Development of an algorithm to identify small cell lung cancer patients in claims databases

IntroductionThe treatment landscape of small cell lung cancer (SCLC) is evolving. Evidence generated from administrative claims is needed to characterize real-world SCLC patients. However, the current ICD-10 coding system cannot distinguish SCLC from non-small cell lung cancer (NSCLC). We developed and estimated the accuracy of an algorithm to identify SCLC in claims-only databases.MethodsWe performed a cross-sectional study of lung cancer patients diagnosed from 2016-2017 using the Surveillance, Epidemiology and End Results (SEER), linked with Medicare database. The analysis included two phases – data exploration (utilizing a 25% random sample) and data validation (remaining 75% sample). The SEER definition of SCLC and NSCLC were used as the gold standard. Claims-based algorithms were identified and evaluated for their sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).ResultsThe eligible cohort included 31,912 lung cancer patients. The mean age was 76.3 years, 44.6% were male, with 9.4% having SCLC and 90.6% identified as NSCLC using SEER. The exploration analysis identified potential algorithms based on treatment data. In the validation analysis of 7,438 lung cancer patients who received systemic treatment in the outpatient setting, an etoposide-based algorithm (etoposide use in 180 days following lung cancer diagnosis) to identify SCLC showed: sensitivity 95%, specificity 95%, PPV 82% and NPV 99%.DiscussionAn etoposide treatment-based algorithm showed good accuracy in identifying SCLC patients. Such algorithms can facilitate analyses of treatment patterns, outcomes, healthcare resource and costs among treated SCLC patients, thereby bolstering the evidence-base for best patient care

Correlations of EGFR mutations and increases in EGFR and HER2 copy number to gefitinib response in a retrospective analysis of lung cancer patients

<p>Abstract</p> <p>Background</p> <p>Gefitinib, a small molecule tyrosine kinase inhibitor of the Epidermal Growth Factor Receptor (<it>EGFR</it>), has shown limited efficacy in the treatment of lung cancer. Recognized clinical predictors of response to this drug, specifically female, non-smoker, Asian descent, and adenocarcinoma, together suggest a genetic basis for drug response. Recent studies have addressed the relationship between response and either sequence mutations or increased copy number of specific receptor tyrosine kinases. We set out to examine the relationship between response and the molecular status of two such kinases, <it>EGFR </it>and <it>HER2</it>, in 39 patients treated with gefitinib at the BC Cancer Agency.</p> <p>Methods</p> <p>Archival patient material was reviewed by a pathologist and malignant cells were selectively isolated by laser microdissection or manual recovery of cells from microscope slides. Genomic DNA was extracted from 37 such patient samples and exons 18–24, coding for the tyrosine kinase domain of <it>EGFR</it>, were amplified by PCR and sequenced. <it>EGFR </it>and <it>HER2 </it>copy number status were also assessed using FISH in 26 samples. Correlations between molecular features and drug response were assessed using the two-sided Fisher's exact test.</p> <p>Results</p> <p>Mutations previously correlated with response were detected in five tumours, four with exon 19 deletions and one with an exon 21 missense L858R point mutation. Increased gene copy number was observed in thirteen tumours, seven with <it>EGFR </it>amplification, three with <it>HER2 </it>amplification, and three with amplification of both genes. In our study cohort, a correlation was not observed between response and <it>EGFR </it>mutations (exon 19 deletion p = 0.0889, we observed a single exon 21 mutation in a non-responder) or increases in <it>EGFR </it>or <it>HER2 </it>copy number (p = 0.552 and 0.437, respectively).</p> <p>Conclusion</p> <p>Neither mutation of <it>EGFR </it>nor increased copy number of <it>EGFR </it>or <it>HER2 </it>was diagnostic of response to gefitinib in this cohort. However, validation of these features in a larger sample set is appropriate. Identification of additional predictive biomarkers beyond <it>EGFR </it>status may be necessary to accurately predict treatment outcome.</p

Symptoms and Experiences with Small Cell Lung Cancer: A Mixed Methods Study of Patients and Caregivers

Abstract Introduction Understanding of the patient-perceived symptom burden of small cell lung cancer (SCLC) is limited. The objective of this study was to explore patients’ experiences with SCLC, identify which treatment-/disease-related symptoms have the greatest impact on their well-being, and gain caregiver perspectives. Methods A noninterventional, cross-sectional, multimodal, mixed methods study was conducted from April–June 2021. Adult patients with SCLC and unpaid caregivers were eligible to participate. Patients’ experiences, captured via 5-day video diaries and follow-up interviews, were scored 1–10 on how bothersome the patients perceived each symptom/symptomatic adverse event. Patients indicated if they believed a symptom was disease or treatment related. Caregivers participated in an online community board. Results The study included nine patients (five with extensive-stage [ES] disease, four with limited-stage [LS] disease) and nine caregivers. Except for one patient/caregiver pairing, patients and caregivers were unmatched. The most common impactful symptoms in patients with ES-SCLC were shortness of breath, fatigue, coughing, chest pain, and nausea/vomiting; in LS-SCLC, these were fatigue and shortness of breath. Among patients with ES disease, SCLC had a high impact on physical (leisure/hobbies, work, sleep, ability to do household chores and errands/responsibilities outside home), social (family dynamics, extrafamilial social interaction), and emotional (mental health) aspects. Patients with LS-SCLC faced the long-term physical effects of treatment, financial implications, and emotional toll of an uncertain prognosis. SCLC had a high personal and psychologic burden among caregivers, whose duties consumed much of their time. Caregivers observed similar symptoms and impacts of SCLC as those reported by patients. Conclusions This study provides valuable insight into patient- and caregiver-perceived burden of SCLC and can inform the design of prospective studies. Clinicians should seek to understand patients’ opinions and priorities before making treatment decisions