Search

Background: Prior research indicates a connection between immune-related adverse events (irAEs) and improved progression-free survival (PFS) and overall survival (OS) in non-small cell lung cancer. However, limited data exists for extensive stage small cell lung cancer (ES-SCLC)., Methods: This study included all ES-SCLC patients who received at least one dose of an immune checkpoint inhibitor between 2 January 2011 and 4 July 2022 using a large retrospective registry from a single institution. PFS and OS were right-censored at the date of last follow-up and were estimated using the Kaplan-Meier method. Differences in PFS and OS between irAE groups were assessed using Cox proportional hazards models., Results: Among 245 patients with ES-SCLC; 56 (23%) experienced irAEs, 24 (42.9%) of which were high-grade (3-4). High-grade irAEs occurred at a median of 1.2 months (interquartile range [IQR] 0.45-2.5), while low-grade irAE occurred at 2.8 months (1.3-5.2). PFS was significantly longer among any irAE vs none (HR = 0.49; [95%CI 0.32-0.77]) as was OS (HR = 0.49; [95%CI 0.34-0.72])., Conclusions: In ES-SCLC patients treated with immunotherapy, those who experienced any irAE demonstrated a two-fold increase in both PFS and OS compared to those without an irAE. This is consistent with other tumor primaries.

Purpose: Immune checkpoint inhibitors are a standard treatment option for many patients with cancer and are most frequently used to treat lung cancer. Chronic obstructive pulmonary disease (COPD) is the most common comorbidity of patients with lung cancer. As the cancer-specific survival of patients with lung cancer continues to increase with modern treatments, it is critical to optimize comorbidities to improve overall survival. This literature review aimed to summarize current research on the impact of COPD upon immunotherapy outcomes., Methods: A comprehensive search was conducted in the PubMed database using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Inclusion criteria focused on peer-reviewed articles published between 2010 and 2024 that addressed COPD, cancer, and immune checkpoint inhibitors. The study team screened the studies for relevance and then synthesized them narratively., Results: This review identified 37 studies that met the inclusion criteria. Findings suggest that COPD is predictive of improved efficacy but slightly worse toxicity from immune checkpoint inhibitor therapy. The chronic inflammation of COPD leads to immune exhaustion including the overexpression of immune checkpoints on T-cells. Particularly within "hot" tumors that have higher concentrations of tumor-infiltrating lymphocytes, the COPD-related increase in programmed cell death protein 1 (PD-1) signaling likely creates sensitivity to immune checkpoint inhibitors. However, COPD can also lead to respiratory dysfunction, debility, and interstitial lung disease; each of which increases the severity of immune-related adverse events., Conclusion: COPD is a critical comorbidity that has a significant impact on many patients with cancer who receive treatment with immune checkpoint inhibitors. Future research is needed to design interventions to optimize COPD care in this high-risk patient population., Competing Interests: Dr Jill Ohar reports grants from Teva, grants from Boehringer Ingelheim, grants from Mylan, personal fees from Astra Zeca, personal fees from Chiesi, personal fees from Boehringer Ingelheim, personal fees from Verona, outside the submitted work. The authors report no other conflicts of interest in this work., (© 2024 Lycan Jr et al.)

Background : While frailty is a well-established predictor of overall mortality among patients with metastatic non-small cell lung cancer (mNSCLC), its association with patient-reported outcomes is not well-characterized. The goal of this study was to examine the association between an electronic frailty index (eFI) score and patient-reported outcome measures along with prognostic awareness among patients with mNSCLC receiving immunotherapy. Methods : In a cross-sectional study, patients with mNSCLC who were on immunotherapy completed the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) and the National Cancer Institute Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). We utilized bivariate analyses to compare quality of life, symptoms, supportive services, and prognostic awareness among 3 groups defined by e-frailty status. Results : Sixty patients (mean age 62.5 years, 75% Caucasian, 60% women) participated. Most patients were pre-frail (68%), with 13% being frail and 18% non-frail. Pre-frail and frail patients had significantly lower physical function scores (mean 83.9 fit vs 74.8 pre-frail vs 60.0 frail, P = .04) and higher rates of self-reported pain (75% frail vs 41.5% pre-frail vs 18.2% fit; P = .04) compared to non-frail patients. We found no differences in palliative referral rates. Conclusion : Pre-frail and frail mNSCLC patients identified by the eFI have higher rates of pain and physical functional impairments than non-frail patients. These findings highlight the importance of emphasizing preventive interventions targeting social needs, functional limitations, and pain management, especially among pre-frail patients to reduce further decline., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Immune checkpoint inhibitors (ICIs) have become common lines of therapy for genitourinary cancers (GUcs). Given their widespread use, understanding the risk factors, comparative profiles, and timing of immune-related adverse events (irAEs) is essential., Methods: We created an IRB-approved retrospective registry of all patients who received at least one dose of an ICI for any indication between 1 February 2011 and 7 April 2022 at a comprehensive cancer center and its outreach clinics. Dichotomous outcomes were modeled using multivariable logistic regression. Survival outcomes were compared using multivariable Cox regression., Results: Among 3101 patients, 196 had renal cell carcinoma (RCC) and 170 had urothelial tumors. RCC patients were more likely to experience irAEs (OR 1.78; 95% CI 1.32-2.39), whereas urothelial carcinoma patients were not (OR 1.22; 95% CI 0.88-1.67). RCC patients were more prone to dermatitis, thyroiditis, acute kidney injury, and myocarditis, compared to other tumors, while urothelial carcinoma patients were not. The impact of irAEs on survival was not significantly different for GUcs compared to other tumors., Conclusions: RCC primaries have a significantly different irAE profile than most tumors, as opposed to urothelial primaries. Further, RCC was more likely to experience any irAEs. Heterogeneity of survival benefits by irAEs was not seen.

Aim: Neurological adverse events (NAEs) are infrequent immune checkpoint inhibitor (ICI) outcomes poorly characterized in extant research, complicating their clinical management. Methods: This study characterized the frequency, severity, patterning and timing of NAEs using a large retrospective registry, including all patients who received at least one dose of an ICI from 2/1/2011-4/7/2022 within our health network. Results: Among 3137 patients, there were 54 NAEs (1.72% any grade; 0.8% grade 3-4). Most NAEs were peripheral (57.4%) versus central (42.6%). Melanoma and renal cell carcinoma were significantly associated with NAEs. Conclusion: The incidence of NAEs was rare though higher than many prior case estimates; the timing was consistent with other AEs. NAEs frequently occurred in tumor types known to favor brain metastases.

Introduction: Radiation dermatitis (RD) is a frequent toxicity during radiotherapy (RT) for head and neck cancer (HNC). We report the first use of KeraStat ® Cream (KC), a topical, keratin-based wound dressing, in patients with HNC receiving RT., Methods: This pilot study randomized HNC patients treated with definitive or postoperative RT (≥60 Gy) to KC or standard of care (SOC), applied at least twice daily during and for 1-month after RT. Outcomes of interest included adherence to the assigned regimen (at least 10 applications per week of treatment), clinician- and patient-reported RD, and skin-related quality of life., Results: 24 patients were randomized and completed the study. Most patients had stage III-IV disease and oropharynx cancer. Median RT dose was 68 Gy; the bilateral neck was treated in 19 patients, and 18 patients received concurrent chemotherapy. Complete adherence was observed in 7/12 (SOC) vs. 10/12 (KC, p = 0.65). Adherence by patient-week was 61/68 versus 64/67, respectively ( p = 0.20). No differences in RD were observed between groups., Conclusion: A randomized trial of KC versus SOC in HNC patients treated with RT is feasible with good adherence to study agent. An adequately powered randomized study is warranted to test the efficacy of KC in reducing RD., Competing Interests: Competing interests. Luke Burnett discloses his role as the chief executive officer and chief science officer of KeraNetics, Inc., a consultancy role with Castle Rock Consulting and a board member position for Smart4Growing. The investigational product used in this study was provided for the purposes of this study by KeraNetics, Inc. The remainder of the authors have no conflicts to disclose.

Background: Immune checkpoint inhibitors (ICIs) can lead to durable responses in patients with lung cancer but may delay transitions to hospice at the end of life (EOL). We aimed to test the association of continuity of care with EOL outcomes in the ICI era., Methods: We collected retrospective data on all patients with lung cancer who started ICI treatment at a single comprehensive cancer center in the United States (1/1/14-5/1/18) and subsequently died. We defined a hospice referral as having continuity of care if placed by a provider from the patient's multidisciplinary cancer team (e.g., a medical oncologist, palliative care specialist, intensivist, and hospitalist)., Results: In this cohort of 143 patients, 58% had a team-based hospice referral which was associated with a lower risk of death in the hospital. The most common reason patients declined hospice at EOL was an unwillingness to discontinue cancer-directed therapy. As compared to a similar historical cohort of patients treated with chemotherapy alone (2008-2010), there was a similar rate of hospice referral (68% vs 74%) but higher rates of new systemic therapy initiated within 30 days of death (17% vs 6%, p .001) and last dose within 14 days of death (13% vs 5%, p .005)., Conclusions: Future studies should test the continuity of care at EOL as a new quality metric for advanced NSCLC.

Background: The efficacy of just-in-time teaching (JiTT) screencasts for graduate medical education on an inpatient adult hematology-oncology service (HOS) setting is not known. Our preceding pilot data identified six high-yield topics for this setting. The study objective was to evaluate screencast educational efficacy., Methods: Internal medicine residents scheduled to start a rotation on the primary HOS of an academic medical center were eligible for this parallel, unblinded, randomized controlled trial with concealed allocation. Participants underwent block randomization to the usual educational curriculum either with or without access to a series of novel screencasts; all participants received an anonymous online end-of-rotation survey and a $20 gift certificate upon completion. The primary outcome was the change in attitude among learners, measured as their self-reported confidence for managing the clinical topics., Results: From 12/9/2019 through 6/15/2020, accrual was completed with 67 of 78 eligible residents (86%) enrolled and randomized. Analysis was by intention-to-treat and participant response rate was 91%. Sixty-four percent of residents in the treatment arm rated their clinical management comfort level as "comfortable" or "very comfortable" versus 21% of residents in the usual education arm (p = 0.001), estimated difference = 43% (95% CI: 21-66%), using a prespecified cumulative cutoff score. Treatment arm participants reported that the screencasts improved medical oncology knowledge base (100%), would improve their care for cancer patients (92%), and had an enjoyable format (96%)., Conclusion: Residents on a busy inpatient HOS found that a JiTT screencast increased clinical comfort level in the management of HOS-specific patient problems., (© 2021. American Association for Cancer Education.)

Introduction: Concurrent chemoradiotherapy (CRT) using high-dose cisplatin (HDC) is standard for patients with locally advanced head and neck squamous cell carcinoma (HNSCC); weekly cisplatin (WC) is an alternative. We aim to compare retrospectively the survival and disease control outcomes between these regimens in our institutional experience., Methods: Patients with stage III-IV HNSCC treated with definitive or postoperative CRT between 2012 and 2018 were identified. Patients were stratified by intent-to-treat CRT. Overall survival (OS) and disease-free survival (DFS) were generated and multivariable Cox models were performed., Results: 193 patients were treated with concurrent HDC (n = 69), WC at 40 mg/m 2 (WC40, n = 88) or WC at <40 mg/m 2 (WC<40, n = 36). Treatment intent was definitive in 74% and adjuvant in 26%. Baseline differences included age, performance status and HPV status. Cumulative cisplatin dose ≥200 mg/m 2 was achieved in 89% (HDC), 86% (WC40) and 25% (WC<40, P < 0.0001). For HDC, WC40 and WC<40, 2-year OS rates were 87%, 77%, 60% and 2-year DFS rates were 75%, 68% and 52%, respectively. Multivariable analysis revealed gender, performance status, primary site, T/N stage and chemotherapy as predictive of OS. Primary site, T/N stage and chemotherapy regimen were associated with DFS. Compared with HDC, no differences in locoregional control (LRC) or distant metastasis were observed between groups., Conclusion: Concurrent HDC is associated with increased total cisplatin intensity, OS and DFS compared with weekly cisplatin regimens. LRC was not associated with chemotherapy regimen. HDC remains the standard of care; WC40 is a reasonable alternative that does not appear to sacrifice LRC., (© 2021 The Royal Australian and New Zealand College of Radiologists.)

Purpose: Immunotherapy or chemoimmunotherapy is now standard treatment for most patients with metastatic non-small-cell lung cancer (mNSCLC), yet patient supportive care needs (SCNs) on immunotherapy are not well defined. This study characterized the SCNs and financial hardship of patients with mNSCLC treated with immunotherapy or chemoimmunotherapy and examined the relationship between patient and caregiver cancer-related employment reductions and patient financial hardship., Methods: Patients with mNSCLC on immunotherapy or chemoimmunotherapy from a single academic medical center completed the SCNs Survey-34, items indexing material, psychological, and behavioral financial hardship, and the Comprehensive Score for Financial Toxicity. Univariate and bivariate analyses examined care needs, financial hardship, and impact of cancer-related employment reductions on patient financial hardship., Results: Sixty patients (40% male; 75% White, mean age = 62.5 years, 57% on immunotherapy alone) participated. Fifty-five percent reported unmet needs in physical or daily living and psychological domains. Financial hardship was common (33% material, 63% psychological, and 57% behavioral). Fifty-two percent reported hardship in at least two domains. Forty percent reported a caregiver cancer-related employment reduction. Caregiver employment reduction was related to patient financial hardship (68% of those reporting caregiver employment reduction reported at least two domains of hardship v 40% of those without reduction, P = .03) and patient financial distress (mean Comprehensive Score for Financial Toxicity = 19.6 among those with caregiver employment reduction v 26.8 without, P = .01)., Conclusion: Patients with mNSCLC treated with immunotherapy or chemoimmunotherapy report multiple unmet care needs and financial hardship. Psychological, functional, financial, and caregiver concerns merit assessment and intervention in this population., Competing Interests: Thomas W. LycanTravel, Accommodations, Expenses: Incyte Jimmy RuizConsulting or Advisory Role: AstraZenecaSpeakers' Bureau: AstraZeneca, GenentechResearch Funding: AstraZeneca, Roche, BeyondSpring Pharmaceuticals, ER SquibTravel, Accommodations, Expenses: AstraZeneca, Genentech/Roche Stefan C. GrantEmployment: TheraBionicLeadership: TheraBionicStock and Other Ownership Interests: TheraBionicResearch Funding: Genentech Mypath, Loxo, Bristol-Myers Squibb, Rafael Pharmaceuticals, Guardant HealthTravel, Accommodations, Expenses: Florence Healthcare W. Jeffrey PettyConsulting or Advisory Role: Jazz PharmaceuticalsResearch Funding: Merck Sharp & Dohme, AbbvieTravel, Accommodations, Expenses: Dava OncologyNo other potential conflicts of interest were reported.

Purpose: Accurate recording of diagnosis (DX) data in electronic health records (EHRs) is important for clinical practice and learning health care. Previous studies show statistically stable patterns of data entry in EHRs that contribute to inaccurate DX, likely because of a lack of data entry support. We conducted qualitative research to characterize the preferences of oncological care providers on cancer DX data entry in EHRs during clinical practice., Methods: We conducted semistructured interviews and focus groups to uncover common themes on DX data entry preferences and barriers to accurate DX recording. Then, we developed a survey questionnaire sent to a cohort of oncologists to verify the generalizability of our initial findings. We constrained our participants to a single specialty and institution to ensure similar clinical backgrounds and clinical experience with a single EHR system., Results: A total of 12 neuro-oncologists and thoracic oncologists were involved in the interviews and focus groups. The survey developed from these two initial thrusts was distributed to 19 participants yielding a 94.7% survey response rate. Clinicians reported similar user interface experiences, barriers, and dissatisfaction with current DX entry systems including repetitive entry operations, difficulty in finding specific DX options, time-consuming interactions, and the need for workarounds to maintain efficiency. The survey revealed inefficient DX search interfaces and challenging entry processes as core barriers., Conclusion: Oncologists seem to be divided between specific DX data entry and time efficiency because of current interfaces and feel hindered by the burdensome and repetitive nature of EHR data entry. Oncologists' top concern for adopting data entry support interventions is ensuring that it provides significant time-saving benefits and increasing workflow efficiency. Future interventions should account for time efficiency, beyond ensuring data entry effectiveness., Competing Interests: Roy StrowdConsulting or Advisory Role: Monteris Medical, NovocureResearch Funding: Southeastern Brain Tumor Foundation, Jazz Pharmaceuticals, NIH, American Board of Psychiatry and Neurology, Alpha Omega AlphaOther Relationship: American Academy of Neurology (AAN) Thomas W. LycanTravel, Accommodations, Expenses: IncyteOpen Payments Link: https://openpaymentsdata.cms.gov/physician/4354581https://openpaymentsdata.cms.gov/physician/4354581 Brian J. WellsResearch Funding: Boehringer Ingelheim Umit TopalogluStock and Other Ownership Interests: CareDirectionsNo other potential conflicts of interest were reported.

Purpose: Diagnosis (DX) information is key to clinical data reuse, yet accessible structured DX data often lack accuracy. Previous research hints at workflow differences in cancer DX entry, but their link to clinical data quality is unclear. We hypothesized that there is a statistically significant relationship between workflow-describing variables and DX data quality., Methods: We extracted DX data from encounter and order tables within our electronic health records (EHRs) for a cohort of patients with confirmed brain neoplasms. We built and optimized logistic regressions to predict the odds of fully accurate (ie, correct neoplasm type and anatomic site), inaccurate, and suboptimal (ie, vague) DX entry across clinical workflows. We selected our variables based on correlation strength of each outcome variable., Results: Both workflow and personnel variables were predictive of DX data quality. For example, a DX entered in departments other than oncology had up to 2.89 times higher odds of being accurate ( P < .0001) compared with an oncology department; an outpatient care location had up to 98% fewer odds of being inaccurate ( P < .0001), but had 458 times higher odds of being suboptimal ( P < .0001) compared with main campus, including the cancer center; and a DX recoded by a physician assistant had 85% fewer odds of being suboptimal ( P = .005) compared with those entered by physicians., Conclusion: These results suggest that differences across clinical workflows and the clinical personnel producing EHR data affect clinical data quality. They also suggest that the need for specific structured DX data recording varies across clinical workflows and may be dependent on clinical information needs. Clinicians and researchers reusing oncologic data should consider such heterogeneity when conducting secondary analyses of EHR data.

Introduction: Immunotherapy and chemoimmunotherapy clinical trials for metastatic non-small-cell lung cancer (mNSCLC) have generally excluded patients with poor performance status (PS) and have utilized patient-reported measures that could miss some symptoms associated with immunotherapy. The goals of this study were to describe quality of life and symptom burden among mNSCLC patients receiving immunotherapy in clinical practice, and to examine burden by Eastern Cooperative Oncology Group performance status (ECOG PS) and age., Patients and Methods: Between 2017 and 2018, mNSCLC patients receiving immuno/chemoimmunotherapy at an academic medical center completed the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) and the National Cancer Institute Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Univariate and bivariate analyses described EORTC-QLQ-C30 subscales and the proportion reporting at least moderate PRO-CTCAE symptoms, and compared scores by ECOG PS (0/1 vs. 2/3) and age (< 70 vs. ≥ 70 years)., Results: Sixty patients (60% female; 75% < 70 years old; 68% ECOG PS 0/1; 57% receiving single-agent immunotherapy) participated. The mean EORTC-QLQ-C30 global health score was 62.6; EORTC symptoms were highest for fatigue, insomnia, dyspnea, and financial concerns (all > 30). Global health and pain were worse in ECOG PS 2/3 patients. For PRO-CTCAE, 20% to 40% reported at least moderate gastrointestinal, respiratory, dermatologic, arthralgia, or myalgia symptoms. The PRO-CTCAE pain score was higher among ECOG PS 2/3 patients., Conclusion: In clinical practice, global health was largely comparable to published clinical trials, but PRO-CTCAE items indicated a higher symptom prevalence. Closer monitoring of symptoms is warranted in ECOG PS 2/3 patients., (Copyright © 2019 Elsevier Inc. All rights reserved.)