes (PRO) measures and healthcare provider reported outcomes (HPRO) measures is warranted, therefore. Methods: A three-phase process was utilized for item generation, item reduction and scale construction. A comprehensive literature review was performed in PubMed, CINAHL and Embase, and study protocols were screened. Keywords were assessment, questionnaire, tool, EGFRI, and rash. All items with potential relevance for the tool were selected for further evaluation. Twentyone EGFRI treated patients filled out the draft-questionnaire. Results: The search resulted in a simultaneous tool in the form of 61 PRO, and 50 HPRO items. Both tools assess experienced mcAEs inclusive number of papules and pustules, area involved, severity and duration of the symptoms, used products, effectiveness of various (medical) interventions, treatment adherence and distress from the symptoms. Patient input resulted in the addition of 1 item, modification of 7 items, and deletion of 2 items. Conclusions: A novel tool has been generated to assess the experienced mcAEs and effectiveness of supportive care interventions. Since the patient and the provider report mcAEs simultaneously, the provided data are directly comparable, facilitating assessment of quality of life and, therefore, improving quality of medical care.

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Impact of Clostridioides difficile infection on patient-reported quality of life

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2021.413 ◽

2021 ◽

pp. 1-6

Author(s):

Zheyi Han ◽

Brittany Lapin ◽

Kevin W. Garey ◽

Curtis J. Donskey ◽

Abhishek Deshpande

Keyword(s):

Quality Of Life ◽

General Population ◽

Linear Regression ◽

Negative Impact ◽

Severe Disease ◽

Tertiary Care ◽

Survey Study ◽

Bivariate Analysis ◽

Patient Reported

Abstract Objective: We investigated the quality of life (QoL) of patients hospitalized with C. difficile infection (CDI). Design: Prospective survey study. Setting: US tertiary-care referral center, acute-care setting. Participants: Adults hospitalized with a diagnosis of CDI, defined as ≥3 episodes of unformed stool in 24 hours and a positive laboratory test for C. difficile. Methods: We surveyed patients from July 2019 to March 2020 using the disease-specific Cdiff32 questionnaire and the generic PROMIS GH survey. We compared differences in Cdiff32 scores among demographic and clinical subgroups (including CDI severity, CDI recurrence, and various comorbidities) using 2-sample t tests. We compared PROMIS GH scores to the general population T score of 50 using 1-sample t tests. We performed multivariable linear regression to identify predictors of Cdiff32 scores. Results: In total, 100 inpatients (mean age, 58.6 ±17.1 years; 53.0% male; 87.0% white) diagnosed with CDI completed QoL surveys. PROMIS GH physical health summary scores (T = 37.3; P < .001) and mental health summary scores (T = 43.4; P < .001) were significantly lower than those of the general population. In bivariate analysis, recurrent CDI, severe CDI, and number of stools were associated with lower Cdiff32 scores. In multivariable linear regression, recurrent CDI, severe CDI, and each additional stool in the previous 24 hours were associated with significantly decreased Cdiff32 scores. Conclusions: Patients hospitalized with CDI reported low scores on the Cdiff32 and PROMIS GH, demonstrating a negative impact of CDI on QoL in multiple health domains. The Cdiff32 questionnaire is particularly sensitive to QoL changes in patients with recurrent or severe disease.

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1504 Impact of worsening in patient reported symptomatic adverse events (AEs) on deterioration of daily assessed quality of life(QOL) in cancer patients receiving initial chemotherapy; prospective exploratory study

European Journal of Cancer ◽

10.1016/s0959-8049(16)30595-0 ◽

2015 ◽

Vol 51 ◽

pp. S205-S206

Author(s):

Y. Horie ◽

K. Mori ◽

C. Kyomori ◽

N. Izawa ◽

T. Taniyama ◽

...

Keyword(s):

Quality Of Life ◽

Adverse Events ◽

Cancer Patients ◽

Exploratory Study ◽

Patient Reported

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Bevacizumab in neurofibromatosis type 2 (NF2) related vestibular schwannomas: a nationally coordinated approach to delivery and prospective evaluation

Neuro-Oncology Practice ◽

10.1093/nop/npv065 ◽

2016 ◽

Vol 3 (4) ◽

pp. 281-289 ◽

Cited By ~ 15

Author(s):

Katrina A. Morris ◽

John F. Golding ◽

Patrick R. Axon ◽

Shazia Afridi ◽

Claire Blesing ◽

...

Keyword(s):

Quality Of Life ◽

Adverse Events ◽

Neurofibromatosis Type ◽

Vestibular Schwannomas ◽

Predictors Of Response ◽

Patient Reported ◽

Iatrogenic Damage ◽

The Impact

Abstract Background NF2 patients develop multiple nervous system tumors including bilateral vestibular schwannomas (VS). The tumors and their surgical treatment are associated with deafness, neurological disability, and mortality. Medical treatment with bevacizumab has been reported to reduce VS growth and to improve hearing. In addition to evaluating these effects, this study also aimed to determine other important consequences of treatment including patient-reported quality of life and the impact of treatment on surgical VS rates. Methods Patients treated with bevacizumab underwent serial prospective MRI, audiology, clinical, CTCAE-4.0 adverse events, and NFTI-QOL quality-of-life assessments. Tumor volumetrics were classified according to the REiNs criteria and annual VS surgical rates reviewed. Results Sixty-one patients (59% male), median age 25 years (range, 10–57), were reviewed. Median follow-up was 23 months (range, 3–53). Partial volumetric tumor response (all tumors) was seen in 39% and 51% had stabilization of previously growing tumors. Age and pretreatment growth rate were predictors of response. Hearing was maintained or improved in 86% of assessable patients. Mean NFTI-QOL scores improved from 12.0 to 10.7 (P < .05). Hypertension was observed in 30% and proteinuria in 16%. Twelve treatment breaks occurred due to adverse events. The rates of VS surgery decreased after the introduction of bevacizumab. Conclusion Treatment with bevacizumab in this large, UK-wide cohort decreased VS growth rates and improved hearing and quality of life. The potential risk of surgical iatrogenic damage was also reduced due to an associated reduction in VS surgical rates. Ongoing follow-up of this cohort will determine the long-term benefits and risks of bevacizumab treatment.

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How Accurate Is Clinician Reporting of Chemotherapy Adverse Effects? A Comparison With Patient-Reported Symptoms From the Quality-of-Life Questionnaire C30

Journal of Clinical Oncology ◽

10.1200/jco.2004.03.025 ◽

2004 ◽

Vol 22 (17) ◽

pp. 3485-3490 ◽

Cited By ~ 308

Author(s):

Erik K. Fromme ◽

Kristine M. Eilers ◽

Motomi Mori ◽

Yi-Ching Hsieh ◽

Tomasz M. Beer

Keyword(s):

Quality Of Life ◽

Clinical Trials ◽

Adverse Event ◽

Adverse Effects ◽

Adverse Events ◽

Life Questionnaire ◽

European Organization ◽

Quality Of Life Questionnaire ◽

Patient Reported

Purpose Adverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log. Patients and Methods Thirty-seven men with metastatic, androgen-independent prostate cancer enrolled onto a phase II trial of weekly calcitriol and docetaxel completed the QLQ every 4 weeks for up to 28 weeks. A patient-reported symptom was defined as an increase in a QLQ symptom score by at least 10 points (0 to 100 scale), sustained for at least 4 weeks. A physician-reported symptom was considered present if it was ever documented in the adverse event log. Results Forty-nine (new or worsened) symptoms were detected by both physician and QLQ, 48 symptoms were detected by the physician alone, and 55 symptoms were detected by the QLQ alone. They agreed on the absence of a symptom in 102 instances of 254 possible opportunities. Their uncorrected agreement was 59.4%, but Cohen's κ, a coefficient of agreement that corrects for chance, was 0.15, indicating only slight agreement. Using the QLQ as the standard, overall physician sensitivity and specificity was 47% and 68%, respectively, although it varied considerably among symptoms. Conclusion Even in a tightly controlled clinical trial, physician reporting was neither sensitive nor specific in detecting common chemotherapy adverse effects. Tools for collecting patient-reported adverse event data in chemotherapy clinical trials should be developed.

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Use of a Cancer Registry to Evaluate Patient-Reported Outcomes of Immune Checkpoint Inhibitors

Cancers ◽

10.3390/cancers13010103 ◽

2020 ◽

Vol 13 (1) ◽

pp. 103

Author(s):

Heather S. L. Jim ◽

Sarah L. Eisel ◽

Aasha I. Hoogland ◽

Sandra Shaw ◽

Jennifer C. King ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Clinical Trial ◽

Adverse Events ◽

Cancer Registry ◽

Patient Reported Outcomes ◽

Immune Checkpoint Inhibitors ◽

Checkpoint Inhibitors ◽

Patient Reported

Immune checkpoint inhibitors (ICIs) are increasingly used for advanced lung cancer, but few studies have reported on patient-reported outcomes (PROs) outside the context of a clinical trial. The goal of the current study was to assess PROs in participants of a lung cancer registry who had been treated with an ICI. Patients participating in the GO2 Foundation’s Lung Cancer Registry who reported receiving atezolizumab, durvalumab, nivolumab, or pembrolizumab were invited to participate in a survey about their experiences during treatment. Quality of life was evaluated using the Functional Assessment of Cancer Therapy–General (FACT-G). Common symptomatic adverse events were evaluated using an item bank generated for ICIs. Internationally, 226 patients (mean age 61, 75% female) participated. Patients reported worse quality of life at the time of assessment than U.S. population and cancer normative samples. The most common moderate to severe adverse events during ICI treatment were fatigue (41%), aching joints (27%), and aching muscles (20%). Due to toxicity, 25% reported a treatment delay, 11% an emergency room visit, and 9% a hospitalization. This study is among the first to our knowledge to report on PROs of ICIs outside the context of a clinical trial. Results suggest higher rates of adverse events than previously reported in clinical trials.

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Response to Brentuximab Vedotin and Quality of Life in Patients with Relapsed/Refractory Hodgkin Lymphoma (RR HL) in the Real World Setting

Blood ◽

10.1182/blood-2019-121997 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 5296-5296 ◽

Cited By ~ 1

Author(s):

Tatyana Ionova ◽

Boris Afanasiev ◽

Maria Andrievskih ◽

Alim Amdiev ◽

Elena A. Baryakh ◽

...

Keyword(s):

Quality Of Life ◽

Adverse Events ◽

Real World ◽

Brentuximab Vedotin ◽

Wilcoxon Test ◽

Patient’S Perspective ◽

Treatment Start ◽

Sf 36 ◽

Patient Reported

There is a continued unmet medical need in pts with relapsed/refractory Hodgkin's lymphoma (RR HL). Curing HL pts who have refractory disease after salvage chemotherapy, who relapse after ASCT, or those who are not candidates for ASCT, remains a clinical challenge due to limited effective treatments. There are data available indicating that brentuximab vedotin (BV) brings considerable promise for the treatment of pts with RR HL. Information about BV treatment effectiveness and tolerability both from physician's and patient's perspective is worthwhile in this difficult patient population. We aimed to evaluate clinical and patient-reported outcomes in RR HL patients receiving BV as >2nd treatment line. Here we report the outcomes with respect to clinical response, tolerability, quality of life (QoL) and symptoms after 3 mos of BV treatment. The total number of pts to be included in the multicenter observational real-world study is 70 pts with RR HL who received BV 1.8 mg/kg q3w till disease progression, intolerance toxicity of BV or refusal. Treatment response was assessed using RECIST criteria v. 1.0. Adverse events (AEs) were assessed in accordance with NCI CTCAE v. 4.03. For QoL assessment pts filled out RAND SF-36, for symptom assessment - ESAS questionnaire; also pts filled out PGIC scale for self-assessment of changes in their health. For QoL analysis paired t-test, Mann-Whitney test, Wilcoxon test and χ2 were used. The analysis was performed in the group of 55 pts RR HL (median age - 28 years, range 18-67, 54.5% males) who were involved in the study: 63.6% pts had advanced stage (III-IV) at diagnosis; ≥50% pts had B-symptoms (58.2%); 82% pts - ECOG 0-1. All the pts received a median of 3 previous treatment lines; among them 14 pts (25.5%) failed to ASCT in the past; half of pts were primary chemotherapy resistant (49%). Before BV treatment start QoL was dramatically worsened for all SF-36 scales (p<0.05). All the pts experienced symptoms, 83.3% pts had moderate-to-severe symptoms. The most frequent (>70% pts) symptoms were drowsiness, tiredness, anxiety, and worse wellbeing. More than half pts had moderate-to-severe drowsiness,tiredness, depression, lack of appetite and worsened wellbeing before BV treatment start. After 3 mos of BV treatment objective response was registered in 55% pts with 27.5% complete response. Adverse events of grade I-II were reported in 8 pts (20%) and were consistent with known toxicities. Most common adverse events (≥10%) were increasing ALT and AST (each 4/8), peripheral neuropathy, fatigue, skin itch (each 3/8). Severe adverse event (III grade) not related with BV occurred in one patient (2.5%) - sepsis, respiratory insufficiency due to agranulocytosis (BV was temporary stopped). During BV treatment meaningful QoL improvement was revealed for all SF-36 scales (p<0.05), excluding mental health. IQoLI significantly increased at 3 mos after treatment start as compared to baseline: 0.260 at baseline vs 0.390 at 3 mos (p<0.001). Proportion of pts with significant Integral QoL Index (IQoLI) impairment dramatically decreased during treatment as compared to baseline: 60% before treatment vs 35% at 3 mos (χ2, p=0.05). The most pronounced meaningful improvement was revealed for role functioning scales (∆>20.0). The severity of the vast majority of symptoms excluding depression significantly decreased during 3 mos of treatment (p<0.05). Total Symptom Score by ESAS significantly decreased at 3 mos after BV treatment start (35.8 vs 25.4, p=0.001). Also according to PGIC, 90% pts noted the improvement of their health. The first results obtained in this multicenter observational real world study demonstrate notable activity of BV as a treatment modality for RR HL. BV showed a safety profile consistent with known toxicities. BV treatment was accompanied with dramatic QoL improvement and significant decrease of symptom burden already after 3 mos of treatment. Evaluation of BV treatment outcomes both from physician's and patient's perspective may provide unique information which will be helpful in decision making for patients with RR HL. Disclosures Ionova: Takeda, BMS: Other: Principal Investigator of IISR, Research Funding. Baryakh:Takeda: Consultancy, Honoraria, Speakers Bureau.

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