Non-small Cell Lung Cancer Survivors Research Articles

Lung cancer-specific symptoms and fear of cancer recurrence among recurrence-free non-small cell lung cancer survivors.

Lung cancer survivors have more psychosocial problems, including depression and anxiety disorder, than other cancer survivors. Lung cancer-specific symptoms, such as cough, dyspnea, or pain in chest, might increase FCR among survivors. We aimed to evaluate the association between lung cancer-specific symptoms and FCR among recurrence-free non-small cell lung cancer (NSCLC) survivors. This is a cross-sectional study. Recurrence-free NSCLC survivors were recruited from January to October 2020 at a tertiary hospital in Seoul, Korea. We measured FCR using the Korean version of FCRI-SF and categorized them into three groups: non-clinical FCR (nFCR, < 13), subclinical FCR (sFCR, 13 to 21), and clinical FCR (cFCR, ≥ 22). Lung cancer-specific symptoms were measured using the Korean version of EORTC QLQ-LC13 and EORTC QLQ-C30. A total of 727 survivors were enrolled. One-third (30.8%) of survivors reported sFCR, and 19.7% had cFCR. In a multivariate analysis, survivors with severe pain in chest were 4.7 times (95% CI: 2.4-9.0) more likely to experience cFCR compared to those without it. Mild dyspnea (OR 1.7, 95% CI: 1.1-2.7) and mild dysphagia (OR 2.4, 95% CI: 1.3-4.4) were associated with cFCR. Survivors with sFCR (Coef. - 6.3, 95% CI: - 9.8, - 2.8) and cFCR (Coef. - 11.3, 95% CI: - 15.5, - 7.2) had poorer quality of life compared to survivors with nFCR. NSCLC survivors were experiencing lung cancer-specific symptoms even a few years after treatment, which were associated with cFCR, resulting in poor HRQoL. It is necessary to develop a lung cancer-specific symptom checklist and use it during even long-term surveillance.

Efficacy of a digital lifestyle intervention on health-related QUAlity of life in non-small cell LUng CAncer survivors following inpatient rehabilitation: protocol of the QUALUCA Swiss multicentre randomised controlled trial

IntroductionNon-small cell lung cancer (NSCLC) survivors suffer from impaired physical and psychological functioning and reduced health-related quality of life (HRQoL) that persist after active treatment ends. Sustaining rehabilitation benefits, promoting...

2160P Sociodemographic disparities associated with financial toxicity in stage IV non-small cell lung cancer survivors

2160P Sociodemographic disparities associated with financial toxicity in stage IV non-small cell lung cancer survivors

Music therapy, quality of life and efficacy of immunotherapy for NSCLC

ObjectiveOur study examines how non-small cell lung cancer (NSCLC) survivors undergoing immunotherapy can experience reduced anxiety and psychological distress, improved quality of life (QOL) and increased immunotherapy efficacy.Methods133 men and...

Unmet Supportive Care Needs after Non-Small Cell Lung Cancer Resection at a Tertiary Hospital in Seoul, South Korea.

The aim of this study is to identify the prevalence and predictors of unmet needs of non-small cell lung cancer (NSCLC) patients undergoing surgical resection in Seoul, South Korea. A total of 949 patients who completed survey questionnaires that included the Cancer Survivors' Unmet Needs Korean version (CaSUN-K), fear of cancer recurrence (FCR) inventory-short form, and European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) were recruited from January to October 2020. Multivariable logistic regression was used to determine the potential correlation of significant unmet needs, defined as any moderate or strong need, for each domain of CaSUN-K. Of the 949 participants, the mean age was 63.4 ± 8.8 years old, and 529 (55.7%) were male. Overall, 91.8% of participants reported one or more unmet need. The highest domains of moderate-to-strong unmet needs were existential survivorship (59.1%), comprehensive cancer care (51.2%), and information (49.7%). High FCR and poor emotional function were associated with moderate-to-strong unmet needs across all domains of CaSUN-K. NSCLC survivors with a recent diagnosis had more frequent disease-related unmet needs. Interventions to reduce the unmet needs of NSCLC patients should focus on relieving FCR and improving emotional functioning. Furthermore, emphasis should be placed on decreasing disease-related needs, particularly for early survivors of lung cancer during the re-entry phase.

Impact of diabetes on stage I lung cancer treatment patterns and prognosis in older adults: A population-based cohort study

BackgroundDiabetes is a common comorbidity in patients with early-stage non-small cell lung cancer (NSCLC), a growing population due to increased LC screening. However, it is unknown if diabetes is associated with less aggressive NSCLC treatment and worse NSCLC outcomes. This study aimed to investigate treatment patterns and outcomes of older patients with Stage I NSCLC and diabetes. MethodsUsing national cancer registry data linked to Medicare, we identified patients ≥65 years old with Stage I NSCLC. Patients were categorized as having no diabetes, diabetes without severe complications (DM-c), or diabetes with ≥1 severe complication (DM + c). We used multinomial logistic regression to assess the association of diabetes and NSCLC treatment. The association of diabetes category with NSCLC and non-NSCLC survival was analyzed with Fine-Grey competing-risks regression. ResultsIn 25,358 patients (75% no diabetes, 12% DM-c and 13% had DM + c), adjusted analyses showed that DM-c and DM + c were associated with increased odds of receiving limited resection rather than lobectomy (odds ratio [OR]: 1.22, 95% confidence interval [CI]: 1.07–1.37 and OR 1.42, 95% CI 1.26–1.59, respectively). Competing risk regression showed diabetes was associated with increased risk of non-NSCLC death (DM-c hazard ratio [HR] 1.16, 95% CI: 1.08–1.25, DM + c HR 1.49, 95% CI: 1.40–1.59), but not NSCLC-specific death. ConclusionThis study uncovers critical information on how diabetes is associated with less aggressive early-stage NSCLC care in older patients. This study also confirms that diabetes increases death from non-lung cancer causes and managing comorbidities is crucial to improving outcomes in older early-stage NSCLC survivors.

PPD01.02 Identifying Physical, Social, Emotional, and Medical Needs of Lung Cancer Survivors with Advanced Non-Small Cell Lung Cancer

Current survivorship research mostly focuses on early-stage non-small cell lung cancer survivors (NSCLCS), however NSCLCS with advanced disease at diagnosis (aNCSLCS) have increased survival. Survivorship programs are beneficial, yet little is known about the physical, psychosocial, and medical needs of aNCSLCS.

Duration of Immunotherapy in Non-Small Cell Lung Cancer Survivors: A Lifelong Commitment?

Lung cancer is one of the most common human malignancies and the leading cause of cancer-related death worldwide. Novel therapeutic approaches, like targeted therapies against specific molecular alterations and immunotherapy, have revolutionized in the last decade the oncological outcomes in patients affected by non-small cell lung cancer (NSCLC). The advent of immunotherapy for the treatment of NSCLC has significantly improved overall and progression-free survival, as well as the patient's quality of life in comparison to traditional chemotherapy. Currently, it is estimated that long-term survival can be achieved in more than 15% of NSCLC patients treated with immunotherapy. Therefore, the optimal duration of immunotherapy in long survivors needs to be established to avoid overtreatment, side effects, and high costs and at the same time, protect them from potential disease relapse or progression. We performed a narrative review to discuss all the aspects related to the optimal duration of immunotherapy in long survivors with NSCLC. Data regarding the duration of immunotherapy in the most impacting clinical trials were collected, along with data regarding the impact of toxicities, side effects, and costs for healthcare providers. In addition, the two-year immunotherapy scheme in patients who benefit from first-line or subsequent treatment lines are examined, and the need for biomarkers that can predict outcomes during and after immunotherapy cessation in patients affected by NSCLC are discussed.

Defining the needs of lung cancer survivors: Physical, social, emotional, and medical needs.

225 Background: Lung cancer survivors (LCS) are a rapidly growing population. Cancer survivors benefit from dedicated survivorship care, but the physical, psychosocial, and medical needs of LCS are poorly defined. Methods: Non-small cell LCS (defined as alive ≥1 years from diagnosis) of any stage treated at Johns Hopkins were invited to complete an IRB-approved cross-sectional survey of needs of 4 subscales (physical, social, emotional, and medical needs) rated on a 5-point Likert scale (1 = no need, 5 = highest need). Demographic and clinical information were collected by chart review and patient reported questionnaire. Multiple regression models identified factors that were significantly associated with greater total number of needs on each subscale. Results: 235 surveys were completed. We excluded surveys with &lt; 80% completion. Non-Caucasian race was associated with a significantly lower rate of survey completion (p = 0.002). Median age of LCS who completed the survey was 69, most were female (62%), Caucasian (74%), married (71%), or had stage III/IV cancer (60%). More than half of respondents reported emotional needs of fear of recurrence (79%) and living with uncertainty (74%). Common physical needs included fatigue (70%), sleep disturbance (60%), memory and concentration (57%), and weakness (54%). Multivariate analysis identified factors associated with higher needs in physical, social, and emotional needs (Table). We did not identify any factors associated with differences in medical needs. NS – non-significant value. Conclusions: We identified physical, emotional, social, and medical needs that burden survivors of NSCLC. Emotional needs are prevalent. Clinical and demographic factors are independently associated with higher needs in physical, social, and emotional domains. These results are critical in identifying high-impact gaps in providing survivorship care for lung cancer survivors. Future work to identify interventions to address needs is crucial.[Table: see text]

Development and Validation of a Nomogram for Predicting Overall Survival in Patients with Second Primary Small Cell Lung Cancer After Non-Small Cell Lung Cancer: A SEER-Based Study

BackgroundNon-small cell lung cancer (NSCLC) survivors are at an increased risk of developing second primary malignancies, such as small cell lung cancer. This paper sought to establish a prognostic nomogram to assess overall survival (OS) in patients with second primary small cell lung cancer (SPSCLC) after NSCLC.Methods420 patients who developed SPSCLC after NSCLC were randomly split into the training and validation groups. A nomogram was established by stepwise regression. Area under the curve (AUC) and calibration plots were applied to assess the prognostic performance of the nomogram. Concordance index (C-index), integrated discrimination improvement (IDI), net reclassification index (NRI) and decision curve analysis (DCA) were performed to compare the nomogram with the American Joint Committee on Cancer (AJCC) 8th staging system. Survival risk classification was constructed based on the nomogram.ResultsFive variables were chosen to construct the nomogram. The AUC showed that it had a satisfactory discrimination ability. All calibration plots displayed good concordance between nomogram and observation. The C-index, IDI, NRI and DCA showed the nomogram was superior to the AJCC 8th staging system. The Kaplan-Meier curves suggested huge differences in prognosis among the three risk groups.ConclusionThis study build a nomogram and risk stratification system for predicting probabilities of OS in patients with SPSCLC after NSCLC, which can help clinicians in individualized survival assessment and treatment decisions.

Psychometric Validation of the Korean Version of the Cancer Survivors' Unmet Needs (CaSUN) Scale among Korean Non-Small Cell Lung Cancer Survivors.

The purpose of the study was to validate the Korean version of Cancer Survivors' Unmet Needs (CaSUN) scale among non-small cell lung cancer survivors. Participants were recruited from outpatient clinics at the Samsung Medical Center in Seoul, South Korea, from January to October 2020. Participants completed a survey questionnaire that included the CaSUN. Exploratory and confirmatory factor analysis and Pearson's correlations were used to evaluate the reliability and validity of the Korean version of the CaSUN (CaSUN-K). We also tested known-group validity using an independent t test or ANOVA. In total, 949 provided informed consent and all of which completed the questionnaire. Among the 949 patients, 529 (55.7%) were male; the mean age and median time since the end of active treatment (standard deviation) was 63.4±8.8 years and the median was 18 months. Although the factor loadings were different from those for the original scale, the Cronbach's alpha coefficients of the six domains in the CaSUN-K ranged from 0.68 to 0.95, indicating satisfactory internal consistency. In the CFA, the goodness-of-fit indices for the CaSUN-K were high. Moderate correlations demonstrated the convergent validity of CaSUN-K with the relevant questionnaire. More than 60% of the participants reported information-related unmet needs, and the CaSUN-K discriminated between the needs reported by the different subgroups that we analyzed. The CaSUN-K is a reliable and valid measure for assessing the unmet needs in a cancer population, thus this tool help population to receive timely, targeted, and relevant care.

Serum tumor necrosis factor‐α, interleukin‐1β, interleukin‐6, and interleukin‐17 relate to anxiety and depression risks to some extent in non‐small cell lung cancer survivor

IntroductionInflammatory cytokines are proposed as modulators for the pathogenesis of anxiety and depression (anxiety/depression), and anxiety/depression are frequently existed in non‐small cell lung cancer (NSCLC) survivors. However, no published study has explored the association of inflammation cytokines with anxiety/depression in NSCLC survivors.ObjectivesWe aimed to evaluate serum tumor necrosis factor‐α (TNF‐α), interleukin‐1 beta (IL‐1β), interleukin‐6 (IL‐6), interleukin‐17 (IL‐17) levels, and their correlations with anxiety/depression in NSCLC survivors.MethodsTotally, 217 NSCLC survivors and 200 controls were recruited. Then, inflammatory cytokines in serum samples were detected by enzyme‐linked immunosorbent assay (ELISA). Besides, their anxiety/depression status was assessed by Hospital Anxiety and Depression Scale (HADS).ResultsHADS‐anxiety score, anxiety rate, anxiety severity, HADS‐depression score, depression rate, and depression severity were all increased in NSCLC survivors compared with controls (all P < 0.001). Regarding inflammatory cytokines, TNF‐α, IL‐1β, and IL‐17 levels were higher (all P < 0.01), while IL‐6 (P = 0.105) level was of no difference in NSCLC survivors compared with controls. Furthermore, TNF‐α, IL‐1β, IL‐6, and IL‐17 were all positively associated with HADS‐A score (all P < 0.05), anxiety occurrence (all P < 0.05), HADS‐D score (all P < 0.05), and depression occurrence (all P < 0.05) in NSCLC survivors, while the correlation‐coefficients were weak. Additionally, multivariate logistic regression analyses disclosed that TNF‐α (both P < 0.05) and IL‐1β (both P < 0.001) were independently correlated with increased anxiety and depression risks in NSCLC survivors.ConclusionSerum TNF‐α, IL‐1β, IL‐6, and IL‐17 are related to increased anxiety and depression risks to some extent in NSCLC survivors.

Prognostic model of long-term advanced stage (IIIB-IV) EGFR mutated non-small cell lung cancer (NSCLC) survivors using real-life data

BackgroundThere is a lack of useful diagnostic tools to identify EGFR mutated NSCLC patients with long-term survival. This study develops a prognostic model using real world data to assist clinicians to predict survival beyond 24 months.MethodsEGFR mutated stage IIIB and IV NSCLC patients diagnosed between January 2009 and December 2017 included in the Spanish Lung Cancer Group (SLCG) thoracic tumor registry. Long-term survival was defined as being alive 24 months after diagnosis. A multivariable prognostic model was carried out using binary logistic regression and internal validation through bootstrapping. A nomogram was developed to facilitate the interpretation and applicability of the model.Results505 of the 961 EGFR mutated patients identified in the registry were included, with a median survival of 27.73 months. Factors associated with overall survival longer than 24 months were: being a woman (OR 1.78); absence of the exon 20 insertion mutation (OR 2.77); functional status (ECOG 0–1) (OR 4.92); absence of central nervous system metastases (OR 2.22), absence of liver metastases (OR 1.90) or adrenal involvement (OR 2.35) and low number of metastatic sites (OR 1.22). The model had a good internal validation with a calibration slope equal to 0.781 and discrimination (optimism corrected C-index 0.680).ConclusionsSurvival greater than 24 months can be predicted from six pre-treatment clinicopathological variables. The model has a good discrimination ability. We hypothesized that this model could help the selection of the best treatment sequence in EGFR mutation NSCLC patients.

Living with and beyond metastatic non-small cell lung cancer: the survivorship experience for people treated with immunotherapy or targeted therapy.

Immunotherapy (IT) and targeted therapy (TT) have improved survival for some patients with metastatic non-small cell lung cancer (NSCLC). Their lived experience is under-studied. We conducted a single centre, qualitative study to understand concerns and unmet needs amongst this novel survivor population. Eligible participants had metastatic NSCLC, aged >18, English-speaking and >6 months post initiation of IT/TT without progressive disease. Semi-structured interviews focused on physical, psychological, social and functional impacts of diagnosis, therapy and prognosis. Interviews were recorded and transcribed. Data were analysed via qualitative thematic analysis. Between May and December 2019, 20 participants were interviewed: median age 62 (range 34-83), 13 (65%) female; median time since diagnosis of metastatic NSCLC 27 months (range 10-108). Twelve out of 20 (60%) participants had a targetable mutation (EGFR/ALK/BRAF); 6 were receiving IT, 11 TT, 2 IT + chemotherapy and 1 IT + TT. Four main themes were identified: living long-term on IT and TT (chronic toxicities), psychological concerns (living with uncertainty, fear of cancer progression, scan-related anxiety), support with practical issues (finances, employment amidst prognostic uncertainty, challenges with trial participation) and wanting information pertinent to NSCLC subtype. Longer-term survivors of metastatic NSCLC experience significant physical, psychological and functional concerns and unmet needs. Results will inform a broader cross-sectional survey and resources to address the needs of this growing survivor group. A 'one-size-fits-all' approach to NSCLC survivorship is no longer appropriate. Survivors of metastatic NSCLC treated with novel therapies may benefit from specific information regarding long-term toxicities and psychological supports.

1051 Level Of Agreement Between Objective And Subjective Sleep Measures In Lung Cancer Survivors With Insomnia

Abstract Introduction Lung cancer survivors (LCS) have the second-highest incidence of impaired sleep among cancer population. Clinical studies use self-reported and objective measures to assess insomnia in LCS. However, negative beliefs of sleep patterns may impair sleep perception, impact psychological state, and influence insomnia treatment and survivorship outcomes. This study aims to assess the level of agreement between subjective and objective sleep measures in LCS. Methods Forty-four non-small cell lung cancer survivors, stage I-III, at least 6 weeks after treatment completion, with Insomnia Severity Index &amp;gt;7, were recruited from two sites from 2014-2016. Individuals with sleep apnea, menopause, rotating shift work, uncontrolled substance abuse, or unstable medical/psychiatric illnesses were excluded from the study. Agreement between total sleep time (TST), sleep latency (SL) and sleep efficiency (SE) from Sleep Diary and wrist-actigraphy (i.e. CamNtech) were assessed with Intraclass Correlation (ICC) and Bland-Altman plots. Analysis of ICC, mean difference, standard deviation (SD) and 95% confidence interval (CI) were conducted using SPSS 24. Results LCS were male (63.6%), 60-69 years old (52.3%), married or living with a partner (50%). Self-reported measurements underestimated TST (-68.2 minutes, ICC 0.45, CI 95%, SD 108.1) and SL (-25.9 minutes, ICC 95%, ICC -0.54, DS 17.5). Objective and self-reported measurements largely overlapped for SE, with a small actigraphy-based overestimation (9.2, ICC 0.2, CI95%, SD 7.3). Bland-Altman plots revealed that the agreement increased with lower SE values. Conclusion LCS tended to underestimate TST and SL. An apparent agreement between objective and self-reported measures for SE may indicate sleep state misperception. Differences in various sleep parameters and potential covariates should be investigated for contribution to the unexplained considerable individual variability in behavioral treatment response among cancer survivors in larger sample sizes. Support 1R01NR018215-01 (GED); T32GM099607(CW).

The association of physical function and quality of life on physical activity for non-small cell lung cancer survivors.

Our study aimed to assess the association between physical function and quality of life (QOL) with physical activity among non-small cell lung cancer (NSCLC) survivors. Participants were 92 NSCLC survivors. Physical activity was assessed by a self-report with physiatrist's interview and the Korean version of the short form of the International Physical Activity Questionnaire (IPAQ-SF). All participants were required to perform three standardized fitness tests. The Korean version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was used to assess QOL. Factors associated with physical functioning and QOL were determined using multiple linear regression. A significant correlation between metabolic equivalent task minutes per week (MET-min/wk) and aerobic fitness was found (r = 0.277, p = 0.008). Factors associated with aerobic fitness include gender, age, and MET-min/wk. The meeting physical activity guideline group was also a factor associated with aerobic fitness. In the QOL aspect, a significant correlation between MET-min/wk and some QOL score was found. The meeting physical activity guideline group was a factor associated with QOL (global health status, physical function, and role function), not total MET-min/wk. Increased physical activity was associated with higher aerobic fitness and QOL. Engagement in physical activity that met physical activity guidelines was a factor related to aerobic fitness and better QOL in some domains. To improve aspects of aerobic fitness and QOL, we may consider the pattern of physical activity, including regular participation and intensity, rather than total physical activity including basal activity.

Risk of second primary malignancy after non-small cell lung cancer: a competing risk nomogram based on the SEER database.

With the improvement of survival for non-small cell lung cancer (NSCLC), research focused on second primary malignancy (SPM) in NSCLC survivors is becoming urgent. This study aimed to estimate the risk of SPM in NSCLC patients. We retrospectively analysed NSCLC patients diagnosed between 2004 and 2010 in SEER database. We firstly evaluated the crude and cumulative incidence of SPM. SPM incidence in NSCLC survivors compared to that in the reference population was calculated as standardized incidence ratio (SIR). A competing risk nomogram was also built, to predict the incidence of SPM. The crude and 10-year cumulative incidences of SPM were 4.04% and 5.05%, respectively, while the SIR was 1.62. The nomogram was well calibrated and had good discriminative ability, with c-index of 0.80. It showed a significantly wide interval of SPM cumulative incidence between the first and tenth-decile according to the risk model (1.04% vs. 16.70%, P<0.05). The decision curve analysis indicated that the clinical net benefit of risk model was larger than that in other scenarios (all-screening or no-screening) in a range of threshold probabilities (1% to 20%). Our study firstly performed a systematic estimation of the incidence of SPM in NSCLC, which implied the necessity of a risk predicting model. We developed the first competing risk nomogram to predict the risk of SPM, which performed well in the evaluation and might be helpful for individualized SPM screening.

Immunotherapy with checkpoint inhibitors in non-small cell lung cancer: insights from long-term survivors.

Immune checkpoint inhibitors (ICIs) targeting the programmed cell death-1 (PD-1)-programmed cell death ligand-1 (PD-L1) axis have shown promising results in non-small cell lung cancer (NSCLC) patients, some of them with persistent responses to these agents that form a population of long-term survivors. Despite the variable definition of PD-L1 positivity in tumors, an association between expression and response has been reasonably consistent in advanced NSCLC. In addition, the clinical efficacy of ICIs seems to be related to the genomic landscape of the tumor in terms of mutational burden and clonal neoantigens. Furthermore, increasing evidence shows that excessive activation of the immune response elicited by ICIs, leading to immune-related toxicities, might be associated with an improved response to immunotherapy. There are still many unanswered questions about the proper use of these agents to maximize their efficacy, which may be improved through combination with radiation, chemotherapy, targeted therapies, or other immune mediators, including dual checkpoint blockade. To search for clues for addressing these challenges, this review focused on the characteristics and clinical features of long-term NSCLC survivors and the potential biomarkers of response to ICIs.

Receipt of recommended surveillance with imaging in elderly survivors of early stage non-small cell lung cancer

PurposeEarly-stage lung cancer survivorsremain at high risk for recurrence or second cancers. We measured the rates and determinants of regular surveillance imaging in early-stage non-small cell lung cancer (NSCLC) survivors. MethodsPatients (diagnosed 2001–2011) with resected stage I and II NSCLC were identified from the Surveillance Epidemiology and End Results (SEER)-Medicare linked database. Patients were censored at recurrence/second cancer diagnosis, loss to follow-up or death. Receipt of a scan during the surveillance periods of 7–18, 19–30, 31–42 and 43–60 months from date of surgery was assessed. ResultsOf 10,680 survivors assessed during the 18-month surveillance period, 71% received imaging in first 18 months. Only 56% and 43% continued to receive regular imaging by 30-month and 60-month of follow-up, respectively. Survivors were less likely to receive imaging if they were older, black, unmarried, received no adjuvant therapy, had stage I disease (vs. stage II) or were diagnosed before 2006. In adjusted analysis, survivors who received recommended imaging up to 18 months from surgery experienced better survival compared to survivors who did not (HR 0.92; 95% CI 0.85–0.99). Survival benefit was also observed in survivors who underwent regular imaging up to 5 years from surgery (HR 0.68; 95% CI 0.60–0.78). ConclusionsMore than half the lung cancer survivors received less than the recommended long-term surveillance imaging. Long-term adherence to surveillance is associated with improved survival. Our study provides evidence to support the current clinical guidelines for surveillance for lung cancer survivors that are primarily consensus-based at present.

Long-term safety and survival with gefitinib in select patients with advanced non-small cell lung cancer: Results from the US IRESSA Clinical Access Program (ICAP).

This is the first report of long-term (>10 years) safety, tolerability, and survival data on patients with non-small cell lung cancer (NSCLC) who received treatment with gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. Patients with advanced NSCLC (N = 191) who entered the IRESSA Clinical Access Program (ICAP) (June 2011 to January 2013) and had previously obtained a clinical benefit from gefitinib therapy (including patients who had received gefitinib since 2001) were analyzed for adverse events (AEs). A subset of patients (n = 79) underwent retrospective chart review to capture demographic, safety, and survival data. Seventy-five of 191 patients (39%) remained on long-term gefitinib therapy as of September 2016. Overall, serious AEs (SAEs) were reported in 64 patients (34%), the majority of which were attributed to underlying disease or comorbidities; only 3 patients (1.6%) had SAEs that were considered as possibly gefitinib-related. In the retrospective chart review cohort, 70% of patients were women; 58% were former smokers, and 30% were never-smokers; 56% were diagnosed with adenocarcinoma, and 13% were diagnosed with squamous carcinoma. Although EGFR mutational status was tested in only 17 patients (22%), it was assumed that most tumors were EGFR-mutation-positive. The median duration of gefitinib therapy was 11.1 years (7.8 years before and 3.5 years during ICAP), with 10-year and 15-year survival rates of 86% and 59%, respectively, from the initiation of therapy. A subset of long-term NSCLC survivors who were receiving gefitinib had an excellent long-term safety profile. Although it is assumed that most of these patients' tumors harbor EGFR mutations, molecular studies of available tumor specimens are planned to uncover the features that predict long-term survival. Cancer 2018;124:2407-14. © 2018 American Cancer Society.