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Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may be spread by individuals unaware they are infected. Such dissemination has heightened ramifications in cancer patients, who may need to visit healthcare facilities frequently, be exposed to immune-compromising therapies, and face greater morbidity from coronavirus disease 2019 (COVID-19). We determined characteristics of (1) asymptomatic, clinically diagnosed, and (2) serologically documented but clinically undiagnosed SARS-CoV-2 infection among individuals with lung cancer., Patients and Methods: In a multicenter registry, individuals with lung cancer (regardless of prior SARS-CoV-2 vaccination or documented infection) underwent collection of clinical data and serial blood samples, which were tested for antinucleocapsid protein antibody (anti-N Ab) or IgG (N) levels. We used multivariable logistic regression models to investigate clinical characteristics associated with the presence or absence of symptoms and the presence or absence of a clinical diagnosis among patients with their first SARS-CoV-2 infection., Results: Among patients with serologic evidence or clinically documented SARS-CoV-2 infection, 80/142 (56%) had no reported symptoms at their first infection, and 61/149 (40%) were never diagnosed. Asymptomatic infection was more common among older individuals and earlier-stage lung cancer. In multivariable analysis, non-white individuals with SARS-CoV-2 serologic positivity were 70% less likely ever to be clinically diagnosed (P = .002)., Conclusions: In a multicenter lung cancer population, a substantial proportion of SARS-CoV-2 infections had no associated symptoms or were never clinically diagnosed. Because such cases appear to occur more frequently in populations that may face greater COVID-19-associated morbidity, measures to limit disease spread and severity remain critical., Competing Interests: Disclosure The authors report no conflicts directly relevant to the submitted work. Beyond this submission, the authors report the following disclosures: P.C.M. reports participation in advisory boards for Guardant Health, consulting for Vivace Therapeutics, and honoraria from Amgen. A.C.M. reports advisory board participation with Bayer, BMS, Exact Sciences, Gilead, and Novartis and board of directors of NTRKers. A.M.’s spouse, Dr. Martin Moore, is CSO and co-founder of Meissa Vaccines. J.C.K. reports consulting and advisory board participation for the following companies, all paid to GO2 for Lung Cancer: Amgen, Bristol Myers Squibb, Boehringer Ingelheim, and EQRX. C.R. reports speaker honoraria from AstraZeneca, Roche, and MSD; advisory board honoraria from Inivata, Archer, Boston Pharmaceuticals, MD Serono and Novartis, Bayer, Invitae, Regeneron, and Bostongene; scientific advisory board member for Imagene; institutional research funding from LCRF-Pfizer and NCRF; non-re-numerated research support from Guardant Health and Foundation Medicine; nonrenumerated leadership roles at the International Society of Liquid Biopsy (ISLB), the International Association for Study of Lung Cancer (IASLC), the European School of Oncology (ESO), and Oncology Latin American Association (OLA). J.D.M. reports licensing fees from the NIH and UTSW for distribution of human tumor cell lines. S.B. reports serving in consulting/advisory roles for Takeda, Mirati, and Merus. F.K. reports filed patents through The Icahn School of Medicine at Mount Sinai relating to SARS-CoV-2 serological assays, NDV-based SARS-CoV-2 vaccines, influenza virus vaccines, and influenza virus therapeutics, which list F.K. as co-inventor. Mount Sinai has spun out a company, Kantaro, to market serological tests for SARS- CoV-2, and another company, Castlevax, to develop SARS-CoV-2 vaccines. F.K. is co-founder and scientific advisory board member of Castle-vax. F.K. has consulted for Merck, Curevac, Seqirus, and Pfizer and is currently consulting for third Rock Ventures, GSK, Gritstone, and Avimex. He is also collaborating with Dynavax on influenza vaccine development. A.G.-S. has received research support from GSK, Pfizer, Senhwa Biosciences, Kenall Manufacturing, Blade Therapeutics, Avi-mex, Johnson & Johnson, Dynavax, 7Hills Pharma,Pharmamar, ImmunityBio, Accurius, Nanocompo-6, Hexamer, N-fold LLC, Model Medicines, Atea Pharma, Applied Biological Laboratories, and Merck, outside of the reported work; consulting agreements for the following companies involving cash and/or stock: Castlevax, Amovir, Vivaldi Biosciences, Contrafect, 7Hills Pharma, Avimex, Pagoda, Accurius, Esperovax, Farmak, Applied Biological Laboratories, Pharmamar, CureLab Oncology, CureLab Veterinary, Syn-airgen, Paratus, Pfizer, and Prosetta, outside of the reported work; has been an invited speaker in meeting events organized by Seqirus, Janssen, Abbott, and Astrazeneca; and is an inventor on patents and patent applications on the use of antivirals and vaccines for the treatment and prevention of virus infections and cancer, owned by the Icahn School of Medicine at Mount Sinai, New York, outside of the reported work. K.L.R. has served on advisory boards for Amgen, AstraZeneca, Bluprint, Daiichi Sankyo, EMD Serono, Genentech, GlaxoSmithKline, Janssen, Lilly, Novocure, and Mirati A.A.M. holds a consultant or advisory role at Novartis, Amgen and MorphoSys and has research funding from Amgen and Pfizer. S.S.R. reports research funding (institutional) from AstraZeneca, Amgen, Merck, Bristol Myers Squibb, and Pfizer. F.R.H. reports advisory board participation with Amgen, AstraZeneca, Genentech, Merck, Novo-cure, NextCure, Regeneron, Sanofi, Daiichi, G1 Therapeutics, Novartis, Merus Therapeutics, and ITeos Therapeutics. F.R.H. also reports a patent through University of Colorado on ‘‘EGFR Protein and Gene Copy Number as Predictive Biomarker for EGFR-directed Therapy. D.E.G. reports consulting fees from Catalyst Pharmaceuticals; U.S. patent 11,747,345; pending patents 17/045,482, 63/386,387, 63/382,972, and 63/382,257; participating in advisory boards for Astra-Zeneca, Daiichi-Sankyo, Elevation Oncology, Janssen Scientific Affairs, Jazz Pharmaceuticals, Regeneron Pharmaceuticals, and Sanofi; stock shares in Gilead; and serving as co-founder and Chief Scientific Officer of OncoSeer Diagnostics, Inc. M.S., C.-Y.H., Y.H., J.E.G., A.M.R., J.C., S.C.T., J.M.C., R.B., N.C.R., P.A.B., J.C.F., E.K., M.N., and Y.S. report no disclosures., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Advances in the testing and treatment of patients with non-small cell lung cancer (NSCLC) harboring oncogenic drivers have improved outcomes. Little is known about testing and treatment patterns in diverse patient populations., Methods: We conducted a retrospective study in a diverse cohort of patients treated in the John Peter Smith safety net healthcare system. We determined patterns of blood- and tissue-based testing and treatment of patients with EGFR and ALK alterations. Cox proportional-hazards regression models were used to assess the impact of EGFR and ALK testing., Results: A total of 220 patients were included, 97 (44%) were non-Hispanic White, 72 (33%) were Black, 28 (13%) were Hispanic, and 23 (10%) were Asian. EGFR and ALK testing increased over time from 55% and 52%, respectively, in 2017 to 87% and 82%, respectively, in 2021. Frequency of EGFR alterations were highest in Asian patients (45%) and comparable among other groups (6-13%). Frequency of ALK alterations were highest in Hispanic (13%), and Asian (11%) patients, and were 2% for both Black and non-Hispanic White patients. In a multivariate model, lack of testing was associated with worse survival (aHR 1.6; P = .003) and testing positive for EGFR (aHR 0.43; P = .01) or ALK (aHR 0.28; P = .04) was associated with improved survival. Race and ethnicity were not associated with survival differences., Conclusion: As molecular testing for oncogenic mutations in NSCLC increases, druggable alterations such as ALK and EGFR can be identified in all race-ethnicity groups and are associated with improved outcomes., Competing Interests: Disclosure The authors have stated that they have no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Antibiotic exposure is associated with worse clinical outcomes in patients receiving immune checkpoint inhibitors (ICI). We analyzed antibiotic prescription patterns in lung cancer and melanoma, two malignancies in which ICI are used broadly across stages., Methods: We performed a retrospective cohort study of adults in the U.S. Veterans Affairs (VA) medical system diagnosed with lung cancer or melanoma from 2003 to 2016. We defined antibiotic exposure as receipt of a prescription for a systemic antibacterial agent between 6 months before and 6 months after cancer diagnosis. Demographics, clinical variables, prescriptions, and diagnostic codes were abstracted from the VA Corporate Data Warehouse. Antibiotic exposure was compared using t tests, Chi-square, and multivariate analyses., Results: A total of 310,321 patients (280,068 lung cancer, 30,253 melanoma) were included in the analysis. Antibiotic exposure was more common among patients with lung cancer (42% vs. 24% for melanoma; P < .001). Among antibiotic-exposed patients, those with lung cancer were more likely to receive prescriptions for multiple antibiotics (47% vs. 30% for melanoma; P < .001). In multivariate analyses, antibiotic exposure was associated with lung cancer diagnosis (HR 1.50; 95% CI, 1.46-1.55), comorbidity score (HR 1.08; 95% CI, 1.08-1.09), non-white race (HR 1.11; 95% CI, 1.06-1.17), and female gender (HR 1.31; 95% CI, 1.24-1.37)., Conclusion: Among cancer patients, antibiotics are prescribed frequently. Antibiotic exposure is more common in certain cancer types and patient populations. Given the negative effect antibiotic exposure has on immunotherapy outcomes, these observations may have clinical and healthy policy implications., (Copyright © 2022. Published by Elsevier Inc.)

As clinical trials have become more complex, with increasing numbers of required procedures and clinic visits, gaining access to promising new treatments has become even more challenging for many individuals. To address these barriers, we implemented a financial reimbursement and outreach program designed to increase the number and diversity of participants in cancer clinical trials at centers in Dallas, Houston, and Philadelphia. As endorsed by U.S. Food and Drug Administration (FDA) and the Texas and Pennsylvania State Legislatures, the program provides financial reimbursement for non-clinical costs (e.g., travel, lodging) to patients on cancer clinical trials with household income up to 700% the Federal poverty rate. The research study described here, centered at the Dallas site, evaluates program impact by assessing (1) numbers and diversity of patients enrolled to cancer clinical trials before and after program implementation; (2) characteristics of patients offered participation in the program who do versus do not enroll; (3) characteristics of patients enrolled in the program who do versus do not complete the reimbursement process. To evaluate perceived barriers and facilitators of program participation, we will conduct semi-structured interviews and administer the Comprehensive Score for Financial Toxicity Patient Reported Outcome Measure (COST PROM) and the Short Assessment of Health Literacy (SAHL). This program will examine how reimbursement of non-clinical costs can improve access to cancer clinical trials, with the eventual goal of increasing trial enrollment, diversity, representativeness, and generalizability., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dana L.Dornsife is Founder, Chief Mission and Strategy Officer, Lazarex Cancer Foundation., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Lung cancer screening trials generally enroll motivated, relatively healthy, and adherent populations. We therefore evaluated the prevalence and effects of comorbidities in a real-world population undergoing low-dose computed tomography (LDCT) scans., Patients and Methods: We calculated the Charlson Comorbidity Index (CCI) of patients for whom an initial low-dose computed tomography (LDCT) for lung cancer screening was ordered between February 2017 and February 2019 in an integrated safety-net healthcare system. We examined the association between CCI and initial LDCT completion using multivariable logistic regression, assessed the association between specific medical comorbidity and LDCT completion using Chi-square test or Fisher's exact test as appropriate, and examined the association between CCI and LDCT Lung-RADS results using Fisher's exact test., Results: A total of 1358 patients were included in the analysis. Mean age was 63 years, 57% were women, and 50% were Black. Patients had moderate comorbidity burden (median CCI 3) with chronic pulmonary disease the most common comorbidity. Overall, 943 LDCT (70%) were completed. There was no difference in 30-day, 90-day, or 1-year completion rates of initial LDCT according to CCI. However, 30-day LDCT completion rates did increase over time (P < .001). Lung-RADS scores were not associated with CCI., Conclusion: In a real-world setting, patients undergoing lung cancer screening have moderate comorbidity burden. The degree and type of medical comorbidity are not associated with initial screening completion or results. Timeliness of LDCT completion may improve as program experience increases., (Copyright © 2022. Published by Elsevier Inc.)

Introduction: The 5 year survival rate for patients with locally advanced non-small-cell lung cancer (NSCLC) not amenable for definitive resection with historical standard-of-care concurrent chemoradiotherapy (cCRT) ranges from 15% to 32%. cCRT primes anti-tumor immunity and also upregulates programmed death ligand-1 (PD-L1), providing a rationale for combining an immune checkpoint inhibitor with cCRT to improve outcomes. In the PACIFIC trial, consolidation therapy with the PD-L1 inhibitor durvalumab improved progression-free survival (PFS) and overall survival (OS) vs. placebo in patients with stage III NSCLC who did not have disease progression after cCRT. CheckMate73L (NCT04026412), a randomized phase 3 study, evaluates the efficacy of nivolumab plus cCRT followed by nivolumab with or without ipilimumab vs. cCRT followed by durvalumab for untreated, stage III NSCLC., Patients and Methods: Patients with untreated, stage III NSCLC will be randomized 1:1:1 to nivolumab plus cCRT followed by nivolumab in combination with ipilimumab (Arm A) or nivolumab alone (Arm B); or cCRT followed by durvalumab (Arm C). Primary endpoints are PFS and OS (Arm A vs. Arm C). Secondary endpoints include additional analyses of PFS and OS (Arm A vs. Arm B; Arm B vs. Arm C), as well as objective response rate, complete response rate, time to response, duration of response, time to death or distant metastases, and safety and tolerability. Recruitment began on August 20, 2019, and the estimated primary completion date is October 17, 2022., (Copyright © 2021. Published by Elsevier Inc.)

Objective: Given the higher rates of tobacco use along with increased mortality specific to lung cancer in rural settings, low-dose CT (LDCT)-based lung cancer screening could be particularly beneficial to such populations. However, limited radiology facilities and increased geographical distance, combined with lower income and education along with reduced patient engagement, present heightened barriers to screening initiation and adherence., Methods: In collaboration with community leaders and stakeholders, we developed and implemented a community-based lung cancer screening program, including telephone-based navigation and tobacco cessation counseling support, serving 18 North Texas counties. Funding was available to support clinical services costs where needed. We collected data on LDCT referrals, orders, and completion., Results: To raise awareness for lung cancer screening, we leveraged our established collaborative network of more than 700 community partners. In the first year of operation, 107 medical providers referred 570 patients for lung cancer screening, of whom 488 (86%) were eligible for LDCT. The most common reasons for ineligibility were age (43%) and insufficient tobacco history (20%). Of 381 ordered LDCTs, 334 (88%) were completed. Among screened patients, 61% were current smokers and 36% had insurance coverage for the procedure. The program cost per patient was $430., Discussion: Implementation, uptake, and completion of LDCT-based lung cancer screening is feasible in rural settings. Community outreach, health promotion, and algorithm-based navigation may support such efforts. Given low lung cancer screening rates nationally and heightened lung cancer risk in rural populations, similar programs in other regions may be particularly impactful., (Copyright © 2022 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Background: Less than 5% of eligible individuals in the United States undergo lung cancer screening. Variation in clinicians' participation in lung cancer screening has not been determined., Patients and Methods: We studied medical providers who ordered ≥ 1 low-dose computed tomography (LDCT) for lung cancer screening from February 2017 through February 2019 in an integrated safety-net healthcare system. We analyzed associations between provider characteristics and LDCT orders and completion using chi-square, Fisher exact, and Student t tests, as well as ANOVA and multinomial logistic regression., Results: Among an estimated 194 adult primary care physicians, 144 (74%) ordered at least 1 LDCT, as did 39 specialists. These 183 medical providers ordered 1594 LDCT (median, 4; interquartile range, 2-9). In univariate and multivariate models, family practice providers (P < .001) and providers aged ≥ 50 years (P = .03) ordered more LDCT than did other clinicians. Across providers, the median proportion of ordered LDCT that were completed was 67%. The total or preceding number of LDCT ordered by a clinician was not associated with the likelihood of LDCT completion., Conclusion: In an integrated safety-net healthcare system, most adult primary care providers order LDCT. The number of LDCT ordered varies widely among clinicians, and a substantial proportion of ordered LDCT are not completed., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Introduction: Brigatinib is a potent next-generation ALK tyrosine kinase inhibitor (TKI) with activity against ALK resistance mutations and central nervous system activity. We prospectively studied the activity and safety of brigatinib in patients with disease progression after other next-generation ALK TKIs., Methods: Patients with stage IIIB or IV ALK+ NSCLC and progressive disease after next-generation ALK TKIs were eligible. Patients were required to undergo tumor biopsy less than or equal to 60 days before enrollment, and circulating tumor DNA was collected at baseline. Brigatinib treatment was 90 mg daily for 7 days and then escalated to 180 mg daily. Primary end point was objective response rate, and two-stage design was used., Results: Between March 2017 and November 2018, a total of 20 patients were treated in stage 1; median age was 55 years (range: 32-71), median number of previous therapies was three (range: 1-6), median number of previous ALK TKIs was two (range: 1-4), and 11 had central nervous system disease at baseline. The objective response rate was 40% (95% confidence interval [CI]: 19%-62%), and the duration of response was 5.3 months (95% CI: 3.6-nonassessable). With follow-up of 22 months, the median progression-free survival was 7.0 months (95% CI: 4.6-10.1). Grade 3 or 4 adverse events were consistent with those of previous studies., Conclusions: Brigatinib has activity in ALK+ NSCLC after previous next-generation ALK TKIs. Further study in patients with disease progression on next-generation ALK TKI is warranted. National Clinical Trials #: NCT02706626., (Copyright © 2020 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)

Introduction: Although chemoradiotherapy (CRT) is the standard of care for patients with unresectable stage III non-small-cell lung cancer (LA-NSCLC), most patients relapse. Tecemotide is a MUC1 antigen-specific cancer immunotherapy vaccine. Bevacizumab improves survival in advanced nonsquamous (NS)-NSCLC and has a role in immune modulation. This phase II trial tested the combination of tecemotide and bevacizumab following CRT in patients with LA-NSCLC., Patients and Methods: Subjects with stage III NS-NSCLC suitable for CRT received carboplatin/paclitaxel weekly + 66 Gy followed by 2 cycles of consolidation carboplatin/paclitaxel ≤ 4 weeks of completion of CRT (Step 1). Patients with partial response/stable disease after consolidation therapy were registered onto step 2, which was 6 weekly tecemotide injections followed by every 6 weekly injections and bevacizumab every 3 weeks for up to 34 doses. The primary endpoint was to determine the safety of this regimen., Results: Seventy patients were enrolled; 68 patients (median age, 63 years; 56% male; 57% stage IIIA) initiated therapy, but only 39 patients completed CRT and consolidation therapy per protocol, primarily owing to disease progression or toxicity. Thirty-three patients (median age, 61 years; 58% male; 61% stage IIIA) were registered to step 2 (tecemotide + bevacizumab). The median number of step 2 cycles received was 11 (range, 2-25). Step 2 worst toxicity included grade 3, N = 9; grade 4, N = 1; and grade 5, N = 1. Grade 5 toxicity in step 2 was esophageal perforation attributed to bevacizumab. Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration., Conclusions: This cooperative group trial met its endpoint, demonstrating tolerability of bevacizumab + tecemotide after CRT and consolidation. In this selected group of patients, the median progression-free survival and overall survival are encouraging. Given that consolidation immunotherapy is now a standard of care following CRT in patients with LA-NSCLC, these results support a role for continued investigation of antiangiogenic and immunotherapy combinations in LA-NSCLC., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Introduction: For lung cancer screening, the available data are often derived from patients enrolled prospectively in clinical trials. We, therefore, investigated lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial., Patients and Methods: From February 2017 through February 2019, we enrolled subjects in a trial examining telephone-based navigation during low-dose computed tomography (LDCT) for lung cancer screening. We identified patients for whom LDCT was ordered and who were approached, but not enrolled, in the trial. We categorized nonenrollment as the patient had declined or could not be reached. We compared the characteristics and LDCT completion rates among these groups and the enrolled population using the 2-sample t test and χ 2 test., Results: Of 900 individuals approached for participation (mean age, 62 years; 45% women, 53% black), 447 were enrolled in the screening clinical trial. No significant demographic differences were found between the enrolled and nonenrolled cohorts. Of the 453 individuals not enrolled, 251 (55%) had declined participation and 202 (45%) could not be reached, despite up to 6 attempts. LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P < .001)., Conclusions: In the present single-center study, demographic factors did not predict for participation in a lung cancer screening trial. Lung cancer screening adherence rates were substantially lower for those not enrolled in a screening trial, especially for those who could not be contacted. These findings may inform the broader implementation of screening programs., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Introduction: Understanding temporal and anatomic patterns of lung cancer recurrence could guide disease management and monitoring. However, these data are not available in population-based datasets and are not routinely recorded in clinical trials., Materials and Methods: We identified cases of stage 1 to 3 lung cancer diagnosed January 1, 2000, to December 31, 2017, in the tumor registry of a National Cancer Institute-designated comprehensive cancer center. For cases with documented disease recurrence, we recorded anatomic site(s) and timing. We estimated time to recurrence using Kaplan-Meier methods. Associations between case characteristics and recurrence features were assessed using univariable and multivariable logistic regression models and Cox regression models., Results: A total of 1619 cases of stage 1 to 3 lung cancer from 1549 patients were included in the analysis. Of these, 466 (30%) patients developed recurrent lung cancer. The most common type of first recurrence was distant disease, most commonly central nervous system (CNS) (37%). In multivariable analyses, race (P = .02) and primary treatment modality (P < .001) correlated with recurrent disease, whereas tumor histology (P = .004) and primary treatment modality (P < .001) were associated specifically with distant recurrence. Patient age (P = .05) and initial TNM stage (P = .001) correlated with timing of recurrence., Conclusion: In this single-center series of stage 1 to 3 lung cancer, recurrent disease was associated with race, histology, and treatment modality, and most commonly occurred in the CNS. Modulation of clinical and radiographic disease monitoring according to recurrence risk, timing, and site may offer a means to identify future lung cancer when it remains asymptomatic and highly treatable., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Concomitant medication use, including agents that prolong the corrected QT (QTc) interval, can result in the exclusion of patients with cancer from clinical trials. To estimate the potential effects on accrual, we determined the prevalence of QTc-prolonging medication prescriptions in a national patient cohort., Patients and Methods: We identified adult patients in the Veterans Affairs system with a diagnosis of lung cancer from 2003 to 2016. The use of QTc interval-prolonging medications and risk category were obtained from CredibleMeds. We calculated the prevalence of prescriptions for QTc-prolonging medications with a known or possible risk of torsade de pointes in the 3 months up to and including the date of cancer diagnosis. The rates across patient groups were compared using χ 2 test., Results: A total of 280,068 patients were included in the present study. The mean age was 70 years, 98% were male, and 72% were white. Overall, 28.4% had been prescribed a QTc-prolonging medication, and 7.3% had been prescribed ≥2 in the 3 months before the cancer diagnosis. The most commonly prescribed QTc-prolonging medications were antimicrobial agents (14.0%), psychiatric agents (10.2%), antiemetic agents (2.6%), and cardiac medications (1.7%). Excluding the antimicrobial agents, 18.4% of the patients had been prescribed a QTc-prolonging medication., Conclusions: A substantial proportion of individuals with lung cancer will be prescribed QTc-prolonging medications. These prescriptions can limit patients' eligibility for clinical trials and complicate the administration of standard cancer therapies. Further research into the actual clinical risks and optimal management of QTc-prolonging medications in cancer populations is warranted., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: The introduction of oral cancer therapies presents new challenges to delivery of quality cancer care. Little is known about how patients and providers address and overcome these challenges. We conducted a qualitative study exploring the range of patient and provider perspectives on oral cancer therapies., Methods: We conducted semi-structured interviews with patients and providers at a tertiary referral center and county safety-net hospital in Dallas, TX. Interviews probed perspectives on differences between parenteral chemotherapy and oral therapies, adherence, communication, and cost/insurance. Interview transcripts were analyzed thematically using a deductively-driven coding scheme corresponding to the interview guide., Results: We conducted 22 patient (13 at tertiary referral center, 9 at safety-net hospital) and 10 provider (7 oncologists, 2 nurses, 1 pharmacist) interviews. Key themes from interviews included: (1) differences in parenteral chemotherapy vs. oral therapy; (2) adherence and dosing; and (3) experiences related to cost and communication., Conclusions: Nearly all providers described challenges engaging with and educating patients about oral cancer therapies. Despite our initial hypothesis, safety-net patients encountered few barriers accessing oral therapies compared to patients receiving care in the tertiary referral center., Practice Implications: Our findings will guide future interventions to monitor and support cancer patients receiving oral therapies., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Primary pericardial mesothelioma (PPM) is a rare cancer for which there is no consensus on treatment. We evaluated and summarized a large contemporary population of published PPM cases to characterize risk factors, treatment patterns, and clinical outcomes. Using Ovid and PubMed, literature published from 2000 through 2016 was searched using the terms "primary pericardial mesothelioma," "pericardial mesothelioma," and "malignant pericardial mesothelioma." We identified 6 case series and 84 case reports for a total of 103 PPM cases published from 2000 through 2016. The median age at diagnosis was 55 years, and the median overall survival was 6 months. In univariate analyses of clinical characteristics including gender, asbestos exposure, tobacco use, prior radiation exposure, histologic subtype, and metastasis and/or mediastinal spread, only the presence of metastasis and/or mediastinal spread was a significant predictor of decreased survival (P = .015). Surgery did not provide a statistically significant survival benefit (P = .12). A survival benefit was noted in those who received chemotherapy (median survival, 13 months vs. 0.5 months, P = .002), specifically chemotherapy with a platinum agent with or without pemetrexed. In multivariate analysis, only the receipt of chemotherapy was associated with improved survival. PPM remains a rare and poorly understood malignancy with unclear etiology and a poor prognosis. In this retrospective systematic review, a survival benefit was seen in patients who received chemotherapy., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Introduction: SCLC accounts for almost 15% of lung cancer cases in the United States. Nomogram prognostic models could greatly facilitate risk stratification and treatment planning, as well as more refined enrollment criteria for clinical trials. We developed and validated a new nomogram prognostic model for SCLC patients using a large SCLC patient cohort from the National Cancer Database (NCDB)., Methods: Clinical data for 24,680 SCLC patients diagnosed from 2004 to 2011 were used to develop the nomogram prognostic model. The model was then validated using an independent cohort of 9700 SCLC patients diagnosed from 2012 to 2013. The prognostic performance was evaluated using p value, concordance index and integrated area under the (time-dependent receiver operating characteristic) curve (AUC)., Results: The following variables were contained in the final prognostic model: age, sex, race, ethnicity, Charlson/Deyo score, TNM stage (assigned according to the American Joint Committee on Cancer [AJCC] eighth edition), treatment type (combination of surgery, radiation therapy, and chemotherapy), and laterality. The model was validated in an independent testing group with a concordance index of 0.722 ± 0.004 and an integrated area under the curve of 0.79. The nomogram model has a significantly higher prognostic accuracy than previously developed models, including the AJCC eighth edition TNM-staging system. We implemented the proposed nomogram and four previously published nomograms in an online webserver., Conclusions: We developed a nomogram prognostic model for SCLC patients, and validated the model using an independent patient cohort. The nomogram performs better than earlier models, including models using AJCC staging., (Copyright © 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)

Introduction: This phase I study evaluated nivolumab combined with erlotinib in patients with advanced EGFR-mutant NSCLC., Methods: Patients with advanced EGFR-mutant NSCLC who were EGFR tyrosine kinase inhibitor (TKI)-naive or TKI-treated but had not received chemotherapy were treated with nivolumab 3 mg/kg every 2 weeks and erlotinib 150 mg/d until disease progression or unacceptable toxicity. The primary objective was safety and tolerability., Results: Twenty patients with TKI-treated and one with TKI-naive EGFR-mutant NSCLC were treated with nivolumab plus erlotinib. Treatment-related grade 3 toxicities occurred in five patients (liver enzyme elevations, n = 2; diarrhea, n = 2; weight loss, n = 1), with no grade ≥4 toxicities. In the TKI-treated population, the objective response rate was 15% (3 of 20, including one complete response), and the 24-week progression-free survival rate was 48%. Responses lasted 13.8, 17.6, and 38.2 months per investigator records. A fourth patient had a nonconventional immune-related response lasting 12.5 months. Among these four patients, two were never-smokers and one each had 35- and <1-pack-year histories. Post-EGFR TKI pre-trial tumor biopsy specimens from these patients detected EGFR T790M mutations in two patients and MNNG HOS Transforming gene (MET) amplification in a third; two patients each had primary EGFR exon 19 deletions or L858R mutations. The TKI-naive patient, who had compound EGFR mutations (L858R and S768I) and ultimately achieved a complete response, had an ongoing response lasting more than 5 years based on investigator records., Conclusions: Nivolumab plus erlotinib was tolerable, with durable responses in patients with EGFR-mutant, TKI-treated NSCLC., (Copyright © 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)

Pulmonary toxicity of cancer immunotherapies has emerged as an important clinical event that requires prompt identification and management. Although often referred to as pneumonitis, pulmonary toxicity associated with immunotherapy covers a broad and overlapping spectrum of pulmonary manifestations, and, once suspected, the range of differential diagnoses of infectious and neoplastic processes might make the diagnostic process challenging for physicians. Optimal care can require multidisciplinary effort by pulmonologists, medical oncologists, and radiologists, and awareness of the possibility of treatment-induced pulmonary toxicity by emergency department and primary care physicians. This Viewpoint gives an overview of the diagnosis and management of pulmonary toxicity arising from cancer immunotherapy, including widely used treatments, such as immune checkpoint inhibitors, and emerging therapies, such as chimeric antigen receptor T cells., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Increasingly, analysis of tumor tissue samples for predictive and pharmacodynamic biomarkers is incorporated into lung cancer clinical trials. We determined the time and effort required for tissue acquisition and submission., Patients and Methods: We analyzed data from patients enrolled from 2009 to 2016 at UT Southwestern onto lung cancer trials with mandatory or optional submission of tumor tissue. We collected dates of treatment-related events and staff communications; nature of tissue requirement and biomarker analysis; and location of archival tissue. Associations between case characteristics, clinical intervals, and number of staff communications were analyzed by Fisher's exact test, Wilcoxon 2-sample test, and Kruskal-Wallis test., Results: We identified 129 patients enrolled onto 19 clinical trials, of whom 108 (84%) ultimately received study therapy. For cases in which tissue submission was required if available or optional, 16% and 0%, respectively, had tissue sent. The median interval between consent and treatment was 28 (interquartile range, 11-43) days if tissue was requested and 7 (interquartile range, 6-13) days if tissue was not requested (P < .001). Among cases with requested tissue, the median number of related research staff communications was 3 (range, 0-10). Over time, the number of staff communications increased (P < .001). Location of archival tissue was not associated with number of staff communications or treatment intervals., Conclusion: Lung cancer clinical trial requirements for tissue acquisition and submission affect the time to treatment initiation and require increasing staff effort. Improved systems to expedite these processes, as well as use of blood- or imaging-based biomarkers, may help address these issues., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Introduction: Eligibility criteria and screening procedures are designed to optimize the scientific yield and maximize the safety of clinical trials. However, they may also heighten trial complexity, hinder enrollment, decrease generalizability, and increase costs. We analyzed the types and number of eligibility criteria and screening procedures among thoracic oncology clinical trials sponsored or endorsed by the Eastern Cooperative Oncology Group., Methods: We identified trials and obtained protocols from the Eastern Cooperative Oncology Group website. Eligibility criteria were grouped and categorized as comorbidity (classified by organ system), administrative requirements, prior treatment, and measurable disease requirements. Associations between trial characteristics and eligibility criteria were analyzed by using the Kruskal-Wallis and Wilcoxon tests., Results: A total of 74 lung cancer trials activated in 1986-2016 were identified. The total number of eligibility criteria was associated with trial principal therapy (a median of nine for surgical, 18 for radiation, and 20 for medical therapy [p = 0.02]), trial primary end point (a median of 20 for overall survival, 28 for progression-free survival, and 17 for other [p = 0.001]), number of therapies (p = 0.05), and year of activation (a median of 16 for 1986-1995, 19 for 1996-2005, and 27 for 2006-2016 [P < 0.001]). The increase in trial eligibility requirements over time was limited to medical therapy trials. Over time, there was also an increase in blood test screening procedures (p = 0.05) but not in imaging, cardiac assessment, or pulmonary function screening procedures., Conclusions: The number of eligibility criteria and screening procedures in medical therapy lung cancer clinical trials continues to rise. Continued efforts to simplify protocol eligibility and procedures are warranted to promote trial adherence, enrollment, completion, and generalizability., (Copyright © 2017 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)

Intracellular compartmentalization and trafficking of molecules plays a critical role in complex and essential cellular processes. In lung cancer and other malignancies, aberrant nucleocytoplasmic transport of tumor suppressor proteins and cell cycle regulators results in tumorigenesis and inactivation of apoptosis. Pharmacologic agents targeting this process, termed selective inhibitors of nuclear export (SINE), have demonstrated antitumor efficacy in preclinical models and human clinical trials. Exportin-1 (XPO1), which serves as the sole exporter of several tumor suppressor proteins and cell cycle regulators, including retinoblastoma, adenomatous polyposis coli, p53, p73, p21, p27, forkhead box O, signal transducer and activator of transcription 3, inhibitor of κB, topoisomerase II, and protease activated receptor 4-is the principal focus of development of SINE. The most extensively studied of the SINE to date, the exportin-1 inhibitor selinexor (KPT-330 [Karyopharm Therapeutics, Inc., Newton Centre, MA]), has demonstrated single-agent anticancer activity and synergistic effects in combination regimens against multiple cancer types, with principal toxicities of low-grade cytopenias and gastrointestinal effects. SINE may have particular relevance in KRAS-driven tumors, for which this treatment strategy demonstrates significant synthetic lethality. A multicenter phase 1/2 clinical trial of selinexor in previously treated advanced KRAS-mutant NSCLC is under way., (Copyright © 2017 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)

The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population. 340 adults who meet standard eligibility for lung cancer screening (age 55-77years, smoking history≥30 pack-years, quit within 15years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas. Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion. Patients complete surveys and semi-structured interviews at baseline, 6-month, and 18-month follow-ups to assess attitudes toward screening. The primary endpoint of this pragmatic trial is adherence to three sequential, prospectively defined steps in the screening protocol. Secondary endpoints include self-reported tobacco use and other patient-reported outcomes. Results will provide real-world insight into the impact of patient navigation on adherence to CT-based lung cancer screening in a medically underserved population. This study was registered with the NIH ClinicalTrials.gov database (NCT02758054) on April 26, 2016., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Radiation Therapy Oncology Group (RTOG) 3505 is a randomized phase 3 study of concurrent chemoradiation followed by immune checkpoint inhibitor therapy or placebo in patients with locally advanced non-small-cell lung cancer (NSCLC). Patients with surgically unresectable stage 3 NSCLC will receive thoracic radiotherapy to 60 Gy with concurrent cisplatin 50 mg/m 2 intravenously (I.V.) on days 1, 8, 29, and 36, and etoposide 50 mg/m 2 I.V. on days 1 to 5 and days 29 to 33. Between 4 and 12 weeks after completion of concurrent chemoradiation, eligible patients will be randomized to the anti-programmed death 1 (PD-1) monoclonal antibody nivolumab 240 mg I.V. or placebo every 2 weeks for up to 1 year. The primary end points are overall survival (OS) and progression-free survival (PFS), as determined by central independent radiology review. Secondary objectives include toxicity assessment, patient-reported outcomes and quality of life, and OS and PFS in programmed death ligand 1 (PD-L1) expressors (≥ 1%) and PD-L1 nonexpressors (< 1%). Assuming a rate of 16.7% due to ineligibility and dropout before randomization, a total of 660 patients will be enrolled to ensure 550 patients will be randomized after completion of chemoradiation. This sample size will provide ≥ 90% power to detect a hazard ratio of 0.7 for OS with 2-sided type I error of 0.04, and to detect a hazard ratio of 0.667 for PFS 2-sided type I error of 0.01. (NCT02768558)., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Bavituximab is a phosphatidylserine-targeting antibody with a selective tumor, vascular-directed immune response. In this phase II trial the efficacy and safety of bavituximab combined with docetaxel for previously treated, advanced nonsquamous non-small-cell lung cancer were evaluated., Patients and Methods: Patients were randomized 1:1:1 to receive docetaxel 75 mg/m(2) every 21 days for up to 6 cycles combined with weekly, blinded infusions of placebo, bavituximab 1 mg/kg, or bavituximab 3 mg/kg until disease progression or unacceptable toxicity. The primary end point was overall response rate (ORR), with a predefined end point of 26% in the bavituximab arms. After study unblinding, vial-coding discrepancies were discovered in the placebo and bavituximab 1 mg/kg groups. In exploratory analyses, data from these groups were pooled to form the control group and compared with the 3 mg/kg group., Results: Efficacy end points in the bavituximab 3 mg/kg group (n = 41) and in the placebo/bavituximab 1 mg/kg group (n = 80), respectively, were as follows: ORR, 17.1% (95% confidence interval [CI], 5.6%-28.6%) and ORR, 11.3% (95% CI, 4.3%-18.2%); median progression-free survival 4.5 and 3.3 months (hazard ratio [HR], 0.74 [95% CI, 0.45-1.21]; P = .24); median overall survival 11.7 and 7.3 months (HR, 0.66 [95% CI, 0.40-1.10]; P = .11). Toxicities were manageable and similar between arms., Conclusion: The combination of bavituximab and docetaxel is well tolerated. Although no firm efficacy conclusions can be drawn and the trial did not meet the predefined primary end point, exploratory analyses suggest trends favoring the combination of bavituximab 3 mg/kg with docetaxel. This regimen is being evaluated in the ongoing, global, phase III SUNRISE trial., (Copyright © 2016 Elsevier Inc. All rights reserved.)

There have been significant advances in the understanding of the biology and treatment of non-small-cell lung cancer (NSCLC) during the past few years. A number of molecularly targeted agents are in the clinic or in development for patients with advanced NSCLC. We are beginning to understand the mechanisms of acquired resistance after exposure to tyrosine kinase inhibitors in patients with oncogene addicted NSCLC. The advent of next-generation sequencing has enabled to study comprehensively genomic alterations in lung cancer. Finally, early results from immune checkpoint inhibitors are very encouraging. This review summarizes recent advances in the area of cancer genomics, targeted therapies, and immunotherapy.

Background: Non-small-cell lung cancer presentation, treatment, and outcomes vary widely according to socioeconomic factors and other patient characteristics. To determine whether medical comorbidities account for these observations, we incorporated a validated medical comorbidity index into an analysis of patients diagnosed with stage I to III NSCLC., Patients and Methods: We performed a retrospective analysis of consecutive patients diagnosed with stage I to III NSCLC. Demographic, tumor, and comorbidity data were obtained from hospital tumor registries and individual patient records. The association between variables was assessed using multivariate logistic regression and survival analysis., Results: A total of 454 patients met criteria for analysis. The median age was 65 years, and 51% were men. Individuals with a higher Charlson Comorbidity Index (CCI) were significantly more likely to present with early stage (stage I-II) NSCLC than were patients with lower CCI (odds ratio, 1.72; 95% confidence interval, 1.14-2.63; P = .01), although this association lost statistical significance (P = .21) in a multivariate model. In multivariate logistic regression, overall survival remained associated with all variables: age, sex, race, insurance type, stage, histology, and CCI (P = .0007). The CCI was associated with survival for patients with early stage (P = .02) and locally advanced (P = .02) disease., Conclusion: In this cohort of patients with stage I to III NSCLC, increasing comorbidity burden had a nonsignificant association with diagnosis at earlier disease stage. Although comorbidity burden was significantly associated with outcome for early stage and locally advanced disease, it did not account for survival differences based on multiple other patient and disease characteristics., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Introduction: There is no consensus chemotherapy regimen with concurrent radiotherapy (RT) for inoperable stage IIIA/B non-small-cell lung cancer. This trial evaluated pemetrexed with carboplatin (PCb) or cisplatin (PC) with concurrent RT followed by consolidation pemetrexed., Methods: In this open-label, noncomparative phase II trial, patients with inoperable stage IIIA/B non-small-cell lung cancer (initially all histologies, later restricted to nonsquamous) were randomized (1:1) to PCb or PC with concurrent RT (64-68 Gy over days 1-45). Consolidation pemetrexed monotherapy was administered every 21 days for three cycles. Primary endpoint was 2-year overall survival (OS) rate., Results: From June 2007 to November 2009, 98 patients were enrolled (PCb: 46; PC: 52). The 2-year OS rate was PCb: 45.4% (95% confidence interval [CI], 29.5-60.0%); PC: 58.4% (95% CI, 42.6-71.3%), and in nonsquamous patients was PCb: 48.0% (95% CI, 29.0-64.8%); PC: 55.8% (95% CI, 38.0-70.3%). Median time to disease progression was PCb: 8.8 months (95% CI, 6.0-12.6 months); PC: 13.1 months (95% CI, 8.3-not evaluable [NE]). Median OS (months) was PCb: 18.7 (95% CI, 12.9-NE); PC: 27.0 (95% CI, 23.2-NE). The objective response rates (ORRs) were PCb: 52.2%; PC: 46.2%. Grade 4 treatment-related toxicities (% PCb/% PC) were: anemia, 0/1.9; neutropenia, 6.5/3.8; thrombocytopenia, 4.3/1.9; and esophagitis, 0/1.9. Most patients completed scheduled chemotherapy and RT during induction and consolidation phases. No drug-related deaths were reported during chemoradiotherapy., Conclusions: Because of study design, efficacy comparisons cannot be made. However, both combinations with concurrent RT were active and well tolerated.

Among the 19 presentations of miscellaneous new agents at this year's meeting, several described novel cytotoxics and hormonal agents. The cytotoxic agents included microtubule inhibitors (eribulin, nanoparticle albumin-bound paclitaxel, peptide-bound paclitaxel), a topoisomerase inhibitor (nanoirinotecan), and an alkylating agent (palifosfamide). Hormonal agents included an aromatase inhibitor (anastrazole), an estrogen receptor antagonist (fulvestrant), and a selective androgen receptor modulator (GTx-024).

Background: Socioeconomic disparities in treatment and outcomes of non-small-cell lung cancer (NSCLC) are well established. To explore whether these differences are secondary to individual or institutional characteristics, we examined treatment selection and outcome in a diverse population treated at a single medical center., Patients and Methods: We performed a retrospective analysis of consecutive patients diagnosed with NSCLC stages I-III from 2000 to 2005 at the University of Texas Southwestern Medical Center. Treatment selection was dichotomized as 'standard' (surgery for stage I-II; surgery and/or radiation therapy for stage III) or 'other.' Associations between patient characteristics (including socioeconomic status) and treatment selection were examined using logistic regression; associations between characteristics and overall survival were examined using Cox regression models and Kaplan-Meier survival analysis., Results: A total of 450 patients were included. Twenty-eight percent of patients had private insurance, 43% had Medicare, and 29% had an indigent care plan. The likelihood of receiving 'standard' therapy was significantly associated with insurance type (indigent plan versus private insurance odds ratio [OR] 0.13, 95% confidence interval [CI] 0.04, 0.43 for stage I-II; OR 0.38, 95% CI 0.14, 1.00 for stage III). For patients with stage I-II NSCLC, survival was associated with age, sex, insurance type (indigent plan versus private insurance hazard ratio for death 1.98; 95% CI 1.16, 3.37), stage, and treatment selection. In stage III NSCLC, survival was associated with treatment selection., Conclusion: Within a single academic medical center, socioeconomically disadvantaged patients with stage I-III NSCLC are less likely to receive 'standard' therapy. Socioeconomically disadvantaged patients with stage I-II NSCLC have inferior survival independent of therapy., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: Maintenance chemotherapy is a recently approved approach to the treatment of advanced non-small cell lung cancer (NSCLC). We sought to gain insight into patients' perceptions of maintenance chemotherapy using qualitative methods., Methods: We conducted thematic content analysis of focus groups at a freestanding cancer center and at an associated safety-net county hospital. Patients with advanced NSCLC who had started but not yet completed first-line platinum doublet chemotherapy were provided visual and written explanations of maintenance chemotherapy before being guided in group discussion., Results: Key themes to emerge for consideration of maintenance chemotherapy included: (1) survival benefits, disease control, and "buying time"; (2) the importance of "doing something"; (3) quality of life concerns; (4) the role of provider opinion/preference; and (5) the importance of logistics., Conclusions: Patients undergoing first-line chemotherapy for advanced NSCLC were able to understand the concept of maintenance chemotherapy, distinguish it from traditional treatment paradigms, identify pros and cons of this approach, and convey reasons for considering it., Practice Implications: Advances in oncology care that alter therapy modalities and delivery may significantly impact patient perceptions and treatment experiences. Clinical team members may wish to elicit treatment preferences of first-line patients through clinical discussion that anticipate these considerations., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Introduction: : Recent clinical trials incorporating maintenance chemotherapy into the initial treatment of advanced non-small cell lung cancer (NSCLC) have highlighted the benefits of exposing patients to second-line therapies. We, therefore, determined the predictors and impact of second-line chemotherapy administration in a contemporary, diverse NSCLC population., Methods: : We performed a retrospective analysis of consecutive patients diagnosed with stage IV NSCLC from 2000 to 2007 at clinical facilities associated with the University of Texas Southwestern Medical Center. Demographic, disease, treatment, and outcome data were obtained from hospital tumor registries. The association between these variables was assessed using univariate analysis and multivariate logistic regression., Results: : A total of 406 patients in this cohort received first-line chemotherapy and were included in the analysis. Mean age was 59 years, 28% were women, and 59% were white. Among these patients, 197 (49%) received second-line chemotherapy. Among those patients who had not progressed after four to six cycles of first-line chemotherapy, 67% received second-line chemotherapy. Receipt of second-line chemotherapy was significantly associated with patient insurance type (p = 0.007), number of cycles of first-line chemotherapy (p < 0.001), and receipt of prechemotherapy palliative radiation therapy (p = 0.005) but was not associated with patient age, gender, race, histology, or year of diagnosis. In a multivariate model, second-line chemotherapy administration remained associated with insurance type (p = 0.003), number of cycles of first-line chemotherapy (p < 0.001), and receipt of prechemotherapy palliative radiation therapy (p = 0.008). The number of cycles of first-line chemotherapy and administration of second-line chemotherapy were associated with overall survival in both univariate and multivariate analyses., Conclusions: : In this unselected, contemporary, and diverse cohort of patients with advanced NSCLC, 67% of individuals whose disease had not progressed after four to six cycles of first-line chemotherapy eventually received second-line chemotherapy. Markers of socioeconomic status, symptom burden, and response to and tolerance of first-line chemotherapy were associated with receipt of second-line chemotherapy. These factors may assist in the selection of patients most likely to benefit from maintenance chemotherapy.

Introduction: Chemotherapy prolongs survival without substantially impairing quality of life for medically fit patients with advanced non-small cell lung cancer (NSCLC), but population-based studies have shown that only 20 to 30% of these patients receive chemotherapy. These earlier studies have relied on Medicare-linked Surveillance, Epidemiology, and End Results (SEER) data, thus excluding the 30 to 35% of lung cancer patients younger than 65 years. Therefore, we determined the use of chemotherapy in a contemporary, diverse NSCLC population encompassing all patient ages., Methods: We performed a retrospective analysis of patients diagnosed with stage IV NSCLC from 2000 to 2007 at the University of Texas Southwestern Medical Center. Demographic, treatment, and outcome data were obtained from hospital tumor registries. The association between these variables was assessed using univariate analysis and multivariate logistic regression., Results: In all, 718 patients met criteria for analysis. Mean age was 60 years, 58% were men, and 45% were white. Three hundred fifty-three patients (49%) received chemotherapy. In univariate analysis, receipt of chemotherapy was associated with age (53% of patients younger than 65 years versus 41% of patients aged 65 years and older; p = 0.003) and insurance type (p < 0.001). In a multivariate model, age and insurance type remained associated with receipt of chemotherapy. For individuals receiving chemotherapy, median survival was 9.2 months, compared with 2.3 months for untreated patients (p < 0.001)., Conclusions: In a contemporary population representing the full age range of patients with advanced NSCLC, chemotherapy was administered to approximately half of all patients-more than twice the rate reported in some earlier studies. Patient age and insurance type are associated with receipt of chemotherapy.

Introduction: Lung cancer diagnostic and treatment delays have been described for several patient populations. However, few studies have analyzed these intervals among patients treated in contemporary health care systems in the United States. We therefore studied the timing of lung cancer diagnosis and treatment at a U.S. medical center providing care to a diverse patient population within two different hospital systems., Methods: We performed a retrospective analysis of consecutive patients diagnosed with non-small cell lung cancer stage I to III from 2000 to 2005 at public and private hospitals affiliated with the University of Texas Southwestern Medical Center. We recorded patient and disease characteristics; dates of initial radiograph suspicious for lung cancer, diagnosis, and treatment; and overall survival. Associations between these factors were assessed using univariate analysis, multivariate logistic regression, and Kaplan-Meier survival analysis., Results: A total of 482 patients met criteria for analysis. In univariate analyses, the image-treatment interval was significantly associated with race, age, income, insurance type, and hospital type (76 days for public versus 45 days for private; p < 0.0001). In multivariate analysis, only hospital type remained significantly associated with the image-treatment interval; patients in the private hospital setting were more likely to receive timely treatment (hazard ratio 1.85; 95% confidence interval, 1.37-2.50; p < 0.001). In univariate analysis, the image-treatment interval was not associated with disease stage (p = 0.27) or with survival (p = 0.42)., Conclusion: Intervals between suspicion, diagnosis, and treatment of lung cancer vary widely among patients. Health care system factors, such as hospital type, largely account for these discrepancies. In this study, these intervals do not appear to be associated with clinical outcomes.

Venous thromboembolism (VTE) is increasingly diagnosed among individuals with hematologic malignancies. However, the risk of VTE among patients undergoing hematopoietic stem cell transplantation (HSCT) is unclear. We examined the incidence and risk factors for VTE and bleeding among 1514 patients undergoing in-patient HSCT. No protocolized VTE prophylaxis was used. By HSCT day 180, 75 symptomatic VTE occurred in 70 patients (4.6%; 95% confidence interval [CI], 3.6%-5.8%). Fifty-five (3.6%) were catheter-associated, 11 (0.7%) were non-catheter-associated deep venous thromboses, and 9 (0.6%) were pulmonary emboli. Thirty-four percent of VTE occurred at a platelet count less than 50 x10(9)/L; 13% occurred at a platelet count less than 20 x10(9)/L. In multivariate analysis, VTE was associated with prior VTE (odds ratio [OR], 2.9; 95% CI, 1.3-6.6) and with graft-versus-host disease (GVHD; OR, 2.4; 95% CI, 1.4-4.0). Clinically significant bleeding occurred in 230 patients (15.2%; 95% CI, 13.4%-17.1%); 55 patients (3.6%; 95% CI, 2.7%-4.7%) had fatal bleeding. Bleeding was associated with anticoagulation (OR, 3.1; 95% CI, 1.8-5.5), GVHD (OR, 2.4; 95% CI, 1.8-3.3), and veno-occlusive disease (OR, 2.2; 95% CI, 1.4-3.6). In HSCT patients, VTE is primarily catheter-related and 3-fold less common than clinically significant bleeding. These findings warrant consideration when selecting VTE prophylaxis in HSCT patients.