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Background: Minimal qualitative data exist on the experiences of cancer patients treated with immune checkpoint inhibitors or costimulatory antibodies. Understanding the day to day experiences of patients being treated with immune checkpoint modulators, and how these relate to their health-related quality of life, can inform future research and lead to better clinical decision-making and care. We report here the first in depth qualitative study to consider patients' diverse and complex experiences with immune checkpoint modulators, with a focus on side effects and how these impact daily life., Methods: This single-center qualitative study was based on focus groups and semistructured interviews. Patients who were being treated or who had been treated with immune checkpoint modulators within the last year for a range of cancer diagnoses were recruited. Interpretive description informed our inductive, iterative approach to analysis., Results: Eight themes were identified, characterizing the complexity of these patients' lived experiences: major categories of side effects experienced and how they impacted patient well-being; the heterogeneous nature of side effects experienced; living with uncertainty; reframing the meaning and severity of SEs; focus on survival, hope, and being positive; acceptance and adaptation; feeling supported; and faith in medical innovation. Throughout their accounts, participants highlighted the profound impact that immune checkpoint modulators had on their daily lives., Conclusion: This is the first in-depth qualitative study into patient accounts of their experiences of treatment with immune checkpoint modulators, related side effects, and how it impacted their daily lives. This research is an integral initial step in developing an instrument that will assess treatment-related side effects in patients treated with this form of therapy., (© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Introduction: Improving health-related quality of life (hrqol) is a key goal of systemic therapy in advanced lung cancer, although routine assessment remains challenging. We analyzed the impact of a real-time electronic hrqol tool, the electronic Lung Cancer Symptom Scale (elcss-ql), on palliative care (pc) referral rates, patterns of chemotherapy treatment, and use of other supportive interventions in patients with advanced non-small-cell lung cancer (nsclc) receiving first-line chemotherapy., Methods: Patients with advanced nsclc starting first-line chemotherapy were randomized to their oncologist receiving or not receiving their elcss-ql data before each clinic visit. Patients completed the elcss-ql at baseline, before each chemotherapy cycle, and at subsequent follow-up visits until disease progression. Prospective data about the pc referral rate, hrqol, and use of other supportive interventions were collected., Results: For the 95 patients with advanced nsclc who participated, oncologists received real-time elcss-ql data for 44 (elcss-ql arm) and standard clinical assessment alone for 51 (standard arm). The primary endpoint, the pc referral rate, was numerically higher, but statistically similar, for patients in the elcss-ql and standard arms. The hrqol scores over time were not significantly different between the two study arms., Conclusions: The elcss-ql is feasible as a tool for use in routine clinical practice, although no statistically significant effect of its use was demonstrated in our study. Improving access to supportive care through the collection of patient-reported outcomes and hrqol should be an important component of care for patients with advanced lung cancer., Competing Interests: CONFLICT OF INTEREST DISCLOSURES We have read and understood Current Oncology’s policy on disclosing conflicts of interest, and we declare that we have none., (2020 Multimed Inc.)

Background: Patients with cancer who are treated with immune checkpoint modulators (ICMs) have their health-related quality of life (HRQOL) measured using general patient-reported outcome (PRO) tools. To the authors' knowledge, no instrument has been developed to date specifically for patients treated with ICMs. The objective of the current study was to develop a toxicity subscale PRO instrument for patients treated with ICMs to assess HRQOL., Methods: Input was collected from a systematic review as well as patients and physicians experienced with ICM treatment. Descriptive thematic analysis was used to evaluate the qualitative data obtained from patient focus groups and interviews, which informed an initial list of items that described ICM side effects and their impact on HRQOL. These inputs informed item generation and/or reduction to develop a toxicity subscale., Results: Focus groups and individual interviews with 37 ICM-treated patients generated an initial list of 176 items. After a first round of item reduction that produced a shortened list of 76 items, 16 physicians who care for patients who are treated with ICMs were surveyed with a list of 49 patient-reported side effects and 11 physicians participated in follow-up interviews. A second round of item reduction was informed by the physician responses to produce a list of 25 items., Conclusions: To the authors' knowledge, this 25-item list is the first HRQOL-focused toxicity subscale for patients treated with ICMs and was developed in accordance with US Food and Drug Administration guidelines, which prioritize patient input in developing PRO tools. The subscale will be combined with the Functional Assessment of Cancer Therapy-General (FACT-G) to form the FACT-ICM. Prior to recommending the formal use of this PRO instrument, the authors will evaluate its validity and reliability in longitudinal studies involving substantially more patients., (© 2019 American Cancer Society.)

Background: Little evidence has been generated for how best to manage patients with non-small-cell lung cancer (nsclc) presenting with rarer clinical scenarios, including oligometastases, oligoprogression, and pseudoprogression. In each of those scenarios, oncologists have to consider how best to balance efficacy with quality of life, while maximizing the duration of each line of therapy and ensuring that patients are still eligible for later options, including clinical trial enrolment., Methods: An expert panel was convened to define the clinical questions. Using case-based presentations, consensus practice recommendations for each clinical scenario were generated through focused, evidence-based discussions., Results: Treatment strategies and best-practice or consensus recommendations are presented, with areas of consensus and areas of uncertainty identified., Conclusions: In each situation, treatment has to be tailored to suit the individual patient, but with the intent of extending and maximizing the use of each line of treatment, while keeping treatment options in reserve for later lines of therapy. Patient participation in clinical trials examining these issues should be encouraged., Competing Interests: CONFLICT OF INTEREST DISCLOSURES We have read and understood Current Oncology’s policy on disclosing conflicts of interest, and we declare the following interests: SAL has received honoraria from Pfizer, AstraZeneca, Boehringer Ingelheim, and Novartis; SB has served on advisory boards for AstraZeneca, Boehringer Ingelheim, Bristol–Myers Squibb, Eli Lilly, Novartis, Pfizer, and Roche, and has received research funding from AstraZeneca and Merck; NB has served on advisory boards for Amgen, AstraZeneca, Merck, Bayer, Boehringer Ingelheim, Bristol–Myers Squibb, Celgene, Eli Lilly, Novartis, Pfizer, Sanofi, and Roche; SB has received honoraria from AstraZeneca, Boehringer Ingelheim, Bristol–Myers Squibb, Eisai, and Merck; PKC has served as an advisor for AstraZeneca, Boehringer Ingelheim, Hoffmann–La Roche, Pfizer, Novartis, Takeda, Eli Lilly, and Bristol–Myers Squibb, and has received research funding from Boehringer Ingelheim and Hoffmann–La Roche; PC has received grants for investigator-initiated research projects from AbbVie, Pfizer, and Sanofi–Aventis; DH has served on advisory boards for AstraZeneca, Boehringer Ingelheim, Bristol–Myers Squibb, and Merck, and has received honoraria from Pfizer; VH has participated on advisory boards for AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol–Myers Squibb, Merck, Pfizer, and Roche; RJ has served as an advisor or consultant for AstraZeneca/MedImmune, Bristol–Myers Squibb, Merck, Pfizer/emd Serono, and Roche, has received honoraria from AstraZeneca, Bristol–Myers Squibb, Merck, Pfizer/emd Serono, and Roche, and has received research funding from AstraZeneca, Bristol–Myers Squibb, and Merck; JL has received honoraria for talks from AstraZeneca, Boehringer Ingelheim, Pfizer, and Roche, and her institution has received grant funding for research trials from AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Roche; in the last 2 years, NL has received honoraria for independent unrelated continuing medical education from AstraZeneca, Bristol–Myers Squibb, and Merck; DR has received honoraria and support from Accuray, BrainLab, Elekta, Pfizer/emd Serono, Siemens Healthineers, and Varian Medical Systems; JR has received speaker and advisory board fees and institutional research support for clinical trials funded by Astra-Zeneca, Bristol–Myers Squibb, Merck, Pfizer, and Roche; DJS has received honoraria (2015–2018) from Roche Canada, Boehringer Ingelheim Canada, Novartis Canada, Merck Canada, AstraZeneca Canada, Bristol–Myers Squibb Canada, Exactis Innovation, and Pfizer Canada, and has received institutional research support from Boehringer Ingelheim, AstraZeneca, Novartis, Bristol– Myers Squibb, and Celgene; MST has received honoraria from AstraZeneca, Bristol–Myers Squibb, Merck, and Roche/Ventana, and a research grant from Merck. The remaining authors have no conflicts to disclose.

We explain the rationale for metabolically adaptive radiation dose escalation in stage III non-small-cell lung cancer and describe the design of a Canadian phase II randomized trial investigating this approach. In the trial, patients are randomized to either conventional chemoradiation treatment (60 Gy in 30 fractions) or metabolically adaptive chemoradiation, where fluorodeoxyglucose-avid tumor sub-volumes receive an integrated boost dose to a maximum of 85 Gy in 30 fractions. The trial sample size is 78 patients, and the target population is patients with newly diagnosed, inoperable stage III non-small-cell lung cancer treated with radical intent chemoradiation. The primary objective of the trial is to determine if dose escalation to metabolically active sub-volumes will reduce 2-year local-regional failure rate from 42.3% to 22.3%, when compared with standard treatment. The secondary objectives are to determine the effect of dose escalation on overall survival, progression-free survival, quality of life, and rate of grade 3 to 5 toxicities., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Early palliative care improves the quality of life (QoL) and satisfaction with care of patients with advanced cancer, but little is known about its effect on caregivers. Here, we report outcomes of caregiver satisfaction with care and QoL from a trial of early palliative care., Patients and Methods: Twenty-four medical oncology clinics were cluster-randomised, stratified by tumour site (lung, gastrointestinal, genitourinary, breast and gynaecological), to early palliative care team referral, or to standard oncology care with palliative care only as needed. Caregivers of patients with advanced cancer (clinical prognosis of 6-24 months, Eastern Cooperative Oncology Group 0-2) in both trial arms completed validated measures assessing satisfaction with care (FAMCARE-19) and QoL [SF-36v2 Health Survey; Caregiver QoL-Cancer (CQoL-C)], at baseline and monthly for 4 months. We used a multilevel linear random-intercept mixed-effect model to test whether there was improvement in the intervention group relative to the control group over 3 and 4 months., Results: A total of 182 caregivers completed baseline measures (94 intervention, 88 control); 151 caregivers (77 intervention, 74 control) completed at least one follow-up assessment. Satisfaction with care improved in the palliative intervention group compared with controls over 3 months (P = 0.007) and 4 months (P = 0.02). There was no significant improvement in the intervention group compared with controls for CQoL-C (3 months: P = 0.92, 4 months: P = 0.51), Physical Component Summary of the SF-36v2 Health Survey (3 months: P = 0.83, 4 months: P = 0.20), or Mental Component Summary of the SF-36v2 Health Survey (3 months: P = 0.87, 4 months: P = 0.60)., Conclusion: Early palliative care increased satisfaction with care in caregivers of patients with advanced cancer., Clinicaltrials.gov Identifier: NCT01248624., (© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

This systematic review aims to improve understanding of the burden of disease associated with brain metastases from non-small-cell lung cancer (NSCLC) in terms of survival, quality of life (QoL) and economic impact. PubMed/MEDLINE, Cochrane collaboration and EMBASE databases were searched for articles published in English from 2000 to 2014. Of 3288 abstracts retrieved, 3156 were eliminated without a full-text review. Of the 132 articles that received a full-text review, a final set of 93 articles was included in an initial literature analysis. In order to homogenize the patient populations evaluated, we included entries that were either entirely composed of NSCLC patients or that had >50% of NSCLC patients in the total study population. From the studies identified in this systematic review, median OS and PFS varied based on the type of treatment received, although whole-brain radiotherapy (WBRT) was associated with the shortest OS and PFS durations. Regimens incorporating targeted therapy in molecularly selected patients were associated with the longest OS and PFS durations. QoL findings varied among studies, generally WBRT resulted in stable or worsening QoL scores rather than improvements. Healthcare costs were increased following diagnosis of brain metastases regardless of treatment. The findings from this review highlight the need for more effective treatments of brain metastases from NSCLC that improve survival function, QoL and potentially decrease costs., (Copyright © 2016. Published by Elsevier Ltd.)

Purpose: This trial assessed the ability to enhance health-related quality of life (HRQL) and patient-reported outcome (PRO) evaluation in trials and patient management using computer assistance with a handheld device, called a personal digital assistant. The study assessed ease of use and psychometric properties of this approach, comparing the Lung Cancer Symptom Scale (LCSS) paper form with the electronic (eLCSS-QL). Objectives were to: (1) measure completion times; (2) evaluate acceptability by patients, nurses, and physicians; (3) determine the correlation of the eLCSS-QL with the paper version; and (4) determine the feasibility of using a shorter visual analogue scale (VAS) in the electronic version., Patients and Methods: Patients were entered at 12 COMET clinics. All had: (a) stage III or IV non-small cell lung cancer, (b) Karnofsky performance status (KPS)  ≥  60, (c) no prior chemotherapy, and (d) received initial courses of docetaxel + platinum. Of the 148 patients enrolled, characteristics were: men, 57 %; median, KPS 80 %; and median age, 67 years. Of these, 131 patients completed the evaluation form., Results: The eLCSS-QL had excellent acceptance by patients, nurses, and physicians. Patients required 2.2 min (mean) to complete the eLCSS-QL. Reliability coefficients using Cronbach's alpha were high for the paper (0.84) and electronic (0.88) versions. The correlation coefficient between forms was high (0.92). The length of the VAS on the handheld pc (53 mm versus 100 mm on the paper format) resulted in nearly identical scores., Conclusions: The high acceptance rate by patients and professionals, the rapid completion time, ease of use, and strong psychometric properties confirm that the electronic LCSS (eLCSS-QL) is practical for use in trials and patient management. This study indicates that computer assistance helps overcome barriers associated with evaluating HRQL and PROs.

Purpose: Improving health-related quality of life (HRQL) is the main goal of palliative care and an important outcome for oncology trials. This study examines medical and sociodemographic determinants of HRQL in outpatients with advanced cancer., Methods: Patients with metastatic gastrointestinal, genitourinary, breast, lung or gynecological cancer, ECOG 0-2, and clinical prognosis of 6 months to 2 years were recruited from outpatient medical oncology clinics. HRQL was measured using the FACT-G questionnaire and the FACIT-Sp meaning and peace (existential) subscale. The influence of demographic and medical characteristics on HRQL was determined using t tests and analysis of variance, with Tukey's correction for multiple comparisons. Multivariate linear regression was used to determine independent predictors., Results: Of 285 patients, 57% were female and the median age was 61 years; 44% were alive at latest follow-up; and of those deceased, the mean survival time was 10 months. The strongest determinants of overall HRQL were increased age (p < 0.001), good performance status (PS; p < 0.001) and survival time >6 months (p = 0.001). Compared to patients receiving cancer treatment, those awaiting new treatment had worse emotional well-being (p < 0.001), while those on surveillance or whose treatment had been stopped had worse existential well-being (p = 0.03). Male gender predicted better emotional and physical well-being and lower income predicted worse social well-being., Conclusions: Age, PS, survival time, and treatment status are important determinants of HRQL in patients with advanced cancer. Decision aids, open communication, and involvement of supportive care specialists may improve emotional and existential distress associated with changing or stopping cancer treatment.

Background: Female sex is a favorable prognostic factor in lung cancer. In small-cell lung cancer, women have been shown to experience greater toxicity from chemotherapy, but there are few studies of sex-related toxicity in non-small cell lung cancer (NSCLC)., Patients and Methods: This retrospective analysis evaluated the effect of sex on efficacy, adverse events (AEs), dose intensity (DI), and quality of life (QoL) in three phase III NSCLC trials conducted by the National Cancer Institute of Canada Clinical Trials Group; BR.10 (adjuvant chemotherapy), BR.14, and BR.18 (first-line advanced disease). Only patients with National Cancer Institute of Canada Clinical Trials Group data were included, and patients in the BR.10 observation arm were excluded., Results: Of 1,108 patients analyzed, 29% were female. On study entry, women were less likely to be overweight or obese (40% versus 51%, p < 0.0001), more likely to have adenocarcinoma (70% versus 44%, p < 0.0001), and less likely to be anemic at baseline (29% versus 55%, p < 0.0001) or have medical comorbidities. There were no significant differences in response rate to chemotherapy (27% versus 31%, p = 0.44 [excluding BR.10]), grade 3 or 4 AEs, DI, or QoL between sexes, although women reported more nausea and vomiting of any grade (77% versus 66%, p = 0.0004). In multivariate analysis, women had longer progression-free survival than men (hazard ratio 0.83, 95% confidence interval 0.71-0.97, p = 0.02) but not overall survival (hazard ratio 0.89, 95% confidence interval 0.75-1.05, p = 0.17)., Conclusion: Women demonstrate modestly longer progression-free survival than men in chemotherapy-treated NSCLC, with no differences observed in response rates, serious AEs, or QoL.

Targeting the epidermal growth factor receptor (EGFR) pathway has become standard practice for the treatment of advanced non-small-cell lung cancer. Compared with chemotherapy, egfr tyrosine kinase inhibitors (TKIS) have been associated with improved efficacy in patients with an EGFR mutation. Together with the increase in efficacy comes an adverse event (AE) profile different from that of chemotherapy. That profile includes three of the most commonly occurring dermatologic aes: acneiform rash, stomatitis, and paronychia. Currently, no randomized clinical trials have evaluated the treatments for the dermatologic aes that patients experience when taking egfr tkis. Based on the expert opinion of the authors, some basic strategies have been developed to manage those key dermatologic aes. Those strategies have the potential to improve patient quality of life and compliance and to prevent inappropriate dose reductions. [ABSTRACT FROM AUTHOR]